PharmaTalkRadio

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 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

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,