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Strategies to Overcome Challenges for Globally Successful BE Investigations


Umesh Banakar, Professor and President, Banakar Consulting Services

Dr Umesh Banakar, Ph.D. is Professor of Pharmaceutics and an Independent Consultant/Advisor to Pharmaceutical Industry and Academia worldwide with extensive contribution in drug product development. He has Ph.D. from Pittsburgh, USA, and Advanced Training in Controlled Release Technology from MIT, USA.
The Founding Chairperson of 2 International CROs, and an International Scientific Advisor to a major CRO in Mexico, he has executed 350+ clinical trials (Phase I-IV including Bioequivalence) for submission to regulatory agencies worldwide [North America (including the US-FDA), Western/Central Europe, South America (including Brazil), Asia and South Africa]. He has planned, directed and executed the development, both in vitro and clinical, of several NDAs (10+) and ANDAs (100+ both IR and MR products) and several NDAs [505 (b)(2)]. Spearheaded/led 3 CROs, 2 CMOs to approvals from various international regulatory agencies. He serves on International Scientific Advisory Boards of several pharmaceutical corporations worldwide.
Since 1985, he has authored over 100 publications, over 100 published abstracts and presentations, numerous specialized workshop manuals, several chapters, monographs, expert book reviews and guest editorials. He has authored textbooks: Pharmaceutical Dissolution Testing, Drug Development Process: Increasing efficiency and cost effectiveness, among others, and electronic text: Basic Pharmacokinetics. Additionally, he has edited numerous Textbooks and served on Editorial Boards of Special Text Series including: NanoBioMedicine. He is on the roster of experts with WHO, United Nations programs and is listed in Who’s Who in Biotechnology, American Men and Women of Science, among others. He has received numerous awards for excellence in teaching, research/scholarly activity, two Service to Country Awards from the UN and nomination for the distinguished Fulbright Scholar Award for Teaching. He is the founding Editor-in-Chief and on Editorial Boards of several scientific journals. He has successfully executed the development of several NDAs and ANDAs. He assists research teams in intellectual property matters. He continues to serve as a Testifying Expert in several Intellectual Property (Patent litigations. He is the founding Board Member and Principal Scientific Adviser to Society for Pharmaceutical Dissolution Science [SPDS].

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