Ms. Kirkegaard’s experience in GMP and GLP training and managing GLP implementation, in addition to her expertise auditing contract manufacturing organizations worldwide will greatly benefit our clients in the CMC development process.
ROCHELLE, VIRGINIA (PRWEB) June 26, 2017
NDA Partners Chairman Carl Peck, MD, announced today that Melissa Kirkegaard, the former Associate Director of Product Development R&D at Allergan and CMC expert with more than twenty-five years of experience developing successful biological and pharmaceutical products at both start-up and established biopharma companies, has joined the firm as an Expert Consultant.
As Associate Director of Product Development R&D at Allergan, she was a CMC Analytical lead for multiple clinical products. She was responsible for developing analytical and stability regulatory strategies, writing CMC sections of INDs and overseeing testing at contract testing labs. She also assisted with establishing quality agreements and performing quality audits for the global auditing team of contract testing labs using the global compliance auditing process. In her role as Associate Director of Analytical and Quality Control at Kythera Biopharmaceuticals, she was responsible for providing quality and compliance oversight of supplier quality systems through supplier assessments, audits, quality agreements, review/approval of investigations, change controls, and technical documentation. She has developed and delivered GMP and GLP training, performed audits of contract manufacturing organizations, and managed good laboratory practices (GLP) implementation. In her early career, she was a Stability Project Manager in Corporate Quality at Amgen.
Ms. Kirkegaard’s experience encompasses identification, implementation, and management of CMC activities for biologics, small molecules, and combination device products from preclinical through commercial, as well as writing and/or reviewing associated regulatory filings and providing oversight and management of contract manufacturers.
“Ms. Kirkegaard’s experience in GMP and GLP training and managing GLP implementation, in addition to her expertise auditing contract manufacturing organizations worldwide will greatly benefit our clients in the CMC development process,” said Dr. David Savello, Partner and Manager, Product Quality & CMC Practice. “We are very pleased she has joined NDA Partners.”
Ms. Kirkegaard earned her Bachelors of Science in Biopsychology from the University of California, Santa Barbara.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; 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 virtual product development teams.
Earle Martin, Chief Executive Officer