Let’s Get Real: The Growing Importance of Real-World Data and Real-World Evidence in Regulatory Decision-Making

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Thursday, September 22, 2022 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Real-world data (RWD) and real-world evidence (RWE) play a growing role in regulatory decision-making on new drug and biologic products. The US Food and Drug Administration’s (FDA) recent release of new guidance on use of this information is prompting sponsors, payers, physicians and others to recognize the value of RWD and RWE. They complement and supplement traditional clinical research methods, prompting the industry to use them more effectively.

In this webinar, development and regulatory experts from Premier Research and Premier Consulting will be discussing aspects of FDA’s RWE Guidance. This refers to the data-sharing provisions within the 21st Century Cures Act and the exploding use of mobile devices, wearables and other biosensors for gathering and storing health-related data and its impact on RWD/RWE.

Just what constitutes “real-world” information, and what qualifies as a reliable real-world data source? How does usage of this intelligence differ between small biotechs and large pharma companies, and how can they leverage this information successfully?

Join this webinar to address the many facets of real-world evidence and real-world data in regulatory decision-making.

Speakers

http://Nach%20Davé,%20Premier%20Research

Nach Davé, RPh, MS, Vice President Development Strategy, Premier Research

Nach Davé provides strategic and commercial input for Premier Research’s business activities. He brings more than 20 years of pharmaceutical and contract research industry experience to the position. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both contract research organizations (CROs) and sponsor companies.

In his current role, Mr. Davé brings innovative solutions and grows Premier’s footprint in the areas of medical device development, real-world evidence and government relations. He is keen to explore how innovative technology like artificial intelligence (AI), machine learning (ML) and other developments can best support the growth of Premier’s business.

Mr. Davé holds a master’s degree in drug regulatory affairs from Long Island University and a bachelor’s degree in pharmacy from the University of Sciences, Philadelphia. He is a registered Pharmacist.

Message Presenter
http://Abie%20Ekangaki,%20Premier%20Research

Abie Ekangaki, PhD, Vice President, Statistical Consulting, Premier Research

Abie Ekangaki brings expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development and operational experience across different therapeutic areas.

With more than 25 years of experience as a biostatistician, Dr. Ekangaki has worked: as a Research Scientist with the World Health Organization in Switzerland, as a Statistics Lecturer at Macquarie University in Australia and has over 19 years of experience in the pharmaceutical industry — both large pharma and CROs — where he has held several lead technical and senior leadership positions.

Message Presenter
http://Angela%20Drew,%20Premier%20Consulting

Angela Drew, PhD, Director Regulatory Strategy, Premier Consulting

Dr. Drew has over 10 years of experience in pharmaceutical research and development programs and 20 years of experience in academic research into nonclinical models of inflammatory diseases and cancer. She is an expert in US regulatory strategy and a lifetime scholar with the American Cancer Society.

Since joining Premier Consulting, Dr. Drew’s role has included: attending and leading the US Food and Drug Administration (FDA) meetings on behalf of sponsors; preparing regulatory submissions such as meeting packages, Investigational New Drug Applications (INDs) and New Drug Applications (NDAs); and preparing strategic assessment and product ideation reports for sponsors. Her current role involves generating and evaluating product concepts, preparing FDA submissions and meeting with the FDA. As part of this role, Dr. Drew has had direct experience with orphan programs and other situations in which real-world evidence can be critical in determining the success of the development program.

Message Presenter

Who Should Attend?

  • R&D Leadership
  • Commercial Leadership
  • Commercial Affairs
  • Business Development
  • Regulatory Affairs
  • Market Access
  • Project Management

What You Will Learn

In this webinar, attendees will:

  • Learn the distinct purposes and meanings behind real-world data (RWD) and real-world evidence (RWE)
  • Learn how to leverage RWD and RWE information in regulatory decisions for an effective impact on clinical trial study design
  • Find out what constitutes reliable sources for RWD, given the large (and growing) body of electronic medical records and other types of medical information
  • Look at strategies for establishing the extent of RWD and RWE for supplementing, or even taking the place of, conventional clinical trials
  • Explore an RWE success story — a case study in the successful use of RWE in obtaining regulatory approval

Xtalks Partner

Premier Consulting

Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.

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