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This session was recorded at DPHARM 2022. As the life sciences industry’s focus on digital transformation advances at a rapid pace, the opportunity to understand how well your organization stacks up to the rest of the industry around digital maturity in clinical operations can be highly valuable. This session examines a new benchmarking effort to help pharmaceutical companies rank their digital capabilities in clinical operations, codify specific terms that are used readily and leverage insights to drive strategic priorities. Specifically, this session will: Discuss the study purpose, methodology and areas being ranked for digital readinessExamine the value for companies participatingConsider how the study with greater industry participation could evolve into an innovation index and generate industry digital maturity metrics Moderated by: Craig Lipset, MBA, Founder, Clinical Innovation Partners Speakers: Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BM

This is a session recorded from DPHARM 2022. As the competition to recruit patients for clinical trials increases and sites are burdened by staffing shortages, technology shifts and more, how can innovative trial designs reduce patient, site and investigator burden? Designing for patient centricity – reducing the burden for patients, sites and investigatorsAddressing organizational implementation challengesEngaging in collaborative partnerships and innovation to operationalize and deliver innovative trials designs Speakers: Victoria L. Chiou, MD, Head of Clinical Excellence and Innovation, AstraZenecaSheryl Jacobs, VP, Global Development Operations, AmgenCamilla Richmond, MD, MA, Medical Director, Translational Medicine, TakedaDaniel Millar, MBA, Senior Director, Strategic Business Transformation, Janssen Research & Development, LLC

In this session recorded at DPHARM 2022, moderated by Pfizer's Amy Cramer, the panelists discuss patient data. Often the elephant in the room that hinders the advancement of innovation in clinical trials for the benefit of patients in the lack of structured, clean patient data. R&D executives know the ability to garner greater data value from all data sources [clinical trials, EHRs, claims data, etc] is critical to supporting the future of drug development. The continued conundrum is that data is too often unstructured, incompatible, incomplete and unreliable and leads to an output of a research-intensive, operational bottlenecks. We have a unique group of panelists who will prioritize the critical issues first, provide potential solutions and address what to do about pending issues to be resolved. Speakers: Amy Cramer, Global Product Development Strategic Partnerships, PfizerXiaoying Wu, MD, MS, VP, Data Science Data Platform & Privacy, The Janssen Pharmaceutical Companies of Johnson & Johnson

In this session recorded at DPHARM 2022, Pfizer's Judy Sewards is joined by Patient Advocate Barry Nelson. Judy Sewards was one of the top 30 leaders who played a critical role in the success of Pfizer’s Covid-19 vaccine clinical trial program. In her role, she led patient and site communications and engagement. She was responsible for Pfizer’s relationships with the over 150 trial sites who conducted the Covid-19 vaccine clinical trials. She also helped create awareness about the clinical trials and worked with community, and government partners to elevate the importance of participation in the trial by diverse communities and organized services to make clinical trial participation more convenient and sustainable for patients. In this fireside keynote chat, Judy will discuss leadership lessons needed to drive innovation and specifically, how to better support patients and sites. Speakers: Judy Sewards, VP, Head of Clinical Trial Experience, PfizerBarry Nelson, Patient Advocate

About The Episode When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data? Join Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel, to discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision. About the Speakers:  Sangeeta Budhia is VP and Global Head, Pricing and Market Access, a

In this podcast, you will hear a presentation from Dr Liping Zhou, AstraZeneca, from the 2022 PODD Conference regarding formulation techniques and developability considerations for LAI peptide delivery, with a case study example. To learn more about the PODD Conference, please visit PODDConference.com.  

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 platforms, possibilities for scalingLessons learned moving forward Speakers: Jessica Perry, Director, Patient Centricity, Clinical Innovation, ModernaJosh Rose, VP, Head of Decentralized Trials, Site Solutions and Strategy, CVS Health

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 Director, Head of Clinical Outcomes Assessment & Patient Innovation, RegeneronBill Illis, Global Head, Collaboration and Technology Strategy, Clinical Development & Analytics, Novartis 

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.  

Learn more about the IO360° Summit at www.io360summit.com

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, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy Panelists: Jared Lunceford, PhD, Distinguished Scientist, Biostatistics and Research Decision Sciences, Merck Research LaboratoriesAngel A Rodriguez, MD, Oncology Medical Director, NateraSamik Upadhaya, PhD, Research Analyst, Anna-Maria Kellen Clinical Accelerator and Venture Fund, Cancer Research Institute (CRI) Learn more about the IO360° Summit at www.io360summit.com

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.    

Dan Chen, MD, PhD, Founder, Engenuity Life Sciences Learn more about the IO360° Summit at www.io360summit.com

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 Advocate and Founder, Karen’s ClubMichel Reid, Sr. Director and Head, Global Demographics & Diversity, Global Clinical, Delivery, Global Clinical Operations, R&D, GSK Learn more about the IO360° Summit at www.io360summit.com

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 applications, manufacturing and scalability challenges, likely conversations around reimbursement from payers. About the Speaker:  Zach Fletcher, Business Development Manager - Implantable Drug Delivery & Combo Products at Trelleborg Healthcare & Medical Zach Fletcher is the Business Development Manager - Implantable Drug Delivery & Combo Products at Trelleborg Healthcare & Medical. In this role, he identifies, establishes and develops relationships with device organizations and pharmaceutical companies to

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

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 national registry of NF patients. He will share lessons learned and offer insights on how best to engage carers to impact clinical research. Claas Röhl, Chairman, NF Kinder, EUPATI Austria, NF PatientsUnited  with: Renata Lazarova, MD, VP Development, Pediatric Programs, Noema Pharma Learn more about the Patients as Partners EU conference at www.patientsaspartners.org

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

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 Manufacturing ParadigmsDr Axel Hoos, Scorpion Therapeutics on Transformational Medicines & The Next Wave of IODr Andrew Baum, Citi on What’s Next on the IO Radar? Top 10 RecommendationsDr Arjun Goyal, Vida Ventures on Investor Perspective on the State of the Current Market and Impact on the IO Cell Therapy FieldOswald Peterson, Stage IV Lung Cancer Survivor who will share his extraordinary story from diagnosis through to immunotherapy treatments that saved his life Plenary Topics: Biomarkers / Assay DevelopmentDisc

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 on utilizing mobile/digital technologies in clinical trialsHow pharma is addressing access and equity from a digital perspectiveEducating, communicating and supporting patients through the use of digital/mobile technologies, reducing anxiety and building trustHow do we think about trial design to accommodate patients using digital/mobile technologiesHow are we addressing and tackling WiFI/Bandwidth connectivity challenges that are required with these technologies such as patient access? Speakers: Adama Ibrahim, VP, Di