Mr. Clissold advises pharmaceutical, biotechnology, medical device and food/dietary supplement industry clients on regulatory and legislative matters. He has also advised health care professionals, major universities, and medical schools on regulatory compliance, as well as provided pro bono counsel to state health care agencies and patient groups.
- Development of lifecycle management strategies for prescription and OTC drugs, medical devices, and biologics.
- Advise on strategies for FDA approval including clinical, preclinical, and toxicology protocol development and data presentation.
- Counseling on clinical trial issues, including clinical trial agreements, informed consent, HIPAA patient privacy, IRB relations, reporting of AEs, and removal of clinical holds.
- Conduct investigations into alleged clinical investigator noncompliance and fraud.
- Counseling on risk management plans for controlled substances and other products.
- Preparation of Orphan Drug designation requests.
- Preparation of drug, device, and biologic product sponsors for meetings with FDA and participation at FDA meetings.
- Development and drafting of comments to FDA proposed rules and Citizen Petitions.
- Conduct FDA regulatory due diligence for venture capital and public financing, both as corporate and underwriter's counsel.
- Respond to FDA inspection reports, warning letters, and Application Integrity Policy as well as preparing clients for inspections and audits.
- Advise on advertising, labeling, and promotional claim compliance for FDA regulated products.
Mr. Clissold has lectured on a variety of FDA-related topics for organizations such as the Food and Drug Law Institute and the Regulatory Affairs Professional Society. Presentations include the regulatory obligations of all parties involved in clinical investigations, strategies for developing and marketing drugs and biologics, orphan drugs, and Hatch-Waxman exclusivity and patent issues. He has authored several papers in journals such as The New England Journal of Medicine, Journal of Pharmacology and Experimental Therapeutics, Pharmacology, Biochemistry & Behavior, and the Food and Drug Law Journal.
Before joining the firm in 1996, Mr. Clissold conducted clinical and pre-clinical research at Nova Pharmaceutical Corp. and the Johns Hopkins University School of Medicine. He has a B.S. in Psychobiology from the University of California at Los Angeles, an M.A. in Experimental Psychology from Indiana University, and a J.D. from the University of Maryland. Mr. Clissold is admitted to practice law in the District of Columbia and Maryland, and is registered to practice before the United States Patent and Trademark Office.