Serving as Head of Regulatory Affairs in startup environment establishing and implementing the global RA function.

In 2019, C-Path began developing a repository (BmDR) for data on novel translational safety biomarkers from a variety of independent academic and corporate drug development qualifications, with the goal of accelerating qualification of novel biomarkers as tools for drug developers. The BmDR provides stakeholders with large, reliable datasets on novel translational safety biomarkers from a variety of nonclinical and clinical study sources. Masked, de-identified data from multiple sponsors are being collected and stored in a secured repository. Once there is sufficient data, the data will be available to C-Path, FDA staff and other stakeholders to support research that leads to the submission of documents to global regulatory agencies to qualify novel safety biomarkers for new Contexts of Use (CoUs), to modify and expand existing CoUs and to identify appropriate exploratory safety biomarkers to advance drug development in the future. Existing biomarker data will be used to significantly advance and accelerate understanding of the utility of novel safety biomarkers as drug development tools. The initial focus of the BmDR is on kidney safety biomarkers. Many drugs are filtered through and eliminated via the kidneys, hence potential kidney toxicity is a key consideration in the development of novel drugs and a useful first step in standardized development of novel safety biomarkers.

Expert Strategic and Tactical Regulatory Guidance across all Phases (I-IV) of Drug Development. Keen awareness of unique needs of Biotech and Start-ups, with unique offering of fractional Regulatory Officer services. Our experience is varied from Small to Large molecule, Gene Therapy, as well as in orphan and rare diseases and large primary care indications. Highly collaborative approach to leverage partners in Commercial, Medical Affairs and Clinical towards bringing the most innovative and accessible products to patients. We are especially insightful for US FDA as well as global health authority engagement with transitional stages of development from Pre-IND idea phase to First in Human; Phase 1 to proof of concept; Scale up of Phase 2 to Phase 3/pre-commercial study and drug design; Completion of studies and Marketing applications and approvals; Life cycle management and planning. We are asked to provide expert due diligence advice for Venture Capital (VC) and Private Equity as well as innovative developers.

Serving in advisor role via Mill Street Consulting LLC

Reporting to the Chief Development Officer.• Responsible for the strategic regulatory considerations in creation and implementation of product development plans (PDP) across multiple kidney diseases and indications toward the development of druggable targets and biomarkers for precision therapies.• Ran virtual regulatory and quality organization via over a dozen consultants for regulatory operations, medical writing, EU and Ex-US reg consulting, epidemiology, orphan, regulatory counsel, regulatory CMC, quality assurance, and GXP auditing.

Reported to the Worldwide Head, Global Regulatory Affairs.• Participated actively as a member of the senior leadership teams of GRA, the CVM TA’s Labeling Committee, Scientific Forum, and Review Board, as well as MeiraGTx/Janssen and Bayer/Janssen Joint Steering Committees.• Drove the strategic regulatory development activities, health authority interactions, meetings, and approvals. Led a global team of approximately 15 direct, plus regionally matrixed and local operating company members.• Oversaw global regulatory aspects of nearly $2Billion Franchise and drove the development of effective and progressive global regulatory strategies and optimized product labeling for all products in the therapeutic area through the entire product lifecycle from discovery through post-life cycle management transition to established products.- Ensured thorough vetting, influencing, and challenging of the regulatory strategies through a collaborative process with therapeutic area leadership to ensure alignment with the goals and objectives of the pharmaceutical organization.- Ensured regulatory strategies also considered non-regulatory market access issues (e.g., health technology assessments, and payor expectations).• Oversaw and conducted CVM and retinal gene therapy related technology or corporate due diligence for new licensing opportunities.

• Responsible for providing global regulatory strategic and tactical leadership and direction to facilitate development and life cycle management of marketed and developmental products in collaboration with Otsuka Global/Executive leadership• Provide regular briefings of regulatory strategy for portfolio products to highest corporate levels (ie Otsuka Pharmaceuticals President, Operating Companies CEOs, etc.) • Provide strategic and tactical direction and regulatory guidance for direct reports on development of product labeling, updates to PLR format, REMS and associated medication guides, and compliance-related activities. Open and maintain INDs and the submission and approval of New Drug Applications;Notable Accomplishments:• Awarded one of company’s highest honors, Otsuka Outstanding Achievement Award for leading tolvaptan NDA submission• Awarded Otsuka Outstanding Achievement Award for Steering Committee leadership of preparations for August 5, 2013, FDA CardioRenal Drugs Advisory Committee meeting• Otsuka Driver and co-representative for the PDUFA VI PhRMA Brainstorming Session in preparing for negotiations with BIO and FDA on the updated legislation. • Recognized by executive management by selection for Leading the Otsuka Way internal leadership development program. Year-long program is a investment that serves to develop and hone management skills and mentor future corporate leaders. • Initiator and Leader of Global Regulatory Team Initiative whose goal is to foster creation of teams that create and manage globally-integrated, and coordinated regulatory strategies to support project teams by delivering value-added Regulatory capabilities.

With other members of the Board, directed program strategy and education topics and fundraising, and actively provided financial support. The mission of the program over the past 30 years has been to offer, free of charge, an intensive, interdisciplinary education experience to academically-talented and personally motivated young people entering their senior year of public or private NJ high school from a broad ethnic and socioeconomic cross-section.

• Serve as overall lead/ Head of US Regulatory Activities providing regulatory strategic and tactical leadership and direction to facilitate US development, life cycle management and advertising/promotional activities in collaboration with Global/Executive leadership and in concert with global regulatory strategy; • Provide strategic and tactical direction and regulatory guidance for development of product labeling, updates to PLR format, REMS and associated medication guides, advertising and promotion-related materials, and compliance-related activities. Open and maintain INDs and the submission and approval of New Drug Applications; Maintain Liaison with FDA• Oversee as well as serve as the regulatory reviewer for the US advertising/promotional review process; Manage the US Labeling Committee • Lead program representative to the TRIG (TIRF REMS Industry Group); Close Collaborator with other partners in the Industry Working group and FDA in finalizing and launching one of the few class-wide REMS programs and the first such REMS program for an opioid, the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program. Notable Accomplishments:• Lead multiple interactions/meetings with FDA regarding the TRIG REMS, pediatric plans and life cycle management development activities. • Provided key guidance for Launch-related meetings, promotional and managed markets materials• Lead proposal/contracting, value proposition, custom design, testing and deployment of advertising copy review software in collaboration with internal stakeholders ; Authored promotional material copy review SOP

Assigned to US FDA to conduct research under the Marketed Unapproved Drugs Initiative to help determine if marketed or imported drug products, suspected of being fraudulent or unapproved new drugs, meet the Generally Recognized as Safe/Effective (GRAS/E) standard as well as find innovative ways to remove such drugs from the market. Project involvement involves collaboration with HHS, US Department of Homeland Security and US Department of Justice.

A boutique regulatory consulting firm with a focus on facilitating quality, on-time health authority or ethics committee dossiers and submissions, regulatory strategies, and decisions; with a focus in clinical development/regulatory organizational processes (including decision-making and goals alignment), advertising and promotion strategy and review, and due diligence evaluations.

Faculty appointment to instruct students enrolled in the Master of Science in Biotechnology graduate program. Lead instructor/Course coordinator for “Regulatory Processes for Domestic and Global Biotechnology Products“; a semester-long course that introduces students to the basic and intermediate concepts of global drug development and US regulation.