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9:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

9:20 a.m. Panel Discussion – Genomic Technologies

Genomic Technologies

The greatest impetus for personalized medicine is the initial sequencing of the human genome at the beginning of this Century. As we began to recognize the importance of genetic factors in human health and disease, efforts to understand genetic variation and its impact on health have accelerated. It was estimated that it cost more than two billion dollars to sequence the first human genome and reduction in the cost of sequence became an imperative to apply this technology to many facets of risk assessment, diagnosis, prognosis and therapeutic intervention. This panel will take a brief historical look back at how the technologies have evolved over the last 15 years and what the future holds and how these technologies are being applied to patient care.

Genomic Technologies

Opening Speaker and Moderator:

George Church, Ph.D.
Professor of Genetics, Harvard Medical School; Director, Personal Genomics

Genomic Technologies and Sequencing

  • highly predictive, preventative
  • non predictive

Shareable Human Genomes Omics Standards

$800 Human Genome Sequence – Moore’s Law does not account for the rapid decrease in cost of Genome Sequencing

Genome Technologies and Applications

  • Genia nanopore – battery operated device
  • RNA & protein traffic
  • Molecular Stratification Methods – more than one read, sequence ties
  • Brain Atlas  – transcriptome of mouse brains
  • Multigenics – 700 genes: hGH therapies

Therapies

  • vaccine
  • hygiene
  • age

~1970 Gene Therapy in Clinical Trials

Is Omic technologies — a Commodity?

  • Some practices will have protocols
  • other will never become a commodity

 

Panelists:

Sam Hanash, M.D., Ph.D. @MDAndersonNews

Director, Red & Charline McCombs Institute for Early Detection & Treatment of Cancer MD Anderson Cancer Center

Heterogeneity among Cancer cells. Data analysis and interpretation is very difficult, back up technology

Proteins and Peptides before analysis with spectrometry:

  • PM  – Immunotherapy approaches need be combined with other techniques
  • How modification in protein type affects disease
  • amplification of an aberrant protein – when that happens cancer developed. Modeling on a CHip of peptide synthesizer

Mark Stevenson @servingscience

Executive Vice President and President, Life Sciences Solutions
Thermo Fisher Scientific

Issues of a Diagnostics Developer:

  • FDA regulation, need to test on several tissues
  • computational environment
  • PCR, qPCR – cost effective
  • BGI – competitiveness

Robert Green, MD @BrighamWomens

Partners, Health Care Personalized Medicine — >>Disclosure: Illumina and three Pharmas

Innovative Clinical Trial: Alzheimer’s Disease, integration of sequencing with drug development

  • Population based screening with diagnosis
  • Cancer predisposition: Cost, Value, BRCA
  • epigenomics technologies to be integrated
  • Real-time diagnostics
  • Screening makes assumption on Predisposition
  • Public Health view: Phenotypes in the Framingham Studies: 64% pathogenic genes were prevalent – complication based in sequencing.

Questions from the Podium:

  • Variants analysis
  • Metastasis different than solid tumor itself – Genomics will not answer issues related to tumor in special tissues variability

 

 

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

@HarvardPMConf

#PMConf

@SachsAssociates

 

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Reporter: Aviva Lev-Ari, PhD, RN

Stanford University and NIST, Launch Biomedical Measurement Science Program; Partners Include Life Tech and Agilent

June 21, 2013

NEW YORK (GenomeWeb News) – Stanford University and the National Institute of Standards and Technology have launched a new program that aims to develop methods for measuring the accuracy and comparability of life sciences and genomics technologies, particularly tools that are expanding beyond the lab and into clinical medicine.

The Advances in Biomedical Measurement Science (ABMS) program will use funding and resources from Stanford and NIST, as well as from commercial partners Life Technologies and Agilent Technologies, to develop industry consensus standards and standard reference materials for a range of genomics and imaging technologies, Marc Salit, leader of NIST’s Multiplexed Biomolecular Science Group, Biosystems and Biomaterials Divisions, told GenomeWeb Daily News today.

The ABMS partners plan to focus on technology areas that are edging their way into clinical medicine and other applications, including the use of high-throughput sequencing for HLA typing; stem cell phenotyping and genotyping; quantitative imaging for non-invasive cancer diagnosis and for drug response and screening; synthetic biology; and multiparameter protein measurement.

The partners expect that improving the accuracy and comparability of data from these tools will make it easier and faster to make decisions about how they will be used in research and in the clinic, and how they might be regulated.

The initiative is part of an effort by NIST to expand its presence in biotechnology, healthcare, and biomedicine, particularly through partnerships with universities that have competencies, medical facilities, and expertise in areas that the institute lacks.

“Stanford has a critical mass of some of these assets, and NIST thought [the ABMS program] would be an efficient way to expand its presence in the healthcare and biomedical areas,” Salit said.

“NIST was a spectacular resource for the century of physics in the 20th Century; we want to be that resource for the century of biology, this century,” he told GWDN. “We wanted to see if we could take what we had developed in chemistry — in terms of measurement assurance and the kinds of things that bring confidence to measurement results — and transfer it into genomic measurement.”

Several NIST researchers have relocated to Stanford from their offices in Gaithersburg, Md., and will work directly with established Stanford investigators and postdocs, while around half of Salit’s team will remain at the Maryland lab, he said.

Another selling point of this partnership for NIST is that it enables the agency to establish “a permanent presence” on the West Coast, near Silicon Valley, Salit said.

NIST has other well-established joint institutes at US universities, and the long-term aim is that the ABMS will be “a seed from which such a joint institute could grow,” Salit explained.

The program will operate as a virtual center at first, where investigators from NIST, Stanford, and the industry partners will “work shoulder to shoulder” to study genomics and imaging technologies that are working their way into clinical care, he added.

“Some of these [Stanford and industry] research groups have instruments and technologies that exist commercially which would benefit from a real thorough study, from a measurement science perspective” said Salit.

Tom Baer, director of the Advances in Biomedical Measurement Science Program, told GWDN that the life sciences companies involved in the program have a strong interest in working with partners to test, measure, and analyze their technologies in new ways. The two companies already involved, and any future industry partners, will pay annual fees to help support the program, he noted.

“We expect that there will be significant standards reference materials and protocols that will come out of the joint research here with Mark’s group on campus. And [Life Technologies and Agilent] are going to benefit because there will be some really first-class scientists working with their instrumentation, studying how well they perform now and coming up with ways that they could potentially be improved,” said Baer, who also is executive director of the Stanford Photonics Research Center.

Salit noted that NIST does not develop government regulations but informs their development, and added that in working with tech companies its mission is to help “grow the whole pie bigger,” and to support the US technology industry enterprise broadly.

This kind of partnership, he said, also will engage experts from the Food and Drug Administration, which will “bring real value” to these companies.

The HLA typing project, which will study the use of high-throughput sequencing and other nucleic acid-based technologies for identifying immune responses to bone marrow and stem cell transplantation, is a “perfect example” of the kind of program the partners will pursue, Baer explained. “This has great resonance with at least one of the commercial partners, who is trying to develop methods and products around HLA typing,” he added.

“We’re looking to identify areas of great medical need in the whole area of tissue transplants, both as it exists today and as it is going to grow with the stem cell and regenerative medicines initiatives that are underway,” said Baer. “This is an area of critical medical need where measurement science can play a very important role with the new quantitative technologies that are currently available.”

He said the HLA typing effort is “a prototype of how we’re developing the research programs at ABMS.” The goal is “to look not just at the concept of how you do this measurement, but what is the problem, where is measurement playing a role, and how we can improve the performance of the systems and technologies through both standards development, better understanding, and measurement science,” Baer said.

Baer also said that he expects this project will serve to educate regulatory agencies about “what is legitimate scientific data with a legitimate use of particular instrumentation, and what protocols have intellectual or scientific merit or not.”

He noted that NIST wasn’t aware of this need prior to beginning a dialogue with the Stanford researchers. “By coming here and interacting directly with groups that have patient contact, and dealing with developing solutions to significant medical problems, we are able to focus NIST on these areas and bring the resources of the medical community here at Stanford to bear with NIST, as well as with the companies that are supplying the instrumentation,” said Baer.

Matt Jones is a staff reporter for GenomeWeb Daily News. He covers public policy, legislation, and funding issues that affect researchers in the genomics field, as well as the operations of research institutes. E-mail Matt Jones or follow GWDN’s headlines at @DailyNewsGW.

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Reporter: Aviva Lev-Ari, PhD, RN

With $15.5M Grant, EU Consortium to Sequence 1,100 Exomes to Develop Diagnostics for Neurologic Diseases

November 28, 2012

A consortium of 18 European and Australian institutions and industry partners will spend five years sequencing the exomes of 1,100 patients with neurodegenerative and neuromuscular diseases to create diagnostic panels and uncover novel therapeutic targets.

The group, known as the Neuromics Consortium, is funded with €12 million ($15.5 million) under the European Union’s seventh framework program.

Headed by the University of Tübingen, the project will involve collaboration between 12 academic centers. Iceland’s Decode Genetics will do the sequencing and will support analysis and return of results to participants. The group also plans to work with Agilent Technologies to develop and validate targeted sequencing-based diagnostic panels for specific neurologic diseases, including ataxia/paraplegias, spinal muscular atrophies and lower motor neuron diseases, and neuromuscular diseases, according to Tübingen’s Holm Graessner, the manager of the consortium.

Graessner told Clinical Sequencing News in an email that the Neuromics Consortium hopes its work will yield better diagnostic panels that can increase the diagnosis rate for ten main neurodegenerative and neuromuscular disease types — including ataxia, spastic paraplegia, Huntington’s disease, muscular dystrophy and spinal muscular atrophy — as well as provide information on genes and pathways that could inform new treatments.

According to the consortium, 30 percent to 80 percent of patients with these diseases are still undiagnosed by current single-gene tests or gene panels, and cohorts for each individual disorder are small. By combining patient groups and data from many centers and looking for commonality between some of these diseases, the consortium hopes to create diagnostics that cover a greater range of causative mutations.

While each specific disorder the group will study is relatively rare, many have overlapping manifestations, which suggest similarities in disease pathways pointing to common therapeutic strategies, according to the group.

Graessner said that the project’s whole-exome sequencing component will take place mostly in the first two years. According to the consortium’s plan, Decode Genetics — which expanded last year from array-based SNP genotyping research to a next-gen sequencing approach (CSN 11/9/2011) — will use its Illumina HiSeqs to sequence at least 1,100 subjects. The group expects this to increase the percentage of disease genes known for some of the more heterogeneous diseases in the set from about 50 percent to 80 percent.

According to Graessner, RNA sequencing is also part of the plan, as well as proteomic and other ‘omic analyses, especially as the researchers move from sequencing toward diagnostic panel development and therapeutic target research.

“We plan to [do whole-exome sequencing for] 1,100 subjects for gene identification … equally distributed over 10 disease areas,” Graessner wrote. “[This] will be done mainly in the first two years. However, for some of the diseases, such as ataxia/paraplegias, we have diagnostic panels already and in that case we [will] do the panels first and send the still unclear families for WES or WGS,” he wrote.

Graessner said that the group is just now shipping its first sample package to Decode. When this is finished the group will hold a workshop to discuss and train all the participating academic centers in the use of the Decode database for analysis of the results.

He said the team plans to work with the Halo Genomics division of Agilent, to validate diagnostic panels for ataxia, spinal muscular atrophies, lower motor neuron disease, and neuromuscular diseases. Halo was acquired by Agilent last year, and had developed an enrichment technology dubbed HaloPlex that it said was especially suited for targeted gene panels less than one megabase in size (IS 12/6/2011).

The group’s bioinformatics partner, Ariadne Genomics, will also analyze data to support the diagnostics research, as well as research on potential novel therapeutic targets, according to Graessner.

In a document describing the project, the consortium wrote that at the end of the funding period, it expects “to have elucidated the genetic basis for [more than] 80 [percent] of investigated patient groups.”

According to the group, the new genes will be added to existing databases and used to develop the first overlapping gene panel that can be used to diagnose several of these individual diseases, “overcoming time consuming and costly single gene analysis.”

Molika Ashford is a GenomeWeb contributing editor and covers personalized medicine and molecular diagnostics. E-mail her here.

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 Reporter: Aviva Lev-Ari, PhD, RN

Ernst & Young (“E&Y”) has published their fifth annual report on the state of the medical technology industry.

Below are the link to this report and also a link to an excerpt from the report displaying charts of the industry’s performance.

Definition of the Global Medical Technology Industry

In this report, medical technology (medtech) companies are defined as companies that primarily design and manufacture medical

technology equipment and supplies and are headquartered within the United States or Europe. For the purposes of this report, we have placed Israel’s data and analysis within the European market, and any grouping of the US and Europe has been referred to as “global.”

This wide ranging definition includes medical device, diagnostic, drug delivery and analytical/life science tool companies, but excludes distributors and service providers such as contract research organizations or contract manufacturing organizations.

By any measure, medical technology is an extraordinarily diverse industry. While developing a consistent and meaningful classification system is important, it is anything but straightforward. Existing taxonomies sometimes segregate companies into scores of thinly populated categories, making it difficult to identify and analyze industry trends.

Furthermore, they tend to combine categories based on products (such as imaging or tools) with those based on diseases targeted by those products (such as cardiovascular or oncology), which makes it harder to analyze trends consistently across either dimension. To address some of these challenges, we have categorized medtech companies across both dimensions —products and diseases targeted.

All publicly traded medtech companies were classified as belonging to one of five broad product groups:

Imaging:

companies developing products used to diagnose or monitor conditions via imaging technologies, including products such as MRI machines, computed tomography (CT) and X-ray imaging and optical biopsy systems

Non-imaging diagnostics:

companies developing products used to diagnose or monitor conditions via non-imaging technologies, which can include patient monitoring and in vitro testing equipment

Research and other equipment:

companies developing equipment used for research or other purposes, including analytical and life science tools, specialized laboratory equipment and furniture

Therapeutic devices:

companies developing products used to treat patients, including therapeutic medical devices, tools or drug delivery/infusion technologies

Other:

companies developing products that do not fi t in any of the above categories were classifi ed in this segment

In addition to product groups, this report tracks conglomerate companies that derive a significant part of their revenues from medical technologies. While a conglomerate medtech division’s technology could technically fall into one of the product groups listed above (e.g., General Electric into “imaging” and Allergan into “therapeutic devices”), all conglomerate data is kept separate from that of the nonconglomerates.

This is due to the fact that, while conglomerates report revenues for their medtech divisions, they typically do not report other financial results for their medtech divisions, such as research and development or net income.

Conglomerate companies:

United States

3M Health Care

Abbott: Medical Products

Agilent Technologies: Life Sciences and Chemical Analysis

Allergan: Medical Devices

Baxter International: Medical Products

Corning: Life Sciences

Danaher: Life Sciences & Diagnostics

Endo Health Solutions: AMS and HealthTronics

GE Healthcare

Hospira: Devices

IDEX: Health & Science Technologies

Johnson & Johnson: Medical Devices & Diagnostics

Kimberly-Clark: Health Care

Pall: Life Sciences

Europe

Agfa HealthCare

Bayer HealthCare: Medical Care

Beiersdorf: Hansaplast

Carl Zeiss Meditec

Dräger: Medical

Eckert & Ziegler: Medizintechnik

Fresenius Kabi

Halma: Health and Analysis

Jenoptik: Medical

Novartis: Alcon

Philips Healthcare

Quantel Medical

Roche Diagnostics

Sanofi : Genzyme Biosurgery

SCA Svenska Cellulosa Aktiebolaget: Personal Care

Sempermed

Siemens Healthcare

Smiths Medical

The big picture

Despite lingering financial and regulatory uncertainties, US and European publicly held medtech companies delivered another strong performance in 2011. For both conglomerates and pure-play companies, revenue growth in 2011 outpaced 2010 growth rates. Net income increased by 14% — the third consecutive year of double digit growth, and certainly impressive in today’s challenging economic climate.

So far, the medical technology industry appears to be weathering a period of slower global economic growth. However, for an industry that was accustomed to double-digit revenue growth, considerable margins and a predictable sales-and regulatory environment, the long-term future may still be turbulent. The industry’s financial performance will likely continue to be challenged by low economic growth in developed markets, the prospect of austerity measures in many countries, a looming Eurozone debt crisis and an imminent 2.3% medical device tax in the US. And while the US Supreme Court’s upholding of the Affordable Care Act has removed some of the uncertainty in the US, the regulatory environment continues to grow ever more complex around the globe.

As payers tackle runaway health care costs, medtech will face rising pricing pressures and expanded use of comparative effectiveness — making organic growth in western markets more challenging. Efforts to heighten disease management and preventive care, and other efforts to drive efficiency within the health care system, may impact both product utilization and profitability. The cost of not adapting the traditional medtech business model to stay ahead of these trends could be disastrous.

Public company data 2011                 2010 % change

Revenues $331.7                                          $313.9 6%

Conglomerates $142.3                                $132.8 7%

Pure-play companies $189.4                     $181.0 5%

R&D expense $12.6                                        $12.1 4%

SG&A expense $60.3                                    $57.4 5%

Net income $19.9                                          $17.4 14%

Cash and cash equivalents and short-term investments $39.2      $39.4 -1%

Market capitalization $436.1                                                              $465.9 -6%

Number of employees 725,900                                                           702,200 3%

Number of public companies 411                                                        423 -3%

Source: Ernst & Young and company financial statement data.

Numbers may appear to be inconsistent due to rounding.

Data shown for US and European public companies.

Market capitalization data is shown for 30 June 2011 and 30 June 2012.

Medical technology at a glance, 2010–2011

(US$b, data for pure-play companies except where indicated)

Medtech companies — long known for innovation, reinvention and risk-taking in product development — will need to apply the same principles to business model development. These trends and implications are discussed more fully in this year’s point of view article.

US and European publicly held medtech companies delivered another strong performance in 2011

Since we first published Pulse of the industry back in 2008 (using 2007 figures), a number of medtech firms have seen their revenues grow significantly. It is notable that 6 of the 10 fastest-growing companies over the period 2007–11 — led by spinal device company NuVasive and Intuitive Surgical (maker of the da Vinci Surgical System) — expanded their top lines mostly through organic growth and without the assistance of sizeable mergers or acquisitions. Corning Life Sciences was the only conglomerate to make the top 10 list.

Selected fast-growing US medtechs by revenue growth, 2007–2011

(US$m)

Companies 2007                          2011 CAGR

NuVasive $154                                 $541 37%

Alere $767                                       $2,387 33%

Life Technologies $1,282             $3,776 31%

Intuitive Surgical $601                 $1,757 31%

Illumina $367                                 $1,056 30%

Hologic $738                                   $1,789 25%

Corning Life Sciences $305            $595 18%

Thoratec $235                                   $423 16%

Greatbatch $319                                $569 16%

ResMed $716                                    $1,243 15%

Source: Ernst & Young and company financial statement data.

Companies in italics have made significant acquisitions between 2007 and 2011.

CAGR= Compounded Annual Growth Rate. 6 of the 10 fastest-growing companies expanded their top lines mostly through organic growth

Selected fast-growing European medtechs by revenue growth, 2007–2011

(US$m)

Source: Ernst & Young and company financial statement data.

Companies in italics have made significant acquisitions between 2007 and 2011.

CAGR= Compounded Annual Growth Rate.

Companies        Location          2007                   2011                CAGR

Fresenius Kabi        Germany        $2,782                $5,515                     19%

Sonova Holding      Switzerland      $926                 $1,827                   19%

ELEKTA                   Sweden              $674                 $1,217                    16%

Qiagen                     Netherlands       $650               $1,170                    16%

Stratec Biomedical Systems Germany $94               $165                     15%

Sempermed             Austria               $300                 $517                      15%

Syneron Medical         Israel               $141                  $228                    13%

Given Imaging             Israel               $113                  $178                     12%

William Demant Holding Denmark $1,010             $1,501                    10%

Essilor International France            $3,986               $5,829                  10%

While the fastest-growing companies in the US were fueled largely by organic growth, the four fastest-growing firms in Europe were aided by significant acquisitions. Germany’s Fresenius Kabi holds the distinction of having the biggest expansion in both real dollar and percentage terms on this list.

The company’s growth was in large part fueled by the addition of APP Pharmaceuticals, which it acquired for US$3.7 billion in 2008. Of the six commercial leaders on this list, five had made sizeable purchases, while the smaller “other” companies grew mostly through organic means.

Future Growth

Fueling future growth Mergers & acquisitions

The big picture

Merger and acquisition (M&A) activity among US and European medical technology companies remained vibrant in the year ended June 30, 2012. While 2011–12’s total of US$35.0 billion was well below the levels seen over the last two years, those two years were driven by megadeals done by Novartis (which paid US$41.2 billion to Nestlé for the remaining 75% of Alcon it didn’t already control) and Johnson & Johnson (which paid US$19.7 billion for Synthes). On a normalized basis (after removing the impact of the aforementioned megadeals), 2011–12’s total deal value was more in line with previous years — 25% below the prior year and 16% above the year before that.

Although no megadeals were consummated in 2011–12, there were eight transactions valued at more than US$1 billion, versus 12 the year before. The year’s largest deal was between private equity firm Apax Partners, two Canadian pension funds and Texas-based wound care company Kinetic Concepts Inc. (KCI). The US$6.3 billion Apax/KCI deal was particularly notable, as the US$6.3 billion represented one of the largest leveraged buyouts — across all industries — since the onset of the financial crisis in 2008. Two other private equity firms were also involved in multibillion-dollar M&As: Cinven sold off Swedish diagnostics company Phadia to Thermo Fisher Scientific for US$3.5 billion, and TPG Capital acquired in vitro diagnostics maker Immucor for nearly US$2 billion.

SOURCES:

Pulse of the Industry – Ernst & Young

http://www.ey.com/Publication/vwLUAssets/Pulse_medical_technology_report_2012/$FILE/Pulse_medical_technology_report_2012.pdf

Pulse of the Industry: Medical Technology Report 2012 – Industry performance

http://www.ey.com/GL/en/Industries/Life-Sciences/Pulse–medical-technology-report-2012—Mergers-and-acquisitions—medtechdata 

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