Named, credentialed, and on the record
Every card below is a real person with a public bio — not a category. Filter by function or region to find the judgment your program needs.
Dr. Ashok Srivastava, MD, Ph.D., MBA
President & Chief Medical Officer · 27 INDs · 9 NDAs · 3 BLAs
CAR-T, ADC, radioligand therapy, oncolytic viruses & vaccines — named modality specialist.
Dr. Jitesh Rana, MD, MBBS
20+ Years PV · Former VP Safety, Dyne Therapeutics
Drug safety, pharmacovigilance, and IND/NDA/BLA regulatory submissions across oncology and rare disease.
Prof. Raghunadharao Digumarti, MD, DM, FRCP, FACP
Principal Investigator, 82 clinical trials since 1993
Oncology, hematopoietic stem cell transplantation, and early-phase clinical trials — India.
Dr. Robert L. De Jager, M.D., F.A.C.P.
40+ years in anticancer drug development, IND to NDA
Monoclonal antibodies, immunotherapy, cancer vaccines, and solid-tumor therapeutics.
Dr. William E. Gannon, Jr., M.D., M.B.A.
Chief Scientific Officer & Medical Director, CCTC
Regulatory strategy, submissions, and clinical trial operations across the U.S., Europe, and Asia.
Dr. Med. Dnyaneshwar Arjun Sanap, MBA
EU/UK QPPV · Zero Inspection Findings
PV system build, signal management, and AI-enhanced safety surveillance across the EU and UK.
Mohamed Bakra, MBChB, MSc, CPHQ, LSSGB
PI/Medical Monitor · 100+ Phase I–III Studies
Oncology, radiopharmaceuticals, neuroscience, and immunology — Australia.
No named expert matches that combination yet — every function and region above is also resourced through our vetted specialist network on engagement.
Seven named experts today, with more joining as they're vetted and profiled. Interested in joining? →
Expertise Gaps at Critical Moments
Small-to-mid-size biopharma companies face a persistent dilemma:
- ►You need C-level expertise to de-risk pivotal trials and regulatory submissions
- ►You can't afford full-time executives with the right credentials and track record
- ►Generic consultants lack the hands-on experience with your specific therapeutic area and technology needs
- ►Time is critical—waiting months for the right guidance can derail funding timelines
The consequence? Protocol design flaws that lead to slow enrollment, costly amendments, or clinical holds. According to Tufts CSDD, 57% of protocols require substantial amendments, adding $500K–$2M in costs and 4–6 months in delays.
The Program Readiness Board Model
Instead of hiring a large consulting firm where you get their B-team, or struggling to find the right expert through traditional networks, AyurDatta provides:
The Program Readiness Board — for your program, not a patient. Unlike a traditional patient-level tumor board, our PRB evaluates the program — integrating clinical, regulatory, safety, data, and technology readiness into one board-level view. A named physician chairs each session and signs every recommendation.
Precision-Matched Expertise
We assemble a custom Program Readiness Board (PRB) from our vetted network of KOLs with direct experience in your therapeutic area, technology stack, and regulatory pathway.
Rapid Deployment
- ►72-hour initial assessment of your protocol and risk landscape
- ►7-day expert team assembly with the right clinical, regulatory, and technology specialists
- ►2–6 week engagements with clear deliverables and principal sign-off at every milestone
Confidential & Strategic
All engagements operate under NDA, positioning our experts as your strategic advisors—not vendor representatives with conflicts of interest.
Powered by the IHASG framework. The PRB is the expert layer within AyurDatta's Integrated High-Acuity Safety Governance (IHASG) standard — the named physicians and specialists who review what AI flags, adjudicate benefit-risk, and sign the documented decision trail.
Learn about IHASG →Three named members, an expanding board
Prof. Raghunadharao Digumarti, Dr. Robert L. De Jager, and Dr. William E. Gannon, Jr. sit on the Advisory Board today, bringing decades of oncology drug development, clinical research, and regulatory strategy judgment. Dr. Ashok Srivastava (President & CMO) and Elias Tharakan (CEO & CTO) are AyurDatta's named principals — the accountable owners every engagement runs through. We are deliberately selective about who joins the board next; every new member carries the same standard: named, credentialed, and on the record.
See the full bench above → · Meet the principals →Five ways the bench shows up in your program
Assembled as a Program Readiness Board for a defined review window, then stood down.
Chairing or serving on data safety monitoring and independent data monitoring committees.
Small, standing groups doing recurring signal or protocol review across a program's lifecycle.
Named medical and safety depth added to a CRO's or FSP's proposal before the sponsor decision.
Medical monitor, PI, or continuous reviewer embedded in your operating rhythm for the program's duration.
Credentials That Matter
Clinical & Regulatory Expertise
Our clinical KOLs bring proven track records, not just credentials:
- ►Direct experience across IND, NDA, and BLA submissions
- ►Direct leadership in approvals for first-in-class therapies
- ►Veteran FDA & EMA experts and reviewers providing mock audit insights
- ►Oncology (Solid Tumors, Hematology, Immuno-Oncology)
- ►Complex toxicity management (renal, cardiac, hepatic)
- ►Advanced therapies (CAR-T, ADCs, oncolytic viruses, RNAi, gene therapy)
We match you with experts who possess the specific combination of MD (clinical execution), PhD (scientific rigor), and MBA (commercial strategy) relevant to your program's stage.
- ►Board positions at cutting-edge biotech companies
- ►Relationships with FDA, EMA, PMDA regulators
- ►Principal Investigators from top academic medical centers
- ►Chairs of Data Safety Monitoring Boards (DSMBs)
- ►Authors of pivotal guidelines (NCCN, ASCO, ESMO)
Need Technology and AI Strategy Support?
Technology and AI advisory is now delivered through our dedicated Fractional CTO offering to ensure clear scope, pricing transparency, and direct founder involvement.
Explore Fractional CTO AdvisoryTwo Engagement Models
Targeted Expert Consultation
When to use: You have a specific challenge that requires deep domain expertise.
Clinical & Regulatory:
- ►IND/BLA/NDA "Red Team" Review
- ►Phase 1/2 Protocol Design & Optimization
- ►Global Health Authority (GHA) Strategy
- ►Safety Review & Pharmacovigilance Audit
Technology & AI:
- ►AI Strategy & Governance Audit
- ►Clinical SaaS Platform Vendor Selection
- ►M&A Technology Integration Planning
- ►GenAI/RAG Proof-of-Concept Development
What you get:
- ►Direct engagement with the named domain expert who owns the work
- ►Detailed written analysis with actionable recommendations
- ►Implementation roadmap with success metrics
- ►30-day post-engagement support
Program Readiness Board (PRB)
When to use: You're approaching a critical inflection point (IND filing, Phase 1b data readout, Series B fundraise) and need comprehensive de-risking.
What you get:
Week 1–2: Dual-Track Assessment
- ►Clinical Track: Complete protocol review, regulatory strategy, feasibility analysis
- ►Technology Track: Data architecture evaluation, AI opportunity identification, vendor stack audit
Week 3: Integration & Synthesis
- ►Joint findings session between clinical and technology experts
- ►Identification of critical disconnects between strategy and execution
- ►Risk prioritization matrix
Week 4: Deliverables
- ►Unified "Board-Ready" report with executive summary
- ►12-month implementation roadmap
- ►Specific protocol modifications and technology recommendations
- ►Investor-facing risk mitigation summary
Why Clients Choose Our Network
"Insider" Advantage
Our clinical experts work with major CROs and bring operational insights to your side of the table. You get the insider knowledge of how CROs think, price, and operate—without the vendor conflicts.
Owner's Representative Model
We don't replace your CRO or technology vendors. We act as your expert agent to:
- ►Validate vendor recommendations
- ►Hold them accountable for deliverables
- ►Identify gaps or inefficiencies early
- ►Provide objective "buy vs. build" guidance
Current, Relevant Expertise
Our experts maintain active C-level roles, giving you access to:
- ►Real-time market intelligence
- ►Current regulatory thinking
- ►Latest technology capabilities
- ►Emerging best practices
Named Accountability
Unlike large consulting firms that staff projects with junior associates, our SOWs name the credentialed expert who performs the work, with a principal accountable for sign-off.
Need dedicated executive leadership instead of network access? Explore Fractional CMO and Fractional CTO options.
Integration with AyurDatta Services
Our KOL network seamlessly integrates with our full suite of services:
KOLs inform protocol design, endpoint selection, and site strategy
Technology experts ensure your data infrastructure supports advanced analytics and AI
Clinical and regulatory KOLs prepare submissions and anticipate health authority questions
PRB model provides program-level governance across clinical, regulatory, safety, and technology readiness
Quality Assurance & Compliance
- ►Minimum 15 years of relevant experience
- ►Verified track record of regulatory approvals or platform deployments
- ►Active conflict-of-interest screening
- ►Confidentiality and IP protection agreements
- ►All work performed under ICH-GCP, ISO 14155, and GDPR compliance
- ►AI recommendations include auditability and explainability
- ►Documentation suitable for regulatory inspection
- ►Quality review by AyurDatta leadership before delivery
Are you a physician or specialist?
We're deliberately selective, but always looking for named, credentialed depth in modalities and functions we don't yet cover. Send us your CV and area of practice — we respond to every inquiry.
Apply to join the networkThree Steps to Expert Access
Initial Consultation
30-minute confidential discussion of your challenge, timeline, and objectives.
Expert Matching & Proposal
We identify the right KOL(s) and provide a detailed SOW with guaranteed expert names, deliverables, and timeline.
Rapid Deployment
Engagement begins within 7 business days of SOW signature.
Frequently Asked Questions
Q: How do you select which experts to engage for my project?
We match based on three criteria: (1) specific therapeutic area and modality experience, (2) regulatory pathway familiarity, and (3) technology stack relevance. You'll receive expert bios before engagement begins.
Q: What if I need expertise outside your current network?
We maintain relationships with vetted specialists across oncology, rare disease, and advanced therapies — spanning medical monitoring, pharmacovigilance, regulatory strategy, biostatistics, and clinical technology. If we don't have the right expert in-network, we'll identify and vet someone within 10 business days at no additional cost.
Q: Can I engage the same expert for multiple projects?
Yes. Many clients establish ongoing relationships with specific KOLs for continuity across their development program.
Q: How do you handle conflicts of interest?
All experts complete conflict disclosure before engagement. We screen for direct competitive conflicts and financial relationships that could compromise objectivity.
Q: What makes this different from traditional expert networks?
Traditional networks provide one-hour phone consultations with experts you'll never speak to again. We provide multi-week engagements with documented deliverables, implementation support, and guaranteed expert involvement—positioning them as strategic advisors to your program.
Ready to de-risk your program with world-class expertise?
Book a Strategy Call or explore our engagement models.