PharmaTalkRadio

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Centralized vs Decentralized Manufacturing Nov 03, 2020

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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 Nov 02, 2020

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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 Chivil's Immunotherapy Trial Pathway Nov 02, 2020

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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 Oct 30, 2020

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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? Oct 30, 2020

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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 neoantigens, or the next wave of oncolytic viruses?Will it be known targets with better approaches to modulating them like TGF-beta, A2AR/CD73, even CTLA-4?Will it be novel targets and pathways targeting transcription or hitting new TNF superfamily members, or new approaches to modulate the TME “bad actors” like MDSCs, CAFs, TAMs, TANs and Tregs? Moderated by: Jeffrey Bockman, PhD, Cello Health BioConsulting Panelists: Jennifer Buell, PhD, Agenus Bio Charles Drake, MD, PhD, Columbia University Medical Center Asthika Goonewardene, MBA, SunTrust Robinson Humphrey Michael King Jr, Fortress Biotech Emmett Schmidt, MD, PhD, Merck Research Labs To learn more about the upcoming 2021 IO360° Summit, please visit www.io360summit.com

Using Sensor Technology to Deploy Decentralized Trials and Improve Patient Care Oct 29, 2020

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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 study participation, Rosamund is excited by the industry shift towards a truly patient centric approach. Ms Round will be speaking at the upcoming Patient as Partners Europe conference,

Current Issues and Potential Solutions for Site Audit Readiness and Monitoring Oct 26, 2020

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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 his work in clinical research, Rick Arlow built the first version of the Complion software platform. Mr Arlow spoke at the DPHARM: Disruptive Innovations in Clinical Trials conference on September 22-23rd, virtually, about bridging sites and sponsors with innovations in site regulatory.

5 Minute Overview of 8th Annual CMO Summit 360º Oct 19, 2020

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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 Oct 07, 2020

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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 partners with doctors to create FDA compliant trial sites within their existing practices (like Airbnb), unlocking the 99% of patients and doctors not involved in trials today and democratizing access to research treatments. TrialSpark runs trials out of these sites using a roaming cohort of research coordinators (like Instacart), optimized by software, data, and machine-learning.

Connecting Care and Research for the Patient with a Decentralized Trial Model Sep 30, 2020

Show notes

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.

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