The Parexel Podcast

The Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit

Chris Learn, Head of Cell and Gene Center of Excellent at Parexel, discusses his participation at the recent Clinical Research Virtual Summit hosted by the Society for Immunotherapy of Cancer, and the implications for clinical research.

Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials

In this third episode of the Decentrally Speaking series, we explore the topic of Integrating the Patient Voice into Decentralized Trials. Join our guests from AstraZeneca, who partnered with Parexel to deploy a fully virtual clinical trial. We’ll learn how the team incorporated the patient voice within trial planning and execution, some of the innovative approaches used in the trial, and lessons learned to take forward into future trial design.

• Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world’s leading global clinical research organizations (CRO).
• Evelina Björnsson, Senior Director, Study Management, AstraZeneca, is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.
• Karin Enarsson Ringqvist, Global Study Director, AstraZeneca, is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.

 

RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry

By designing quality into trials, we focus on the most critical data and create a framework for efficiently identifying and addressing any risks to patients, the integrity of data, or regulatory compliance. While part of regulatory guidance, consistent interpretation of RBQM approaches by regulatory inspectors is an area of concern. In such a highly regulated industry that is notably slow to adopt change, biopharmaceutical companies and CROs are still debating how to go with evidence-backed documentation to satisfy regulatory requirements when using risk-based approaches.

In the third episode of our RBQM podcast series, Amy Kissam-Sands, Senior Vice President of Clinical Operations, John Bell, Chief Quality Officer, and Dr. Kristin Murphy, Senior Director and Global Head of the Change and Adoption Center of Excellence, discuss how to work within the regulatory guardrails when establishing a risk assessment framework.

Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment

In this second episode in the Decentrally Speaking series, we will be discussing how pharmaceutical depots are evolving their services and operations to support both sites and patients as a critical part of decentralized trials (DCTs). Expanding geographies, ancillary procurement, and storage of investigational drugs and supplies to be shipped either direct to patient or direct to site create a complex supply chain that must be carefully managed and controlled.

Join our Parexel clinical trial supplies and logistics experts who share their collective experience to ensure the right mix of solutions for conducting decentralized trials to benefit sponsors, sites, and patients within a complicated and evolving regulatory environment.

• Sanjay Vyas, Executive Vice President And Global Strategic Business Unit, Head For Clinical Trial Supplies And Logistics
• Laurie McRae, Senior Director, Solutions for Clinical Trial Supplies and Logistics
• Daniel Meyer, Project Manager Leader, Supply and Logistics

Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials. Join us as we also explore opportunities to operationalize DCTs across our industry. 

 

RBQM Podcast Series | Episode 2: Cultivating Risk-based Behaviors

As risk-based quality management (RBQM) practices become a requirement of global regulators, industry adoption will require end-to-end organizational change.

In this second episode of our RBQM series, Amy Kissam-Sands, Senior Vice President of Clinical Operations, Dr. Kristin Murphy, Senior Director and Global of the Change in Adoption Center of Excellence, and Amy Adams, Senior Director of Clinical Operations, discuss the key questions and practices that form a robust change management strategy that impacts behavior from the organizational level down to the individual.

Decentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented Communities

Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials (DCTs). Join us as we also explore opportunities to operationalize DCTs across our industry.  

In this first series episode, we will be discussing operational experiences and best practices in optimizing inclusivity for patients from Under-Represented Communities (UCs). We’ll share ideas for trial recruiting, protocol review, patient and community outreach, and on-site implementation for inclusive practices from experts:

• Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world's leading global clinical research organizations (CRO).
• Carlos Orantes, CEO, Alcanza Clinical Research, whose purpose and mission is to defend wellness for all people through the science of clinical research with efforts that are inclusive, impactful, and outstanding.

Episode 19: Improving Rare Disease Drug Development

Researchers have identified more than seven thousand rare diseases, but effective treatments are available for fewer than ten percent. Drug development for rare diseases is complex given the challenges of the limited, geographically dispersed patient populations, many of which are children.

In this Parexel podcast episode we explore those challenges with rare disease experts:

• Dr. Lucas Kempf, Vice President, Regulatory Affairs at Parexel, who has former rare disease regulatory experience at the FDA
• Sarah Glass, Chief Development Officer at n-Lorem Foundation, a non-profit organization dedicated to charitably provide medicines to treat nano-rare patients diagnosed with diseases that are the result of a single genetic defect unique to only one or very few individuals
• Stacy Hurt, whose youngest son, Emmet suffers from a genetic chromosome abnormality so rare that his syndrome doesn’t have a name.

 

RBQM Podcast Series | Episode 1: Getting it Right Upfront - Managing Study Risk from End-to-End

Risk-based quality management (RBQM) is fast becoming a critical success factor for clinical development programs. Global regulatory agencies are putting more focus on RBQM components to ensure patient safety, data quality and the validity of study results. However, companies don’t always approach risk management in a holistic, collaborative approach increasing their chances of missing risk signals.

 

In this Parexel podcast episode, the first of our RBQM five-part series, RBQM experts Amy Adams, Senior Director of Clinical Operations Liz Gough, Associate Director Business Process Excellence, and Kirsty Botes, Associate Director Clinical Operations, discuss strategies and best practices for getting RBQM right from the start to successfully manage study risk from end-to-end.

Episode 17: Funding Biotech Innovation: How to Attract Investors

The biotech industry posted record financing, deals, and M&A numbers in 2020 and 2021, spurred in part by the swift and successful development of COVID-19 vaccines. Despite this favorable funding environment, the industry faces ongoing challenges. The cost of developing new therapies continues to climb and fewer than 8% of product candidates make it from Phase I to market.

In this episode, biotech experts – Jim Anthony, Executive Vice President and Global Head of Parexel Biotech, and Mike Davitian, Vice President, Health Advances – share findings from a proprietary research report on the biotech investment landscape. Find out what investors are looking for when evaluating a company, how to attract investors, and what to look for in a partner to help guide your business strategy to achieve a strong competitive advantage.

Visit www.Parexel.com to access the full report, Five Ways to Attract Early-Stage Investors.

Show notes:

[0:49] There were record financing and deals in the biotech industry in 2020 and 2021— How has COVID-19 played a role in innovation and increased investment in biotech?

[2:40] How do you think the development needs of biotech customers evolved in this environment?

[6:58] One of the five strategies identified in the report to help emerging companies differentiate their value proposition is “Expand your definition of unmet need”. How can companies do that?

[10:59] The second strategy identified in the report is “Develop a strong plan, then de-risk it”. How can companies do that?

[13:34] Recent advances in drug development tools and technologies can lower risk and reduce the time to bring a new product to market. How can companies accelerate development with innovation?

[15:45] What did you learn from this research about what biotechs need to consider when looking at potential investors?

[18:00] The final strategy and the report is “Reveal your exit strategy”. Why is that important?

[19:18] For biotechs, success or failure hinges on getting their strategy right and knowing how to effectively articulate their value in looking for a partner to help guide that strategy. How could Parexel Biotech and Health Advances support companies?

Episode 16: COVID-19 Vaccines and Kids: The Research and Vaccine Explained

In the United States, the FDA and CDC recently granted emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine for 5–11-year-olds, making it the first COVID-19 vaccine available for younger children and arriving nearly one year after Pfizer’s COVID-19 vaccine received EUA for adults. If the adult vaccine was authorized for this long, why did it take so long to make one available for younger children?

In today’s episode, Nathalie Sohier, Global Head of Infectious Disease and Vaccines, and Shipra Patel, Global Head of Pediatrics explain the clinical trial process for vaccines, the nuances in this process for children, and the facts parents should know now that the vaccine is available for younger children.