Consulting in ophthalmic drug and device R&D

Ocular Pharmacology

• Appointed to Graduate Faculty• Appointed to the Academy of Medical Educators of the Texas College of Osteopathic Medicine • Taught clinical & drug development to faculty, students, & staff of UNTHSC, UT Southwestern, UT Arlington, & John Peter Smith Health Network.

As an Executive-In-Residence (EIR) at the University of North Texas Health Science Center (UNTHSC), I, and the other EIRs, provided early stage entrepreneurial life science companies in the UNTHSC incubator with real-world, limited general business guidance for the critical early stages of pharmaceutical and medical device product development.

Identified industry sponsored clinical trials that meshed with the academic interests of Orthopaedic Surgery faculty and managed the efforts to be selected as a site. PIs and trials quadrupled, and the revenues increased ten-fold.

Co-Author of one of a series of 3 articles receiving the 2013 George W. Northup, DO, Medical Writing Award, as the best articles published in the Journal of the American Osteopathic Association in 2012.

Executive oversight of all activities related to the conduct of pharmaceutical and medical device industry sponsored clinical trials at UNTHSC and its affiliated institutions. Developed relations, oversaw contract negotiations, implemented standardized pricing schedules, etc. with sponsors and CROs for 18 new trials of FDA-regulated small molecules and biologics in Cardiology, Infectious Disease, Geriatrics, Orthopedics, Pediatrics, Rheumatology, and Surgery. Identified areas of risk and potential non-compliance and coordinated institutional officials, Principal Investigators (PIs), sub-investigators, and clinical research staff to develop and implement action plans and to respond to internal and external audits. • Initiated a clinical trial Research Registry for UNT Health (medical practice plan) patients.• Provided development expertise (CMC & clinical) and project management for a start-up that received $2 million from the Texas Emerging Technology Fund and was named a 2011 Small Business of the Year.• Invited member of NIH NCATS Therapeutics for Rare and Neglected Diseases (TRND) panel of expert reviewers.

Consulting services concerning posterior blepharitis and nitric oxide donation in the field of ophthalmology.

Responsible for R&D, QRV, & Manufacturing (via CMOs) of Nicox, a new international ophthalmic company, aiming to build a diversified portfolio of therapeutic products addressing the needs of eyecare practitioners and patients around the world.

Executive accountable for the development of new ophthalmic pharmaceutical products (recently focused on glaucoma) for the world leader in Ophthalmology. Direct the Project Team Captains to move projects through the development and approval cycle to provide Alcon new products on a consistent schedule and within the $100+ million development budget. Direct the Viability Project group to provide rapid clinical read-out in order to define novel products with advantages over competitive products or for new therapeutic opportunities. Direct Glaucoma and Anterior Segment Clinical Sciences to meet study targets. Accountable for developing strategies, maintaining appropriate mix of projects, and resolving resource conflicts for all development projects to meet the overall goals of R&D.•Led/mentored development activities and resolved resource conflicts leading to submission, approval, and launch of TRAVATAN®, VIGAMOX®, TRAVATAN® Dosing Aid, DUOTRAV®, TRAVATAN® Z, PATADAY®, and AZARGA™.

Executive responsible for a consistent flow from European external sources (companies/institutions) of therapeutic product opportunities for development. Direct activities to ensure expedient evaluation and licensing of candidate compounds and establish strategic alliances and directions to meet the overall goals of R&D. •Negotiated license/supply agreement and 2 strategic alliances for potential breakthrough retinal therapies.

CEO of the worldwide R&D center for a multinational pharmaceutical company specializing in ophthalmic (as well as dermatologic & ENT) therapeutics and ophthalmic surgical adjuncts. Directed biological R&D (cell biology, microbiology, pharmacology, toxicology,& vivarium); pharmaceutical R&D (formulation development, analytical chemistry, package development, pilot manufacturing/scale-up, & product maintenance); clinical R&D (clinical pharmacology, clinical development, & pharmacovigilance); regulatory affairs (Spain, Europe, & Rest of World); government relations; quality assurance; project management; and technical information services for all new and existing products. Researched, developed, and industrialized new and generic topical, parenteral, & oral formulations of drugs and devices. Identified, negotiated, and acquired in-licensed molecules for R&D. Instilled GLP & GCP compliance. Managed a 75 person R&D center, substantial off-site research contracts, and multi-company international R&D collaborations. Patented and developed OCUBRAX®.•Initiated a project management system to control and directed task forces to develop and launch 2 new Rx (OFTALMOTRIM-DEXA®, OTIX®) and 2 dozen generics, a dozen OTC, and 2 dozen cosmeceutical products in domestic and international markets. IMS(S1) market share grew from 34% to 43%; sales doubled in 4.5 yr. •Revamped the focus, style, and pace of R&D such that Cusí was rated in the top 2 for innovation in Spain for 1991 & 1992, advanced 2 levels in the "Plan de Fomento Industria" into top 10%, and received 9 accelerated registration reviews (and approvals) from the Spanish Ministry of Health. •Initiated the design and implementation of the first 24 hr/day pharmacovigilance program in Spain.•Integrated Cusí R&D Center into Alcon R&D. Reduced head-count to 55 while finding positions for all affected personnel and maintaining schedule of regulatory submissions and product launches.

Executive manager of worldwide R&D and pharmaceutical product maintenance for a multinational vision care company. Directed all pharmaceutical development, package development, analytical chemistry, microbiology, pharmacology/toxicology, project management, local area network, and technical information services for ophthalmic therapeutics, contact lens care products, surgical adjuncts, and related devices. Developed new drugs and devices using conventional and biotechnological approaches. Managed a 60 person R&D division and substantial off-site research contracts. Designed, equipped, and staffed new laboratories to triple R&D capabilities.•Initiated and led task forces to launch 6 new international and domestic OTC contact lens products that accounted for 40% of company’s contact lens care product sales. Developed strategy and led re-entry into ophthalmic therapeutics. Developed OCCUCOAT® (now Bausch & Lomb’s OcuCoat®).

Director of all preclinical and clinical ophthalmic research, both for internal product development projects and for external contract projects, for a biotechnology firm specializing in the use of liposomes as novel sustained drug delivery systems. Matrix managed 10 Ph.D. and 30 M.S./B.S. scientists/technicians to accomplish project objectives. Directed an off-site academic research laboratory to conduct project support and basic research.•Directed the first external contract to achieve acceptance of a prototype formulation by a sponsor.•Principal Investigator of a funded SBIR grant.

Manager of pharmacological research for the then world leader in ophthalmic pharmaceuticals. Planned and managed by objectives the activities of 4 Ph.D. investigators, designed projects and allocated resources using PERT, designed and supervised the construction of new laboratory facilities, and recruited, hired, and developed the entire 20 person department. Participated in the R&D that lead to PROPINE®, BETAGAN®, OCUFEN®.•Led the Glaucoma, Inflammation/Immune Regulation, and Cataract Research Programs as well as specific compound evaluation projects.•Directed the evaluation of a novel New Chemical Entity from primary animal screening, through analytical and formulation development, preservative selection and effectiveness testing, and toxicological evaluation, to the completion of initial clinical ocular and systemic safety and ocular efficacy assessment - in 18 months

Legal Officer MarBksBklyn, Company XO, Rifle & Weapons Platoon Commander, PLC