Gopala Krishna, PhD, MBA, DABT, FATS

Gopala Krishna, PhD, MBA, DABT, FATS

Gopala Krishna, PhD, MBA, DABT, FATS

Principal Consultant

Gopala is a senior nonclinical professional with over 30 years of experience from preclinical R&D through approval. He has experience in nonclinical drug development strategies including those for new molecular entities as well as creating unique strategies for 505(b)(2) drug development programs in a variety of therapeutic areas including oncology, cardiovascular and CNS. Prior to joining Parexel, Gopala held scientific and leadership nonclinical positions at pharma companies including Pfizer, Abbott, MGI/Guilford, Enzon and Supernus. 

Work Experience

At Parexel, Gopala uses his extensive experience to assist clients in the negotiation of nonclinical/ clinical development plans and regulatory strategies with FDA to achieve their company objectives. Gopala serves as the Technical Lead on nonclinical development programs including proposing strategies, preparing regulatory dossiers, meeting packages, attending and assisting FDA meetings as well as eventual IND/NDA submissions.

Over the years, Gopala was responsible for nonclinical study conduct, report writing, interactions with a variety of multidisciplinary drug discovery and development scientists and teams in meeting all aspects of nonclinical requirements. He has assisted in the preparation of multiple IND and NDA/BLA applications, has participated in pre-IND, EOP2, pre-NDA meetings as well as in dispute resolution/ lifting IND-holds and has participated in advisory committee meetings.

Experience

Gopala holds a PhD in Genetic Toxicology/ Developmental Biology (West Virginia University, Morgantown) and a Master’s in Business Administration (Eastern Michigan University). He is a Diplomate, American Board of Toxicology and a Fellow of Academy of Toxicological Sciences. He has contributed to multiple marketed products and in the selection of multiple promising lead molecular entities. He has published over 60 articles and presented 85 abstracts in the nonclinical drug discovery and development area. He has also written multiple book chapters particularly on alternative animal testing strategies. He currently serves as an Associate Editor, Drug and Chemical Toxicology and as an Editorial Board member.

Connect With Me

We are always available for a conversation.

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