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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from March 2023
This webinar will cover areas such as the broadening role of Regulatory Affairs across the product lifecycle, how technology can help accelerate label development and approval, and unlocking the value of published literature and clinical trial data to advance Regulatory Strategy. The format is a Q&A with regulatory leaders from Merck, Scholar Rock and Sobi.
Given the pressure on regulatory professionals to move ever more quickly to regulatory approval, technology can be an enabler. Technology can also help regulatory professionals take on more of a leadership role across the organization by providing a more comprehensive view of the landscape and the ability to rapidly interrogate and interpret data.
This topic is one that is relevant from the most senior level, as executives look to empower their teams with the most impactful tools, to the most junior level, as employees strive to advance their careers.
The regulatory leaders on the panel will offer insights from a range of life sciences segments, including large pharma, mid-market pharma and biotech.
David DoornstreichChief Commercial Officer, Dr. Evidence
David Dornstreich is Chief Commercial Officer at Dr.Evidence, a leading medical intelligence platform for life sciences companies, where he leads the Business Development, Client Success, Marketing and Revenue Operations teams, focused on developing and implementing a commercial strategy to optimize growth and client experience. Previously, Dornstreich served as Vice President, Strategic Initiatives and Data Partnerships at Veradigm, an Allscripts company, where he focused on biopharma business development and engagement with organizations including medical societies, regulatory and government agencies and academic institutions to enrich and extend data content and capabilities. Prior to Veradigm, Dornstreich held roles with increasing responsibility at Concert AI, an oncology real world evidence company, the American Society of Clinical Oncology’s (ASCO) CancerLinQ and the American College of Cardiology.
Karen CipreroSenior Director, Global Labeling, Merck
Karen has 17 years of experience in the pharmaceutical industry, more than 7 of which have been in Global Labeling at Merck. As a Global Labeling Strategic Director, she currently leads a team of Global Labeling Leads across the Infectious Disease and General Medicine therapeutic areas. She was an integral member of the Label Process and Documentation Redesign team (2019-2020), leading the communication workstream. She continues to champion process management and is the US labeling process owner. Prior to joining Global Labeling, Karen gained pharmaceutical experience within Merck in Clinical Research in Vaccines and in Clinical Operations with InfaCare Pharmaceutical Corporation. Before joining the pharmaceutical industry, she was a Genetic Counselor for several years at Children’s Hospital of Philadelphia. Karen earned her B.S. in Biology from Dickinson College and M.S. in Genetic Counseling from Virginia Commonwealth University.
Hayley ParkerVice President, Global Regulatory Affairs, Scholar Rock
Currently, Hayley is Vice President of Regulatory Affairs at Scholar Rock and has a Regulatory career that spans almost 20 years. Hayley enjoys working in an environment that has a shared sense of drive and passion for patient‐centric drug development. Before joining Scholar Rock, she held increasingly senior positions across multiple disciplines within the Regulatory function, including establishing and leading strategic labeling functions, global and regional Regulatory strategy, and advertising and promotion positions.
Hayley earned her Ph.D. in Respiratory Viral Exacerbations of Chronic Lung Diseases from Imperial College, London, and it is here that her interest in the potential of applying technology solutions to complex drug development riddles was established when she was faced with the overwhelming task of analyzing 10s of thousands of data points from the output of microarray technologies.
Olivia MaurelHead of Global Regulatory Affairs, Sobi
Olivia is the head of Global Regulatory Affairs at Sobi. Prior to joining Sobi, she was head of Rare Diseases for Takeda’ Global Regulatory Affairs organisation. She was also head of International Regulatory Affairs and Advertising & Promotion (AdPromo) group at Takeda, overseeing all regions outside of the US (EUCAN, GEM, Japan), Regulatory Policy and AdPromo function. Between 2011 and 2018, she held various roles in Global Regulatory Affairs as head of Global Regulatory Strategy supporting various Therapeutic Areas (Rare diseases, Gastro-enterology, Immunology, Hematology). In 2018, she was appointed as head of Drug Safety Surveillance, leading the medical function of Pharmacovigilance at Shire.
Between 1995 and 2011, Olivia held various Regulatory Affairs roles of increasing responsibility at NovImmune (Switzerland), Centocor/Johnson & Johnson (the Netherlands), Genzyme (the Netherlands), Servier (France) and Sanofi (France) with global and regional responsibilities.
Olivia holds a Pharmacist Doctorate from the University of Montpellier, France. She’s skilled at leading global organizational changes. She has extensive experience in developing and executing global regulatory strategies throughout a drug’s development and life-cycle management phases and guiding teams through changes. She possesses an in-depth knowledge and expertise in Drug Development, Biologics, Rare Diseases, Regulatory Policy and Pharmacovigilance. She’s currently based in Switzerland.