— 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
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