Our Speaker Faculty
Ax-S Pharma brings together world leaders from industry, medicine, and policy centers to provide members an unparalleled range of information and perspective on the integration of research and healthcare.
Amy Abernethy, MD, PhD
Principal Deputy Commissioner and Acting Chief Information Officer, FDA
Paul Aliu, PhD
Global Head Medical Governance, Chief Medical Office, Novartis Pharmaceuticals
Chris Austin, MD
Director, National Center for Advancing Translational Sciences, NIH
Christopher P. Austin has served as director of the National Center for Advancing Translational Sciences at the National Institutes of Health since 2012. Prior to this role, he was NCATS’ scientific director, focusing on translating basic science discoveries into new treatments and technologies to improve the efficiency of therapeutic/diagnostic development. He founded several initiatives, including the NIH Chemical Genomics Center, the Therapeutics for Rare and Neglected Diseases program, and the Toxicology in the 21st Century program.
Before joining NIH in 2002, he led genomic-based target discovery, pharmacogenomic, and neuropsychiatric drug-development programs at Merck. From 2016 to 2018, he served as chair of the International Rare Disease Research Consortium (IRDiRC); Dr. Austin is also a member of National Academy of Medicine.
He earned an A.B. from Princeton University, an M.D. from Harvard Medical School, and completed training in internal medicine and neurology at Massachusetts General Hospital.
Georges van Baelen, MScPh
Founder and President of Arctiryon, Inc.
Behtash Bahador, MSc
Associate Director, Center for Information and Study on Clinical Research Participation (CISCRP)
Amy Barone, MD
Medical Officer, FDA Office of Hematology and Oncology Products
As a medical officer, she is responsible for the review and regulatory oversight of expanded access programs, numerous investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), and single patient INDs.
She is very involved in the FDA effort to move the field of oncology drug development for rare diseases forward.
Naomi Lopez Bauman
Director of Healthcare Policy, Goldwater Institute
She has twenty-five years’ experience in policy at both the federal and state levels and has previously served at organizations including the Pacific Research Institute and the Cato Institute. Lopez Bauman holds a B.A. in economics from Trinity University and an M.A. in government from The Johns Hopkins University.
CEO & Co-Founder, Anova
Stuart Bell, PhD
VP Consulting, Inceptua Medicines Access
Stuart has more than 20 years of healthcare and pharma consulting experience, with a particular focus in unlicensed medicines and pre-approval access. He is one of the senior management team responsible for establishing Inceptua Medicines Access and is responsible for Inceptua’s consulting engagements, covering strategy and policy, real-world evidence, communications and market access.
Prior to Inceptua, Stuart set up the Consulting Dept. at Idis/Clinigen, pioneering the development of global corporate strategies on pre-approval access and developing the first pre-approval-specific EDC for real-world data collection. He has formerly held roles as: Principal, Real-World Evidence at IQVIA, Director, Informatics Initiative, UK Dept. of Health, Consultant to the European Association of Neuro-Oncology and Director of Communications for the European Cancer Organization.
Amar Bhat, PhD
Interim Executive Director, Reagan-Udall Foundation, FDA
Marc Boutin, JD
Chief Executive Officer, National Health Council
Suanna Bruinooge, MPH
Director of Research Strategy, CENTRA, American Society of Clinical Oncology (ASCO)
Suanna Bruinooge, MPH, is the Division Director of Research Strategy and Operations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates, integrates, analyzes, and shares oncology data to foster innovation in research and patient care and help develop and evaluate ASCO’s policy positions. CENTRA develops and implements ASCO’s research agenda, including the Targeted Agent Profiling and Utilization (TAPUR) clinical trial and projects to advance clinical trial design and methodology. CENTRA also staffs ASCO’s Cancer Research Committee, Research Community Forum, and Workforce Advisory Group.
Prior to joining ASCO, Suanna worked for seven and a half years in the U.S. House of Representatives, working for Congresswoman Nancy Johnson (R-CT) and Congressman Vernon Ehlers (R-MI). Ms. Bruinooge earned a Master’s of Public Health in Health Policy at The George Washington University’s Milken Institute School of Public Health in 2015.
Connie Coulomb, MBA
Managing Partner, Coulomb Strategy Consulting LLC
Connie Coulomb is Managing Partner at Coulomb Strategy Consulting LLC, a firm dedicated to helping companies advance their strategy and turn exciting research into successful products that can benefit patients’ lives.
With more than 20 years’ experience in biopharma, Mrs. Coulomb has held a variety of roles in the areas of strategy, business development, marketing, sales, market research and market access in large, medium and small biopharma companies, including Merck, Amgen, Biogen, Gilead, and Onyx.
Mrs. Coulomb has extensive international experience, having served as Executive Director of Commercial Operations at Amgen, overseeing a 35-country division that included Canada, Mexico, Latin America, the Middle East, Turkey, Australia and Africa. Previously at Onyx, she was responsible for the launch of Kyprolis in the Americas markets. At Merck & Co., she served as the commercial lead of the Oncology business for Puerto Rico, Central America and the Caribbean.
Connie has worked across several therapeutic areas including oncology, hematology, CNS, cardio-metabolic, osteoporosis, vaccines, autoimmune diseases, HIV, pain management, generics and biosimilars.
A native of Argentina, Connie received degrees in Business Administration and Accounting from the University of Buenos Aires, graduating with honors as Magna Cum Laude. She later completed her MBA at Stanford University.
Mrs. Coulomb is one of the co-authors of The Global Guide to Compassionate Use Programs.
Anne Cropp, PharmD
Chief Scientific Officer, Early Access Care, LLC
Anne Cropp, BSc, Pharm.D. BCAP serves as the Chief Scientific Officer for Early Access Care, providing consultative, functional and operational support to biopharmaceutical companies for Expanded Access / Compassionate Use of investigational drugs.
Prior to founding Early Access Care, Anne was Vice President at Pfizer Inc. Anne has extensive experience in pharmaceutical and biopharmaceutical drug development. She has built high-performing, diverse leadership teams supporting pipeline products from Phase 1 through NDA/MAA submission. Her expertise spans drugs, biologics and devices.
Anne is a globally recognized expert in Expanded Access US and ex-US and led the development and execution of the industry’s first physician-entry request portal for a global pharmaceutical company. As a life long member of the scientific research community, Anne’s passion has always been to bring solutions to advance patient care.
Anne began as a pharmacist meeting the needs of hospitalized patients. She certified as a clinical pharmacologist and completed two post-doctoral research fellowships in cardiovascular clinical pharmacology. While at the NHLBI of the NIH she first experienced Expanded Access. Motivated by a desire to help patients, she founded Early Access Care.
Merit Cudkowicz, MD
Director, Sean Healey & AMG Center for ALS at Massachusetts General Hospital
Dr. Merit Cudkowicz is the Director of the Sean M. Healey & AMG Center for ALS, Chief of Neurology at Mass General, Director and the Julieanne Dorn Professor of Neurology at Harvard Medical School. Dr. Cudkowicz’s research and clinical activities are dedicated to the study and treatment of people with Amyotrophic Lateral Sclerosis (ALS). Dr. Cudkowicz is one of the founders and past Co-Chairs of the Northeast ALS Consortium (NEALS), a group of over 134 clinical sites performing collaborative clinical trials and research in ALS. She has brought innovations to accelerate the development of treatments for people with ALS, including senior role in first antisense oligonucleotide treatment for a neurological disorder (SOD1 ALS), adaptive trial designs, central IRB – all with goal to bring the best treatments rapidly. Dr. Cudkowicz is Principal Investigator of the Clinical Coordination Center for the National Institute of Neurological Disorders and Stroke’s Neurology Network of Excellence in Clinical Trials (NeuroNEXT). Dr. Cudkowicz is launching the first platform trial initiative in ALS, the HEALEY ALS Platform Trial, which is expected to greatly accelerate therapy development in ALS.
Jonathan Darrow, S.J.D.
Faculty, Harvard Medical School; Associate Scientist, Women and Brigham’s Hospital
Khrystal K. Davis
Founder & President of Texas Rare Alliance, Texas Newborn Screening Advisory Committee
David Farber, JD
Senior Partner, King & Spalding
Anthony Fauci, MD
Director, National Institute of Allergy and Infectious Diseases (NIAID), NIH
Director, Global Medical Affairs, Early Access Programs, Alnylam Pharmaceuticals
Karen has over 26 years of experience in the biopharma industry, in a variety of commercial and strategic consulting roles. She started her career as a pharmaceutical sales representative and was promoted into increasing levels of responsibility eventually having managerial oversight for primary care and specialty sales teams across the US for Pfizer and AstraZeneca.
Karen moved into the global early access area in 2010 first with Clinigen Group, then Caligor Coghlan Pharma Services. During this time, she was responsible for helping biotech and pharma companies establish strategies and implementation of early access programs for their innovative medicines, with a special focus on orphan drugs and oncology. In 2019, she joined Alnylam Pharmaceuticals to lead the strategy and operational execution of early access programs and compassionate use across their pipeline.
Karen graduated with honors and holds a BS in Biology from the University of Akron. She has been a contributor to several patient-facing publications which center around obtaining early access to medicines as well as a frequent presenter at rare disease industry conferences over the past 9 years.
Founding President and CEO, Parent Project Muscular Dystrophy (PPMD)
Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Its mission is to improve the treatment, quality of life, and long-term outlook for all individuals affected by Duchenne through research, advocacy, education, and compassion.
Pat graduated from Mt. St. Joseph College in Cincinnati, Ohio with a BS in Nursing. She attended Graduate School at Ohio State University. While attending Ohio State, Pat spent most of her time in the Medical Intensive Care Unit.
After marrying Dr. Tom Furlong, Pat ran the Renal Dialysis Unit and Patient Education Center at Akron General Hospital. In 1994, Pat, together with other parents of young men with Duchenne, founded PPMD to change the course of Duchenne and, ultimately, to find a cure. Today, Pat continues to lead the organization and is considered one of the foremost authorities on Duchenne in the world.
Lee Gehrke, PhD
Professor, Institute for Medical Engineering and Science, MIT
Christina Hartman, MPH
Senior Director of Advocacy, The Assistance Fund
William Hoos, MBA, MS
Chief Commercial Officer, xCures
xCures is a health technology and services company founded by Marty Tenenbaum, a renowned computer scientist, Internet entrepreneur and cancer survivor and Jeff Shrager, a Stanford professor and expert in applying high-performance cloud computing and machine learning in biological science.
They assembled a boundary-pushing team with extensive experience in AI, health tech, and Pharma, and with the expertise, creativity, and persistence needed to solve the biggest problems in oncology. Mika Newton, a 20+ year veteran of the life sciences industry, is xCures’ CEO.
Through its precision oncology platform, xCures provides patients, and their physicians with the best individualized treatment options and services including access via reimbursement, clinical trials, expanded-access support and outcomes generation. By tightly integrating cancer research and clinical care, xCures enables bio-pharmas to slash the time and cost of developing drugs, physicians to make better treatment decisions, and patients to achieve superior outcomes.
Willy earned an MBA from Georgia Institute of Technology. He holds a BS Chemistry from Wake Forest University and MS Organic Chemistry from the University of California, Los Angeles.
Peter Barton Hutt, JD
Senior Counsel, Covington & Burling LLP
Michael Joyner, MD
Faculty Member, Mayo Clinic
Former Director, FDA, Office of Health and Constituent Affairs
Michael Kurilla, MD, PhD
Director of the Division of Clinical Innovation, NCATS-NIH
Managing Director of Business Development, Tanner Pharma Group
President, X2 Foundation
Founder, Clinical Innovation Partners
Michelle Longmire, MD
CEO & Co-Founder, Medable
Dr. Michelle Longmire is the founder and Chief Executive Officer of Medable. Dr. Longmire is mission driven to accelerate the development of new therapies for disease. As a Stanford-trained physician-scientist, Dr. Longmire identified critical barriers to drug development and founded Medable to pioneer a new category of clinical trial technologies that remove traditional roadblocks to participation and radically accelerate the research process. Medable is now the industry leader in decentralized and direct-to-patient research, serving patients in clinical trials in over 30 languages, 40 countries, and across all therapeutic areas. In addition to having raised over 40 million dollars in venture capital and driving Medable to an industry-leading position, Dr. Longmire has received recognition as a leading innovator and business woman, including being named as one of the 100 most creative people in business by Fast Company
Peter Marks MD PhD
Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.
Hilary Marston, MD, MPH
Medical Officer, National Institute of Allergy and Infectious Diseases (NIAID), NIH
Hilary Marston, MD, MPH is a Medical Officer and Policy Advisor for Global Health focusing on emerging infectious disease preparedness and response. In this role, she coordinates the National Institute of Allergy and Infectious Diseases’ response to outbreaks including Zika in the Americas and Ebola in West Africa and the Democratic Republic of the Congo. Dr. Marston trained in internal medicine at Brigham & Women’s Hospital, during which time she worked with Partners in Health and the Clinton Health Access Initiative. Before her medical training, Dr. Marston worked for McKinsey & Company and at the Bill & Melinda Gates Foundation as a Program Officer and Special Assistant to the Co-Chair.
Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Edmund Pezalla, MD, MPH
Former National Medical Director and VP, Aetna (2007 – 2016); CEO of Enlightenment BioConsult
President, Center for Medicine in the Public Interest (CMPI)
Tobias Polak, MSc
Department of Health Technology Assessment, Erasmus MC
Jess Rabourn, CFA
Founder and CEO, WideTrial
Principal and Founder, ORPHA Strategy Consulting
David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access in the European environment of orphan and advanced therapy medicinal products.
David’s experience includes rare oncology and haematology (ALL, AML, MM, CD30+ HL/NHL, CTCL, ALK+/EGFR+ NSCLC, breast cancer), metabolic and endocrine diseases (MPS, Graves’, acromegaly), neurology (CIDP, RTT, MG, narcolepsy, Friedrich’s ataxia), ophthalmic disorders (LCA), hepatic conditions (PSC), and rare immunological diseases (AMR, GvHD).
He is the author and co-author of numerous peer-reviewed publications, a rare disease, orphan drugs and gene therapies trainer, and speaker at international meetings (ISPOR, RAPS EU Congress, Orphan Drugs Development and Commercialization).
Erika Segear, PhD, RAC
Associate Director of Regulatory Affairs, Duke University School of Medicine
Andrew Shuman, MD, FACS
Chief of Ethics Service, University of Michigan Medical School
Marjorie Speers, PhD
Executive Director, Clinical Research Pathways
Douglas Sproule, MD
Vice President, Spinal Muscular Atrophy Therapeutic Area Head, AveXis
CEO, NRG Collective Ltd
Senior Editor, BioCentury
Steve Usdin has been Washington Editor of BioCentury since 1993, and has spent the past 25 years in the nation’s capital covering political and policy issues affecting the life sciences sector. He also is BioCentury Senior Editor responsible for coverage of social issues involving biotechnology, as well as the former host of BioCentury This Week, BioCentury’s public affairs television program.
Steve’s reporting about biotechnology and biomedical policy has been cited in The Economist, The Wall Street Journal, the Washington Post, New Scientist and other publications.
In 2012, the FDA Alumni Association named Steve the Harvey W. Wiley Lecturer, making him the first journalist to receive the Wiley Award. His book, “Engineering Communism: How Two Americans Spied for Stalin and Founded the Soviet Silicon Valley,” was published in 2005 by Yale University Press.
Robert Walker, MD
Director, Division of Clinical Development, Biomedical Advanced Research and Development Authority (BARDA), HHS
Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Medical System
Co-Chair, Expanded Access Oversight Committee, Michigan Medicine; Adjunct Associate Clinical Professor, College of Pharmacy
Kevin is the Managing Director of the Michigan Institute for Clinical & Health Research (MICHR) and Adjunct Associate Clinical Professor in the College of Pharmacy. He also serves as Co-chair of the Michigan Medicine Expanded Access Oversight Committee to develop and enhance processes and infrastructure to support treating clinicians interested in providing access to investigational therapies/agents to patients with no alternatives.
Kevin has been instrumental in the development of institutional policy and processes as they relate to FDA-regulated research at the University of Michigan. Kevin is Co-principal investigator with Dr. George Mashour on a NIH U01 award promoting a national network for the FDA’s Expanded Access program.
In the role of Managing Director, Kevin is the administrative lead and is responsible for operational, fiscal, and executive oversight. He works closely with Dr. Mashour and the MICHR leadership team to build the organization, shape strategy, and implement programs and resources to serve the research enterprise.
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research, FDA
Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ).
Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations.
Before joining CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.
Frank Young, MD, PhD
Executive Vice President Clinical & Reg Affairs, TissueTech Inc.; Former FDA Commissioner, 1984-1989
Dr. Frank Young was a previous Commissioner of the U.S. Food and Drug Administration (FDA), and had served as Deputy Assistant Secretary of the U.S. Department of Health and Human Services.
He was most recently Executive Vice President for Clinical, Regulatory Affairs, and Quality and had served in a leadership capacity with multiple other life sciences companies. Previous to his appointment to lead the FDA, Dr. Young was Dean of the School of Medicine and Dentistry and Vice President for Health Affairs at the University of Rochester.
While serving at the U.S. Department of Health Human Services, Dr. Young received the Inspector General’s Award for Outstanding Integrity, and the Surgeon General’s Exemplary Service Medal from the U.S. Public Health Service. Dr. Young was a member of the National Academy of Medicine. In 2015, he received the Distinguished Scientist Award from the American College of Toxicology.
Dr. Young contributed to more than 200 scientific publications in microbiology, biotechnology and pathology.