Scientist CEOs need clinical guidance at exactly the moment capital efficiency matters most.
Most scientist-founded biotechs have brilliant science and no internal medical leadership — at the stage when its absence is most costly.
Protocol amendments cost $100K–$500K each and add 4–6 months to your timeline. The right clinical leadership prevents most of these before they happen.
FDA meetings are make-or-break moments — without experienced medical leadership, you may not ask the right questions or bring the right data.
Investors are asking for clinical strategy you haven't validated — and you need a credible medical voice to back your roadmap.
Dr. Ashok Srivastava — the 60-second version
Dr. Ashok Srivastava
President & Chief Medical Officer, AyurDatta
MD, Ph.D., MBA with 135 clinical trials led across Phase 1–3, including 11 first-in-human studies. Contributing physician on the AUCATZYL® (Obe-cel) BLA — FDA-approved CD19 CAR-T therapy. 27 INDs, 9 NDAs, 3 BLAs filed across FDA, EMA, PMDA. DSMB and IDMC Chair for novel modality programs including CAR-T, ADC, and oncolytic virus.
Clinical leadership without full-time overhead
Engage senior medical leadership for decisive trial strategy, protocol confidence, and risk mitigation at critical milestones.
Reduce amendment risk with early expert review and practical site-facing guidance.
Strengthen briefing packages, authority interactions, and submission narratives.
Support medical monitoring, safety committees, and cross-functional decision cadence.
Four advisory domains
Clinical Strategy
- ► Early-phase and late-phase clinical roadmap planning
- ► Endpoint and patient population strategy
- ► Go/no-go decision support for portfolio milestones
Protocol and Safety Leadership
- ► Protocol and amendment reviews
- ► Safety governance and medical review support
- ► Medical monitoring escalation frameworks
Regulatory Readiness
- ► Health authority meeting readiness
- ► IND, NDA, and BLA strategic alignment
- ► Medical narrative quality control
Executive Collaboration
- ► Board and investor clinical strategy communication
- ► Collaboration with CTO and operations leadership
- ► Cross-functional risk governance
Three commitment levels
Scope and investment are finalized on the discovery call to align with your stage, indication, and timeline.
Clinical Advisor
4–8 hrs / month
Strategic guidance and milestone reviews for programs with an existing internal medical function.
Scoped on discovery call
Fractional CMO
20–40 hrs / month
Active medical leadership across protocol, regulatory strategy, safety oversight, and cross-functional decision cadence.
Scoped on discovery call
Embedded Medical Lead
40+ hrs / month
Full principal availability across all program workstreams — suited for pivotal-stage programs or pre-submission periods.
Custom scope
Not ready for a retainer?
Project fees can be credited toward a future retainer engagement.
Protocol Design & IND Prep
Fixed-fee engagement
Protocol design, endpoint selection, IND package review.
FDA Meeting Strategy
Fixed-fee engagement
Pre-meeting prep, briefing package, attendance support.
DSMB/IDMC Setup & Chairmanship
Fixed-fee engagement
Charter development, member selection, ongoing governance.
Clinical Program Assessment
Fixed-fee engagement
Current program review, gap analysis, remediation roadmap.
Ideal client profile
Series A or B biotech with an active or planned clinical program and no internal CMO
Scientist-founded companies transitioning from discovery to clinical development
Companies preparing for their first IND or first-in-human study
Any team that has experienced costly protocol amendments and wants to prevent recurrence
Frequently asked questions
How quickly can you start?
Most engagements begin within 2 weeks of SOW signature.
Do you work with companies outside the US?
Yes. Dr. Ashok has filed INDs across FDA, EMA, PMDA, and DCGI, and works with companies globally.
Is this separate from AyurDatta's safety governance services?
The clinical advisory can be engaged completely independently. Many clients use only the fractional CMO engagement. Others engage both — clinical medical leadership and safety governance oversight — and benefit from the integration between them.
What if my need is project-based rather than ongoing?
Project-based engagements are the most common starting point. Most convert to an ongoing retainer after the first defined project.
Need technology and medical leadership together?
Combine Fractional CMO and Fractional CTO support for unified clinical and platform execution.