The Parexel Podcast

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.

Episode 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine development

Viral infections continue to emerge and represent a serious threat to global public health, from SARS to H1N1 influenza to MERS. Yet none has caused the level of global devastation levied by the coronavirus. In fact, the long-term complications of COVID-19 on our healthcare system are just beginning to come into focus. Managing these complications will increase the demand for healthcare resources in the years to come and will elevate the need for novel therapies to manage them. This episode features Sy Pretorius, Parexel’s President, Clinical Development & Chief Medical Officer; Paul Bridges, Senior Vice President, Regulatory and Access at Parexel; and Ruggero Rossi, Vice President, Health Advances on how biopharmaceutical companies are preparing for COVID-19-related complications, the development of novel treatments to manage them, and future investments in vaccine development for infectious diseases so that we are better prepared for future pandemics.

Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights

Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet the vast majority of medications are only evaluated in adults, and pediatric participation in clinical trials remains exceedingly low worldwide. In this podcast, experts discuss critical insights gleaned from a survey of 500 parents and children about their perceptions and experiences of clinical research. Hear from Sarah Glass, Global Head of Rare Diseases at Parexel; Shipra Patel, Senior Medical Director at Parexel and a pediatric endocrinologist at UNC-Chapel Hill; Annick de Bruin, Senior Director, Research Services at CISCRP; and parent advocate Rachel Daley about how to incorporate learnings from the pediatric survey — sponsored by Parexel and conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) — into designing more child-friendly and family-friendly trials.

Episode 13: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief Commercial and Strategy Officer, talks with Paul Bridges, Worldwide Head of Regulatory and Access, and Sheela Hegde, a Partner with Parexel’s Health Advances subsidiary, about the regulatory, investing and clinical development changes that are most likely here to stay – The New Pragmatism. After listening, you can read more about Paul and Sheela’s perspective in this article: https://regulatory-access.parexel.com/parexels-covid-19-expert-content/covid-19-and-the-new-pragmatism

Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster, MD, Head of Parexel’s Oncology Center of Excellence; Matthew Cooney, MD, co-lead of Parexel’s Cell and Gene Therapy initiative; and Keith Donovan, an expert in Early Phase Development with a focus on oncology, join Alberto Grignolo, Corporate Vice President, Regulatory and Access, to discuss the progress made in cell and gene therapy as presented at ASCO and how the industry can continue to move these developments forward today and in the future.