Current Trends and Opportunities for Chemical Engineering to Impact the Pharmaceutical R&D Pipeline
Shailendra Bordawekar, Ph.D.
Development Sciences, AbbVie Inc., North Chicago, IL
The pharmaceutical R&D pipeline has rapidly evolved over the last decade. Focus on development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in pharmaceutical development. Innovation is key to reduce development costs and shorten time to market. Automation, predictive modeling via first principles and AI-ML are becoming increasingly important to accelerate the development of patient-centric medicines by allowing more optimal routes to be implemented earlier in the development cycle. Further, robust processes for increasingly complex molecular moieties require innovation in both reactor design and reaction chemistry. To meet these needs, techniques such as photochemistry and electrochemistry can provide uniquely advantaged bond activation. Finally, novel modalities, such as antibody drug conjugates that can provide a potent payload to targeted cells, require understanding of both small molecules and biologics. Pairing reactor design fundamentals with mechanistic understanding of conjugation chemistry facilitates delivery of these therapies. This presentation will provide an overview of current opportunities and the application of these tools to drive pharmaceutical R&D in this ever-evolving landscape.
Bio:
Shailendra leads the Synthetic Molecules CMC Development organization at AbbVie. The organization is responsible for physicochemical profiling of target molecules to guide selection of candidates to advance into pre-clinical studies and clinical development; development of drug substance processes, drug product formulations and analytical tools to enable manufacture of clinical supplies; development of commercial processes and product presentations. The organization is focused on developing novel scientific approaches and implementing technologies which drive business efficiency and result in patient friendly products. Shailendra joined AbbVie in 2004 after working at Bristol-Myers Squibb and DuPont Pharmaceuticals. At AbbVie, Shailendra established the Process Engineering organization which championed fundamental approaches to CMC development and application of novel technologies in pharmaceutical processes. He later led the Process R&D organization responsible for all small molecule and ADC drug substance development. Shailendra has been actively involved in the AIChE community and serves on the AIChE Foundation’s Board of Trustees and the Corporate Council. He has also engaged in academic collaborations and industrial consortia. He served on the Board of Directors of the IQ Consortium and the Enabling Technologies Consortium. Shailendra played a key role in the development and commercialization of many important pharmaceutical products including, Mavyret, Venclexta, Rinvoq and Vyalev.
Shailendra holds a Bachelor’s degree in Chemical Engineering from the University of Bombay and a Ph.D. in Chemical Engineering from the University of Virginia.