In this session recorded at DPHARM 2022, Moderna discusses its recent partnership with CVS Health to bring its clinical trial closer to patients and expand patient access into more communities. Review the complexities of forming a new partnership and developing a model for implementation and executionExamine the model in terms of investigator strategy, shipping and logistics approach and overall quality & monitoringOperationalizing each part of the model – key considerations, digital platfor...
Dec 20, 2022•15 min
In this session recorded at DPHARM 2022, Bari Kowal, SVP & Head, Development Operations and Portfolio Management, Regeneron, moderates a panel discussion on: Examining how modernizations like the implementation of AI/ML, RWE, DE&I, DCTs impact the need for more flexibility clinical trial designBuilding protocols in tandem with study design and re-envisioning methods to execute trials Panelists include: Henry Wei, MD, Head of Development Innovation, RegeneronRinol Alaj, MBA, Senior Direct...
Dec 19, 2022•28 min
In this podcast, you will hear a keynote presentation from Dr Peter Cullis, UBC, from the 2021 PODD Conference regarding the path of discovery and innovation that led to the lipid nanoparticle delivery system driving one of the most successful vaccines against COVID-19. To learn more about the PODD Conference, please visit PODDConference.com.
Dec 19, 2022•35 min
Learn more about the IO360° Summit at www.io360summit.com
Dec 14, 2022•19 min
Evaluating single cell omics to understand the heterogeneity in immune and tumor cellsMulti-omic biomarkers for patient selection in solid tumor IO: is there a path to more personalized therapy?In an era of ‘targeted’ therapies against cell-intrinsic mechanisms (e.g. PARP, NTRK, BRAF) and surface molecules (Nectin-4, HER2), is there a path forward for pan-tumor biomarkers, or is multi-tumor more likely to be the dominant development mechanism? Moderated by: Theresa LaVallee, PhD, VP, Translation...
Dec 12, 2022•42 min
In this podcast, you will hear a presentation from Dr Barbara Lueckel, Roche Pharma Partnering, from the 2021 PODD Conference summarizing trends, approvals and pipelines within the drug delivery space. To learn more about the PODD Conference, please visit PODDConference.com.
Dec 12, 2022•21 min
Dan Chen, MD, PhD, Founder, Engenuity Life Sciences Learn more about the IO360° Summit at www.io360summit.com
Dec 08, 2022•21 min
This panel, first recorded at the 2022 IO360° Summit, reported on advances in achieving more diversity and inclusion in oncology clinical trials. Moderated by: Adrelia Allen, PharmD, Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Labs Panelists: Chétna Rao, PhD, Head of Site Strategy and Operations, BMSRobert Vonderheide, MD, DPhil, Director, Abramson Cancer Center, Perelman School of Medicine, University of PennsylvaniaKaren Peterson, Patient Advoca...
Dec 07, 2022•51 min
About The Episode With pharma’s focus on the extension of drug release windows, new technologies are needed that can lengthen that duration. Today, Zach Fletcher of Trelleborg Healthcare & Medical provides an insight into how the emerging field of long-acting implantables & polymeric drug delivery can address that need. He will be addressing: current applications of implantables and likely future applications, top concerns from pharma and assessing your portfolio for lifecycle applicatio...
Dec 07, 2022•20 min
CAR T cells for solid tumors: Lessons learned from on-going clinical trials in glioblastoma.Interplay between CAR T cells and the endogenous immune systemNext-generation CAR designs to overcome barriers for solid tumor CAR therapy Christine Brown, PhD, Deputy Director, T Cell Therapeutics Research Laboratory, Beckman Research Institute, City of Hope Learn more about the IO360° Summit at www.io360summit.com
Dec 06, 2022•12 min
When Claas Röhl’s 12-year old daughter was an infant, she was diagnosed with Neurofibromatosis Type 1 (NF), a rare genetic disorder that causes tumors to form along nerves. With no prior background in research, Claas founded NF Kinder and became an advocate for his daughter and patients impacted by this rare disorder. Claas will discuss his involvement in research, how he helped set up the first pediatric department for NF at a major medical University in Austria, and his efforts to create a nat...
Dec 06, 2022•20 min
Where have we come over the past 5 yearsWhat are the approvals and approval activity over the past year?What are the challenges and issues?What have we learned?What are the real important technologies that are being developed that might help transform the cell and gene therapy spaceWhat are the key things we need to think about moving forward? Michael Kalos, PhD, Managing Director, Next Pillar Consulting Learn more about the IO360° Summit at www.io360summit.com
Dec 05, 2022•20 min
Kate Woda, IO360° Conference Director, gives a 6 minute overview on what you can expect at the 9th annual IO360° Summit taking place February 7-10 in Brooklyn, NY. Keynotes Include: Dr Carolyn Bertozzi, Stanford University on Bioorthogonal and Click Chemistries Impact on Advancing Cancer ImmunotherapyDr Marcela Maus, Massachusetts General Hospital on Mechanisms Driving CAR T CellsDr Isabelle Rivière, Memorial Sloan Kettering Cancer Center on Cell Therapy Manufacturing Progress Report and Novel M...
Dec 05, 2022•6 min
There are many reasons why patients don’t trust or feel comfortable using a digital/mobile device. Implementing mobile technologies in clinical trials can sometimes create barriers to participation amongst patients who struggle to access them, are digitally challenged and/or do not have the bandwidth to support the utilization. This session addresses the digital divide, the challenges of accessing and using mobile technologies and solutions to reduce these barriers. Patient and site perspectives...
Dec 02, 2022•48 min
Moderna shares how they created and implemented their digital-first organizational infrastructure that has transformed the way clinical research is getting done. They will discuss their approach to agility, delivering value early and often. They will also specifically discuss the example of their COVID-19 vaccine trial. Key topics include: About Moderna’s Digital-first infrastructure that allows for rapid adoptionHow they built the infrastructure to support one of the biggest infectious disease ...
Dec 01, 2022•21 min
Mark Schiebler, PhD, Global Search and Evaluation Lead for Research Technologies, Roche
Nov 30, 2022•22 min
AbbVie’s Head of Digital Science, Michelle Crouthamel, joins Mobile Technologies in Clinical Trials to discuss how AbbVie has implemented digital health technologies to digitize measurements that can improve existing endpoints, uncover new endpoints and reduce the burden on patients by eliminating the need to travel to sleep labs. Key topics include: Early patient engagement to identify what is meaningful to themHow mobile technologies were implemented into a clinical study and the impactNavigat...
Nov 30, 2022•22 min
Speakers: Sandeep Bhat, Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSKDan Karlin, MD, CMO, MindMed
Nov 29, 2022•22 min
Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial participants. Following the discussion, the FDA representatives hold open Q&A. Topics include: Guidance updatesThe requirements to test all of these digital health technologiesEfforts the agency is putting in place to harmonize the requiremen...
Nov 28, 2022•42 min
For many years, Pfizer has been a leader in the writing of plain language summaries. Now they’re partnering with diverse patient advocates to develop guidance on how to co-author scientific publications that are relevant to patients and written in language they can understand. Hear how Pfizer is working with patient advocates to co-develop this internal process and what the impact has been so far in involving patients in this new way. Angela Sykes, Director, Team Leader, Publications Management ...
Nov 28, 2022•18 min
Compliance with rules and regulations in patient engagement while necessary can also be an impediment to meaningful collaboration. We’ll hear from companies that have taken steps to work through compliance challenges internally and the efforts by associations such as ABPI to enable more collaboration. More specifically: Where do the problems still exist in contracting with patient organizations?What are solutions we can match to some of the problems?What are some case studies of successful colla...
Nov 21, 2022•27 min
About the Episode In this podcast, you will hear a panel discussion moderated by Dr Sheela Kolluri, Teva Pharmaceuticals, from the 2022 Chief Medical Officer Summit 360° regarding what CMOs need to know about statistics, strategies for clinical development, strengths and weaknesses of complex trial designs and how to maximize the use of your statisticians. Panelists include: Marcia Levenstein, ScD, MBE, VivliNatasha Mühlemann, MD, MBA, CytelJeffrey Bornstein, MD, Eledon Pharmaceuticals To learn ...
Nov 17, 2022•32 min
In this podcast, you will hear a panel discussion moderated by Dr David Chen, Bill & Melinda Gates Medical Research Institute, from the 2022 PODD Conference regarding managing systems standards of new formulations and modalities and developing newer and improved methods of manufacturing complex delivery systems, such as LNPs. Panelists include: Julia Rashba-Step, PhD, PhosphorexMichael Schmidt, PfizerCornell Stamoran, PhD, Catalent Pharma SolutionsSathya Venkataramani, PhD, Amgen To learn mo...
Nov 16, 2022•30 min
In this session, moderator Craig Lipset speaks with Dr Suzanne Steinbaum on: Patient preferences for learning about researchBarriers for physicians in exploring research as an option for their patientsPlaces where health systems can helpBarriers for diversity in research participationOvercoming implicit biases among providersHow COVID exposes the disparities in access to both care and research, as well as the lack of collaborationMaking research participation more accessible for providers and fo...
Nov 16, 2022•38 min
Dr Simeone, the national PI leader on the adaptive platform trial on metastatic pancreatic cancer, Precision Promise, share her vision on embarking upon and building a new clinical-trial ecosystem. Speaker: Diane M Simeone, MD, Perlmutter Professor of Surgery and Pathology, NYU Langone, Director of the Pancreatic Cancer Center, NYU Perlmutter Cancer Center
Nov 15, 2022•29 min
University Hospital’s Chief Strategic Integration and Health Equity Officer, Dr Chris Pernell, participated in the Moderna COVID vaccine trial. Dr Pernell tells us what we can do to improve health equity in care and research. Speakers Sharon Hanlon, Group Director, Clinical Trial Engagement & Enrollment, Bristol-Myers SquibbChris Pernell, MD, MPH, FACPM, Chief Strategic Integration and Health Equity Officer, University Hospital
Nov 14, 2022•30 min
Amgen leadership joins Patients as Partners to discuss their RISE (Representation in Clinical Research) Initiative that is transforming clinical trial diversity at Amgen. Key topics include: The development of RISE, what it took to get off the ground Working with internal global development operations and other key groups by diversifying investigators and collaborating with those who serve diverse patient areas at clinical trial sites Collaborations with non-profits in communities that can help ...
Nov 14, 2022•29 min
Drs Janet Woodcock and Laura Esserman discuss why integrating clinical research and care is so critical and explore how we can get patients more access to clinical trials. Together they address: What is missing for the vision of integrating care and researchReal world dataPlatform trials and adaptive design solutionsHarmonizing data collectionNew models for covering costDeveloping a centralized IRBSimplifying the trial activation processIntegrating data collection with clinical care help from co...
Nov 11, 2022•35 min
Non-profits can influence the community in a way that sponsors and site organizations cannot. In this session, Javara and Greater Gift present a partnership case study and show how they were able to achieve community access as a team. Speakers: Amanda Wright, Co-Founder & Chief Development Officer, JavaraJennifer Byrne, Founder, Greater Gift / CEO, JavaraKushal Gohil, MBA, SVP, Corporate Strategy & Innovation, Parexel
Nov 10, 2022•20 min
In this session, panelists share best practices in raising awareness for clinical trials and improving patient satisfaction by educating patients and non-research physicians on the clinical trial process. Speakers: Lora Black, RN, MPH, OCN, CCRP, Executive Director, Clinical Research, Sanford HealthRobert Loll, SVP, Business Development & Strategic Planning, PraxisIrfan Khan, MD, Founder & CEO, Circuit Clinical
Nov 09, 2022•32 min
