Pharmatalkradio

Learn lessons from a healthcare communications and clinical trial recruitment expert about addressing health disparities in racial and ethnic minorities, utilizing technology to precisely raise awareness, and bridging the digital divide, and how to:  Leverage technology to raise awareness and engage post-trialChange practices to address mistrust amongst typically underserved populationsUse technology to recruit more diversely and representatively in the pandemic   Speaker: Becky Johnson, PhD, Director, Global Diversity & Inclusion in Clinical Trials, IQVIA: Becky has 20 years of experience in the biopharmaceutical industry and is a subject matter expert in healthcare communications and clinical trial recruitment with a focus on diversity, equity and inclusion. Becky leverages her expertise to inform the strategic direction and initiatives to support pharmaceutical company sponsors with their efforts to achieve more racially and ethnically diverse trial populations. Becky has a Master’s in Public Health

In this podcast, Roger Boutin, VP of Communications at SCORR Marketing discusses the results of an audience survey from the 2020 CRAACO: Clinical Research as a Care Option Conference. The poll focused on the areas of: Patient Input and EngagementDealing with COVID and Patient OutreachDiversity and Collaboration Around Clinical TrialsAccelerating the CRAACO Movement

In this conversation, you'll learn lessons of how to implement sensors for the most impact in your clinical trials. Join three sensor experts as they discuss: What phases of clinical trials are more suited for sensor useHow to select and integrate the deviceHow to ensure compliance Speaking: Keith Wenzel, Senior Director, Parexel’s Scientific Data Organization: Keith's areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials.Julia Lakeland, Solutions Architect and Program Director, Parexel: Julia is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in product management, operational delivery and support of phase III/IV clinical trials. Thomas Wells, CEO, Precision Digital Health: Thomas is currently focused on bringing innovative big data solutions to market to support real-world evidence research and clini

Patients as Partners Europe conference producer, Mark Scherzer, provides an overview of the upcoming virtual conference agenda to take place 25-26 January 2021. Hear about the sessions, keynotes, interactive opportunities, and what you will walk away with, including: A range of examples of patient engagement ideas in the early stages of research to advance clinical outcomesAn understanding of how to design hybrid trials around patient preferences to drive better enrollment and retentionHow to increase diversity in clinical trialsHow to manage the issues that arise when implementing new approachesHow to influence organizational change to support patient engagement and clinical research awareness strategiesExpand your professional network by connecting with peers who can provide a wide range of insightsLearn directly from patient advocates who bring a broad spectrum of ideas to the conversations Learn more about the conference here.

In this podcast, you will hear a panel discussion moderated by Dr Annette Schmid, Takeda Pharmaceuticals from the 2020 IO360° Summit regarding innovations and novel approaches in IO imaging and assessing responses. Panelists inclue: Gregory Goldmacher, MD, PhD, MBA, MerckS. Peter Eggleton, MD, FFPM, Merck KGaARon Korn, MD, PhD, Imaging EndpointsMatthew Silva, PhD, Invicro To learn more about the upcoming 2021 IO360° Summit please visit www.io360summit.com

Loss of the HLA locus impairs presentation of tumor antigens and is frequently found in advanced cancers. This talk presented by Dr Lee Albacker, Foundation Medicine and first recorded at the 2020 IO360° Summit, will describe the landscape of HLA loss and other response biomarkers in a dataset of 90,000 solid tumor samples and highlight the effect of HLA loss on checkpoint inhibitor response.  To learn more about the upcoming IO360° 2021 Summit please visit www.io360summit.com

In this podcast first recorded at the 2020 IO360° Summit, Dr Aiman Shalabi, GSK, moderated a cell and gene therapy debate on intrinsic editing vs systemic combination  Participants included: Mark O’Hara, MD, University of PennsylvaniaSaul Priceman, PhD, City of Hope To learn more about the upcoming IO360° 2021 Summit please visit www.io360summit.com

In this podcast, first recorded at the IO360° 2020 Summit, Dr Millie Schultz, Seattle Genetics, discusses operational dynamics of implementing and managing basket trials. Discussion points include: What are the operational complexities of basket trials? How do they differ from standard IO trials?How do you identify the right institutions who can handle basket trials? What goes into that decision making?How do you set up your protocol in an open ended way so that you can add a cohort or make adjustments based on signals you received?How do you set up your database to be able to manage all the different tumor types and different types of case port forms. To learn more about the upcoming IO360° 2021 Summit please visit www.io360summit.com

How two companies collaborated on a master trial to drastically improve site startup speed, reduce delays and optimize CRA productivity.    In this podcast, Rick Arlow, Complion, and Dr Len Rosenberg, Leukemia and Lymphoma Society, discuss their collaboration on a LLS master trial, and how adopting Complion’s a purpose-built design optimized site functions and reduces startup time.   Some specific discussion points included: The challenges sites face today with arduous manual tasksHow to pick the right point solution technology for your studyWhat the impacts of their collaboration have been on study progressHow this all benefits patients   For more information about optimizing clinical research for the patient benefit and for improving care, visit the Clinical Research as a Care Option webpage. The 2021 Clinical Research as a Care Option event will be held April 26-28, virtually.   

In this podcast, first recorded at the 2021 IO360° Summit, Dr Peter Marks, Center for Biologics Evaluation and Research (CBER), FDA, moderated a panel on the evolution of regulatory policy for cell/gene therapy. Discussion points include: What are the greatest challenges to the expeditious development of cell and gene therapies at this time?How does the existing regulatory framework mesh with the current state of development of cell and gene therapy products?What adaptations or adjustments to the regulatory framework that might further advance manufacturing or clinical development of these products?Are there scientific developments coming that will require further adaptation or adjustment to the regulatory framework? Panelists include: Jeff Allen, PhD, Friends of Cancer Research Anne Chew, PhD, University of Pennsylvania Alberto Santagostino, Lonza Pharma & Biotech To learn more about the upcoming 2021 IO360° conference, please visit www.io360summit.com

In this podcast first recorded at the 2020 IO360° Summit, Michael Paglia, ElevateBio, moderated a cell & gene therapy debate on centralized vs decentralized manufacturing. Participants included: Boro Dropulić, PhD, Lentigen Patrick Hanley, PhD, Children’s National Medical Center/George Washington University To learn more about the upcoming 2021 IO360° Summit, please visit www.io360summit.com

In this podcast, you will hear a panel discussion moderated by Dr Priti Hegde, Foundation Medicine, from the 2020 IO360° Summit regarding next generation bispecifics in solid tumors. Discussion questions include: What is happening in hematology bispecific programs compared to solid tumor bispecific programs?What do bispecifics look like in solid tumors and what is driving efficacy?What’s hindering efficacy in solid tumors compared to hematology?How can we improve on it?What should we be doing on the next generation bispecifics? Panelists: Julie Bailis, PhD, Amgen Dimitris Skokos, PhD, Regeneron Pharmaceuticals David Schaer, PhD, Pfizer Pablo Umaña, PhD, Roche To learn more about the 2021 IO360° Summit, please visit www.io360summit.com

In this podcast, you will hear a fireside discussion from the 2020 IO360° Summit featuring cancer survivor and advocate, Ariella Chivil who walked the audience through her immunotherapy trial pathway alongside patient advocate, Cindy Geoghegan, who moderated the chat.  To learn more about the 2021 IO360° Summit, please visit www.IO360Summit.com

In this podcast first recorded at the 2020 IO360° Summit, Asthika Goonewardene, SunTrust Robinson Humphrey, moderated a cancer immunotherapy debate on insitu vaccinations vs systemic neo-epitope vaccinations. Participants included: Charles Drake, MD, PhD, Columbia University Medical Center Karin Jooss, PhD, Gritstone Oncology To learn more about the upcoming 2021 IO360° Summit, please visit www.io360summit.com

The frenzy of deals around IO programs and companies has led to what could be referred to as “BD outpacing science.” That might be said too of the combination trials that have displayed varied results, with a few showing clear benefit, some being outright failures and some promising but not definitive signs of efficacy. These results, while not exactly slowing the IO gold rush, have somewhat tempered enthusiasm and perhaps led to a certain maturing in dealmaking, as seen by the shifting to more back loaded terms. Which is all by way of framing the context of the macroenvironment, which now begs the question of where will the next big shift come from in immunotherapy. This podcast, recorded at the 2020 IO360° Summit, will tie together discussion on scientific, translational and business development considerations into the latest thinking on strategizing development in IO that will impact collaborations and investment decision making. Discussion points: Will it be innovative cell therapies, vaccines against

In this PharmaTalk episode, get guidance from patient innovation and technology experts about the proper ways of harnessing technology in order to deploy Decentralized Clinical Trials and improve patient care. Specifically, in this episode Rosamund Round and Julia Lakeland, both of Parexel, discuss: How sensors can be utilizedThe patient impact of COVID-19 and clinical trialsEfforts to support patient safety and trial continuityProtocol around assessments for data collection with sensors   Interview Guests: Julia Lakeland, Solutions Architect and Program Director at Parexel, is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in product management, operational delivery and support of phase III/IV clinical trials.  Rosamund Round, VP, Patient Innovation Center, spends her time devoted to simplifying the patient journey in clinical trials. Focused on the reduction of geographical, financial and practical barriers to st

In this PharmaTalk episode, learn what can be done to enhance site audit readiness and monitoring.    Rick Arlow, CEO of Complion, recently spoke with DPHARM quarterly newsletter writer, Danny McCarthy, to discuss: Why he believes that the traditional model for site monitoring doesn't serve the industry anymoreHow a purpose-built approach could free up valuable CRA time and reduce costly delays and amendmentsWhat these new processes could mean for research moving forward, answering the question, "How do we make site monitoring better, not just digital?"  About Rick Arlow: Rick Arlow is the CEO and founder of Complion, an eRegulatory and Document Management provider. Mr Arlow began his career in clinical research while participating in a NIH-funded MD/PhD medical scientist training program, and was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Drawing on his engineering background, and inspired by hi

In this podcast, conference producer, Andrew Goldstein, provides a brief overview of what to expect at the 8th annual Chief Medical Officer Summit 360º. The 2020 program will attract the largest gathering of physicians in biotech on October 26-27, 2020. Although the program is primarily designed for CMOs of emerging biotech companies, large pharma CMOs and other R&D decision-makers also attend to exchange best practices in drug development and business management. Learn more about the 2020 Summit here.

In this PharmaTalk podcast, Benjamine Liu, DPhil, CEO of TrialSpark, discusses the impacts of COVID-19 on the future of clinical research and the innovation being created as a result. Ben recently spoke at DPHARM: Disruptive Innovations to Advance Clinical Trials, moderating an R&D leadership fireside chat with Drs Mark Fishman and Michel Mina. In this podcast, he recently spoke with DPHARM writer Danny McCarthy about: Embracing powerful technology into trials, particularly for the benefit of at-home monitoringDiversity in clinical researchThe growing and potential impact of artificial intelligence on clinical research Ben will be demonstrating the value of OpenAI's GPT-3 natural language processing model and artificial intelligence at an upcoming webinar, October 22 at 1pm EST. For more information and to register to attend, go to theconferenceforum.org.    Guest: Benjamine Liu, DPhil, is the co-founder and CEO of TrialSpark, a technology company that is reimagining drug development. TrialSpark partn

In this PharmaTalk episode, John Potthoff, PhD, CEO of Elligo Health Research explains the benefits of decentralized clinical trials.  He recently spoke with CRAACO quarterly news writer, Danny McCarthy to discuss why he believes that decentralized clinical trials can be more patient-friendly, how it epitomizes clinical research as a care option and how the model helps to access patients who have no other way of participating in trials. Dr Potthoff will be speaking at the CRAACO: Clinical Research as a Care Option conference on November 4-6th virtually.  About John Potthoff, PhD: John Potthoff, PhD, is the CEO and co-founder of Elligo Health Research, which aims to accelerate the development of new pharmaceutical, biotechnology, medical device, and diagnostic products using their novel clinical technology.