van Rooijen & Partners: Team: Senior Consultant: Bruce Mackler



	ma	senior consultant
	Dr. Bruce F. Mackler << Core expertise Life sciences industries Regulatory affairs Preclinical, clinical, marketing approval Legal Exemplified experience Legal/regulatory experience in biomedical products Biologics Drugs Medical diagnostic devices In vitro diagnostic devices Food Cosmetics manufactured by traditional and biotechnology processes. Regulatory approval strategies Preclinical producs Clinical products Drugs Biologicals In vitro diagnostics and devices Achieving USA marketing approval Drugs Biologics Medical/diagnostic devices Therapeutic areas include Multiple sclerosis ALS Stroke Spinal cord injuries Endocrine hormones Opthalmics Anti-infectives Pulmonary delivery Medical devices areas include Bandages Surgical medical devices Wound healing In vitro diagnostics Instrumentation Implants Drafting and evaluating numerous FDA regulatory documents, include INDs/NDAs DMFs BLAs 510(k)s Accelerated and Fast Track Approvals Orphan Drug Designation applications USDA submissions Consultancy of a number of US and European venture capital groups and banks Operational experience Interim operational management in several companies undergoing management transitions Entrepreneurial experience Investor and founder of several businesses in the biotech industry space Industry network Broad network in: Pharmaceutical industry Biotech industry Venture Capital industry At various levels: General Management R&D Management Founded the Association of Biotechnology Companies (ABC) and grew it to over 250 members before it merged to form the current Biotechnology Industry Organization (BIO) Admitted to practice before U.S. Federal District Court U.S. Appeals Court U.S. Supreme Court Academic training South Texas College of Law, USA University of Oregon Medical School, USA Pennsylvania State University, USA Temple University, USA Publications More than 100 published scientific papers and abstracts in immunology, immunopathology, and dental/mucosal diseases Numerous additional articles and briefing papers on FDA and FDA-related legal and regulatory issues Language command Fluent: English E-mail or Phone: +1-301-529-6984 Back <<