2011 – Present
- Regulatory Affairs and Quality Assurance services including assistance with regulatory filings, meetings with FDA, assignment as US Agent, vendor audits, mock pre-approval inspections, GMP and GCP audits, development of compliance and regulatory strategies, “third party” oversight under Consent Decree, meetings with regulatory authorities, etc. Expert report and testimony in legal cases.
2004 – 2010
AAIPharma Inc., Wilmington, NC
Sr. Vice President, Global Regulatory Affairs and Quality Assurance
- Key executive in well-established provider of contract GLP/GMP/GCP research and development services including formulations; clinical materials and marketed product manufacturing (non-sterile and sterile); analytical, micro and bioanalytical methods development, validation and testing; stability program management; Phase I first-in-man programs (clinics in US and Europe); Phase II-IV clinical study management; pharmacovigilance and RA/QA consulting.
- Returned to successfully lead the rebuilding of strong and respected RA/QA functions and assist new Board and management team in the rebuilding of AAIPharma and achieving record revenues in 2007 and 2008.
- Directed RA staffs in the US and Europe offering advice and strategy, meetings with regulatory agencies and assistance in the writing, compilation and filing of various investigational and marketing applications in the US, Canada and Europe.
- Directed QA staffs in the US, Canada, Europe and South America setting policy and developing and carrying out programs to oversee company compliance with global GMPs, GLPs and GCPs while assisting clients in balancing development needs and cost-containment in light of regulations, guidances and regulatory and business expectations.
- Instrumental in assuring AAIPharma maintained an outstanding compliance history with the US, European and South American regulatory agencies and clients and advised executive management regarding RA and QA policies, programs, requirements, needs and challenges.
- Routinely represented the company in business development, legal and financial activities including client meetings, contract negotiations and problem resolution.
- Often sought-after speaker for national and international conferences.
2001 – 2003
Endeavor Pharmaceuticals, Wilmington, NC
Vice President, Regulatory Affairs and Quality Assurance
- Executive Management Committee member of this privately funded pharmaceutical start-up focused on women’s health.
- Responsible for all RA strategy and programs; filed three INDs and one NDA. Developed and managed QA programs to establish, monitor and assure the quality of activities with vendors including contract CMC and clinical services providers.
- Grew company to 20+ employees, but as marketing plans were implemented in anticipation of NDA approval, investors (private equity) sold the intellectual property, INDs and NDA to Barr Laboratories. The NDA was approved and the drug is marketed.
- Left because company was sold.
1993 – 2000
AAI Inc., Wilmington, NC
VP, Global Regulatory Affairs, Quality Assurance and Validations, (1999 – 2000)
VP, Regulatory Affairs, Quality Assurance, Validations and Training, (1997 – 1998)
Sr. Director, Regulatory Affairs and Quality Assurance, (1995 – 1996)
Director, Regulatory Affairs and Stability Operations, (1993 – 1994)
- Career move to join a fast-growing CRO with goals of becoming a public company and establishing global drug research and development services.
- Built RA consulting franchise while managing a growing Stability Department.
- Directed RA services while building QA consulting services and assuming leadership of all internal QA, Training and Validations functions.
- Managed company’s Pharmaceutical Seminars Division planning, coordinating and hosting a series of professional seminars on key topics in pharmaceutical research and development.
- Advanced to position on Executive Management Committee as the company grew into a successful, publicly traded full service CRO with facilities throughout US and Europe and added phase I clinics, bioanalytical laboratories and phase II-IV clinical study management services.
- Left for an opportunity as a founding member of a pharmaceutical start-up.
1987 – 1992
Abbott Laboratories, Inc., Abbott Park, IL
Associate Director, Regulatory Affairs
- Career move to join a well-established, Fortune 100, “big pharma” company and transfer, develop and advance regulatory affairs skills within private industry.
- Primarily responsible for all RA activities in the neuroscience therapeutic area including products in development and marketed.
- Secondarily responsible for RA activities in the cardiovascular therapeutic area including biological cardiovascular products under development and marketed.
- Responsible for routine regulatory activities including active participation in project strategy and planning meetings, teleconferences and meetings with the FDA, writing, compiling and submission of new INDs and NDAs and the maintenance of applications already filed.
- Left for career excitement (and better weather).
1976 – 1987
US Food and Drug Administration
Deputy Associate Commissioner, Public Affairs, (1987)
Associate Director, Program Management, Commissioner’s Office, (1986)
Assistant Director, Congressional Operations, (1984 – 1985)
Public Information Specialist, (1982 – 1983)
FDA Executive Development Program, (1980 – 1981)
Investigator, Detroit District Office, (1976 – 1979)
- Conducted inspections of GMP pharmaceutical operations, GLP laboratories and GCP phase I clinics and phase II-IV clinical study sites.
- One of seven candidates accepted for FDA’s prestigious Executive Development Program.
- Promoted to Agency headquarters in Rockville, Maryland, developing excellent organization, management and communication skills and quickly advancing to positions of greater responsibility, independence and decision-making.
- Represented the Agency to Congress and Congressional Oversight Committees, crafted speeches and testimony formulating and communicating Agency policy and programs, led new program and budget initiatives, wrote regulations and guidelines including the IND and NDA “rewrites” of the 1980s, and managed several crisis response initiatives including responses to Toxic Shock Syndrome, the Tylenol poisonings and the Selacryn and Oraflex market withdrawals.
- Advanced to Deputy Associate Commissioner to head FDA’s public affairs staffs including press, publications and FOI services.
1982 – 1984
American University, Washington, D.C.
Ferris State College, Big Rapids, MI (FDA sponsored)
1974 – 1976
Wayne State University, Detroit, MI
Master of Science: Microbiology
1969 – 1973
Michigan State / Oakland U, Rochester, MI
Bachelor of Arts: Biology
- Regulatory Affairs Professional Society (Regulatory Affairs Certified)
- American Society for Quality (Certified Quality Engineer)
- Drug Information Association
- Parental Drug Association
- American Association of Pharmaceutical Scientists
- RegAffairsNC (Member, Board of Directors)
- “A Fish Story: The One That Got Bigger,” Communicating in a Healthcare Crisis, FDANews, 2007.
- “Speed Dating: the Rapid Way to Phase I Clinical Studies,” Pharmaceutical Manufacturing and Packaging Sourcer, Winter 2006.
- “Laboratory Operations: A Vital Link,” GMP Compliance, Productivity, and Quality: Achieving Synergy in Healthcare Manufacturing, Interpharm Press Inc., 1998.
- “A Fish Story: The One That Got Bigger,” When Lightning Strikes: A How-To Crisis Manual with Classic Case Studies, Washington Business Information Inc., 1994.
- “Preparing for an FDA GCP Audit,” Client training, 2012 - 2017.
- “Preparing for an FDA GMP audit,” Client training, 2012 - 2017.
- “Conducting and Documenting Investigations that Impress Regulators,” Institute of Validation Technology Lab Week, Philadelphia, PA, 2015
- “Auditing Stability Programs,” Institute of Validation Technology Lab Week, Philadelphia, PA, 2015
- “An Introduction to FDA,” “Navigating and FDA Inspection,” Current US FDA GMP Initiatives,” CPhI/UBM Workshops, Mubai and Ahmedabad, India, 2015
- “Meeting ICH Q10 Objectives in Manufacturing,” Innovative Approaches to Quality Systems, Pharmaceutical Technical Exchange Association, Kansas, 2013.
- “Inspection Case Study – A Consultant’s View,” 37th International GMP Conference, University of Georgia College of Pharmacy, Athens, 2013.
- “Regulation Review,” Institute of Validation Technology Conference, San Diego, 2012.
- “A Deep Dive into Quality Agreements,” Planning Committee Member, Moderator and Speaker at the FDA/Xavier University “Global Outsourcing Conference,” Cincinnati, 2012 (also a member of the conference strategic planning committee and moderator for several conference sessions).
- “Planning for Success When Outsourcing Stability,” International Pharmaceutical Academy Advances in Stability Testing, Boston 2012.
- “Auditing Your Stability Program Before the FDA Steps In,” International Pharmaceutical Academy Advances in Stability Testing, Somerset, NJ 2012.
- “Due Diligence, Mock PAI and GxP Audits, FDA/Xavier University Global Outsourcing Conference, Cincinnati 2011 (and member of conference strategic planning committee).
- “Auditing Your Stability Program Before the FDA Steps In,” International Pharmaceutical Academy Advances in Stability Testing, Boston 2011.
- “Planning for Success When Outsourcing Stability,” International Pharmaceutical Academy Advances in Stability Testing, Boston 2011.
- “505(b)(2) New Drug Applications,” RegAffairsNC Spring Conference, Chapel Hill, NC April 2011.
- “Quality Agreements: Truly Adding Value Without Needless Burden,” Clinical Supply Forum, Durham, NC, February 2011.
- Workshops on FDA Inspections and Outsourcing Stability Programs, Institute of Validation Technology, December 2010.
- “Quality Systems: Expectations from the FDA,” Novatek International QSM Webinar Series, April 2009.
- “PQS – the new GMPs?” International Pharmaceutical Academy GMP Update, October 2008.
- “Navigating an FDA Audit of Stability Operations,” Center for Business Intelligence Annual Forum on Stability Programs, 2007 and 2008.
- “Applying Good Manufacturing Practices During Drug Development,” Marcus Evans Pharma Edge Manufacturing Summit, January 2007 and Clinical Evolution Summit, 2007.
- “Preparing for and Surviving an FDA Inspection,” Institute of Validation Technology Workshop, June 2006 and September 2006.
- “Selecting a Stability Study Management Contractor,” Institute of Validation Technology Seminar, 2005 and 2006.
- “FDA Regulations and ICH Guidelines for Stability Testing,” Institute of Validation Technology Workshop, 2005.
- “Surviving an FDA Inspection,” Novateck Stability Seminar/Workshop, 2005.
- “Outsourcing and the Impact on the PAI Process: Balancing the Needs of Regulators and Industry,” FDA Investigator Training Program, 2001.
- “The Drug Development Process,” Project Management: the Plan, the Process, the Pitfalls, Seminar Series, AAI International Seminars, 2000 and 2001.
- “Applying GMPs to Clinical Trial Supply Manufacturing,” Complying with Global GMPs for Clinical Supplies, Institute for International Research Seminars, 2000.
- “Laboratory Efficiency and Compliance: Meeting the Challenges of Both in the Pharmaceutical Industry,” AAI International Seminars, 2000.
- “Outsourcing: Out-of-Sight Does Not Mean Out-of-Mind,” Auditing Techniques for Pharmaceutical Operations, AAI International Seminars, 1999 and 2000.
- “Evaluating the Supply Chain Before the PAI: A View from the Vendor’s Perspective,” Pre-Approval Inspections, Center for Business Intelligence, 1999.
- “Implementing a Biotech Stability Program and the Impact of the New FDA Stability Guidance for Industry,” Biotech Stability: Current Scientific and Regulatory Issues, AAI International Seminars, 1998.
- “An Industry Perspective on Compliance,” Cleaning Validation in the Pharmaceutical Industry, AAI International Seminars, 1998.
- “Validation Requirements for Pharmaceutical and Biotech Analytical Laboratories,” AAI International Seminars, 1998.
- “Pharmaceutical Photostability Testing: The FDA Perspective,” Photostability Scientific, Regulatory and Practical Issues, AAI International Seminars, 1997.
- “Planning for FDA Approval,” Contract Process Development, Barnett International Seminars, 1997.
- “Preparing for and Facilitating Key FDA Meetings,” Pharmaceutical Education and Research Institute, 1997.
- “Regulatory Aspects of Validation: Industry Perspective,” Process Validation: Successful Strategies for Pharmaceutical Dosage Forms, AAI International Seminars, 1997.
- “Controlled Substances: Compliance Issues and Practices for the Pharmaceutical Industry,” AAI International Seminars, 1997.