PharmaTalkRadio

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.

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 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.

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.

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 deeper detail on this subject at the 2020 DPHARM: Disruptive Innovations conference.

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.

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 conference. 

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.

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 Cancer SurvivorEdward Tenthoff, Piper Sandler & Co.

2020 Strategic Leadership:

Dan Chen, MD, PhD, IGM BiosciencesAxel Hoos, MD, PhD, GSKAlexandra Snyder, MD, Merck Research LabsOmid Hamid, MD, The Angeles Clinic and Research InstituteRaluca Verona, PhD, Janssen R&DJames Gulley, MD, PhD, National Cancer Institute, NIHTheresa LaVallee, PhD, Parker Institute for Cancer ImmunotherapyRoy Baynes, MD, PhD, Merck Research LabsMichael Kalos, PhD, ArsenalBio

Learn more about the upcoming IO Combinations 360° virtual conference at www.iocombinations360.com

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 hybrid trials becoming the new normal for the near future. 

Host:

Kelly McKee is the Senior Director of Patient Recruitment and Registries at Medidata

Guests: 

Anne Marie Mercurio is a patient and research advocate and caregiver. Rosamund Round is Vice President of PAREXEL’s Patient Innovation Center. Jeff Kingsley, DO, is the founder and CEO of IACT Health. 

For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at Medidata for their support in presenting this podcast.

Valerie Bowling, Executive Director at the Conference Forum gives a 5 minute overview on what you can expect at the 10th annual PODD taking place October 8-9 virtually. PODD is celebrating its tenth year and we are committed to making this virtual experience the best it can possibly be. We are equally committed to providing outstanding networking, interactivity and partnering opportunities to meet and exchange ideas through a first-rate virtual platform. Partnering will be open before during and after PODD. Enjoy the podcast and get a quick run down on PODD 2020!

Learn more about the upcoming PODD virtual conference at www.poddconference.com

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 of the Roche Pharma Partnering leadership team since May 2019. In her role she is working closely with the two research and early development organizations at Genentech and Roche (gRED and pRED) to identify transformative science developed by biotechs around the globe and help set up partnerships with such biotechs to enable novel discovery programs with the goal to increase the number of medicines impacting patients’ lives.

Prior to Roche, Barbara worked at Novartis for ten years both on formulation development of poorly soluble molecules as well as on evaluations of reformulation opportunities as potential line extensions based on external drug delivery technologies. She is trained as a pharmacist with a PhD from the University of Basel.