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Podcast: Accelerated approvals – what’s next, confirmatory trials, access, and pricing
12:51
12:51
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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.By PAREXEL
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De-risking Drug Development | Episode 3: Plan how to get to market quickly, post proof-of-concept
39:29
39:29
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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 succes…
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Enabling Successful Sites Ep. 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training
27:09
27:09
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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 leve…
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Enabling Successful Sites Ep. 3: Taking the complexity out of oncology trials
26:40
26:40
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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 …
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De-risking Drug Development | Episode 2: Focus on safety and efficacy and prove quickly that your product works
38:13
38:13
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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 succes…
…
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1
De-risking Drug Development | Episode 1: How to drive value in pre-clinical development
23:37
23:37
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By PAREXEL
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Enabling Successful Sites, Episode 1: Solving Site Feasibility and Start-Up Challenges
16:40
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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 o…
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Rare Endpoints: Delivering on Unmet Patient Needs
11:19
11:19
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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 es…
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Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 3
13:22
13:22
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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 test…
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Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 2
13:27
13:27
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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…
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Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 1
20:51
20:51
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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 expe…
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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 regu…
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Preparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 Achievements
17:41
17:41
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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 Excellen…
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Three trends impacting market access in the EU
13:23
13:23
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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.By PAREXEL
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How can we advance fair and ethical reimbursement for patients?
11:21
11:21
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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 …
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Beyond the Binary: Navigating Gender Diversity in Clinical Research
27:13
27:13
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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) report…
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Why Rare Disease Therapeutics Need Early Market Access Planning
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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 b…
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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 wit…
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RBQM Podcast Series | Episode 4: Three ways to de-risk your DCT implementation
9:42
9:42
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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 pat…
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Careers at Parexel — FSP Podcast Series | Episode 2: Celebrating a 25-Year Career with Kerri McCaul-Claus
16:44
16:44
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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…
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Careers at Parexel — FSP Podcast Series | Episode 1: Get Recruited to Be a Clinical Research Associate: The Benefits of Parexel’s FSP Program
18:34
18:34
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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…
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The Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit
8:27
8:27
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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 PAREXEL
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Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials
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14:36
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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 inn…
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RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry
14:44
14:44
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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 highl…
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Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment
21:18
21:18
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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 eith…
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RBQM Podcast Series | Episode 2: Cultivating Risk-based Behaviors
9:29
9:29
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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 Ex…
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Decentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented Communities
15:01
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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 pr…
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Episode 19: Improving Rare Disease Drug Development
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39:19
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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 challenge…
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RBQM Podcast Series | Episode 1: Getting it Right Upfront - Managing Study Risk from End-to-End
12:27
12:27
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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 approa…
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Episode 17: Funding Biotech Innovation: How to Attract Investors
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23:25
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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 i…
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Episode 16: COVID-19 Vaccines and Kids: The Research and Vaccine Explained
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14:45
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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 di…
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Episode 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine development
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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 …
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Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights
39:18
39:18
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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 pod…
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Episode 13: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
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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 Advance…
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Episode 12: ASCO20 Debrief: The latest in cell and gene therapy
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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 exp…
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Episode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective
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42:24
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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 …
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Episode 10: The emerging role of wearables in clinical trials
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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 critic…
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Episode 9: Making the Most of Functional Service Provider (FSP) Relationships
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23:11
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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 …
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Episode 8: Performing clinical trials in a shifting development landscape
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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; Bridg…
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Episode 7: International Women’s Day: Insights from Ascending Davos
27:15
27:15
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By PAREXEL
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Episode 6: The opportunity for biotechs in precision medicine: driving value and bringing important new therapies to patients
31:19
31:19
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By PAREXEL
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Episode 5: CAR-T: How far have we come and where are we going?
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By PAREXEL
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Episode 3: Bridging the Gap – How Minimizing Patient Barriers Can Improve Clinical Research
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38:49
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By PAREXEL
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Episode 2: Tackling Rare Diseases & Inside the FDA
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24:05
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By PAREXEL
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By PAREXEL
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