Queen Creek, Arizona, United States
Highly experienced global Regulatory Affairs professional well versed in the overall drug development process with focus on products used to treat orphan diseases. Experience in building Regulatory Affairs and Quality Assurance functions in smaller biotechnology companies. Firm belief in right-sizing operational systems to suit development stage of portfolio, business strategy and clinical approach to addressing unmet medical needs.
I am Principle Regulatory Strategist at Veristat, LLC. With over 30 years of experience in Regulatory Affairs for both developmental and approved products, I have worked for both large and small pharma companies, including Parke-Davis, Pfizer, Esperion Therapeutics and Amicus Therapeutics. Although I have experience in cardiovascular, metabolic and inflammation therapeutic areas, my passion is in the rare disease space, where the unmet medical needs are high. I have also participated on joint operating committees with strategic partners, e.g., Pfizer, Shire and GSK, and have provided business development support of due diligence efforts. Academically, I hold a BS in Biological Sciences, MS in Chemistry and the Sc.D. in Outcomes Research from the Tulane University School of Public Health and tropical Medicine.
The objective of JP Kirk and Associates, LLC is to apply learnings from over 30 years of experience in Regulatory Affairs and Quality Assurance to product candidates intended to treat rare diseases. Focus is on - but not limited to - smaller biotechnology companies who need rapid access to Regulatory and Quality expertise. Extensive experience enables straightforward coverage in diverse settings across multiple therapeutic areas. Immediate skills are available to support preparation of documents intended to support regulatory agency meetings, early stage IND submissions, submissions to request special designations for orphan product candidates, including: Orphan Designation; Breakthrough Therapy Designation; Fast Track Designation and Priority Review. Experience includes planning, submission, review and approval of NDA and MAA submissions, as well as conduct of post-marketing activities. In addition, JP Kirk and Associates, LLC is positioned to establish appropriately sized Quality Management Systems that govern GMP/GCP compliance in smaller biotechnology companies.
Shared regulatory perspectives on design and execution of clinical trials in the orphan drug space to align data with regulatory agency guidance and target label claims. Oversaw drug regulatory activities pertaining to orphan drug development. Worked with relevant line functions to establish quality system to ensure GCP and GMP compliance. Provided quality assurance guidance pertaining to GxP vendor selection and monitoring, including execution of annual quality auditing activities.
Directed drug regulatory activities pertaining to global drug development, approval, and post-approval regulatory activities for orphan drug products. Built and oversaw team of 15 regulatory affairs, quality assurance, and medical writing professionals. Participated in joint development teams with partners, GSK and Shire, to execute Phase 3 clinical trials for use in treatment of patients with lysosomal storage disorders. Oversaw the EU marketing approval of Galafold® for treatment of Fabry disease. Provided regulatory perspective to design, execution, and analysis of clinical trials, to align study outcomes with regulatory agency guidance and target product profiles. Provided regulatory oversight for issues related to chemistry, manufacturing, and controls. Worked with relevant line functions to establish a quality system to ensure GCP and GMP compliance.
Oversaw regulatory activities in the metabolic disease therapeutic area, with drug development efforts focused on LDL-C as the therapeutics target. Maintained responsibility for regulatory aspects of projects related to chemistry, manufacturing, and control.