Disruptions in the microbiome are increasingly being linked to an associated risk for serious illnesses, opening up vast potential to create a new category of innovative microbiome-based live biotherapeutics to help people live better lives and advance current standards of care. Today, Dr James Tursi, Chief Scientific Officer of Ferring Pharmaceuticals, discusses study results of Ferring’s Phase III Trial for their microbiome-based live therapeutic (RBX2660), used in the treatment of recurrent C...
Jul 19, 2021•23 min•Season 1Ep. 1
DPHARM Executive Director, Valerie Bowling gives a 10 minute run down on what you can expect from DPHARM 2021. Learn more about the conference taking place Septmeber 28-29, 2021 at DPHARMconference.com.
Jul 12, 2021•10 min
This PharmaTalk Radio episode features Dr Shawn Carbonell, CEO and co-founder of Brazen Bio. In this conversation, Dr Carbonell describes how the Brazen Incubator, a turn-key biotech startup incubator, hopes to help fledgling entrepreneurs, the common hurdles that prevent startups from getting off the ground, and recruiting underrepresented founders. Dr Carbonell started the incubator, based in Los Angeles, with cofounder Dr Brent Witgen. About Dr Carbonell and Brazen: In 2009, Dr Carbonell quit...
Jul 07, 2021•18 min•Season 1Ep. 1
In this conversation between two decentralized clinical trial experts, John Reites, CEO of THREAD, and Andy Iverson, Clinical Outcomes Solutions lead at Medtronic, are discussing decentralized clinical trials: where they don’t work yet and how that might change, the considerations for disease indication and trial type, what technology to use, and what an adoption journey could look like. Key Takeaways: When DCTs don’t work (yet) Technology, operations and knowledge perspectives What a phased app...
Jun 15, 2021•28 min
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, Direc...
Apr 15, 2021•27 min•Season 1Ep. 1
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
Apr 09, 2021•17 min
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 eClinica...
Jan 22, 2021•23 min•Season 1Ep. 1
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 in...
Jan 11, 2021•5 min
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
Dec 27, 2020•31 min
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
Dec 27, 2020•21 min
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
Dec 27, 2020•21 min
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 adju...
Dec 27, 2020•18 min
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 rig...
Dec 11, 2020•31 min•Season 1Ep. 1
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 th...
Nov 03, 2020•44 min
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
Nov 03, 2020•28 min
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...
Nov 02, 2020•32 min
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
Nov 02, 2020•28 min
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
Oct 30, 2020•29 min
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 ...
Oct 30, 2020•52 min
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 Intervi...
Oct 29, 2020•23 min•Season 1Ep. 1
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, "H...
Oct 26, 2020•24 min•Season 1Ep. 1
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 S...
Oct 19, 2020•6 min
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 o...
Oct 07, 2020•20 min
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 Researc...
Sep 30, 2020•25 min•Season 1Ep. 1
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 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. Dr Rizk went into de...
Sep 18, 2020•24 min
In this PharmaTalk episode, Thomas Klein, founder and CEO of Be the Partner, discusses how to implement new retention and engagement methods to stop patients from "vanishing" in the clinical trial process. Mr Klein sat down with PharmaTalk's Danny McCarthy to discuss potential solutions, including transparency of data, increasing communication before, during and after trials, and truly making patients "partners" in the research. Mr Klein presented at the 2020 Patients as Partners virtual confere...
Sep 09, 2020•20 min•Season 1Ep. 1
Kate Woda, IO Combinations 360° Conference Director, gives a 7 minute overview on what you can expect at the 5th annual IO Combinations 360° conference taking place October 1-2 virtually. 2020 Key Topics: Discovery / Preclinical ScienceBispecificsTranslational Science & BiomarkersNext Generation Cell TherapyClinical DevelopmentsOperationalizing CombinationsBusiness AspectsEmerging Technologies Keynotes Include: Ronald Germain, MD, PhD, National Institutes of HealthSteve Hamilton, Melanoma Ca...
Sep 08, 2020•7 min
In this PharmaTalk podcast, Kelly McKee of Medidata leads a multi-perspective panel discussion on the challenges and opportunities of adopting a decentralized model for clinical trials and ensuring clinical trial continuity with live video visits. Together they discuss lessons learned from the rapid adoption of technologies to allow for more decentralized trials, how incorporating multiple perspectives highlights areas of growth when utilizing a decentralized approach, and the possibility of hyb...
Sep 08, 2020•28 min•Season 1Ep. 1
Chair of the Partnership Opportunities in Drug Delivery (PODD) event, Dr Barbara Lueckel, Global Head of Research Technologies Partnering at Roche, presents an annual year-in-review of the drug delivery landscape from 2018. Dr Lueckel’s opening remarks are a highlight of PODD every year, and we’re excited to have her return as program chair for the 2020 event, taking place virtually October 8-9, 2020. About Dr Lueckel: Barbara is the Global Head of Research Technologies Partnering and a member o...
Aug 26, 2020•24 min
This podcast dives into the history of creating a gene therapeutic for Duchenne Muscular Dystrophy. Dr Richard Jude Samulski has been studying gene therapy and the use of the AAV vector for decades. Recently, preliminary results from Pfizer were published on a small gene therapy trial for Duchenne Muscular Dystrophy with promising results, and Pfizer is scheduling a larger trial for later this year. That gene therapy originated from Dr Samulski work and from AskBio, and uses an adeno-associated ...
Aug 25, 2020•28 min•Season 1Ep. 1
