PharmaTalkRadio

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 p...

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...

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 Riviè...

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...

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...

Mark Schiebler, PhD, Global Search and Evaluation Lead for Research Technologies, Roche

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 me...

Speakers: Sandeep Bhat, Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSKDan Karlin, MD, CMO, MindMed

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...

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...

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? W...

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...

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...

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...

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

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...

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...

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 IR...

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 Strat...

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 &...

In this podcast, you will hear a panel discussion moderated by Dr Cindy Wu, AbbVie, from the 2022 PODD Conference regarding opportunities for long acting injectable biologics, stability, manufacturing processes, storage, release periods, and new delivery technologies including conjugate-based delivery. Panelists include: Brent A Buchine, PhD, Windgap MedicalFrederic Dargelas, PhD, MBA, DelSiTechMa...

In this session, panelists from pharma and healthcare share perspectives on innovations in decentralized clinical trial technologies that have and have not worked during and throughout COVID. They also discuss: How we are bringing forth trial options to people on their own terms and getting patient inputCreating flexible systems that don’t increase undue burden on hospitals and sitesWhat hasn’t wo...

Using specific trials as examples, Dr Chetan Karyekar shares how Janssen Immunology is partnering with academic and community health systems to enhance diversity in clinical trials through recruitment strategies, outreach to local institutions, engaging in market research and building trustworthiness. Speaker: Chetan Karyekar, MD, PhD, VP, Clinical Development — Rare Diseases & Rheumatology, J...

Marc Boutin, JD, Global Head, Patient Engagement, Novartis Moderated by: Sarah Krüg, CEO/Founder, Cancer101/Health Collaboratory Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this session, panelists share challenges and new initiatives to support building the clinical researcher workforce, workforce planning and flexibility. They address: Efforts to train new clinical researchersMaintaining a remote vs in office hybrid work environment to allow for work/home life balance strategies to reduce churn Speakers: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of R...