Podcast: Accelerated approvals – what’s next, confirmatory trials, access, and pricing

Investigative sites have shared that one of their top frustrations  with the clinical trial process is with the poor communication flow and overall lack of responsiveness from sponsors and CROs.  In this episode of ‘Enabling Successful Sites’, Karen McIntyre, Vice President, Global Site Alliances  sits down with Jakub Jedrzejewski, Global Project Manager at Future Meds, Iwona Tongbhoyai, Chief Client Solutions Officer at Future Meds and Heidi Juncher-Benzon, Senior Director Clinical Operations for EMEA East at Parexel to discuss the biggest communication challenges facing sites and strategies to resolve them.

As we strive to improve health outcomes for patients with neurological conditions, the development of new clinical outcomes assessments (COAs) is crucial. Advancements in COAs are at a tipping point, significantly impacting the future of clinical trials and patient care. Our clinical development and regulatory experts discuss the importance of developing new COAs to better capture the full spectrum of patient experiences, particularly in conditions like multiple sclerosis (MS). With MS as a focal point, our experts highlight the gaps in current assessments and In this episode, Andreas Lysandropoulos, Naomi Suminski, and Simona Stankeviciute share insights on the evolving understanding of neurological conditions and the hidden problems that current COAs may overlook. They emphasize the importance of patient-centered research and the role of early and strategic planning in regulatory success. Pushing the boundaries with innovative approaches to COAs in neuroscience we can ensure that clinical trials reflect meaningful changes in patients’ lives.

AI is becoming increasingly prevalent in the healthcare industry and clinical research. For clinical trial recruitment, AI can be extremely helpful in finding potential patient volunteers as well improving overall retention rates.  In part two of this ‘Enabling Successful Sites’ podcast episode on improving patient recruitment and retention, Karen McIntyre, Vice President, Global Site Alliances, Steve Sattik, recently retired, former EVP at Flourish Research and Leslie Ives, Senior Director, Patient Recruitment at Parexel, discuss how we can leverage AI today to improve patient recruitment and retention and how they see AI evolving recruitment practices in the future.

Patient recruitment continues to be a major cost driver and top challenge in clinical research. More than half of sites have to pay recruitment expenses out of their own funds, as sponsor budgets won’t cover some of necessary education and recruitment practices that sites must perform in order to meet enrollment goals and stay in business. This ‘Enabling Successful Sites’ podcast episode, moderated by Karen McIntyre, Vice President, Global Site Alliances  with insights from Steve Sattik, recently retired, former EVP at Flourish Research and Leslie Ives, Senior Director, Patient Recruitment at Parexel, discusses the challenges sites face with patient recruitment, the need for close collaboration between sites, sponsors and CROs,  and flexible options that satisfy all parties.

Small and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on data, to acquisition, and sometimes even launching a compound themselves. And they need a partner that brings deep clinical, scientific, therapeutic, and regulatory expertise, and still being agile and nimble to help them develop and execute their plans with confidence. In this podcast, Jennifer Warneke, Senior Vice President of Parexel Biotech. Sarah Berry, Senior Director, Portfolio Management, Parexel Biotech and Daniel Montoya Giraldo, Project Director, Parexel Biotech discuss the different goals that they help our biotech customers achieve, what a good partnership looks like and examples of how they address challenges when they arise.

Dr. Andreas Lysandropoulos, Senior Vice President and Global Therapeutic Head of Neurosciences, and Wyatt Gotbetter, Senior Vice President, Worldwide Access Consulting, join Bev Hope, Parexel’s Marketing Strategy Director, in a podcast discussion of how sponsors can build a value proposition and market access strategy for novel neurological and psychiatric treatments. Neuroscience disorders present significant challenges, including incomplete scientific understanding, patients’ unequal access to accurate diagnosis and prognosis, payers’ focus on short-term clinical outcomes, a relative lack of patient-relevant endpoints, and collecting high-quality real-world evidence, to name a few. Our experts offer examples and insights on how to overcome obstacles and de-risk sponsors’ access strategies.

Small and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on data, to acquisition, and sometimes even launching a compound themselves. And they need a partner that brings deep clinical, scientific, therapeutic, and regulatory expertise, and still being agile and nimble to help them develop and execute their plans with confidence. In this podcast, Jennifer Warneke, Senior Vice President of Parexel Biotech. Sarah Berry, Senior Director, Portfolio Management, Parexel Biotech and Daniel Montoya Giraldo, Project Director, Parexel Biotech discuss the different goals that they help our biotech customers achieve, what a good partnership looks like and examples of how they address challenges when they arise.

De-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial success. Episode five is the last in our series, and we focus on post-launch market development and how to expand the use and value of your product over time. Exploring lifecycle optimization for biotech companies, our experts discuss the importance of planning as early as Phase 1-2 clinical trials, and thinking globally from the outset. They discuss an alternative definition for TPP, which is “target product potential” and how this emphasizes the future possibilities and opportunities for the product beyond its initial approval. Lastly, each of our speakers shares one key piece of advice that biotech developers should – but often don’t – consider at this stage of the product lifecycle.

De-risking Drug Development is a five-part podcast series that explores the business-critical decisions that take place at each stage of the drug development process. We know that novel therapies often don’t meet their revenue expectations, but through informed decision-making, you can minimize risk and maximize the probability of commercial success. In episode 4, we focus on the pre-approval phase of drug development, where commercial launch planning should be started 2 - 3 years before marketing authorization. We discuss why it’s critical to start early, and highlight approaches that biotechs should implement, specifically those with a first-time launch. Our experts offer practical examples of how to build and embed launch excellence, focusing on actionable insight to mitigate risk at this stage in the product lifecycle.

Focusing on cell and gene therapies, this podcast discusses the use of accelerated approvals for fast tracking promising novel medicines through clinical development to registration.