Kendle

Paul Roney, Ph.D., DABT, and Lisa Jenkins, Ph.D., have been appointed senior regulatory consultants, Kendle. These appointments were made to help drive continued growth in the company’s regulatory business worldwide by providing strengthened regulatory consulting expertise to advise customers on their regulatory strategies from early stage through registration, according to the company.

Dr. Roney will provide strategic advice and expertise regarding nonclinical toxicology, including strategic planning, preparation of the nonclinical section of INDs and NDAs, helping customers to prepare and meet with the FDA and construction of expert reports and other regulatory documents. He will be based at the company’s office in Rockville, MD.

Dr. Jenkins, who will be based out of the company’s Cincinnati office, will be responsible for regulatory submission projects, including INDs and NDAs. She will provide guidance to the company’s biopharmaceutical customers for Prescription Drug User Fee Act milestone meetings and related briefing documents, as well as strategic advice on clinical and regulatory development plans.

Prior to joining the company, Dr. Roney was a toxicology reviewer in the Division of Neurology Products at the FDA. In this position, he wrote the primary review of the nonclinical sections of INDs and NDAs for drugs in development to treat neurological and psychiatric diseases. He worked closely with other members of the review team to produce integrated assessments of the risks associated with these drugs and frequently met with industry representatives to offer guidance on the nonclinical issues associated with all phases of drug development.

Dr. Jenkins joins the company from Wyeth Pharmaceuticals, Inc. where she served most recently as senior manager, worldwide regulatory affairs, responsible for providing strategic and functional regulatory support for several global eCTD, IND and NDA filings. Dr. Jenkins also served as a principal statistician at Wyeth and was actively involved in the planning, execution and reporting of Phase I-III CNS trials.