The Parexel Podcast

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.

The site feasibility and initiation process can be a frustrating one for investigative sites due to lengthy questionnaires, duplication in data requests, and unrealistic recruitment targets and start-up timelines.

In the first episode of our Enabling Successful Sites podcast Parexel's Karen McIntyre, VP of Global Site Alliances and Marta Leon, VP of Launch Excellence are joined by Mohammad Millwala, CEO of DM Clinical Research to discuss solutions to help improve the feasibility and start- up process.

The latest episode of Preparing for a Cell and Gene Future features a discussion between Jamie Pierson (Program Lead within Parexel’s Cell and Gene Center of Excellence) and Kim MacDonnell (Associate Director for Rare Diseases). They consider uses of surrogate markers as endpoints in rare disease development and look ahead to positive directions established by FDA's current initiatives.

 In this third episode on advancing precision oncology, we continue discussing the role of expanding patient access to biomarkers and evolving testing capabilities. Our precision oncology experts delve into the challenges and opportunities that lie ahead in the rapidly changing landscape. They explore advancements in data, machine learning, and testing capabilities on the horizon. They also discuss the roles of payers and healthcare providers in ensuring patient access to these advancements.  

In this second episode on advancing precision oncology through patient access to biomarkers and testing, the discussion focuses on the benefits of integrating multi-omic data in precision oncology and how it can enhance treatment selection. Our experts discuss the importance of looking beyond genomics and considering other omics, such as immunomics and metabolomics, to gain a better understanding of the tumor and the patient's immune system and physiology.