The Parexel Podcast

CAR-T boxed warnings: What comes next?

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials. 

In today’s episode, Fierce Pharma’s Angus Liu talks with Parexel regulatory experts Mwango Kashoki, M.D., Senior Vice President, Global Head of Regulatory Strategy, and Steve Winitsky, M.D., Vice President, Technical - Regulatory Strategy, to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line.

Preparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 Achievements

This episode is the first of our new 2024 series – Preparing for a Cell and Gene Future. In this episode, we take a look back at a banner year for cell and gene therapies and what to expect in 2024 in terms of next-generation therapies and gene editing progress with Chris Learn, Senior Vice President and Head of the Cell and Gene Center of Excellence.

Three trends impacting market access in the EU

Rare disease drug developers face three major market access challenges in the EU market today. Parexel Pricing and Market Access expert, Sangeeta Budhia, shares what they need to know to succeed.

How can we advance fair and ethical reimbursement for patients?

In this podcast, Parexel Vice President of Patient Engagement Rosamund Round leads a discussion on practical challenges and regulatory considerations for patient reimbursement programs in clinical trials. Elizabeth Barksdale, Director of Regulatory Affairs and Scientific Policy for LUNGevity Foundation, a non-profit lung cancer advocacy group, and Luke Gelinas, Senior IRB Chair Director for the global clinical research compliance organization Advarra, advocate for a new framework that fully reimburses patients for travel and compensates them for an additional tier of “soft” costs that will positively impact many patients’ ability to join or remain in a clinical trial, and improve health equity.

Beyond the Binary: Navigating Gender Diversity in Clinical Research

There are an estimated 1.6 million transgender people in the U.S. alone, with about 25% identifying as nonbinary. However, based on our research for the Beyond the Binary: Navigating Gender Diversity in Clinical Research report, we found that of the 141,000+ articles published on PubMed (a database of biomedical and life sciences literature) reporting interventional clinical trial results from 2018-2022, fewer than 1% reported study participation of transgender and nonbinary patients. We then set out to determine why this patient population is not being accurately represented in clinical research.     

In this episode, Parexel subject matter experts – Rosamund Round, Vice President, Patient Engagement Center; Liam Paschall, Senior Consultant, Management Development; Amy McKee, M.D., Chief Medical Officer & Global Head, Oncology Center of Excellence – discuss the barriers faced by the transgender and nonbinary communities and provide recommendations for more gender-inclusive clinical trials.  

To view the Discussions on Diversity report, click here.  

 

 

Why Rare Disease Therapeutics Need Early Market Access Planning

When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data?

In this podcast by Blog Talk Radio, Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision.

CROs and Their Role for Nano-rare

In this episode on n-Lorem Foundation’s podcast series, Patient Empowerment Program, our CEO Jamie Macdonald interviews with Dr. Stanley T. Crooke, Founder, CEO and Chairman of n-Lorem Foundation. During their conversation, Jamie shares the moment he realized his desire to make a difference, Parexel’s role in clinical trials and our partnership with n-Lorem aimed to serve patients.

RBQM Podcast Series | Episode 4: Three ways to de-risk your DCT implementation

Much like RBQM, decentralized clinical trials (DCTs) are an approach to conducting clinical trials, interacting with patients and sites, and implementing fit for purpose technologies for the collection and capture of critical data and monitoring patient safety.  The overall objective of DCTs is the facilitation is to lessen the patient burden of patients and sites, therefore increasing patient participation, while ensuring the collection and capture of critical data, such as efficacy endpoints and safety data. 

 

In the fourth episode of the RBQM podcast series, Amy Adams, Senior Director, Clinical Operations and Cris McDavid, Director, Clinical Operations discuss some questions to ask when developing a risk-based framework for decentralized clinical trials.

Careers at Parexel — FSP Podcast Series | Episode 2: Celebrating a 25-Year Career with Kerri McCaul-Claus

At Parexel, we are committed to improving patients’ lives through clinical research. Within Parexel FSP — a division of Parexel — we fulfill key clinical development roles through functional service outsourcing models across a variety of disciplines for leading pharmaceutical sponsors.

To explore a Parexel FSP employee advancement journey, Host Mrs. Jan Back, Recruitment Marketing Manager, Parexel FSP, is joined by Kerri McCaul Claus, Vice President, FSP Solutions Biometrics. Kerri has held various roles during her 25-year career. Today we delve into her career development and subsequent advancement to become a Vice President within the organization.

Key Takeaways:
[1:11] Kerri shares her career pathway at Parexel FSP including the multiple opportunities that led to her role as VP of FSP Solutions Biometrics.
[4:30] Leading the dedicated client support teams offers insights into the key differences in how FSP supports clients and the full-service model.
[5:32] Kerri attributes the ongoing learning opportunities in her various roles as the lens that allows her to see the full scope of FSP’s bigger picture.
[6:59] In Kerri’s pursuit to grow the business, a key factor of the FSP team’s success is taking every step forward from a client’s perspective.
[8:05] Kerri expresses how Parexel’s guiding principles of patience, quality, respect, empowerment, and accountability assist dedicated FSP team members in contributing to positive client outcomes.
[9:44] Kerri shares the long-term growth and development
opportunities that exist at Parexel FSP for career seekers and the flexible environment in which they can expect to work.
[12:06] With 25 years of experience, Kerri still appreciates the dynamic career opportunities and the support she receives from the leadership team at Parexel.
[13:37] With regard to career development, Parexel believes
individuals have the opportunity to craft the type of career they want for themselves.

How to find out more:
Explore: Parexel’s Functional Service Provider Career Website

Careers at Parexel — FSP Podcast Series | Episode 1: Get Recruited to Be a Clinical Research Associate: The Benefits of Parexel’s FSP Program

At Parexel, we are committed to improving patient’s lives through clinical research. Within Parexel FSP — a division of Parexel — we fulfill key clinical development roles through functional service outsourcing models across a variety of disciplines for leading pharmaceutical sponsors. This includes finding the best candidates for vitally important CRA positions.

To explore how Parexel FSP meets sponsor needs while creating rewarding career opportunities for talented clinical research professionals, Host Mrs. Jan Back, Recruitment Marketing Manager, Parexel FSP, speaks with Nannette Penny, Director, FSP Operations, and Alex Raines, Senior Executive Clinical Recruiter. The trio discuss how working for an FSP client differs from supporting a full-service client engagement, how the recruitment process works at Parexel FSP, the current career opportunities available for CRAs, and resources available to candidates interested in building an impactful career with a better quality of life.

Key Takeaways:

[:51] In her role as Director, Nannette oversees all recruitment and sourcing activities for a key client.

[2:34] In his role as a Senior Executive Recruiter, Alex is responsible for finding, interviewing, and extending offers to candidates.

[3:44] Nannette explains how the FSP model differs from full-service client engagement from a candidate’s perspective.

[5:50] Roles and responsibilities of a CRA in FSP on a typical day.

[7:33] In the clinical research global landscape, a mismatch exists in available talent and the current increased demand for CRAs.

[9:18] Alex shares the characteristics he looks for when seeking out CRA candidates.

[10:38] The benefits and opportunities available when working with Parexel in an FSP.

[11:59] Current CRA positions available and common contract terms.

[13:40] How candidates can contact a Clinical Recruiter at Parexel FSP.

[14:23] Nannette and Alex share their first-hand employee feedback about working at Parexel FSP.

How to find out more:

Visit: Parexel’s Functional Service Provider Career Website

Connect with: Alex Raines on LinkedIn

Explore: Current CRA positions available at Parexel