When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data?
In this podcast by Blog Talk Radio, Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision.
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RBQM Podcast Series | Episode 4: Three ways to de-risk your DCT implementation
Careers at Parexel — FSP Podcast Series | Episode 2: Celebrating a 25-Year Career with Kerri McCaul-Claus
Careers at Parexel — FSP Podcast Series | Episode 1: Get Recruited to Be a Clinical Research Associate: The Benefits of Parexel’s FSP Program
The Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit
Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials
RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry
Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment
RBQM Podcast Series | Episode 2: Cultivating Risk-based Behaviors
Decentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented Communities
Episode 19: Improving Rare Disease Drug Development
RBQM Podcast Series | Episode 1: Getting it Right Upfront - Managing Study Risk from End-to-End
Episode 17: Funding Biotech Innovation: How to Attract Investors
Episode 16: COVID-19 Vaccines and Kids: The Research and Vaccine Explained
Episode 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine development
Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights
Episode 13: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
Episode 12: ASCO20 Debrief: The latest in cell and gene therapy
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