WCG Talks Trials podcast

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All About Change

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Eli Beer & United Hatzalah: Saving Lives in 90 seconds or Less 30:20

18 päivää sitten30:20

Toista Myöhemmin

Listat

Tykkää

Tykätty

30:20

Eli Beer is a pioneer, social entrepreneur, President and Founder of United Hatzalah of Israel. In thirty years, the organization has grown to more than 6,500 volunteers who unite together to provide immediate, life-saving care to anyone in need - regardless of race or religion. This community EMS force network treats over 730,000 incidents per year, in Israel, as they wait for ambulances and medical attention. Eli’s vision is to bring this life-saving model across the world. In 2015, Beer expanded internationally with the establishment of branches in South America and other countries, including “United Rescue” in Jersey City, USA, where the response time was reduced to just two minutes and thirty-five seconds. Episode Chapters (0:00) intro (1:04) Hatzalah’s reputation for speed (4:48) Hatzalah’s volunteer EMTs and ambucycles (5:50) Entrepreneurism at Hatzalah (8:09) Chutzpah (14:15) Hatzalah’s recruitment (18:31) Volunteers from all walks of life (22:51) Having COVID changed Eli’s perspective (26:00) operating around the world amid antisemitism (28:06) goodbye For video episodes, watch on www.youtube.com/@therudermanfamilyfoundation Stay in touch: X: @JayRuderman | @RudermanFdn LinkedIn: Jay Ruderman | Ruderman Family Foundation Instagram: All About Change Podcast | Ruderman Family Foundation To learn more about the podcast, visit https://allaboutchangepodcast.com/ Looking for more insights into the world of activism? Be sure to check out Jay’s brand new book, Find Your Fight , in which Jay teaches the next generation of activists and advocates how to step up and bring about lasting change. You can find Find Your Fight wherever you buy your books, and you can learn more about it at www.jayruderman.com .…

WCG Talks Trials

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Sarjan koti•Feed

Insights from leaders in clinical research and trial optimization, hosted by the WCG Clinical.

81 jaksoa

#Business #Clinical Trials #Pharmaceutical #Drug Development #Science #Fitness #Biology #Medicine #WCG

WCG Talks Trials

updated vuosi sitten

Jaa

Sarjan koti•Feed

Insights from leaders in clinical research and trial optimization, hosted by the WCG Clinical.

81 jaksoa

#Business #Clinical Trials #Pharmaceutical #Drug Development #Science #Fitness #Biology #Medicine #WCG

All episodes

WCG Talks Trials

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AI in Clinical Trials: Unlocking the Potential 27:54

8 weeks sitten27:54

27:54

In this episode of WCG Talks Trials, join Silvio Galea, chief data and analytics officer, WCG, and Melissa Hutchens, vice president of research and benchmarking, WCG, as they discuss the transformative role of AI in clinical trials. Discover how generative AI and other AI technologies are enhancing the quality of clinical trials, reducing cycle times, and cutting costs. The episode covers the benefits, barriers, and concerns associated with AI, and explores its applications in drug discovery, participant recruitment, trial design, and more. Tune in to learn about the latest advancements in AI and how they are shaping the future of clinical trials. Guests: Silvio Galea, chief data and analytics officer, WCG Melissa Hutchens, vice president of research and benchmarking, WCG…

WCG Talks Trials

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Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials 25:44

12 weeks sitten25:44

25:44

Join us for "Breaking Down Site Complexities and Start-Up Barriers in Clinical Trials" as we uncover the complexities of site management and the barriers to effective study start-ups. Discover the top issues impacting research sites and strategies to overcome them, including trial complexity, start-up hurdles, and long initiation timelines. Learn how effective communication, teamwork, and clear processes can drive success, and the importance of human connections and inclusivity in clinical research. Get practical advice for improving site readiness and trial efficiency from our expert guests. Don't miss this essential episode on navigating the evolving clinical trial landscape at sites. Guests: Jessica Thurmond, program director, WCG Pat Harrington, senior vice president, Clinical Solutions & Strategic Partnering, WCG Brad Gruener, vice president, Site Services, WCG…

WCG Talks Trials

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From Patient Care to Discovery: A Clinician's Journey into Research 19:45

22 weeks sitten19:45

19:45

Join us for a compelling episode of WCG Talks Trials where we take a look into the rewarding world of clinical trials and clinical development. In this episode, George Cokenakes, director of clinical services, review solutions, WCG, speaks with Dr. James Januzzi, a renowned cardiologist at Massachusetts General Hospital, and chief scientific officer at Baim Institute for Clinical Research. Dr. Januzzi shares his inspiring journey, highlighting the significance of clinical trial participation and the diverse opportunities that can shape a medical career. Learn from Dr. Januzzi's extensive experience in clinical research, including his work on cardiac biomarkers, drug therapy development, and involvement in various therapeutic areas. Discover how career decisions and active engagement in clinical trials can open doors to numerous possibilities and significantly impact patient care. Tune in for this insightful conversation and gain valuable advice for budding clinicians and researchers. Speakers: George Cokenakes, PMP, director of clinical services, review solutions, WCG James Januzzi, MD, FACC, cardiologist, Massachusetts General Hospital and chief scientific officer, Baim Institute for Clinical Research…

WCG Talks Trials

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Inside MAGI: Innovation, Education, and Industry Trends 29:19

25 weeks sitten29:19

29:19

In this episode of "WCG Talks Trials," host Geoffrey Schick, director of strategic site partnerships, WCG, is joined by fellow MAGI@home 2024 speakers Sandy Smith, Jess Thompson, and Wesley Warren. They share their unique perspectives and key takeaways from this year's virtual conference, including discussions on contract negotiations, the evolving role of advanced practice practitioners, and the collaborative panels featuring both site and sponsor/CRO insights. The episode also recaps the impactful session on the FDA's Diversity Action Plan and what it means for the future of clinical trials. Tune in to hear about the dynamic energy, valuable connections, and innovative challenges that make MAGI and MAGI@home standout events in clinical research. Don't miss out on the exciting plans for MAGI 2025 in Boston, where trends will continue to evolve and new opportunities will emerge. Guests: Geoffrey Schick, MBA, CHRC, Director of Strategic Site Partnerships, WCG Sandy Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG Jess Thompson, MS, MBA, PMP, Founder, ACRPM.org Wesley Warren, J.D., Executive Director, Research Strategy & Partnerships, City of Hope…

WCG Talks Trials

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Revolutionizing Clinical Research Through Collaboration and Innovation 28:54

27 weeks sitten28:54

28:54

In this episode of WCG Talks Trials, host Sandy Smith, senior vice president of clinical solutions and strategic partnering at WCG, dives into the highlights of the Florence Healthcare Research Revolution event. Sandy is joined by industry experts Andrea Bastek, vice president of innovation at Florence, and Lauren Sobocinski, senior vice president of strategic alliances at WCG, to discuss transformative insights from the event. Discover the latest trends shaping clinical research, including site engagement, protocol complexity, and effective sponsor-site relationships. Tune in for a compelling discussion on how collaborative efforts and innovative technologies are driving positive change in the clinical trial landscape.…

WCG Talks Trials

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Have a Safe Trip: Clinical and Patient Alignment in Research with Psychedelics 23:27

32 weeks sitten23:27

23:27

In this episode of WCG Talks Trials , host Kelly FitzGerald sits down with Dr. Currien MacDonald, Medical Chair Director at WCG, and Sara Reed, a participant in two psychedelic clinical trials, to explore the evolving landscape of psychedelics research. Dr. MacDonald shares his expertise on the growing acceptance of psychedelics in clinical settings, recent FDA updates, and the inner workings of ongoing trials. Later, Sara provides a firsthand account of her experiences as a trial participant, offering unique insights into how psychedelics are being tested as potential therapeutic options. Tune in to learn more about aligning clinical practice with patient experience in this emerging field.…

WCG Talks Trials

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Breaking Barriers: Reasons to Expand Site Cancer Trial Portfolios 28:53

34 weeks sitten28:53

28:53

In this episode of WCG Talks Trials, Geoff Schick, director of strategic site partnerships, joins our host Sandy Smith, senior vice president of clinical solutions and strategic partnering, to discuss the expansion of research site cancer portfolios.

WCG Talks Trials

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Patient Advocacy Advancing Breakthrough Science and Community Engagement 28:54

35 weeks sitten28:54

28:54

Join Desiree Underwood-Williams, director of project management organization at WCG and guest Steve Smith, CEO of SteveSmithPlans LLC and facilitator of the WCG Patient Forum , as they recap the latest Patient Forum Focus Session on breakthrough science and community engagement. Discussion highlights include: The impact of medical diagnoses on families with Sickle cell disease and melanoma. New research in cell and gene therapy that’s directly impacting Sickle cell disease and melanoma patients. New diversity laws shaping the future of drug development. Community engagement and how patients can get involved in their care. And more insights into the WCG Patient Forum, now in its fifth year. Tune in to learn more about clinical research, community engagement, and the latest developments in patient care.…

WCG Talks Trials

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Guarding Research Integrity: The IRB's Essential Role 27:27

35 weeks sitten27:27

27:27

In this episode of WCG Talks Trials, we are joined by host Joanne Thomas, clinical reviewer and patient advocate at WCG, along with our guest Currien MacDonald, medical chair director at WCG. This episode covers the roles of IRB in ethical clinical research, frequently asked questions, and a general overview of the IRB’s role in clinical trials.…

WCG Talks Trials

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Addressing Challenges in Site Feasibility 20:14

37 weeks sitten20:14

20:14

This episode of WCG Talks Trials addresses site feasibility challenges impacting the clinical trials industry. Join Michelle Yu, associate director of clinical strategy at WCG, and our guest Trevor Cole, director of client delivery, site and strategic operations for WCG, as we discuss approaches to adopt innovative feasibility and site start-up solutions. Here are links to documents referenced in this episode: Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement Main Article: https://ascopubs.org/doi/10.1200/OP.20.00821 PDF Data Supplement: https://society.asco.org/sites/new-www.asco.org/files/content-files/about-asco/documents/2020-ASCO-Site-Feasibility-Assessment-Statement-Data-Supplement-for-JCO-OP.pdf…

WCG Talks Trials

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Ethical Review and AI in Clinical Trials 39:43

47 weeks sitten39:43

39:43

Join our Chief Analytics Officer Silvio Galea, along with Dr. Donna Snyder & Dr. Barbara Bierer to discuss opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The discussion is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and WCG will address the growing need for guidance in this rapidly evolving area of research.…

WCG Talks Trials

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Addressing Measurement Challenges for PTSD Trials with Technology 21:40

48 weeks sitten21:40

21:40

In this episode of WCG Talks Trials, we are joined by WCG clinical science experts as they discuss traditional measurement challenges for PTSD trials and how the use of an electronic CAPS-5 scale is improving administration and scoring errors. Tune in as we discuss the CAPS-5 scale, the opportunities and benefits of using an electronic version to help standardize scale administration and scoring across clinical research, and the promising results to date.…

WCG Talks Trials

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What Is E-Consent? Interview with Erin Brower 9:35

1 year sitten9:35

9:35

WCG Talks Trials

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Creating Partnerships: Aligning Vendor Support for Success in Clinical Research 20:56

1 year sitten20:56

20:56

In the most recent episode of WCG Talks Trials, we are joined by three industry experts, Amy Thue and Shelby Ward from WCG, and Russell Lampman from Merck to discuss the topic of optimizing vendor support, and ultimately the success, of clinical trials. Listen in as we dive into feedback and perspectives from both the sponsor and vendor side of the table—for valuable take-aways and insights into how vendor support is best aligned across all stakeholders.…

WCG Talks Trials

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WCG's IRB Policy Change: Harmonizing Consent (Part 2) 8:06

1 year sitten8:06

8:06

In Part 2 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses new FDA regulations for waiver of consent with Kelly Fitzgerald, PhD, WCG's IRB Executive Chair and VP IBC Affairs.

WCG Talks Trials

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WCG's IRB Policy Change: Harmonizing Consent (Part 1) 6:06

1 year sitten6:06

6:06

In Part 1 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses a policy change that is going into effect for WCG IRB with Lindsay Abrahams, Regulatory Chair Director. Lindsay and Currien discuss the concise summary and its application to consent forms, especially for WCG.…

WCG Talks Trials

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The Ethical and Safety Considerations of Accelerating Oncology Trials 43:16

1 year sitten43:16

43:16

In this episode of WCG Talks Trials, our expert panel discusses various ethical, safety, and logistical challenges in accelerating clinical trials for gene and cell therapies in oncology. The conversation explores the role of Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), Endpoint Adjudication Committees (EACs), and Data Monitoring Committees (DMCs) in overseeing these trials, addressing issues such as patient safety, complex trial designs, and emerging biosafety concerns. Our panelists emphasize the importance of transparent communication and collaboration between IRBs and IBCs, highlighting the need to balance the urgency of advancing research with ethical considerations. Additionally, the podcast explores unrealized ethical and safety issues, such as the pace of technological advancements and potential risks associated with gene editing. The speakers also touch upon future opportunities in oncology research, including precision medicine, artificial intelligence, wearable devices, and accelerated regulatory pathways.…

WCG Talks Trials

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Embarking on a Research Revolution – A Conversation with Florence Healthcare 30:37

1 year sitten30:37

30:37

In episode 10 of WCG Talks Trials, we are joined by Catherine Gregor, the Chief Clinical Trial Officer at Florence Healthcare, to discuss Florence’s recent Research Revolution event and the importance of site enablement in clinical research. Listen in as we recap Research Revolution, share insights on emerging clinical trial trends and innovations, and have a candid conversation about what stands in the way of successful site enablement in clinical research.…

WCG Talks Trials

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The CRA’s Evolving Role in a Postpandemic Industry 36:47

1 year sitten36:47

36:47

In this episode of WCG Talks Trials , we are joined by Elizabeth Weeks-Rowe, CCRA, author of The CRA’s Guide to Monitoring Clinical Research , 6th Edition. Led by WCG Director of Publications and Content, Leslie Ramsey, the discussion will delve into the ways the clinical trials industry has become more complex and technologically focused and the challenges clinical research associates (CRAs) face as monitors of clinical trials. Host: Leslie Ramsey, Director of Publications and Content, WCG Participant: Elizabeth Weeks-Rowe, Independent Clinical Research Consultant…

WCG Talks Trials

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MAGI@home: Practical Intelligence, Real-life Examples, Actionable Information 29:26

1 year sitten29:26

29:26

In this episode of WCG Talks Trials, we are joined by MAGI@home Steering Committee members, Jennifer Peterson, Director, Head of Clinical Quality at M3 Wake Research, and Geoffrey Schick, Director, Strategic Site Partnerships at WCG. Led by Carmin Gade, Chief Marketing Officer at WCG, the discussion will delve into the insights and value MAGI events provide that enable attendees to achieve success in their roles and professional development.…

WCG Talks Trials

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Diversity & Inclusion with Technology in Decentralized Trials 1:05:05

1 year sitten1:05:05

1:05:05

This episode of WCG Talks Trials, hosted by Kelly Fitzgerald, Executive IRB Chair and Vice President of IBC Affairs at WCG, dives into the topic of diversity and inclusion with technology in decentralized clinical trials (DCTs). The episode explores the transformative opportunities that DCTs present for addressing diversity gaps in clinical research. The discussion features a panel of experts, including Otis Johnson, former Chief Diversity, Inclusion, and Sustainability Officer at Clario; Archana Sah, a seasoned clinical development leader with a focus on oncology and healthcare technology; and Ken McCann, a physician with a background in pediatrics and a keen interest in social determinants of health. The panelists share insights on how DCTs can improve accessibility, overcome barriers, and enhance representation in clinical trials, emphasizing the potential for these trials to be a game-changer in making clinical research more equitable and inclusive. Guests: Archana Sah MS (Pharm.) PMP Otis Johnson, PhD, MPA Ken McCann, MD…

WCG Talks Trials

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Amplifying Patient Voices to Advance Clinical Research: The Importance of Patient Advocacy 29:38

2 years sitten29:38

29:38

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of patient advocacy in clinical research and key takeaways from WCG's 2023 Patient Forum. We'll summarize how the patient forum elevates the voices of those changing drug development for the better and recap breakthroughs and best practices shared during the most recent event. Discover more about patient and researcher collaboration, expanding diversity, equity, and inclusion in trials, and the latest advocacy-driven technology, science, and policy breakthroughs leading to modernized clinical research. Guests: Desiree Underwood-Williams, PMP, CLSSBB, Director, Project Management Office, WCG Steve Smith, President, Patient Advocacy, WCG…

WCG Talks Trials

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The Importance of Diversity, Equity, Inclusion, and Intersectionality in Clinical Research 36:48

2 years sitten36:48

36:48

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We'll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today. Discover how communities can be more actively engaged in clinical research and hear real-world examples of success stories in promoting diversity, equity, and inclusion within clinical research. Moderator: Scott J. Hunter, PhD - Senior Scientific Expert, Neurodevelopmental and Rare Pediatric Diseases, WCG Speakers: Sonya Dinizulu, PhD - Associate Professor of Psychiatry and Behavioral Neuroscience, University of Chicago Desiree Underwood-Williams, PMP, CLSSBB – Director, Project Management Office, WCG…

WCG Talks Trials

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Delve into the World of Psychedelic Research and Ethical Inquiry 25:48

2 years sitten25:48

25:48

Join WCG Talks Trials podcast host Kelly Fitzgerald, PhD, in a riveting dialogue with guest expert Currien MacDonald, MD, as they unravel the nuances of "Psychedelics in Research: Ethical and Medical Perspectives." Dr. MacDonald, with a solid foundation in family medicine and clinical trials administration, guides listeners through a grounded exploration of psychedelic substances. In this episode, they demystify the realm of psychedelics, encompassing both dissociative and classic varieties, such as LSD and MDMA. As the conversation delves into ongoing research, the potential applications of these compounds in treating mental health challenges like depression, anxiety, and post-traumatic stress disorder come to the fore. The dialogue doesn't shy away from probing the ethical dimensions surrounding psychedelic research, addressing concerns about study design, potential abuse, and the intricate balance between benefits and risks. This insightful podcast offers an engaging journey into the evolving field of psychedelic research, shedding light on its medical potential and the ethical considerations that guide its path.…

WCG Talks Trials

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A 360-degree View on Motivators and Deterrents to Clinical Trial Participation 30:32

2 years sitten30:32

30:32

In episode three of WCG Talks Trials , two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report , which provides a 360-degree view on motivators and deterrents to clinical trial participation. Listen in as we dive into feedback from perspectives across all clinical research stakeholders — sponsors, providers, sites, and patients — for valuable take-aways and insights into the trial experience. Speakers: Crissy MacDonald, PhD, Vice President, Client Delivery, WCG Avoca Gina DiCindio, Associate Director, Industry and Client Research, WCG Avoca…

WCG Talks Trials

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Breaking Down Enrollment Barriers: How DE&I, Technology, and Protocol Design Impact Enrollment Success 18:28

2 years sitten18:28

18:28

In episode two of WCG Talks Trials, we are joined by two WCG experts to discuss overcoming common enrollment challenges and how DE&I, technology, and protocol design factor into enrollment success. Listen in as we delve into the critical topic of common enrollment barriers in clinical trials, how to improve enrollment by focusing on DE&I efforts, the importance of site-centric and patient-centric technologies, and how thoughtful protocol design plays a significant role in enrollment success. Speakers: Dawn Sauro, Chief Growth Officer, WCG Jamie Harper, MHA, CCRP - Vice President, Site Solutions & Engagement at WCG Tyler Bye - Director, Site Solutions & Product Strategy at WCG…

WCG Talks Trials

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Unlocking Site Potential: Reducing Site Burden and Enhancing Clinical Trial Efficiency 35:53

2 years sitten35:53

35:53

In the first episode of our new podcast series, WCG Talks Trials, we are joined by three industry experts, Lisa Ballance from Virginia Commonwealth University, John Musser from Florida Cancer Specialists and Research Institute, and Dan Otap from Genentech, to discuss the topic of overcoming site challenges and addressing site burden. Listen in as we discuss the results of WCG’s recently published 2023 Clinical Research Site Challenges Survey Report, gain insights from our guests on solutions their organizations have implemented to reduce site burden, and share perspectives on how sites, sponsors, and CROs can work to improve site and trial efficiency. Speakers: Sandy Smith, RN, MSN, AOCN Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG Clinical Lisa Richman Balance Associate Vice President for Research Strategy and Regulatory Affairs at Virginia Commonwealth University John Musser Senior Director, Clinical Research Administration at Florida Cancer Specialists & Research Institute Dan Otap Principal, Alliance and Partnerships Lead at Genentech…

WCG Talks Trials

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Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research 12:27

4 years sitten12:27

12:27

Bernadette Siddiqi, associate director of research partnerships at The Michael J. Fox Foundation for Parkinson’s Research talks about how they give members of the public access to the Fox Trial Finder. This clinical trial search tool that allows anyone to search for Parkinson’s disease clinical trials. More than 300 are listed on the site. It’s a bottleneck in clinical research. Patients are eager for a cure, but it can be difficult for them to connect to trials and for researchers to connect to volunteers. Bernadette speaks of why it is critical to the foundation’s mission to provide an easy way to make this connection. Just as important, she says, is educating people about research. Fox Trial Finder provides both. Roughly 700 people visit the site each month. The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.…

WCG Talks Trials

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On the Future of Movement Disorder Trials: Part 4 of WCG’s Transforming CNS Trials Series 9:34

5 years sitten9:34

9:34

Movement disorder trials have always been demanding. Now, sponsors face an additional challenge: How do you ensure data integrity in the era of remote clinical trials? In this podcast, Bob Dagher, MD, WCG MedAvante-ProPhase’s Chief Medical Officer, addresses this in conversation with Steve Smith, WCG President of Patient Advocacy. This is the fourth episode in our series, “Transforming CNS Trials During COVID-19—and Beyond.” Sponsors planning to restart movement disorder programs need to be clear-eyed and realistic, Dagher counsels. “When it comes to remote assessments, we have to be vigilant and aware of what we can do and also about what we really cannot do.” Some assessments simply cannot be performed remotely. This means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking the database. FDA guidance on the conduct of trials during COVID-19 helps provide a roadmap. For example, in the case of anticipated missing data the guidance clearly states to capture specific information in the case report form that explains the relationship to COVID-19. But it also requires in-depth scientific and clinically-informed knowledge so that the quality of the data captured isn’t sacrificed as direct result. Accordingly, WCG has been working with clients to tailor remote assessments for sponsors’ trials, yielding assessments that are as close as possible to the in-person versions (minus those particular items that cannot be done remotely). Dagher’s message? “Ensuring data integrity at every step of the process should be the primary guide for any decision-making process when deciding to restart your study.” Prior to joining WCG MA-PP, Dr. Dagher, was the Chief Medical Officer of Cadent Therapeutics in Cambridge, Mass. Before that, he served in many leadership roles at small and large biopharmaceutical and clinical research organizations, including GlaxoSmithKline, Genzyme, Sanofi and Covance, among others. Dr. Dagher has fostered the development of multiple products in different indications and development platforms and advanced several small molecules and biologics across all stages of clinical development. His background includes therapeutic experience in psychiatry, neurology and rare diseases.…

WCG Talks Trials

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Prostate Cancer Survivor Bryce Olson’s Message: “Sequence Me!” 24:26

5 years sitten24:26

24:26

As a global strategist for Intel’s Health and Life Sciences Group, Bryce Olson had an up close view of innovation happening in the lab—especially in terms of genomic sequencing and gene therapy. As a man diagnosed with aggressive stage 4 prostate cancer at 44, he had as well an up close view of how that innovation was not being translated into the clinic. He was started on a one-size-fits-all standard of care. It didn’t work, and chemo made him ill. In this podcast episode, he talks about how he demanded—and received—DNA sequencing. That data led him to find the right trial and the right medicine for his type of prostate cancer. He’s now a very vocal advocate of sequencing. Among other endeavors, he founded Sequence Me ( www.sequenceme.org ), a patient-driven movement to accelerate access and adoption of new genomic sequencing innovations for cancer.…

WCG Talks Trials

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On the Future of Depression Trials: Part 3 of WCG’s Transforming CNS Trials Series 10:51

5 years sitten10:51

10:51

In major depressive disorder, researchers have used remote assessments for decades. As a result, many of these studies have had an easier time adapting to the new clinical trial landscape. But that doesn’t mean they are pandemic-proof. So what are the critical success factors for clinical depression programs—especially now? In his conversation with WCG President of Patient Advocacy Steve Smith, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase offers his insights on the future of clinical depression trials. This is the third episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.” We’re headed in the right direction by enabling more patient-friendly evaluation, but – especially in light of the pandemic – we must continue to refine these systems and make sure that we have the input of patients, caregivers, and of course, investigators. Among his recommendations: Ensure clinicians have the right depression-assessment tools and that they are using them correctly. It’s also critical, he says, to have a solid remote assessment methodology in place. This means not only incorporating the right tools, but also establishing a way of continuously protecting data quality, such as WCG's Study Insight Analytics Platform . Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.…

WCG Talks Trials

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LaTasha H. Lee, PhD, MPH: Advocating for Health Equity, Advancing Sickle Cell Disease Research 26:35

5 years sitten26:35

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LaTasha Lee, PhD, MPH’s path to becoming a sickle cell disease (SCD) researcher and policy advocate began as a child. Because the SCD trait ran in her family, she became a patient advocate while still small. Today, she is Vice President, Social and Clinical Research & Development, at the National Minority Quality Forum. In this wide-ranging interview, she touches on an array of issues affecting the SCD community. Among them: adult patients who end up in the emergency room, the increased number of available therapeutics and the robust pipeline of SCD therapies. Of particular concern is the challenge of accessing pain medication — both in the ER and in primary care practices. “Individuals with this disease often aren’t believed. They are considered drug seekers when they aren’t.” She also makes a passionate call for increased minority participation in healthcare and in research to enhance equity and improve outcomes. Dr. Lee is responsible for the oversight and implementation of research projects and programs focused on reducing patient risk and identifying optimal care to reduce health disparities and bring about health equity at the National Minority Quality Forum. Before that, she served as Senior Manager of Partnership Engagement of the Sickle Cell Disease Clinical Trials Network (SCD CTN) at the American Society of Hematology (ASH) Research Collaborative. She was responsible for establishing, implementing and maintaining effective partnerships with stakeholders including patients, academic medical centers, other clinical research sites, industry, and federal agencies regarding their interests in SCD CTN. As an experienced research manager at ASH she was tasked with the development of a patient engagement strategy and clinical trials network for SCD. While at ASH, Dr. Lee was also responsible for the day-to-day management and implementation of projects, programs and activities related to ASH’s Call to Action on Sickle Cell Disease.…

WCG Talks Trials

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Jeffrey Borghoff: Finding Joy and Purpose after an Early-Onset Alzheimer’s Diagnosis 27:22

5 years sitten27:22

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At 51, Jeffrey Borghoff was diagnosed with Alzheimer’s disease. What would devastate many people turned Borghoff into an advocate. The former software architect and developer is now a national spokesperson for the Alzheimer's Association and board member of the Greater New Jersey chapter. In this podcast, he talks about how the diagnosis forced him to reprioritize his life. “I've been pretty successful at that. I've been leading a very purposeful, engaging, joyful life.” With his care partner—his wife, Kimberly—he travels around the country making the case for research funding—and for clinical trial participation. That’s critical because important Alzheimer’s trials focus on younger-onset AD patients. Unfortunately, many people who are beginning to show signs at a very young age want to deny they have the disease. They won’t go into trials or even get a diagnosis. His messages to them: This disease does not define who you are, and research is important.…

WCG Talks Trials

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On the Future of Schizophrenia Trials: Part 2 of WCG’s Transforming CNS Trials Series 10:37

5 years sitten10:37

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Remote assessments have become a necessity across CNS trials, but some areas are more complicated than others. Schizophrenia provides one such example; the risk of variability is high, and sponsors are concerned. In this podcast, Mark Opler, PhD, MPH, Chief Research Officer at WCG MedAvante-ProPhase, sits down with WCG President of Patient Advocacy Steve Smith to discuss the topic. This is the second episode in our podcast series, “Transforming CNS Trials During COVID-19—and Beyond.” PANSS—the gold standard rating scale for schizophrenia primary outcomes—is based largely on face-to-face interviews; it wasn’t developed for remote assessments. Is it still usable? Yes, says Dr. Opler. “I’m pleased to report that the anecdotal experience, as well as available data, suggests assessments conducted with patients with schizophrenia via video can be done reliably and can be done in a way that produces valid data.” It can be done—the tools exist. But it’s the way sponsors and CROs approach remote assessments that can make or break data integrity—and he delves into that topic in this podcast. In particular, he shares how sponsors and CROs can leverage remote assessments in their next clinical trial. Mark Opler, PhD, MPH, is Chief Research Officer at WCG MedAvante-ProPhase. Dr. Opler was the founder of ProPhase and served as its CEO and Chief Scientific Officer, among other roles. He serves as adjunct assistant professor of psychiatry at New York University and assistant professor of clinical neuroscience at Columbia University’s College of Physicians and Surgeons. He is also leading the development of the forthcoming edition of the PANSS Manual.…

WCG Talks Trials

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Lisa Deck: Young Stroke Survivor Transforms Life-Altering Challenge into Purpose-Driven Advocacy for Others 16:41

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Lisa Deck was a healthy 21-year old a week away from college graduation when her first stroke put her in the hospital. She barely made it to her graduation ceremony. She suffered two more strokes before she turned 25, and after that, a fourth stroke. After serious misdiagnosis and incorrect treatments, she was finally diagnosed with Moyamoya disease, a rare condition without a cure, but it does have a surgical treatment. In this podcast, she shares her diagnostic odyssey, her commitment to advocacy and the value of peer and family support. She also talks about the importance of staying positive and why patients must advocate for themselves.…

WCG Talks Trials

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The Case for Centralized Monitoring: Optimizing Data Quality and Risk Management with Linda Sullivan and Steve Young 36:14

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How can CROs and sponsors detect potential problems and issues in clinical trial conduct and data quality? That’s one of the critical issues discussed in Steve Young’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young, Chief Scientific Officer at CluePoint, discusses how risk-based quality management (RBQM) methodology, data analytics, and data surveillance are being utilized today to go beyond just ferreting out fraud. Now, Young says, clinical trial stakeholders are deploying advanced statistical engines to detect quality and data breaches in investigational studies. According to Young, while there are still instances, to varying degrees, of major misconduct in clinical trials, CROs and sponsors are increasingly turning to online solutions to risk planning. It’s important, he adds, that when risks are discovered, the solutions are integrated into the workflow of clinical trials. In fact, Young asserts, one of the biggest challenges facing the industry today is to embrace change and accept the use of centralized monitoring data to aid in the discovery and resolution of risk. Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.…

WCG Talks Trials

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Michael Poku, MD, MBA: Improving Minority Representation in Clinical Trials 21:19

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For many of the same reasons underrepresented populations lack access to appropriate healthcare services, they are also left out of clinical trials. The problem is widely known, but solutions have been hard to come by. In this episode, Michael Poku, MD, MBA, biopharma medical director at Signify Health, explains why this is the case and then shares some approaches he and his colleagues have successfully used to remove the barriers to clinical trial participation. An important aspect is understanding the larger picture—that inequality is due to in large measure to longstanding and systemic issues. He discusses how unmet social needs rarely occur in isolation. Addressing those needs together can lead to better representation in clinical trials. “Sponsors are incredibly excited about opportunities to make their trials more representative and to have underrepresented minorities participate,” he says. In addition to his work at Signify Health, Dr. Poku is on clinical faculty at Methodist Dallas Medical Center and the University of Texas Southwestern Medical Center, where he cares for patients as an internist and teaches trainees and medical students. Prior to his role at Signify Health, Dr Poku was a consultant at McKinsey & Company.…

WCG Talks Trials

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Dana Deighton: Esophageal Cancer Patient and Persistent Activist For Her Own Survival 24:52

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Dana Deighton, an esophageal cancer survivor, shares her diagnostic odyssey of false starts and life-threatening detours. Deighton had always been healthy—she didn’t smoke, didn’t drink and exercised every day. Then came a joint pain that wouldn’t go away, visits to numerous doctors, a series of misdiagnoses, invasive tests, and growing symptoms. The correct diagnosis of stage 4 esophageal cancer “was not the diagnosis anyone wants.” But she refused to accept physicians’ recommendations for palliative care as a solution. She describes her persistent advocacy to convince doctors to consider her as an individual different from expectations and generalizations. She asked the hard questions and had the hard discussions, resulting in an outcome better than expected. She recommends physicians and patients do the homework, energetically collaborate and consider the individual patient in the quest for a solution. “Don’t be a passive patient.” Dana Deighton works for the online patient community provider Inspire.com that helps connect patients with others experiencing the same disease, for a wide variety of diseases and over 4 million members. She also serves as an Executive Board Member of the Esophageal Cancer Action Network (ECAN), is a patient representative on the Locally Advanced Esophageal Cancer Guideline Panel for the American Society of Clinical Oncology (ASCO), a member of NCI Patient Advocate Steering Committee and NCI Esophago-Gastric Task Force and serves on the Esophageal and Stomach Cancer Project Patient Advisory Committee, a project led by the Broad Institute of MIT and Harvard. She lives outside of Alexandria with her husband and three teenagers.…

WCG Talks Trials

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Striving for Reliability: Optimizing Patient Report Data through World-Class Design Management with Linda Sullivan, Nat Katz, and Art Morales 38:58

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Can patients be trained to report their symptoms more accurately? That’s one of the key topics discussed in Nat Katz’s and Art Morales’ interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Katz, the Chief Science Officer of WCG-Analgesic Solutions and Morales , Vice President, Technology Solutions at WCG, assert that, with proper design and implementation, you can structure clinical trials, such as pain management studies, so that patients learn how to better report their symptoms. With proper training, patients learn to accurately report their symptoms, resulting in more reliable data, according to Katz and Morales. During COVID-19, they add, sponsors have had the opportunity to examine ways to introduce new technologies, such as telehealth, to clinical trial operations and to use more science-based tools for evaluating the performance of clinical trials. COVID-19 also has accelerated the scientific evaluation of clinical sites by optimizing the analysis of patient data. The result: Clearer and more reliable data collected during the conduct of study — without unblinding the data. Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.…

WCG Talks Trials

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The Upside of Centralized Monitoring During a Pandemic: Linda Sullivan, Duncan Hall, and Rachel Oakley on Optimizing Clinical Trials through Innovative RBQM Technology 41:55

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How are clinical trial companies pivoting to implement Risk-Based Quality Management programs during the pandemic? That’s one of the deep dives explored in Duncan Hall’s and Rachel Oakley’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Hall, founder and CEO of Triumph Research Intelligence (TRI) and Oakley, Vice President of RBQM Services at TRI, note that, when the COVID-19 pandemic first hit, CROs and sites performed risk assessments on their existing studies. Then those organizations took advantage of innovative technology that had a key tool for optimizing clinical trials — centralized monitoring. According to Hall and Oakley, that tool enables critical oversight and monitoring of investigational sites, even when in-person visits are not feasible. They point out that regulatory agencies are issuing new guidance during the pandemic, and that sponsors, CROs, and sites need to figure out how to comply with both those new mandates as well as existing rules. According to Hall and Oakley, there has been a renewed sense of community in the industry in dealing with the pandemic as stakeholders try to stay current through a variety of trusted sources, including MCC’s weekly COVID calls. Finally, they note, one component for optimizing clinical trials is taking center stage — training, especially in the area of RBQM. I nterested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020 . If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.…

WCG Talks Trials

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Get Rid of Those Silos: Linda Sullivan, Artem Andrianov, and Johann Proeve on How To Optimize Clinical Trials through RBQM 42:22

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What’s the secret to success for implementing a world-class holistic approach to a Risk-Based Quality Management (RBQM) system? That’s one of the key topics from Artem Andrianov‘s and Johanna Proeve’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. Andrianov, CEO, and Proeve, Chief Science Officer at Cyntegrity emphasize the importance of developing a clinical trial platform that enables your organization to manage the entire quality management cycle rather than continuing with traditional silo-based approaches. This comprehensive approach, they explain, enables pharmaceutical companies to become more efficient in reducing risk, which is especially important during the current pandemic. In addition, they note, in the COVID-19 era, more organizations have had to turn to holistic risk-based quality management systems because, for example, Excel doesn’t always work for managing RBQM, especially in larger clinical trials. Today, both CROs and sponsors are implementing innovative RBQM technology and asking for additional training to deal with data quality deterioration and other issues brought about by the onslaught of the pandemic, according to Andrianov and Proeve. Listen to this episode to find out how COVID-19 has magnified festering clinical trial shortcomings and why it’s essential that pharmaceutical company leaders become “data scientists.” Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020 .…

WCG Talks Trials

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Gregory L. Hall, MD: Writing the Book on Health Disparities in African Americans 22:29

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Ever since elementary school, Gregory L. Hall, MD, knew he would be a doctor. In this interview, he shares that journey and how he came to write the book—literally—on health disparities for African Americans. His focus on disparities began more than 30 years ago with his appointment to the Ohio Commission on Minority Health—the first such commission in the country. Eventually, when he became the chairman, he had to give quarterly reports. The research he conducted on disparities for those reports opened his eyes, he says. “I naively believed that providers and physicians didn’t contribute to health disparities. I thought it was just poverty and a lack of insurance. I didn’t know that, actually, providers contribute to it, health systems contribute to it.” He was shocked, and what he learned led to him write his book, Patient-Centered Clinical Care for African Americans: A Concise, Evidence-Based Guide to Important Differences and Better Outcomes . It is for physicians and clinicians and is a guide outlining specific differences in communication, clinical therapies, medications, protocols and other critical approaches to the care of African Americans. The book discusses a wide range of disorders that affect African Americans It includes clinical pearls, but it also provides the background clinicians need to understand just what drives disparities. Providers don’t want to exacerbate disparities, but they are often unaware. If you don’t know what you’re doing wrong, you can’t fix it, he says. He is helping with both. Even when providers do a better job addressing the specific needs of African-American patients, hurdles remain, he says. For example, lack of trust remains a huge issue among African-American patients; the shadow of historic discrimination in medical settings looms large. Almost half of African Americans report low trust of healthcare providers—and what’s interesting, he notes, is that this distrust extends to providers of all races. As a result, African Americans often don’t seek out the care they need, and they are wary of clinical trials. In addition to being a practicing primary care physician in Cleveland, Dr. Hall has a dual appointment on the teaching faculty at Northeast Ohio Medical University College of Medicine as associate professor of both internal medicine and integrative medical sciences. He also has an assistant clinical professor appointment at the Case Western Reserve University School of Medicine.…

WCG Talks Trials

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Turning Insights Into Action: Linda Sullivan and Ken Getz on How Metrics and Benchmarking Provide a Path To Optimizing Clinical Trials 34:38

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"What impact does a remote clinical team operating model have on clinical trial performance?" That’s one of the hot topics from Ken Getz’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. He describes several projects that the Tufts Center for the Study of Drug Development (Tufts CSDD) is currently working on; ones that will provide robust, data-driven analysis and strategic insights that help drug development professionals improve pharmaceutical R&D. Getz is the Deputy Director of Tufts CSDD and Professor at the Tufts University School of Medicine. At any given time, Getz states that Tufts is conducting between 12 and 15 grant-funded projects. The ideas for their studies are often generated from conversations in working groups, like MCC’s member networks. They also arise from thought-provoking conversations at industry conferences. But no matter where the studies come from, the studies always provide a “think tank for that very high-level, macro-level view of what’s happening in drug development,” Getz explains. Listen to this podcast to learn how Tufts – and the data it publishes – offers insights for organizations to transform clinical trials. “Everyone I speak with tells me they’ve tried to measure and benchmark. There are lots of internal forces that have tried to tackle benchmarking, so we’re excited to have an evidence-based approach that provides an opportunity to help organizations shape their practices moving forward.” Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit September 8-10? Visit https://www.centerwatch.com/mcc-summit-2020 . If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.…

WCG Talks Trials

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Lisa Carlton, PhD: Fighting Rare Diseases as a Mother, Patient Advocate and Regulatory Affairs Professional 22:13

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Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. This makes her an ideal person to co-chair an industry-patient-advocacy group called the Working Group on Regulatory Science, a part of the EveryLife Foundation for Rare Disorders that seeks to advance the development of treatment and diagnostic opportunities for rare disease patients through science-driven public policy. Tuberous sclerosis, a rare genetic disorder, affects one in every 6,000 newborns in the United States. It is a disorder that causes benign growth in almost any tissue; it’s of particular concern when it occurs in the brain, lungs or kidneys. Some people who have tuberous sclerosis may have learning problems or difficult-to-control seizures. Her daughter—one of a pair of twins—was diagnosed in utero. She’s doing well, although the speech and language disorders associated with the condition have made it hard to access the curriculum in school. Dr. Carlton talks about the challenges of developing new treatments for rare diseases and the approaches taken to try to overcome them. She also talks about her daughter’s disease, and how families can bring their best to their journey as they adapt to support their child. Based on her experience as a parent and advocate—as well as her experience in the industry—she has this advice for families: “Take a breath.” Drug development is slow, especially in rare diseases. “You are in for a marathon of supporting your child.” When possible, connect with other parents and advocacy groups. Or build your own tribe—work, friends, family, etc. “You have to be healthy and rested enough to do this. You have to be at your best.” She’s often asked how she manages to keep going. “I don’t know how I wouldn’t do it. You’ve been given this gift of a special child. Now it’s time to find your tribe and push ahead.” Her advice for a biotech company considering launch of a clinical trial for a rare disease? Nobody knows more about a patient’s journey, the patient’s experience, than the patient—or a parent or caregiver. “Just listen to what patients are saying. You are going to learn a lot.” Lisa Carlton, PhD, has previously worked in regulatory roles at the National Institutes of Health, Otsuka Pharmaceuticals and International Partnership for Microbicides. She is currently serving as Vice President of Global Regulatory Affairs at REGENXBIO, a gene therapy-focused biotech company with headquarters in Rockville, MD. Lisa received her PhD in Pharmaceutics and MS in Medicinal Chemistry from the University of North Carolina in Chapel Hill and a BS in Biochemistry from North Carolina State University.…

WCG Talks Trials

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Peter A. DiBiaso, MHA: Taking on the Ironman, Mount Kilimanjaro and Parkinson’s disease: a clinical trials patient recruitment expert speaks about his own life as a patient 19:06

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Pharmaceutical executive Peter A. DiBiaso, MHA, a triathlete who has successfully completed the grueling Ironman, learned at age 49 he had early-onset Parkinson’s disease. He shares his experiences—and triumphs—in this episode. What started as a small tremor in his right hand and a stiffness in his right ankle ended up changing his life. It was a blow, but he knew what to do: The diagnosis brought his personal and professional life full circle. Five years later, he reports minimal disease progression. He is doing well and remains incredibly active. Other than well-managed medication, to what does he attribute his success so far? Staying fit and continuing to be an athlete. He is still running marathons and recently scaled Mount Kilimanjaro, the highest mountain in Africa. Engaging with patient advocacy groups—in particular, the Michael J. Fox Foundation. (In fact, his Kilimanjaro trek was part of a Team Fox effort to raise money for the foundation.) His ability to navigate the system. He has also been involved in six clinical trials—both interventional and observational. He knew the value as an industry insider. Now, he appreciates the value from the patient perspective—and he better understands the frustrations patients face. It too often falls on the patients to initiate discussions about clinical trials. That’s fine for him, he says, but what about those who don’t know trials are available? His professional life has focused on patient recruitment issues, so he brings a 360-degree perspective. Sponsors, he says, need to focus on more than the academic and clinical elements; they must address real-world issues and trial participants’ challenges—even those that seem minor, like parking. It comes down to patient-centricity, he explains—putting patients at the center of the clinical research enterprise. It is becoming more common, but there’s still a long way to go. Peter DiBiaso, MHA, is a consultant to drug development companies and has worked at Pfizer, Shire, Vertex, and IQVIA. He is married and has two children, and he and his family split their time between Paris and Boston.…

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