PharmaTalkRadio

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, BMSTim Joy Executive Director, Head of Strategic Solutions, PfizerAman Thukral, Head of Digital Operations and Clinical Systems, AbbVieBrandon Maggio, Director, Digital & Process Optimization, GSK

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 & JohnsonPaul Bleicher, MD, PhD, Executive Partner, Arden EquityLekan Wang, Head, Machine Learning Services, Parexel

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, at Parexel. Her role is to ensure that global strategies including pivotal clinical trials, long-term data collection studies, real world evidence generation plans and HEOR strategies are prepared for the reimbursement challenges that each product will face. 

Wyatt Gotbetter is SVP & WW Head of Access Consulting, leading all facets of Parexel's Access Consulting business with a focus on helping customers position products for market success.  With more than 25 years of industry experience, he brings unique insights to guide Parexel's strategy as we invest in this segment of the business to further our patients-first focus.

Sangeeta and Wyatt can be contacted at [email protected] & [email protected].

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