Advances in Payload Delivery and Drug Conjugation

Sudhakar Garad, PhD, received his PhD from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr M S Nagarsenker. Soon after completion of his PhD, he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his PhD, he was selected as a postdoctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers with Dr Robin Bogner. After his post-doctoral fellowship, Dr Garad worked with Vertex Pharmaceuticals for a period of three years as Senior Investigator in the formulation development group. After Vertex, he joined Novartis as a Group Head. Dr Garad worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Dr Garad is working as a Global head of Chemical and Pharmaceutical profiling (Discovery Pharmaceutics/Novel Drug Delivery) and Disease Area Head (New Indications) at Novartis. His primary role is to collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration.

Mandana Borna is the head of oligonucleotide drug product development at Biogen overseeing all aspects of drug product development from formulation design and container closure selection to process development, scale up and tech transfer to support Biogen’s expanding oligonucleotide portfolio. Her responsibilities encompass every phase of product development from preclinical, and clinical stages through to commercialization and life cycle management. Additionally, Mandana continues to lead the non-viral drug delivery activities at Biogen to advance new technologies and overcome challenges of delivery of oligonucleotide and other large molecule therapeutics. She plays a key role in shaping short-term and long-term drug delivery strategies to support Biogen’s pipeline. In addition to internal drug delivery formulation development, Mandana’s team identifies cutting-edge non-viral delivery technologies, design feasibility studies, performs technical assessment and leads project partnership. Mandana holds PhD degree in Materials Science & Biomedical Engineering from McGill University, and her research is focused on formulation development and drug delivery. She has been invited speaker in multiple drug delivery conferences and serves as a reviewer for several journals.

Dr Suman Luthra is currently Director in Discovery Pharmaceutical Sciences at Merck Boston site and is responsible for providing strategic and technical leadership at the discovery-development interface to enable the discovery of new drug candidates including small molecules, peptides and biologics. She oversees preclinical drug product development activities that include nomination of candidate for clinical development through developability risk assessment and application of insights to assess and mitigate CMC drug product developability risks. Dr Luthra’s team enables the transition of the right molecules from discovery to clinical formulation development with clinical formulation strategies in place. With 30+ active programs including various modalities and stages of development, she provides scientific oversight and make strategic decisions for acceleration. She is passionate about advancing patient friendly drug delivery solutions of diverse modalities including macrocyclic peptides which is the focus of the panel discussion today.

Dr Stefan Yohe is an Associate Research Fellow at Pfizer within Pharmaceutical R&D, where he and his team focuses on the development of ADCs and drug delivery innovation. Stefan joined Pfizer in 2023, with prior roles at Seagen, Genentech, and Bayer. He has 15 years of experience in drug product development, delivery and device technology innovation, and material science. Dr Yohe is an author or co-author on 20 peer-review journal articles. He received his PhD in Biomedical Engineering and Pharmacology from Boston University, and a BS in Material Science and Biomedical Engineering from The Pennsylvania State University.

Benjamin Smith, PhD, is a scientific leader in biologics drug discovery and development specializing in tissue-targeted delivery technologies and applications across modalities, particularly for neurodegenerative disease. With 12 years of industry experience (at Voyager and Biogen) in blood-brain barrier penetrant technology, novel target discovery, and antibody engineering/optimization, he has advanced neurotherapeutic drug candidates from concept to clinical development. Dr Smith obtained a PhD in biophysics from McGill University and apply knowledge of protein-protein interactions and cellular mechanisms to connect the molecular and pharmacological functions of drug candidates.