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Frontage Laboratories Appoints Senior Executives to Expand Regulatory and Drug Development Consulting Services



10/1/2013 9:49:09 AM

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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 Warangal, India.

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

About Frontage

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.

Contact:

Katherine Cloninger

Director, Marketing

kcloninger@frontagelab.com

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