Sheetal Agarwal Email & Phone Number

Brentford, Middlesex, Gb

Senior Global Regulatory Lead (GRL) with global regulatory strategic oversight for 3 early phase accelerated development assets, all cutting edge oncology products in synthetic lethality. I provide strategic regulatory input for assets at product development cross-functional teams. My role includes presenting regulatory plans at governance for candidate selection, commit to first time in human, working on probability of regulatory success, designing first in human studies, initial registration plans and global filings plans. I have led multiple agency interactions including PIND, type B, C D, scientific advice, I have submitted IND and global CTA submissions including EU-CTR, and have been a core member in providing regulatory input to clinical development plans to procure funding for projects. Im working on including considerations for orphan, breakthrough designation possibilities and accelerated approval pathways globally where such pathways are feasible into the CDPs. Tumor types include pan-tumor, ovarian, colorectal, endometrial, breast and gastric cancers. I am influencing cross functional team members and successfully and effectively presenting regulatory point of view. Im leading and influencing global regulatory teams attended by representatives from CMC, nonclinical and CDx. For the first 6 months at GSK, I worked on global filing plans for a late-stage asset in a second line multiple myeloma setting including critical FDA and EUmeetings to plan for filing.

Late stage Global Regulatory Lead (GRL) for regulatory strategy development, global filings and Agency interactions (leading FDA and participation in EMA, PMDA and CDE interactions) for pembrolizumab in combination with tucatinib or pembrolizumab alone in breast, gastric, Merkel and melanoma cancers. Agency interactions included FDA, PMDA, NMPA, EU as well as middle east, other Asian regions and Australia. Managed one direct report. Filed BLA for small molecule in breast cancer ex-US including in Singapore, Australia, Israel, Taiwan. Conducted pre-filing meetings in several rest of the world regions.

Durham, North Carolina, Us

- Global regulatory strategy lead for consulting on drug development projects + global submissions-Authoring Module 1 and 2 documents for IND/NDA/BLA submissions for CDER and CBER -Experience with Rare diseases including applying for Orphan, Fast Track, Breakthrough Designations-Therapeutic area experience includes oncology, respiratory, immunology, cardiovascular, and neurology products-Line manager to two US regulatory leads-Led several agency meetings and meetings preparation

Durham, North Carolina, Us

-Crossdiscipline Technical Lead and Global Regulatory Lead for global submissions, US agent for FDA submissions (IND, NDA, BLA, ANDA, pediatric study plans, and drug development milestone meetings such as PIND, PNDA)-Filed several INDs, 1 BLA and 1 NDA, led storyboards in US-Clinical and regulatory strategy expert on projects including gap analysis, due diligence, FDA IND and NDA submissions, MAA and Japan NDA submissions-Part of post-FDA submission rapid response team for FDA IRs-Worked on products with orphan designation and breakthrough designation -Special expertise in 505(b)(2) NDAs-Participated in BID defense, proposal building and project scoping activities for US and global submissions-Therapeutic area experience includes oncology, respiratory, immunology, cardiovascular, and neurology products among others

Silver Spring, Md, Us

Drug development, Reviewing Marketing Applications, INDs and Meeting Packages, Policy development, regulatory affairs, NMEs, 505(b)(2) NDAs, BLAs, biosimilar product development, regulatory research

Ph.D., Pharmaceutical Sciences

Masters Certificate, Project Management

Rac-Usa, Regulatory Affairs

Bachelor'S Degree, Pharmaceutical Sciences