Pharmaceutical Consultant: Drug Development, Regulatory Affairs, Quality, cGMP, FDA, and Clinical Research

Expertise

• Senior Pharmaceutical Executive concentrating in medical devices, and the pharmaceutical research industries.
• Global pharmaceutical business development.
• Regulatory affairs, quality control, clinical research industries and operations.
• Submission preparation: IND, CTD, ANDA, NDA and MAA.
• Clinical research including protocol and medical writing.
• Strategic planning and business analysis.
• New pharmaceutical development and support.
• Domestic and international pharmaceutical contract negotiations.
• Business and pharmaceutical partner alliances.
• Preclinical and clinical trial study optimization.
• Quality assurance and regulatory affairs.
• FDA communications and cGMPs.
• Laboratory operations and management.
• Clinical monitoring.
• Auditing.
• Compliance remediation.

Experience

Undisclosed Company, 2013 - Present

Vice President of Regulatory Affairs, Quality Assurance, Quality Control and Clinical Research

• Provide leadership to the regulatory affairs, quality and clinical research operations.
• Responsible for implementation of regulatory strategies and processes to obtain product approvals.
• Provide guidance to new product development team and manufacturing group. Serve as key contact for regulatory agencies and external partners.

Hercon Pharmaceuticals, LLC, Emigsville, PA, 2012 - 2013

Executive Director of Regulatory Affairs, Quality Control and Quality Assurance

• Responsible for all quality, regulatory and clinical research activities.
• Leading quality and regulatory efforts for new product development.
• Upgrading all laboratory operations and manage all staff.
• Compliance remediation.

Undisclosed Company, 2003 - 2012

Co-Founder, Vice President of Regulatory and Technical Affairs

• Provider of innovative patented pharmaceutical tablet technologies.
• Accurate and customized dosing of single and combination drug products and standard and controlled-release formulations, with broad application in human and veterinary medicines.
• Responsible for all infrastructure services: regulatory affairs, clinical research, and business development.
• Implementing broad applications across therapeutic categories, pharmaceutical segments, formulations, and combinations.
• Obtain initial financing including writing business plans and private placement memorandums.
• Inspection of foreign contract manufacturing organizations.
• Developed and refined regulatory strategies to ensure compliance and to resolve regulatory issues.
• Conducted GMP inspections of pharmaceutical companies engaged to manufacture or co-develop products.
• As co-founder in obtaining the company's initial financing. Wrote business plan and private placement memorandums and led financial and technical discussions with investment bankers.
• Facilitated corporate product strategy realignment and go-to-market strategies and actively advises customers and partners on regulatory considerations and approaches as an instrumental member of the senior management product development team.
• Collaborated with physician investigators in the design of clinical studies and monitored the clinical research organizations (CROs) for compliance throughout the study, leveraging extensive expertise. Designated as a key team member for the leading edge technology's next pivotal study.
• Engaged in active business development activities:
• Recognized as the technical expert advising on business development efforts and contract arrangements for US, Europe and Asia sales of the tablet technologies to the healthcare industry including big and small pharmaceutical, OTC, and veterinary companies.
• Evaluates companies and conducts product screening for future business viability.
• Influential contributor to a major veterinary enterprise adopting technology for the development of two products.
• Negotiated and reviewed contracts with pharmaceutical partners to attract a co-developer and marketer of the company's pipeline.
• Led sales efforts to win two licensing contracts with pharmaceutical companies located in the US and Asia.

Noven Pharmaceuticals, Inc., Miami, FL, 1987 - 2003

Executive Director of Medical and Regulatory Affairs

• Engaged in the research, development, manufacture, marketing, and sale of prescription pharmaceutical products for this specialty pharmaceutical company providing industry leading transdermal expertise.
• Spearheaded the development and expansion of quality, regulatory and clinical research departments which rapidly grew from a start-up position to a fully integrated, $55 million pharmaceutical company with 250 employees.
• Initially focused on developing several women's health and hormonal replacement products internally, then collaborated with two partners for second generation drugs, and later pursued the development of follow on ethical products in such therapeutic areas as CNS, pain management, and cardiovascular.
• Accountable for a $10 million budget, offered product development insight in the formation of corporate five and ten year strategic plans.
• Served as a liaison with the FDA, European Health Authorities, and national/global partners. Contributed to formulation development advancements prior to a formal research and development department
• Designed and conducted preclinical/clinical studies for the entire company product portfolio.
• Submitted protocols to IRB and responded to issues.
• Selected and inspected CROs for specific trials and personally led the evaluation of clinical sites and investigators for other studies.
• Conducted vigorous research and prepared detailed technical documents necessary for filing approximately 10 INDs, 1 ANDA, 4 NDAs, and 3 MAAs with the FDA and European Regulatory Agencies.
• Ensured seamless and timely regulatory processing by proactively anticipating and addressing inquiries, evidenced by minimal regulatory follow-up questions, including the chemistry, manufacturing and control (CMC) section.
• Designed, researched, and drafted the compliant Current Good Manufacturing Practices documentation system, incorporating the standard operating procedures (SOP) and standard testing procedures (STP), which is still used today. Inspected frequently as a new company, passing all FDA visits with minimal observations.
• Attained FDA approval on four transdermal products currently being marketed and one transmucosal product.
• Collaborated with two Big Pharma licensing partners to gain MAA (Marketing Authorization Application) approval on three products. Led negotiations for product approvals with the FDA and MAA.
• Formed the company's first Clinical Advisory Board for psychotropic medications and women's health specialties.
• Identified and recruited industry and academic experts, including a leader in women's health who convinced the FDA to approve Noven Pharmaceuticals' hormonal replacement patch, which became the lowest dosage available on the market.

Key Pharmaceuticals, Inc., Miami, FL, 1984 - 1987

Quality Control Supervisor

• Led all quality operations related to the company's product portfolio which included transdermals, solid dose, and OTC products.
• Managed a staff of 30 in conducting microbiology/raw material/tablets and transdermal testing.

Cordis Dow Corporation, Miami, FL, 1979 - 1984

Quality Assurance Department Head, QC Biological Laboratory Supervisor

• For this manufacturer of artificial kidneys: Developed in-house cell culture, pyrogen and hemolysis assays for determining biocompatibility of polymers used in medical devices.

Honors & Publications

Academic and Professional Affiliations

Board of Directors

• Accu-Break Pharmaceuticals, Inc.
• SoLapharm Inc.
• PharmaNet Development Group, Inc.

Memberships

• Regulatory Affairs Professional Society
• American Society for Quality

Publications

• Author of a medical publication.

Education

• B.S. Biological Science, (Minor: Chemistry) Florida State University, Tallahassee, FL