Importance of Early Integrated Evidence Strategy for Cell & Gene Therapies

The healthcare ecosystem is a complex network of stakeholders that requires a focused engagement strategy to navigate the evolving landscape. Traditional clinical development is primarily focused on meeting evidentiary needs for regulatory authorities and does not necessarily meet the needs of the broader network of diverse stakeholders, each with their own engagement preferences and evidence needs. An integrated, cross-functional evidence strategy can ensure that the right processes, tools, culture, governance and training are available to support evidence generation and evidence dissemination activities. Many organizations already work in a cross-functional manner to address their evidentiary needs; however, the critical next step is truly integrated thinking around value creation as well as a refined strategy to generate and disseminate the right evidence to the right stakeholders at the right time.

Integrated Evidence Strategy represents the next generation of clinical development and could be particularly important for companies developing cell and gene therapies (CGT), for whom the complexities of CGT have introduced new uncertainties among stakeholders across the healthcare ecosystem. For example, as a result of the high upfront costs of CGT, payers are beginning to introduce Outcomes-Based Contracts, which stipulate that the amount a health plan pays for a therapy depends on how effective the therapy is at treating the condition. An Integrated Evidence Strategy can address these evolving payer dynamics to ensure a successful product launch and lifecycle while also protecting companies from risk by proactively anticipating and meeting critical evidentiary needs in a timely manner.

Register for this webinar and find out through case studies and panel discussion, the value of defining an Integrated Evidence Strategy early on in cell and gene therapy development.

Speakers

Colin Oliver, Managing Director, Consulting, Syneos Health

Colin Oliver is a leader in the medical affairs organization at Syneos Health with over 10 years of biopharmaceutical experience at small, medium and large companies working across multiple therapeutic areas from the field as a MSL to building and leading a global medical affairs organization.

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Jessica B. Lee, Senior Managing Director, Commercial Advisory Group, Head of Oncology, Cell and Gene Therapy Consulting, Syneos Health

Jessica Lee leads Syneos Health Consulting’s Oncology, Cell and Gene Therapy Center of Excellence. She has over 10+ years of experience supporting clients across a range of product types to commercialize innovative therapeutics. Her expertise includes launch strategy and planning, market opportunity assessments, therapeutic area growth strategies, indication and disease assessments, customer facing model design and effectiveness, and clinical development strategies.

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Susan Board, MD, Executive Director, Medical Sciences, Oncology and Cell Therapy, Kite, a Gilead Company

Susan Board, MD has over two decades of clinical practice and Medical Affairs hematology-oncology leadership experience. Susan has been involved in setting strategy for US Medical Affairs teams and leading field medical organizations since 2006.  She’s been a key member of the Medical Affairs organization of Kite, a Gilead company, since 2016, where she and her team, working cross-functionally, have been instrumental in the success of five launches of two CAR T products and in educating the healthcare community about CAR T.

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Matthew Magestro, Senior Market Access Lead, Syneos Health Consulting

Matthew Magestro has over two decades of payer, pharmaceutical and consulting experience in value & access as well as extensive product launch experience in the US and major ex-US markets. He was most recently Group Vice President, Value & Access for Kiniksa Pharmaceuticals with prior roles as Head of Global Market Access & Pricing – Neurology and Immunology at Merck KgAa and Global Head Rare Disease Market Access, Pricing & HEOR at Novartis Oncology. He is currently a Senior Market Access Lead for Syneos Health Consulting.

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Frank Zhang, Vice President, Commercial, Sales and Marketing, Uniqure

Frank Zhang is currently Head of Commercial for uniQure, the developer of HEMGENIX, the first gene therapy in Hemophilia B, which was approved by FDA in last Nov. Prior to this position, he was with Alnylam from 2017-2019 as VP, Global and US Market Access, and launched the first RNAi product Onpattro. He was with Celgene from 2010-2017 as Head of Market Access for Immunology and Inflammation Franchise, and launched Otezla successfully in over 25 countries. He led HEOR, pricing and market access for Virology franchise for J&J from 2005-2010, and was with Eli Lilly and GSK in his earlier career. Frank was a physician by training and had a Master of Public Health from Yale.

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