Kim joined the NDA Group in 2018 and primarily focuses on identifying the most appropriate experts within the NDA Group to best support the regulatory needs of new and existing clients. Her 30 years of experience in global clinical and regulatory strategies for medicinal and aesthetic drugs and devices span all phases of development. She provides advice to clients on development and regulatory strategies and interactions with the FDA. Kim has product development experience in multiple therapeutic areas including dermatology, respiratory, cardiovascular, hormone replacement, and autoimmune disorders.
Key Areas Of Expertise
- Global development strategy
- Specialist in Dermatology Drug and Device Development
- IND, NDA/BLA, MAA and PMA submissions
- Branded, Generic and 505(b)(2) development strategies and approvals
- Product Life Cycle Management
- Extensive expertise in regulatory strategy and operations
- Client Preparation for key milestone meetings including Pre-IND, End-of-Phase 2, Pre-Registration, other Guidance or Advisory Committee Meetings
- FDA Meeting documents (Meeting Request Letters and Briefing Books)
- Labeling negotiations with regulatory authorities
- Expedited review programs (Fast Track, Breakthrough Designation Requests)
- Rare Disease Development Programs (Orphan Drug Designations)
- Project Management
- Development of Target Product Profiles
- Business Development and Due Diligence
- Strong technical, managerial and communication skills
- Management of cross functional teams for pharmaceutical development
- US Agent and main contact with FDA/other Regulatory Authorities
Kim worked in both large and small pharmaceutical companies where she successfully built and led cross functional teams for development of drug and device products. She has demonstrated success in negotiations with worldwide regulatory agencies resulting in approval and commercial launch of successful novel products.
Kim also has experience presenting overall regulatory and development strategy, company objectives and technology to the investment community and other potential partners, to raise capital or negotiate co-development or out-licensing arrangements.
Kim has a PhD in Analytical Chemistry and unique ability to communicate across all disciplines of the pharmaceutical business and to propose viable solutions to difficult problems.
Kimberley Forbes-McKean, PhD