Navigating Patient-Enabled Technology Innovation Post-Pandemic

Janice Chang is the Chief Executive Officer at TransCelerate BioPharma Inc. Ms Chang has been involved with the organization since its inception. As CEO, she works closely with the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Ms Chang defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio. She also actively participates in various cross-stakeholder global discussions to help evolve the R&D paradigm.With a background of 20+ years of experience leading initiatives in large pharma and biotech companies, Ms Chang has experience spanning across regulatory, clinical, and manufacturing.  Janice is passionate in driving meaningful change across our ecosystem and not settling for the status quo.  She believes in reimagining the way we advance innovative medicine and advocates for the power of open collaboration across stakeholder groups.

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science.  Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

Bari Kowal joined Regeneron in 2015 and became Head of Global Clinical Operations in 2017. Ms Kowal currently serves as Senior Vice President, Development Operations and Portfolio Management and is responsible for clinical trial strategy and execution, along with overseeing our development shared services functions. Prior to Regeneron, Ms Kowal was previously at Pfizer where she held the positions of Vice President, Business Operations and Analytics, and, prior to that, Vice President, Strategic Alliance and Development Operations Lead. Ms. Kowal also served as Vice President, Clinical Operations, on the clinical research organization side of the industry at a number of biotech organizations in a variety of clinical research roles early in her career. She holds a BS in Biology from the State University of New York at Binghamton and an MS in Neuroscience from New York University.

Dr Lynn Kramer is Chief Clinical Officer, ADBH (Alzheimer’s Disease & Brain Health) at Eisai and a member of the Eisai Company Ltd. Executive Committee. Dr Kramer oversees the product creation cycle including clinical introduction, and regulatory approval of innovative projects in the neuroscience and general medicine area globally. He recently received the 2022 Epilepsy Foundation Lifetime Accelerator Award.In 2007, Dr Kramer started as the Executive Vice President of Global Clinical Research at Eisai and was promoted to the additional role of Chief Operating Officer of Eisai Medical Research. He was named Chief Clinical Officer and a member of the Executive Committee, Eisai Company, Ltd. in 2012. In addition to those roles Dr Kramer was named Chief Medical Officer of the Neuroscience Business Group in April 2016.Before joining Eisai, Dr Kramer oversaw clinical development, pharmacovigilance, drug safety and medical affairs for PAR Pharmaceutical, Inc. Earlier in his career he held senior positions in drug development at Purdue Pharmaceuticals and was Vice President Clinical Research and Head of the Therapeutic Area Strategy Team at Novartis, and Vice President Clinical Research at the R.W. Johnson Pharmaceutical Research Institute.Dr Kramer received his MD from Hahnemann Medical College. He has been Co-PI on several NIH grants: Clinical and Epidemiologic Studies of Human Epilepsies, Pharmacologic Prophylaxis of Post-Traumatic Epilepsy, and had a Master Agreement Evaluation of Investigational Antiepileptic Drugs prior to his move into industry. He also holds a BA degree from Lycoming College.

Andy Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO). In this role, Mr Lee leads and manages GCTO, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed and quality standards. Mr Lee is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems and processes to conduct Merck clinical trials.Mr Lee joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Mr Lee led the integration of Sanofi with Genzyme, where he was Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer.Mr Lee holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc, a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He also serves as a member of the TransCelerate Operating Committee. Mr Lee received his Masters in Bioenergetics and Physiology from Ball State University in Indiana and two undergraduate degrees from Rhodes University in South Africa.