About Ingenious Global Health Team
Connect with your Partner Team:
Dr Shailesh Chavan (Co-Founder, Chief Medical Officer)
Dr. Chavan is a physician-scientist executive with extensive experience in pharma, biotech, and CRO leadership. He specializes in patient-centric innovation, product development from early to late phases, and life-cycle management.
With a strong track record in successful phase 3 program leadership, submissions and approvals (Hepatitis B, Hepatitis C, CMV and Primary Immuno-deficiency), he brings deep expertise across immunology, oncology, neurology, and transplantation.
Dr Chavan is currently focused on investing, consulting and mentoring start-up founders (drugs, medtech, diagnostics, techbio, digital health) to solve healthcare's critical problems.
Key strengths include: Strategic leader with deep operational execution expertise.
- Clinical Development: TPP, Asset review, pre-IND, Ph1-4 protocol writing, review, clinical development & operational lead, medical monitoring, trial data reviews, CSR, regulatory submission, post-marketing study writing, real world study, registry
- Technical Operations & Program Management: CRO and consultant strategy, oversight and management.
- Regulatory Leadership: Global regulatory (FDA, EMEA, PMDA, sFDA, CDSCO) submissions contact for early- and late-stage programs
- Safety: safety lead, risk-benefit strategy, documents (IB, safety narratives, aggregate (PSUR/ DSUR) reports, literature monitoring, DSMB reviews, regulatory submissions
- Medical Affairs: Strategic planning, Medical communications, evidence generation, stakeholder (KOLs/ HCPs/ patient advocacy/payors), launch readiness and organization optimization (MSLs and operations).
- Regulatory Affairs: IND, NDA, BLA, 510(k), Orphan, Fast Track, Breakthrough designation submissions
- GxP Compliance: FDA, EMA, PMDA, MHRA audit readiness and remediation
- Quality Systems: SOPs, batch records, deviations, CAPAs, validation protocols