Dates:
- US (ET): Thursday, November 6, 11:00am – 11:30am
- EMEA (GMT): Thursday, November 13, 10:00am – 10:30am
- APAC (JST): Thursday, November 20, 10:00am – 10:30am
Overview
Join us for a webinar highlighting what factors contribute to asset value and how the choices developers make matter when out-licensing. In today’s market—where long development timelines and cautious investors make fundraising and partnerships more challenging—MIDD provides a de-risked, evidence-based approach to attract funding, build confidence, and strengthen due diligence.
Far beyond its regulatory applications, MIDD helps companies assess market potential, understand competitive positioning, and make more informed investment decisions. In the webinar, Certara’s experts will introduce an overview of MIDD and Modeling and Simulation (M&S), discuss their regulatory significance, and highlight their role in asset value like product assessment, dose justification, and target population selection, all aimed at improving success rates in drug development and in/out-licensing.
What you will learn from the webinar
- MIDD approaches to support Buyer’s assessment
- MIDD as a tool to enhance asset value from Seller’s perspective
- MIDD as a digital twin for virtual evaluation
- How can the approach help both small and large companies
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Senior Vice President, Certara Drug Development Solutions
Dr. Fran Brown is a highly respected professional with proven leadership skills and 28 years of broad experience within pharmaceutical development and due diligence. She has extensive experience with strategic and operational global drug development from early discovery to filing and post-marketing. This experience spans multiple therapeutic areas, small molecules and biologics, global regulatory requirements and registration pathways. She possesses a broad knowledge of product development and portfolio management, with a special focus on development strategy, regulatory interactions and product filings.
Her past appointments include leadership roles within large Pharma as well as in small biotech organizations including head of clinical pharmacology, clinical leader, project development leader, head of clinical operations and due diligence asset assessment. She has over 10 years of experience in providing consulting advice to the pharmaceutical industry and non-profit Global Health Organizations ranging from individual project support, to strategic TA strategy and development planning, portfolio management and corporate transformation. She joined Certara in 2017 and is currently the SVP of Drug Development Science within Integrated Drug Development.
Vice President, Certara Drug Development Solutions
S.Y. Amy Cheung, PhD, is a Vice President at Certara, regional lead (EU and APAC) for Quantitative Science Services within Certara Drug Development Services, and Global Lead of the Pediatric and Maternal Health Center of Excellence/Innovation Engines. Dr. Cheung has more than 20 years of experience in modeling and simulation, as well as clinical pharmacology, with expertise in PBPK/PD mechanistic modelling, special populations (e.g., pediatrics, maternal, and geriatrics), extrapolation, model-based meta-analysis, vaccines, infections, HIV, complex biologics, and different therapeutic areas across early to late-phase drug development. She is currently an honorary professor in the School of Engineering at the University of Warwick, UK. She is leading an EU funding project, ERAMET (grant agreement number 101137141), in work package 5, championing the enhancement and utilisation of extrapolation in the pediatric population and for rare diseases.
Before joining Certara, she was a Senior Pharmacometrician and Scientific and Project Leader at the AZ Pediatric Working Group, which included 22+ cross-functional pediatric experts. During this time, she also served as the company representative on the IMI DDMoRe initiative and co-led work packages (e.g., PMX-workflow, cardiovascular training). Dr. Cheung has been a member of the EFPIA MID3 workgroup since the 2011 EMA M&S workshop, which resulted in several white papers. Currently, she is contributing her expertise to various professional societies, such as the IQ Consortium, EFPIA, EFGCP, ASCPT, and EU Horizon-funded projects. She has published over 50 papers on MIDD methodology/applications, reviews, and white papers in peer-reviewed journals.
Certara Drug Development Solutions
Dr. Yu-Wei Lin is Director of Pharmacometrics at Certara, adjunct Senior Researcher at Monash University, and adjunct Guest Lecturer and Elite Fellow at the University of Malaya. With over a decade of combined academic and industry experience in PK/PD/TD modeling and MIDD, he has partnered with leading pharmaceutical companies to enable regulatory approvals, trial design, and dose optimization across oncology, immunology, pediatrics, and infectious diseases. His work spans small molecules, biologics, ADCs, and siRNA, including a patented pediatric HIV dosing strategy (Patent No. 63/407425). Dr. Lin has published 60+ papers, received NIH and NHMRC funding, and serves as Associate Editor of IJAA, Guest Theme Editor for ADDR, Communication Chair of the ASCPT Oncology Community, and member of several international working groups advancing MIDD standards and education.
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