Dr. Linda McKibben, Former FDA Pediatric Medical Officer, Division of Vaccines and Related Products, Joins NDA Partners

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NDA Partners Chairman Carl Peck, MD, announced today that Dr. Linda McKibben, a former Pediatric Medical Officer/Clinical Reviewer in the Division of Vaccines and Related Products at the FDA Center for Biologics Evaluation and Research, has joined the firm as an Expert Consultant.

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Dr. McKibben’s first-hand knowledge and experience in pediatric therapies, pediatric trials, preventative medicine, and clinical regulatory strategy, both at the FDA and in the Industry, make her an excellent addition to our team of Expert Consultants.

NDA Partners Chairman Carl Peck, MD, announced today that Dr. Linda McKibben, a former Pediatric Medical Officer/Clinical Reviewer in the Division of Vaccines and Related Products at the FDA Center for Biologics Evaluation and Research (CBER), has joined the firm as an Expert Consultant. Dr. McKibben’s expertise includes pediatric therapies, pediatric trials, preventative medicine, public health, health policy, and clinical regulatory strategy.

Prior to joining the FDA, Dr. McKibben served in multiple roles at the US Centers for Disease Control and Prevention as Senior Advisor for Health Services Research at the National Center for Infectious Diseases (NCID), Senior Medical Officer in the Office of HealthCare Partnerships (OHP), and Medical Epidemiologist at the National Center for Prevention of Injuries (NCIPC). She has also served as a Senior Policy Analyst/Medical Director of Altarum Institute (Alexandria, Virginia), and Vice President of Health Policy at The Lewin Group (Falls Church, Virginia).

Most recently, she served as a Clinical Trials Medical Consultant for Ripple Effect Communications, where she supported the Deputy Director of Extramural Research at NIH’s National Institute for Child Health and Human Development, and as a Medical Consultant in the Integrated Product Development Division of PAREXEL Consulting.

According to Dr. Carl Peck, “Dr. McKibben’s first-hand knowledge and experience in pediatric therapies, pediatric trials, preventative medicine, and clinical regulatory strategy, both at the FDA and in the Industry, make her an excellent addition to our team of Expert Consultants. We are very pleased to welcome her to NDA Partners.”

Dr. McKibben earned her medical degree from the Medical College of Georgia, Doctor of Public Health degree in Health Policy from the University of Michigan, Master of Public Health degree from Harvard University, School of Public Health, and bachelor’s degree in microbiology/pre-medicine from the University of Georgia. She is a fellow of the American Academy of Pediatrics and board certified in preventative medicine.

About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

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Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle@ndapartners.com

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Earle Martin
NDA Partners LLC

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