Pharmatalkradio

Informações:

Sinopse

Guest hosts interview industry insiders on strategies, business models, leadership, technologies & innovations in advancing drug development for the benefit of patients. More specifically: clinical trials, patient-centricity, mobile/digital in R&D, drug delivery, emerging biotechs and Immuno-Oncology. PharmaTalkRadio is a non-profit program to provide easy and free access of helpful information for professionals in life sciences as well as patient advocates. It is organized and supported by the Conference Forum.

Episódios

  • The Practical Implementation of Sensors in the Changing Drug Development World

    The Practical Implementation of Sensors in the Changing Drug Development World

    22/01/2021 Duração: 23min

    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 2021 Overview in 5 Minutes

    Patients as Partners Europe 2021 Overview in 5 Minutes

    11/01/2021 Duração: 06min

    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.

  • Innovations  Novel Approaches in IO Imaging  Assessing Responses

    Innovations & Novel Approaches in IO Imaging & Assessing Responses

    27/12/2020 Duração: 32min

    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

  • HLA Loss and the Impact on Immunotherapy

    HLA Loss and the Impact on Immunotherapy

    27/12/2020 Duração: 21min

    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

  • Cell  Gene Therapy Debate: Intrinsic Editing vs Systemic Combination

    Cell & Gene Therapy Debate: Intrinsic Editing vs Systemic Combination

    27/12/2020 Duração: 22min

    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

  • Operational Dynamics of Implementing  Managing Basket Trials

    Operational Dynamics of Implementing & Managing Basket Trials

    27/12/2020 Duração: 18min

    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

  • Overcoming Site Regulatory Issues to Optimize Clinical Quality

    Overcoming Site Regulatory Issues to Optimize Clinical Quality

    11/12/2020 Duração: 31min

    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.   

  • Evolution of Regulatory Policy For Cell/Gene Therapy

    Evolution of Regulatory Policy For Cell/Gene Therapy

    03/11/2020 Duração: 45min

    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

  • Centralized vs Decentralized Manufacturing

    Centralized vs Decentralized Manufacturing

    03/11/2020 Duração: 28min

    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

  • Next Generation Bispecifics in Solid Tumors

    Next Generation Bispecifics in Solid Tumors

    02/11/2020 Duração: 33min

    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

  • Ariella Chivils Immunotherapy Trial Pathway

    Ariella Chivil's Immunotherapy Trial Pathway

    02/11/2020 Duração: 28min

    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

  • Insitu Vaccinations vs Systemic Neo-Epitope Vaccinations

    Insitu Vaccinations vs Systemic Neo-Epitope Vaccinations

    30/10/2020 Duração: 30min

    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

  • What Do Next Generation of Immunotherapies Need to Look Like to Move the Needle?

    What Do Next Generation of Immunotherapies Need to Look Like to Move the Needle?

    30/10/2020 Duração: 52min

    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

  • Using Sensor Technology to Deploy Decentralized Trials and Improve Patient Care

    Using Sensor Technology to Deploy Decentralized Trials and Improve Patient Care

    29/10/2020 Duração: 23min

    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

  • Current Issues and Potential Solutions for Site Audit Readiness and Monitoring

    Current Issues and Potential Solutions for Site Audit Readiness and Monitoring

    26/10/2020 Duração: 25min

    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

  • 5 Minute Overview of 8th Annual CMO Summit 360º

    5 Minute Overview of 8th Annual CMO Summit 360º

    19/10/2020 Duração: 06min

    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.

  • The Future of Clinical Research and the Innovation from the COVID-19 Pandemic

    The Future of Clinical Research and the Innovation from the COVID-19 Pandemic

    07/10/2020 Duração: 20min

    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

  • Connecting Care and Research for the Patient with a Decentralized Trial Model

    Connecting Care and Research for the Patient with a Decentralized Trial Model

    30/09/2020 Duração: 26min

    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. 

  • Remote Monitoring for Clinical Research in the Digital Age

    Remote Monitoring for Clinical Research in the Digital Age

    18/09/2020 Duração: 25min

    In this PharmaTalk podcast, MaryAnne Rizk, PhD, of IQVIA leads a multi-perspective panel discussion on monitoring in the digital age as data becomes the new currency. Together they discuss the how AI and ML are empowering sponsors and sites to predict risk before it happens, how modernization is expanding remote monitoring capabilities and the waterfall impact of that on analytical roles, and how this technology can be leveraged to benefit patient engagement and data standards.    Moderator: MaryAnne Rizk, Ph.D. - SVP Digital R&D, IQVIA Guests: Michael Mittleman – Patient Advocate Ray Reilly – VP, Clinical Operations, TG TherapeuticsRajneesh Patil – Head, Process, Technology & Analytics, IQVIA For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at IQVIA for their support in presenting this podcast. 

  • Solving for the Patient Retention Problem in Clinical Research

    Solving for the Patient Retention Problem in Clinical Research

    09/09/2020 Duração: 20min

    In this podcast, PharmaTalk's Danny McCarthy sits down with Thomas Klein, founder and CEO of Be the Partner, to discuss increasing patient retention throughout the entire clinical trial process. Some potential solutions include transparency of data, increasing communication before, during and after trials, and truly making patients "partners" in the research.  Guest: Thomas Klein is the CEO and founder of Be the Partner, a technology company that is focused on how patients can use their health data to improve outcomes for themselves and others around the world. For more information go to or contact www.bethepartner.com. 

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