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Drug and Device Advisory Committee (DDAC)

Drug and Device Advisory Committee (DDAC)

The Drug and Device Advisory Committee (DDAC) reviews proposed innovations and provides up to 8 hours of free consultation per project to discuss specific pre-clinical development plans, focusing on tasks needed to efficiently move the drug to the clinic according to FDA guidelines.  The DDAC can also provide insight into associated costs and complications that you might anticipate during the process.

Typical Consulting Services

  • Manufacturing
  • Toxicology
  • Animal models
  • Analytic methods
  • Pharmacokinetics and ADME
  • Biomarker assay development and validation

The DDAC will also provide assistance to investigators and small companies in preparing needed government grants and contracts for translational drug development and business plans. Longer-term support of DDAC activities is included as an expense in the grants and contracts.

Committee Faculty & Staff

Committee Faculty & Staff

The committee is composed of ITHS faculty and other ad hoc advisors from member institutions and industry.

Kim Folger Bruce, PhD

Kim Folger Bruce, PhD
ITHS Director of Research Partnerships

Dr. Folger Bruce 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.

Rodney Ho, PhD

Rodney Ho, PhD
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.

Peter Korytko, PhD, MBA

Peter Korytko, PhD, MBA
President of Preclinical GPS

Dr. Korytko is a preclinical consultant with extensive industry experience at Pfizer, Amgen and as an independent consultant. Dr. Korytko helps virtual, small and mid-sized biotechnology companies design and implement preclinical discovery and development programs. Preclinical GPS executes preclinical programs for two to four INDs and Phase 2 starts per year; this includes planning, study design, project management, study monitoring, study interpretation, and regulatory writing, as well as interactions with FDA and other regulatory agencies. In addition to helping biotech companies with preclinical research and initiation of clinical trials, Dr. Korytko conducts due diligence reviews of biotech companies on behalf of venture companies and investors.

Denny Liggitt, DVM, PhD

Denny Liggitt, DVM, PhD
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.

Lynn Rose, PhD

Lynn Rose, PhD
Research Associate Professor, Department of Pharmacy, UW School of Pharmacy
Faculty director of ITHS Drug and Device Committee

Dr. Rose is currently Director of Scientific Administration for Benaroya Research Institute and faculty for the Biomedical Regulatory Affairs Master In Science (BRAMS) program, UW School of Pharmacy.  She has 16 years of 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.

Fiona Wills, PhD

Fiona Wills, PhD
Director of Technology Licensing
University of Washington Center for Commercialization

Dr. Wills has been with UW C4C since 2003, initially managing innovations in life sciences, and later the activities of the licensing group across all disciplines. She also works closely with the UW Office of Sponsored Programs on intellectual property terms in industry sponsored research agreements. Fiona holds a Ph.D. in Biochemistry, and completed post doctoral studies in cell biology. Prior to joining UW C4C, Fiona worked for the business development department of Molecular Probes, Inc., engaged in both in-licensing and out-licensing activities for the research reagent and diagnostic markets. She has also worked in the Health Technology Assessment field, providing health care funding agencies with evaluations of new and emerging medical technologies.

Examples of How Researchers Use the DDAC

Examples of How Researchers Use the DDAC

A local biotech company working with two UW immunology and virology researchers consulted with the DDAC about planning a preclinical development plan for an innate immune modulator SBIR grant. The investigators planned to include support in the application to fund DDAC members to provide regulatory and formulation support.

A spin-off company from a program initiated at the School of Pharmacy for a nasal delivery device met with the DDAC to get insight into things to consider for preclinical programs for various applications of the technology, including testing in animal models of human disease, formulation strategies and planning requirements for toxicology studies.

Fees

Fees

The DDAC provides a variety of free and fee-based services. We will build a budget for requested services on a case by case basis. Typically, follow-on support must be built into the grant or contract supporting the program.

Getting Started

Getting Started

Contact the Preclinical Research Development Program and fill out the preclinical consulting template prior to meeting with the DDAC.

50 kBPreclinical Consulting Template
Contact Us / Ask the Research Navigator

Ask the Research Navigator

Request Services

Request Services

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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.