Episodes
16 hours ago
16 hours ago
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.
4 days ago
4 days ago
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.
Thursday Apr 25, 2024
Thursday Apr 25, 2024
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.
Thursday Apr 25, 2024
Thursday Apr 25, 2024
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.
Thursday Apr 25, 2024
Thursday Apr 25, 2024
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
Wednesday Mar 06, 2024
CAR-T boxed warnings: What comes next?
Wednesday Mar 06, 2024
Wednesday Mar 06, 2024
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.
Wednesday Jan 10, 2024
Preparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 Achievements
Wednesday Jan 10, 2024
Wednesday Jan 10, 2024
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.
Thursday Jan 04, 2024
Three trends impacting market access in the EU
Thursday Jan 04, 2024
Thursday Jan 04, 2024
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.
Tuesday Nov 21, 2023
How can we advance fair and ethical reimbursement for patients?
Tuesday Nov 21, 2023
Tuesday Nov 21, 2023
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.
Thursday Jun 08, 2023
Beyond the Binary: Navigating Gender Diversity in Clinical Research
Thursday Jun 08, 2023
Thursday Jun 08, 2023
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.