Dennis K. Anderson, M.Sc

Email: danderson@biovirx.com

Dennis K. Anderson has been involved in research, commercial development, and regulation of biotechnology-derived products, bio-pharmaceuticals, and medical devices for more than 21 years.  Mr. Anderson's expertise and experience encompasses broad responsibilities for identification, acquisition, development, and regulation of new biopharmaceutical and device candidates.

He has extensive experience with research and development of pharmaceutical and biological products including conventional as well as rDNA-derived and plant-based vaccines and other immunogens such as herpes simplex, cytomegalovirus, papillomavirus, adenoviruses, rotavirus, parvoviruses, Rift Valley Fever virus, Hemophilus sp., Chlamydia sp., Helicobacter sp., Staphylococcus sp., and Escherchia coli.  His expertise includes developing and directing preclinical pharmacology and safety studies of new drugs, biologics and devices as well as Phase I and Phase IV human clinical studies.  Mr. Anderson has over 15 years of regulatory experience with biologics, drugs, medical and in vitro devices, and foods manufactured via traditional processes and biotechnology.  He has provided effective counsel regarding development, testing, and regulatory oversight of new and generic drugs, biologics (vaccines, monoclonal antibodies, immunogens, tissue culture-derived products), and innovative, combination drugs-devices.  Mr. Anderson's experience with regulatory affairs, including communications and interactions with the U.S. FDA and EU, is extensive as a result of presenting and defending applications and submissions before key regulators and leading crucial meetings concerning the aforementioned submissions (e.g., pre-IND, Phase I, II and III clinical trial presentations, pre-NDA and NDA-Day meetings, etc.).  He has been principal author or taken leadership for development and evaluation of major regulatory documents and submissions to the appropriate authorities (e.g., INDs/NDAs, IDEs/PMAs, 510k, and BLAs) as well as various orphan drug applications. 

Mr. Anderson has considerable practical experience with identification, procurement, and supervision of contract service organizations, consultants, clinical study sites, clinical investigators, etc. leading to successful completion of various key phases of bio-pharmaceutical research and development.  Mr. Anderson has also supervised the contract manufacture of APIs and final drug products where he assumed responsibilities for implementing and enforcing quality assurance and control procedures and standards and oversaw audits of contract organizations for compliance.  Mr. Anderson is well versed in the standards and practices prescribed by ICH, ISO, GCPs, cGMPs, GLPs, and other applicable rules, regulations, and guidelines. 

Mr. Anderson has managed or oversaw technology research and development as well as intellectual property (patenting, licensing, technology transfer, and the like.).  He has consulted on technology licensing, material transfers and other aspects of intellectual property management and has performed due diligence, negotiations, and execution of technology licenses with established or projected market values in the millions of dollars.  Mr. Anderson has also been responsible for procuring and managing research and development of multimillion-dollar contracts and grants with major governmental agencies as well as chemical, bio-pharmaceutical and medical device companies. 

He has served as an officer of several innovative technology companies, and is familiar with the commercial and financial realities that such firms face in developing and marketing regulated healthcare products.  The business and regulatory strategies he develops and implements are sensitive and responsive to such commercial realities. 

Mr. Anderson received his M. Sc. in virology/molecular biology from Kansas State University in 1981 and has completed post-graduate studies in marketing and business administration.  He has been a volunteer member of numerous committees concerning scientific affairs, biotechnology, and biosafety for such prestigious organizations as U.S. Department of State/U.S. Agency for International Development, University of Minnesota, Minnesota Academy of Sciences, Science Museum of Minnesota and the like.