Frontage Laboratories Appoints Senior Executives to Expand Regulatory and Drug Development Consulting Services
10/1/2013 9:49:09 AM
Exton, P.A., (October 1, 2013) – Frontage Laboratories announces two senior-level appointments to lead
its consulting service expansion in regulatory affairs and drug development strategies.
Vijay Tammara, Ph.D., was named Vice President of Regulatory Affairs. Dr. Tammara joins Frontage from
Nuron Biotech, where he led efforts involving regulatory and strategic clinical development support for
global development of novel biologics and vaccines.
Dr. Tammara will lead Frontage’s initiative to build a comprehensive regulatory service offering. In
addition to his experience at Nuron, he served as Director of Regulatory Affairs for Merck Research
Laboratories for more than six years. There, he led regulatory activities across a wide range of key
therapeutic areas, including cardiovascular, endocrine and gastroenterology. Earlier in his career, Dr.
Tammara held multiple positions at the U.S. Food and Drug Administration (FDA) in the Office of Clinical
Pharmacology and Biopharmaceutics, CDER. Dr. Tammara is an American Association of Pharmaceutical
Scientists (AAPS) Fellow and received an AAPS Regulatory Sciences Achievement Award in 2012.
Dr. Tammara earned a doctor of philosophy degree in Pharmaceutics and Pharmacokinetics from
Northeast Louisiana University School of Pharmacy. He received a master’s degree in pharmacy from
Nagpur University in Nagpur, India and a bachelor’s degree in pharmacy from Kakatiya University in
John (Zhenze) Hu, Ph.D. was named Vice President, Pharmaceutical Development Consulting Services.
An expert in development of ophthalmic and dermatologic products, he brings extensive experience in
preformulation, formulation, preclinical studies, manufacturing process, project management,
regulatory sciences and technology licensing.
Dr. Hu will provide project coordination of multiple drug development disciplines in a rational approach.
His most recent experience includes serving as President of ZhenSight Laboratories, a specialty
consulting service for ophthalmic product development. He worked at Bausch and Lomb, holding several
key positions of increasing responsibility, beginning as a Principal Scientist, then Director of External
Technologies and Preclinical Outsourcing, Director of Pharmaceutical Evaluation and Licensing, and
Global Director of R & D and Business Development for Asia. Dr. Hu’s professional highlights at Bausch
and Lomb included execution of patent strategy, product licensing in key markets, therapeutic strategy
development for major ocular diseases, and creation of an extensive technology network across
multiple commercialization disciplines. His career milestones include more than 10 patents granted and
four novel commercial products launched.
Dr. Hu earned a doctor of philosophy degree in pharmaceutics from the University of Michigan. He
received a master of science degree in management of product development from Rochester Institute
of Technology and a bachelor of science degree in pharmacy from China Pharmaceutical University.
“I am excited to welcome these two renowned leaders in regulatory affairs and drug development to
our company”, said Dr. Song Li, Chairman and CEO. “Frontage will continue its strong commitment to
exceptional science and service through enhancing internal talent and deepening the range of expertise
offered to clients. We look forward to growing our business and serving customers through this
strategic service expansion.”
Frontage’s regulatory consulting services are designed to facilitate the planning and strategy of global
regulatory dossier submissions. These services include:
- Comprehensive product development strategy
- Product registration / global expansion strategy
- Health authority/agency consulting, advisory, and liaison services
- Formulation switch and criteria for bioavailability and bioequivalence bridging studies
- Filing and maintenance of regulatory submissions (INDs, CTAs, NDA/BLAs, and ANDAs)
- Full or partial common technical document (CTD) completion for NDA and BLA
- Post approval life cycle management including 505(b) (2) strategy
- Biosimilars - regulatory strategy and development
Frontage’s drug development consulting offers comprehensive services for end-to-end new drug
development from product selection/licensing, development, to manufacturing, including:
- Identification and evaluation of licensing opportunities
- Design and implementation of nonclinical testing and clinical development programs
- Development of formulation strategies to meet the targeted product profile
- Development and validation consultation for manufacturing processes
- Identification and management of contract manufacturing
- CMC development for IND, 505(b)2, BLA and NDA
- Facilitation of partnering for late-stage development and commercialization
Frontage Laboratories helps biopharmaceutical organizations advance research and development of new
products with full service offerings – including bioanalysis, preclinical and clinical studies, analytical testing
and product development support– that spans discovery stages through late phase clinical trials. Frontage
also provides turnkey product development, bioequivalence/bioavailability and analytical services to generic
pharmaceutical, consumer health, and specialty companies to support ANDA and 505(b)2 submissions.
With a 12-year history of bioanalytical, clinical research and CMC operations, eight state-of-the art research
facilities and more than 325 professionals in the US and China, Frontage has enabled biopharmaceutical and
generic companies of all sizes to advance hundreds of molecules through clinical development and
commercial launch in global markets. For more information, visit www.frontagelab.com.
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