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Leveraging post-marketing regulatory requirements to drive commercial value

While long-term surveillance and ongoing studies are inevitable for certain products and approvals via accelerated pathways, this regulatory requirement also represents an opportunity to substantiate product value.

With the FDA’s recent black box mandate, we use the CAR T product class as a working example to explore opportunities for evidence generation beyond required safety and efficacy data to support all stakeholders, including HCPs, payers and patients.

In this webinar, Parexel’s regulatory, access, and real-world research experts will focus on value creation through an integrated evidence approach, including:

  • Regulatory expectations and acceptability during clinical development, marketing application and post-marketing stages
  • Best practices for real-world evidence generation in the context of long-term population surveillance
  • Strategies for generating evidence on long-term effectiveness to support product value
  • How this approach can support reimbursement and value-based pricing models
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Matthew Gordon

Matthew Gordon

Vice President, Real-World Evidence Strategy, Parexel

Matthew has over 20 years' experience designing global real-world evidence solutions to support the development and commercialization of pharmaceutical/biotechnology products and devices. His experience covers a wide-range of therapeutic areas, as well as strategic objectives from natural history programs, external control arm studies for regulatory approval, and global safety-surveillance mandate. His technical expertise includes program strategy and operational structure in disease and product registries, prospective pharmacoeconomic studies, and systematic reviews of scientific literature.

Mwango Kashoki

Mwango Kashoki

Senior Vice President, Global Head of Regulatory Strategy, Parexel

As the Head of Regulatory Strategy, Mwango leads a global team in supporting companies with formulating and implementing innovative and efficient product development plans and regulatory strategies, across all phases of development and across multiple therapeutic areas. She has successfully supported clients with Health Authority meetings and regulatory submissions, and in obtaining expedited program, orphan and other designations to accelerate product development. Her therapeutic areas of experience include but are not limited to: neurology (pain disorders, dementias), psychiatry (mood disorders, substance dependence), dermatology (dermatitis), and infectious disease. Prior to joining Parexel, Mwango spent 16 years at the US FDA.

Alex Gee

Alex Gee

Senior Director, Customer Strategy, Access Consulting, Parexel

Alex has 25 years of pharmaceutical industry experience, including 10 years in consulting. He specializes in global pricing and market access projects, ranging from early-phase rare diseases to generic defense for blockbuster brands. With a degree in Genetics and early career experience in the NHS, Alex brings a unique blend of scientific and business acumen to his role. His expertise spans value message development, market research, payer evidence planning, commercialization, and market access submissions. Alex collaborates across various Parexel functional groups to address client challenges, working with payers, KOLs, and HCPs in diverse therapeutic areas, particularly oncology and CNS.

Kim Maguire-Wright

Kim Maguire-Wright

Vice President, Real-World Evidence, Parexel

As Vice President for Parexel’s Real-World Evidence Services, Kim helps clients develop strategies which align to their business plan. With over 20 years of experience in clinical research, Kim has extensive knowledge of a variety of therapeutic areas in both Phase IIIb and IV studies and risk management programs.

Kim has been responsible for designing and delivering several programs which have been developed to meet FDA and EMEA mandates for post approval regulatory commitments and for risk assessment and risk minimization. She recently provided oversight for a large cardiovascular outcomes trial consisting of 250 sites and 9,000 patients.

Steve Winitsky

Steve Winitsky

Vice President, Technical, Regulatory Consulting, Parexel

Steve spent more than 11 years at the FDA as a former Medical Officer, Team Leader, and Acting Branch Chief in the Center for Biologics Evaluation and Research’s (CBER’s) Office of Tissues and Advanced Therapies, which has been renamed the Office of Therapeutic Products (OTP). He has extensive experience with the review and supervision of cell and gene therapy (CGT) applications, including sponsor requests for Breakthrough Therapy and Regenerative Medicine Advanced Therapy designation. He also supervised numerous Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) and pre-IND meetings for CGTs.

Surani Fernando
moderator

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.