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 &amp; 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.  

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 &amp; 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, <a href="https://www.parexel.com/insights/discussions-diversity/gender-identity-in-clinical-trials" rel="nofollow" target="_blank">click here.</a>

Beyond the Binary: Navigating Gender Diversity in Clinical Research

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.

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, <a href="https://www.parexel.com/solutions/consulting/market-access-consulting" rel="nofollow" target="_blank">Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel</a> 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.

Why Rare Disease Therapeutics Need Early Market Access 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.

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.

CROs and Their Role for Nano-rare

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.

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.

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

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 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: <a href="https://jobs.parexel.com/functional-service-provider" rel="nofollow" target="_blank">Explore: Parexel’s Functional Service Provider Career Website</a>

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

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

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: <a href="https://jobs.parexel.com/functional-service-provider" rel="nofollow" target="_blank">Parexel’s Functional Service Provider Career Website</a> Connect with: <a href="https://uk.linkedin.com/in/alexanderraines" rel="nofollow" target="_blank">Alex Raines on LinkedIn</a> Explore: <a href="https://jobs.parexel.com/search-jobs?orgIds=877&amp;acm=15032&amp;alrpm=ALL&amp;ascf=%5B%7B%22key%22:%22ALL%22,%22value%22:%22%22%7D%5D" rel="nofollow" target="_blank">Current CRA positions available at Parexel</a>

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

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.

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.

The Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit

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 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. <ul><li>Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world’s leading global clinical research organizations (CRO).</li> <li>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.</li> <li>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.</li></ul>

Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials

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.

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.

RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry

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. 

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. <ul><li>Sanjay Vyas, Executive Vice President And Global Strategic Business Unit, Head For Clinical Trial Supplies And Logistics</li> <li>Laurie McRae, Senior Director, Solutions for Clinical Trial Supplies and Logistics</li> <li>Daniel Meyer, Project Manager Leader, Supply and Logistics</li> </ul> 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.

Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment

This podcast focuses on topics relating to the global journey to create a healthier world through developing innovative new therapies for patients everywhere.

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.

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.

RBQM Podcast Series | Episode 2: Cultivating Risk-based Behaviors

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.

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: <ul><li>Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world's leading global clinical research organizations (CRO).</li> <li>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.</li></ul>

Decentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented Communities

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.

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: <ul><li>Dr. Lucas Kempf, Vice President, Regulatory Affairs at Parexel, who has former rare disease regulatory experience at the FDA</li> <li>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</li> <li>Stacy Hurt, whose youngest son, Emmet suffers from a genetic chromosome abnormality so rare that his syndrome doesn’t have a name.</li></ul>

Episode 19: Improving Rare Disease Drug Development

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.

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.

RBQM Podcast Series | Episode 1: Getting it Right Upfront - Managing Study Risk from End-to-End

The biotech industry posted record financing, deals, and M&amp;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 biotech industry posted record financing, deals, and M&amp;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 <a href="http://www.Parexel.com" rel="nofollow" target="_blank">www.Parexel.com</a> 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 17: Funding Biotech Innovation: How to Attract Investors

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.

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 16: COVID-19 Vaccines and Kids: The Research and Vaccine Explained

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 &amp; 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.

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 &amp; 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 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine development

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.

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

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

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 – <a href="https://regulatory-access.parexel.com/parexels-covid-19-expert-content/covid-19-and-the-new-pragmatism" rel="nofollow" target="_blank">The New Pragmatism</a>. After listening, you can read more about Paul and Sheela’s perspective in this article: <a href="https://protect-us.mimecast.com/s/S3W4CBBv22FKpEQczKjeh?domain=regulatory-access.parexel.com" rel="nofollow" target="_blank">https://regulatory-access.parexel.com/parexels-covid-19-expert-content/covid-19-and-the-new-pragmatism</a>

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

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.

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.

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

This podcast provides access to some really thoughtful experts who have a lot to give to patients and the future of healthcare. Keep it up!

Good start and ready for more

Excited about this podcast ! Have been a fan of Parexel organization forever and due to Sanjay Vyas came to know about this series ! Best wishes to continue to post amazing content here

Excited about this one !

The Parexel Podcast

In this episode, Parexel Executive Vice President and Chief Commercial &amp; 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 episode, Parexel Executive Vice President and Chief Commercial &amp; 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.

Episode 7:  International Women’s Day: Insights from Ascending Davos

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.

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.

Episode 3: Bridging the Gap – How Minimizing Patient Barriers Can Improve Clinical Research

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.

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.

Episode 10: The emerging role of wearables in clinical trials

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.

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.

Episode 9: Making the Most of Functional Service Provider (FSP) Relationships

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?

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?

Episode 8:  Performing clinical trials in a shifting development landscape

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