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
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
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AGENDA
Schedule
PART I
Diagnosing, Different
Joseph B. Martin Conference Center at Harvard Medical School
77 Avenue Louis Pasteur, Boston, MA 02115
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
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
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.
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
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
- Chemical testing
- Immune therapy testing
- test utilization
- test coverage
- scaling
- Standardization of care in each Hospital, medical education
- 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
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
- Prescriptions per 100 persons
- overdose death pwe 100,000 persons
- 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
- OPTIN – Treatment to Pain chronic
- GOALS 0 Genomics of Opiod Addiction treatment aptients
- 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
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
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
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
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
SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition
PART II
Targeting Treatment
Joseph B. Martin Conference Center at Harvard Medical School
77 Avenue Louis Pasteur, Boston, MA 02115
SPEAKER | Stephen L. Eck, M.D., Ph.D., Chief Medical Officer, Immatics US
SPEAKER | Joseph B. Martin, M.D., Ph.D., Dean Emeritus, Harvard Medical School
Personal story of familial heritage from Europe to Alberta, CA
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
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
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
- off the shelf cells from health donors
- 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
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
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
SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition
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