Developing a comprehensive strategy for long-term follow-up in cellular and gene therapy clinical development
Based in San Francisco, California, I specialize in helping early-stage biopharmaceutical companies and academic researchers efficiently translate groundbreaking discoveries into FDA-approved therapies that reach patients faster.
Combining over two decades of scientific expertise with MBA-level business acumen, I provide targeted mentorship for new C-level executives navigating the complex journey from academic research to commercial success. My unique approach bridges the gap between scientific innovation and regulatory approval.
Serving as your primary liaison with global regulatory agencies such as the FDA and EMA, I streamline communication during pre-IND engagements and review cycles, develop efficient regulatory strategies across jurisdictions, and align stakeholder expectations to help turn scientific discoveries into approved therapies faster worldwide.
Good advice is not about following strict rules. Real innovation often starts when we question rules that do not fit the fact.
This is an interview with Dr. Cori Gorman that explores her remarkable transition from earning a PhD in cell biology and genetics in 1980 to becoming a driving force in the biotech industry. The conversation follows her path through the National Institutes of Health to her groundbreaking work at Genentech, where she contributed to the development of life-changing therapies like Herceptin and treatments for hemophilia. Dr. Gorman shares her unique perspective on managing career pivots, the necessity of taking calculated risks, and the vital lessons learned while shaping the future of genomic medicine.
Bridging academic innovation and FDA approval through strategic guidance and regulatory expertise
Specialized guidance for new C-level executives and founders transitioning from academic research to commercial biopharmaceutical development, combining scientific expertise with MBA-level business strategy.
Primary point of contact between academic teams and FDA regulators, facilitating pre-IND meetings, managing review cycle communications, and developing efficient regulatory roadmaps that accelerate approval timelines.
Proven track record of helping academics efficiently translate groundbreaking discoveries into FDA-approved therapies, optimizing resources and timelines to benefit patients sooner.
Comprehensive support for global pre-IND planning, submission pathway determination across multiple regulatory agencies, and regulatory document development to drive efficient reviews and first-time approval success for early-stage companies.
Expert guidance on clinical trial design specifically tailored for academic discoveries transitioning to first-in-human studies, with focus on efficient protocols that meet FDA requirements.
Distinguished research career including American Cancer Society Fellowship at NCI with Ira Pastan, NATO and EMBO Fellowships at Imperial College, and extensive publications on recombinant protein production and therapeutic development.
Led the development and manufacturing of trastuzumab (Herceptin®) at Genentech, transforming HER2+ breast cancer treatment and extending survival for thousands of patients worldwide.
Pioneered ADC technology development, contributing to breakthrough therapies like Kadcyla® and advancing precision medicine approaches in oncology.
Built and led multidisciplinary teams across CMC, regulatory affairs, and quality assurance, ensuring seamless integration from discovery through commercial launch.
Developed comprehensive regulatory strategies for advanced therapies, including long-term follow-up protocols that balance patient safety with practical implementation.
Demonstrated why mammalian cell systems outperform bacteria for producing complex, biologically active proteins and eliminates inefficient refolding steps common in bacterial production at Genentech.
Bridging academic innovation and FDA approval through strategic guidance and regulatory expertise
• Phase I: 1–1.5 years
• Phase II: 2–2.5 years
• Phase III: 2–3 years
• Phase I/II seamless: 1–2 years
• Adaptive Phase II/III: 2–3 years
*Overlapping stages reduce total time
Accelerated development is not about lowering standards. It is about preventing avoidable risk. Early regulatory alignment, parallel execution, and integrated clinical, CMC, and manufacturing strategy reduce rework, control costs, and improve decision quality across development.
Bridging the gap between academic discovery and FDA-approved therapies, helping early-stage companies bring life-saving treatments to patients faster
Specialized support for emerging biopharmaceutical companies and academic spinouts navigating the transition from discovery to clinical development, with focused mentorship for new C-level executives.
Leveraging MBA expertise combined with scientific knowledge to help academics efficiently translate groundbreaking discoveries into therapies that reach patients faster.
Serving as the primary bridge between academic research teams and global regulatory authorities including FDA, EMA, Health Canada, and other worldwide agencies, ensuring clear communication, managing expectations, and facilitating productive interactions throughout review cycles across multiple jurisdictions.
Creating efficient, strategic pathways for interactions with global regulatory agencies including FDA, EMA, Health Canada, and other worldwide authorities that accelerate approval timelines and increase success probability for academic discoveries becoming approved therapies across multiple markets.
Expert guidance on clinical trial design and execution specifically tailored for early-stage companies transitioning from preclinical research to first-in-human studies.
Comprehensive regulatory support ensuring early-stage companies meet FDA and EMA requirements efficiently, avoiding costly delays and increasing approval likelihood across global markets.
Trusted by early-stage companies and academic researchers navigating the path to FDA approval
Let’s discuss how to accelerate your path from academic discovery to FDA-approved therapy