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Dr. Eric Gruff is a pharmaceutical R&D professional with more than 20 years of experience in the biotechnology, pharmaceutical and medical device industry. He has expertise in pharmaceutical development and project/portfolio management from discovery stage through NDA/MAA filing. Dr. Gruff has a record of proven success in developing strategy at the project and corporate level, and overseeing the progression of drug candidates through development and approval. He has experience in establishing and managing outsourcing relationships with external contract partners. Dr. Gruff led Pfizer’s SARS Project Team that was tasked with the development of a medical countermeasure during the 2003-2004 outbreak.

Examples of Dr. Gruff’s specific experiences include: Oral, Parenteral, Topical, and Intranasal Dosage Forms; GLP/GMP and 21 CFR Part 11 Regulations; Small Molecule and Biological Candidates; Orphan Drugs; US and EU Regulatory Filings (IND, IMPD, NDA, MAA, CTD); Medical Devices: IDE, 510(k), and PMA; Therapeutic Areas: Antivirals, Diabetes, Oncology, CNS, Antitoxin, and Inborn Diseases of Metabolism; Creation and submission of paper and electronic filings to FDA; Design and Improvement of Quality Systems; Internal and External Auditing and Mock Inspections; Cross-Functional Team Leadership; US Agent for Foreign Drug and Device Companies; Strategic Management and Financial Planning; Process Design and Validation; Veterinary Drug Development and Approval; Development of Project and Program Strategy.