CMC Personnel
Led by Dr. Dongmei Wang, the Frontage CMC group consists of accomplished pharmaceutical scientists with the experience to deliver solutions on time and on budget.
Venkata Vadlapatla, PhD, Director of API and Organic Synthesis
Dr. Vadlapatla has over 20 years of research and pharmaceutical industry experience in several pharmaceutical companies in India and Australia. His expertise is in process development, scale-up of new drug candidates for clinical trials, technology transfer operations, and development of various innovative processes for API manufacturing. Prior to joining Frontage in September 2006, he spent over 8 years in the pharmaceutical industry in Australia. He has extensive experience in the preparation of validation protocols, reports, master batch records, Drug Master Files (DMF) and supporting documentation suitable for FDA inspections. He is also very familiar with various regulatory requirements and guidelines and has gained considerable expertise in preparing technical data packages for regulatory support documentation. Dr. Vadlapatla received two PhD degrees in Organic Chemistry, from Andhra University, India, and University of Queensland, Australia.
Feng-Jing (FJ) Chen, PhD, Senior Director, Product Development
Dr. Chen’s responsibilities include formulation development for Sterile (Injection and Ophthalmic), Oral Solid (IR and CR), Topical, and High Potent products. Dr. Chen has more than 14 years of experience in the pharmaceutical industry. His expertise is in preformulation and formulation/process development of immediate/modified release liquid/solid dosage forms for oral/parenteral administrations. Dr. Chen is very familiar with various drug delivery technologies and proficient in providing formulation/patent strategy to support 505(b)(2) and ANDA submissions adapting a QbD approach. He has focused his researches on material and time-sparing formulation approaches to address the scale up issues related to tablet compaction and the long term compatibility of liquid-filled capsules. Prior to joining Frontage in March 2012, Dr. Chen headed the product development at Teva Parenteral Medicines, Inc., as Director of Formulation Science, responsible for the design and development of sterile injectables. Prior to joining Teva in September 2009, Dr. Chen led the Physical Pharmaceutics group at Boehringer Ingelheim Pharmaceuticals Inc. for preformulation and formulation activities. Prior to joining Boehringer in February 2004, Dr. Chen had worked since 1998 at Lipocine, Inc. where he helped establish proprietary lipid-based drug delivery technologies for water insolubles and membrane impermeables. Dr. Chen received his PhD in Pharmaceutics from The University of North Carolina at Chapel Hill and BS in Chemical Engineering from National Taiwan University.
Vaishali Ketkar, PhD, Director, Product Development and Clinical Trial Material Manufacturing
Dr. Ketkar has more than 10 years of experience in pharmaceutical industry. Her expertise is in formulation and analytical development studies for parenteral, ophthalmic, oral, and topical dosage forms for IND and ANDA applications and clinical trial material manufacture for Phase I and Phase II studies. Prior to joining Frontage in February 2004, Dr. Ketkar worked at ESI Lederle, Wyeth on generic parenteral product development. She provided analytical and formulation development studies for ANDA applications. Her extensive academic and hands-on analytical/formulation development training includes a six year Research Assistantship at the Pharmaceutical Service Division of the University Of Iowa College of Pharmacy while completing Ph.D. in the department of Pharmaceutics. She earned her B.S. in Pharmaceutical Sciences from the Bombay College of Pharmacy, University of Bombay.
Veerarajendra (Raj) Yadwad, PhD, Senior Director, Manufacturing Services
Dr. Raj Yadwad joined Frontage Laboratories, Inc., as Senior Director of Manufacturing Services in January 2011. He has over 20 years of experience in biopharmaceutical research and development, technology transfer, and commercial GMP manufacturing including sterile fill -finish and lyophilization. Prior to joining Frontage, Dr. Yadwad held senior level management positions at Charles River Laboratories and Sanofi Pasteur. His experience in the management of manufacturing operations includes facility design, start-up, taking products through approval and launch process, and leading manufacturing operations for licensed products. Dr. Yadwad has experience working with pharmaceutical companies and research organizations in the US, Europe, Asia and Australia to develop and rapidly advance promising small molecule and biologic drug candidates. He has significant experience in leading and supporting regulatory pre-approval and routine inspections, as well as FDA and international regulatory agency interactions. Dr. Yadwad received his PhD, MS and BS degrees from Karnatak University, India.
Kang Wang, PhD, Senior Director, Analytical Services
Dr. Wang has over 11 years of experience in pharmaceutical analysis. His expertise is in various method development and validation, impurity identification, and GMP sample analysis. Prior to joining Frontage in January 2007, he worked for nearly 8 years with Pharmaceutical International Inc. a contract manufacturing company, where he held a Section Head position in Analytical Service Department. He has developed and validated a number of methods to support NDA and ANDA filings. Dr. Wang also worked in the Department of Pharmacokinetics in St. Jude Children’s Research Hospital for two years and performed bio sample analysis for several PK studies. Before Dr. Wang came to the US in 1992, he worked 7 years for Xiamen Fuda Photographic Materials Company Inc, where he was an assistant director and managed QC testing of raw materials by following Kodak’s SOPs. Dr. Wang received his PhD in Analytical Chemistry from the University of Memphis, his MS from Xiamen University, and BS from Wuhan University.
Yimin Wei, PhD, Director, Analytical Development
Dr. Yimin Wei has 16 years of experience in pharmaceutical analysis. His expertise is in various analytical method development, method validation, sample release testing and stability testing, pharmaceutical R&D support, and manufacture support. Prior to joining Frontage in July 2009, Dr. Wei worked for Teva Pharmaceuticals USA Analytical Research & Development Department for 14 years, with increasing responsibilities from Scientist to Senior Scientist, and Manager to Associate Director. As an Associate Director with Teva, he was responsible for managing an Analytical Research and Development laboratory to provide all analytical support for new product ANDA submissions and FDA deficiency responses. Teva made more than 20 ANDA submissions during the years he was in the Manager and Associate Director positions. Dr. Wei received his PhD in Pharmaceutical Sciences from North Dakota State University, and his MS and BS degrees in Pharmaceutical Sciences from Beijing University.
Donna Eash, PhD, Director, CMC Project Management
Dr. Donna Eash has over 8 years of experience in the pharmaceutical industry and joined Frontage in 2004. Her responsibilities are very broad, ranging from identifying new work with the Business Development group to final management of awarded projects. Once new projects have been approved she will manage the timelines to ensure that resources are adequate for projects to ensure delivery of the project goals. Dr. Eash has experience helping clients with INDs, NDAs and ANDAs. Prior to Frontage, she was the team leader for the chromatography group at Lyondell Chemical Company and worked with various global manufacturing sites to standardize test methods and transfer methods from the tech site to manufacturing plants. It was also the responsibility of the chromatography group to evaluate new techniques to enhance the capabilities of the analytical group. Dr. Eash received her PhD in Food & Nutritional Science with emphasis in analytical chemistry from the University of Maine, her MS in Clinical Lab Science from the University of Massachusetts at Lowell, and BS in Medical Technology from the University of New Hampshire.
Ellen Jimenez, MS – Senior Director, Quality Assurance, US and China
Ms. Jimenez, provides leadership for the CMC, Bioanalytical/Biomarker, and Clinical Divisions in the US and China. She has more than 16 years of experience in the pharmaceutical industry in areas such as QC and QA Compliance, analytical/bioanalytical, computer administration and validation, CTM manufacturing, API manufacturing and clinical trials. Prior to joining Frontage, she worked for Ohio State University Comprehensive Cancer Center (clinical trials), Fujisawa USA (Melrose Park, IL) and Wyeth Baxter Healthcare (Cherry Hill, NJ) (generic/parenteral development and manufacturing research). Ms. Jimenez has hosted 7 FDA inspections in the Bio and CMC areas since 2004. She was awarded a MS in Chemistry from Ateneo de Manila University in the Philippines. She became a Certified Microsoft System Administrator in 2003. In 2006, she completed 3 graduate credits in Good Clinical Practices (GCP) at Temple University.
