Khyati Desai

Gene Therapy- mRNA- Clinical Early and Late Stage Programs - Rare Diseases- CMC Regulatory Strategy

Biologics- Oncology- Large Molecules- Clinical Early and Late Stage Products • Served as CMC regulatory strategy lead for biologics programs, supporting IND submission. • Led eCTD Module-3 CMC sections authoring team consisting of cross functional SMEs for a BLA and an IND submission. • Designed and implemented a BLA data verification process, secured cross-functional endorsement, and trained SMEs—strengthening data integrity and right-first-time submission outcomes. • Contributed to development of early-stage templates for biologic molecules IND and IMPD as a reviewer. • Created a template for CMC strategy planning to document phase-appropriate regulatory CMC strategy and risk mitigation for various phases of biologics programs.

Antisense Oligonucleotides- Small Molecules - Clinical and Post-approval - Rare Diseases • Served as a global regulatory CMC lead for early-stage antisense oligonucleotide (ASO) programs, providing strategic regulatory guidance from pre-IND through clinical development. • Developed Module 3 templates for early-stage programs, achieving an estimated 50% reduction in authoring and review timelines. • Led CMC documentation preparation and successful submission of phase- 1 IND/ CTAs across five global markets. • Supported NDA and MAA filings, coordinating cross-functional SMEs to deliver high-quality CMC documentation aligned with global regulatory standards. • Led eCTD CMC sections authoring team consisting of cross functional SMEs for post approval, variations, briefing materials annual reports and life cycle management. • Acted as regulatory CMC representative in change control governance, assessing regulatory impact and defining submission strategies for manufacturing and process changes. • Led and contributed to department-wide initiatives for improving processes, template life cycle management and creating health authority questions database and implementation of a trending tool.

Oncology- Small Molecules - Post Approval Products • Authored and reviewed high-quality eCTD CMC documentation to support global regulatory submissions for Oncology products. • Performed regulatory impact assessment for change controls affecting post approval products.

Small Molecules - OTC - Monograph - NDA - Technical Authoring - Post Approval Products - Formulation Development Global CMC Documentation · Supported global CMC documentation and lifecycle management for consumer health products, including authoring and maintenance of CTD Module 3 dossiers. · Performed review of change control requests for completeness and accuracy; assessed impact of change with regards to the regulatory application. · Worked cross functionally to coordinate the preparation of draft responses to technical-regulatory questions from health authorities about product composition, manufacturing, and analytical processes. · Participated in USP and ICH-focused training initiatives (e.g., ICH Q3D), disseminating regulatory intelligence to CMC teams. Formulation Development • Led orally disintegrating tablet prototype development for Consumer Care molecule and gained hands on experience in operating various laboratory scale equipment for solid dosage forms. • Designed and conducted accelerated stability studies for faster and cost-effective prototype development and presented results to the cross functional team.

Oncology Products Quality Control