Kevin Slatkavitz

An innovative consulting firm providing clients across the life science ecosystem with practical customized strategies, solutions and coaching to address a wide array of quality and regulatory compliance-related challenges and opportunities. Recent services have included strategic quality consulting, quality systems management and organizational design and effectiveness. Non-client initiatives include: • MassBio (Massachusetts Biotechnology Council) Associate Industry Member; MassConnect Mentor; Forum Working Group Co-Chair, "Drug Development, Manufacturing and Supply" [2018+]. • U.S. Editorial Staff Contributor, International Pharmaceutical Quality (IPQ), Washington, DC [2018+]. • Round Table Discussion Leader on "Risk Management and CMC Outsourcing" at MassBio CRO/CMO Conference during Biotech Week Boston [2018]. • Invited Speaker on "Quality - The Secret Sauce from Bench to Business", Biotech Buzz, Tufts Biomedical Business Club, Boston [2018/19]. • Back Page Editorial on "A Seat at the Strategy Table" for Pharmaceutical Executive, July Issue [2018]. • Invited Panelist on "Understanding Healthcare Economics and How it Will Affect Your Start-up", Tenth Massachusetts Life Sciences Innovation (MALSI) Day, Harvard Club of Boston [2017]. • Team member/contributor on industry/FDA whitepapers "Pharmaceutical Quality Metrics" (Xavier / PwC sponsored) and "Case for Quality" (Medical Device Innovation Consortium sponsored) [2016]. • Invited Speaker on "Quality Beyond Regulatory Compliance", Thirty-Ninth International GMP Conference, University of Georgia - College of Pharmacy [2015]. • Book in progress, "Quality Beyond Regulatory Compliance - Practical Strategies for the Pharma / BioPharma Industry", DHI/PDA publisher.

Recruited key talent, built and transformed Quality organization with vision and strategy as a value-added, fit-for-purpose business partner across R&D and Commercial enabling innovation, productivity, continuous improvement, patient safety and Regulatory Compliance - including GMP, GLP, GCP, GxP and Pharmacovigilance. • Provided significant vision and strategic/situational Quality Management leadership (partnering extensively with Manufacturing, Program Management, R&D and Commercial) that was pivotal to the linaclotide NDA approval and LINZESS launch. • Championed regulatory-compliant NDA submission and a regulatory-compliant supply chain prior to launch. • Proactively resolved key quality and regulatory compliance concerns throughout the complex, global supply chain - applying science-based risk management and cross-functional problem solving approaches. • Designed/led GXP regulatory inspection readiness campaign resulting in successful NDA approval and launch. • Champion with global business partners on preparedness of successful Clinical Sponsor regulatory inspections - positively impacting broader global submissions. • Enabled R&D pipeline with proactive, risk-managed and right-first-time approach to Quality and Regulatory Compliance - including one program's rapid shift from US to EU regulatory strategy.

Led the Corporate Quality (QA/QC) Organization through significant, complex business transformations and the company through corresponding strategic quality transformations. • Championed a Quality Vision/Mission cross-functionally and across multiple sites – enabling innovation and productivity while maintaining regulatory compliance and a focus on patient safety. • Successfully provided strategic leadership/technical expertise in cross-functional and cross-company resolutions of business critical GMP/GLP/GCP-related issues – promoting collaboration at all organizational levels. • Motivated and led Quality Professionals across three sites and significant reductions-in-staff while delivering business objectives on time for both development and commercial products.

Led a global organization of 80 professionals across seven sites/three countries with a +$7 million budget for one of the world's leading pharmaceutical companies. • Influenced the strategic direction and communication of quality and compliance worldwide as a member of several senior global leadership/management teams. • Improved productivity and work environment by leading a transformation of both the Quality and broader global R&D Product and API organizations’ ways of working and approach to Quality and Regulatory Compliance. • Successfully recruited key leadership talent both internally and externally, and led talent development initiatives in building the Quality organization. • Innovated and led design, development, and implementation of a leading-edge Global Quality System approach to cGMP for R&D, incorporating opportunities for science-based risk management and “Quality by Design.” • Delivered product portfolio timelines on time (no delays due to quality/compliance issues) and only positive outcomes resulting from regulatory agency inspections. • Supported licensing initiatives (including Biotech), and R&D GMP programs in India and Japan.

Responsible for establishing quality systems and performing cGMP regulatory compliance audits for one of the most rapidly growing global pharmaceutical organizations at the time. • Led strong partnerships with project teams/regulatory affairs to build quality/compliance into the CMC process. • Anticipated/resolved potential compliance issues internally and at CMO facilities prior to regulatory inspections. • Established cGMP readiness of new facility/innovative product via the FDA’s voluntary inspection program.

Transitioned from Analytical Chemistry leader to Quality Assurance/Regulatory Compliance leader as part of a business critical response to the Warner-Lambert/FDA consent decree. • Anticipated, identified, and resolved potential regulatory compliance concerns prior to FDA involvement. • Formed and led an extensive team to achieve specific regulatory compliance objectives during the consent decree, building effective partnerships across the organization, including Operations and Legal. • Developed strategies and spearheaded preparedness activities resulting in numerous successful pre-approval inspections worldwide; interacted extensively with FDA investigators. • Led R&D QA globalization initiative with vision, expectations, and mentorship to colleagues worldwide. • Improved productivity by managing the direction and implementation of cGMP and pre-cGMP (early development) quality programs as part of broader Go-to-Man and Go-to-Market company initiatives. • Represented Product Development for Fosphenytoin/Cerebyx® on multi-disciplined Go-to-Market Team. • Established cGMP systems at new international R&D facility in France. • Prepared and reviewed numerous drug product CMC sections for submission to regulatory affairs.

• Developed IND/NDA methods for several products including Atorvastatin (LIPITOR®). • Successfully mitigated a significant sample backlog ($10M) at a QC manufacturing site.

Unilever Research, US; The Pillsbury Company; Union Camp Corporation.