CardioMed Device Consultants - Vice President, Daniel J. Chwirut, MS, PE

A medical device consulting company working with medical device manufacturers around the world

1327 Bluegrass Way, Gambrills, MD 21054 410.674.2060

CardioMed Device Consultants, LLC

Affiliate Consultant - Steven R. Koepke, PhD

MEET OUR STAFF

PRESIDENT AND FOUNDER

H. Semih Oktay, PhD

VICE PRESIDENT, ENGINEERING

Daniel J. Chwirut, MS, PE

PRINCIPAL CONSULTANTS

Judith J. Danielson, RN, BSN, MPH

Richard E. Galgon, MD, MS

Elisa D. Harvey, DVM, PhD

AFFILIATE CONSULTANTS

Candace F. Cederman, MS

Mona M. Advani, BS, MS, MBA

Jodell D. Kause, BS, RAC

Qmed Consulting

Steven R. Koepke, PhD

Pauline E. McEwan, PhD

Dr. Koepke works with CardioMed Device Consultants as an affiliate consultant. He is a well-recognized consultant in the area of combination products, most recently, with emphasis on drug-eluting stents (DES). However, his experience is extensive.

Dr. Koepke received his PhD in organic physical chemistry from the University of Nebraska in 1978. During the next 12 years, he worked as a research scientist at the Frederick Cancer Research Center (FCRC) in the field of chemical carcinogenesis. His work during this time resulted in the discovery of a new mode of activation of chemical carcinogens and his transition from purely organic physical chemistry to the design and performance of both in vitro and in vivo metabolism and DNA modification studies as well as carcinogenicity trials. In 1990, he joined the U.S. Environmental Protection Agency (EPA) in the Office of Pesticide Programs, where he worked as a reviewer on new pesticide approvals. Two years later, he joined the U.S. Food and Drug Administration (FDA) as a chemistry reviewer in the Center for Drug Evaluation and Research (CDER) in the Division of Oncology and Pulmonary Drug Products. In 1997, Dr. Koepke became the Deputy Director of the Division of New Drug Chemistry II, overseeing chemistry reviews of six clinical divisions in CDER. In 2001, Dr. Koepke departed FDA and joined PharmaNet Inc as a consultant for in-house clinical projects and stand-alone regulatory projects involving chemistry, manufacturing, and controls (CMC) issues. In addition, he prepared technical CMC documents to support both IND and NDA regulatory applications. Further, he planned, organized, and moderated CMC-related meetings with FDA. In January 2005, he founded SRK Consulting LLC and initiated an independent consulting career. He consults on drug-related products, emphasizing strategic planning for interactions with U.S. and international regulatory bodies, with particular emphasis on combination drug products and drug eluting stents.

Contact CardioMed Device Consultants for information on what Dr. Koepke can do for you.

CONTACT INFORMATION

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com