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