Research Interests

Drug and product development, regulatory science, translational sciences, drug development tools/methods/approaches/standards to streamline clinical trials and product development, collaborations and partnerships with stakeholders in government/industry/academia/researchers/consortia/patient groups.

Proposed Research Project for FDA Commissioner's Fellow

CDER’s main focus is safe/effective/quality drug development and approval. To advance development in areas of unmet public health needs, CDER has established processes to streamline reviews and external collaborations. CDER collaborates in precompetitive scientific discussions with internal and external stakeholders towards the development of innovative drug development tools/methods/approaches/standards. Every 2-3 years, the FDA, EMA and IMI host a summit with participation from government agencies, trade associations (including PhRMA and EFPIA), public-private-partnerships, academic institutions and patient groups.
The objectives of the meeting are to:

• Discuss the relevance of scientific data generated by public-private partnerships
• Review the interactions between stakeholders and discuss lessons learned
• Identify and prioritize areas of particular interest for funding and collaboration
• Determine how to better collaborate with the goal of early patient access to innovative treatments.

Planning for the summit usually occurs for well over a year and involves intense collaboration with international stakeholders. There is also extensive follow up with stakeholders for years after the meeting has concluded. The FDA Fellow will work with the preceptor and the Office Director to help plan, conduct, follow up and write reports on the scientific content, progress and deliverables of the summit meetings.

Applicant Requirements:

It is desirable that the Fellow has:

• An advanced degree in medical or social or scientific or public health field
• An understanding of drug development and regulatory processes
• Good writing, communication, time management skills

Selected Recent Publications

1. A Parekh, S Buckman-Garner, S McCune, R ONeill, M Geanocopoulos, S Amur, C Clingman, R Barratt, M Rocca, I Hills, J Woodcock, ‘Catalyzing the Critical Path Initiative: FDA’s Progress in Drug Development Activities’; Clinical Pharmacology & Therapeutics, Volume 97, Issue 3, Online January 28, 2015
2. R Poon, K Khanijow, S Umarjee, E Fadiran, M Yu, L Zhang, A Parekh, ‘Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009’; Journal of Women’s Health, Volume 22, Number 7, 2013
Book Chapters 2012:
1. Chapter in Principles of Clinical Pharmacology (3rd Edition), edited by Art Atkinson, Shiew-Mei Huang, Juan Lertora, Sanford Markey; Elsevier Inc., Chapter 23 ‘Pharmacological Differences between Men and Women’, Ameeta Parekh.
2. Chapter in Handbook of Clinical Gender Medicine: Book Chapter titled ‘Women in Clinical Drug Trials: United States Food and Drug Administration Update on Policies and Practices’, Ameeta Parekh; edited by Karin Schenck-Gustafsson, Paula DeCola, Donald Pfaff, David Pisetsky; Karger AG; p.466.
3. Ameeta Parekh, E. Fadiran, K. Uhl, Throckmorton, D: Adverse Effects in Women: Implications for Drug Development and Regulatory Policies. Expert Review of Clinical Pharmacology, Vol. 4, 453-466, July 2011.