FDA regulatory advice and consultation
THE MADISON AREA has two significant locally available resources that provide expertise related to FDA regulatory affairs. One is the Madison law firm of Godfrey & Kahn. That firm has served a number of UW-startup businesses with legal services for many years. The firm took the additional step of launching its FDA Practice Group in 2002 to expand its services to the Midwest's growing biotechnology and medical product industries, and to provide counsel to its universities and medical schools. The firm's practice grew, and now assists clients throughout the United States on regulatory matters. It is one of the few law firms outside Washington D.C. with a substantial FDA practice.
Godfrey & Kahn's FDA Practice Group combines law, science, and regulatory experience with the resources of a full-service law firm based in the Madison. The practice includes seven attorneys and one regulatory expert. Two practice group members served in FDA for a collective period of 36 years. One person who is available to assist Madison area companies in the biomedical field, for example, is Morris Waxler, Ph.D., a former Branch Chief in FDA's Center for Devices and Radiological Health. Dr. Waxler joined the firm in 2002 after 26 years of regulatory experience at FDA and several years of experience as an industry consultant. His skills and extensive r egulatory experience complement the team's attorney resources.
In addition to Godfrey & Kahn, Madison also has several locally available consultants having experience in FDA regulatory matters. These include:
- Hansi Dean — a specialist in biologicals regulatory issues and product development
- Terry Dolan — Formerly developed and ran the Waisman Clinical biomanufacturing facility and has developed other larger FDA GMP certified facilities outside the US.
Clinical trial design and management
The Office of Clinical Trials at the University of Wisconsin Medical Center is an opportunity center for biotechnology and pharmaceutical manufacturers. Established in 1989, the Office serves as a single contact point for private industry seeking to conduct clinical trials with one of the nation's premier medical and research centers.
Since the Office's beginnings, it has coordinated administrative aspects of clinical investigations for more than 800 studies. Its work in support of clinical investigations is underscored by a commitment to timely, accurate responses in all aspects of clinical trials, as well as a commitment to clinical investigations aimed at benefiting the public.
The Mission of the office of Clinical Trials is to:
- Promote and enhance quality clinical research activities at the University of Wisconsin Medical School
- Provide a wide range of trial support services allowing our investigators to concentrate on their research
- Act as an institutional contact for sponsors facilitating identification of an investigator whose clinical trial interests, experience, and patients match a sponsors study requirements
In addition to the clinical trials resources within the university, Madison is home to major facilities of Covance and PPD.
Covance is one of the world's largest and most comprehensive drug development services companies serving pharmaceutical and biotechnology companies in meeting the needs of drug development. Covance offers a portfolio of preclinical and clinical development and commercial service offerings — delivered through industry-leading non-clinical testing services, the world's largest central laboratory network, and a global team of clinical trial professionals and cardiac safety experts
PPD is a leading global provider of discovery and development services and products for pharmaceutical, biotechnology and medical device companies, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients maximize the return on their R&D investments. With proven discovery through post-market resources, the company also offers in-licensing and out-licensing opportunities. PPD has more than 7,100 professionals in 28 countries around the world.
Intellectual property advice and consultation
The College of Engineering has an associate dean for research and policy who reports to the Dean of Engineering. This person, Deanna Dietrich, Esq., has degrees in engineering and law, and serves as the advisor to faculty, staff and students on matters relating to intellectual property. The School of Medicine has an assistant dean for research and technology transfer. This individual, Dr. Steve Harsey, likewise provides consultation to faculty in Medicine on intellectual property matters. Both of these individuals have close working relationships with staff, including legal staff, at the Wisconsin Alumni Research Foundation (WARF), the patenting and licensing agency of UW-Madison. These individuals also have a close working relationships with University of Wisconsin legal staff in Administrative Legal Services.
Intellectual property advice and consultation for faculty, staff and student startups is provided by a number of legal firms in Madison. Since Madison is home to state government as well as the University of Wisconsin with its large research infrastructure, there are excellent, national legal firms available through local offices with outstanding intellectual property sections. Many of these companies provide pro bono legal advice to startups.
Patenting is handled through WARF, which retains patent attorneys for the purpose of preparing and filing patents on inventions disclosed to WARF.