Posts Tagged ‘Harvard Medical School’

The ACUITY-PCI score: Will it Replace Four Established Risk Scores — TIMI, GRACE, SYNTAX, and Clinical SYNTAX

Posted in Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, Cardiac & Vascular Repair Tools Subsegment, Cerebrovascular and Neurodegenerative Diseases, Coagulation Therapy and Internal Bleeding, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, HTN, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, PCI, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Population Health Management, Genetics & Pharmaceutical, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Statistical Methods for Research Evaluation, Stents & Tools, tagged ACS, Columbia University Medical Center, Harvard Medical School, myocardial infarction, ST elevation, TIMI on January 3, 2013| 17 Comments »

Reporter: Aviva Lev-Ari, PhD, RN

Acute Coronary Syndrome

Tool Identifies Risk in Stenting ACS Patients

By Todd Neale, Senior Staff Writer, MedPage Today

Published: November 19, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner

A new, easy-to-calculate risk score developed for patients with non-ST-segment elevation acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) had better prognostic accuracy than other widely used risk scores, researchers found.

The ACUITY-PCI risk score includes six variables — insulin-treated diabetes, renal insufficiency, baseline cardiac biomarker elevation or ST-segment deviation, presence of a bifurcation lesion, small vessel/diffuse coronary artery disease, and extent of coronary artery disease, according to Gregg Stone, MD, of Columbia University Medical Center in New York City, and colleagues.

The 1-year rate of death or MI significantly increased from 5.3% in the lowest risk tertile to 9.1% in the middle tertile to 19% in the highest tertile (P<0.001), the researchers reported in the November issue of JACC: Cardiovascular Interventions.

Discrimination and calibration were greater with the ACUITY-PCI score than with other established scores.

“Although the TIMI and the GRACE scores have been shown to be valuable prognostic tools at the time of hospital admission for selecting pharmacological strategies and identifying those patients most likely to benefit from an invasive strategy, they have not been optimized for patients undergoing PCI and, thus, have relatively poor prognostic power to further risk stratify acute coronary syndrome patients undergoing PCI,” Stone and colleagues wrote.

“The ACUITY-PCI score is therefore intended to supplement the TIMI and GRACE scores when an invasive strategy has been undertaken and PCI is being considered.”

The researchers created the risk score using data from 1,692 patients enrolled in the angiographic substudy of the ACUITY trial, which was a comparison of heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin (Angiomax) plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone in patients with ACS undergoing an early invasive strategy. They then validated the score using another 846 patients from the same study.

Multivariate analysis revealed six variables that were significantly associated with 1-year mortality and MI and were included in the score. The researchers assigned points based on the strength of the predictor:

• Insulin-treated diabetes (12 points)
• Renal insufficiency (12 points)
• Baseline cardiac biomarker elevation or ST-segment deviation (8 points)
• Bifurcation lesion (4 points)
• Small vessel/diffuse coronary artery disease (2 points)
• Extent of coronary artery disease (1 point for each 10 mm of disease)

The C-statistic for the risk score — a measure of discrimination — was 0.67 in the derivation cohort and 0.70 in the validation cohort. In the validation cohort, the chi-square statistic for calibration was 6.2 and the index of separation was 0.44.

All of those values were better than those seen for four other established risk scores — TIMI, GRACE, SYNTAX, and Clinical SYNTAX. In addition, the net reclassification improvement with the new score ranged from 9% to 38% and the integrated discrimination index varied from 1.9% to 2.7%.

The researchers noted that the ACUITY-PCI score also was a good predictor of 1-year definite or probable stent thrombosis, with a C-statistic of 0.72.

In another study in the same journal, George Dangas, MD, PhD, of Mount Sinai Medical Center in New York City, and colleagues — including Stone — reported on the development of a risk score specifically for stent thrombosis in patients with ACS undergoing PCI.

The study included 6,139 patients from the HORIZONS-AMI and ACUITY trials, which included those with ST-segment elevation MI (STEMI) in the former trial and those with non-STEMI and unstable angina in the latter. The researchers used 4,093 patients for the derivation cohort and 2,046 for the validation cohort.

The risk score included 10 variables that were significantly associated with the risk of Academic Research Consortium-defined definite or probable stent thrombosis at 1 year:

• Type of acute coronary syndrome (4 points for STEMI, 2 points for non-ST-segment elevation ACS with ST deviation, and 1 point for non-ST-segment elevation ACS without ST changes)
• Current smoking (1 point)
• Insulin-dependent diabetes (2 points)
• Prior PCI (1 point)
• Baseline platelet count (1 point for 250 to 400 K/µL and 2 points for more than 400 K/µL)
• Absence of pre-PCI heparin therapy (1 point)
• Aneurysmal/ulcerated lesion (2 points)
• Baseline TIMI flow grade 0/1 (1 point)
• Final TIMI flow grade less than 3 (1 point)
• Number of treated vessels (1 point for two vessels and 2 points for three vessels)

Scores from 1 to 6 are considered low risk, 7 to 9 are intermediate risk, and 10 or higher are high risk.

The rates of stent thrombosis at 1 year were 1.36%, 3.06%, and 9.18% across the three risk tertiles in the derivation cohort (P<0.001 for trend), with a similar trend seen in the validation cohort.

The C-statistics were 0.67 in the derivation cohort and 0.66 in the validation cohort. Performance was comparable for events occurring both early (within the first 30 days) and late (from 1 month to 1 year).

“We believe that the development and initial validation of this stent thrombosis risk score can be a useful tool for both clinical practice and future clinical investigation (future analyses of trials or registries), as it can be a simple way to risk stratify patients immediately following a procedure,” Dangas and colleagues wrote. “The risk score could also be used in the informed consent process to better inform patients of their individual risk of stent thrombosis.”

But Ron Waksman, MD, and Israel Barbash, MD, of MedStar Washington Hospital Center in Washington, D.C., noted some limitations of the tool, including the pooling of different types of patients, the exclusion of important variables associated with stent thrombosis risk, and the use of mostly first-generation drug-eluting stents in the trials.

“It is imperative that the user of such a prediction tool be aware of its capabilities and performance, as well as its limitations, in various clinical scenarios,” they wrote in an accompanying editorial.

“A newly developed risk score for stent thrombosis should be robust and should be tested across broad study populations, stents, and antiplatelet regimens. A new model should also be validated in a setting different from the one in which it was derived,” they wrote. “Unfortunately, this is not the case with the newly proposed model.”

“Until such an encompassing tool is developed and validated,” they wrote, “one should rely on the known stent thrombosis risk factors and tailor an appropriate treatment for each patient.”

The ACUITY trial was funded by The Medicines Company and Nycomed.

Stone has served as a consultant to Abbott Vascular, Boston Scientific, Medtronic, and The Medicines Company. His co-authors reported relationships with Abbott, Regado, Ortho McNeil, Janssen, Merck, Maya Medical, AstraZeneca, Sanofi/Bristol-Myers Squibb, Eli Lilly, and Daiichi Sankyo.

The HORIZONS-AMI trial was supported by the Cardiovascular Research Foundation, with grant support from Boston Scientific and The Medicines Company.

Dangas has received speaker honoraria from AstraZeneca, Bristol-Myers Squibb, The Medicines Company, sanofi-aventis, and Abbott Vascular. His co-authors reported relationships with sanofi-aventis, The Medicines Company, Abbott Vascular, Bristol-Myers Squibb, Cordis, AstraZeneca, Daiichi Sankyo, Eli Lilly, Maquet, Roche, Boehringer Ingelheim, Liposcience, Merck, Pozen, Gilead Sciences, WebMD, the NIH, Pfizer, Johnson & Johnson, Schering-Plough, Merck Sharpe and Dohme, GlaxoSmithKline, Regado Biosciences, Boston Scientific, and Bristol-Myers Squibb/Sanofi.

Waksman and Barbash reported that they had no conflicts of interest.

From the American Heart Association:

• 2011 ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention

Primary source: JACC: Cardiovascular Interventions
Source reference:
Palmerini T, et al “A new score for risk stratification of patients with acute coronary syndromes undergoing percutaneous coronary intervention: the ACUITY-PCI (Acute Catheterization and Urgent Intervention Triage Strategy-Percutaneous Coronary Intervention) risk score” JACC Cardiovasc Interv 2012; 5: 1108-1116.

Additional source: JACC: Cardiovascular Interventions
Source reference:
Dangas G, et al “Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes” JACC Cardiovasc Interv 2012; 5: 1097-1105.

Additional source: JACC: Cardiovascular Interventions
Source reference:
Waksman R, Barbash I “The appropriate use of risk scores” JACC Cardiovasc Interv 2012; 5: 1106-1107.

---

Todd Neale

Senior Staff Writer

Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University. He is based atMedPage Today headquarters in Little Falls, N.J.

SOURCE:

http://www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/36010

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Big Data in Genomic Medicine

Posted in Bio Instrumentation in Experimental Life Sciences Research, Chemical Biology and its relations to Metabolic Disease, Chemical Genetics, Computational Biology/Systems and Bioinformatics, Genome Biology, Genomic Testing: Methodology for Diagnosis, Molecular Genetics & Pharmaceutical, Personalized and Precision Medicine & Genomic Research, Population Health Management, Genetics & Pharmaceutical, Statistical Methods for Research Evaluation, Technology Transfer: Biotech and Pharmaceutical, tagged Beth Israel Deaconess Medical Center, Big data, Digital pathology, DNA, DNA Sequencing, Harvard Medical School, Jim Golden, Laboratory News on December 17, 2012| 9 Comments »

Reporter: Larry H Bernstein, MD, FCAP

Image Source: Created by Noam Steiner Tomer 7/31/2020

Pathologists May Be Healthcare’s Rock Stars of Big Data in Genomic Medicine’s ’Third Wave’

Category: Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations

Published: December 17 2012

Pathologists are positioned to be the primary interpreters of big data as genomic medicine further evolves

Pathologists and clinical laboratory managers may be surprised to learn that at least one data scientist has proclaimed pathologists the real big data rock stars of healthcare. The reason has to do with the shift in focus of genomic medicine from therapeutics and presymptomatic disease assessment to big data analytics.

In a recent posting published at Forbes.com, data scientist Jim Golden heralded the pronouncement of Harvard pathologist Mark S. Boguski, M.D., Ph.D., FACM. He declared that “The time of the $1,000 genome meme is over!”

DNA Sequencing Systems and the $1,000 Genome

Golden has designed, built, and programmed DNA sequencing devices. He apprenticed under the Human Genome program and spent 15 years working towards the $1,000 genome. “I’m a believer,” he blogged. “[That’s] why I was so intrigued [by Boguski’s remarks].

Boguski is Associate Professor of Pathology at the Center for Biomedical Informatics at Harvard Medical School and the Department of Pathology at Beth Israel Deaconess Medical Center. It was in a presentation at a healthcare conference in Boston that Boguski pronounced that it is time for the $1,000 genome to go.

Both Golden and Boguski acknowledged the benefits generated by the race to the $1,000 genome. Competition to be first to achieve this milestone motivated scientists and engineers to swiftly drive down the cost of decoding DNA. The result was a series of advances in instrumentation, chemistry, and biology.

Pathologists and Big Data Analytics

“Our notions about how genome science and technology would improve health and healthcare have changed,” Boguski wrote in an editorial published at Future Medicine. He then noted that the focus has shifted to big data analytics.

In the editorial, Boguski described the phases of development of genomic medicine as “waves.” The first wave occurred during the mid- to late-1990s. It focused on single- nucleotide polymorphisms (SNP) and therapeutics.

Medical Laboratories Have Opportunity to Perform Presymptomatic Testing

The second wave focused on presymptomatic testing for disease risk assessment and Genome Wide Association Studies (GWAS). Researchers expected this data to help manage common diseases.

The first two waves of medical genomics were conducted largely by the pharmaceutical industry, as well as with  primary care and public health communities, according to Boguski. Considerable optimism accompanied each wave of medical genomics.

“Despite the earlier optimism, progress in improving human health has been modest and incremental, rather than paradigm-shifting,” noted Boguski, who wrote that,to date, only a handful of genome-derived drugs have reached the market. He further observed that products such as direct-to-consumer genomic testing have proved more educational and recreational than medical.

“Third Wave” of Genomic Medicine

It was rapid declines in the cost of next-generation DNA sequencing technologies that now has triggered the third wave of genomic medicine. Its focus is postsymptomatic genotyping for individualized and optimized disease management.

“This is where genomics is likely to bring the most direct and sustained impact on healthcare for several reasons,” stated Boguski. “Genomics technologies enable disease diagnosis of sufficient precision to drive both cost-effective [patient] management and better patient outcomes. Thus, they are an essential part of the prescription for disruptive healthcare reform.”

Boguski reiterated the case for the value of laboratory medicine. He stated the following critical—but often overlooked—points, each of which is familiar to pathologists and clinical laboratory managers:

1. Pathologist-directed, licensed clinical laboratory testing has a major effect on clinical decision-making.

2. Medical laboratory testing services account for only about 2% of healthcare expenditures in the United States.

3. Medical laboratory services strongly influence the remaining 98% of costs through the information they provide on the prevention, diagnosis, treatment, and management of disease.

Molecular Diagnostics Reaching Maturity for Clinical Laboratory Testing

“Genome analytics are just another technology in the evolution of molecular diagnostics,” Boguski declared in his editorial.

Read more: Pathologists May Be Healthcare’s Rock Stars of Big Data in Genomic Medicine’s ’Third Wave’ | Dark Daily http://www.darkdaily.com/pathologists-may-be-healthcare%e2%80%99s-rock-stars-of-big-data-in-genomic-medicines-third-wave-1217#ixzz2FL24IRAA

English: Created by Abizar Lakdawalla. (Photo credit: Wikipedia)

English: Workflow for DNA nanoball sequencing (Photo credit: Wikipedia)

DNA sequence (Photo credit: Wikipedia)

Big Data: water wordscape (Photo credit: Marius B)

Related articles

• Digital Pathology Market Expected to Reach $336.6 Million at a CAGR of 12% from 2012 to 2017 by MarketsandMarkets (prweb.com)
• Response to UK’s Plan to sequence genomes of 100,000 Cancer Patients (grosenfeld.wordpress.com)
• The Fast Changing Landscape of Sequencing Technologies and Their Impact on Microbial Genome Assemblies and Annotation (plosone.org)
• Stanford to rival Broad Institute with Big Data-focused genomics center (fiercebiotechit.com)
• New Method To Directly Sequence Small Genomes Without Library Preparation (medicalnewstoday.com)
• Three Big Themes from the Personalized Medicine Conference (xconomy.com)
• NIH Grant Moves Pathologists to the Forefront of Genomic Medicine (prweb.com)
• Tool developed to evaluate genome sequencing method (rdmag.com)
• Big Data To Become Powerful Driver Of IT Spending – Gartner (misco.co.uk)
• Video: DDN Powers Genomics at the Virginia Bioinformatics Institute (insidehpc.com)

Comment & Response

Right now the cost of the testing and the turnaround times are not favorable. It is going to take a decade or more for clinical labs to catch up. For some time it will be send out tests to Quest, LabCorp, and State or University lab consortia.

The power of the research technology is pushing this along, but for Personalized Medicine the testing should be coincident with the patient visit, and the best list of probable issues should be accessible on the report screen. The EHR industry is dominated by 2 companies that I see have no interest in meeting the needs of the physicians. The payback has to be on efficient workflow, accurate assessment of the record, and timely information. The focus for 25 years has been on billing structure. But even the revised billing codes (ICD10) can’t be less than 5 years out-of-date because of improvements in the knowledge base and improvements in applied math algorithms.

The medical record still may have information buried min a word heap, and the laboratory work is a go-to-you know where sheet with perhaps 15 variables on a page, with chemistry and hematology, immunology, blood bank, and microbiology on separate pages. The ability of the physician to fully digest the information with “errorless” discrimination is tested, and the stress imposed by the time for each patient compromises performance. There is work going on in moving proteomics along to a high throughput system for improved commercial viability, that was reported by Leigh Anderson a few years ago. The genomics is more difficult, but the genomics is partly moving to rapid micropanel tools.

In summary, there are 3 factors:

1. Automation and interpretation
2. Integration into the EHR in real time and usable by a physician.
3. The sorting out of the highest feature “predictors” and classifying them into clinically meaningful sets and subsets.

When this is done, then the next generation of recoding will be in demand.
The Automated Malnutrition Assessment
Gil David1, Larry Bernstein2, Ronald R. Coifman1

1Department of Mathematics, Program in Applied Mathematics,
Yale University, New Haven, CT 06510, USA,
2Triplex Consulting, Trumbull, CT 06611

Abstract

Introduction: We propose an automated nutritional assessment (ANA) algorithm that provides a method for malnutrition risk prediction with high accuracy and reliability.

Materials and Methods: The database used for this study is a file of 432 patients, where each patient is described by 4 laboratory parameters and 11 clinical parameters. A malnutrition risk assessment of low (1), moderate (2) or high (3) was assigned by a dietitian for each patient. An algorithm for data organization and classification via characteristic metrics is proposed. For each patient, the algorithm characterizes its unique profile and builds a characteristic metric to identify similar patients who are mapped into a classification.

Results: The algorithm assigned a malnutrition risk level for each patient based on different training sizes that were taken out of the data.

Our method resulted in an average error (distance between the automated score and the real score) of 0.386, 0.3507, 0.3454, 0.34 and 0.2907 for 10%, 30%, 50%, 70% and 90% training sizes, respectively.

Our method outperformed the compared method even when our method used a smaller training set then the compared method. In addition, we show that the laboratory parameters themselves are sufficient for the automated risk prediction and organize the patients into clusters that correspond to low, low-moderate, moderate, moderate-high and high risk areas.

Discussion: The problem of rapidly identifying risk and severity of malnutrition is crucial for minimizing medical and surgical complications. These are not easily performed or adequately expedited. We characterize for each patient a unique profile and map similar patients into a classification. We also find that the laboratory parameters themselves are sufficient for the automated risk prediction.

Keywords: Network Algorithm, unsupervised classification, malnutrition screening, protein energy malnutrition (PEM), malnutrition risk, characteristic metric, characteristic profile, data characterization, non-linear differential diagnosis.

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Highlights from 8th Annual Personalized Medicine Conference, November 28-29, 2012, Harvard Medical School, Boston, MA

Posted in Interviews with Scientific Leaders, Personalized and Precision Medicine & Genomic Research, tagged Aviva Lev-Ari, Biology, Doctor of Philosophy, genetics, Harvard Medical School, Michael Snyder, PerkinElmer, Personalized medicine on November 24, 2012| 4 Comments »

Highlights from 8^th Annual Personalized Medicine Conference, November 28-29,  2012, Harvard Medical School, Boston, MA — Method used “Tweets Content Analysis”

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #5: Highlights from 8th Annual Personalized Medicine Conference, November 28-29, 2012, Harvard Medical School, Boston, MA. Published on 11/24/2012

WordCloud Image Produced by Adam Tubman

 

• Patents have the potential to prevent folks from getting into next generation sequencing

 

 

 

• Audience poll: 75% think a hypothetical cancer diagnostic is patentable, but the number plummets to 25% if that Dx is DNA-based.

 

 

 

• 30% of #PMConf audience says lack of physician education & awareness is biggest obstacle to adoption of #personalizedmedicine in the clinic

 

 

 

• 30% of #PMConf audience says lack of physician education & awareness is biggest obstacle to adoption of #personalizedmedicine in the clinic

 

 

 

• Cost of informatics can be a bottleneck, but technology pushes boundaries & advances

 

 

 

• “next generation sequencing will become the sole platform for molecular diagnostics”

 

 

 

• Personalized medicine evolving into personalized health with addition of prevention & detection

 

 

 

• 56% of #PMConf audience thinks that DNA sequence will become a routine part of an individual’s medical record within the next 10 years

 

 

 

• Programs @AmerMedicalAssn are being developed to support physicians as genetic medicine is put into practice

 

 

 

• “#personalizedmedicine is the solution to the healthcare cost challenge that we all face”

 

 

 

• “We have the ability and the technology. It just needs to be applied appropriately”

 

 

 

 

 

• Information is only going to grow & change over time. We’ll always be interpreting our genomes

 

 

 

• audience comment on need to adjust insurance system to use genetic info, encourage prevention and disease management

 

 

 

• We need to be cognizant of how economics can affect the delivery of healthcare

 

 

 

• John Lauerman, reporter @BloombergNews comments on his diagnosis with the JAK-2 gene variation and benefits of #genomesequencing

 

 

 

• Joe Beery @LIFECorporation shares the “medical odyssey” of his children and his personal experience with #rarediseases

 

 

 

• Dr. Michael Snyder @SUMedicine discusses #genomics integration into medicine, may lead to a shift to predictive healthcare

 

 

 

• Audience poll: 75% think clinical whole-genome sequencing useful in select situations only (vs say standard for all…

 

 

 

• 75% of attendees think #personalizedmedicine is being built into medical practice

 

 

 

• Dr. Jeffrey Filer @harvardmed discusses key impacts of #personalizedmedicine across multiple disease areas

 

 

 

• After 10 years of the genomic revolution, #genomics is entering clinical medicine at an accelerated rate

 

SELECTIVE Live TWEETS from the conference are recorded below:

Tweets

PM Conference ‏@HarvardPMConf

David Resnick (@NixonPeabodyLLP): Patents have the potential to prevent folks from getting into next generation sequencing #PMConf#NGS

 

6mPM Conference ‏@HarvardPMConf

David Resnick @NixonPeabodyLLP & Laura Coruzzi @JonesDaydiscuss Myriad gene patent case @ #PMConf

7mBio-IT World ‏@bioitworld

Audience poll: 75% think a hypothetical cancer diagnostic is patentable, but the number plummets to 25% if that Dx is DNA-based. #PMConf

7mPM Conference ‏@HarvardPMConf

RT @nixonpeabodyllp: We’ll be live tweeting the next hour of the@HarvardPMConf. NP’s David Resnick talking #genetics & law.#PMConf…

 

12mPM Conference ‏@HarvardPMConf

Dr. Bob Tepper (Third Rock) introduces panelists from @JonesDay@NixonPeabodyLLP @kpcb for a discussion on genetics & the law#PMConf

28mPM Conference ‏@HarvardPMConf

Dr. Joshi (@Oracle) – Clinicians must communicate w/ researchers to faithfully implement standards & avoid redundant infrastructures#PMConf

39mPM Conference ‏@HarvardPMConf

30% of #PMConf audience says lack of physician education & awareness is biggest obstacle to adoption of #personalizedmedicinein the clinic

41mPM Conference ‏@HarvardPMConf

Joshi (@Oracle) – Cost of informatics can be a bottleneck, but technology pushes boundaries & advances #personalizedmedicine#PMConf

 

48mPM Conference ‏@HarvardPMConf

Trevor Hawkins (@SiemensHealth) says “next generation sequencing will become the sole platform for molecular diagnostics” #PMConf

 

56mThe Age of PM ‏@AgeofPM

Kevin Hrusovsky @PerkinElmer Personalized medicine evolving into personalized health with addition of prevention & detection #PMConf

 Retweeted by PM Conference

 

1hPM Conference ‏@HarvardPMConf

56% of #PMConf audience thinks that DNA sequence will become a routine part of an individual’s medical record within the next 10 years

1hPM Conference ‏@HarvardPMConf

Kris Joshi @Oracle_at_HIMSS comments on the likely transformation of healthcare into a truly global network #PMConf

 

1hPM Conference ‏@HarvardPMConf

Beginning now: panel discussion on “Business Models for Use of Genetic Information,” moderated by Dr. Brophy of @GEHealthcare#PMConf

 

2hPM Conference ‏@HarvardPMConf

Dr. Scott says “In next 10-20 yrs, anyone in any developed healthcare system will have access to #genomesequencing“#PMConf

 

2hPM Conference ‏@HarvardPMConf

RT @bioitworld: Randy Scott: It’s Metcalfe’s Law on network effect — not Moore’s Law — that drove computing boom, and will by…

 

2hPM Conference ‏@HarvardPMConf

Dr. Randall Scott (@Genomic_Health & InVitae Corporation): “Every disease is a rare disease & #genomics will help us prove this”#PMConf

 

2hPM Conference ‏@HarvardPMConf

Ed Abrahams & Stafford O’Kelly (PMC) present Award for Leadership in #PersonalizedMedicine to Randall Scott (InVitae Corporation) at#PMConf

 

3hThe Age of PM ‏@AgeofPM

Panel highlights need for drug developers to collaborate with Dx companies & build partnerships throughout development process.#PMConf

 Retweeted by PM Conference

 

3hPM Conference ‏@HarvardPMConf

Pharma engaging in solid partnerships w/ FDA to try new approaches to #drugdevelopment, says Dr. Yancopoulos #PMConf

 

3hPM Conference ‏@HarvardPMConf

Dr. Hakan Sakul @pfizer_news begins Q&A session, asking about changing attitudes of the use of #genetics in #drugdevelopment#PMConf

 

3hPM Conference ‏@HarvardPMConf

Dr. Yancopoulos @ Regeneron Pharma comments that the ability to humanize mouse models has had great impact on#drugdevelopment #PMConf

 

3hPM Conference ‏@HarvardPMConf

Michael Streit @GSKUS: “One size does not fit all. Thinking beyond one pathway mutation is necessary to help #cancer patients”#PMConf

 

3hPM Conference ‏@HarvardPMConf

Jeff Leiden @VertexPharma on Genetics & #DrugDevelopment panel @ #PMConf “Need to think about diff molecules to treat specific disease”

 

4hThe Age of PM ‏@AgeofPM

Biggest barrier to widespread use of genetics in drug dvlpmt: 29% say attitude of drug dvlprs, 22% say regulatory considerations#PMConf

Retweeted by PM Conference

 

3hPM Conference ‏@HarvardPMConf

Audience poll at #PMConf: 84% say #genetics is making a meaningful impact on #drugdevelopment

 

4hPM Conference ‏@HarvardPMConf

Heidi Rehm @PartnersNews @harvardmed expresses need for more communication btw physicians & scientists in world of genomic analysis #PMConf

 

4hThe Age of PM ‏@AgeofPM

Jon Retzlaff explains @AACR work to advance#personalizedmedicine, including Cancer Biomarkers Collaborative w/ @theNCI @US_FDA #PMConf

Retweeted by PM Conference

 

4hPM Conference ‏@HarvardPMConf

Programs @AmerMedicalAssn are being developed to support physicians as genetic medicine is put into practice #PMConf – Katie Johansen Taber

5hPM Conference ‏@HarvardPMConf

Randy Burkholder @PhRMA – “#personalizedmedicine is the solution to the healthcare cost challenge that we all face” #PMConf

 

5hPM Conference ‏@HarvardPMConf

Joe Beery (@LIFECorporation): “We have the ability and the technology. It just needs to be applied appropriately” #PMConf

 

5hPM Conference ‏@HarvardPMConf

Dr. Snyder @SUMedicine: Information is only going to grow & change over time. We’ll always be interpreting our genomes#PMConf

 

5hThe Age of PM ‏@AgeofPM

Beery agrees w/ audience comment on need to adjust insurance system to use genetic info, encourage prevention and disease management #PMConf

 Retweeted by PM Conference

 

5hPM Conference ‏@HarvardPMConf

Dr. Holmes Morton (The Clinic for Special Children): We need to be cognizant of how economics can affect the delivery of healthcare#PMConf

 

5hPM Conference ‏@HarvardPMConf

John Lauerman, reporter @BloombergNews comments on his diagnosis with the JAK-2 gene variation and benefits of#genomesequencing #PMConf

 

5hPM Conference ‏@HarvardPMConf

Joe Beery @LIFECorporation shares the “medical odyssey” of his children and his personal experience with #rarediseases at #PMConf

 

6hPM Conference ‏@HarvardPMConf

Dr. Michael Snyder @SUMedicine discusses #genomics integration into medicine, may lead to a shift to predictive healthcare #PMConf

 

6hPM Conference ‏@HarvardPMConf

RT @bioitworld: Audience poll: 75% think clinical whole-genome sequencing useful in select situations only (vs say standard for all…

 

6hPM Conference ‏@HarvardPMConf

Dr. Stephen Eck of @AstellasUS begins a panel discussion on the impact of #genomesequencing #PMConf

 

6hPM Conference ‏@HarvardPMConf

Dr. Kucherlapati @harvardmed polls #PMConf audience: 75% of attendees think #personalizedmedicine is being built into medical practice

 

6hPM Conference ‏@HarvardPMConf

Dr. Jeffrey Filer @harvardmed discusses key impacts of#personalizedmedicine across multiple disease areas #PMConf

 

6hPM Conference ‏@HarvardPMConf

Dr. Weiss @PartnersNews: After 10 years of the genomic revolution,#genomics is entering clinical medicine at an accelerated rate#PMConf

 

Conference Introduction

The past few years have witnessed a revolution in the understanding of health and disease, brought on in large part by the sequencing of the human genome and the creation of a map of human genetic variation. Personalized medicine is the translation of this knowledge to patient care by using genetic and genomic information in diagnosis, prognosis and treatment. The goal of personalized medicine is to provide the right diagnosis and treatment to the right patient at the right time at the right cost. Already there are abundant examples that personalized medicine is poised to transform healthcare by offering the possibility of improved health outcomes and the potential to make healthcare more cost-effective.

The eighth annual Personalized Medicine conference will take place November 28-29, 2012 at The Joseph B. Martin Conference Center at Harvard Medical School in Boston. This year’s two-day conference will once again bring the most current updates on Personalized Medicine and how recent experience may guide and inform the policies, plans and actions of stakeholders among government, academe and the private sector. Widely considered the premier event in the field, the conference attracts over 600 national and international thought leaders.

The conference reflects a distinctive collaboration of the Partners HealthCare Center for Personalized Genetic Medicine, Harvard Medical School and Harvard Business School. The alliance of these renowned academic enterprises presents an exceptional opportunity to address the integrating of medicine and business in facilitating personalized medicine.

PROGRAM

Wednesday, November 28, 2012
7:00 a.m.	Registration and Continental Breakfast
8:00 a.m.	Welcome & Opening Remarks	Raju Kucherlapati, Ph.D. Paul C. Cabot Professor of Genetics, Professor of Medicine, Harvard Medical School Scott Weiss, M.D., M.S. Scientific Director, Partners HealthCare Center for Personalized Genetic Medicine; Associate Director, Channing Laboratory; Professor of Medicine, Harvard Medical School Jeffrey Flier, M.D. Dean of the Faculty of Medicine, Harvard Medical School Introducer:  Jeffrey Leerink Chair and CEO, Leerink Swann LLC
8:30 a.m.	Panel: Impact of Genome Sequencing on Health Human genome sequencing promises to be an important tool in assessing risk, diagnosing disease and stratifying patient populations for targeted therapy.  The panelists will describe some personal experiences of receiving sequence information and talk about how this rapidly growing technology is transforming medical practice.	Moderator: Stephen Eck, M.D., Ph.D. Vice President, Global Head of Medical Oncology, Astellas Pharma Global Development, Inc. Joe Beery Senior Vice President & Chief Information Officer, Life Technologies John Lauerman Reporter-at-Large, Bloomberg News D. Holmes Morton, M.D. Clinic Director, The Clinic for Special Children Michael Snyder, Ph.D. Stanford University School of Medicine
9:45 a.m.	Perspectives From Professional Organizations	Randy Burkholder Deputy Vice President, Policy Pharmaceutical Research and Manufacturers of America (PhRMA) Heidi Rehm, Ph.D., FACMG Director, Laboratory for Molecular Medicine, Partners HealthCare Center for Personalized Genetic Medicine; Assistant Professor of Pathology, Harvard Medical School Jon Retzlaff Managing Director, Office of Science Policy & Government Affairs, American Association for Cancer Research (AARC) Katherine Johansen Taber, Ph.D. Senior Scientist, American Medical Association
10:15 a.m.	Networking Break
11:00 a.m.	Speakers: Genetic Basis for Drug Development Many drug developers are beginning to successfully use genetic information and genetic markers in drug development.  This panel will provide perspectives from three different companies on how they have used and are using genetic information in successful drug development.	Moderator:  Hakan Sakul, Ph.D. Executive Director, Head of Diagnostics, Worldwide R&D, Clinical Research and Precision Medicine, Pfizer, Inc. Jeffrey Leiden, M.D., Ph.D. President & CEO, Vertex Pharmaceuticals Michael Streit, M.D., M.B.A. Executive Director, GlaxoSmithKline-Oncology George D. Yancopoulos, M.D., Ph.D. President, Research Laboratories and  Chief Scientific Officer , Regeneron Pharmaceuticals, Inc.
12:00 noon	Presentation of Personalized Medicine Coalition’s Eighth Annual Award for Leadership in Personalized Medicine	Award Recipient: Randall Scott, Ph.D. Founder and Director, Genomic Health, CEO, InVitae Corporation Introduction:  Edward Abrahams, Ph.D. President, Personalized Medicine Coalition Presenter: D. Stafford O’Kelly Chairman of the Board, Personalized Medicine Coalition
12:30 p.m.	Luncheon
1:45 p.m.	Panel: Business Models for Use of Genetic Information The discussion should highlight new business opportunities for large companies, such as the three represented on the panel and for small businesses in the services and IT sectors.	Moderator:  Ger Brophy, Ph.D.General Manager, New Product Development, Medical Diagnostics, GE Healthcare Kris Joshi, Ph.D. Global Vice President, Healthcare Strategy, Oracle Trevor Hawkins, Ph.D. Chief Strategy Officer, Siemens Healthcare Diagnostics Kevin Hrusovsky President of Life Sciences & Technology, PerkinElmer
2:45 p.m.	Conversation: Genetics and the Law There are conflicting views regarding Intellectual Property for genetic tests.  The panel will offer opposing views on prominent recent litigation and consider how investors see the impact of the legal decisions.	Moderator: Robert Tepper, M.D. Partner, Third Rock Ventures Laura Coruzzi, Ph.D., J.D. Partner, Jones Day David Resnick, Esq. Partner, Co-Leader Patents, Nixon Peabody Risa Stack, Ph.D. Partner, Kleiner Perkins Caufield & Byers
3:45 p.m.	Networking Break
4:15 p.m.	Panel: International  Commitments to Personalized Medicine Many countries are considering and developing plans to implement the principles of personalized medicine.  Are there lessons from these efforts that the U.S. can learn from?  How can we make personalized medicine a world-wide effort?	Moderator: Jeffrey Elton, Ph.D. Managing Director, Accenture Prof. Abraham Israeli, M.D., M.P.H., M.B.A. Chief Scientist of the Ministry of Health, Head, Department of Health Policy, Health Care Management and Health Economics, Hebrew University – Hadassah Faculty of Medicine; Professor, Hewbrew University – Hadassah School of Public Health, Jerusalem, Israel Michael Hayden, M.D., Ph.D. Director and Senior Scientist, Center for Molecular Medicine and Therapeutics, University of British Columbia, Canada Prof. Ola Myklebost, Ph.D. Senior Scientist and Group Leader, Department of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Norway Ming Qi, Ph.D.Professor, Zhejiang UniversitySchool of Medicine, China
5:15 p.m.	Reception at Elements Café
Thursday, November 29, 2012
7:30 a.m.	Registration & Continental Breakfast
8:30 a.m.	Keynote	William Hait, M.D., Ph.D. Global Head of Janssen R&D, Johnson & Johnson Introducer: John Niederhuber, M.D. Professor of Oncology & Surgery, Johns Hopkins University School of Medicine; Former Director of the National Cancer Institute; Executive Vice President, Inova Health System; CEO, Inova Translational Medicine Institute
9:00 a.m.	Panel: Genetics in Medical Practice Each institution represented in this panel is making efforts to bring personalized medicine to their patients What are the different approaches that are being used? How are they evolving? What kinds of investments are necessary to build these enterprises? How do these efforts inform us about the progress of personalized medicine?	Moderator: M. Kathleen Behrens Wilsey, Ph.D. President & CEO, KEW Group Joe Vockley, Ph.D. Chief Operating Officer, Chief Scientific Officer Inova Translational Medicine Institute A. John Iafrate, M.D., Ph.D. Associate Chief of Pathology, Massachusetts General Hospital, Center for Integrated Diagnostics Mia Levy, M.D., Ph.D. Assistant Professor of Biomedical Informatics, Assistant Professor of Medicine, Cancer Clinical Informatics Officer, Vanderbilt Ingram Cancer Center
10:00 a.m.	Networking Break
10:30 a.m.	Panel: Molecular Diagnostics and Public Policy Will bringing molecular diagnostics into routine practice require bringing together many interest groups and educating and informing regulatory and legislative bodies about the importance of personalized medicine and the need for policy change? What changes are needed? How and by whom the views can best be presented to policy makers and legislators?	Moderator: Amy Miller, Ph.D. Vice President, Public Policy, Personalized Medicine Coalition Alan Mertz President, American Clinical Laboratory Association Richard Naples Sr. Vice President, Regulatory Affairs, BD Biosciences Paul Radensky, M.D. Partner, McDermott Will & Emery
11:30 a.m.	Ethical Aspects of Whole Genome Sequencing	Lisa Lee, Ph.D., M.S. Executive Director, Presidential Commission for the Study of Bioethical Issues Robert Green, M.D., M.P.H. Associate Professor of Medicine, Division of Genetics, Brigham and Women’s Hospital and Harvard Medical School; Associate Director for Research, Partners HealthCare Center for Personalized Genetic Medicine
12:00 noon	Bag Lunch	Open Seating
1:00 p.m.	Conversation: Decision Making in the Development of Zelboraf Roche and Plexxicon collaborated in developing a targeted therapy for a subset of melanoma patients.  How did the two companies decide to collaborate?  What were the mechanics of the collaboration?  How did the submission of a NDA with a companion diagnostic come about?  What lessons can be drawn from this experience?	K. Peter Hirth, Ph.D. CEO, Plexxikon Suzanne Cheng, Ph.D. Director, Genomics & Oncology Research, Roche Molecular Systems, Inc. Raju Kucherlapati, Ph.D. Paul C. Cabot Professor of Genetics, Professor of Medicine, Harvard Medical School
1:45 p.m.	Keynote	Lt. Col.  Cecili K. Sessions, M.D., M.P.H., FAAP Chief, AFMS Personalized Medicine, Air Force Medical Support Agency (AFMSA), Medical Research &  Innovations (SG5I) Introducer: Heidi Rehm, Ph.D., FACMG Director, Laboratory for Molecular Medicine, Partners HealthCare Center for Personalized Genetic Medicine; Assistant Professor of Pathology, Harvard Medical School
2:15 p.m.	Industry Study on Interpretation	Anthony Flynn Chief Marketing Officer, Director of Healthcare Strategy and Commercialization, GenomeQuest
2:20 p.m.	Interactive Case Study on Business Strategies for Personalized Medicine Case: Companion Diagnostics: Uncertainties for Approval and Reimbursement	Richard Hamermesh, D.B.A. MBA Class of 1961 Professor of Management Practice, Faculty Chair, HBS Healthcare Initiative, Harvard Business School Norman Selby Executive Chairman, Physicians Interactive Inc. and Real Endpoints llc
3:35 p.m.	Closing Remarks	Raju Kucherlapati, Ph.D. Paul C. Cabot Professor of Genetics, Professor of Medicine, Harvard Medical School

SPEAKERS

Joe Beery Joe Beery is Chief Information Officer for Life Technologies and served the same role at Invitrogen since September 2008. Prior to Invitrogen, Mr. Beery held the executive position of Chief Information Officer at US Airways and America West Airlines. Previously, Mr. Beery spent ten years at Motorola Semiconductor, holding various positions in the computer integrated manufacturing group. Mr. Beery also served as a manufacturing and software engineer at NV Philips in Albuquerque, N.M. Mr. Beery holds a B.S. in business administration and business computer systems from the University of New Mexico.

 

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Ger Brophy, Ph.D. Ger Brophy, Ph.D. is General Manager, New Product Development at GE Healthcare Medical Diagnostics. In this role, Ger is responsible for the overarching R&D strategy encompassing in vivo and in vitro diagnostic technologies, with oversight of discovery (research) and clinical development; regulatory and medical affairs; project and portfolio management; product acquisition and licensing; R&D efficiency projects and collaborations across GE. Previously, Ger led Strategic Planning & Licensing within Medical Diagnostics business. He was centrally involved in the expansion of the business into the Personalized Medicine space through inorganic and organic investments in in vitro diagnostics and pathology. Ger joined GE Healthcare through the acquisition of Amersham in 2004. Before joining the Medical Diagnostics business, Ger ran the Life Sciences Advanced Systems business in Sweden. The focus on that business was in the commercialization of improved tools for drug discovery. In that capacity he lead an R&D group of 200 researchers developing new products and services used in academia and Pharma to better understand disease. Ger began his career in R&D developing high throughput drug screening tools. He advanced to become Development Director for Amersham’s Bioassay’s business unit, leading a group of 60 people. Within GE Healthcare he has held positions in Licensing, Business Development and R&D. Ger has had international assignments in the UK, Sweden and in Chicago & New Jersey. He relocated to New Jersey in August 2009. Ger holds a Ph.D. in Molecular Biology.

 

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Randy Burkholder Randy Burkholder is Deputy Vice President of Policy at the Pharmaceutical Research and Manufacturers of America. Mr. Burkholder directs PhRMA work on issues related to use of evidence in healthcare decision-making, health technology assessment, comparative and cost-effectiveness research, Medicare coverage policy, and innovation and personalized medicine. Mr. Burkholder represents PhRMA at federal agencies and advisory bodies including the Medicare Evidence Development and Coverage Advisory Committee, the Federal Coordinating Council for Comparative Effectiveness Research, Institute of Medicine Committees, and President’s Council of Advisors on Science and Technology. He also is a founding member of the Board of Directors of the Personalized Medicine Coalition and serves on the Steering Committee of the Partnership to Improve Patient Care. Mr. Burkholder has over 17 years experience in health care policy, advocacy and communications in the medical technology and pharmaceutical industries. Prior to joining PhRMA, Mr. Burkholder was Associate Vice President for Public Affairs at AdvaMed, the leading association of the medical device and diagnostics industries.

 

Suzanne Cheng, Ph.D. Suzanne Cheng, Ph.D. is currently a Director in the Genomics and Oncology Research Department at Roche Molecular Systems, overseeing several assay teams that support the early development of companion diagnostic assays in oncology. She was the IVD Lead for vemurafenib, a targeted therapy for treatment of patients with BRAF V600E mutation-positive metastatic or inoperable melanoma that was approved in 2011 together with a companion diagnostic, the cobas® 4800 BRAF V600 Mutation Test. She has experienced first-hand the challenges of drug and diagnostic co-development from early development through to successful FDA approvals. Prior to joining Genomics and Oncology, Dr. Cheng was a member of the Human Genetics Department, contributing to the development of long PCR technology and the evaluation of genetic predisposition markers for the development and progression of cardiovascular disease. She received her degree from the University of California, Berkeley.

 

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Laura Coruzzi, Ph.D., J.D. Laura Coruzzi, Ph.D., J.D. has represented clients in biotechnology and pharmaceuticals for close to 30 years. Prior to joining Jones Day, she practiced at Pennie & Edmonds LLP and was one of the first members of that firm’s biotechnology group founded by S. Leslie Misrock, affectionately known as the “father of biotechnology patent law.” Laura’s practice has evolved with the patent laws and matured with the needs of the biotechnology and pharmaceutical industries. Her practice involves all aspects of patent law as it relates to a variety of disciplines in the life sciences, including genetic engineering, molecular biology, virology, vaccines, immunology, therapeutic antibodies, biologic and small molecule therapeutics, diagnostics, drug discovery, and drug delivery. Laura’s patent procurement practice focuses on strategic planning and management of patent portfolios designed to protect emerging new technologies as well as mature biologic and pharmaceutical therapeutics and diagnostics. She counsels clients on portfolio evaluation, due diligence investigations, patent prosecution and interferences, European oppositions, and licensing. Laura’s practice also encompasses patent litigation and appeals before the USPTO Board of Appeals and the Federal Circuit. She is a member of the Jones Day team representing Myriad in Association for Molecular Pathology v. Myriad Genetics (2011) upholding the patent-eligibility of isolated human genes. Prior to joining Jones Day, she and her team won reversal of an $18 million jury verdict in 2000 for Cadus Pharmaceutical Corporation in a case involving cell-based assays for drug screening. Laura is frequently invited to speak at symposia on patent law issues related to life sciences.

 

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Stephen Eck, M.D., Ph.D. Stephen Eck, M.D., Ph.D is Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma Global Development (Headquartered in Northbrook, IL). He is directly responsible for the oversight of oncology drug development plans. Much of this work is focused on special cancer populations for which unique biology enables the development of personalized cancer therapies. Dr. Eck previously served as Vice President, Translational Medicine & Pharmacogenomics at Eli Lilly and Company (2007-2011) where he was responsible for the clinical pharmacology components of drug development including both early phase clinical studies and late stage drug development studies.  His group also developed the biomarkers and companion diagnostics needed for effective decision-making and for tailoring therapeutics to the right patient population.  An essential part of this work was conducted in the Diagnostic and Experimental Medicine Group and the Laboratory for Experimental Medicine. Prior to Joining Lilly, Dr. Eck served in a variety of drug development leadership roles at Pfizer, Inc (2002-2007). Dr. Eck is a board certified Hematologist/Oncologist with broad drug development experience in Oncology and Neuroscience. He is a Fellow of the American Association for the Advancement of Science. He serves on the Scientific Advisory Board of the ACGT Foundation, which supports academic cancer research, and is a member of the Scientific Advisory Committee of the Fairbanks Institute, an institution dedicated to developing data banks to enable personalized medicine. He also serves on the Advisory Board of the Keck Graduate School (Claremont, CA), and is a Board member of the Personalized Medicine Coalition.

 

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Jeffrey Elton, Ph.D. Jeff Elton, Ph.D. is Managing Director in Life Sciences in Accenture. Jeff has over 20 years of experience as a global executive and consultant in the biopharmaceutical and healthcare sectors. Jeff serves clients in pharmaceutical, biopharmaceutical, and health provider sectors. Jeff also co-leads Accenture’s pilot initiative in the application of health data analytics to pharmaceutical managed markets, commercial, and clinical development analytics. Recently, Jeff was founding CEO of a Personalized Oncology Company, and Board member and senior advisor to four early stage companies in protein therapeutics, diabetes, oncology therapeutics, and oncology diagnostics. From 2004 through 2009, Jeff served as Senior Vice President of Strategy and Global Chief Operating Officer at Novartis Institutes of BioMedical Research, Inc. (NIBR) in Cambridge, MA. He led the definition of therapeutic area strategies, formed strategic partnerships, and oversaw global operations in the US, Europe, and Asia. Prior to Novartis, Jeff was a senior partner with McKinsey & Company for pharmaceutical & medical products practice where he focused on healthcare delivery strategies, new product launches, global commercial management structures, and R&D performance. Jeff is currently a board member of the Massachusetts Biotechnology Council, a board and executive committee member of the Elizabeth Glaser Pediatric AIDS Foundation, and faculty member of the Boston University School of Management, Health Management Program.

 

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Jeffrey Flier, M.D. Jeffrey Flier, M.D. is one of the country’s leading investigators in the areas of obesity and diabetes. His research has produced major insights into the molecular mechanism of insulin action, the molecular mechanisms of insulin resistance in human disease, and the molecular pathophysiology of obesity. Flier was born in New York City. He received a BS from City College of New York in 1968, and an MD from Mount Sinai School of Medicine in 1972, graduating with the Elster Award for Highest Academic Standing. Following residency training in internal medicine at Mount Sinai Hospital from 1972 to 1974, Flier moved to the National Institutes of Health as a Clinical Associate. In 1978, he joined the Faculty of Medicine at Harvard Medical School, serving as Chief of the Diabetes Unit at Beth Israel Hospital until 1990, when he was named chief of the hospital’s Endocrine Division. In 2002, Flier was named Chief Academic Officer of BIDMC, a newly created senior position responsible for research and academic programs. He worked with Beth Israel Deaconess academic department chairs to ensure the quality and breadth of academic programs at the Medical Center, through which most Harvard Medical School students pass. He also served as the formal liaison to Harvard Medical School, sitting on the Council of Academic Deans. Flier has authored over 200 scholarly papers and reviews and has held many editorial positions. An elected member of the Institute of Medicine and a fellow of the American Academy of Arts and Sciences, Flier’s honors also include the Eli Lilly Award of the American Diabetes Association, the Berson Lecture of the American Physiological Society, and Honorary Doctorates from the University of Athens and the University of Edinburgh. He was the recipient of the 2003 Edwin B. Astwood Lecture Award from the Endocrine Society, and In 2005, he received the Banting Medal from the American Diabetes Association, its highest scientific honor. Flier, the father of two daughters, lives in Newton, MA with his wife Eleftheria Maratos-Flier, MD, who is a Professor of Medicine at Harvard Medical School and with whom he has collaborated on research in the area of neuroendocrine

 

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Robert C. Green, M.D., M.P.H. Robert C. Green, M.D., M.P.H. is a medical geneticist and a clinical researcher who directs the G2P research program (genomes2people.org) in translational genomics and health outcomes in the Division of Genetics at Brigham and Women’s Hospital and Harvard Medical School. Dr. Green is principal investigator of the NIH-funded REVEAL Study, in which a cross-disciplinary team has conducted 4 separate multi-center randomized clinical trials collectively enrolling 1100 individuals to disclose a genetic risk factor for Alzheimer’s disease in order to explore emerging themes in translational genomics. Dr. Green also co-directs the NIH-funded PGen Study, the first prospective study of direct-to-consumer genetic testing services and leads the MedSeq Project, the first NIH-funded research study to explore the use of whole genome sequencing in the clinical practice of medicine. Dr. Green is currently Associate Director for Research of the Partners Center for Personalized Genetic Medicine, a Board Member of the Council for Responsible Genetics and a member of the Informed Cohort Oversight Boards for both the Children’s Hospital Boston Gene Partnership Program and the Coriell Personalized Medicine Collaborative. He co-chairs the ACMG working group that is currently developing recommendations for management of incidental findings in clinical sequencing.

 

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William N. Hait, M.D., Ph.D. William N. Hait, M.D., Ph.D. is Global Head, Janssen Research & Development, LLC, the global research and development arm of Janssen, the pharmaceutical companies of Johnson & Johnson. In this role, he leads the global R&D group in its mission to discover and develop innovative new medicines to address the world’s most serious unmet medical needs. Dr. Hait joined Johnson & Johnson in 2007 as Senior Vice President, Worldwide Head of Hematology and Oncology, Ortho Biotech Oncology R&D, and assumed the role of Global TA Head, Oncology, in 2009. Prior to joining Johnson & Johnson, he was the founding Director of The Cancer Institute of New Jersey and Professor of Medicine and Pharmacology and Associate Dean for Oncology Programs at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School from January 1993 to March 2007. Under Dr. Hait’s leadership, The Cancer Institute of New Jersey was successful in obtaining cancer center designation from the National Cancer Institute in 1996 and received the National Cancer Institute’s highest designation of Comprehensive Cancer Center in 2002. After earning his B.A. from the University of Pennsylvania, Dr. Hait received his M.D. and Ph.D. (Pharmacology) cum laude from the Medical College of Pennsylvania, where he was elected to Alpha Omega Alpha. He joined the Yale University School of Medicine faculty in 1984 and was quickly promoted to Associate Professor of Medicine and Pharmacology. Dr. Hait served as Associate Director of the Yale University Comprehensive Cancer Center and Director of the Breast Cancer Unit and Co-Director of the Lung Cancer Unit at the Yale University School of Medicine. He was appointed Chief of Medical Oncology at the Yale University School of Medicine in 1988. Dr. Hait is Board Certified in Internal Medicine and Medical Oncology. Dr. Hait is a member of the Medical Advisory Board of both the New Jersey Breast Cancer Coalition and Susan G. Komen Foundation and is an active member on Scientific Advisory Boards of several universities. He served on various committees for the American Association for Cancer Research (Chair, Clinical Cancer Research Committee), American Society of Clinical Oncology, the Association of American Cancer Institutes (Board of Directors), and the National Cancer Institute Board of Scientific Advisors. Dr. Hait served as President of the American Association for Cancer Research from 2007 – 2008, and is currently serving as treasurer.

 

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Richard Hamermesh, D.B.A. Richard Hamermesh is the MBA Class of 1961 Professor of Management Practice at the Harvard Business School where he teaches in the MBA Program and is the Faculty Chair of the HBS Healthcare Initiative. Richard created and teaches the second-year MBA elective, Entrepreneurship and Venture Capital in Healthcare. Previously, he was the Course Head for the required first year course entitled The Entrepreneurial Manager. In addition Richard participates in several HBS Executive Education programs. From 1987 to 2001, Richard was a co-founder and a Managing Partner of The Center for Executive Development, an executive education and development consulting firm. Prior to this, from 1976 to 1987, he was a member of the faculty of the Harvard Business School. Richard is also an active investor and entrepreneur, having participated as a principal, director, and investor in the founding and early stages of over 20 organizations. These have included start-ups, leveraged buy-outs, industry roll-ups, and non-profit foundations. He was the founding president of the Newton (MA) Schools Foundation and served on the editorial board of the Harvard Business Review. He is currently on the Boards of one public and two private corporations, as well as two non-profit Boards. From 1991 to 1996, he was the founding Chairman of Synthes Spine, Inc. Richard is the author or co-author of five books, including New Business Ventures and the Entrepreneur. His best-known book, Fad-Free Management, was published in 1996. He has published numerous articles and more than 100 case studies. His most recent article, “Realizing the Potential of Personalized Medicine”, appeared in the Harvard Business Review(October 2007). Richard received his AB from the University of California, and his MBA and DBA from HBS. He is married, has two children, and his hobbies include tennis, skiing, and yoga.

 

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Trevor Hawkins, Ph.D. Trevor Hawkins, Ph.D., as the past Director of the Human Genome Project for the US DOE, has built a recognized career in the healthcare industry over the past 20 years spanning business, academic innovation and as an entrepreneur. Dr. Hawkins is the Senior Vice President of Strategy and Innovation for Siemens Healthcare Diagnostics. Prior to joining Siemens he has held several senior executive roles, as Chief Scientific Officer of Royal Philips Electronics focusing on healthcare, CEO of Philips Molecular Healthcare business unit, CEO of GEs Molecular diagnostics business and President of Amershams Genomics business. He was also Chairman & CEO of ProGenTech, a privately held company based in Shanghai & San Francisco. Dr. Hawkins invented SPRI, Solid Phase Reversible Immobilization the magnetic bead nucleic acid isolation method that was used extensively as the sample prep method for the Human Genome Project. The SPRI patent remains as one of the most important in the field of magnetic bead use for life sciences and diagnostics. Dr. Hawkins has published over 50 peer-reviewed articles on automation, genomics, human diseases and the human genome project. He was also a founder of the Beijing Genome Institute (BGI), Chinas’ genome program and remains an Honorary Professor of the BGI. Dr. Hawkins has served on several public and private Boards and is currently involved in non-profit organizations in California.

 

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Michael Hayden, M.D., Ph.D. Michael Hayden, M.D., Ph.D. is the Killam Professor of Medical Genetics at the UBC and Canada Research Chair in Human Genetics and Molecular Medicine. He is the Director of the Center for Molecular Medicine and Therapeutics (CMMT) and founder of three biotechnology companies: NeuroVir Therapeutics Inc., Xenon Pharmaceuticals Inc., and Aspreva Pharmaceuticals Corp. Author of over 700 peer-reviewed publications and invited submissions, Michael focuses his research primarily on genetic diseases, including genetics of lipoprotein disorders, Huntington disease, predictive and personalized medicine. Michael and his research group have identified 10 disease-causing genes which includes the identification of the major gene underlying high-density lipoprotein (HDL) in humans. Michael also identified the first mutations underlying Lipoprotein Lipase (LPL) Deficiency and developed gene therapy approaches to treat this condition. Michael is also the most cited author in the world for ABCA1 and Huntington Disease. Michael is the recipient of numerous recent prestigious honours and awards, including the Margolese National Brain Disorder Prize (2011), awarded to Canadians who have made outstanding contributions to the treatment, amelioration, or cure of brain diseases; the Killam Prize by the Canada Council of the Arts (2011), in recognition of his outstanding career achievements; and the Canada Gairdner Wightman award (2011), recognizing him as a physician-scientist who has demonstrated outstanding leadership in medicine and medical science. Michael has also been awarded the Order of Canada (2011), and the Order of British Columbia (2010). He was named Canada’s Health Researcher of the Year by CIHR in 2008, and he received the Prix Galien in 2007, which recognizes the outstanding contribution of a researcher to Canadian pharmaceutical research.

 

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K. Peter Hirth, Ph.D. K. Peter Hirth, Ph.D. co-founded Plexxikon in December 2000, and has over 25 years of biotechnology and pharmaceutical discovery and development experience. Plexxikon was built as a novel, structure-guided drug discovery platform. Over the last ten years, Plexxikon has brought several NCEs into the clinic in a variety of indications. Most advanced from this portfolio is a selective B-raf V600 inhibitor that has been approved by the FDA for the treatment of patients with BRAFV600E mutation-positive inoperable or metastatic melanoma, as detected by an FDA-approved test, and is sold under the brand name Zelboraf®. Plexxikon was acquired in April 2011 by Daiichi Sankyo and is now a member of the Daiichi Sankyo Group. Previously, Peter was president of Sugen, Inc. until the sale of the company to Pharmacia Corporation in 1999. At Sugen, he helped build the company from its inception and advanced several kinase inhibitors through clinical trials for the treatment of oncology. This includes the drug Sutent, now owned by Pfizer through its acquisition of Pharmacia. Prior to Sugen, Dr. Hirth was a vice president in research with Boehringer Mannheim where, among other responsibilities, he successfully led the company’s erythropoietin program. Previously, he also was a research scientist with the Max Planck Institute, following the completion of his post doctoral work at the University of California, San Diego. Dr. Hirth received his Ph.D. in molecular genetics from Heidelberg University, Germany.

 

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E. Kevin Hrusovsky E. Kevin Hrusovsky was appointed President, Life Sciences & Technology, PerkinElmer in November 2011 when Caliper Life Sciences (CALP) was acquired. This transaction was the culmination of significant value creation for the CALP stakeholders. In July 2003, Hrusovsky became CEO of Caliper Life Sciences, when Zymark Corporation was acquired by Caliper. Subsequently, Caliper acquired and integrated three additional innovative tools companies and made substantial R&D and commercialization investments. Through these actions, Hrusovsky and Team transformed Caliper into a leading edge personalized medicine / health technology company. The Company’s rapid growth in sales and market valuation over the past three years made Caliper one of the fastest growing innovative life science technology companies in the industry, and a credible resource for articulating these important trends in medicine and health. Prior to the acquisition, Hrusovsky served as President and CEO for Zymark starting in late 1996, where he successfully transformed Zymark from a custom robotics company into a formidable Life Sciences tools company. From 1992 to 1996, he was Director of International Business, Agricultural Chemical Division, and President of the Pharmaceutical Division, for FMC Corporation. From 1983 to 1992, he held several management positions at E.I. DuPont de Nemours, including North American Sales and Marketing Head, Teflon. Hrusovsky currently sits on the Educational Board of the Massachusetts Biotech Council, the Advisory Committee for the Center for Biomedical Engineering at Brown University, the Association for Laboratory Automation, the JALA Editorial Board, and the Strategy Committee of Children’s Hospital Boston. He formerly served on the boards of SeraCare Life Sciences, Caliper Life Sciences, Xenogen Corporation and Alliant Medical Technology. Hrusovsky received an Honorary Doctorate degree from Framingham State University for contributions to life sciences. He received his B.S. in Mechanical Engineering from Ohio State University and an M.B.A. from Ohio University. He and his family are authentic Buckeyes!

 

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Professor Abraham Israeli, M.D., M.P.H., M.B.A. Professor Abraham (Avi) Israeli, M.D., M.P.H., M.B.A. is Chief Scientist of the Ministry of Health, and the Head of the Health Policy, Health Care Management and Health Economics Department at the Hebrew University – Hadassah Faculty of Medicine. Prior to this he was the Director General of the Israel Ministry of Health (2003-2009) and the Director – General of Hadassah Medical Organization (1998 -2001).  He holds the Chair of Dr. Julien Rozan Professorship of Family Medicine and Health Promotion Chair at the Hebrew University-Hadassah Medical School, Jerusalem (since 1996) and teaches there regularly. Professor Israeli chaired the national committee to update the Israeli national standard basket of health services. Professor Israeli received his medical degree and his master in public health from the Hadassah – Hebrew University Medical School. He completed residencies in Internal Medicine and in Health-Care Management at Hadassah University Hospital and has certification in both specialties. He received his Master’s Degree from the Sloan School of Management at MIT, Boston. His scientific activities are related to applied, methodological and theoretical research in the fields of health policy, health care management, and the epidemiological, economic, social and cultural basis for decision-making. His publications deal with translation of academic knowledge and inputs from the field into policy setting and decision-making processes. Two additional key research foci are rationing / priority setting and comparative health care systems.

 

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Kris Joshi, Ph.D. Kris Joshi, Ph.D.  is Global Vice President responsible for Oracle’s Healthcare product portfolio. Kris helped launch the Health Sciences Global Business Unit within Oracle, and led the business unit’s growth strategy, including the acquisitions of Relsys and Phase Forward. He oversees a product portfolio that covers Analytics, Health Information Exchange, Care Management, and solutions for Personalized Medicine and Translational Research serving healthcare payer, provider and life sciences segments. Prior to Oracle, Kris served in senior strategy roles in IBM’s Global Sales & Distribution organization where he helped shape IBM’s global distribution strategy and emerging markets strategy. Prior to IBM, Kris spent several years as a consultant with McKinsey and Co where he served Fortune 500 clients in Banking, Media, Healthcare and Life Sciences industries on business strategy issues. Kris has a long-standing personal commitment to help bridge the gap between the social and business worlds through entrepreneurship, innovation, and public-private partnerships. He has championed numerous initiatives aimed at leveraging technology to improve the quality, safety, and affordability of healthcare globally. Kris holds a Bachelor of Science in Mathematics from CalTech and a Ph.D. in Astrophysics from MIT.

 

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Raju Kucherlapati, Ph.D. Raju Kucherlapati, Ph.D. is the Paul C.Cabot Professor in the Harvard Medical School Department of Genetics. He is also a professor in the Department of Medicine at Brigham and Women’s Hospital. Dr. Kucherlapati was the first Scientific Director of the Harvard Medical School-Partners Healthcare Center for Genetics and Genomics. His research focuses on gene mapping, gene modification, and cloning disease genes. During 1989-2001, Dr. Kucherlapati was the Lola and Saul Kramer Professor of Molecular Genetics and Chairman of the Department of Molecular Genetics at the Albert Einstein College of Medicine in New York. He was previously a professor in the Department of Genetics at the University of Illinois, College of Medicine. He began his research as an assistant professor in the Department of Biochemical Sciences at Princeton University. He has chaired numerous NIH committees and served on the National Advisory Council for Human Genome Research and the NCI Mouse Models for Human Cancer Consortium. He is also a member of the Cancer Genome Atlas project of the National Institutes of Health. He is a member of the Institute of Medicine of the National Academy of Sciences and a fellow of the American Association for the Advancement of Science. He is a member of Presidential Commission for the Study of Bioethical Issues. Dr. Kucherlapati received his B.S. and M.S. in Biology from universities in India, and he received his Ph.D. from the University of Illinois at Urbana, as well as conducting post-doctoral work at Yale University.

 

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John Lauerman John Lauerman is a reporter-at-large at Bloomberg News writing about health and higher education. Lauerman and his colleagues won a Polk Award and were Pulitzer finalists in 2011 for a series of stories on for-profit colleges that recruit low-income students, often to leave them with debt and no degree. The series also won a Gerald Loeb Award, a National Headliner Award, and the Education Writers Association Grand Prize. In 2010, he won a New York Press Club award for coverage of Harvard University’s $1 billion loss on risky investments. He won a 2009 award from the Society of the Silurians for his stories on the failed search for a vaccine against HIV. His team won a 2005 award from the Society of American Business Writers and Editors for coverage of Merck & Co.’s withdrawal of the painkiller Vioxx after it was linked to heart disease. He has been a fellow of the Blue Cross Blue Shield of Massachusetts Health Coverage program and the Kaiser Family Foundation’s program for science journalists. Before coming to Bloomberg, Lauerman was a science writer at Harvard Medical School from 1985 thorugh 1988. Later, as a freelance journalist, he wrote a health column for Harvard Magazine, contributed to newspapers and magazines across the U.S., and edited the public health journal “Health and Human Rights.” He is the co-author of two books: “Diabetes: Understand Your Condition, Make the Right Treatment Choices, and Cope Effectively,” and “Living to 100.” He lives with his wife and two children in Brookline, Massachusetts.

 

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Lisa M. Lee, Ph.D., M.S. Lisa M. Lee, Ph.D., M.S., is the Executive Director of the Presidential Commission for the Study of Bioethical Issues. Lee previously had been with the Centers for Disease Control and Prevention (CDC) since 1998, most recently serving as Chief Science Officer in the Office of Surveillance, Epidemiology, and Laboratory Sciences. Lee, who has a Ph.D. from Johns Hopkins and an M.S. in bioethics from Alden March Bioethics Institute at Albany Medical College, is an epidemiologist, surveillance scientist, and public health ethicist. Lee’s work at CDC has included ethics of public health surveillance, scientific integrity, development and evaluation of surveillance systems, research on HIV and fertility, HIV/AIDS survival, HIV and tuberculosis, and data quality. She has led several agency and cross-agency committees working to establish and maintain an environment of scientific integrity and excellence. Lee is the lead editor of Principles and Practice of Public Health Surveillance, 3d edition (Oxford University Press, 2010). She has authored numerous scientific publications and has served as a peer and guest reviewer for many scientific conferences and scientific journals. She serves on the Board of Advisors and is adjunct faculty at Georgia State University’s Institute of Public Health, where she teaches ethics.

 

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Jeffrey Leiden, M.D., Ph.D. Jeffrey Leiden, M.D., Ph.D., President, CEO and Chairman, joined Vertex Pharmaceuticals in December 2011 and served on Vertex’s board since 2009. Dr. Leiden brings to Vertex more than 20 years of scientific, commercial and financial experience in the pharmaceutical and biotechnology industries and clinical experience in academia as a practicing cardiologist and molecular biologist. Dr. Leiden is a Senior Advisor for Clarus Ventures, a life sciences venture capital firm he joined in 2006. In 2000, he joined Abbott Laboratories as President and Chief Operating Officer where he had responsibility for running Abbott’s global pharmaceuticals business. While at Abbott, Dr. Leiden helped launch multiple breakthrough medicines, including Humira for rheumatoid arthritis and other autoimmune diseases and Kaletra for HIV infection, among others. He also served as a member of the Board of Directors of Abbott Laboratories from 2001 to 2006. Dr. Leiden began his career in academia as a practicing cardiologist and molecular biologist. From 1987 to 2000, Dr. Leiden held several academic appointments, including roles as Chief of Cardiology at the University of Chicago and Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. During his academic career, Dr. Leiden was also involved in starting several biotechnology companies including Vical and Cardiogene. Dr. Leiden held a number of board positions for pharmaceutical and biotechnology companies, including the role of non-executive Vice Chairman for Shire Pharmaceuticals plc. He was also a member of the Board of Directors of Millennium Pharmaceuticals, Inc. He is an elected member of both the American Academy of Arts and Sciences, and the Institute of Medicine of the National Academy of Sciences. Dr. Leiden received his M.D., Ph.D. and B.A. degrees from the University of Chicago.

Mia Levy, M.D., Ph.D. Dr. Mia A. Levy is the Director of Cancer Clinical Informatics for the Vanderbilt-Ingram Cancer Center and an Assistant Professor of Biomedical Informatics and Medicine. Dr. Levy received her undergraduate degree in Bioengineering from The University of Pennsylvania in 1997 and her Medical Doctorate from Rush University in 2003. She then spent 6 years at Stanford University completing post-graduate training in Internal Medicine and Medical Oncology while completing her PhD in Biomedical Informatics. She joined the faculty at Vanderbilt as an Assistant Professor in Biomedical Informatics and Medicine in August 2009. She is a practicing medical oncologist specializing in the treatment of breast cancer. Dr. Levy’s research interests include biomedical informatics methods to support the continuum of cancer care and cancer research. Current research projects include informatics methods for 1) image based cancer treatment response assessment using quantitative imaging, 2) clinical decision support for treatment prioritization of molecular subtypes of cancer, 3) protocol based plan management and 4) learning cancer systems.

 

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Alan Mertz Alan Mertz became President of ACLA in 2003 and since that time he has exponentially grown ACLA’s membership, visibility and advocacy efforts.  ACLA has led a series of successful advocacy campaigns on laboratory reimbursement, regulation, coding, health IT and many other issues, including stopping legislation imposing laboratory co-pays in Medicare and repealing a laboratory Medicare competitive bidding project.  ACLA also led industry efforts to ensure that regulatory changes with respect to genetic and molecular testing do not stifle innovation or harm patient care.  ACLA launched the “Results for Life” educational campaign in 2007 to promote the value of laboratory services and in 2009, ACLA started its Associate Member program for non-laboratory health care companies and organizations. Prior to his current position, Mertz was Executive Vice President and Acting President of the Healthcare Leadership Council (HLC), and prior to that served in three senior staff positions in the House and Senate over 18 years.  He is a frequent lecturer at American University, and was an adjunct professor at George Washington University (both in Washington, DC).  Mertz holds a Masters Degree in American Politics from American University and a BA in Government from Monmouth College (IL).

 

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Amy Miller, Ph.D Amy Miller, Ph.D. is the Vice President of Public Policy for the Personalized Medicine Coalition (PMC) which represents a broad spectrum of academic, industrial, patient, provider, and payer organizations that seek to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. Dr. Miller works with these communities to reach consensus on policy issues impacting personalized medicine and share those views with policy makers. Before joining the PMC, Dr. Miller worked in the office of the Director of the National Institute of Mental Health where she served as a liaison among the scientific community, the legislative branch, and the consumers of mental health care and their families. A former AAAS fellow, she also served as a domestic policy advisor to Senator Jay Rockefeller. She began her career as a researcher at National Institute of Child Health and Human Development. Dr. Miller received a BA from the University of New Orleans and holds a doctoral degree in Human Development from the University of Connecticut.

 

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D. Holmes Morton, M.D. D. Holmes Morton M.D. is a pediatrician and was the cofounder with his wife Caroline of the Clinic for Special Children in Strasburg Pennsylvania, which Clinic is a non-profit medical center that provides care for children with complex medical problems arising from inherited predispositions to disease. The Clinic for Special Children is located on an Amish farm near Strasburg in Lancaster County Pennsylvania. Although it is a local pediatric medical center, the Clinic has become recognized internationally for innovative studies in the discovery and treatment of inherited disorders. The Clinic’s publications about the treatment of maple syrup urine disease can be found in Pediatrics, Current Treatment Options in Neurology, Molecular Genetics and Metabolism, Brain, Journal of Pediatrics, Pediatric Transplant, Nature, and Gene Reviews. Holmes Morton graduated from Trinity College in 1979 with Honors in Biology and Psychology and was elected to Pi Beta Kappa. He studied medicine at Harvard Medical School and completed a 3-year Residency in Pediatrics at Children’s Hospital. In 1986 Dr. Morton moved to Children’s Hospital of Philadelphia to study biochemical genetics under Richard Kelley. In 1988, with the support of Hugo Moser, he moved Dr. Kelley’s new laboratory at Kennedy Krieger Institute at Johns Hopkins to develop methods for diagnosis and treatment of the Amish variant of Glutaric Aciduria Type 1. This work led to the establishment of the Clinic for Special Children in Lancaster County Pennsylvania in 1989. Dr. Morton is a member of the American Academy of Pediatrics and the Society for Inherited Metabolic Disorders. In 1993, he was given the Albert Schweitzer Prize for Humanitarianism, a prize awarded jointly by the Alexander von Humbolt Foundation of Germany and Johns Hopkins University. In 2006 Dr. Morton was awarded a John D. and Catherine T. MacArthur Fellowship

 

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Professor Ola Myklebost, Ph.D. Ola Myklebost, Ph.D. is Senior Scientist and Group Leader at the Department of Tumor Biology, Institute for Cancer Research, and Professor at the Department for Molecular Biosciences at the University of Oslo. He is also Assistant Director of CAST, the Centre for research-based Innovation (SFI) on Cancer Stem Cells, and previous head of the Norwegian Genomics Consortium. Currently he is heading the Norwegian Cancer Genomics Consortium, with the aim to introduce and investigate the use of tumor genome profiles for therapeutic decisions. Dr. Myklebost took his MSc under Per Seglen at what is now Dept. of Cell Biology in 1982, then went to St. Mary’s Hospital in London where he worked with recombinant DNA technology under the leadership of Bob Williamson. Returning to Oslo, he worked at the Institute for Internal Medicine at the National Hospital under Hans Prydz until 1987, when he had a research stay in the group of Keith Stanley at EMBL. Since 1988 he has again been employed at the Institute of Cancer Research, now at the Dept. of Tumor Biology. Dr. Myklebost received his Doctor of philosophia from the Medical Faculty, University of Oslo.

 

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Richard Naples Richard Naples, Senior Vice President of Regulatory Affairs, is responsible for global market access and regulatory compliance functions, including premarket submissions, reimbursement and public policy. He has been with BD for a total of five years. Mr. Naples has over 30 years experience in medical devices and diagnostics. He has been a chief corporate regulatory officer, an FDA regulator, and a clinical laboratory manager. He is currently co-chair of the AdvaMed Diagnostics Task Force and has been recognized as one of the top regulatory professionals in the industry. His experience includes over 300 successful regulatory submissions and leadership of numerous industry-wide initiatives to ensure more timely patient access to innovative new technologies. Most recently prior to joining BD, Rick was Roche Diagnostics VP of Regulatory and Government Affairs after serving as a Consumer Safety Officer at FDA HQ Center for Biologics, Evaluation and Research (CBER). He also served on the boards of the New England Healthcare Institute (NEHI) and the Indiana Medical Device Manufacturers Council (IMDMC). Rick holds a Bachelor of Science degree in Chemistry/Medical Technology from Youngstown State University (Ohio).

 

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Ming Qi, Ph.D. Ming Qi, Ph.D. received his B.S. from South China Normal University in 1982. He received his M.S. from Fudan University, Shanghai in 1985 and was mentored by Dr. C.C. Tan, the “Father of Genetics at China”. He succeeded in the national competition to be a student of the CUSBEA (China-USA Biochemistry / Molecular Biology) Program and received his Ph.D. from the University of Pittsburgh in 1991. Dr. Qi did his postdoctoral training in Dr. Stan McKnight’s Lab, University of Washington from 1991-1994. Dr. Qi had his clinical postdoctoral fellowship in Molecular Genetics with Dr. Peter Byers at the University of Washington from 1994-1998 and was certified in clinical molecular genetics by American Board of Medical Genetics in 1999. He is a Fellow of American College of Medical Genetics. He has been the faculty of University of Rochester Medical School since 1998 as a Assistant Professor, Associate Professor and Professor. Dr. Qi served as a consultant of Harvard Medical School-Partner Center for Genetics and Genomics and Visiting Geneticist of the Laboratory of Molecular Medicine in 2006. His research has been published in numerous peer reviewed scientific journals, including in Nat Genet, PNAS, Cell, Human Mol Genetics, JAMA, Circulation, Am J Med Genet, Human Mutation, etc. He is the Chief Advisor of the Chinese National Gene Health Committee, and the coordinator of the international Human Variome Project Chinese Consortium. He is an editorial board member of several international journals including Human Mutation, Giga-Science and ANE. He also serves as a reviewer for a number of international journals. Dr. Qi has recently been news-report interviewed by Nature and Science (http://www.nature.com/news/2011/110125/full/469455a.html;

 

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Paul Radensky, M.D. Paul Radensky, M.D. is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. and Miami offices. Paul is co-chair of the Firm’s Life Sciences Government Strategies team and a member of the Personalized Medicine team. Paul is a recognized authority on the full range of legal, regulatory and reimbursement issues pertaining to pharmaceutical, biotechnology, medical device, and clinical laboratory development and marketing. His background as a clinical researcher and medical practitioner informs his practical and scientific understanding of both product manufacturers and clinical laboratories. He advises manufacturers at every stage of product development, including the design and monitoring of clinical trials, positioning and applying for FDA approval, maintaining regulatory compliance, and obtaining coverage, coding and payment for new technologies by Medicare, Medicaid and other third party payors. Paul also advises clinical laboratories on CLIA and state licensure compliance as well as evolving policies on FDA regulation of  laboratory-developed tests. Paul is ranked in The Best Lawyers in America (2009-2012). Paul is board certified in internal medicine and is a member of the American College of Physicians and the Alpha Omega Alpha Honor Medical Society. He is a member of the District of Columbia Bar as well as the Florida Bar.

 

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Heidi Rehm, Ph.D., FACMG Heidi Rehm, Ph.D., FACMG is the Chief Laboratory Director for the Laboratory for Molecular Medicine at the Partners Healthcare Center for Personalized Genetic Medicine and Assistant Professor of Pathology at Harvard Medical School. She was recruited in 2001 to build the CLIA lab after completing her graduate degree in Genetics from Harvard University and her postdoctoral and fellowship training at Harvard Medical School. The lab focuses on the rapid translation of new genetic discoveries into clinical tests that can be used to improve patient outcomes, supporting the model of personalized medicine. In addition, the lab focuses on bringing novel technologies and software systems into molecular diagnostics to support the integration of genetics into clinical use. The laboratory has been a leader in translational medicine, launching the first clinical tests for cardiomyopathy and lung cancer treatment among many achievements. In 2012, the lab will launch a CLIA-approved interpretive service for whole genome sequencing. Dr. Rehm is involved in defining standards for the use of next generation sequencing in clinical diagnostics through her committee roles at the American College of Medical Genetics and collaborative efforts with the CDC. Dr. Rehm is also involved in a major effort to develop and curate a universal clinical genomic variant database through collaborative efforts with NCBI and many other groups. Dr. Rehm also conducts research in hearing loss, Usher syndrome, cardiomyopathy, and healthcare IT.

 

David Resnick, Esq. David Resnick, Esq. is the co-leader of the Patents practice group at Nixon Peabody. His practice is focused on patent prosecution and overall portfolio management, transactional matters, and associated client counseling. David represents, and manages the portfolios of, some of the leading academic research institutions in the U.S., as well as some of the world’s most recognized life science companies. He has extensive experience in the life sciences and is widely regarded as a thought leader in the area of personalized medicine, particularly with respect to pharmacogenomics, proteomics, and disease biomarkers, and their application in the field of personalized medicine.

 

Jon Retzlaff Jon Retzlaff is the Managing Director of Science Policy and Government Affairs. Before joining the AACR in 2010, Mr. Retzlaff worked in government relations for Lewis-Burke Associates, LLC and led the firm’s health and biomedical research practice. Previously, he served as legislative director for the Federation of American Societies for Experimental Biology from 2004-2007. Additionally, he worked for the National Institutes of Health, first as a program analyst within the Office of the Director’s legislative office; then as a senior legislative advisor to the National Institute of Neurological Disorders and Stroke; and finally as the Executive Officer of the National Library of Medicine. Mr. Retzlaff was assigned to the House (1998) and Senate (2000-2001) appropriations subcommittees on labor, health and human services, education and related agencies on health research funding issues, as well as within the Office of the Secretary for Legislation at the Department of Health and Human Services. He entered the Federal Government as a Presidential Management Intern in 1993 and completed a rotation in the Office of Senator Herb Kohl (D-Wis.) during his training. Mr. Retzlaff earned a Bachelor of Science degree from the University of Minnesota, a master’s degree in public administration from Indiana University and a master’s degree in business administration from the Massachusetts Institute of Technology.

 

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Hakan Sakul, Ph.D. Hakan Sakul, Ph.D. is a Senior Director in the Translational Oncology Group where he serves as a program manager for Companion Diagnostics. He received his BS and MS degrees from Ankara University in Turkey. He was a recipient of the “Freedom from Hunger Scholarship” from The Rotary Foundation, and completed his PhD degree in Quantitative Genetics from the University of Minnesota (1990) as a Rotary Foundation Scholar. Subsequently, he conducted postdoctoral studies at the University of California-Davis. After spending four years in the biotech industry working in human genetics, pharmacogenomics and statistical genetics fields, Hakan spent a few years at Parke-Davis Pharmaceuticals as the Director of Human Genetics, Statistical Genetics and Pharmacogenetics programs. He then served as Vice President of Statistical Genomics at Ardais Corporation in Boston briefly before returning to Pfizer in 2001 as Director and Site Head for Clinical Pharmacogenomics in Groton/New London Laboratories, with responsibilities across all therapeutic areas. Hakan was promoted to Senior Director in mid-2005 and took on the role of Global Head of Companion Diagnostics for about four years to oversee the companion diagnostics needs across Pfizer’s pharmaceutical portfolio. In 2010, Hakan assumed his current role in the Oncology Business Unit where most of Pfizer’s companion diagnostics needs reside. A member of the Editorial Board of the Personalized Medicine Journal, the Organizing Committee of the annual Personalized Medicine meeting at Harvard, and the author of over 30 scientific refereed articles and several book chapters, Hakan has served as an invited speaker on many scientific meetings and panel discussions. His external representation of Pfizer includes memberships on the Clinical Science and Technology Committee of The Personalized Medicine Coalition, the Research Tools and Molecular Diagnostics Sub Team of BIO, and the California Healthcare Institute’s Diagnostics Working Group. Hakan currently serves as the Co-Chair of Pfizer’s Personalized Medicine team, and is keenly interested in applications of companion diagnostics, pharmacogenomics and related technologies to the pharmaceutical pipeline to advance Personalized Medicine for the improvement of individualized healthcare.

 

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Randall Scott, Ph.D. Randall Scott, Ph.D. founded Genomic Health in 2000 and led the company as CEO for 9 years with a focus on improving the quality of treatment decisions for patients with cancer. Genomic Health was one of the first companies to translate genomic information into clinical practice by developing the Oncotype DX series of tests for breast, colon, and prostate cancer, each ofwhich is designed to improve the quality of care and reduce healthcare costs. Under his leadership, Genomic Health led a transformation in medical and business practice to incorporate complex genomic tests into routine medical practice with full reimbursement support by national payers. Dr. Scott has played a role in founding several successful biotech companies in addition to Genomic Health Inc. such as Incyte, a leading biopharmaceutical company as well as his newest enterprise InVitae Corporation where he is focused on expanding beyond cancer to bring the power of the human genome into routine medical practice for every individual at risk for common or rare genetic conditions. He is the author of over 40 scientific publications, 20 patents, and is the recipient of numerous awards.

 

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Norman C. Selby Norman C. Selby has spent 30 years in the healthcare world in a variety of consulting, managerial, investment and Board roles. He is currently Executive Chairman of two innovative healthcare information businesses: Real Endpoints llc and Physicians Interactive Inc. In addition, Mr. Selby serves as a Senior Advisor to Perseus llc, a private equity firm based in Washington, D.C. Mr. Selby is currently on the Board of three healthcare product companies: Infinity Pharmaceuticals, a leading public (INFI) oncology biotech company, Metamark Genetics, an oncology diagnostics company, and Merz Group GmbH, a global specialty pharma company based in Frankfurt, Germany. In the decade of the 2000s he was on the Board of three other companies all of which had successful exits: Millennium Pharmaceuticals (MLNM) which was acquired by Takeda; TransForm Pharmaceuticals (where he was also CEO) which was acquired by Johnson & Johnson; and Windhover Information (where he was Executice Chairman) which was acquired by Reed Elsevier. Mr. Selby spent the bulk of his career at McKinsey & Company where he was Director (Senior Partner) in the firm’s New York office. He held several leadership roles at McKinsey, including head of the firm’s Global Pharmaceuticals and Medical Products Practice. From 1987-1989, Mr. Selby took a leave of absence from McKinsey to serve as Chief Operating Officer of the New York Blood Center, the largest community blood organization in the country, where he led its financial and operational turnaround. After McKinsey he went to Citicorp/Citigroup where he was an Executive Vice President. Mr. Selby serves on the Board of Trustees of the Central Park Conservancy, the Memorial Sloan-Kettering Cancer Center and the Ralph Lauren Center for Cancer Care and Prevention, all based in New York City. He is also a member of the advisory board of the Harvard Business School’s Healthcare Initiative, and a Board member of the National Parks Conservation Association in Washington D.C. Mr. Selby holds a B.A. in Architecture from Yale College and an M.B.A. with Distinction from the Harvard Graduate School of Business Administration.

 

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Lt. Col. Cecili Sessions, M.D., M.P.H., FAAP Lt Col Cecili K. Sessions, MD, MPH, FAAP is assigned to the United States Air Force Medical Support Agency, Medical Research & Innovations Division, as Chief, Personalized Medicine, and directs the Patient-Centered Precision Care Genomic Medicine Research Program (PC2-Z). Prior to this assignment, she served as the Air Force Liaison to the Armed Forces Health Surveillance Center, the central strategic epidemiological resource for the Armed Forces of the United States. As an active duty pediatrician, she was stationed at Incirlik AB, Turkey, and Kadena AB, Okinawa. Dr. Sessions received her degree from the Keck School of Medicine at the University of Southern California in 2000, after which she completed a Pediatric Residency at Georgetown University, where she was selected Resident of the Year in her graduating class of 2003.Both her undergraduate degree at Stanford University (AB, 1996) and graduate coursework (MPH, 2007) during the General Preventive Medicine Residency at the Uniformed Services University of the Health Sciences focused on International Health. During her graduate medical education, Dr Sessions completed two externships with the Pan American Health Organization at their headquarters in Washington, D.C.

Michael Snyder, Ph.D. Michael Snyder, Ph.D. is the Stanford Ascherman Professor and Chair of Genetics and the Director of the Center of Genomics and Personalized Medicine. Dr. Snyder received his Ph.D. training at the California Institute of Technology and carried out postdoctoral training at Stanford University. He is a leader in the field of functional genomics and proteomics. His laboratory study was the first to perform a large-scale functional genomics project in any organism, and has launched many technologies in genomics and proteomics. These including the development of proteome chips, high resolution tiling arrays for the entire human genome, methods for global mapping of transcription factor binding sites (ChIP-chip now replaced by ChIP-seq), paired end sequencing for mapping of structural variation in eukaryotes, and RNA-Seq. These technologies have been used for characterizing genomes, proteomes and regulatory networks. Seminal findings from the Snyder laboratory include the discovery that much more of the human genome is transcribed and contains regulatory information than was previously appreciated, and a high diversity of transcription factor binding occurs between and within species. He is a cofounder of several biotechnology companies, including Protometrix (now part of Life Tehcnologies), Affomix (now part of Illumina), Excelix, and Personalis, and he presently serves on the board of a number of companies.

 

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Risa Stack, Ph.D. Risa Stack, Ph.D. is a partner at Kleiner Perkins Caufield & Byers. Since joining the firm in 2003, she has worked to build and support KPCB’s personalized medicine portfolio. Risa has been the founding CEO and a board member of several personalized medicine companies, including CardioDx and Nodality. Risa is a board observer at Tethys, Veracyte and Xdx. In addition to her work directly with portfolio companies, Risa is involved in developing public policy in molecular diagnostics and personalized medicine. Risa is also involved in the development of therapeutics companies, including Corthera and Trius. She was most recently a board member of Corthera (sold to Novartis in 2009), and she is a board observer at Epizyme and Pacific Biosciences. Risa has 15 years of experience investing in personalized medicine, therapeutics and platform technologies. Her investment career spans from incubations to public companies. Most recently, she has focused on starting companies, often taking operational roles. Before joining KPCB, Risa was a principal at J.P. Morgan Partners in the life science practice for six years. While at J.P. Morgan Partners, she sponsored a series of investments including Acurian, Connetics (acquired by Steifel Laboratories), Diatide (acquired by Berlex), Ilex Oncology (acquired by Genzyme), Illumina, and Triangle Pharmaceuticals (acquired by Gilead). Risa was also involved in JP Morgan Partners’ international investing efforts, which included European life sciences companies and managing a portfolio of Israeli early stage life sciences and IT companies. Before joining the venture capital industry, Risa worked as a derivative specialist on the Chicago Board of Trade, where she traded futures and options on government securities. Risa received her B.S. degree in genetics and development with distinction from the University of Illinois and her Ph.D. in immunology from the University of Chicago. She was also a member of the second class of Kauffman Fellows. Risa also serves as a member of the advisory board of the National Summit on Personalized Healthcare and GE’s Healthymagination effort. In 2004, Risa was named as one of the 100 Most Influential Women in Business by the San Francisco Business Times.

 

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Michael Streit, M.D., M.B.A. Michael R. Streit, M.D., M.B.A., is Executive Director at GlaxoSmithKline-Oncology and the Program Physician Leader for the small-molecule GSK1120212 (MEK-inhibitor) clinical development program. Dr. Streit received his MD from the Free University of Berlin (Germany) in 1985 and did postgraduate training at the Benjamin Franklin Medical Center in Berlin and the Massachusetts General Hospital in Boston.  Prior to joining GSK in 2011, Dr. Streit worked in the field of clinical drug research and development for Bristol-Myers Squibb, Boehringer-Ingelheim Pharmaceuticals, and Berlex Biosciences.

 

Katherine Johansen Taber, Ph.D. Katherine Johansen Taber, PhD has been a Senior Scientist at the American Medical Association since 2006. She leads the AMA’s Program in Genetics and Molecular Medicine, which focuses on educating physicians about the clinical implementation of genetics and on identifying emerging genetic policy issues affecting health care providers. She also advises the AMA Board of Trustees and the House of Delegates on genetics issues such as the oversight of genetic testing, gene patenting, stem cell research, and newborn screening. Dr. Johansen Taber has held a position on the Board of NCHPEG since 2006, and will be Vice Chair beginning in 2012. She also serves as the AMA appointment to the Institute of Medicine’s Roundtable on Genomics, and has served as an Advisory Board member for Genetic Services Policy Project and as an advisor for the Illinois Humanities Council’s community genetics education program Future Perfect. Dr. Johansen Taber earned her PhD in Molecular, Cell, and Developmental Biology at the University of California, Los Angeles, and conducted post-doctoral research at the USDA. She has held teaching appointments at UCLA, California State Polytechnic University, University of Idaho, and Columbia College Chicago.

 

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Robert I. Tepper, M.D. Robert I. Tepper, M.D. is a distinguished scientist with over 25 years of experience building and operating leading R&D operations. Bob co-founded Third Rock Ventures in 2007 and focuses on the formation, development and scientific strategy of our portfolio companies as well as actively identifying and evaluating new investments. He also assumes active leadership roles in our portfolio companies, functioning as Chief Scientific Officer through the first 12-18 months post launch. Prior to joining Third Rock Ventures, Bob was President of R&D at Millennium Pharmaceuticals and was vital in its expansion from a drug discovery company to a fully-integrated biopharmaceutical company. Prior to Millennium, Bob co-founded Cell Genesys/Abgenix. Bob holds an AB in Biochemistry from Princeton University and received his MD degree from Harvard Medical School. Bob serves as an adjunct faculty member at Harvard Medical School and Massachusetts General Hospital and is an advisory board member of several leading health care institutions including the Partners HealthCare Center for Personalized Genetic Medicine, the Massachusetts General Hospital and Tufts Medical School.

 

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Joe Vockley, Ph.D. Joe Vockley, Ph.D., is Chief Operating Officer and Chief Scientific Officer of the Inova Translational Medicine Institute. Dr. Vockley brings 25 years of experience in academic, pharmaceutical, biotechnology CROs and government research. He has broad and deep expertise in the fields of genetics, genomics, molecular diagnostics, bioinformatics and large program management. Dr. Vockley is a results-oriented manager and scientist. He is an inventor on numerous US and international genomic and bioinformatic technology patents in the areas of DNA diagnostics, laboratory methods for microarray analysis, gene discoveries and bioinformatic tool development. His basic research interests are in the fields of cancer and inborn errors of metabolism. Dr. Vockley has previously held the positions of Chief Scientific Officer, Vice President of Research, Director of Genomics and Director of Bioinformatics. Most recently, he was the director of National Cancer Institute’s Cancer Genome Atlas Project and The Cancer Genome Atlas Program Office.

 

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Scott Weiss, M.D., M.S. Scott Weiss, M.D., M.S. is currently Scientific Director of the Partners HealthCare Center for Personalized Genetic Medicine (PCPGM) and Associate Director, Channing Laboratory, and Professor of Medicine at Harvard Medical School. In this latter capacity, he leads a 28 investigator, 120 person research group examining the environmental and genetic origins of asthma and COPD. He has authored or coauthored over 500 publications and four books in the area of asthma and COPD risk factors, natural history, and genetics. His initial work concerned the role of airways responsiveness and environmental tobacco smoke exposure in asthma and COPD, the effect of allergen exposure and airways responsiveness on markers of inflammation and the combined effect of these factors on the development of COPD. In 1996, he developed a strong interest in the genetics of asthma and his work over the past 14 years has focused on this, and novel environmental exposures such as vitamin D and the bowel flora. His laboratory is the only laboratory in the world that has active NIH research in the areas of asthma genetics, asthma pharmacogenetics, and COPD genetics. He is the principal investigator or co-investigator on a total of six separate NHLBI-funded grant proposals in the area of the genetics of asthma and Asthma Pharmacogenetics, including a MERIT award.

 

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M. Kathleen Behrens Wilsey, Ph.D. M. Kathleen Behrens Wilsey, Ph.D. served as a Member of the President’s Council of Advisors on Science and Technology (PCAST), from 2001 to 2009, working on multiple national policy matters. She Chaired PCAST’s Subcommittee on Personalized Medicine and led a two year study that culminated in the September 15, 2008 report, Priorities for Personalized Medicine. Kathy was a director of the Board on Science, Technology and Economic Policy (STEP) for the National Research Council from 1997-2005, at which time she participated as a member of the Institute of Medicine Committee on New Approaches to Early Detection and Diagnosis of Breast Cancer. Kathy was a director of the National Venture Capital Association from 1993 to 2000, also serving as President, Chairman and Past Chairman from October of1999 through April of 2000. Dr. Behrens Wilsey currently serves as a member of the Board of Directors of Sarepta Therapeutics, Inc. and KEW Group Inc. Kathy holds a Ph.D. in Microbiology from the University of California, Davis. Kathy established a career in the financial services industry, working with Robertson Stephens & Co. until 1996, where she became a general partner and managing director. Dr. Behrens Wilsey continued in her capacity as a General Partner for selected venture funds for RS Investments, after management led a buy-out of that firm from Bank of America. Her professional career includes tenures as a public-market life-sciences securities analyst, as well as venture capitalist focusing on healthcare and technology investments. She was instrumental in the founding of several life-sciences companies including Protein Design Labs, Inc. and COR Therapeutics, Inc. and participated in financing a broad range of health care services and products companies. Dr. Behrens Wilsey served as a director of Abgenix, Inc. in a role that spanned that firm’s early rounds of private financings through the company’s sale in 2006 to Amgen, Inc. and was a director of Amylin Pharmaceuticals, Inc. from 2009 until the company’s recent sale in 2012 to Bristol-Myers Squibb Co. Dr. Behrens Wilsey has worked for the last several years with KEW Group Inc. in developing a personalized medicine oncology management company and currently serves as KEW Group’s President & CEO.

 

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Pascale Witz Pascale Witz is the President and Chief Executive Officer of GE Healthcare’s Medical Diagnostics business (MDx), and an officer of the General Electric Company. MDx is a $2bn global leader in pharmaceutical and molecular diagnostics which are used by physicians in the early detection, diagnosis, and management of disease. Since joining MDx in 2009, Pascale has successfully expanded GE Healthcare’s diagnostics capabilities to include molecular diagnostics, broadening the portfolio through acquisition, investment and partnership. Pascale is deeply committed to enabling personalized medicine. She believes that combining in vivo and in vitro diagnostics will drive an integrated solution encompassing risk stratification, early detection, prediction and monitoring, which will enable physicians to diagnose and treat disease more effectively. According to Pascale, precision diagnostics allow us to interrogate the pathways that drive cancer and age-related neurodegenerative diseases such as Alzheimer’s Disease and Parkinson’s Disease. Pascale has more than 16 years of leadership at GE Healthcare including heading the Functional Imaging (Nuclear Medicine and PET) and the CT (Computed Tomography) businesses in EMEA. Prior to her current position, she led GEHC’s global Interventional business, developing innovative medical technologies for interventional radiology and cardiology. Prior to joining GE, Pascale spent five years in the pharmaceutical industry, having started her career working in a molecular biology research laboratory. She is an active leader in the GE Women’s Network and now serves on its executive board. The GE Women’s Network boasts a membership of over 180,000 women globally with a goal of focusing on the professional development of women throughout the company. Pascale holds a Master’s degree in life sciences/molecular biology from INSA Lyon, and an MBA from INSEAD.

 

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George Yancopoulos, M.D., Ph.D. George Yancopoulos, M.D., Ph.D. graduated as valedictorian of both the Bronx High School of Science and Columbia College, and earned his advanced degrees at Columbia University’s College of Physicians and Surgeons. Following widely-recognized work in the field of molecular immunology at Columbia with Dr. Fred Alt, Dr. Yancopoulos left academia in 1989 as founding scientist for Regeneron Pharmaceuticals, where he continues to serve as President of the Laboratories and Chief Scientific Officer. He is also adjunct full professor at Columbia University and was awarded Columbia’s Stevens Triennial prize for Research and the University Medal of Excellence for Distinguished Achievement. Dr. Yancopoulos is widely regarded as a world leader in several fields of biology and has authored more than 350 scientific manuscripts. According to a study by the Institute for Scientific Information, Dr. Yancopoulos was the eleventh most highly cited scientist in the world during the 1990’s. In 2004, he was elected to both the National Academy of Sciences and the American Academy of Sciences. Dr. Yancopoulos’ scientific efforts have focused on the discovery of growth factors (such as the neurotrophins, ephrins and angiopoietins), their receptors, and their signaling pathways, as well as on developing new platforms for target and drug discovery such as Trap Technology, VelociGene and VelocImmune. His research has led to unifying models of molecular and biologic function, as well as new approaches to treating disease. Dr. Yancopoulos and his team have progressed numerous drug candidates to human trials, including the IL1-Trap (ARCALYST®) which has recently been approved for treatment of an orphan inflammatory disease, the VEGF Trap-Eye (EYLEA®) which has recently been approved for age-related macular degeneration (the most common cause of blindness in the elderly), the VEGF Trap-Onc (ZALTRAP®) for cancer, and several fully human monoclonal antibodies derived using VelocImmune technology for various indications including cholesterol-lowering and inflammatory diseases.

 

Register online at www.personalizedmedicineconference.org .
Follow the conversation online at @HarvardPMConf and #PMConf.

BLOG UPDATES

http://pcpgm.partners.org/blog_updates

 SOURCE:

http://pcpgm.partners.org/education/pmconference

 

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Personal Tale of JL’s Whole Genome Sequencing

Posted in Bio Instrumentation in Experimental Life Sciences Research, Chemical Genetics, Computational Biology/Systems and Bioinformatics, Genome Biology, Genomic Testing: Methodology for Diagnosis, Medical and Population Genetics, Molecular Genetics & Pharmaceutical, Patient Experience: Personal Memories of Invasive Medical Intervantion, Personalized and Precision Medicine & Genomic Research, Population Health Management, Genetics & Pharmaceutical, Technology Transfer: Biotech and Pharmaceutical, tagged Full genome sequencing, genetics, George Church, Harvard Medical School, Harvard University, John Lauerman, Personal Genome Project on November 24, 2012| 2 Comments »

Reporter: Aviva Lev-Ari, PhD, RN

Word Cloud by Daniel Menzin

Unexpected scary findings: the tale of John Lauerman’s whole genome sequencing

FEBRUARY 15, 2012

Joe Thakuria draws John Lauerman’s blood for whole genome sequencing. By Madeleine Price Ball, licensed under CC-BY-SA.

Unexpected scary findings: the tale of John Lauerman’s whole genome sequencing » Joe Thakuria draws John Lauerman’s blood

by Madeleine Price Ball

Madeleine Price Ball, PhD is a PGP research scientist in George Church’s lab at Harvard Medical School.

Several months ago John Lauerman, a reporter for Bloomberg News, approached the Personal Genome Project interested in having his whole genome sequenced. While we have hundreds of genomes in the sequencing pipeline, of the dozen or so genomes we have sequenced to-date, so far the results have been for the most part uneventful.

Lauerman’s case was different: we found something rare and “famous”, and something that nobody could have anticipated by looking through family history: a mutation that was acquired rather than inherited. This genetic variant (JAK2-V617F) is one of a number of mutations that can accumulate in blood stem cells, a precursor that could lead to several rare blood diseases.

Last night Lauerman published his experience, and we encourage all participants to read it. It confronts us with a scenario that seems likely to affect others who forge into this new and unknown territory: the very real possibility that whole genome sequencing may uncover something unexpected, ambiguous, and scary. This certainly isn’t an outcome we anticipate for most participants, but it is a rare possibility all should be aware of. Would you rather know that you carry such a variant, even if that knowledge might not help your health at all? Although some would decline, PGP participants are the sort of people who say: “Yes, I’ll take that risk, I’d rather know!” [see footnote]

His experience also illustrates potential for the Personal Genome Project to guide health care, for himself and for those who follow. The JAK2-V617F variant is so rarely seen in healthy individuals, we have very little understanding of what to expect. It has almost always been seen after a patient is diagnosed with a disease, not before. Will he develop one of these diseases? If so, which one? Perhaps many people carry the variant but never develop any symptoms of disease. In coming years Lauerman will likely continue to monitor his blood for signs of disease. It is possible that he will never develop the disease, and we hope this is the case. On the other hand, through monitoring he may detect disease sooner than he otherwise would have. By making his experiences public, his case can inform future individuals who confront the same finding.

As we move onward to sequencing hundreds and thousands of genomes, we can’t promise such interpretations will be made in a timely manner. We’re working with other groups to improve our ability to interpret genomes — and PGP participants are the perfect testbed for this development! — but it’s much harder than you might think. Genome data is made public in 30 days, but months or even years could pass before a serious and potentially scary variant is noticed. Participating in the PGP not only means that you risk learning ambiguous and scary news, but that it may be uncovered long after your data has been made public. We are always grateful to participants who choose to step into that unknown territory of genome sequencing, and who share their data so that others may learn.

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Footnote: In the early stages of enrollment, individuals interested in joining the Personal Genome Project are asked to think about whether there are specific types of genetic information that they might not want to learn about themselves. Our examples include medical conditions with no effective cures or therapies, cancer, degenerative diseases, and stigmatized traits (e.g. mental illness). We do not offer the review or redacting of such information on a case-by-case basis. Only participants who wish to take the risk of learning such information are allowed to proceed with enrollment.

SOURCE:

http://blog.personalgenomes.org/2012/02/15/unexpected-scary-findings-the-tale-of-john-lauermans-whole-genome-sequencing-2/lauerman_blood_draw/

http://www.personalgenomes.org/

Harvard Mapping My DNA Turns Scary as Threatening Gene Emerges

By John Lauerman – Feb 15, 2012 12:01 AM ET

Four months after I walked into a lab at Harvard University and gave a vial of blood to have my genome sequenced, my search to understand my DNA led me to Mark Sanders, a former Indiana firefighter.

It took a little while to explain why I was calling and then he told me his story:

Enlarge image

Sophie Liu, research scientist at Complete Genomics Inc., at a sequencing center at the company’s research facility in Mountain View, California. Photographer: David Paul Morris/Bloomberg

Feb. 15 (Bloomberg) — Bloomberg News reporter John Lauerman talks about the results of his genome sequencing. The genome contains the DNA instructions for making all the body’s cells and tissues. Lauerman discussed the report with a team from Harvard Medical School’s Personal Genome Project, who will use the results in their efforts to better understand variations in the human genome and their implications for health and disease. (Source: Bloomberg)

Joseph Thakuria, clinical director of the Personal Genome Project draws blood from Bloomberg reporter John Lauerman for the Project at Harvard Medical School in Boston on Sept. 13, 2011. Photographer: Madeleine Price Ball/Harvard Medical School via Bloomberg

Deep Breath

After recovering, Sanders retired from firefighting to garden and play the fiddle. He knows other myelofibrosis patients who haven’t fared as well.

“I had been so physically fit all my life,” he said. “There’s no reason or rhyme to why I have it or got it, and there’s not a lot of people around you can talk to who have it.”

I hung up the phone and took a deep breath. DNA in his blood cells carried the same rare genetic variant that my sequencing had revealed.

The variant is linked to a group of blood disorders, of which primary myelofibrosis is the most serious. Doctors don’t know whether this gene variant itself causes disease, yet it is seen so often in three blood disorders that its presence is used to confirm their diagnosis. I had to consider that my future might hold a fate similar to Sanders’s.

Genome-Sequencing Report

My path to Sanders began on Monday, Jan. 2, when I was sitting alone in my office in downtown Boston. Just after 4 p.m., I got an e-mail message from Madeleine Ball, a Harvard University researcher, telling me that the results of my genome sequencing were ready. The procedure is gaining use in cancer clinics and children’s hospitals, and will become increasingly common as the cost drops to $1,000, no more than that of many diagnostic procedures, such as MRI or colonoscopy, manufacturers and researchers say.

Before even a minute had gone by, the lengthy report was there for me to view.

“Here it is,” I thought, clicking on my inbox. “Mortality in an e-mail.”

Even as my DNA was chopped up, labeled, photographed and decoded by machines in California, the speed and power of sequencing was exploding. Life Technologies Corp. (LIFE) said Jan. 10 that its new Ion Proton machine will be able to sequence an entire genome in a day, for $1,000. Last month,Roche Holding AG (ROG) made a $5.7 billion hostile bid forIllumina Inc. (ILMN), which said it will also soon have machines that can provide 24-hour genome sequencing. Google Inc. (GOOG) and Amazon.com Inc. were investing in technologies to manage the tidal wave of information coming from these machines.

Personal Struggle

Now my own deciphered genome, the chemical instructions for making all the cells and tissues of my body, was complete. That evening marked the start of a medical and personal struggle to understand the report’s findings. The genome rules our bodies in ways that remain enigmatic. Many of the diseases and medical conditions I thought would emerge in the analysis, didn’t. At the same time, there were unpleasant surprises that cast a shadow on my future and now confront me and my family with tough medical decisions.

Before my sample was taken, I met with Denise Lautenbach, a genetic counselor who works in research programs at Harvard Medical School. We’d discussed the possible revelations that might come. My father, grandfather and some uncles have suffered from a shaking disorder called essential tremor. I worried about other conditions that run in my family, such as thyroid disease, diabetes and depression. While dementia isn’t a theme, I was curious about whether I have the APOE4 gene variant that raises the risk of Alzheimer’s disease.

Breast Cancer Risk

I also prepared by speaking with others who have had their genomes sequenced. Greg Lucier, chief executive officer of sequencer maker Life Technologies, discovered he has a gene that might raise the risk of breast cancer in himself and his daughter. Would I find out the same thing? What about far rarer conditions, such as amyotrophic lateral sclerosis and Huntington’s disease, both of which can be predicted by sequencing?

My mind raced as I scanned the results that late Monday afternoon, looking for familiar words and phrases that might be connected to other conditions that run in my family.

Good Report

It appeared to be a good report. I saw a genetic variant linked to slightly higher-than-normal risk of an age-related eye disease called macular degeneration. No surprise; about 10 percent of the U.S. develops this condition, and my mother has it. There was a variant linked to higher schizophrenia risk; again, not a huge boost in odds of a disease that affects about 1 percent of the population (and which I’m probably too old to develop). There were gene variants linked to liver and bowel disease, neither of which I suffer from.

Then my eyes were drawn back to the top of the report and a variant called JAK2-V617F. I realized then that the list was ranked in order of medical importance. Clicking on an entry brought me to a few pages of medical information, and those pages were linked to published scientific and medical studies. I began reading about JAK2 more closely.

This wasn’t good. The report classified the JAK2 variant’s clinical importance as “high,” and its impact as “well- established pathogenic,” meaning harmful. It’s seen frequently in people with rare “cancer-like” blood diseases. Indeed, as the report said, doctors test for the JAK2 variant to confirm cases of these diseases, called myeloproliferative disorders.

Unclear View

Did that mean that I already had a rare disease? My eyes widened. I read on.

Researchers currently see the variant as “one of an accumulation of changes that leads to the development of these cancer-like diseases,” the report said. “It is unclear how to view the presence of the variant in people who don’t have symptoms of the disease.”

After about 40 minutes of reading and thinking, I remained mystified. The report said “cancer-like.” I kept staring at the word “cancer,” while the companion “like” seemed to disappear. I’ve written about other people’s illnesses for years. What had started out as a cutting-edge science story was beginning to feel more like an unsettling visit to the doctor’s office with its confusion, struggles to understand, and shivers of dread.

Puzzling Medical News

“How worried should I be?” I kept thinking. Anticipation had been building inside me for months. Now my results were here and I barely knew what to make of the most important one.

I picked up the phone and called my wife, Judi, who’s a nurse. After 21 years of marriage, we’re accustomed to regular discussions of medical issues, in part because Judi has type 1 diabetes, which requires daily monitoring and insulin. Still, this was some of the most serious and puzzling medical news I’d ever received. I was careful to keep from sounding frightened.

“I got my results,” I said when she picked up the phone. I poured out the details, focusing on the JAK2 variant.

Judi’s voice was calm. I didn’t have any of the symptoms of diseases associated with the gene, she said. I’m usually energetic and active; that meant it wasn’t clear what the variant meant in my case.

“At least if there is a problem, we’ll find it earlier if you’re evaluated yearly,” she said.

“They told me that none of these results should be used to make medical decisions,” I said. “I’ll meet with the researchers later this week to talk about everything.”

New Chapter?

We agreed that, overall, the report was good news. I didn’t realize there was more news to come.

I left the office and got on my bike, which I had ridden to work that day. I pedaled carefully to make it home safely through the streets of Boston, which is never guaranteed, genes or no genes.

Three days after getting my results, I took a seat in the office of George Church, the Harvard scientist who started the Personal Genome Project that arranged my sequencing. Joe Thakuria, the clinical geneticist and project medical director who took my blood sample in this same office in September, was there to lead the discussion of my results. The team had been through meetings like this before, having analyzed and released the genomes of 10 people, including Church, in 2008. I was already feeling a stomach full of emotions: was this about to be a new chapter in my life? And if so, how long would that chapter be?

Thakuria asked if I had any questions before we began. I told them how thrilled I was that I hadn’t seen certain genes that I expected given my family’s medical history, such as the variant for essential tremor. I’d seen nothing in my report about Alzheimer’s risk, which I considered a good sign.

Not Bad News

The researchers stopped me. The technology used to sequence my DNA has difficulty penetrating certain portions of the genome. One such region contains the gene that makes a blood fat called apolipoprotein E. Consequently, my results might not show whether I have the version of a gene, called APOE4, which raises the risk of Alzheimer’s disease.

Never mind, I thought. I can live without that knowledge.

The absence of the gene for benign tremor, the condition my father and grandfather had, wasn’t necessarily such good news, the team explained. As-yet unknown genes might cause the same condition. No news wasn’t always good news; it just wasn’t bad news.

‘Very Rare’

With the three of us, along with Ball and Alexander Zaranek, another project researcher, crowded around the table in Church’s office, the team then turned to the JAK2 variant. The appearance of the gene in my blood had surprised even the Harvard scientists.

“This is probably the most serious variant that we’ve actually seen to date in the study,” Thakuria said. “It’s very rare.”

The JAK2 gene contains the DNA code for making a protein used to send signals through cells. About two out of 1,000 people have the V617F variant, which was discovered in 2005 and appears to encourage blood cells to grow and divide.

Many scientists believe it’s an acquired gene variant, meaning that I wasn’t born with it and my children and other blood relatives probably don’t have it. While JAK2 may have arisen in response to my own habits, at this point, it’s unclear what may have led to the mutation.

Blood Disorders

The JAK2 variant is found in about 90 percent of people with polycythemia vera, an oversupply of red blood cells. This disease is usually treated with drugs or phlebotomy, the draining of some blood from the system. It’s also frequently found in patients with essential thrombocytosis, an overproduction of platelets that usually requires no treatment and can be addressed with blood-thinners when patients have symptoms. It’s also used to diagnose primary myelofibrosis, the condition Sanders, the former firefighter, had. About 10 percent of these cases can develop into dangerous leukemias.

That’s three conditions linked to one gene. One of the three has a possibility of becoming cancerous, Thakuria said.

“I don’t want you to fret about this,” he said. It was the first of several times I would hear him say it.

At that point, Thakuria opened up a link to a 2010 study attached to the report. Scientists have been conducting studies of individual genes for years. The team had found a study of 10,507 people in Copenhagen who gave blood samples and then were followed for as long as 18 years. The Copenhagen researchers went back and analyzed the blood samples; 18 had the JAK2 variant.

‘Very Scary Figure’

What it showed was that 14 of the 18 people with the variant developed cancer in their lifetimes. All of the 18 died within the study period.

“That’s a very scary figure,” Thakuria said.

Information was starting to wash over me without really penetrating. I struggled to keep thinking of good questions for the team. Instead, I started asking myself questions: “What am I doing here? What are these people telling me?” I searched the faces arrayed around me, trying to see whether any of the researchers looked as panicked as I felt.

I tried to listen closely as Thakuria explained what the variant and the study might mean. There were a number of shortcomings in the Copenhagen study that made it difficult to interpret, he said. For example, he said, the authors had been liberal in their use of the word “cancer.” Some of the disorders developed by patients with the JAK2 variant were of the milder variety such as polycythemia vera, which isn’t typically classified as a cancer.

Issue of Deaths

Then there was the issue of deaths. It wasn’t clear whether people with the variant had died of the conditions they had been diagnosed with, or other causes, Thakuria said. Half of them had died in their 80s, and seven had died in their 70s. This is not far from average life expectancy, he pointed out.

“Half of them could have died of bicycle accidents,” he said, smiling.

There were other reasons not to fret, Thakuria said. Although the JAK2 variant often shows up in these conditions, no one knows precisely what role it plays. It may be a cause of the disorders, or an effect of changes elsewhere in the genome. The JAK2 variant was unlikely to be the only cause of these diseases; several things — things that remain unknown to us — would probably have to go wrong before any disease would arise. In this context, the gene wasn’t quite so scary, Thakuria said.

Black and White

I thought about a conversation I’d had with Ball just a few days earlier, while my genome were still being analyzed. I had called to see when the results were coming. She said they were “interesting,” but didn’t want to discuss them until a clinical geneticist had a chance to review them. Her voice sounded like she didn’t want to reveal everything she knew.

“I wish everything were black and white,” she said. “Unfortunately, things just don’t turn out that way very often.”

The researchers said I now needed to confirm that the sequencing was correct with another round of testing using a different technique. I would give another blood sample. If the variant was there, we’d talk more about what steps to take.

The meeting lasted almost two hours, and I left Church’s office with Thakuria. We walked to a restaurant about halfway between Harvard Medical School and Fenway Park to sit and have a drink. I continued to quiz him on the relationship between the JAK2 variant and the diseases we’d been talking about.

Ask Again

Sitting on a barstool next to Thakuria and listening to him discuss the JAK2 variant, I felt reassured. It occurred to me that this wasn’t how most people would receive the news of their results. As a reporter working on a story about genomics, I had access to experts that many people wouldn’t. What will happen as more people get results from broad genome sequencing?

I spoke about this during a meeting with Harold Varmus, director of the U.S. National Cancer Institute, and a co-winner of a Nobel Prize in 1989 for his work to find genes that promote the growth of cancer cells. I mentioned I had just received my results.

“How do you feel?” he asked.

“It’s been an interesting process,” I said. “It’s still playing out.”

Varmus nodded. Gathering genetic data from thousands of people can help researchers understand health by correlating gene variations with diseases, he said. He was concerned, however, that companies may not always ensure that people who have undergone sequencing will get a full understanding of their results.

‘How to Deal’

“Accumulating the information and studying it is good,” he said. “My concern is whether individuals are getting guidance on how to deal with the information.”

“People are being told they have a certain gene variant. In a mass population, that increases the risk of some diseases by, say, two-fold. That might be true in a mass population, but in any single individual’s genome, it’s not certain what that means.”

The Harvard researchers are struggling with these same issues, and are still working to streamline and improve their approach to giving results to study participants, Thakuria said.

“As we get more information from participants like you, we’ll gain a much better understanding of how to do it,” Thakuria said.

Animal Studies

I still felt like someone who kept shaking a toy Magic 8 Ball and getting the message: “Concentrate and ask again.” I decided to do a little research on my own. I found a 2010 study in the journal Blood showing that when the JAK2 variant was added to the genomes of mice, the animals later suffered from disorders similar to those seen in people with the gene.

This is just one of several animal studies suggesting that the JAK2 variant contributes directly to blood disorders, said John Crispino, a professor at Northwestern University Feinberg School of Medicine, who studies the gene. Skeptics point out that drugs that interfere with JAK2 don’t cure patients suffering from the gene-linked blood disorders.

“The field is mixed,” he said. “My bias is that the JAK2 variant contributes to the pathology of the disease.”

I wanted to find out what kind of people have the JAK2 mutation I have, and what’s happened to them. In addition to Sanders, the Indiana firefighter, I spoke with Bob Rosen, chairman of theMPN Research Foundation, a Chicago-based advocacy group for people with myeloproliferative disorders, and he had a surprise for me.

Red Blood Cells

About 14 years ago, Rosen went to a doctor because of pain in his fingers and toes. A complete blood count revealed high levels of red blood cells. He was diagnosed with polycythemia vera and was first treated with phlebotomy. He now takes a drug that controls his blood cell levels. With his treatment, he’s still able to work out, and had been playing basketball on the day I called him.

“I’ve been lucky,” he said. “The risk is that, over time, new symptoms will emerge or there will be a progression to something worse.”

A small percentage of patients with polycythemia vera can develop more serious conditions, such as primary myelofibrosis and certain leukemias, Rosen said. I hadn’t realized this, or hadn’t absorbed it, until now.

Another Surprise

Then, another surprise arrived. Looking at my report, I saw it had been updated electronically, as the genome project research team had told me would happen from time to time. Now, the second entry on my list of variants was labeled “APOE- C130R” — that’s another name for the APOE4 gene associated with increased risk of Alzheimer’s disease.

I kept reading, recalling that I had been told my ApoE result wasn’t accessible with the technology used to sequence my genome. As it turned out, the technology had worked after all. I was at increased risk for Alzheimer’s.

This was exactly the kind of news I had hoped I wouldn’t receive.

A few days later I got an e-mail from Ball, of the Harvard team.

“Sorry this was missed earlier,” she said in the e-mail. She recommended that I look at the studies she’d collected on APOE4, some of which casts doubt on the role of the variant as a strong factor in causing Alzheimer’s. According to one estimate, people who have one copy of the gene, as I do, have a 3 percent increased risk of developing the disease by age 80.

Better to Know

One of my parents must have had this gene variant in order for me to get it. Yet my mother is in her late 70s and my father is 80; neither of them has Alzheimer’s disease. The longer I thought about it, the less I worried.

I talked with my two children, Hanna and James, about their feelings regarding the JAK2 and Alzheimer’s gene variants. My daughter, a sophomore in college, said she thinks it’s an advantage to be aware of a health threat.

“If there’s a treatment for it, you could start earlier,” she said. “It’s better to know.”

My next stop was to see my doctor. While she didn’t want her name used in this story, she agreed to let me write about our conversations and paraphrase her comments.

I followed an aide into an exam room. Nothing about my body had changed since the genome test was done. I still had normal blood pressure and pulse, and my weight was steady.

My doctor had heard of the JAK2 variant. If the result was confirmed, I would need to have my blood count tested. If there was an oversupply of red blood cells or platelets, or signs of damaged bone marrow, we would start thinking about treatment, such as removing blood. She asked me how I was feeling.

‘Not Sick’

“I feel fine,” I said. “I’m not sick.”

I didn’t mention that every time I thought about the JAK2 variant, itching followed. I had read that itching was one of the symptoms of polycythemia vera. Even as I write these words, I’m scratching my forehead. I never feel itchy when not thinking about my genome. I also started noticing memory lapses.

This kind of behavior is often called “medical student syndrome,” because doctors in training who are learning to diagnose new diseases turn their skills on themselves. I assumed it was this syndrome I was suffering from, rather than a blood disorder.

It seemed like a good time to return to the Boston office of Aubrey Milunsky, the director of the Boston University Center for Human Genetics who had warned me in May that having my genome sequenced would just cause me needless worry.

“Why would you want to know that?” he had asked me then.

Milunsky was well-acquainted with the JAK2 variant on my report. Just as the team at Harvard had said, he mentioned that there was little known about the long-term impact of the variant in people. He noted that it’s also associated with some cases of dangerous clotting in abdominal blood vessels.

“You know it’s there, but you don’t know what it means,” he said. “You’re smack in the territory of inviting anxiety into your life. And this may have no meaning whatsoever in your entire life.”

Useful Vigilance

I disagreed. The results had actually taken some uncertainty out of my life, I told Milunsky. We all bear some health risks, and that’s why doctors recommend, for instance, that everyone get regular checkups and those 50 and older undergo tests for colon cancer. I have a rare mutation linked to rare conditions, most cases of which can be treated. Wouldn’t it make sense for me to undergo a blood test regularly to see whether my blood counts had changed?

Such vigilance might be beneficial, and it might not, Milunsky said. I might live the rest of my life with my health unaffected by the variant. Yet the exercise had shown that I had discovered things I’d rather not know, he said. Others who undergo the same procedure will surely find out that they have mutations that practically guarantee they will develop serious and perhaps even fatal diseases, he said.

Huntington’s Disease

Indeed, a 1999 study in the American Journal of Human Genetics found that about 1 percent of 4,527 people who were told they had the gene that causes Huntington’s disease, a progressive nervous system disorder, attempted or committed suicide, or were hospitalized for psychiatric reasons.

Medical researchers are still trying to determine when it makes sense to do more common tests for breast and prostate cancer. A certain percentage of people who get positive results on these screening exams will go on to have unneeded treatment that may cause harm. In October, a government panel recommended that blood tests used to screen for prostate cancer should only be performed on men with symptoms. The same panel said in 2009 that women should start getting mammograms at age 50, rather than 40.

On Jan. 25, at about 11 p.m., I got a phone call from Thakuria. We had arranged to speak late in the day to accommodate busy schedules.

‘Mutation Confirmed’

“The mutation confirmed,” he said. He didn’t say “JAK2,” but I knew that was what he was talking about.

The next step for me is to have my white and red blood-cell levels measured, along with those of platelets. Doctors will also study the appearance of these cells under a microscope and check to see how much oxygen my blood can carry. I expect these tests to be normal. If they aren’t, it’s possible that I’ll start getting blood drawn from my system or drug treatment for polycythemia vera. I may need to take a blood thinner, such as aspirin, to counteract the effects of excess platelets. Should I have evidence of more serious disease, stronger treatment may be needed.

“I’m not going to lie to you: I’d rather you didn’t have it,” Thakuria said. “This isn’t like one of those mutations that have specific recommendations. There are no guidelines here. This is part of being on the frontier.”

To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net

To contact the editor responsible for this story: Jonathan Kaufman at

jkaufman17@bloomberg.net

SOURCE:

http://www.bloomberg.com/news/2012-02-15/harvard-mapping-my-dna-turns-scary-as-threatening-gene-emerges.html

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Expanded Capabilities in Fluorescence Microscopy

Posted in Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Disease Biology, Small Molecules in Development of Therapeutic Drugs, FDA Regulatory Affairs, Imaging-based Cancer Patient Management, Medical Devices R&D Investment, Molecular Genetics & Pharmaceutical, Technology Transfer: Biotech and Pharmaceutical, tagged DNA, Harvard Medical School, Harvard University on November 5, 2012| Leave a Comment »

Barcode Of Me (Photo credit: Purple_Mecha)

Larry H Bernstein, MD, FACP, Reporter

from the DARK Report (—Pamela Scherer McLeod)

 

Harvard Researchers’ New DNA Barcoding May Give Pathologists Expanded Capabilities in Fluorescence Microscopy 

November 5, 2012

New biomedical imaging technology could enhance pathologists’ ability to examine tissue samples via fluorescence microscopy
Scientists at Harvard University’s Wyss Institute for Biologically Inspired Engineeringhave developed a new DNA, barcoding technique. The fluorescence microscopy approach has significant implications for the imaging community.

Beyond imaging, however, pathologists will be able to use this same technology when evaluating tissue specimens.

The new method could enable simultaneous imaging of many different types of molecules in a single cell, according to Peng Yin, Ph.D., Associate Professor of Systems Biology at Harvard Medical School and Core Faculty Member at Wyss Institute. The developers expect the method to provide researchers with a richer, more accurate view of cell behavior than is possible using current techniques.

Pathologists Could Adopt DNA Barcoding for In Vitro Diagnostics

“We hope this new method will provide much-needed molecular tools for usingfluorescence microscopy to study complex biological problems,” stated Yin, the study’s co-author, in a recent press release.

1903 Siedentopf Fluorescence Microscope (Photo credit: Carl Zeiss Microscopy)

 

 

Using DNA Origami to Create Fluorescent Linear DNA Barcodes
The newly engineered DNA barcode harnesses the natural ability of DNA to self-assemble. The basis of the new technology is a process called DNA origami. This enables scientists to arrange colored dots, or fluorophores, into geometric patterns, or fluorescent linear DNA barcodes.

These imaging probes translate a cell’s invisible biological information, such asproteins or RNA molecules, into detectable signals, noted a summary of Yin’s research on the Wyss website. These signals help researchers better understand the role of cell behavior in the onset and progression of disease.

New Barcode Could Offer a Virtually Unlimited Number of Styles

Scientists currently use fluorescence microscopy to pair fluorescent elements—the barcodes—with molecules they know will attach to the part of the cells they want to investigate. When they illuminate the sample, it triggers each kind of barcode to fluoresce at a particular wavelength of light, which indicates the location of the molecules of interest.

Click Here for Photo
Researchers at Harvard’s Wyss Institute recently engineered a new DNA barcode. Labeled DNA samples appear as multi-colored barcodes under fluorescent light at certain wavelengths. Pathologists and clinical laboratory professionals will recognize the potential of this technology in the examination of tissue specimens. (Photo credit: Rick Groleau, Harvard University.)

However, the multiplexing ability of fluorescence microscopy is limited by the number of spectrally distinguishable fluorophores, a story in Nature Chemistry explained. The barcodes that scientists currently use have only three or four colors available, such as red, blue, or green. And sometimes those colors blur. This limits the number of objects scientists have been able to study in a cell sample at one time.

Multiplex Capability with 216 Readable Color Combinations

Using the new method, Yin was able to demonstrate 216 color combinations resulting from attaching just three colors to a DNA nanotube, the press release stated. With the new barcode, the combinations are almost limitless. This will significantly advance the ability to fluoresce more cellular structure than previously possible.

DNA origami works by programming a long strand of DNA to self-assemble by folding in on itself, the release stated. Shorter strands, called staples, help it to create predetermined forms. Researchers then attach fluorescent molecules to the desired spots on the now more structurally complex DNA nanostructures. In this way, they use origami technology to generate a large pool of barcodes out of only a few fluorescent molecules.

“We can essentially use DNA joints to assemble the nanostructures into long rods, and we can modify the rods with fluorescence at different locations,” declared Yin. “We then use these tiny rods to arrange the fluorescent spots into colorful barcodes. Basically now using three or four colors, we can have hundreds of different barcodes,” he observed in a story in The Harvard Crimson.

A New Tool in the Cellular Imaging—and In Situ Examination—Toolbox

“[The technique] holds great promise for using the method to study cells in their native environments,” Yin observed. Additionally, the technique is low-cost, easy to do, and more robust compared to current methods, according to Yin.

Pathologists and clinical laboratory managers will recognize the range of potential of this new technology, from developing targeted drug-delivery mechanisms to improving the scope of cellular and molecular activities scientists are able to observe at a disease site.

—Pamela Scherer McLeod

 

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Country’s Genetic Diversity can predict the success of its Economy: On Economics and Genetics

Posted in Computational Biology/Systems and Bioinformatics, Genome Biology, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, Personalized and Precision Medicine & Genomic Research, Population Health Management, Genetics & Pharmaceutical, tagged Genetic diversity, Harvard Medical School, Harvard University, Stephen Jay Gould, Tufts University on October 16, 2012| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

 

Economics and genetics meet in uneasy union

Use of population-genetic data to predict economic success sparks war of words.

• Ewen Callaway

10 October 2012 Corrected: 

1. 12 October 2012

The United States has the right amount of genetic diversity to buoy its economy, claim economists.

picture: D. ACKER/BLOOMBERG VIA GETTY

“The invalid assumption that correlation implies cause is probably among the two or three most serious and common errors of human reasoning.” Evolutionary biologist Stephen Jay Gould was referring to purported links between genetics and an individual’s intelligence when he made this familiar complaint in his 1981 book The Mismeasure of Man. 

Fast-forward three decades, and leading geneticists and anthropologists are levelling a similar charge at economics researchers who claim that a country’s genetic diversity can predict the success of its economy. To critics, the economists’ paper seems to suggest that a country’s poverty could be the result of its citizens’ genetic make-up, and the paper is attracting charges of genetic determinism, and even racism. But the economists say that they have been misunderstood, and are merely using genetics as a proxy for other factors that can drive an economy, such as history and culture. The debate holds cautionary lessons for a nascent field that blends genetics with economics, sometimes called genoeconomics. The work could have real-world pay-offs, such as helping policy-makers to “reduce barriers to the flows of ideas and innovations across populations”, says Enrico Spolaore, an economist at Tufts University near Boston, Massachusetts, who has also used global genetic-diversity data in his research.

But the economists at the forefront of this field clearly need to be prepared for harsh scrutiny of their techniques and conclusions. At the centre of the storm is a 107-page paper by Oded Galor of Brown University in Providence, Rhode Island, and Quamrul Ashraf of Williams College in Williamstown, Massachusetts¹. It has been peer-reviewed by economists and biologists, and will soon appear in American Economic Review, one of the most prestigious economics journals.

Related stories

• Studies slow the human DNA clock
• Human cycles: History as science
• Political instability may be a contributor in the coming decade

More related stories

The paper argues that there are strong links between estimates of genetic diversity for 145 countries and per-capita incomes, even after accounting for myriad factors such as economic-based migration. High genetic diversity in a country’s population is linked with greater innovation, the paper says, because diverse populations have a greater range of cognitive abilities and styles. By contrast, low genetic diversity tends to produce societies with greater interpersonal trust, because there are fewer differences between populations. Countries with intermediate levels of diversity, such as the United States, balance these factors and have the most productive economies as a result, the economists conclude.

The manuscript had been circulating on the Internet for more than two years, garnering little attention outside economics — until last month, when Science published a summary of the paper in its section on new research in other journals. This sparked a sharp response from a long list of prominent scientists, including geneticist David Reich of Harvard Medical School in Boston, Massachusetts, and Harvard University palaeoanthropologist Daniel Lieberman in Cambridge.

In an open letter, the group said that it is worried about the political implications of the economists’ work: “the suggestion that an ideal level of genetic variation could foster economic growth and could even be engineered has the potential to be misused with frightening consequences to justify indefensible practices such as ethnic cleansing or genocide,” it said.

“Our study is not about a nature or nurture debate.”

The critics add that the economists made blunders such as treating the genetic diversity of different countries as independent data, when they are intrinsically linked by human migration and shared history. “It’s a misuse of data,” says Reich, which undermines the paper’s main conclusions. The populations of East Asian countries share a common genetic history, and cultural practices — but the former is not necessarily responsible for the latter. “Such haphazard methods and erroneous assumptions of statistical independence could equally find a genetic cause for the use of chopsticks,” the critics wrote.

They have missed the point, responds Galor, a prominent economist whose work examines the ancient origins of contemporary economic factors. “The entire criticism is based on a gross misinterpretation of our work and, in some respects, a superficial understanding of the empirical techniques employed,” he says. Galor and Ashraf told Nature that, far from claiming that genetic diversity directly influences economic development, they are using it as a proxy for immeasurable cultural, historical and biological factors that influence economies. “Our study is not about a nature or nurture debate,” says Ashraf. 

“It seems like the devil is in the interpretation more than the actual application of the statistics,” says Sohini Ramachandran, a population geneticist at Brown University who provided the genetic data for the study. She adds that Galor and Ashraf used estimates of genetic diversity that she and her colleagues specifically developed to overcome many of the confounding factors caused by the overlapping genetic and cultural histories of neighbouring countries.

Galor and Ashraf are not the first economists to use genetic-diversity data. Spolaore has also found that the differences in genetic diversity between countries can predict discrepancies in their level of economic development². But he is clear that this is not necessarily a causal relationship:  “In my view it’s not genetic diversity itself that is responsible for this correlation,” he says. “A lot of this could be culture.”

Some say that the field needs a dose of rigour. Many studies linking genetic variation to economic traits make basic methodological errors, says Daniel Benjamin, a behavioural economist at Cornell University in Ithaca, New York. He is part of the Social Science Genetics Association Consortium, a group that brings together social scientists, epidemiologists and geneticists to improve such studies. Problems that medical geneticists have known about for years — such as those stemming from small sample sizes — crop up all too often when economists start to work with the data, he says.

For instance, while searching for genetic associations with factors such as happiness and income in a study of 2,349 Icelanders, Benjamin and his colleagues found a statistically significant association between educational attainment and a variant in a gene involved in breaking down a neurotransmitter molecule³. But the researchers could not replicate this association in three other population samples — a test for false positives that is standard practice in medical genetics — and the team now has reservations about the association. If the field is to develop fruitfully, “I think it’s essential for us to have geneticists involved”, says Benjamin. “We couldn’t do it without their help and insight.”

Nature 490, 154–155 (11 October 2012) doi:10.1038/490154a

Corrected:

In the original text, we wrongly attributed to Enrico Spolaore the opinion that using genetic data in economics could help policy-makers to set immigration levels. He actually suggested that the work could reduce barriers to the flows of ideas and innovations across populations. The text has been amended to reflect that.

References

1. Ashraf, Q. & Galor, O. Am. Econ. Rev. (in the press).

   Show context

2. Spolaore, E. & Wacziarg, W. Q. J. Econ. 124, 469–529 (2009).

   Show context

3. Benjamin, D. J. et al. Annu. Rev. Econ. 4, 627–662 (2012).

Related stories and links

From nature.com

• Studies slow the human DNA clock

  18 September 2012

• Human cycles: History as science

  01 August 2012

• Political instability may be a contributor in the coming decade

  03 February 2010

  Source:

   http://www.nature.com/news/economics-and-genetics-meet-in-uneasy-union-1.11565

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