RICHARD A. PEROTTI 723 Prairie Creek Drive a" Pacifica - CA 94044 650-355-1703 rp80c23c@westpost.

net Mobile: 415-407-2509 ________________________________________________________________________ REGULATORY AFFAIRS a" REGULATORY OPERATIONS a" CLINICAL REGULATORY SUMMARY Over 12 years Pharmaceutical and Biotechnical Experience Regulatory Affairs, Regulatory Operations and Clinical Regulatory Affairs New Drug Applications, Investigational New Drug Applications, Clinical Trial App lications Marketing Authorization Applications and Dossier Preparation PROFESSIONAL HISTORY Regulatory Affairs Consultant 2009 a" Current Primary Consultant in Regulatory Affairs and Clinical Regulatory activities to t he Pharmaceutical Industry Clients: Stanford Hospital a" Palo Alto, Medicines 360 a" San Francisco, Medivat ion, San Francisco a" OXiGENE, South San Francisco a" Anesiva, South San Francis co Specializing in IND and CTA submissions, approvals and maintenance Therapies: Alzheimeras disease a" Huntington Disease a" Prostate Cancer a" AntiVascular Drugs: Vascular Disrupting Agents a" Pain Therapeutics Anesiva, Inc. Manager, Regulatory Affairs 2008 a" 2009 South San Francisco, CA Responsible for the preparation of drug submissions to FDA and European Agencies including Investigational New Drug applications, Clinical Trial Applications, A mendments, Annual Reports and Safety Reports. Instituted new Clinical Trial Mon itoring, Principal Investigator Authorization and Drug Shipment Approval procedu res that expedited the approval of new Investigators and reduced paper file prod uction. Updated Regulatory SOPs to reflect and comply with current practices. Developed Electronic Document Management Systems. Therapies a" Novel therapeutic treatments for pain, Needle free drug delivery sy stem Chiltern International / CoGenesys, Inc. Manager, Regulatory Affairs 2007 Rockville, MD a" Palo Alto, CA Preparation of Investigational New Drug applications and Clinical Trial Applicat ions to FDA and European Agencies. Development and maintenance of INDs includin g Amendments, Annual Reports and Safety Reports. Directed Clinical Trial Monito ring and Drug Shipment Approval. Managed the development of Regulatory SOPs. Therapies - Type 1 and 2 Diabetes Mellitus a" Treatment of Patients with Heart F ailure a" Treatment of Infections Associated with Heart Failure ALZA Corporation Manager, Regulatory Affairs & Operations 2006 [A Subsidiary of Johnson & Johnson] Mountain View, CA 1997-

Maintained full responsibility for tracking all company projects for Regulatory Affairs Department and coordinating input from project team members to insure ti meline completion. Established and directed the Regulatory Affairsa Operations Group. Responsible for the preparation of IND and NDA new drug submissions to F

DA including annual reports, supplements and amendments. Principle team member in the development and submission of five New Drug Applications including eNDAs. R. Perotti rp80c23c@westpost.net 650-355-1703 Provided regulatory support and document management for international regulatory filings; including the coordination of responses to regulatory authorities rela ted to new NDA and MAA products. Primary responsibilities included the obtaining and maintaining Federal Registra tion of Drug Establishment / Labeler Code Assignments and State Drug and Device Manufacturing licenses. Direct management of Johnson & Johnsonas Operations Gro up within Regulatory Affairs Department for submission of documents to Agencies and partners. Assisted with the preparation and maintenance of Standard Operati ng Procedures and Material Safety Data Sheets pertaining to department functions . Management of budget for Regulatory Affairsa Operations Group, vendor contracts for internal Document Scanning and Publishing Systems and external document scan ning and printing. Coordinated litigation data disclosures and document prepara tion for Legal Department and Management of Data Disclosure relating to Mergers and Acquisitions. Coordinated product development tracking meetings, including Research and Development, Marketing, Sales, Management, Purchasing and Manufactu ring. Therapies - Oncology, Urologic, Pain, ADHD a" Specializing in Drug Delivery Syst ems: E-TRANS, D-TRANS, Inserts, Controlled Release Tablets, Micro-Abrasion Perotti & Associates - Pacifica, CA Consultant 1995 a" 1997

Maintained full responsibility for Product Development and Environmental Protect ion Agency interaction for registration of products associated with Agribusiness Companies The Scotts Company - Marysville, OH Director, Regulatory Affairs 1989 a" 1994 Gracea"Sierra Crop Protection Company - Milpitas, CA Management of worldwide Regulatory Affairsa activities for Multinational Corpora tion in Crop Protection, Nursery and Lawn & Garden areas

EDUCATION Bachelor of Arts Degree, Marketing - San Francisco State University Associate in Arts Degree, Chemical Technology - San Francisco City College CONTINUING EDUCATION Review of Practices, Policies and ICH Guidelines Specifications Managing Multiple Projects - Project Management Controlled Substances - Overview of Drug Development Good Manufacturing Practices Awareness - Basic Training Course on Drug Develop ment Introduction to International Regulatory Affairs & Strategies Expert Reports for European Marketing Applications Supervising for Safety - Managing Conflict in the Workplace - General Safety Training

Unlawful Harassment Prevention - Quality Orientation - Focus on GXPs - Forei gn Corrupt Practices Act Effective Workplace Communication - Change Management Adverse Event Reporting for Marketed Products - Responding to FDA Investigatio ns

MILITARY SERVICE United States Army - Vietnam Era Veteran