Bioengineering alumnus Wayne Gombotz (M.S. ’85, Ph.D. ’88) has received the UW College of Engineering’s 2019 Diamond Award for Distinguished Achievement in Industry. The Diamond Awards recognize alumni and friends of the University who have made significant contributions to the field of engineering. He was honored May 17 at a ceremony in Seattle.
Dr. Gombotz has made major impacts on human health through his significant contributions to several successful therapeutic products and processes to treat cancer, infectious diseases and autoimmune diseases. His work has provided the basis of many drug delivery strategies in use and in development today, and it spurred the development of the biotechnology industry in Seattle. Over his 30-year career, his influence spans the biopharma field, from the early stages of biologic and protein development to small molecule development, and the cutting edge of gene medicine and immune therapies.
Few scientists have a chance to work on drugs that make it to market, as only about one percent of all investigated drugs are approved by the FDA. However, Dr. Gombotz’s skill and leadership in shepherding science from ideas to real products has resulted in multiple FDA-approved drugs at four different companies.
At Immunex (now Amgen), where he worked as the senior director of analytical chemistry and formulation, he played a key role in developing and launching the drug Enbrel®, dramatically improving the lives of hundreds of thousands of people with rheumatoid arthritis and psoriasis worldwide. Initially approved in 1998, Enbrel is one of the top-selling drugs of all time, now earning about $8 billion a year.
Other drugs he helped develop through his career include Leukine®, Bexxar®, Melacine® and Thioplex® for cancer treatments, MPL® to boost vaccine response, and Omidria® for use during eye surgery.
“Wayne has a unique ability to transform a good idea into a valuable product,” wrote Allan Hoffman, professor emeritus of bioengineering and chemical engineering, in nominating Dr. Gombtoz for the award. “His excellence in research, his brilliant, insightful vision, and the resulting collaborations he has created with many scientists have had a huge impact on the tremendous growth of the biotech industry in Seattle in the past 20 years.”
Graduate student research collaborations
After earning a biology degree at Colby College, Dr. Gombotz came to UW to work with Dr. Hoffman, who co-supervised his master’s and doctoral research projects in Bioengineering in the 1980s. They worked on several successful collaborations and published 14 peer-reviewed papers together during that time. His research focused on attachment of a polymer known as Poly(Ethylene Glycol) or “PEG,” to biomaterials to render the surfaces repellent to proteins and cells. This work on “non-fouling” surfaces generated development in the drug delivery field. Dr. Hoffman and Gombotz, in collaboration with bioengineering professors Buddy Ratner and Thomas Horbett, also developed several radiation-based methods for chemically-activating surfaces of polymeric biomaterials to provide sites for attachment of biomolecules.
Following graduation from UW, he joined Enzytech in Cambridge, Mass., where he developed and patented drug delivery technology enabling extended release of injected drugs over days or weeks, used in Prolease®.
In 1990 he moved to Bristol-Myers Squibb in Seattle, where he led research on site-specific protein delivery products and biodegradable microspheres, along with drug development to aid wound healing, infection prevention and bone regeneration.
Five years after graduating, he joined Immunex Corp., where he began a series of high-impact product development efforts. First, he established a new Formulation and Drug Delivery Department, which developed several stable drug formulations and innovative delivery systems, including the use of PEGylation technology to increase the time that a drug stays in circulation. He was quickly promoted to direct the Analytical Chemistry and Formulation department, leading 58 people and managing a $7.5 million budget. He had a major impact on biopharmaceuticals as well as conventional drugs, and he worked on all stages of a drug’s lifetime, from toxicology testing to manufacturing and scale-up to post-market approval. He played a key role in the development and launch of Enbrel.
While at Immunex, Dr. Gombotz also worked on Leukine, acquired in early 2018 by Partner Therapeutics, and Thioplex, two FDA-approved cancer-related treatments. He regularly interacted with the FDA on numerous aspects of the filing, inspection, and approval process, including presenting the Chemistry, Manufacturing, Controls Strategy for Enbrel. As part of his role, he educated leading rheumatologists and directors of major pharmaceutical companies across the country about the Enbrel manufacturing strategy and Immunex’s product capabilities.
In 2002, Dr. Gombotz joined Corixa Corp. in Seattle as Vice President, Process Science & Pharmaceutical Development, actively leading design and development of their product line. He built a department of 65 people and oversaw a $17 million budget supporting development of therapeutic proteins, cancer and infectious disease vaccines, adjuvants and monotherapy drug candidates. He worked on FDA-approved cancer medicines Bexxar and Melacine and MPL, the vaccine ingredient.
In 2005 he brought his leadership skills to Omeros Corp. as Vice President for Pharmaceutical Operations. He oversaw all product development and led the Chemistry, Manufacturing, Controls efforts for FDA-approved drug Omidria, used in cataract surgery to maintain pupil size and prevent post-operative pain. He also contributed significantly to commercial development of a new anti-inflammatory drug for use in arthroscopic knee surgery.
Dr. Gombotz has been at Immune Design Corp. in Seattle since 2011, where he drives product development, manufacturing, quality, and project management focused on infectious disease and cancer vaccines. As Chief Development Officer, he has moved two products from the lab bench into Phase 3 clinical studies, both designed to harness the body’s immune system to fight cancer cells. He’s responsible for the manufacture of recombinant proteins, viral vectors, and small synthetic molecules with potential impact in cancer therapy, allergy, and infectious diseases. He serves as liaison with several corporate partners including Sanofi, Sanofi Pasteur, and AstraZeneca.
In all his major roles, he has worked across company groups to ensure effective communication and position appropriate drug candidates for success.
On June 3, Alpine Immune Sciences in Seattle announced that Dr. Gombotz has joined their leadership team as Chief Technology Officer.
Dr. Gombotz also serves as an Affiliate Assistant Professor in Bioengineering at UW, teaching the next generation of bioengineers. He has served as a Ph.D. dissertation committee member for many Bioengineering graduate students. Wayne also worked on a grant together with Dr. Suzie Pun to develop micellar delivery systems for cancer imaging applications, which resulted in 3 publications and one patent application. He is a member of the Department of Bioengineering’s External Advisory Board and a Corporate Advisory Board member of the UW School of Pharmacy. In addition to past service on numerous scientific boards, he currently serves on the editorial advisory boards of Pharmaceutical Technology (since 2000) and European J. of Pharmaceutics and Biopharmaceutics (since 2005).
In addition to his many innovative technical contributions to the field – he is co-inventor on 17 patents –Dr. Gombotz’s proven ability to foster collaboration within companies and among academia and industry partners has resulted in improved products and better quality of life for people worldwide.