— Integrated Pharma Consulting, LLC
Preclinical & CMC Expertise,
Available to Your Program
Helping early-stage biotech companies and academic spinouts advance drug candidates from discovery through first-in-human dosing with the strategic depth and pragmatic approach of an experienced industry team and dedicated partner.
15+
Years in Preclinical R&D
10+
INDs Filed & Initiated
— About
Pharma Veteran Depth.
Startup Speed.
Integrated Pharma Consulting, LLC was founded to give early-stage biotech companies and academic spinouts access to senior preclinical & CMC expertise typically available only inside larger pharmaceutical organizations — without the costly overhead.
With over 15 years leading preclinical R&D at Zentalis Pharmaceuticals and Kalyra Pharmaceuticals, I have personally guided oncology and pain programs through candidate design, nomination, IND-enabling study packages, nonclinical toxicology, DMPK, radiochemistry, and CMC strategy.
My early background as a medicinal chemist — co-inventor of kinase inhibitors, estrogen receptor degraders, and analgesic compounds that reached Phase I/II/III clinical trials — means I engage credibly across the full translational continuum, from discovery science to regulatory submission.
Please visit my LinkedIn profile (links in header & footer) for more information.
— Areas of Expertise
Scientific Depth Across
the Translational Spectrum
△ Nonclinical Toxicology
△ IND Strategy & Authoring
△ Medicinal Chemistry
△ Oncology Therapeutics
◈ DMPK / ADME
◈ CMC - Drug Substance & Product
◈ Schrödinger / Structure-Based Design
◈ Pain Therapeutics
◆ Radiochemistry & Mass Balance
◆ Import / Export
◆ CRO / CDMO Management
◆ Antibody Drug Conjugates (ADCs)
— Services
What I Offer
From development candidate nomination (DCN) to IND strategy to FIH clinical supply logistics, my team and I provide end-to-end preclinical and CMC development support tailored to your program stage and team structure.
△ Preclinical Strategy & IND Planning
Gap analysis, risk assessment, and study design to build a regulatory-ready data package. Clear go/no-go frameworks aligned to your corporate timeline and investor milestones.
△ CMC Advisory
Drug substance and drug product strategy for preclinical-stage programs. ICH stability design, tentative regulatory starting material designations, batch record review, and implementation of phase-appropriate controls and specifications.
△ Fractional Preclinical Leadership
Embedded senior leadership on a fractional basis for early-stage companies that need a seasoned preclinical or CMC head without a full-time hire. I integrate with your team and CRO network.
◈ DMPK & Toxicology Program Oversight
End-to-end management of ADME, metabolite identification, and nonclinical toxicology programs — including CRO selection, study oversight, and data interpretation for regulatory submissions.
◈ IND Authoring & Review
Authoring, co-authoring, and review of nonclinical & CMC IND modules and sections. Strategic cross-functional alignment with regulatory & clinical affairs to support timely filing.
◈ Due Diligence
Rigorous preclinical portfolio assessment for investors, partners, acquirers, and asset in-licensing. Independent evaluation of nonclinical data packages, regulatory readiness, and program risk profiles.
◆ Radiochemistry & AME Strategy
Radiolabeled synthesis, in vitro/in vivo studies (metabolite ID, mass balance, QWBA), and translation into human AME clinical pharmacology.
◆ Import/Export & Clinical Supply
Strategic planning and execution of US import/export for regulated and non-regulated drug substances and products to secure timely first-in-human dosing.
◆ Structure-Based Drug Design Advisory
Medicinal chemistry guidance for lead optimization, including Schrödinger platform expertise, SAR analysis, and route design for clinical candidates.
— Resources
Whitepapers, Articles & Useful Links
Useful resources covering CMC, Toxicology, DMPK, and much more. Check back in for updates!
- Whitepapers
- Articles: CMC
- Articles: Toxicology
- Articles: DMPK
- Links
- Calculators
Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material
Part 2: Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium
Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective
Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members
Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances
Coming soon!
Coming soon!
— Contact
Let's Advance Your Program!
Whether you need fractional leadership, project-specific advisory, or help navigating your first IND - I'd welcome the opportunity for a conversation. Please complete the form on the right for a free 30 minute consultation.
- Location
Indianapolis, IN
Available for remote & onsite engagements
- Engagement Types
Fractional leadership, project advisory, due diligence, IND support
- Therapeutic Areas and Modalities of Expertise
Oncology, Pain, small molecules, ADCs