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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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?

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.