My Services
Hands-On Expertise Across the Early-Phase Biologics Lifecycle
I specialize in the disciplines that determine whether an early-phase cell therapy or biologics program reaches first-in-human — IND-enabling CMC strategy, GMP quality systems, and FDA regulatory affairs.
CMC Development, GMP Quality & Manufacturing Support
Building the Manufacturing and Quality Foundation Your Program Needs
For early-phase translational programs, CMC strategy and GMP quality infrastructure are often the most underestimated challenges. FDA scrutinizes manufacturing data at every IND-enabling stage — and the decisions you make in early development set the trajectory for everything that follows. I help you build a CMC and quality program that is scientifically rigorous, resource-appropriate for your stage, and designed to satisfy FDA expectations from your first IND filing.
IND-Enabling CMC Strategy
End-to-end CMC planning for IND-enabling programs — from initial process development through Phase 1 manufacturing readiness. I help you define what FDA needs to see and build a program that delivers it efficiently, with direct experience in autologous cell therapies and iPSC-derived products.
GMP Quality System Development
Design and implementation of GMP quality systems for early-phase investigational products — including SOPs, quality indicators, event trending, equipment and materials management, and environmental monitoring programs tailored to your manufacturing environment.
Cleanroom Facility Design & Commissioning
Hands-on guidance for cleanroom facility design, commissioning, and ongoing monitoring — including validation master plans, preventive maintenance schedules, and environmental monitoring programs for GMP manufacturing environments.
Analytical Characterization & Method Development
Strategy and oversight for early-phase analytical characterization, method development, and qualification — ensuring your analytical package meets Phase 1 IND expectations without over-investing in premature validation.
CDMO Selection & Technical Oversight
Support in identifying, evaluating, and managing contract development and manufacturing organizations for early-phase programs — including due diligence, technical oversight, and ensuring your CDMO delivers what your IND requires.
CMC Sections for IND Applications
Authoring and review of CMC sections for IND applications and IND amendments — written to meet FDA expectations for early-phase programs, with direct experience authoring first-in-human IND submissions for cell therapy products.
Right-Sized CMC and Quality Strategy for Early-Phase Programs
Early-phase CMC and GMP quality programs don't need to be commercial-scale — but they do need to be strategically designed. I help biotech startups invest in the right activities at the right time, building a foundation that satisfies FDA for Phase 1 while setting up efficient transitions to later stages.
Regulatory Strategy & FDA Submissions
Navigate the IND-Enabling Regulatory Path with Confidence
For translational programs, regulatory strategy begins long before your first FDA submission. The decisions you make in early development — study designs, manufacturing choices, clinical endpoints — are all shaped by regulatory expectations. I help biotech founders understand the IND-enabling regulatory landscape and build development programs that move efficiently from bench to first-in-human, with direct experience leading regulatory affairs at a cell therapy startup.
Pre-IND Strategy & FDA Meeting Preparation
Strategic planning for pre-IND interactions with FDA, including pre-IND meeting requests, briefing document preparation, and question strategy — ensuring you get the guidance you need before committing to your development plan.
IND Application Preparation & Submission
End-to-end support for Investigational New Drug applications — from initial regulatory strategy through module authoring, cross-functional coordination, and FDA submission. I have primary experience authoring and submitting first-in-human INDs for cell therapy products, including autologous cardiac cells derived from iPSCs.
Regulatory Pathway Assessment
Evaluation of available regulatory pathways and expedited programs — Fast Track, Breakthrough Therapy, Rare Pediatric Disease, Orphan Drug designation — and strategy for pursuing designations that can accelerate your early-phase program.
IND-Enabling Study Design Guidance
Regulatory input on the design of IND-enabling nonclinical studies — pharmacology, toxicology, and safety pharmacology programs — ensuring your study designs will support the IND and the clinical program you intend to run.
Clinical Hold Response & IND Amendment Strategy
Rapid, strategic responses to FDA clinical holds, information requests, and IND amendments — minimizing delays and protecting your first-in-human timeline.
Regulatory Compliance & Inspection Readiness
Preparation for FDA, FACT, AABB, and other regulatory inspections — including quality system review, documentation readiness, and staff training on regulatory requirements for GMP manufacturing environments.
Regulatory Strategy Starts Before the IND
The most costly regulatory mistakes in early-phase programs are made before the first submission — in study designs, manufacturing decisions, and development assumptions that don't align with FDA expectations. I integrate regulatory thinking into your translational program from the earliest stages, so you arrive at your IND ready.
Not Sure Where to Start?
Many of my clients come to me at an inflection point — a new translational program, a pre-IND meeting to prepare for, or a manufacturing decision that will define their development path. Let's talk through your situation.