Paula Mendenhall, Pharm D. ~ Due Diligence in Selecting Vendors
Paula Mendenhall, Pharm D., is a senior Vice President of Operations, DURECT Corporation.
Dr. Mendenhall has over 30 years of pharmaceutical experience covering areas such as research, manufacturing and pharmaceutical operations. She has recently joined DURECT to lead their facility, quality, compliance and manufacturing efforts as the company moves forward to producing their first registration batches and preparing for pre-approval inspections for a number of development programs.
During 1979 to 1997, Dr. Mendenhall served in a variety of roles for Hoffmann-La Roche Inc./Syntex, including in the areas of manufacturing, quality assurance, finance, planning and facilities, as well as provided technical assistance and support to Syntex Global Operations for marketed products and new product launches. Most recently prior to her joining DURECT, Dr. Mendenhall was an independent consultant for various pharmaceutical companies for in-house and outsourcing of pharmaceutical manufacturing, including development of manufacturing strategies and plans and development and training of personnel.
Dr. Mendenhall received a Pharm D. degree from the University of California San Francisco, and is a member of the American Association of Pharmaceutical Scientists, the American Pharmaceutical Association and the Society of Cosmetic Chemists.”
Michael K. Eckstut ~ Entrepreneur Perspective, Due Diligence in Selecting Vendors
Michael Eckstut is the Vice President of Business Operations - Life Sciences for Conformia Software, Inc. Michael is an experienced senior business professional with a broad range of business and operational experience in large, small and early stage companies in the life science and chemical industries as an executive, investor, advisor and board member. He holds a BS and MS cum laude in Chemical Engineering from Rensselaer Polytechnic
Institute and an MBA.
Lewis Michaels ~ Quality Agreements to Establish Deliverables
Lewis Michaels is the Sr. Director of Compliance at Peninsula Pharmaceuticals, Inc., where he is responsible for all GXP compliance activities. Lewis has over 20 years of Quality Assurance and Manufacturing experience in the pharmaceutical industry. He has worked for large, medium, and small companies in positions of increasing responsibility, including Syntex, Roche, and Sugen.
Prior to taking his current position, Lewis spent over 8 years consulting with start-up and virtual companies, implementing quality systems and coordinating the quality aspects of all outsourcing activities. He has performed GMP audits world-wide of API and final dose manufacturers, and prepared numerous Quality Agreements on behalf of his clients.
Lewis has a BS in Biological Sciences from the University of South Florida, Tampa, Florida.
Chad M. Nikel, MBA, PMP ~ Project Management to Control the Process
Chad M. Nikel has ten years of experience in project management and business process development that includes a number of engagements within start-up companies in the life sciences industry. Mr. Nikel is a Senior Project Manager at Integrated Project Management Company, Inc. (IPM), a Chicago based firm focused to providing outsourced project management leadership to biotechnology and pharmaceutical companies.
Mr. Nikel has successfully managed drug development projects involving multiple third parties collaborating in research, technology and development, regulatory approvals and compliance, drug substance and product manufacturing, and clinical trials. In addition, Mr. Nikel has developed and implemented project management practices and methodologies tailored for early-stage organizations resulting in increased efficiencies in their development process. Mr. Nikel currently leads IPM’s operations on the West Coast with an emphasis in the biotechnology sector. He graduated from the United States Air Force Academy with a degree in Engineering, received an MBA from St. Mary’s University, and is a certified Project Management Professional (PMP).
Jennifer Lorenzen ~ Entrepreneur Perspective, Project Management to Control the Process
Jennifer joined Corcept in November of 2001 as Executive
Director, Development Programs with extensive experience in strategic
marketing and new product development for pharmaceutical and medical
diagnostic products. Previously, Ms. Lorenzen was Vice President of
Business Development and Program Management at Cytel Corporation. She also served as Vice President and Program Director, leading a multidisciplinary team responsible for the development of new drugs at Syntex Corporation.
Barbara H. Paley, MBA ~ Moderator
Barbara H. Paley is a seasoned professional with international marketing and product development experience at Syntex (now Roche). She co-led a Syntex ~ Procter & Gamble ~ Off-Shore Manufacturing team to launch Aleve® line extensions. Barbara has worked with drug delivery companies including ALZA and Inhale (now Nektar). She holds a BA degree in biology from Hofstra University and an MBA in marketing and finance from the University of Illinois.
Ms. Paley is currently an independent contractor who provides program management services to various size biopharma and medical device companies. The scope of Barbara’s participation includes cross-functional development team leadership, management consulting, outsourcing due diligence, product positioning and marketing, and vendor and partnership management.
