Key Achievements:-Identified, evaluated and licensed 5 novel prodrugs and self-forming nanoparticles from an Academic & Research University. -Established collaboration with an University to conduct ophthalmic research in animal models of retinal neurodegeneration and choroidal neovascularization (CNV). -Applied for and awarded Phase I SBIR/STTR grant from National Eye Institute (NEI) at NIH.-R&D, Chemistry Manufacturing & Control (CMC) and New Dietary Ingredient (NDI) acknowledgement for an endogenous PPAR-alpha agonist Oleoylethanolamide (OEA) from the US FDA- Market launch & growth of RiduZone (OEA Supplement) & HEART (Healthy Eating & Activity with RiduZone for Transformation - iOS & Android Ap) via digital and traditional media strategies- Orphan Drug Designation for Prader-Willi Syndrome (PWS) for OEA- Pre-IND and Clinical Development StrategyKey words: #PPAR-Alpha Agonist, Healthy Cholesterol, Healthy Weight, Healthy Appetite

Biomedical Technology Licesing, Scouting & Development (Pharmaceuticals, Medical Devices & Dietary Suppliments)Product Life Cycle Management: Medical Devices: • Regulatory and business development consultation for the development of Class II medical device (510(k) preparation and licensing/acquisition of embryo micro-manipulation device.• Regulatory strategy for reproductive media and supplements (Class II medical device, Traditional (510(k)).• Post-notification 510(k) Supplement upon changing vendor/s and manufacturing facility for reproductive products.• Regulatory strategy for development of in vitro diagnostic (IVD) tests for detection of autoantibodies for breast cancer biomarker (Class III medical device).• Regulatory strategy for development of in vitro diagnostic (IVD) tests to diagnose and differentiate naturally infected and vaccinated individuals (for an immuno-deficiency disorder, Class III medical device).Pharmaceutical: • Developed preclinical IND-enabling study plan for anti-cancer molecules. • Submitted a Phase I SBIR, NExT (NCI Experimental Therapeutics) and CPRIT (Cancer Prevention and Research Institute of Texas) grant application in collaboration with the inventor for anti-cancer molecules.• Review of NADA (New Animal Drug Application).Nutraceuticals: • Development of dietary supplements (metabolite and herbal based) in compliance with FDA requirements (familiar with FDA requirements for facility registration, labeling and advertising).Technology Evaluation: • Evaluation of various life science technologies (pharma, biotech, medical devices, diagnostics and dietary supplements) at US universities and federal labs for scientific and commercial feasibility.Grants & Funding:• SBIR: Assisted a medical device company in securing Phase II SBIR, non-dilutive funding of $1.78M from NIH.

Chemistry, manufacturing and control (CMC) and immuno-oncology of biopharmaceutical agent - AME-133v (ocaratuzumab), a clinical stage anti-CD20 antibody.

- Business Plan and Scientific Research Plan development (application for orphan drug status, orphan drug grants, small business innovation research (SBIR) application, commercialization grants of Texas like CPRIT and ETF). - Pre-clinical projects and grant management - Perform competitive intelligence - FDA and ICH Regulatory affairs- Protocol and clinical Report Forms preparation

- Business plan development for R&D in cancer research.- Research grant writing for development of therapeutic molecules for cancer. - Training in Good Management Practices (GMP) in clinical trial management.- Training in FDA application process for preclinical and clinical (Phase 1,2 3) trials and Phase 4 studies for regulatory approval.

MS (Veterinary Pathobiology): Virology, Molecular Biology, Veterinary Biomedical Sciences, Bioinformatics, Alternative energy (biofuel production).MBA: Marketing, Technology commercialization, Entrepreunership, Business Plan Development.

Course: Canine and Feline Anatomy (VMED-7144).