October 18
1:00 pm - 2:00 pm EDT

LOCAL TIME

The Biotech landscape: Market trends, priorities, predictions, and pathways to FDA approval

As we adjust to the post-COVID environment, hear from industry leaders about the biotech global investment and drug pipeline environment. In addition, we'll look at why biotech companies are increasingly exploring clinical opportunities in APAC, to achieve FDA accepted data and what actionable strategies can be implemented to leverage APAC’s streamlined regulatory processes and accelerated clinical development. Our Regulatory affairs leaders from North America and Australia will share insight into processes supporting a robust clinical program, and how Phase 1 FDA accepted data from Australia, specifically, can launch global drug development programs.

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Yi Larson

Yi Larson

Chief Financial Officer, LianBio

Yi Larson has served as LianBio’ s Chief Financial Officer since May 2021. Ms. Larson previously served as Executive Vice President and Chief Financial Officer at Turning Point Therapeutics, Inc., a clinical stage precision oncology company, from August 2019 to March 2021. Prior to that, Ms. Larson worked at Goldman Sachs & Co. LLC, where she held various roles since 2008, most recently as a Managing Director of Healthcare Investment Banking. During her tenure at Goldman Sachs & Co. LLC, Ms. Larson advised a variety of biopharmaceutical company boards of directors and management teams on a range of strategic financial matters and executed equity offerings, debt offerings and M&A transactions. She also has served as a member of the board of directors of Olema Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, since April 2021. Ms. Larson graduated from The Wharton School at the University of Pennsylvania with a master’s degree in business administration concentrated in finance. She also earned a master’s degree in electrical engineering and computer science and a bachelor’s degree in electrical engineering, both from the Massachusetts Institute of Technology.

Kasey Kime

Kasey Kime

Director Regulatory Affairs, Novotech

Kasey Kime has over 15 years of global quality and regulatory affairs experience in Life Sciences. She is the Director of Regulatory Affairs for Novotech’s in-house consulting group, BioDesk. Her areas of expertise include CMC for Advanced Therapies, regulatory compliance for cell and gene therapy automated equipment, and IVD development including companion diagnostics. Kasey holds a bachelor’s degree in Medical Laboratory Science and post-graduate degrees in Medical Microbiology, Quality Systems Management, and Business Administration. Kasey serves on the Australia and New Zealand ISCT Regulatory Committee and the early-stage professionals sub-committee.

Jeanne M. Novak

Jeanne M. Novak

CEO & President, CBR International Corp.®

Dr. Jeanne M. Novak is President and CEO of CBR International Corp., a full-service product, clinical, and regulatory strategy group. Dr. Novak is a recognized regulatory expert in the biotechnology and pharmaceutical industries supporting successful pre-clinical through post-approval strategies and dossiers in the US and Europe. She is an author, lecturer and development advisor to industry and government agencies.

Dr. Novak has served as a Staff Research Scientist, (Commissioned Officer, U.S. Army), at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Senior Scientific Reviewer at the Center for Biologics at FDA, a Regulatory Scientist at the Center for Device and Radiologic Health (CDRH) at FDA and Principal Regulatory Scientist at Quintiles, Inc.

In addition, Dr. Novak has been an Adjunct Professor of Cell and Molecular Biology at Colorado State University (CSU) and served as an editorial reviewer for several peer-reviewed scientific journals throughout her career.

Dr. Novak completed her undergraduate degree (B.S. Biology, with honors) and received her Ph.D. in Experimental Pathology (Cell Biology and Immunology) in the Pathology Department (College of Medicine) at the University of Utah.

Fred Cohen

Fred Cohen

Co-founder & Chairman, Monograph Capital Partners

Dr. Fred Cohen, M.D., D.Phil is a Co-Founder and Chairman of Monograph Capital Partners. He is also a Co-Founder and Senior Managing Director at Vida Ventures.

Prior to Monograph, Dr. Cohen was a Partner and founder of TPG Biotechnology, a life science-focused investment effort from 2001-2016.

From 1980 through 2014, Dr. Cohen was at UCSF where he held various clinical responsibilities as a research scientist, an internist for hospitalized patients, a consulting endocrinologist, and as the Chief of the Division of Endocrinology and Metabolism.

Dr. Cohen received his B.S. degree in Molecular Biophysics and Biochemistry from Yale University, his D.Phil. in Molecular Biophysics from Oxford on a Rhodes Scholarship, his M.D. from Stanford and his postdoctoral training and postgraduate medical training in Internal Medicine and Endocrinology at UCSF. Dr. Cohen has been a member of the National Academy of Medicine since 2004 and the American Academy of Arts and Sciences since 2008.

ArsalanArif
moderator

Arsalan Arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.