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 — with 30+ years of AAV gene therapy CMC experience — supports drug developers, manufacturers, CDMOs, as well as investors across AAV gene therapy CMC.
Engagements range from focused project consulting and retainer arrangements to fractional or interim CMC 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.
What to Expect
Our Consultation Process
You will work directly with Dr. Franz Gerner 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 as needed
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 or interim CMC leadership.
Hourly Consulting
Focused expertise on specific questions
Pay only for time used
No long-term commitment
Ideal for: Specific technical questions, short-term projects, ad-hoc advice
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
Retainer Arrangements
Ongoing support and availability
Predictable monthly cost
Priority access
Ideal for: Multi-phase projects, ongoing technical advisory, continuous strategic guidance
Fractional or Interim CMC Leadership
Embedded part-time CMC leadership
Cross-functional team and program oversight
Hands-on engagement and execution
Ideal for: Drug developers and CDMOs requiring senior CMC oversight, leadership transitions, 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 solving problems, not writing 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: What industries do you serve?
A: Primarily biotechnology and pharmaceutical companies developing AAV gene therapies, plus CDMOs, investors, and service providers supporting gene therapy development.
Next Steps
Ready to discuss your AAV gene therapy needs?
To Get Started:
Download our Consultation Preparation Checklist to identify your priority areas
Email the completed checklist — or simply reference your priorities — to fgerner@smatconsultants.com
We will respond 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.