An Overview of Biopharmaceutical and Biologic Drug Development and Its Complexities
Wednesday, November 9, 2022
4:00 PM-5:30 PM
BIOMED Hybrid Seminar
CLICK HERE TO ATTEND VIA ZOOM
Title:
An Overview of Biopharmaceutical and Biologic Drug Development and Its Complexities
Speaker:
Uma Prabhakar, PhD
Consultant (Early Development to Point of Care)
Details:
The drug development process is driven by both medical need and business opportunity. The process itself is arduous, expensive and time-consuming. Invariably, it takes not only expertise, but robust infrastructure and significant funds to bring a therapy to market. Almost 70 percent of the total spent in drug development is for failures at various stages of the drug development process. For example, in the case of small molecular drugs, as many as 10,000 compounds are screened during the discovery phase for each product that eventually reaches the market and the development timeline from identification of a molecule through clinical testing can be as long as 15 years Since the passage of the Food, Drug, and Cosmetic Act in 1938, every new drug brought to market in the United States has been subject to approval by the US FDA through the New Drug Application (NDA) process.
Biopharmaceutical products (or “biologics”)–which include, vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins–are complex, large-molecule substances that require sophisticated technology and controlled processes to manufacture. Successful development and commercialization of a biologic requires a nuanced understanding of the scientific, logistical, and regulatory challenges specific to biologics.
Within the biopharmaceutical products, genes and gene therapy which has been actively evolving over the past 30 years, has produced only a handful of products that have recently become approved gene therapies. While gene therapy products provide potential for exciting breakthroughs, they are also extremely complex to develop for the market. This complexity has prompted the FDA to recently release additional guidance’s to help move these products forward. Early FDA gene therapy guidance’s include traditional investigational new drug (IND) requirements and Phase I good manufacturing practice (GMP) guidance. Two of the six 2018 gene therapy guidance’s are related to requirements for long-term follow-up monitoring and other clinical study design considerations, as well as chemistry and manufacturing and controls (CMC) procedures and practices to ensure safety.
In this overview presentation, steps involved in the drug development process and associated challenges relating to small molecule drugs, biologics and gene therapy (biopharmaceutics) will be presented.
Biosketch:
Uma Prabhakar, PhD, is a highly experienced pharmaceutical research and development (R&D) personnel with comprehensive understanding of the end-to-end product development cycle for both biologics and small drug molecules. She has an entrepreneurial and strategy-oriented mindset; superior leadership and organizational management skills and in-depth knowledge and practical experience in bioassay development, validation for PK, IR, biomarker research and translational medicine in various therapeutic areas including Oncology & Inflammation. She has served in various roles of increasing responsibility across all stages of the product development cycle within the pharmaceutical industry for both small molecule drugs as well as for biologics, in the therapeutic areas of oncology, rheumatology, inflammation, and bone biology, and is associated with a number of approved drugs in these therapeutic areas.
Currently, Dr. Prabhakar is an independent consultant for start-up companies where she provides her expertise across all aspects of early drug development through proof of concept for various therapeutic areas with emphasis on Oncology. Previously, she was the Chief Scientific Officer for BRIM Biotechnology, a global company based in Taiwan, where she successfully managed 2 successful IND submissions within a year for Ophthalmology and Oncology indications respectively. She has also held an advisory position at the National Cancer Institute (NCI) of the National Institutes of Health (NIH) in Bethesda where she had was responsible for enhancing the translation of NCI’s Alliance for Nanotechnology through a public private partnership between industry and academia (TONIC) to promote advancements in nanotechnology translation. She also served as Vice President of a Contract Research Organization, Frontage Laboratories, where she created and established a new service line franchise focused on outsourcing bio-analytical services and assay development & validation of biologics and biomarkers for priority customers. Prior to that, she has held various leadership positions at Centocor, a Johnson & Johnson Company, including that of Senior Director in Oncology Biomarkers and Translational Medicine and Clinical Pharmacology.
Uma holds a PhD in Human Genetics from Osmania University in Hyderabad, India. She currently lives with her husband in BlueBell, PA.
Contact Information
Lisa Williams
ltw22@drexel.edu