The Parexel Podcast (PAREXEL)

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 marketing authorization. We discuss why it’s critical to start early, and highlight approaches that biotechs should implement, specifically those with a first-time launch. Our experts offer practical examples of how to build and embed launch excellence, focusing on actionable insight to mitigate risk at this stage in the product lifecycle.

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 retired, former EVP at Flourish Research and Leslie Ives, Senior Director, Patient Recruitment at Parexel, discusses the challenges sites face with patient recruitment, the need for close collaboration between sites, sponsors and CROs,  and flexible options that satisfy all parties.

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, and regulatory expertise, and still being agile and nimble to help them develop and execute their plans with confidence.

In this podcast, Jennifer Warneke, Senior Vice President of Parexel Biotech. Sarah Berry, Senior Director, Portfolio Management, Parexel Biotech and Daniel Montoya Giraldo, Project Director, Parexel Biotech discuss the different goals that they help our biotech customers achieve, what a good partnership looks like and examples of how they address challenges when they arise.

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 adaptive trial design. We focus on the importance of creating evidence packages that meet both regulatory and payer requirements, and the critical role of early value story development alongside target product profile (TPP) planning.

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.

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.

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.

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 focal point, our experts highlight the gaps in current assessments and

In this episode, Andreas Lysandropoulos, Naomi Suminski, and Simona Stankeviciute share insights on the evolving understanding of neurological conditions and the hidden problems that current COAs may overlook. They emphasize the importance of patient-centered research and the role of early and strategic planning in regulatory success. Pushing the boundaries with innovative approaches to COAs in neuroscience we can ensure that clinical trials reflect meaningful changes in patients’ lives.

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.

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.

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.

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 impact of not including diverse patient populations in studies is discussed, the need for sponsors and CROs to share their diversity, equity, and inclusion strategies with investigator sites, and soft skills site staff need to have for necessary conversations.

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 time. Exploring lifecycle optimization for biotech companies, our experts discuss the importance of planning as early as Phase 1-2 clinical trials, and thinking globally from the outset. They discuss an alternative definition for TPP, which is “target product potential” and how this emphasizes the future possibilities and opportunities for the product beyond its initial approval. Lastly, each of our speakers shares one key piece of advice that biotech developers should – but often don’t – consider at this stage of the product lifecycle.

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.

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.

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.

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.

Now more than ever it's important to recognize and show our appreciation for clinical trials and the critical role that they play in advancing public health. Since the outbreak of the COVID-19 pandemic we've seen many changes that have been made to clinical trials to maintain continuity. In this podcast, we explore how clinical trials have changed and adapted, and how those changes may impact clinical trials in the future for patients. Ken Getz, professor at Tufts University School of Medicine and the Founder and Chairman of the Center for Information and Study on Clinical Research Participation (CISCRP) moderates this discussion on this most important #ICTD2020 featuring three members of Parexel's Patient Advisory Council along with Parexel’s Chief Medical & Scientific Officer, Dr. Sy Pretorius.

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.

The COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leaders about the implications of this pandemic for the important work of drug developers, researchers, and regulators. How are we to cope with the new realities? What new behaviors should we adopt to sustain progress? What are the new best practices when working with regulatory authorities, with clinical sites, and with each other?

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

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.

Within the past 20 years, the field of precision medicine has been transformed. For biotech companies, this new landscape holds tremendous promise for innovation. So, why aren’t more companies leveraging this approach? In this episode, Parexel precision medicine experts Angela Qu and Arlene Hughes join host Alberto Grignolo to discuss this conundrum, and what biotechs should be thinking about right from the start, to open up the opportunity for this approach to help bring innovation and new therapies to more patients.  

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.

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.

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.

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?

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 process.

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 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.

In this episode, Parexel Executive Vice President and Chief Commercial & Strategy Officer Peyton Howell interviews Meghan FitzGerald, Parexel Board Advisor and author of the new book Ascending Davos: A Career Journey from the Emergency Room to the Boardroom. The two healthcare leaders discuss topics including Meghan’s career pivots from nursing to the healthcare industry to private equity, why you should take your CFO to lunch, and their unexpected friendship.

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. 

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, Patient Recruitment at Parexel, discuss how we can leverage AI today to improve patient recruitment and retention and how they see AI evolving recruitment practices in the future.

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.

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

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.

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 your product. Specifically, we discuss why drugs fail at this early stage, focusing on safety, tolerability and efficacy. We focus on the importance of integrated clinical development planning, with our experts' informed perspectives on regulatory, feasibility and early phase requirements. Our discussion covers how risk can be mitigated, and key takeaways that biotech leaders should - but often don't - consider in early phase development.

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

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 START Network as they talk about the competition for patients and experienced sites for oncology trials, why a site would pass on a study opportunity and how we can make oncology studies less burdensome for both patients and sites.

The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs). Today, wearables are enabling at-home care and providing long-term monitoring of COVID-19 patients. How can wearables change the game in this most critical time for our industry? What considerations need to be kept in mind when involving wearables in a clinical trial? Julia Lakeland, solutions architect, program director, and wearables expert for Parexel joins Sheng Feng, Parexel’s head of real-world data in Asia-Pacific, in this episode hosted by Keith Wenzel, a leader of our Scientific Data Organization, discussing the role of wearables in the future of clinical trials.

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 accurate diagnosis and prognosis, payers’ focus on short-term clinical outcomes, a relative lack of patient-relevant endpoints, and collecting high-quality real-world evidence, to name a few. Our experts offer examples and insights on how to overcome obstacles and de-risk sponsors’ access strategies.

 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.  

In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days. Parexel’s experts Mo Heidaran, Alexander Gee and host Alberto Grignolo, all part of our newly-integrated Regulatory & Access consulting unit, also weigh in on the current regulatory and reimbursement landscape for CAR-T and what we might look forward to in the future for this and other cell and gene therapies.

In this episode, we discuss how Functional Service Provider or FSP partnerships have been gaining traction and increasing in relevance in today’s environment because of their potential to offer flexibility, access to expertise, and reduce costs in outsourcing without compromising quality. Parexel’s Head of Global FSP Chris Baker discusses with FSP leaders Joanne Sullivan, Alisdair Falconer and Beth Shaleesh several “tips and tricks” for making the most of FSP relationships, how Parexel has built a successful FSP culture in areas including India, and what factors contribute to a successful FSP relationship - right from the outset.

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, and regulatory expertise, and still being agile and nimble to help them develop and execute their plans with confidence.

In this podcast, Jennifer Warneke, Senior Vice President of Parexel Biotech. Sarah Berry, Senior Director, Portfolio Management, Parexel Biotech and Daniel Montoya Giraldo, Project Director, Parexel Biotech discuss the different goals that they help our biotech customers achieve, what a good partnership looks like and examples of how they address challenges when they arise.

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.  

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 types of cancer. 

• Dr. Gwyn Bebb, Senior Vice President and Global Therapeutic Head of Oncology 
• Wyatt Gotbetter, Senior Vice President Worldwide, Access Consulting 

In our inaugural podcast, Siri Chilazi, a gender equality expert and Harvard Kennedy School Research Fellow, speaks with female leaders from PAREXEL - Dr. Kemi Olugemo, Dr. Ubavka DeNoble, Aida Sabo, and Peyton Howell - in celebration of International Women’s Day. They discuss what it means to be a female leader in a STEM field and what challenges they have faced throughout their journeys, with the hope that their stories and lessons learned will inspire other young women currently rising through the ranks. They also dive into how their experiences at PAREXEL have influenced their leadership, and what the 2019 International Women’s Day motto of “Balance for Better” means to them. 

Recorded during the 2019 World Orphan Drug Congress, this episode brings together Amy McKee and Mo Heidaran who both recently joined PAREXEL from the FDA, as well as Zizi Imatorbhebhe, an expert in rare disease drug development. Amy, Mo and Zizi discuss how the industry can work to deliver more innovative treatments for rare disease patients and the reality of working with the Food and Drug Administration (FDA). In the first segment, the experts share their insights working with the rare disease/orphan drug community, including patients, physicians, regulators and patient advocacy groups. Next, they focus on FDA’s recent leadership change and tackle some common misconceptions about working with the Agency.

In this episode Alberto Grignolo, Corporate Vice President, Parexel, Sy Pretorius, Executive Vice President and Chief Medical and Scientific Officer, Parexel, and Roz Round, Director of Parexel's Patient Innovation Center, team up to discuss how the clinical research industry can bridge the gap between the scientific needs of research and development and the needs of patients. Stemming from feedback based on a survey looking at perceptions of clinical trials, the episode explores current barriers to clinical trial participation patients face, how we can make research more patient-centric, and techniques to adopt to increase patient-centricity. Later, Roz interviews Shannon Scarlett, a Parexel employee and cancer survivor, about her experience as a trial participant.

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 EMEA East at Parexel to discuss the biggest communication challenges facing sites and strategies to resolve them.

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.