John (Jack) McLane

An innovative leader and consultant, experienced in start-ups, venture capital funding, and global clinical research (CRO) firms encompassing all Phases of products in the pharmaceutical, generic, biological and medical device industries. Known for formulating and executing strategies that align mission, operations, products and goals for competitive advantage, improved ROI and generating quality results. Skilled at leading full regulatory and clinical development projects and teams resulting in successful INDs, IDEs, NDAs, MAAs and developing regulatory and clinical processes and strategies. Extensive experience leading global management teams by providing strategic assessment, management and program metrics to develop innovative drugs. Select Accomplishments• Submitted NDAs in Parkinson’s, Alzheimer’s, orphan diseases and Dermatology indications. • Achieved successful audits by creating comprehensive SOPs and Quality systems. • Overcame vendor issues for Hoffmann-La Roche, Ariston, Clinquest and Tolmar • Won more than $20M in venture capital funding for start-up Ariston Pharmaceuticals. • Led $900M of product submissions sent to regulatory authorities on time and within 3-5% of budget. • Spearheaded new formulation of old drug, completing project 10% under budget at Roche. • Turned around stalled international project for Hoffmann-La Roche. • Led successful FDA meetings for clinical programs and safety programs and issues• Successfully filed multiple Orphan Drug Designations applications in the US and EU for several companies including Roche. Core CompetenciesConsulting on clinical/regulatory strategiesP&L • Regulatory Compliance • Global Management * PharmacovigilanceStart-ups • Negotiation • Vendor RelationsStrategic Planning • Risk Assessment • Conflict ResolutionQuality • Communications • Investor RelationsRegulatory Submissions (INDs, IDEs, CTA, ANDAs, NDAs, PMAs etc.)Clinical Trial Design & Operations • Business Development