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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.
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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.
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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 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.
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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 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.
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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 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.
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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 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.
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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 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.
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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 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.
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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 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.
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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 established by FDA's current initiatives.
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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 testing capabilities on the horizon. They also discuss the roles of payers and healthcare providers in ensuring patient access to these advancements.
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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 and metabolomics, to gain a better understanding of the tumor and the patient's immune system and physiology.
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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 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 -
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.
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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 Excellence.
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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.
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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 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.
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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) 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.
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