BRIAN DAVID KAUFMAN
Wilmington, N.C. 28411
https://www.linkedin.com/in/briandkaufman
bkaufman@clbpharmaconsulting.com 919.628.2130
BIOTECHNOLOGY AND PHARMACEUTICAL CONSULTANT
Global Quality | Product Development |Regulatory Affairs
Translates Concepts into Product Development at Startup for Emerging and Commercial Companies
Expert at integrated strategies to achieve business goals and regulatory requirements. Extensive experience at transition from preclinical development to IND, clinical phase progression and commercial products. Quality consulting skills include design of program progression in accordance with the following international current Good Practice (GxP) regulations Clinical (GCP) | Laboratory (GLP) | Manufacturing (cGMP).
Adaptable multi-tasker known for organization and ability to make sound decisions in high pressure situations with meticulous attention to detail. Leverages a breadth of regulatory experience across multiple therapeutics areas including ophthalmic, antiviral and respiratory. Depth of experience designing and implementing risk management programs.
Experience highlights include:
Clinical Quality Management (e.g. ICH E6(R2))
Regulatory Strategy and Submissions
Domestic and international GxP audits
Bioanalytical Method Validation
Management of Contract Organizations
Cross-functional Project Teams: Internal and External
Quality Risk Management Preclinical through Commercial Products
PROFESSIONAL EXPERIENCE
CLB CONSULTING 2009 — Present
Global Product Development
Risk Management
Regulatory Affairs
Conducts GxP audits at sites or remotely based on customer requirements
Writes contractual GxP quality agreements and clinical quality management plans
Evaluates/resolves quality and regulatory matters at GxP contract vendor organizations
Global GxP Quality Management
Bioanalytical Method Development and Validation
Project Management
ONCOC4
Vice President, Quality and Regulatory Affairs 2021 — 2022
Review/feedback/approval of CMC, Clinical and Nonclinical regulatory submissions
Developed/led Fast Track and Orphan Drug Designation Submissions (both granted)
Led Successful Type C Meeting
Designed and implemented Quality Management System
ABVIRO LLC
Executive, Product Development 2017 — 2021
Global product development for monoclonal antibodies
Led and completed Phase 1 clinical study
Sponsor reviewer/signatory for GxP clinical, manufacturing and nonclinical documents (e.g. Study Protocols and Batch Records)
Led Manufacturing, Testing, Release and Distribution of Drug Substances and Drug Products
Worked under an NIH government contract
Designed and implemented Quality Management System
UNITHER VIROLOGY, LLC: A UNITED THERAPEUTICS COMPANY 2012 — 2015
Director, Quality Assurance
Led Committee to establish internal quality systems and cross-functional GxP compliance strategy
Quality management of GxP sites
Met NIH contract requirements by designing/registering Federalwide Assurance for the Protection of Human Subjects program and providing presentations with written reports to NIH.
CHELSEA THERAPEUTICS 2010 — 2011
Director, Quality Management
Integrated clinical and regulatory requirements in Phase 3 by implementing systems, corrective actions at pharmacovigilance vendor and organizing centralized cross-functional Quality Committee.
Contributed to meeting company goal by writing and reviewing across Modules (e.g. ISS/ISE/label) of approved NDA for Parkinson’s therapeutic.
INSPIRE PHARMACEUTICALS, INC. 1998 — 2009
Chief Quality and Continuous Improvement 2008 — 2009
Defined, measured and analyzed metrics for implementation of continuous improvement initiatives
Chief Quality and Compliance Officer 2005 — 2008
Led company Compliance Committee for Sales/Marketing and Sarbanes-Oxley Internal Controls over Financial Reporting
Achieved regulatory requirements by developing policies/procedures for GxP, sales, marketing and distribution
Executed public company internal controls over financial reporting / IT requirement by developing Sarbanes-Oxley Compliance Officer position accountable for Internal Audit and reporting to Board of Directors Audit Committee
Trained company for regulatory inspection and established inspection readiness at clinical sites
Senior Director, Pharmaceutical Development 1998 — 2005
Mitigated regulatory risk by conducting audits at international GxP sites and verifying CAPA closure
Met product development team accountabilities by providing strategy/content for regulatory submissions
Achieved project team requirements by managing international GxP contract organization audits
Integrated quality/regulatory strategies by planning with internal teams and business partners to meet objectives
Verified clinical study controls by oversight of labeling, packaging and distribution of Investigational Product
Communicated internal systems by issuing GxP Quality Manual and conducting associated training
MAGELLAN LABORATORIES, INC. 1992 — 1998
Supervisor, Quality Assurance (15+ GLP/cGMP auditors)
Project Management and Business Development
Supervisor, Laboratory Operations (5+ Inhalation Product, Device and Stability Testing Analysts)
Analytical Chemist (Sterile liquid and solid dosage forms; inhalation medical devices; stability testing)
ADDITIONAL RELATED EXPERIENCE
BURROUGHS WELLCOME
Researcher, Department of Pharmacokinetics and Drug Metabolism
U.N.C. CHAPEL HILL
Researcher, Department of Biochemistry and Biophysics
DUKE UNIVERSITY MEDICAL CENTER
Researcher, Department of Neurosurgery
EDUCATION AND PROFESSIONAL DEVELOPMENT
BA, Hampden-Sydney College
American Society for Quality
Pharmaceutical Compliance Forum
American Association of Pharmaceutical Scientists
Six Sigma and Kaizen Continuous Improvement
General Hugh Shelton National Leadership Forum
NIH Protecting Human Research Participants