The Parexel Podcast

Enabling Successful Sites, Episode 5: Strategies for improving communication between sites, sponsors and CROs

Investigative sites have shared that one of their top frustrations with the clinical trial process is with the poor communication flow and overall lack of responsiveness from sponsors and CROs. In this episode of ‘Enabling Successful Sites’, Karen McIntyre, Vice President, Global Site Alliances sits down with Jakub Jedrzejewski, Global Project Manager at Future Meds, Iwona Tongbhoyai, Chief Client Solutions Officer at Future Meds and Heidi Juncher-Benzon, Senior Director Clinical Operations for ...

Is there room for new COAs in neuroscience?

As we strive to improve health outcomes for patients with neurological conditions, the development of new clinical outcomes assessments (COAs) is crucial. Advancements in COAs are at a tipping point, significantly impacting the future of clinical trials and patient care. Our clinical development and regulatory experts discuss the importance of developing new COAs to better capture the full spectrum of patient experiences, particularly in conditions like multiple sclerosis (MS). With MS as a foca...

Enabling Successful Sites: Episode 4, Part Two: Leveraging AI to improve patient recruitment and retention

AI is becoming increasingly prevalent in the healthcare industry and clinical research. For clinical trial recruitment, AI can be extremely helpful in finding potential patient volunteers as well improving overall retention rates. In part two of this ‘Enabling Successful Sites’ podcast episode on improving patient recruitment and retention, Karen McIntyre, Vice President, Global Site Alliances, Steve Sattik, recently retired, former EVP at Flourish Research and Leslie Ives, Senior Director, Pati...

Enabling Successful Sites: Episode 4, Part One: Partnering with sites to improve patient recruitment and retention

Patient recruitment continues to be a major cost driver and top challenge in clinical research. More than half of sites have to pay recruitment expenses out of their own funds, as sponsor budgets won’t cover some of necessary education and recruitment practices that sites must perform in order to meet enrollment goals and stay in business. This ‘Enabling Successful Sites’ podcast episode, moderated by Karen McIntyre, Vice President, Global Site Alliances with insights from Steve Sattik, recently...

Leveraging people, processes and technology to deliver for biotech

Small and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on data, to acquisition, and sometimes even launching a compound themselves. And they need a partner that brings deep clinical, scientific, therapeutic,...

Navigating market access in neuroscience: Challenges and strategies

Dr. Andreas Lysandropoulos, Senior Vice President and Global Therapeutic Head of Neurosciences, and Wyatt Gotbetter, Senior Vice President, Worldwide Access Consulting, join Bev Hope, Parexel’s Marketing Strategy Director, in a podcast discussion of how sponsors can build a value proposition and market access strategy for novel neurological and psychiatric treatments. Neuroscience disorders present significant challenges, including incomplete scientific understanding, patients’ unequal access to...

Leveraging people, processes and technology to deliver for biotech

Small and emerging biotech companies have varied challenges compared to mid-large size pharma companies, with paths that aren’t always as straightforward as taking a compound through clinical development to launch. Our biotech clients drive towards these key inflection points from proof of concept to compound development, to capital raises based on data, to acquisition, and sometimes even launching a compound themselves. And they need a partner that brings deep clinical, scientific, therapeutic,...

De-risking Drug Development | Episode 5: Expand the use and value of your product over time

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. Episode five is the last in our series, and we focus on post-launch market development and how to expand the use and value of your product over tim...

De-risking Drug Development | Episode 4: Implement market launch strategy, pre-approval

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 4, we focus on the pre-approval phase of drug development, where commercial launch planning should be started 2 - 3 years before marketi...

Podcast: Accelerated approvals – what’s next, confirmatory trials, access, and pricing

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 | Episode 3: Plan how to get to market quickly, post proof-of-concept

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 adapti...

Enabling Successful Sites Ep. 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training

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 impac...

Enabling Successful Sites Ep. 3: Taking the complexity out of oncology trials

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 ...

De-risking Drug Development | Episode 2: Focus on safety and efficacy and prove quickly that your product works

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 you...

De-risking Drug Development | Episode 1: How to drive value in pre-clinical development

Enabling Successful Sites, Episode 1: Solving Site Feasibility and Start-Up Challenges

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 pr...

Rare Endpoints: Delivering on Unmet Patient Needs

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.

Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 3

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....

Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 2

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.

Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 1

In this first episode, join our clinical development and market access experts who discuss the role of biomarker research, discovery, and patient access in advancing precision oncology to date. Biomarkers have been central to improving patient outcomes and guiding treatment guidelines in lung, breast, and blood cancers. With that backdrop, our experts discuss the role of large-scale data sets and real-world evidence in furthering precision oncology research and improving patient outcomes in more...

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 - ...

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 re...

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 se...

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 o...

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 an...

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 vari...

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 profession...