How Do Life Science Companies Make Portfolio Decisions? Implications for Pediatric / Neonatal Clinical Development Programs

Only available as part of a package

This module provides a "behind the scenes" view of how life science companies make product development decisions impacting selection of conditions and patients studied. Limited funds, staff, and time, require prioritization of what products to move forward into development and clinical trials. A quantitative approach, the Risk Adjusted Net Present Value is discussed. This is a value equation, presented as a fraction that looks at drivers of value/detractors of value. Dr Miller provides examples of the drivers and detractors of value and applies these concepts to three specific neonatal conditions. He discusses the role of nurses and the neonatal community in helping companies to identify appropriate patient populations, assess feasibility and identify relevant clinical trial outcomes to support development programs. Dr Miller also discusses how current trends, use of Real-World Data, and study of rare disease, potentially benefits the development of new therapies for neonates.

CE Credit Information:

Participants can earn 0.5 CE credit and 0.13 pharmacology credits for viewing the presentation and completing the evaluation.

The National Association of Neonatal Nurses is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

Dr. Thomas Miller, PhD

Dr. Thomas F. Miller is Vice President & Global Head, Acute, Chronic and Pediatric Disease Nucleus in Bayer’s Pharmaceutical Division, a role he assumed earlier this year. He joined Bayer in 2017 to create and effectuate their Pediatric Clinical Development function. In total, Dr. Miller’s career in the life science industry spans more than 28 years, with a primary focus on the development of therapeutics, medical devices and combination products for pediatric and rare disease patients. Prior to joining Bayer, Dr. Miller served in the capacity of Chief Executive Officer of Therabron Therapeutics, Inc. with oversight of all operational functions for the company (R&D, manufacturing, quality, regulatory affairs, etc.). While at Therabron, he oversaw their clinical program through Phase 2 completion for their lead molecule (orphan pediatric disease) and secured both the Rare Pediatric Disease and Fast Track designations for this program. Prior to Therabron, Dr. Miller served in the capacity of Chief Operating Officer of Discovery Laboratories, Inc. During his tenure, the company successfully secured marketing authorization for their first approved therapeutic, successfully registered their first medical device and advanced multiple rare disease pipeline programs into the clinic. Earlier, Dr. Miller served in operational roles of increasing responsibility at Pfizer, Novartis, BASF Pharma, and Johnson & Johnson. He received his doctorate from the Temple University School of Medicine, his MBA from Fairleigh Dickenson University and his bachelor’s degree from Fairfield University. Dr. Miller has authored several peer-reviewed publications, given numerous presentations at scientific symposia and is an inventor with an issued and licensed patent in the field of pediatric respiratory drug delivery