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Are you curious to learn more about the path to success for Women in Regulatory Affairs (RA)? Are you interested in expanding your influence, increasing your impact, and building savvy relationships? If yes, please join us for a panel discussion by six Women Leaders who have navigated and overcome barriers to chart paths for themselves and others in RA. We will also explore the importance of leveraging Mentors and Coaches in shaping careers and breaking the glass ceiling.
This event will be of a question-and-answer format, followed by a live Q&A portion with the panelists.
This event is brought to you by the RAPS NY/NJ Chapter to encourage knowledge sharing and RA community development. RAC holders may claim 1.5 RAC recertification credit.
Enterprise Member: Free
RAPS Member: Free
Regulatory Affairs Professionals (Strategy, CMC, Policy) and anyone in the healthcare industry that aspires to establish a career in Regulatory Affairs.
HOW DO WEBCASTS WORK?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.
Madhuri B Jerfy, MS, RAC, Senior Associate Director, Global Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.
Joanne Palmisano, MD, FACP, FRAPS, Former Vice President, Head Global Regulatory Strategy, Vertex Pharmaceuticals
Dr. Palmisano earned her MD at Columbia University College of Physicians & Surgeons and is a Fellow of the American College of Physicians. For the first 18 years of her medical career before entering the pharmaceutical industry, she served on the faculties of Harvard Medical School and the State University of New York engaged in teaching, patient care and research in diabetes and cardio-metabolic disorders. Joanne’s career in Industry includes biopharma leadership in both clinical drug development, regulatory affairs, and regulatory policy. She has directed teams in all phases of drug development for small molecules, biologics and biosimilars, in multiple therapeutic areas. Joanne most recently was Vice President, Regulatory Affairs, Head Global Regulatory Strategy at Vertex Pharmaceuticals. She has held positions of Vice President, US Regulatory Affairs at Boehringer Ingelheim Pharmaceuticals, Assistant Vice President of Regulatory Affairs at Wyeth/Pfizer, and Senior Director, Clinical Development for Endocrine/Metabolic and Cardiovascular, Merck. Joanne served as the PhRMA/BIO Industry member to the expert working group for ICH E8(R1) – Revision on General Considerations for Clinical Studies (adopted October 2021), as well as serving on the expert working group for ICH E11(R1) – revision to Clinical Investigation of Medicinal Products in the Pediatric Population (adopted August 2017). Joanne is a 2017 Fellow of the Regulatory Affairs Professionals Society (FRAPS), in recognition of significant contributions and leadership in advancing the regulatory profession. She is recipient of the 2018 PharmaVoice 100 Award for inspirational executive leadership in advancing Regulatory Affairs.
Lauren Quinn, BA, JD, Vice President, US Regulatory Affairs, GSK Consumer Healthcare
Lauren Quinn is currently Vice President, US Regulatory Affairs for GSK Consumer Healthcare. During her more than 20 years as a Regulatory professional she has held roles in Global Strategy, Regulatory Operations and Regulatory Policy across Rx, OTC, Medical Devices and Dietary Supplements. Lauren began her career at Baxter Anesthesia and Critical Care, and has worked for Wyeth, Novartis, Pfizer and GSK. She holds a BA from Rutgers University and a JD from Seton Hall School of Law.
Weining Hu, BSc, MSc, MSc, Associate Vice President, Global Regulatory Affairs, CMC, Merck
Weining Hu has more than 20 years of regulatory CMC experiences ranging from vaccines, monoclonal antibodies/peptides/ADC, and cell and gene therapy products. She holds a BSc in Chemistry from the Sichuan University (China), MSc in Biochemistry from University of Wisconsin Milwaukee, and MSc in QA/RA from Temple University. Weining is an Associate Vice President at Merck and is leading Global Regulatory Affairs CMC for ADC and Cell and Gene Therapy. Prior to joining Merck, Weining worked at Gan & Lee Pharmaceuticals in Bridgewater, NJ as the VP of Global Regulatory Affairs, where she built the regulatory team to support the development and registration of biosimilar products and NCE for oncology. Weining was also a Director in Global Biologics CMC at Merck previously and had led/contributed the filing of BLA/MAA for multiple biological products, including initial Keytruda BLA filing and subsequent worldwide marketing authorization applications. While working at GSK Vaccine, she was the CMC lead for Cervarix US BLA submission as well as the development of multiple immunotherapeutic vaccines (Gene Therapy Products). In this role, she had worked with FDA, Office of Tissues and Advanced Therapies (OTAT), previously Office of Cellular/Tissue/Gene Therapy (OCTGT).
Leah Christl, PhD, Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy, Amgen
Dr. Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS-Global CMC, Device & Biosimilar Regulatory Affairs, and Business Operations with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s regulatory and R&D policy positions. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs (OND) in the FDA's Center for Drug Evaluation and Research (CDER). In this role, she developed and led CDER’s approach to implementation of the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Dr. Christl was also the director of the Therapeutic Biologics and Biosimilars Staff (TBBS) at the US FDA and served as a scientific, regulatory, and policy expert to FDA, HHS, and external stakeholders, on biosimilar products. In addition, Dr. Christl engaged in international activities by serving as a CDER and FDA strategist and lead for international activities related to biosimilars, including serving as FDA lead for the FDA-EMA-Health Canada-PMDA biosimilars cluster and the International Pharmaceutical Regulators Programme – Biosimilars Working Group. Dr. Christl held several positions of increasing seniority at FDA during her 16+ year tenure. Prior to joining FDA, she was a Research Assistant Professor at the University of South Carolina in Columbia. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston.
Yogita Bahl, PhD, Senior Director, Team Lead RACMC Cell Therapy, Bristol Myers Squibb
Dr. Yogita Bahl is a seasoned, results-focused Regulatory Affairs professional with over 20 years of experience in Pharmaceutical and Biotech industry. In her current role as Senior Director in the RA-CMC group at BMS, she leads the regulatory CMC team responsible for developing Regulatory CMC strategies for Car-T products. Prior to BMS, she has worked at Daiichi, Novartis, Merck and Amgen. Her 20+ years of experience spans several different CMC areas, including formulation development, CMC commercialization, and Regulatory CMC supporting registration and post approval activities of ADCs, Biologics and Combination products (Biologics+Devices). Yogita received her Ph.D. in Pharmaceutical Sciences from University of TN at Memphis. As a Leader in healthcare industry committed to mentoring, her passion is talent development and building diverse and inclusive teams working together to bring innovative medicines to the patients.
Corinne Pillai, BPharm, MBA, Senior Director, Global Regulatory Affairs, Viatris
Corinne Pillai holds approximately 15 years’ experience in the pharmaceutical industry spanning global and in-country roles covering end to end spectrum from product development and product life cycle management across AFME/LATAM/APAC/Eastern Europe. She is currently employed at Viatris Inc. in the United States, as Senior Director, Team Lead for the CNS/Pain/Ophthalmology Portfolio. Corinne is a South National and immigrated to the United States in 2018. She began her pharmaceutical industry career in 2008 at Aspen Pharmaceuticals South Africa working in the Manufacturing & Warehousing facility, Regulatory Compliance and Regulatory Affairs divisions, following which; she moved to Pfizer South Africa where she held roles of increasing responsibility within local and global regulatory divisions in the organization. She also has experience working as a hospital and retail pharmacist. Corinne has represented on trade and industry associations, serving as Vice Chair for the Southern African region Regulatory Affairs Association, and represented on South African Industry Task Group (ITG) pharmaceutical industry regulator interface. Corinne holds a Bachelor of Pharmacy, Honors degree from the University of Witwatersrand South Africa and is currently completing her MBA at Stevens Institute of Technology in New Jersey where she, her husband and two sons reside.
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RAPS will send an electronic letter or a certificate of attendance following the workshop.