About
25 Years Navigating FDA-Regulated Biologics Development
Anderson Biologics Consulting is a boutique solo practice built on deep, hands-on experience in translational cell therapy, IND strategy, and quality systems for early-phase investigational products.
My Story
I built this practice after 25 years working at the intersection of translational research, GMP manufacturing, and FDA regulatory affairs — most of it focused on early-phase cell therapies and investigational biologics.
My career spans the full arc of early-phase development: from translating basic research protocols into clinical-grade manufacturing processes, to leading quality system development for GMP facilities, to serving as Chief Regulatory Officer at a biotech startup where I was directly responsible for strategy and submission of a first-in-human IND for autologous cardiac cells derived from iPSCs.
I founded Anderson Biologics Consulting to bring that depth of experience directly to emerging biotech companies — without the overhead of a large firm. If you're navigating the IND process, building out your quality infrastructure, or trying to get your manufacturing program ready for FDA scrutiny, I've done it firsthand.
You Work Directly With Me
There are no junior consultants, no account managers, and no handoffs. Every engagement is led by me personally — so you get direct access to 25 years of hands-on experience, on every call and in every deliverable.
Regulatory and Quality in One Practice
IND strategy and quality systems are inseparable in early-phase manufacturing. I bring both lenses to every engagement — ensuring your GMP infrastructure and your regulatory submissions are built to work together from day one.
Practical, Milestone-Focused Advice
I understand the resource constraints of early-stage companies. My recommendations are calibrated to your stage, your budget, and your next milestone — not to a theoretical ideal that doesn't account for your reality.
About Me
J.M. Anderson
Founder & Principal Consultant
B.S. Medical Technology, North Dakota State University | 25 Years in FDA-Regulated Biologics & Cell Therapy
My career spans 25 years in FDA-regulated environments, with deep expertise in translational research for experimental cell therapies, IND preparation and submission, GMP quality systems, and cleanroom facility development. I have served as Chief Regulatory Officer at HeartWorks/ReGen Theranostics, where I led all regulatory and quality activities for a small biotech startup developing autologous cardiac cells from iPSCs — including primary responsibility for the strategy, authoring, and submission of the program's first-in-human IND. Prior to that, I held senior regulatory and quality roles at Mayo Clinic's Center for Regenerative Medicine and Department of Laboratory Medicine and Pathology, where I led GMP facility commissioning, enterprise quality program development, and IND process navigation for early-phase investigational products. I have direct experience with FDA, FACT, and AABB inspections, and have trained and mentored scientists, clinicians, and manufacturing staff at all levels.
Work With Me
I take on a limited number of engagements each year to ensure every client receives the attention their program deserves. If you're building an early-phase biologics or cell therapy program, I'd like to hear about it.