CONSULTANTS and STAFF

CBR International is a global, full-service product, clinical, and regulatory development consulting group dedicated to providing comprehensive consulting services. Our experienced staff and consulting affiliates offer detailed as well as strategic consulting services to the biotech, pharmaceutical, and device industries.

Below is a brief summary of each consultant’s expertise. Be sure to see our complete consultant bios as well as our services literature for our full scope of capabilities and credentials.

Jeanne M. Novak, Ph.D., Principal Consultant: Former FDA Reviewer and Inspector - Dr. Novak provides detailed scientific and regulatory consulting, program oversight and staff training in the areas of FDA interactions, cGMP and cGCP compliance, quality assurance, strategic development, comparability, and process and analytical development. Read Full Bio

David L. Hines, Ph.D., Chief Scientific Officer: Dr. David Hines provides strategic regulatory advice, program and project management services, and expertise in manufacturing process development and development of analytical methods. Dr. Hines’s scientific expertise is Immunology. Read Full Bio

Judy Ruckman, Ph.D., Scientific Consultant: Dr. Ruckman provides technical writing services in the areas of analytical methods development, product and process development, and cGMP compliance to support FDA and IND submissions to both CBER and CDER. Read Full Bio

Linda E. Keyes ,M.D., Clinical Consultant :Dr. Linda Keyes is a board-certified Emergency Physician and a Fellow of the American College of Emergency Physicians. She earned her MD degree from Yale University School of Medicine, where she spent two extra research years completing her award winning honors thesis studying the effects of pregnancy and estradiol on vascular smooth muscle cell growth. Read Full Bio

Maria Straub ,M.D., Clinical Consultant :Read Full Bio

Michael Strauss, Ph.D., Scientific Consultant: Dr. Strauss provides critical review of scientific and regulatory documentation, as well as technical writing, methods evaluation, and biotechnology product development processes. Read Full Bio

Kathleen Hanley, Ph.D., Senior Consultant: Dr. Kathy Hanley provides strategic regulatory advice, program and project management services, expertise in manufacturing process development and analytical method development. Dr. Hanley’s scientific expertise is biochemistry, molecular biology and analytical chemistry, including mass spectrometry. Read Full Bio

Dana Weinberger, Ph.D., RAC, Scientific and Regulatory Consultant: Dr. Weinberger provides strategic advice on scientific, regulatory and product development issues and provides oversight for internal regulatory operations. Dr. Weinberger has expanded the company expertise in the areas of chemistry, technical writing, and regulatory affairs. Read Full Bio

Kevin Hennegan, M.S.,Senior Managing Consultant: Mr. Hennegan provides strategic consulting and technical writing services in the areas of Regulatory Submissions, Quality Systems, cGMP compliance, Analytical Methods, Clinical Program Development, cGCP compliance training and clinical auditing. Read Full Bio

Mariam Mehran, Ph.D., . Read Full Bio

Mark Brown, Ph.D., Scientific and Quality Consultant: Dr. Brown's consulting specialties are QA and QC development, GMP and GLP compliance, program management, and critical scientific and process review. This includes critical analysis of scientific and regulatory documentation, technical writing and methods evaluation. Read Full Bio

Angela Zimmermann , Ph.D., Scientific Consultant: Read Full Bio

Jessice E. Allmond, M.A.S., RAC, Director of Clinical Operations and Regularoty Affairs. Ms. Allmond provides regulatory strategy and project management, regulatory assistance for submissions in the U.S., Canada, and Europe, clinical development, technical writing services in the areas of Quality Systems document management and cGMP compliance, and clinical auditing and document preparation. Read Full Bio

Lee Buttrill, B.S.., Consulting Operations Manager. Mr. Buttrill provides oversight on project resources and manages project timelines to ensure CBR’s clients receive quality products in a timely manner. Mr. Buttrill also serves as technical associate on many of CBRs programs. Read Full Bio

Sara Symons, M.S., Technical Consultant: Ms. Symons provides project management, regulatory assistance for submissions in the U.S., Canada, Europe and Japan, medical writing support, document management and document preparation. Read Full Bio

Nicholas Inhelder , B.S., Operatations Manager: Mr. Inhelder assists the COO with all management of the daily office operations including; administrative staff, vendor management, office ordering, conference coordination and facilities maintenance. In addition, Mr. Inhelder collaborates with the marketing team to ensure that strategic objectives for the organization are measured and achieved. Read Full Bio

M. Joan Lawson, B.A., Chief Operating Officer: Ms. Lawson provides over all daily operations management, program development, finance and accounting, information systems, fiscal and budget management. As an award winning and Emmy nominated videographer, she also manages on-site video production of training sessions, Video news releases, editing, marketing and publications.

Ernest Schipman., IT Administrator: Read Full Bio

Kathleen Trumbo., Accounting Manager: Read Full Bio

Anthony Roe, A.A.S., Contracts Manager/Assistant Accounting Manager: Read Full Bio

Jan Zehr , Senior Office Administrator: Read Full Bio


_______________________________________________________________

AFFILIATES

Valerie Durkalski ,Ph.D., M.P.H.,: Dr. Valerie Durkalski is on faculty in the Department of Biostatistics, Bioinformatics and Epidemiology at the Medical University of South Carolina (MUSC) and holds membership in the International Biometric Society, The Society for Clinical Trials and the American Statistical Association, and serves on the ITV review committee for NIMH. She is also the Associate Director of MUSC's Data Coordination Unit, a clinical data management and statistical center located in Charleston, SC. Read Full Bio

Consistent, thorough and up-to-date analysis of your evolving needs is just the beginning of our commitment to your program. For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.