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eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA

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eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA

 

The 15th Annual Personalized Medicine Conference at Harvard Medical School will explore the science, business, and policy issues facing personalized medicine as scientists refine their understanding of how groundbreaking molecular diagnostics augmented by artificial intelligence, advanced data analytics, and digital health applications can empower both physicians and patients with information about how an expanded set of biological characteristics — including those found in the proteome and microbiome — may influence their health and their responses to increasingly impactful therapies.

 

WELCOME RECEPTION – NOVEMBER 13, 2019 – 6:15 P.M.

at the Isabella Stewart Gardner Museum, 25 Evans Way, Boston, MA 02115

http://www.personalizedmedicineconference.org/schedule/

 

Dear Colleague: Use the link to access videos of the keynote sessions featuring Scott Gottlieb, M.D., of the American Enterprise Institute; Carl June, M.D., of the University of Pennsylvania; Steven Shak, M.D., of Genomic Health; and Paul Stoffels, M.D., of Johnson & Johnson. As senior leaders from the GO2 Foundation for Lung Cancer, Harvard Pilgrim Health Care, the Institute for Clinical and Economic Review, M2Gen, and Novartis walked off the stage after the 15th Annual Personalized Medicine Conference at Harvard Medical School‘s final session, which was titled “Toward a Shared Value Proposition in Health Care,” Natasha Loder, Health Policy Editor, The Economist, told me it was “remarkable” to “see all of these people discuss the issues together” as she prepares to write a feature story on personalized medicine. Her comments capture the spirit of this year’s conference and speak to PMC’s approach to advancing personalized medicine. From: “Christopher Wells (PMC)” <cwells@personalizedmedicinecoalition.org> Reply-To: “Christopher Wells (PMC)” <cwells@personalizedmedicinecoalition.org> Date: Thursday, November 21, 2019 at 2:05 PM To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu> Subject: Thank You for Joining Us

ANNOUNCEMENT

 

Leaders in Pharmaceutical Business Intelligence (LPBI) Group will cover this event in Real Time for pharmaceuticalintelligence.com 

In attendance generating in realtime event’s eProceeding and social media coverage by

 

Aviva Lev-Ari, PhD, RN

Director & Founder

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

Editor-in-Chief

http://pharmaceuticalintelligence.com 

e-Mail: avivalev-ari@alum.berkeley.edu

(M) 617-775-0451

https://cal.berkeley.edu/AvivaLev-Ari,PhD,RN

SkypeID: HarpPlayer83          LinkedIn Profile        Twitter Profile

#PMConf

@pharma_BI

@AVIVA1950

AGENDA

Schedule

• November 13
• Reception
• November 14

PART I

Diagnosing, Different

8:00 a.m.

Registration and Breakfast

Joseph B. Martin Conference Center at Harvard Medical School
77 Avenue Louis Pasteur, Boston, MA 02115

8:50 a.m.

Opening Remarks

SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

• 170 drugs with biomarkers, up 15% from 2000 in Biomarker strategy
• Gene therapy started in 2005, today personalized medicine is becoming standard of care.
• Science & Technology need additional friendly environment for market penetration into care delivery

8:55 a.m.

Welcoming Remarks

SPEAKER | Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics, Harvard Medical School

• 15th Annual meeting is at a historic moment in Boston where Prof. Church launched the Human Genome Project and Eric Launder at MIT and the Cancer Genome Project.
• Genzyme conceived gene therapy sold to Sanofi for $ Billion
• Foundation Medicine acquired by Roche for $ Billion
• Cystic Fibrosis – therapy discovery in Boston
• MGH, Dana Farber, Lung Cancer discovery in 2004 theraphy PD-1
• BWH, Dana Farber, sequence every patient at DF and treatment is guided by the genomic profile
• 1993 was Millianum start, today Takeda – genetics in disease, initiated PMC
• Promote Personalized Medicine by the Annual conference, now 15th in a row – promotion of PM is continuing in MA and beyond
• Case studies at HBS – Kraft Center for Personalized Medicine

9:00 a.m.

The Era of the ‘Living Drug:’ A Keynote Conversation With Dr. Carl June, Pioneer of CAR T-cell Therapy

During this opening keynote session, the University of Pennsylvania’s Dr. Carl June, the discoverer of the chimeric antigen receptor (CAR) T-cell therapies that are unlocking a new era of personalized cancer care, will join Immatics US Chief Medical Officer Dr. Stephen L. Eck for a wide-ranging conversation about the future of personalized medicine, touching on issues including but not limited to access and affordability, regulation and manufacturing, and T-cell therapies beyond cancer.
» Read More

MODERATOR | Stephen L. Eck, M.D., Ph.D., Chief Medical Officer, Immatics US

Carl June, M.D., Richard W. Vague Professor in Immunotherapy, University of Pennsylvania

• 1997 first patient treated – 15 years follow up CAR-T cells survived, 3 patient were infused, 2 out of 3 leukemia cell free.
• Children vs Adults 2011 reported better results in Adults, children’s immune system is evolving
• In 2019 – 13 biotech companies in CAR-T cell therapies, Gene therapy is growing
• FDA, drug cycle T cells vs stem cells: engineering T cells life farming – innovation is the driver, FDA is evolving in handling patents involved in Cell engineering
• Regulatory science needs to evolve in light of gene therapy in Human cell line in China has investments government and VC backed,
• Similarity between Transfusion Medicine industry and Cell therapy – Transfection of cells therapy
• Manufacturing of Cells for transfection: Over regulation like in small molecules vs too little regulation
• Cost of cell transfection therapy: Cost of Goods, Cost of Labor – pay for performance,
• Manufacture in NJ shipped to Europe – not effective
• Beyond Cancer: Chronic diseases have systemic of specific immune or autoimmune components: CNS, neurodegenerative and Diabetes, Sickle cell anemia – treatment by cell therapy microphages
• Diagnostics innovations: Epigenetics, cell sequencing,
• Liability of a product that everyone wants: Class action law suit,
• N of 1,
• China ahead of US, Europe is behind US
• How to fund and how to transfer from University Hospitals to community Hospital.

9:45 a.m.

Transformative Technologies: Previewing the Value Proposition and Outlook for Disruptive Tools Designed to Enable Personalized Medicine

Emerging personalized medicine technologies may help facilitate earlier interventions that eliminate the need for expensive treatment of advanced diseases that have devastating consequences for patients. They can also help target treatments to only those patients who will benefit. But the success of these technologies depends on whether they can be integrated into a health system that has historically focused on treating diseases after symptoms have intensified, usually based on the assumption that every patient taking a given medication will respond to the treatment in a similar way.

During this session, Section 32 Managing Partner Dr. Michael J. Pellini will moderate a discussion between industry representatives and a payer about the value proposition and outlook for disruptive technologies that are designed to support more informed disease prevention and treatment plans. The conversation will focus on how developments in areas including but not limited to artificial intelligence, data analytics, genomic sequencing, liquid biopsies, and proteomics may impact the prevention, diagnosis, and treatment of diseases including cancer, cardiovascular diseases, and diabetes.
» Read More

MODERATOR | Michael J. Pellini, M.D., Managing Partner, Section 32

• surgery, chemo, radiation – cost, harmful, INEFFECTIVE, Dr. Reza Columbia Medical School Oncologist 35 years
• How are we doing with technology? Very remarkable
• Clinical Utility to the Payer
• Regulatory – a super star in ten years, Dr. Gottlieb
• Diagnostics
• Pain  management
• Patients can fight more broadly
• F for sharing data and data exchange
• 80% patients do not access Academic Centers for treatment
• Challenge: Not each Payer needs to partner – need for a “coalition” of Payers
• Standards: Will Payers welcome Government to provide guides – SHARING DATA is a guideline from the Government, i.e., Cystic Fibrosis where data was shared the most – success achieved faster

 

Steven J. Kafka, Ph.D., Partner, Third Rock Ventures; Executive Chairman, Thrive Earlier Detection

• ex-Millenium, ex-Foundations,
• Earlier detection of multiple cancers in Healthy individuals, Blood test – developed at John Hopkins, negative vs positive survival curve, early vs late stage
• genetic profiling genotype used with the Blood test

Nancy Mendelsohn, M.D., Chief Medical Officer, Special Needs Initiative, UnitedHealth Group

• Pediatrician
• 2years with UniterHealthCare
• Better outcome from more expensive treatment is justified
• How to make effective treatment to rural areas, populations without access

Eric Schadt, Ph.D., CEO, Sema4

• Spun off Mount Sinai 2 years ago, transfer of innovations to patients is slow, deriving insight is not easy
• COmplications of pregnancy

Roy Smythe, M.D., CEO, SomaLogic

• Access to technology and equity is an issue, delivery of care was pure,
• SomaLogic, measurement of protein expression, applied to predict risk for future disease
• Many Omics companies, Payers will bet on whom?
• Standards

10:45 a.m.

Networking Break

11:15 a.m.

Developing Diagnostics — Opportunities and Challenges in Personalized Medicine: A Two-Part Discussion

Diagnostic test developers are working to make personalized medicine possible by giving physicians tools that help them select the optimal treatment for every patient. Doing so requires that they navigate a complex business and policy landscape while being mindful of the day-to-day needs of payers and health care providers.

In this context, Mr. Mark P. Stevenson, Executive Vice President, Chief Operating Officer, Thermo Fisher Scientific, will take 10 minutes to introduce this two-part discussion titled “Developing Diagnostics — Opportunities and Challenges in Personalized Medicine.”

INTRODUCTION | Mark P. Stevenson, Executive Vice President, Chief Operating Officer, Thermo Fisher Scientific

• Context: Therapy selection in personalized medicine navigate diagnostics in use and policies when implementations is considered
• Physicians need precise testing now
• Payers – evidence of utility is needed
• Patient Outcome – Data analytics, ML, AI for genomics, proteomics, metabolomics,
• Tests must be precise and inform the diagnosis by diagnostics
• Solutions are

1. Chemical testing
2. Immune therapy testing
3. test utilization
4. test coverage
5. scaling
6. Standardization of care in each Hospital, medical education
7. Diagnostics & Pharma

 

Discussion Part 1
Developing Diagnostics — From Concept to the Clinic: Perspectives on the Landscape for Developing and Integrating Personalized Medicine Diagnostics into Health Systems

To kick off the “Developing Diagnostics” discussion, Moffitt Cancer Center’s DeBartolo Family Personalized Medicine Institute Medical Director Dr. Howard McLeod will moderate a conversation among leaders from the clinical, diagnostics, IT, and pharmaceutical communities about the landscape for developing and integrating personalized medicine diagnostics into health systems.
» Read More

MODERATOR | Howard McLeod, Pharm.D., Medical Director, DeBartolo Family Personalized Medicine Institute at Moffitt Cancer Center

Assaf Halevy, Founder, CEO, 2bPrecise

• challenge – which genetic test id relevant for which patient
• genomic signature available to match
• close the loop with the physician from testing, research to therapy
• Bridge needed to assist physicians to select medications within a class: SSRI based on genomics profile

Kris Joshi, Ph.D., Executive Vice President, President, Network Solutions, Change Healthcare is the Largest IT Healthcare in the US

• Use of Data
• Personalized Diagnostics: Education of patients and patient taking charge because OUT OF POCKET cost till deductible is reached is very high $800 for cancer diagnostics before diagnosis is been established
• Patients access of own medical records by 2 million patients in the US
• Molecular diagnostics
• Genomics data management

Peter Maag, Ph.D., CEO, CareDx

• Transplantation patients – prolong survival of populations using markers vs negative longevity of one patient
• Diagnostics tied to registry to demonstrate efficacy of treatment
• 94% survival after 1 year — no one survive 5 years
• Data sharing is long term view
• Consortium of 27 competing organization sharing data

Hakan Sakul, Ph.D., Vice President, Head of Diagnostics, Worldwide R & D and Medical, Pfizer

• Responsive to drug and drug efficacy is determined by diagnostics test
• Regulatory oversight
• consistency across countries using same drugs and same diagnostics

Kenna R. Mills Shaw, Ph.D., Executive Director, MD Anderson Institute for Personalized Cancer Therapy

• MD Anderson Institute does not sequence genome of each patient unlike Dana Farber
• clinicians need to access information for decision making when disease progresses – what new test to order
• data sharing inside the institution is not complete HOW data can be shared across institution

Discussion Part 2
Developing Diagnostics — The Role of Research: A Closer Look at Efforts to Encourage the Clinical Adoption of Personalized Medicine Diagnostics by Studying the Clinical and Economic Utility of Genomic Sequencing

During the second portion of the “Developing Diagnostics” session, a health care provider, a health economist, an industry leader, and a payer representative will join moderator and Personalized Medicine Coalition Senior Vice President for Science Policy Dr. Daryl Pritchard to examine the impact of emerging research on the clinical and economic utility of genomic sequencing for patients with diseases including but not limited to cancer and suspected rare diseases.
» Read More

MODERATOR | Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, Personalized Medicine Coalition

• Genomic sequencing for a single test that covers many biomarkers
• Improve treatment efficiency
• Growing recognizion of the need to demonstrate value, evidence for Payers to pay
• barriers for adoption of genomic sequencing

Roy J. Gandolfi, M.D., Medical Director, SelectHealth, UT is the Payer of Intermountain Healthcare, UT

• Regional approach vs National perspective
• medical policies requires experts for Payer to approve a treatment
• Consumer in the health plan – they buy insurance, self insure, safety, quality care, keep premium to affort care insurance

Lincoln Nadauld, M.D., Ph.D., Chief, Precision Health, Intermountain Healthcare, UT

• Precision Oncology Program: Need, study, analysis outcome, publish data
• Pharmacogenetics testing will be covered for all employees
• Neonatal, genomic sequence of all neonatal patients
• 500,000 people to be sequenced: Genomic information of every medical chart and measure clinical and economic outcomes

Peter J. Neumann, Sc.D., Director, Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center

• clinical utility
• evidence of value: saving by diagnostics
• cost for quality
• cost of diagnostics
• cost effectiveness – characterize utility
• cost effectiveness – study
• Value to families
•  value of knowledge
• externalities

Ammar Qadan, Vice President, Global Head of Market Access, Illumina

• Illumina is partnering with providers and Payer
• Illumina & Blue Cross Blue Shield – 150 Million are covered for genomics 2500 genomics test done
• Under utilization – education of physician needed
• Illumina is building evidence for Harvard Pilgrim on theirs patient data on risk pregnancies
• Illimina is expanding  building evidence for ALL rare diseases for all Test diagnostics developers

12:55 p.m.

Seated Luncheon

2:10 p.m.

Overcoming Opioids: Considering the Potential of Personalized Medicine to Address the Opioid Crisis in the US

Emerging technologies present new opportunities to study the genetic, biological, and environmental factors that drive public health crises, with an eye toward developing personalized medicine health care strategies that can mitigate their devastating consequences.

During this session, Dr. Alissa M. Resch, Chief Scientific Officer, Coriell Institute for Medical Research, will explore the significance of Coriell’s ongoing effort to inform interventions that may help prevent opioid addiction by identifying with more precision which patients are most likely to develop dependency on this class of drugs.
» Read More

SPEAKER | Alissa M. Resch, Ph.D., Chief Scientific Officer, Coriell Institute for Medical Research

• CORI – Camden Opioid Reseach Initiative Camden County, NJ – 3 years longitudinal study funded by State of NJ: COriell Institute, Cooper Medical School, NJ Health, Cooper University HC

1. Prescriptions per 100 persons
2. overdose death pwe 100,000 persons
3. US, NJ, Camden, County, NJ

• 2010 – increase in Prescription
• 2013 – Synthetic Opioid
• 2017 – Public health epidemic

THREE ARMS Opiod USE continuum: Exposure __>>> Addiction __>>> Overdose death

1. OPTIN – Treatment to Pain chronic
2. GOALS 0 Genomics of Opiod Addiction treatment aptients
3. BIOBANK – biological samples from deceased aptients: who died of ipiod-related dealth : Saliva, blood, tissue – cellular function & DNA and Stem cells

A. Identify patients at risk

B. Epigenetics

C. drug-drug interaction (combination of drugs – toxicology contribuion to mortality rates

D. Can genetic information be used to study heritability of opioid use disorder

2:30 p.m.

Assessing Progress Toward the Clinical Integration of Personalized Medicine: A Landscape Analysis

Case studies and anecdotal reports suggest that leading academic medical centers and pioneering community health systems have begun to integrate personalized medicine approaches into their clinical work streams. The extent to which health care providers more generally have begun to adopt personalized medicine strategies that go beyond the ordering of genomic sequencing, however, remains unclear.

During this session, Gary Gustavsen, Partner, Managing Director, Health Advances, will share preliminary findings from a PMC-commissioned survey that examined the landscape for the clinical integration of personalized medicine in the U.S. based on a multi-factorial definition of the field. Survey respondents included a geographically diverse set of academic medical centers and community health systems.
» Read More

INTRODUCTION | Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, Personalized Medicine Coalition

SPEAKER | Gary Gustavsen, Partner, Managing Director, Health Advances

• Across community hospital systems and Academic, across geographies, across therapeutics areas, across levels of adoption

Part I: Profiling select community health systems

Part II

III

IV Testing Guidance and Data accessibility

V Utilization of Data

VI Data sharing – Inter-institutional not cross institutions

VII Funding

Interviewees were across all functions

ADOPTION ASSESSMENT of Personalized Medicine

• Collection of genomics data
• Physician ordering Genomics Testing

2:50 p.m.

The 15th Annual Leadership in Personalized Medicine Award

After accepting the 15th Annual Leadership in Personalized Medicine Award, Genomic Health Chief Scientific Officer Dr. Steven Shak will share his vision for the future of the field with conference attendees.
» Read More

INTRODUCTION | Kimberly Popovits, Chairman of the Board, CEO, President, Genomic Health

• ex-Genetech: Herceptin, CF therapy
• Genomic Health – 130 studies

AWARDEE | Steven Shak, M.D., Co-Founder, Chief Scientific Officer, Genomic Health

1986 – Joined Genetech to work on big goals and big ideas

TPA – clinical trials

CF cases – Enzyme clone DNA – tube od sputum inside enzyme – first drug to CF approved in 1997, 30 years a go gene clones

Heceptin – 90% of Breast cancer is treated by – one injected antibody on solid tumor, metastatic BR CA

2000 – Genomic Health was launched 4 out of 100 benefited from chemotherapy

• Oncotype – can improve care and reduce cost
• NCI Trial breast cancer 10,000 – 2018 concluded
• Chemo therapy was transform to a targeted drug – molecular insights
• Academia, Industry Govenment – no walls – optimally innovate
• More precision Teamwork, Precision Leadership — NEEDED
•  Fragmented care
• Four request: End in mind, few target truth seeking, experiment and continue to learn, be honest with yourself,
• evemy of innovation is illusion the answer is known
• loose key changes
• communitive: inspire others, challenge self and others,
• Clinical Trials: learn from enrolees

 

3:20 p.m.

Networking Break

4:00 p.m.

Wellness in the Workplace: Understanding the Opportunities and Challenges Associated With Employer-Sponsored Genetic Testing Programs for Healthy Patients

Reasoning that genetic testing may encourage healthy lifestyles by providing information about an employee’s relative risk of developing various diseases, employers seeking to improve patients’ lives and mitigate downstream health care costs have begun to sponsor genetic testing for healthy employees by partnering with various genetic testing companies, some of which sell the tests directly to consumers.

This session, moderated by Quest Diagnostics Chief Medical Officer Dr. Jay G. Wohlgemuth, who is responsible for overseeing health care benefits for Quest’s employees, will spotlight two employer-sponsored genetic testing partnerships and explore the relevant issues. The panel discussion will focus on the significance of information generated from genetic testing, the differences between various genetic testing business models, and the privacy risks associated with the collection of genetic data.
» Read More

MODERATOR | Jay G. Wohlgemuth, M.D., Chief Medical Officer, Senior Vice President, Quest Diagnostics

• Employers employ Pharmacogenetics, select by polypharmacy
• Mental Health engagement through employer is problematic

Jane Cheshire Gilbert, C.P.A., Director, Retiree Health Care, Teachers’ Retirement System of Kentucky

• average 74, 15 prescriptions on average, 65% are 84 years old
• contain cost for retirees teachers in KY – pool of $$ for medications covered
• 72% women 28% male
• 36,000 retirees
• 64% drug changes due to review following genetic testing 80% of change Medication recommended by Pharmacist was accepted by physicians

Michael Doney, M.D., Ph.D., M.S., Head of Medical Affairs, Color

• Genetic counseling

Karen E. Knudsen, M.B.A., Ph.D., Executive Vice President, Oncology Services, Jefferson Health; Enterprise Director, Sidney Kimmel Cancer Center at Thomas Jefferson University

• 36,000 employees all enrolled in

Scott Megill, President, CEO, Coriell Life Sciences

• Pharmacogenomics
• provide consultation to patient and physicians
• Pharmacy team provide services to populations, delivery of medication plan

5:00 p.m.

Preparing Policies: A Keynote Address on the Policy Landscape for Personalized Medicine by Dr. Scott Gottlieb, Resident Fellow, American Enterprise Institute

During this keynote address, former U.S. Food and Drug Administration (FDA) commissioner Dr. Scott Gottlieb will share his thoughts on the evolving policy landscape for personalized medicine.
» Read More

INTRODUCTION | Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

SPEAKER | Scott Gottlieb, M.D., Resident Fellow, American Enterprise Institute

• create incentives in clinical trial
• personalized care
• improve delivery of care
• Create a new framework for clinical trials
• cell based therapy to get approval  advanced the frameworkCommon molecular features of a cancer enabling – common backbone change only pathways without the need to recreate the backbone again for another clinical trial
• site licenses vs individual investigator in need for site license
• 4 concorsium on this topic
• innovations on data: data network for post market surveillance
• Insights on drug safety drug efficacy – model simulation team 35 persons – adoption faster
• standardize Drug Review: Standard Template vs collections of Drug application process
• O&D Report tobe standardized
• legislative solution for diagnostics – laboratory tests and lab-developed tests
• Digital health tools – slow adoption in context of drug approval drug label put tool into promotional material
• Taking less risk will affect negatively innovations done by policy in place: Like Gene editing and regenerative medicine vs a small molecule that the biology is well understood
• Design Part D – premium came lower, specialty drugs, incentives to encorage NEW drugs development like alternative to statins
• Value delivered to consumers: FDA determination for expeditious approval than coverage need to follow easier to get investment in the development process
• CMS is setting the ceiling not the floor and its coverage is followed by the entire market size wise
• DNA data set was EKG on AppleWatch NGS and AI Medical Devices – same approach taken

5:45 p.m.

Closing Remarks

SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

6:00 p.m.

Welcome Reception at the Isabella Stewart Gardner Museum

 

• Reception
• November 14

PART II

Targeting Treatment

8:00 a.m.

Registration and Breakfast

Joseph B. Martin Conference Center at Harvard Medical School
77 Avenue Louis Pasteur, Boston, MA 02115

8:50 a.m.

Opening Remarks

SPEAKER | Stephen L. Eck, M.D., Ph.D., Chief Medical Officer, Immatics US

8:55 a.m.

Welcoming Remarks

SPEAKER | Joseph B. Martin, M.D., Ph.D., Dean Emeritus, Harvard Medical School

Personal story of familial heritage from Europe to Alberta, CA

9:00 a.m.

Going Global: Learning From Governmental Efforts to Advance Personalized Medicine Around the World

Global leaders are working to accelerate an era of personalized medicine around the world by encouraging innovation, modernizing policies, and reforming health systems to speed the clinical adoption of personalized medicine products and services.

During this panel discussion, four governmental representatives will share their visions for the future of personalized medicine and elaborate on their efforts to accelerate progress in the field.
» Read More

MODERATOR | Antonio L. Andreu, M.D., Ph.D., Scientific Director, EATRIS (European Infrastructure for Translational Medicine)

• Education of the Medical community on genomics and its use in therapy
• Japan and Denmark are building national sequencing centers

Wadha Al Muftah, M.D., Ph.D., Manager, Clinical Initiatives, Qatar Genome Program

• 2011BioBank launched as national resource, 20,000 Quataris 3,000 foreigners recruited
• Interest in the population to understand their Genome for future health
• Rare disease identified
• Training & Education in schools about the Genome using comics, Education of Healthcare professionals about Genomics
• At the University level – Genetic counseling by professionals that understand the culture of patients
• Precision medicine education for physicians
• Centralized genomics implementation because the health system is centralized
• A Pilot study on Cardiovascular Genomics

–>>>>>>>>>> Not attended —<<<<<<<<< Noella Bigirimana, Strategic Advisor, Rwanda Biomedical Center, Ministry of Health, Government of Rwanda; Government Fellow, World Economic Forum

Erja Heikkinen, Ph.D., Deputy Director, General Ministry of Education and Culture, Finland

• Helsinki – leading cancer research academic center
• Infrastructure investment in data management and representation of all pharma companies in Finland, all big pharma have offices in Finland
• English is the language of communication in the research community
• Three political parties and three ministries
• Center for Research in Genomic is centralized and is in construction — Research will be following a distributed system of research centers in multiple locations
• National investment in Genomics like in to other time in the past in any other discipline in Medicine

Raquel Yotti, M.D., Ph.D., General Director, Instituto de Salud Carlos III (Spain)

• Universal coverage centralized national healthcare system
• research is national and ministry of Health funds research and integrate it with the health system
• interaction of clinical application and research studies
• pharmaco-genomics, genomics testing,
• challenge – therapies based on genetics and access to all the populations, safety and quality
• PCPs are a source in the system, network used for systemic change and involve the clinical community including the PCP community
• International organization under the umbrella of International Personalized medicine – the purpose of Research vs practicing Medicine
• Government and industry manufacturing cell lines
• Distribute results of genomics sequencing

10:00 a.m.

Networking Break

10:15 a.m.

Innovation in the Era of Personalized Medicine: A Keynote Conversation With Dr. Paul Stoffels, Chief Scientific Officer, Johnson & Johnson

During this fireside chat with CNBC Reporter Ms. Meg Tirrell, Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels will help frame the second half of the conference program by sharing the pharmaceutical industry’s perspective on the emerging issues in health care, touching on topics including costs, prices, and access.
» Read More

MODERATOR | Meg Tirrell, Reporter, CNBC

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson

Goals of medicine in 2019

• early detection
• Vaccines in disease prevention
• Longevity

Challenges

• Platforms are established, every 20-30 another one emergences
• access to data – critical platform
• AI for diagnostics and decision making,
• biomarkers
• J&J try to learn on every disease: Lungs and GI
• Diagnosis, Medical devices,
• Genomics testing done with diagnosis
• HIV Vaccine – long development cycle
• Passion of Scientists
• pharmaceutics development is based on insights looking into the future – important goal to solve
• Combination therapy emerges, MOA
• partnerships: cell therapy can transform cancer treatment

 

10:45 a.m.

Prospecting the Pipeline: Exploring the Implications of a Biopharmaceutical Pipeline Dominated by Personalized Treatments

As researchers develop an enhanced understanding of the molecular causes that underpin various diseases, many biopharmaceutical companies have begun to develop therapies that are targeted to patient subgroups and even personalized to individual patients. In oncology, for example, there are reportedly more than 900 personalized “immunotherapy” treatments being tested in the clinic, with more than 1,000 in preclinical development. The challenging scientific questions and systemic implications associated with these new therapies do not always fit neatly into existing regulatory, payment, and care delivery frameworks.

During this session, CNBC Reporter Ms. Meg Tirrell will moderate a panel discussion that explores the scientific, regulatory, reimbursement, and other systemic issues associated with future gene editing treatments, gene therapies, immunotherapies, and targeted therapies. The panelists, who include industry representatives, a researcher, and an academic leader, will also consider a new approach to immunotherapy for cancer patients in which a unique product is developed for every patient treated.
» Read More

MODERATOR | Meg Tirrell, Reporter, CNBC

Donald L. Siegel, Ph.D., M.D., Director, Division of Transfusion Medicine & Therapeutic Biology, Director, Clinical Cell and Vaccine Production Facility, University of Pennsylvania’s Perelman School of Medicine

• CAR-T therapy started the Transfusion Medicine & Therapeutic Biology industry
• no relations explored between Immune T cells and microbiome
• Cost of CAR-T therapy – use of off the shelf CAR=T cells will lower the proce while it will scale up if no rejection
• DOGS USED WITH CAR-T TREATMENT OF CANCER IN DOG

 

Harpreet Singh, Ph.D., CEO, Immatics

• T Cell peptide started 15 years ago Peptonomics,
• tumors of solid cancer – cell therapies selected from libraries

1. off the shelf cells from health donors
2. Biologics bridges tumor cells and solid cells

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson

• Impact of Mirobiome it plays a key role in many diseases
• difficult to develop therapeutics derived from microbiome data
• Price of Drug support innovations that are transformational need to be valued by society

Alex Vadas, Ph.D., Managing Director, Partner, LEK Consulting

• TECHNOLOGY TO SELECT COMBINATION THERAPIES

 

11:45 a.m.

Bag Lunch

12:45 p.m.

Balancing Business and Social Objectives to Advance Personalized Medicine: A Case Study of the Dementia Discovery Fund

This interactive case study discussion will explore how and why a group of government agencies, nonprofit organizations, and pharmaceutical companies came together to support the Dementia Discovery Fund, focusing on whether a disease-specific venture that seeks to create meaningful new medicines in part by capitalizing on the evolving science underpinning personalized medicine can successfully balance social and business objectives.
» Read More

MODERATOR | Richard Hamermesh, D.B.A., Co-Faculty Chair, Harvard Business School Kraft Precision Medicine Accelerator

1:45 p.m.

Toward a Shared Value Proposition in Health Care: Pursuing Value-Based Solutions in Research, Regulation, Reimbursement, and Clinical Adoption

To advance the principles of personalized medicine, the field’s proponents will need to align representatives from multiple sectors of the health system on a shared value proposition that recognizes the importance of addressing the shortcomings of one-size-fits-all medicine.

During this session, M2Gen Executive Chairman Dr. William S. Dalton will convene a commercial payer, an industry representative, a patient, and a value assessment framework developer to explore research, regulatory, clinical adoption, and especially reimbursement solutions that will, in the interest of patients, advance the principles of personalized medicine.
» Read More

MODERATOR | William S. Dalton, Ph.D., M.D., Executive Chairman, M2Gen

Bonnie J. Addario, Co-Founder, Chair, GO₂ Foundation for Lung Cancer

Sarah K. Emond, Executive Vice President, Chief Operating Officer, Institute for Clinical and Economic Review

Anne-Marie Martin, Ph.D., Senior Vice President, Global Head of Precision Medicine, Novartis Pharmaceuticals Corporation

Michael Sherman, M.D., Chief Medical Officer, Senior Vice President, Harvard Pilgrim Health Care

2:45 p.m.

Closing Remarks

SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

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eProceedings – Day 1: Charles River Laboratories – 3rd World Congress, Delivering Therapies to the Clinic Faster, September 23 – 24, 2019, Cambridge, MA

Posted in Conference Coverage with Social Media, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Drug Carrier Design, Drug Delivery Platform Technology, Drug Development Process, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment on July 19, 2019| Leave a Comment »

eProceedings – Day 1: Charles River Laboratories – 3rd World Congress, Delivering Therapies to the Clinic Faster, September 23 – 24, 2019, 25 Edwin H. Land Boulevard, Cambridge, MA

 

https://events.criver.com/event/9eab0ee1-982e-42c6-a4cd-fb43f9f2f1d0/confirmation:7c68cf9b-c599-469e-b602-42178c77e4f9

 

ANNOUNCEMENT

 

Leaders in Pharmaceutical Business Intelligence (LPBI) Group will cover this event in Real Time for pharmaceuticalintelligence.com 

Confirmation Number: 8ZNCBYNGHCK

In attendance generating in realtime event’s eProceeding and social media coverage by

 

Aviva Lev-Ari, PhD, RN

Director & Founder

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

Editor-in-Chief

http://pharmaceuticalintelligence.com 

e-Mail: avivalev-ari@alum.berkeley.edu

(M) 617-775-0451

https://cal.berkeley.edu/AvivaLev-Ari,PhD,RN

SkypeID: HarpPlayer83          LinkedIn Profile        Twitter Profile

#crlworldcon

@CRiverLabs

@pharma_BI

@AVIVA1950

 

 

Join us this year as we explore novel approaches to drug development that effectively reduce program timelines and accelerate delivery to the clinic. Using a variety of case studies, our speakers will illustrate methods that successfully cut time to market and highlight how artificial intelligence and genomics are expediting target discovery and drug development. In an agenda that includes presentations, panel discussions, and short technology demonstrations, you will learn how the latest science and regulatory strategies are helping us get drugs to patients faster than ever.

AGENDA

Day One, September 23, 2019

• Novel approaches to silence disease drivers
• The role of AI in expediting drug discovery

Monday, September 23

8:30 – 9:00 a.m.	Introduction and Welcome Remarks James C. Foster, Chairman of the Board, President, and Chief Executive Officer, Charles River
9:00 – 9:30 a.m.	2019 Award Winner: A Silicon Valley Approach to Understanding and Treating Disease Matt Wilsey, Chairman, President, and Co-Founder, Grace Science Foundation
9:30 – 10:15 a.m.	Keynote Session Brian Hubbard, PhD, Chief Executive Officer, Dogma Therapeutics
10:15 – 10:30 a.m.	Break
10:30 – 11:15 a.m.	Novel Approaches to Silence Disease Drivers Systemic Delivery of Investigational RNAi Therapeutics: Safety Considerations and Clinical Outcomes Peter Smith, PhD, Senior Vice President, Early Development, Alnylam Pharmaceuticals
11:15 a.m. – 12:00 p.m.	Novel Approaches to Silence Disease Drivers: Considerations for Viral Vector Manufacturing to Support Product Commercialization Richard Snyder, PhD, Chief Scientific Officer and Founder, Brammer Bio
12:00 – 1:00 p.m.	Lunch
1:00 – 1:45 p.m.	Accelerating Drug Discovery Through the Power of Microscopy Images Anne E. Carpenter, Ph.D., Institute Scientist, Sr. Director, Imaging Platform, Merkin Institute Fellow, Broad Institute of Harvard and MIT
1:45 – 2:30 p.m.	The Role of AI in Expediting Drug Discovery Target Identification for Nonalcoholic Steatohepatitis Using Machine Learning: The Case for nference Tyler Wagner PhD, Head of Cardiovascular Research, nference
2:30 – 2:45 p.m.	Break
2:45 – 3:30 p.m.	Technobite Sessions with Emulate Bio and University of Pittsburgh Drug Discovery Institute Kyung Jin H Jang, VP of Bio Product development, Emulate, Inc. Albert Gough, PhD, U Pittsburg School of Medicine
3:30 – 4:15 p.m.	Artificial Intelligence Panel Discussion: Real World Applications from Discovery to Clinic Moderated by Carey Goldberg, WBUR
4:15 – 4:45 p.m.	Jack’s Journey Jake and Elizabeth Burke, Cure NF with Jack
4:45 – 5:00 p.m.	Closing Remarks
5:00 – 6:00 p.m.	Networking Reception

 

 

Day Two – September 24, 2019

• How genomics is expediting drug discovery
• Accelerating therapies through the regulatory process

Tuesday, September 24

8:45 – 9:00 a.m.	Opening Remarks and Recap James C. Foster, Chairman of the Board, President, and Chief Executive Officer, Charles River
9:00 – 9:30 a.m.	2018 Award Winner Update David Hysong, Patient Founder and Chief Executive Officer, Shepherd Therapeutics William Siders, CDO, Shepherd Therapeutics
9:30 – 10:15 a.m.	Advances in Human Genetics and Therapeutic Modalities Enable Novel Therapies Eric Green, Vice President of Research and Development, Maze Therapeutics
10:15 – 11:00 a.m.	How Genomics is Expediting Drug Discovery Manuel Rivas, Assistant Professor, Department of Biomedical Data Science, Stanford University
11:00 – 11:15 a.m.	Break
11:15 a.m. – 12:00 p.m.	Genomics Panel Discussion: Signposting Targets That Will Speed the Path to Market Moderated by Martin Mackay, Co-Founder, RallyBio
12:00 – 1:00 p.m.	Lunch
1:00 – 1:45 p.m	Truly Personalized Medicines for Ultra-rare Diseases: New Opportunities in Genomic Medicine Timothy Yu, Attending Physician, Division of Genetics and Genomics and Assistant Professor in Pediatrics, Boston Children’s Hospital
1:45 – 2:30 p.m.	Application of Machine Learning Technology for the Assessment of Bulbar Symptoms in ALS Fernando Vieira, Chief Scientific Officer, ALS Therapy Development Institute
2:30 – 2:45 p.m.	Break
2:45 – 3:30 p.m.	Accelerating Rare Disease Therapies Through the Regulatory Process Martine Zimmermann, Senior Vice President and Head of Global Regulatory Affairs, Alexion Pharmaceuticals, Inc.
3:30 – 4:00 p.m.	Wearing ALL the Hats: From Impossible to Possible Allyson Berent, Chief Operating Officer, GeneTx Biotherapeutics
4:00 – 4:15 p.m.	Closing Remarks

 

Introduction and Welcome Remarks

8:30 AM-9:00 AM

A Silicon Valley Approach to Understanding and Treating Disease

9:00 AM-9:30 AM

Accelerating Therapies Through the Regulatory Process

Keynote Session

9:30 AM-10:15 AM

Keynote Session Brian Hubbard, PhD, Chief Executive Officer, Dogma Therapeutics

• Find a cause and work with passion
• CVD increased 53% from 2005 to 2016
• Cholesterol, LDL receptor and CV disease
• Genetics  evolution and discovery of PCSK9

1. A PCSK9 Variant lowers CV risk
2. complete lack of PCSK9 is safe – protects from CVD

• LDL receptor
• Statins do not work on LDL receptor if the mutation exists
• Antibody and antisense for the PCSK9 mutation – Inexpensive Oral Medications can change Global Diseases
• Dogma of Drug DIscovery: Approach a Patent vs Approach a Disease
• Ligands bind within a cryptic binding pocket adjacent to a novel PCSK9 polymorphism

12 years of drug discovery

1. 2003: PCSK9 mutation discovered
2. 2005:
3. 2006:
4. 2012;
5. 2012: Dogma Scientists begin
6. compound found binds to primates
7. 2015:
8. 2018: Efficiency DGM-4403 lowers LDL-c by 55% 0ver 14 days

Break

10:15 AM-10:30 AM

Systemic Delivery of Investigational RNAi Therapeutics: Safety Considerations and Clinical Outcomes

10:30 AM-11:15 AM

Novel Approaches to Silence Disease Drivers

• 2014 – @Moderna, mRNA
• 2017 – Alnylam

RNAi – delivery is the most difficult

• gene silencing changes medicine and diseases
• Small Interfeering RNA (siRNA) Therapeutics
• Delivery challenges – stability and targeting
• RNA Interference (RNAi) – Onpattro (patisiran)
• GalNAc-siRNA Conjugates – delivery to the hepatocytes
• N-Acetyl Galactosamine (GalNACc-siRNA conjugates
• Hepatocyte specific : Liver across species: ASGPR expression
• Metabolic Stability: Chemistry to Improve siRNA
• Platform for genetic diseases
• Evolution of COnjugate Design: GalNAc-siRNA – enhanced stabilization chemistry
• ALN-TTRSC02 compared to Revusiran
• ALN-TTRsc02 (advanced) –  – tetrameric protein binds transports serum retinol binding
• AL Amyloidosis
• ApoA1 Amyloidosis
• ATTR Amyloidosis – manufacture in the Liver: Hereditery vs non-hereditary – Wild-Type
• Patisiran Therapeutic Hypothesis – siRNA targeting TTR formulated
• Pharmacology of TTR siRNA in Animal Model
• V30M TTR Transgenic Mouse Model: Patisiran Phase 1 Study to Phase 3 APOLLA Study Design for any TTR mutation – Prior tetramer stabilizer used permitted
• hATTR Amyloidosis and APOLLO Assessment: Phase 3 is Global – Cardiomyopathy – potential,
• Patisiran met all secondary Endpoints: Canadian, Japanese approval – US approved indication, European approved
• Alnylam Investigational RNAi Therapeutics:
• Pipeline: Genetic medicines
• Hepatic Infectious diseases
• CNS & Ocular
• Cardiovascular

11:15 AM-12:00 PM

Considerations for Viral Vector Manufacturing to Support Product Commercialization

• Viral-Vector-mediated in vivo Gene Therapy
• VVS Viral Vector Platforms:

1. Adenovirus immunogenicity
2. Lentivirus
3. Retrovirus
4. Herpes
5. Recombinant Adeno-Associated Viral Vectors: Glybera, Luxturna
6. Zolgenzma

• Establish the product specifications based on data (CQAs)
• Is the vector product: parenteral or anciliary material

Considerations:

• Large scall vs small
• lot demand vs platform choice
• Proof of concept
• Own/License the manufacturing reagents (portability) vs reliance on providers
• Process and Analytical Design & Development: Cell line: Mamalian, others
• Raw materials: Viral clearance steps – cell banks generation
• impurity profiles
• Cell Substrates
• Cell clone screening
• Preclinical/Clinical, Alachua, FL; Phase III/Commercial: Cambridge & Lexington
• Biologics Upstream Process Flow: Master cell banks
• Transient Transfection Process (Lenti and AAV)
• rAAV Proviral cell line
• Production Vector-based Process (Baculo or HSV)
• Product purification: Filtration methods, Chromatography, centrifugal separation: Concentration/filtration
• Formulation
• Compatibility wiht vial: Glass, CZ, COP: absorption vs Inactivation
• Single use
• Frozen storage
• Storage, Packing and Distribution
• Technology Transfer: Research vs Mature Process (Qualified cell bank)
• Plasmids: E.coli MCB backbone
• Analytics Design & Development: Testing: Nucleic-acid based, protein-based

1. AAV Vector Lot Release Assays
2. Lentivirus

• QA: QA Management System –
• Analytical Assays
• FDA Issues SIX New Draft Guidance Documents in 7/2018
• Process Validation: Life cycle approach: Process caracterizationProcess performance qualification

Lunch

12:00 PM-1:00 PM

Accelerating Drug Discovery Through the Power of Microscopy Images

1:00 PM-1:45 PM

The Role of AI in Drug Discovery

• assayGene clusterbased on morphological similarity: Express each gene, gene painting Image analysis, cluster morphological profiles
• identification of allelle that are not constitutively activating mutants.
• weakly supervised deep learning to extract features
• identify similarities and differences among treatments at the same population level
• Predict many distinct expensive assays on a huge compound library using a single cell painting

1. Test 5,000 compounds in the assay of interest as well as cell painting
2. Find combination of iamge-based features that predict in the assay of interest
3. Predict “hit” from existing 1Million compound cell paining data set

The Role of AI in Expediting Drug Discovery Target Identification for Nonalcoholic Steatohepatitis Using Machine Learning: The Case for nference

Tyler Wagner PhD, Head of Cardiovascular Research, nference

1:45 PM-2:30 PM

The Role of AI in Drug Discovery

• In Kendall Square
• Partnership with Janssen
• all employees: MD/PhD and Data Scientists

NASH

• Gene FXR

1. Literature Synthesis
2. Molecular Analytics
3. Competitive Intelligence

• Diseases – GI, digestive, Signs & Symptoms, cellular Profileration, Carcinoma, GI
• Biomolecules – Cholesterol,
• Drugs: Inhibitors, agonists, Antagonists
• Cells and Tissues – Cell ontology

Epigenetics – effects on systems:

• Endocrine
• Liver
• Enrichment Set & related Phenotypes
• Genes: signal expression strong vs weak

PROCESS –

1. Increase research efficiency,
2. assess the validity of associations
3. evaluate the clinical and regulatory landscapes
4. large-scale workflows

• Literature Signals
• molecular data sets
• protein expression
• epigenetics
• SNP Phenotypes
• Druggability Clinical novelty

Break

2:30 PM-2:45 PM

Technobite Sessions : Towards organ-on-a-chip

Kyung Jin Jang, VP of Bio Product development, Emulate, Inc. 

2:45 PM-3:30 PM

• Lung-Chip Applications
• Pulmonary inflammation
• Intestine-chip Applications
• Liver-Chip: Building Tissue Complexity: Co-culture, tri-culture, quatro-culture, Transcriptomic Analysis
• Liver-Chip: Kupffer cells Characterization
• Stellate Cells
• parenchymal channel, non-parenchymal channel
• Liver Chip: Predicting species differences in liver toxicity: Effects of Bosentan on Albumin secretion
• Acetaminophen Toxicity in Liver-Chip: APAP Metabolism: detected changes in morphology, ATP, GSH – Dosepdependent increase of ROS
• Steatosis and Stellate Cell Activation: and Species difference in Toxicity Liver chip data correlates with in vivo data
• Predict Human safety risks with liver chip

Albert Gough, PhD, U Pittsburg School of Medicine

• Approaches for repurposing drugs:

1. Integrated, fluidic organ MPD,
2. cells, 3D structures,
3. O2 Modulation & Sensing
4. Biosensors
5. secretome

• Higher Biomimetic content Higher throughput
• regulatory liver-pancreas axis in Type 2 Diabetes model
• Estradiol-Induced proliferation of mutants in Breast Cancer varies from 2D monoculture to 3D LAMP
• MPS Models:

1. celle and organ Structure in MPS
2. Single organ MPS & Coupled organ

Artificial Intelligence Panel Discussion : Real world applications from discovery to clinic

3:30 PM-4:15 PM

• Ann Carpenther @Broadinstitute
• Google Venture
• Charles River – UK

Carey Goldberg, WBUR

Cure NF with Jack – Patient Advocacy

4:15 PM-4:45 PM

Closing Remarks

4:45 PM-5:00 PM

Networking Reception

5:00 PM-6:00 PM

September 24, 2019

Opening Remarks and Recap

8:45 AM-9:00 AM

Development of novel therapies for the treatment of rare cancers

9:00 AM-9:30 AM

How Genomics is Expediting Drug Discovery

9:30 AM-10:15 AM

How Genomics is Expediting Drug Discovery

10:15 AM-11:00 AM

Break

11:00 AM-11:15 AM

Genomics Panel Discussion: Signposting Targets That Will Speed the Path to Market

11:15 AM-12:00 PM

Lunch

12:00 PM-1:00 PM

Truly Personalized Medicines for Ultra-rare Diseases: New Opportunities in Genomic Medicine

1:00 PM-1:45 PM

Accelerating Therapies Through the Regulatory Process

Accelerating Therapies Through the Regulatory Process

1:45 PM-2:30 PM

Break

2:30 PM-2:45 PM

Accelerating Rare Disease Therapies Through the Regulatory Process

2:45 PM-3:30 PM

Accelerating Therapies Through the Regulatory Process

Wearing ALL the hats: From Impossible to Possible

3:30 PM-4:00 PM

Patient Advocacy Session

Closing Remarks

4:00 PM-4:15 PM

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2019 Warren Alpert Foundation Award goes to Four Scientists for Seminal Discoveries in OptoGenetics – Illuminating the Human Brain

Posted in Interviews with Scientific Leaders, Warren Alpert Foundation Prize Recipients on July 18, 2019| Leave a Comment »

WordCloud Image Produced by Adam Tubman

2019 Warren Alpert Foundation Award goes to Four Scientists for Seminal Discoveries in OptoGenetics – Illuminating the Human Brain

Reporter: Aviva Lev-Ari, PhD, RN

@AVIVA1950

@phharma_BI

Optogenetics, a revolutionary technique that uses light and genetic modification to control the activity of cells in the brain.

Each year the recipient(s) of the Warren Alpert Foundation Prize are recognized at a scientific symposium hosted by Harvard Medical School.

OCTOBER 3, 2019 – 1:30PM TO 5:30PM

2019 WARREN ALPERT FOUNDATION PRIZE SYMPOSIUM

Optogenetics: Illuminating the Path toward Causal Neuroscience

In honor of Edward Boyden, Karl Deisseroth, Peter Hegemann, Gero Miesenböck

for the development of optogenetics as a way to control the activity of specific circuits in the nervous system, to determine their function and ultimately to control them to treat neurological and psychiatric disorders.

Moderated by 

• Bernardo Sabatini, MD, PhD, Professor of Neurology, HMS

Cells in the brain studied by opto-genetics for treatment of neuropsychiatric disorders

Opening Remarks

• George Q. Daley, Dean, Harvard Medical School

 

 

Featured Speakers Include:

Edward Boyden, PhD – In honor of and Speaker
Y. Eva Tan Professor in Neuro technology
MIT Media Lab and McGovern Institute
Investigator, Howard Hughes Medical Institute

• microbial opsins binding endogenuous all-trans-retinal
• search locally in genomics space: sensitivity to ArchT
• In response to yellow light vs red light
• Map the molecules, wiring and connections

 

Karl Deisseroth, MD, PhD – In honor of and Speaker
D.H. Chen Professor of Bioengineering and Psychiatry
Stanford University
Investigator, Howard Hughes Medical Institute

• Channelrhodopsins – Inner workings of – light-dated pores
• Diverse modes of designed photon-spike logic, ion selectivity, color tuning – ANION-conducting ChRs
• microbial opsin genesMolecular biology on neuroscience
• neurol codes of behavior
• Identification of feeding-responsive OFC cells
• activity-guided optogenetic stimulation: social interaction vs self feeding
• Time spent licking – all-optical Read/Write across cortical layers: L2/3 through
• Stimulation: Visual stimuli vs Optogenetic stimuli vs Ensemble-specific stimulation: Tuned vs Random
• Unstimulated population dynamics – visually-evoked vs stimulated popualtion using Classifier – discrimination behavior
• Number stimulated neurons: Laminar population recruitment corresponds to behavior
• neuronal activity during task performance: Thirst-motivated behavior
• Epigenetics: Optogenetic stimulation restores

Peter Hegemann, PhD – In honor of and Speaker

Hertie Professor for Neuroscience and Head of Experimental Biophysics
Humboldt-Universität zu Berlin

• Optogrnetic excitation
• channel-rhodopsin (ChR) during MD calculation, intracellulat and extracellular sideCentral gate Inner gate
• all-trans
• elements of light switch
• Improved Na+ over H+ sensitivity
• outer pore constriction – K-channels hyper polarization n neuroscience
• PAC-K silencing of vertical cardiocytes
• Optogenetic Actuators

 

Gero Miesenböck, FRS – In honor of and Speaker
Waynflete Professor of Physiology and Founding Director of the Centre for Neural Circuits and Behavior
University of Oxford

• Asleep vs Awake electrically active vs silent signals
• Dopamine and arousal – OFF/ON of the dopaminergic system
• operating the sleep switch
• mechanisms: Sleep-Control Neurons current vs membrane potential
• What is the biologic process of switch in sleep? it is: A voltage-controlled oxidoreductase OR a
• redux-controlled ion channel
• Mitochondrial Electron Transport in the matrix membrane: NADPH – The missing link: NADH>NAD+, O2>O2- O2>H2O ADP>ATPm- mitoTimer
• redox changes accompany changes in sleep pressure: Sleep-deprived vs Rested
• Perturbing the Redox Chemistry of dFB – AOX = PUFAs – 4-OXO~2~nonenal
• Flipping the Redox Switch Promotes Sleep
• Redox sensing by Hyperkinetics regulates the activity of dFB Neurons

Invited Speakers Include:

Charlotte Arlt, PhD, Speaker
Postdoctoral Research Fellow, Department of Neurobiology
Harvard Medical School

• Virtual reality in decision making: Left or right
• GABAergic neuron ChR2+Photostimulation vs no photostimulation
• identical decisions in different context
• The brain persists using same areas weeks after trained in simple context
• Flexible environments
• simple context: Brain areas used in flexible decisions

 

Kimberly Reinhold, PhD, Speaker
Postdoctoral Research Fellow, Department of Neurobiology
Harvard Medical School

• Trial and erroe learning – impaired in Parkinsosn’s
• episodic learning: Amnesia impaired
• Pathwat in Basal ganglia: Cortex-Striatum optogenetic cue to achieve motor output
• Action potential recorded neural activity to disengage the striatum: Output neuron – inhibitory neuronspatially and temporality loss function – mice perform cued reaches despite
• striatum does not trigger cues – needed during learning
• measuring learning for reinforced learning – non cues reached within a day
• inhibiting the Striatum impede learning it is not needed after learning
• Behavior space: healhty learning VS Parkinson’s, PTSD and other

Closing Remarks

George Q. Daley, Dean, Harvard Medical School

 

 

RSVP Here

Location:
Joseph B. Martin Conference Center, New Research Building
Harvard Medical School
77 Avenue Louis Pasteur, Boston

SOURCE

https://warrenalpert.org/symposium

@@@

Optogenetic manipulation of degenerating or aberrant neural circuits in the human brain carries the promise to

• restore vision loss,
• Alterations in Gait i.e., Parkinson’s Disease
• preserve movement following spinal cord injury, or
• dampen down circuits that fuel anxiety, depression and other psychiatric conditions (i.e., addictions).

“The 2019 Warren Alpert Prize for medical research recognizes one of the transformative technical advances of the past decade. The ability to selectively turn on neuronal signals with light exposure has made achievable a more refined analysis of neural connections underlying behavior,” said Joseph Martin, director and chairman of the board of the Warren Alpert Foundation and former dean of Harvard Medical School.

The Warren Alpert Foundation in association with Harvard Medical School

Each year the Warren Alpert Foundation receives between 30 and 50 nominations from scientific leaders worldwide. Prize recipients are selected by the foundation’s scientific advisory board, which is composed of distinguished biomedical scientists and chaired by the dean of Harvard Medical School.

Warren Alpert (1920-2007), a native of Chelsea, Mass., established the prize in 1987 after reading about the development of a vaccine for hepatitis B. The inaugural recipient of the award was Kenneth Murray of the University of Edinburgh, who designed the hepatitis B vaccine. To award subsequent prizes, Alpert asked Daniel Tosteson (1925-2009), then dean of Harvard Medical School, to convene a panel of experts to identify scientists from around the world whose research had a direct impact on the treatment of disease.

Past winners

Last year’s award went to five scientists for transformative discoveries in the fields of genetics, physiology, pulmonology and pharmacology that led to the development of life-altering precision-targeted treatments for the devastating multiorgan disease cystic fibrosis. They were Francis Collins, Paul Negulescu, Bonnie Ramsey, Lap-Chee Tsui, Michael Welsh.

Other past recipients of the Warren Alpert award include:

• James Allison, Lieping Chen, Gordon Freeman, Tasuku Honjo and Arlene Sharpe for discoveries into cancer’s ability to evade immune surveillance that led to the development of a class of cancer immunotherapies.

• Rodolphe Barrangou, Emmanuelle Charpentier, Jennifer Doudna, Philippe Horvath and Virginijus Siksnys for CRISPR-related discoveries.

• Tu Youyou, who went on to receive the 2015 Nobel Prize in Physiology or Medicine with two others, and Ruth and Victor for their pioneering discoveries in the chemistry and parasitology of malaria and the translation of that work into the development of drug therapies and an antimalarial vaccine.

• Oleh Hornykiewicz, Roger Nicol, and Solomon Snyder for research into neurotransmission and neurodegeneration.

• Alain Carpentier for innovations in bioengineering.

• Harald zur Hausen and Lutz Gissmann for work on the human papillomavirus (HPV) and its role in cervical cancer. Zur Hausen and others were honored with the Nobel Prize in Physiology or Medicine in 2008.

The honorees will share a $500,000 prize and will be recognized at a daylong symposium on Oct. 3 at Harvard Medical School.

The 2019 Warren Alpert Foundation Prize recipients are:

• Edward Boyden, the Y. Eva Tan Professor in Neurotechnology at MIT, associate professor of media arts and sciences at the MIT Media Lab and an investigator at the McGovern Institute for Brain Research at MIT, for his insight in leveraging natural biomolecules for the manipulation and understanding of neuronal and brain function, which established and deployed the tools needed for optogenetics.

• Karl Deisseroth, the D.H. Chen Professor of Bioengineering and of Psychiatry and Behavioral Sciences at Stanford University, for establishing the modern field of optogenetics, for rendering the technique an invaluable tool for biological discovery, and for discovering along with Peter Hegemann the key principles of light-sensitive channel structure and function.

• Peter Hegemann, the Hertie professor of Neuroscience at Humboldt University of Berlin, for his study of light-sensitive molecular channels in single-cell organisms—the key proteins that make optogenetic manipulation possible—and discovering along with Karl Deisseroth the key principles of light-sensitive channel structure and function.

• Gero Miesenböck, the Waynflete Professor of Physiology and director of the Centre for Neural Circuits and Behaviour at the University of Oxford in the United Kingdom, for the first demonstrations of optogenetic control of neural activity and animal behavior and for discoveries proving the utility of optogenetics for neurobiological research

“The discoveries made by this year’s four honorees have fundamentally changed the landscape of neuroscience,” said George Q. Daley, dean of Harvard Medical School. “Their work has enabled scientists to see, understand and manipulate neurons, providing the foundation for understanding the ultimate enigma—the human brain.”

The Warren Alpert Foundation Prize recognizes the work of scientists throughout the world. To date, the Warren Alpert Foundation Prize has awarded nearly $5 million to 69 scientists. Since the award’s inception in 1987, 10 honorees have gone on to receive a Nobel Prize.

SOURCE

https://warrenalpert.org/

https://warrenalpert.org/news/2019-warren-alpert-prize-recipients-announced

Ed Boyden receives 2019 Warren Alpert Prize – MIT McGovern Institute

Ed Boyden holds the titles of

• Investigator, McGovern Institute;
• Y. Eva Tan Professor in Neurotechnology at MIT;
• Leader, Synthetic Neurobiology Group, Media Lab;
• Associate Professor, Biological Engineering, Brain and Cognitive Sciences, Media Lab;
• Co-Director, MIT Center for Neurobiological Engineering;
• Member, MIT Center for Environmental Health Sciences,
• Member Computational and Systems Biology Initiative, and Koch Institute.

“It is truly an honor to be included among the extremely distinguished list of winners of the Alpert Award,” says Boyden, the Y. Eva Tan Professor in Neurotechnology at the McGovern Institute, MIT. “To me personally, it is exciting to see the relatively new field of neurotechnology recognized. The brain implements our thoughts and feelings. It makes us who we are. This mysteries and challenge requires new technologies to make the brain understandable and repairable. It is a great honor that our technology of optogenetics is being thus recognized.”

While they were students, Boyden, and fellow awardee Karl Deisseroth, brainstormed about how microbial opsins could be used to mediate optical control of neural activity. In mid-2004, the pair collaborated to show that microbial opsins can be used to optically control neural activity.

Upon launching his lab at MIT, Boyden’s team developed the

• first optogenetic silencing tool,
• the first effective optogenetic silencing in live mammals,
• noninvasive optogenetic silencing, and
• single-cell optogenetic control.

“The discoveries made by this year’s four honorees have fundamentally changed the landscape of neuroscience,” said George Q. Daley, dean of Harvard Medical School. “Their work has enabled scientists to see, understand and manipulate neurons, providing the foundation for understanding the ultimate enigma—the human brain.”

Beyond optogenetics, Boyden has

• pioneered transformative technologies that image, record, and manipulate
• complex systems, including expansion microscopy, robotic patch clamping, and even shrinking objects to the nanoscale.
• He was elected this year to the ranks of the National Academy of Sciences, and selected as
• an HHMI Investigator.
• Boyden has received numerous awards for this work, including the
• 2018 Gairdner International Prize and the
• 2016 Breakthrough Prize in Life Sciences.

SOURCE

Ed Boyden receives 2019 Warren Alpert Prize

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At Technical University of Munich (TUM) Successful Genetical modification of a patient’s own immune cells, T cell receptors, using CRISPR-Cas9 gene editing tool. The engineered T cells are very similar to the physiological immune cells.

Posted in CRISPR/Cas9 & Gene Editing on July 17, 2019| Leave a Comment »

At Technical University of Munich (TUM) Successful Genetical modification of a patient’s own immune cells, T cell receptors, using CRISPR-Cas9 gene editing tool. The engineered T cells are very similar to the physiological immune cells.

Reporter: Aviva Lev-Ari, PhD, RN

 

Targeted exchange using the CRISPR-Cas9 gene scissors

The problem with conventional methods is that the genetic information for the new receptors is randomly inserted into the genome. This means that T cells are produced with both new and old receptors or with receptors having one old and one new chain. As a result, the cells do not function as effectively as physiological T cells and are also controlled differently. Moreover, there is a danger that the mixed chains could trigger dangerous side effects (Graft-versus-Host Disease, GvHD).

“Using the CRISPR method, we’ve been able to completely replace the natural receptors with new ones, because we’re able to insert them into the very same location in the genome. In addition, we’ve replaced the information for both chains so that there are no longer any mixed receptors,” explains Kilian Schober, who is a lead author of the new study along with his colleague Thomas Müller.

Near-natural properties

Thomas Müller explains the advantages of the modified T cells: “They’re much more similar to physiological T cells, yet they can be changed flexibly. They’re controlled like physiological cells and have the same structure, but are capable of being genetically modified.“ The scientists have demonstrated in a cell culture model that T cells modified in this way behave nearly exactly like their natural counterparts.

“Another advantage is that the new method allows multiple T cells to be modified simultaneously so that they’re able to recognize different targets and can be used in combination. This is especially interesting for cancer therapy, because tumors are highly heterogeneous,” Dirk Busch adds. In the future, the team plans to investigate the new cells and their properties in preclinical mouse models, an important step in preparing for clinical trials with humans.

Original Publication

Kilian Schober, Thomas R. Müller, Füsun Gökmen, Simon Grassmann, Manuel Effenberger, Mateusz Poltorak, Christian Stemberger, Kathrin Schumann, Theodore L. Roth, Alexander Marson and Dirk H. Busch: Orthotopic replacement of T-cell receptor ɑ- and β-chains with preservation of near-physiological, Nature Biomedical Engineering, June 12, 2019, DOI: 10.1038/s41551-019-0409-0

 

SOURCE

https://www.tum.de/nc/en/about-tum/news/press-releases/details/35560/

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