Learned Consulting Group, LLC provides strategic R&D consulting to the Pharmaceutical industry and to those firms / entities interested in investing in such, specifically in the areas of clinical development, clinical pharmacology & pharmacokinetics, overall end to end drug discovery and development, clinical and preclinical safety evaluation, global regulatory affairs, regulatory dossier development, business development and M&A, translational and experimental medicine, and utilizing innovative approaches to clinical study design and regulatory strategy. I have 27+ years of leadership experience within the Pharmaceutical Industry, with >20 years in senior leadership / Exec Committee positions leading the discovery and development of both NCEs (small molecules) and NBEs (large molecules) within the neurosciences, immunology, dermatology and oncology therapeutic areas. Overall, I have directly led or been an integral part of over 60 successful NDA , sNDA and global regulatory submissions and approvals worldwide. Currently, I lead R&D at two clinical stage biotech companies --- one focused in endocannabinoid pharmacology and the other in the psychedelic space (both with primary indications within the neurosciences therapeutic area). In addition, I sit on Scientific Advisory Boards and Data and Safety Monitoring Boards (for various companies in the neurosciences space), and provide therapy area and drug development expertise to VCs / healthcare-focused funds within financial institutions on investment strategy and due diligence of opportunities.

Led and built strategic & operational organizations accountable for all clinical sciences, clinical operations, preclinical sciences, epidemiology, data & statistical sciences, clinical pharmacology, scientific communications, REMS program, clinical, medical & safety compliance, & health economics & outcomes support to all Indivior products in development and within the marketplace globally. Provided therapeutic area, regulatory strategy, & drug development expertise & oversight to the global Indivior organization across 4 R&D sites in Europe & US. • Oversight of all end-to-end global strategic & operational medicines’ development activities, budget oversight, global development planning & implementation• Management of a large global organization, ~100 clinical & clinical pharmacology scientists and physicians, data managers, biostatisticians, statistical programmers, health outcomes scientists, preclinical pharmacology and toxicology scientists, PK and PK/PD modeling experts, epidemiologists, clinical operations personnel, medical writers, clinical, medical and safety compliance personnel, & all personnel supporting Indivior’s REMS programs.• Oversight & accountability for all regulatory submissions, including all enabling & associated activities, & support for all business development activitieso 3 NDAs submitted between Dec 2016 – Sept 2017o >20 ex-US regulatory submissions between 2018-2021o Multiple regulatory approvals within US and globally (SUBOXONE™ tablet, SUBLOCADE™ extended-release injection™, NALSCUE spray™) within 2017; PERSERIS™ for extended-release injectable suspension, SUBLOCADE™ extended-release injection, SUBOXONE™ tablet and SUBOXONE™ film in 2018-2021 (ex-US global submissions and approvals)o Leadership of successful FDA Advisory Committee team for SUBLOCADE™o Oversight of all pre-approval inspection-readiness activities• Implementation of innovative development strategies & negotiation of such with global regulatory agencies

Led strategic and operational teams accountable for all areas of R&D, Commercial and support functions for the Psoriasis and Atopic Dermatitis Care Areas for all assets (>20) from preclinical development through life cycle management • Portfolio prioritization, allocation of resources, budget oversight, global development planning and implementation• Business development strategy and globalization / geographic expansion of compounds for psoriasis and atopic dermatitiso acquisitions of Phase II asset GSK2894512 (Welichem) cream for psoriasis and atopic dermatitis and Phase III asset TOCTINO™ (Basilea) soft-gelatin capsules for severe, refractory chronic hand eczema; o >25 global regulatory submissions and approvals for OLUX™, OLUX-E™, LUXIQ™, CUTIVATE™ (cream/oint), DERMOVATE™ (solution / oint / cream), EUMOVATE™ cream, BETNOVATE™ (cream/oint/lotion), TOCTINO™ oral soft-gelatin capsules • Management of ~100 clinical, preclinical, product development, legal, medical affairs, project management, business development, GMS, regulatory affairs, commercial, portfolio analysis, market access, finance, QA , global health outcomes and clinical pharmacology/translational med staff• One successfully filed and approved NDA and one successfully filed and approved sNDA (SORILUX™ foam for body psoriasis; SORILUX™ foam for scalp psoriasis). • Implementation of innovative development strategies (i.e., exposure-response modeling) and successful negotiation of such with FDA resulting in successful NDA submission for TOCTINO™oral soft-gelatin capsules years ahead of plan and >$30 mill USD under budget.

Set up early development neuroscience organization for GSK in Shanghai, China. Led all clinical development activities for the global Neurology R&D Pipeline including translational medicine (including lab oversight), experimental medicine, data management and discovery biometrics, clinical operations, epidemiology and clinical PK modeling and simulation• Line managed a department of ~30 neurologists and clinical pharmacology physicians, clinical scientists, data management and statistical staff, epidemiologists, translational medicine physician scientists/ scientists, clinical pharmacokineticists and clinical operations staff across 3 continents and 5 R&D sites• Led development and implementation of strategic clinical development plans for all compounds within the Neurosciences Discovery pipeline, from Candidate Selection through to Commit to Medicines Development (C2MD) milestones. Strategies included the incorporation of neuroimaging and other biomarker / experimental medicine technologies, and the assessment of PK/PD relationships for efficacy and tolerability throughout the clinical phases of development• Led the cross-functional, company-wide Neurodegeneration Working Group, with membership from every organization in GSK involved with the discovery, development, and commercialization of medicines for neurodegenerative disorders (~60 members).• Established a neurology clinical network in East Asia and was GSK representative on a cross-company consortium that was successful in proposing and influencing better regulatory guidances for clinical registration in China (SFDA; later CFDA) • Led the large cross-functional anti-IL7R mAb project team as Medicines Development Leader for all (neurosciences and immunology) indications

• Developed and implemented strategic clinical development plans for all neurosciences compounds within the Neurosciences Discovery pipeline at GlaxoSmithKline, from Candidate Selection through to Proof of Concept (Phase II) • Management of ~ 30 staff including psychiatrists, neurologists, clinical pharmacologists (physicians and scientists), clinical pharmacokinetic experts, and post-doctoral fellows across 2 continents and 4 R&D sites• Design and delivery of Proof of Concept strategies for all North-American based neurosciences projects within the Neurosciences Drug Discovery portfolio• Incorporation of neuroimaging and other biomarker / experimental medicine technologies, and the assessment of pharmacokinetic / pharmacodynamic relationships for efficacy and tolerability throughout the clinical phases of development• Responsible for authorship, review and approval (sponsor signatory) of key documents such as protocols, clinical study reports, CIBs, INDs, CTX/CTAs and NDAs• Project Leader for multiple projects within the Neurosciences discovery portfolio• Lead liaison for GSK NS discovery with academic partners within the US and the lead clinical GSK contact for all GSK/NIMH and GSK/NIDA grants in NS discovery