Ajai Chaudhary, PhD

Bio

Dr. Ajai Chaudhary has recently retired as an Executive Director, Pharmacokinetics, Pharmacodynamics and Drug metabolism (PPDM) in Merck Research laboratories. His group was responsible for the PPDM outsourcing strategy working closely with leaders within other functions within MRL in support of discovery and development portfolio.   This involved building and managing end to end capabilities for ADME, Discovery and Regulated Bioanalytics in a modality agnostic manner (small molecules, large molecules, peptides, vaccines etc.) and Quantitative Pharmacology and Pharmacometrics (QP²).  Dr. Chaudhary was instrumental in establishing a flexible network of external providers with a global footprint.  He is well respected in global outsourcing fraternity and has considerable experience (>20 years) in end-to-end PPDM outsourcing in multiple modalities.  His Group was also responsible for business development and licensing (BD & L), regulatory publishing and archiving activities within PPDM.

Prior to joining Merck, Dr. Chaudhary worked at Eli Lilly and Company in roles of increasing responsibilities including the position of Director for Lead Optimization to Clinical Proof-of-Concept (LO-POC) DMPK group.  The Group supported all the ADME related scientific and regulatory activities during lead optimization through clinical proof of concept studies working very closely with Discovery Chemistry, Therapeutic areas (oncology, diabetes, neuroscience and musculo-sketetal), Toxicology, PR&D, CM&C, Clinical, Regulatory and Project Management organizations within Lilly Research laboratories.  Job responsibilities also included authoring and reviewing of regulatory documents including preclinical CTD modules (2.4 and 2.6) and clinical sections (2.5 and 2.7).  During his tenure at Lilly, Dr. Chaudhary had led several Groups within DMPK such as, Bioanalytical and Radiochemistry, Lead Optimization and Candidate Development Group, Groups supporting DMPK activities for cancer and endocrine therapeutic areas and DMPK Business Office.  He was also the part of development Team as Lead DMPK scientist and was responsible for successful global submission and approval (US, Europe and Japan) of Alimta, a dihydrofolate reductase inhibitor, in the treatment of mesothelioma and non-small cell lung cancer.  During his tenure at Lilly, Dr. Chaudhary was the key DMPK person in evaluating, establishing and maintaining external collaborations (fee for service providers and shared-risk collaborations) with a number of partners in South Asia. 

Dr. Chaudhary has over 45 publications in the scientific literature and has presented at more than 125 national and international forums.  Dr. Chaudhary has held number of leadership positions in various professional organizations such as Chair, DMPK Interest Group, ASMS; Chair, Bioanalytical Focus Group, AAPS, Organizing Committee memberships for a number of conferences, symposia and workshops etc.  He was the co-organizer and session chair for Crystal City AAPS-FDA workshop on Incurred Sample Reproducibility.  He is also an Associate Editor for the journal “Bioanalysis” and is on editorial advisory board of a number of other journals.