Built by the people
who set the FDA standards.

Liz Wang

Cofounder & Chief Executive Officer

Liz brings nearly 7 years of hands-on industry cGMP experience leading Tech Transfer, Process Validation, and CMC activities for vaccines, mRNA therapeutics, monoclonal antibodies, and lipid nanoparticle products. Her technical expertise spans mammalian and insect cell culture, viral vectors, mRNA-LNP formulation, TFF, and anion-exchange and affinity chromatography. Liz led engineering teams across 3 continents on drug substance (DS), drug product (DP) scale-up and manufacturing on critical pre-IND to clinical activities for regulatory submissions. Liz is an advisor for Hong Kong Science and Technology Park.

Laura C. Rose, PhD

Cofounder & Chief Regulatory Officer

Laura is a former FDA Director with nearly 8 years of FDA experience at CDER (Center for Drug Evaluation and Research) and CDRH (Center for Devices and Radiological Health), where she directed a multi-disciplinary team of 14+ medical officers, epidemiologists, engineers, biologists, and chemists.

As signing authority on FDA submissions, Dr. Rose oversaw 300+ decisions spanning tissue engineering, regenerative medicine, restorative and repair orthopedic devices and combination products with biologics, small molecules, recombinant proteins, and peptides. Her supervisory record includes 25+ original IDEs, 220+ 510(k)s, 300+ Q-Submissions, 8+ De Novo petitions (including the first-granted combination product), and multiple original PMAs. Dr. Rose worked extensively with CBER on product containing human cells and tissue.

Johnny Lam, PhD

Head of Regulatory Strategy

Johnny is a former FDA CMC reviewer and Director for Policy with nearly 12 years of FDA experience at CBER (Center for Biologics Evaluation and Research) with a special focus in cell & gene therapy (CGT), regenerative medicine therapies, tissue engineering, complex biologics, and therapeutic medical devices (that are under CBER purview).

Dr. Lam has reviewed 300+ submissions across INTERACT, pre-IND, IND, IDE, PMA, and Master Files including RMAT designations. He oversaw product jurisdiction activities for OTP-regulated products and served on the Tissue Reference Group adjudicating whether HCT/Ps qualify for 361 regulation or require premarket review as a drug, device, or biological product. He also provided scientific support and served as the main point of contact for CBER compliance actions that impacted OTP-regulated products. He conducted over 100 product assessments and served as policy lead on FDA guidance documents including Potency Assurance for Cellular and Gene Therapy Products and Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.

Scott A. Brubaker

Special Advisor

Scott has served the human tissues and cells profession for nearly 40 years, first in industry and later as a federal regulator. He is a former Director and Senior Advisor in FDA/CBER's Office of Cellular Therapy and Human Tissue within the Office of Therapeutic Products (OTP). For nearly 8 years, he was Director of FDA's Division of Human Tissues, where he led the development and maintenance of federal policy under 21 CFR part 1271 and associated guidance governing oversight of HCT/Ps. During this tenure, he chaired CBER's Tissue Reference Group, the Tissue Safety Team, and the Tissue Policy Team, and represented FDA/CBER on the HHS Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA), on OPTN's ad hoc Disease Transmission Advisory Committee (DTAC), and HRSA's Advisory Committee on Organ Transplantation (ACOT). Scott was OTP's primary contact with colleagues at CDC's Office of Blood, Organ and Other Tissue Safety (BOOTS).

Prior to joining the FDA, Scott served for 12 years as Senior Vice President of Policy at the American Association of Tissue Banks (AATB), where, among many accomplishments while working with the Association's membership, he led the creation and revision of standards, drafted guidance documents, organized and hosted Donor Suitability Workshops, championed development of the Uniform Donor Risk Assessment Interview (UDRAI) forms and tools, and he represented the AATB internationally. Practical experience in organ donation and tissue banking was gained while employed for 18 years in various managerial roles at LifeNet Transplant Services that included extensive donor screening activities as well as tissue recovery, processing and distribution. He was a founding member of their Cardiovascular Services and developed the tissue Procurement Relations department.

Scott has given presentations on 5 continents, and has authored or co-authored more than 45 publications including books such as the Standards for Tissue Banking (AATB, editions 11–14); a trilogy of Guides: Tissue and Cell Donation, Tissue and Cell Processing, and Tissue and Cell Clinical Use (Wiley-Blackwell); and was the sole contributing author from the United States for the EDQM/Council of Europe's Guide to the Quality and Safety of Tissues and Cells for Human Application (editions 1–3). Scott is proud to have worked on numerous projects with many knowledgeable, dedicated professional colleagues nationally and internationally.