Discuss Your AAV Program with SMAT Consultants
Whether you are planning an IND or CTA submission, optimizing manufacturing costs, evaluating CDMOs, conducting technical due diligence, or working through unexpected manufacturing challenges, SMAT Consultants supports drug developers, manufacturers and CDMOs, as well as investors and strategic partners — drawing on Franz Gerner's three decades in AAV gene therapy CMC.
Engagements range from retainer advisory and focused project consulting to fractional Head of CMC or interim CTO leadership for early-stage drug developers requiring senior CMC oversight without a full-time hire. Schedule a confidential, no-obligation consultation to discuss your program.
Attending Cell & Gene Meeting on the Mesa 2026 — Phoenix, October 5-7
Available for partnering meetings during the Cell & Gene Meeting on the Mesa. CMC lifecycle support for drug developers, technical due diligence and COGS analysis for life sciences investors, as well as process and analytical optimization for AAV CDMOs. Retainer, project-based, as well as fractional Head of CMC and interim CTO engagements.
What to Expect
Our Consultation Process
You will work directly with Franz Gerner, PhD throughout the engagement — no junior consultants or account managers. The process below outlines what to expect from initial conversation through engagement kickoff.
Step 1: Initial Consultation (30 minutes, no charge)
Discuss your priorities, challenges, and objectives
Assess fit and identify the most relevant approach
Completely confidential — we sign NDAs before any detailed program discussion
No obligation whatsoever
Step 2: Proposal Development (if appropriate)
Detailed scope of work tailored to your specific needs
Clear pricing structure and engagement model options (see Engagement Models below)
Expected timeline and deliverables (for project-based work)
Flexible terms to fit your budget and urgency
Step 3: Engagement Kickoff (if we proceed)
Engagement agreement signed and project formally initiated
Project communication channels and cadence established
Direct, senior-level engagement throughout
Engagement Models
Engagements are structured to fit your project, scope, and budget — from focused project consulting to fractional Head of CMC or interim CTO leadership.
Retainer Advisory
On-call access at an agreed rate, structured as a statement of work
No minimum hours required, with rate discounts for committed quarterly minimums
Predictable availability and priority response
Ideal for: Ongoing technical advisory, on-call support between milestones, continuous strategic guidance
Project-Based Consulting
Defined scope and deliverables
Fixed price or time-and-materials
Clear timeline and milestones
Ideal for: Technology assessments, CDMO selection, due diligence, method development
Fractional CMC Leadership
Fractional Head of CMC for preclinical and clinical-stage programs
Cross-functional team and program oversight, with hands-on engagement
A standing senior CMC presence without a full-time hire
Ideal for: Drug developers needing ongoing senior CMC leadership without a full-time commitment
Interim CTO
Full-scope CMC and technical leadership during a transition or gap
Steps in to maintain momentum and decision-making continuity
Defined duration, with a clear handover at the close
Ideal for: Leadership transitions, covering a vacancy, rapid program acceleration
During the initial consultation, we will recommend the approach that best fits your situation.
Our Commitment to You
Confidentiality
All discussions are strictly confidential. We sign NDAs before any detailed program discussion.
Conflict-Free Engagements
We maintain strict separation between clients working on competitive programs. Potential conflicts are discussed transparently during initial consultations and managed through clear scope boundaries.
No-Pressure Approach
Initial consultations are genuinely exploratory — we are here to help you understand your options, not to pressure you into engagement. If we are not the right fit, we will tell you and may suggest alternatives.
Responsive Communication
Prompt email responses and flexible scheduling for calls — including time-zone accommodation for international clients.
Practical, Actionable Advice
Our goal is to solve problems, not write reports that sit on shelves. We deliver practical, implementable solutions with clear action steps.
Transparent Pricing
No hidden fees or surprise charges. You will know exactly what services cost before any engagement begins.
Objective Recommendations
Recommendations on CDMOs, vendors, and technologies are based on technical fit and program needs — never referral relationships or commissions.
Frequently Asked Questions
Q: How quickly can you start supporting our program?
A: Often within 1-2 weeks of initial consultation, depending on scope. For urgent needs, we can sometimes begin even sooner.
Q: Do you work with early-stage companies with limited budgets?
A: Yes. We offer flexible pricing and engagement models. Many early-stage clients start with targeted consulting on critical questions, then expand as budgets allow.
Q: Do you take equity in lieu of fees?
A: We consider equity arrangements for very early-stage companies where cash is extremely limited and there is strong strategic alignment.
Q: Do you work internationally, and can you work on-site?
A: Yes to both. We support clients globally, with most work conducted remotely. On-site support is provided for facility design reviews, equipment qualification, process troubleshooting, audits, technology transfer, as well as other situations where on-site presence adds value.
Q: Who do you work with?
A: Primarily biotechnology and pharmaceutical companies developing AAV gene therapies, as well as manufacturers and CDMOs, investors, and strategic partners supporting gene therapy development.
Q: How are engagements billed?
A: Most consulting is billed hourly, with caps or committed-hour arrangements available. Fractional leadership is typically structured as a monthly fee. We will work with you on the structure that best fits your scope and budget.
Next Steps
Ready to discuss your AAV gene therapy needs?
To Get Started:
Optional: To get the most out of the call, download our Consultation Preparation Checklist to identify your priority areas and attach it to your email (step 2).
Email a few lines about your program and what you need help with — or simply send the completed checklist — to fgerner@smatconsultants.com.
We will respond promptly to schedule a complimentary 30-minute initial consultation.
Contact Information:
Email: fgerner@smatconsultants.com
LinkedIn: Connect on LinkedIn
Initial consultations are confidential and no-obligation. We work with clients globally — see What to Expect for the full consultation and engagement process.