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R&D in an age of Covid-19: Tackling the key issues around starting, or restarting an early-stage study

The pandemic has hit early stage studies the hardest, often forcing sponsors to suspend or scrap their Phase I plans as sites closed up and patients hunkered down. So what are developers doing now to get their Phase I trials back on track? We’ll hear from some of the top players in the business.

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Sekar Kathiresan

Sekar Kathiresan, MD

CEO, Verve Therapeutics

Sekar Kathiresan is co-founder and chief executive officer of Verve Therapeutics and serves on the company’s board of directors. He is a preventive cardiologist who has made groundbreaking discoveries of cardioprotective genetic mutations, which confer resistance to cardiovascular disease. Prior to joining Verve, he served as director of the Massachusetts General Hospital (MGH) Center for Genomic Medicine and was the Ofer and Shelly Nemirovsky MGH Research Scholar. He also served as director of the Cardiovascular Disease Initiative at the Broad Institute and was professor of medicine at Harvard Medical School. His research laboratory focused on understanding the inherited basis for blood lipids and myocardial infarction and using these insights to improve preventive cardiac care. Among his scientific contributions, he has helped highlight new biological mechanisms underlying heart attack, discovered mutations that protect against heart attack risk, and developed a genetic test for personalized heart attack prevention. He was honored with a Distinguished Scientist Award from the American Heart Association in 2017 and the 2018 Curt Stern Award from the American Society of Human Genetics. In tandem with his research, his clinical focus was the primary prevention of myocardial infarction in individuals with a family history of heart attack. He graduated summa cum laude with a B.A. in history from the University of Pennsylvania and received his M.D. from Harvard Medical School. He completed his clinical training in internal medicine and cardiology at MGH and his postdoctoral research training in human genetics at the Framingham Heart Study and the Broad Institute.

Uma Sinha, PhD

Uma Sinha, PhD

Chief Scientific Officer (CSO), BridgeBio

Uma Sinha, Ph.D. is BridgeBio Pharma’s chief scientific officer. She also serves as the chief scientific officer of BridgeBio’s affiliate company, Eidos Therapeutics, and is a member of Eidos’ board of directors. Prior to joining BridgeBio in 2016, Dr. Sinha served as chief scientific officer of Global Blood Therapeutics, Inc. from 2014-2015 and previously was its senior vice president of research from 2013-2014. She was vice president, head of biology, at Portola Pharmaceuticals, Inc. from 2010-2012 and was the vice president of translational biology from 2004-2010. Previously, Dr. Sinha held senior research positions at Millennium Pharmaceuticals, Inc. and COR Therapeutics, Inc. Dr. Sinha received her Ph.D. in biochemistry from the University of Georgia and her B.Sc. with honors in chemistry from Presidency College.

David Epstein

David Epstein

Executive Partner, Flagship Pioneering

David Epstein is executive partner at Flagship Pioneering, chairman of Axcella Health, chairman of Rubius Therapeutics and chairman of Evelo Biosciences. David is also a board member at International Flavors and Fragrances, Tarus Therapeutics and Valo Health. David is a Director at Three Opinions Foundation and South Florida’s Pelican Harbor Seabird Station (PHSS). PHSS is dedicated to the rescue, rehabilitation, and release of sick, injured or orphaned brown pelicans, seabirds, and other native wildlife and the preservation and protection of these species through educational and scientific means.

From early 2010 to mid 2016 he served as chief executive officer of Novartis Pharmaceuticals, a division of Novartis AG. Previously, David started and led Novartis’ Oncology and Molecular Diagnostic units. Under his leadership the company’s oncology business grew to the second largest in the world.

David has more than 25 years of extensive drug development, deal making, commercialization and leadership experience on a global scale. Over the course of his career he led the development and commercialization of over 30 new molecular entities, including major breakthroughs such as Glivec, Tasigna, Gilenya, Afinitor, Cosentyx and Entresto. His teams developed 3 Prix Galien award winning medicines and he has developed several CEOs. He was named by FierceBiotech as one of the “25 most influential people in biopharma.”

Shehnaaz Suliman

Shehnaaz Suliman

President & Chief Operating Officer (COO), Alector

Shehnaaz Suliman (M.D., MPhil, M.B.A) is a physician, drug developer and strategic deal-maker focused on driving value for patients and investors through transformational acquisition and licensing transactions. She is currently the President and COO of Alector, a leading immuno-neurology company developing novel treatments for neurodegenerative diseases. Dr. Suliman serves on the board of directors for Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and 10x Genomics (NASDAQ: TXG) and has served on the Board of Parvus Therapeutics.

Dr. Suliman was previously Senior Vice President, Corporate Development and Strategy of Theravance Biopharma, Inc., a position she held since July 2017. Prior to her position at Theravance, Dr. Suliman worked for Genentech, Inc. as Group Leader and Project Team Leader in the R&D Portfolio Management and Operations Group from September 2010 to May 2015 and was Vice President and Global Therapeutic Head, Roche Partnering from June 2015 to July 2017.

Prior to Genentech, Dr. Suliman held various management roles of increasing responsibility at Gilead Sciences, Inc. between January 2005 and September 2010 and played a significant role in forward-integrating Gilead into new therapeutic areas through M&A. Before Gilead, Dr. Suliman was an investment banker advising public and private companies on buy- and sell-side transactions.

Dr. Suliman received her M.D. (MB, ChB) at the University of Cape Town Medical School, South Africa, and holds an M.B.A, with distinction, and M.Phil. in Development Studies degrees from Oxford University, where she was a Rhodes Scholar.

She named as one of 2017 Fiercest Women in Life Sciences and currently serves as the Co-Chair of Executive Women in Bio. She is forging new paths for Women on Boards with the Board Room Ready program and continues to be a career mentor to dozens of rising stars.

Ralf Rosskamp, M.D.

Ralf Rosskamp, M.D.

Medical Consultant and Former Chief Medical Officer (CMO), Dicerna Pharmaceuticals

Ralf Rosskamp, M.D., is a medical consultant for Dicerna after previously serving as the Company’s chief medical officer (CMO) since June 2017. He was responsible for leading the Company’s clinical development, medical affairs and regulatory functions. Prior to joining Dicerna, Dr. Rosskamp was CMO at Summit Therapeutics, where he was responsible for directing and overseeing all clinical development and medical activities for Summit’s clinical candidates in development for the rare genetic disease, Duchenne muscular dystrophy, and the infectious disease caused by Clostridium difficile bacteria. Prior to Summit, Dr. Rosskamp held executive-level positions in clinical research and drug development at NPS Pharmaceuticals (acquired by Shire), Ikaria, Kos Pharmaceuticals (acquired by Abbott Laboratories), Aventis Pharmaceuticals (formerly Hoechst Marion Roussel) and Hoechst AG. Dr. Rosskamp is a pediatric endocrinologist with more than 15 years of experience in clinical medicine. He received his M.D. from the University of Bonn, Germany.

Alok Tayi
presenting sponsor

Alok Tayi

VP of Life Sciences

Alok is the Vice President of Life Sciences at Egnyte where he is responsible for building and executing the company's strategy for the life sciences market segment. Alok works across the organization to verticalize our marketing, sales, product, compliance, and account management practices for this domain. Before joining Egnyte, Alok was a YCombinator-backed entrepreneur and started two vertical software-as-a-service companies. Prior to his career in software, Alok spent over 15 years as a scientist: he took part in postdoctoral work at Harvard University with George Whitesides, and has published papers in Nature and Nature Chemistry. Alok holds a PhD from Northwestern University and BS from Cornell University.

John Carroll
moderator

John Carroll

Founder & Editor, Endpoints News

John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 15 years. Aside from his previous daily industry coverage at FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.