Patient-Focused Development of Biopharmaceutical Products

This open access book builds the case for the business motivation, techniques, and approaches to use in development of a medicinal product for human therapy, whether delivered via an oral dose form (＂pill＂ or solution) or a delivery system (device). It shares the growing demands by patients and caregivers, as well as regulators, for designs which are most easily understood and usable, and which can ensure the medication can be consistently delivered and will, therefore, allow best outcomes. The book weaves skills in ＂human-centered design＂ into the design of medicinal delivery systems. It would be a reference for those in academia studying pharmacokinetics, formulation or product design and development, as well as those in the development of biopharmaceutical therapies.

This is an open access book.

Robert Nesbitt is Senior Director, Landscaping & Platform Definition in AbbVie’s Combination Product Development group. Prior to that, he was Director, Human-Centered Design & Human Factors, and led the team that drove user needs assessment and usability validation for AbbVie Combination Products.He was co-editor of Development of Biopharmaceutical Drug-Device Products, a book for pharmaceutical development professionals on drug product formulation, development and the delivery systems which are required to deliver them. This 800-page book was published by Springer as Volume 35 of AAPS’ ＂Advances in the Pharmaceutical Sciences＂ series (2020).

He joined AbbVie in January-2015, after 16 years at Eli Lilly and Company, where as Director of Advanced Development and Research, he built patient-centered design into early concept design and development of new Lilly delivery devices. His work drove the design of nine (9) different Lilly delivery devices in use today globally - his team led the design of the device Lilly uses for Trulicity, Emgality, Taltz, Mounjaro and Zepbound. After retirement from Lilly (2015), he was called back and recognized as a ＂Top Innovator＂ for his leadership in driving the patient-centered design of the auto-injector used for three Lilly therapeutics.

Ramakrishna (＂Krishna＂) Venugopalan is currently the Co-Founder and CEO of Continuity Biosciences, LLC, a biotechnology company established with the mission of revolutionizing therapeutic delivery. At Continuity, proprietary platform technologies are leveraged to develop next-generation drug delivery systems aimed at addressing bioavailability challenges and mitigating systemic toxicity, particularly in oncology and metabolic diseases.

Prior to founding Continuity, Krishna led AbbVie’s combination product, drug delivery, and sterile packaging development organization, integrating medical technology with biotechnology within AbbVie’s pipeline. He played a central role in the launch of impactful therapies, including Skyrizi(R)--an IL-23 inhibitor widely used to treat autoimmune diseases--and Vyalev(TM), a continuous subcutaneous infusion therapy providing enhanced symptom control for patients with advanced Parkinson’s disease.

Before his tenure at AbbVie, he held leadership positions at Johnson & Johnson focused on drug-device combination development, M&A integration, and external partnerships. In 2016, he received the Johnson Medal for co-developing a continuous glucose monitor integrated insulin pump; an effort which complemented his research and development focus on closed-loop insulin delivery systems for type 1 diabetes.

Wolfgang Fraunhofer is Senior Director, CMC Strategy and Portfolio Leadership, in Development Sciences, R&D at AbbVie. Previously, he led teams in NCE Analytical R&D, Combination Product Development, NBE Formulation Development and NCE/NBE Pharmaceutics/Preformulation.

He began his pharmaceutical development career at BASF/Knoll, first while completing his doctoral research on protein aggregate characterization, and later as member of the team developing formulations and product presentations for adalimumab, one of the most widely used monoclonal antibodies that has transformed immunology treatments. His pharmaceutical expertise has been deployed in the development of various pharmaceutical excipients as well as the development of lyophilized and liquid new biological entities (NBEs). Upon Abbott Labs purchase of BASF’s Knoll Division, Dr. Fraunhofer worked on Drug Product scale up and transfer to manufacturing sites at locations in Germany as well as Puerto Rico, supporting the development of manufacturing quality criteria and training of the operators in the manufacture and final GMP release of adalimumab (Humira(R)).