The Parexel Podcast

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.

We are at a major tipping point of scientific breakthroughs. There are accelerating the frontiers in neuroscience; there is a greater sense of hope, but delivering on that hope for patients and caregivers requires a new approach to market access. In this podcast episode, we will delve into the unique challenges of access strategies in neurology and psychiatry,

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.

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.

This is episode three, where we discuss how to accelerate development and opportunities to differentiate your product through innovative and adaptive trial design. We focus on the importance of creating evidence packages that meet both regulatory and payer requirements, and the critical role of early value story development alongside target product profile (TPP) planning.

The second episode of our ‘Enabling Successful Sites’ series features a discussion between Karen McIntyre (VP, Global Site Alliances), Xoli Belgrave (Sr. Director, Head of Clinical Trial Diversity and Inclusion), Jamie Langley (Executive Director, Parexel Academy) and Dr. Lovie Negrin, CEO and Founder of Randomize now on how we can empower and leverage sites with the tools and training they need to more successfully recruit diverse patient populations for their studies. They talk about the impact of not including diverse patient populations in studies is discussed, the need for sponsors and CROs to share their diversity, equity, and inclusion strategies with investigator sites, and soft skills site staff need to have for necessary conversations.

Oncology clinical trials present unique challenges for investigative sites, including complex trial designs, challenging eligibility criteria, and invasive procedures. In addition, the oversaturation of trials leads to competition for patients and experienced sites.

The third episode of Enabling Successful Sites features a discussion between Karen McIntyre (VP, Global Site Alliances), Mitch Carter (Assoc. Director, Global Site Alliances), and Angela Galindo, Vice President, Client Engagement at START Network as they talk about the competition for patients and experienced sites for oncology trials, why a site would pass on a study opportunity and how we can make oncology studies less burdensome for both patients and sites.

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 two we discuss the critical decision points in early phase development (phase I to IIa) that can ultimately determine the success of your product. Specifically, we discuss why drugs fail at this early stage, focusing on safety, tolerability and efficacy. We focus on the importance of integrated clinical development planning, with our experts' informed perspectives on regulatory, feasibility and early phase requirements. Our discussion covers how risk can be mitigated, and key takeaways that biotech leaders should - but often don't - consider in early phase development.