Research Resources
Drug and Device Development Advisory Committee
The Drug and Device Development Advisory Committee (DDDAC) is composed
of ITHS faculty and other ad hoc advisors from member institutions. The Committee reviews
the merits of proposed innovations and provides appropriate preclinical, clinical and
regulatory guidance to investigators seeking to transition their research innovations
into the clinic. The committee includes experts in therapeutic drug and device development,
product formulation, toxicology, clinical and regulatory affairs and will provide high-quality
guidance and mentoring to investigators.
The DDDAC will provide preclinical and clinical review and consulting for member institutions
investigators who submit a formal Request for Information. At review, the DDDAC will determine
whether the therapeutic approach is feasible or requires modification. If modifications are in
order, the committee will recommend further laboratory studies that may help strengthen the
feasibility of the approach. The types of consultation that the committee will provide may
include those listed below.
- Development and interpretation of preclinical animal toxicology and PK studies
- Preparation of a pre-IND application including a clinical development plan
- Development of a Phase 1 PK trial to assess initial drug safety, absorption, distribution, metabolism and excretion (ADME)
- Vaccine clinical development plans
- Clinical development plans and regulatory issues for gene therapy trials
- Clinical development plans and regulatory issues for device development
The faculty/staff and their expertise are:
Kim Folger Bruce, PhD - Dr. Folger Bruce serves as the Director of Research
Partnerships. She coordinates interactions between academic consultants, clinical
investigators, industry sponsors and contract research organizations to move promising
therapeutic candidates into clinical evaluation. She has 18 years of experience in the
Seattle pharmaceutical and biotechnology industry in research and product development
in oncology, immunology and infectious disease. Dr. Folger Bruce is experienced in directing
basic research in a pharmaceutical setting and the process of evaluating and prioritizing
research programs and moving them through the preclinical evaluation process.
Thomas K. Hazlet, Pharm. D, Dr. P.H., Associate Professor, Pharmaceutical Outcomes
Research and Policy Program, UW School of Pharmacy. Dr. Hazlet's experience includes industrial
microbiology with Baxter Healthcare Corporation, a Food and Drug Scientist with the California
Department of Health Services' Food and Drug Branch and a member of the Food and Drug
Administration's Pacific Region Biotechnology Team. Dr. Hazlet has co-taught a Biomedical
Regulatory Affairs Certificate Program-offered through University of Washington Educational
Outreach – for the past eight years, and will direct a Master of Science in Biomedical
Regulatory Affairs program that is targeting admissions for the Autumn Quarter 2008.
Rodney JY Ho, Ph.D., Milo Gibaldi Endowed Professor and Associate Dean for Research
and New Initiatives, UW School of Pharmacy. Dr. Ho has been working in the area of HIV and
HSV virology, antiviral, CANCER AND ANALGESIC drug therapeutic strategies, and drug and vaccine
delivery for more than 20 years. He is a Professor of Pharmaceutics and the Director of the
Center for DNA Sequence and Gene Analysis. He is also an elected fellow of the American
Association of Pharmaceutical Scientists recognized for his breath and depth of knowledge
in drug formulation, delivery, and metabolism.
Victoria (Tory) Lake, BA, BSc, RAC, Regulatory Affairs Director, Fred Hutchinson
Cancer Research Center (FHCRC). Ms. Lake is responsible for providing regulatory support
to University of Washington/FHCRC Cancer Consortium clinical investigators conducting clinical
trials under FDA regulations. Additionally, she provides regulatory support and guidance to
manufacturing facilities producing novel biological investigational products and hematopoietic
progenitor stem cells, subject to FDA's regulations for current Good Manufacturing Practices
(cGMP) and current Good Tissue Practices (cGTP).
Denny Liggitt, D.V.M, Ph.D, Professor and Chair UW Department of Comparative Medicine.
Dr. Liggitt is a board-certified veterinary pathologist (ACVP) with extensive experience in the
pre-clinical development process. He initially gained this experience by serving as an Associate
Director of Pharmacology and Head of the Pathology unit at Genentech Inc. During this period he
established the pre-clinical pathology group at Genentech and served as the principal
pathologist. As Professor and Chairman of the Department of Comparative Medicine he continues
collaborative efforts with UW and other academic investigators – some of which involve
preclinical drug development pathways.
Dusty Miller, Ph.D., Member Fred Hutchinson Cancer Research Center and Affiliate
Professor, UW Department of Pathology. Dr. Miller is a pioneer in the development of human
gene therapy. He has been significantly involved in regulatory aspects of gene therapy,
especially regarding vector safety issues. He served on the RAC from 1991-1996 and has
interacted with the FDA and other regulatory agencies to gain approval for human gene therapy
trials.
Sean O'Connor, Associate Professor of Law, Faculty Director, Entrepreneurial Law Clinic
Associate Director UW School of Law. Sean O'Connor's research focuses on legal issues
involved in commercializing art, science, and technology. He is the Associate Director of both
the Center for Advanced Study & Research on Intellectual Property (CASRIP) and Intellectual
Property Law & Policy Program.
Lynn M. Rose, Ph.D., Research Associate Professor, Department of Pediatrics, UW
School of Medicine, Children's Hospital and Regional Medical Center, Division of Infectious
Disease and Immunology serves as director of the core and chairman of the DDDAC. She is
currently Director of Clinical Operations and Regulatory Affairs for the Cystic Fibrosis
Therapeutics Development Network. She has 16 years experience in the Seattle biotechnology
industry where she gained extensive drug development experience, including management of
manufacturing, preclinical, and clinical programs. Her extensive knowledge of and contacts
within the regional biotechnology and pharmaceutical industry will help facilitate and
sustain relationships between ITHS investigators and various corporate partners.
Director:
Lynn M. Rose
Research Associate Professor, Pediatrics
Director, Clinical Operations, Cystic Fibrosis TDN Coordinating Center
Box 359300, MPW 5-4
Phone: 206 987-7540
FAX: 206 987-7505
lynn.rose@seattlechildrens.org