Fort Myers, Florida, United States
────────────────────────── Unique Value Proposition: ────────────────────────── 30 years experience as a Pharmaceutics Research Scientist / Advisor, with a proven history in conquering drug candidate challenges: low API availability, drug bioavailability, solubility and stability to ACCELERATE DEVELOPMENT TIMELINES. Expertise in defining and executing effective preformulation programs to AVOID COSTLY MISTAKES in Phase I, Phase II, Phase III or post launch. Industry thought leader, with background encompassing 13 Patents, more than 70 Publications and frequent Citations, as well as Research Gate scores in the top 5%. ────────────────────────── Consistent Delivery of Value-Added Results: ────────────────────────── Throughout my career, I have demonstrated the ability to understand the major aspects of the drug discovery process – from target selection, to compound screening and designing lead candidates – as well as ensure that preformulation studies generate data that is highly useful for formulation development work. By providing a sound scientific approach and proven project delivery methodologies, I have played an integral role in ENSURING SUCCESSFUL DRUG DEVELOPMENT AND COMMERCIALIZATION. Built into my leadership background is finesse in managing a cross-functional team, aggregating input and maintaining a balance between clinical excellence and successful commercialization. In addition, I leverage a strong knowledge network with internal and external stakeholders and key opinion leaders, to stay current with research developments, monitor competitors, and influence the design and optimization of drug products.
Review and interpret scientific results and recommend studies to initiate. Participate in evaluation of technical challenges of pharmaceutical projects. Review patents. Evaluate their scientific strength, help structure claims supported by data, discover physical forms of compounds that enabled them to be commercially viable products. Summarize CMC information and assemble it in CTD format for regulatory submissions.
Instructor of Introductory Chemistry Students
ACCELERATING DRUG DEVELOPMENT PROCESS: Led rapid, high quality evaluation and detailing of drug candidates’ to identify physical properties for producing developable, (chemically and physically) stable with processing qualities that lend itself to manufactured by continuous process, preferably DC tablets. Solid scientific basis resulted in determining candidates with real potential as early as possible – discovering those with greatest likelihood of success for clinical trials and commercialization earlier and increasing the probability of technical success. Patents 2013-2015 (13 granted in total, multiple in process) Hipskind, P. A.; Stephenson, Gregory A. Preparation of 4,4,4-trifluoro-N-[(1S)-2-[[(7S)-5-(2- hydroxyethyl)-6-oxo-7H-pyrido[2,3-d][3]benzazepin-7-yl]amino]-1-methyl-2-oxo-ethyl]butanamide, its salt or hydrate as notch pathway signaling inhibitors From PCT Int. Appl. (2013), WO 2013016081 A1 20130131. US Patent Number 8569286, October 29, 2013. Jadhav, P. K.; Saeed, A.; Green, J. E.; Krishnan, V.; Matthews, D. P; Stephenson, Gregory . Preparation of cyclopentyl benzonitrile compounds as selective androgen receptor modulators (SARM) for therapy US 8658693 B3 Feb. 25, 2014 More than 70 Peer Reviewed Publications, numerous invited presentations) Implementing Quality by Design in Pharmaceutical Salt Selection: A Modeling Approach to Understanding Disproportionation. Pharmaceutical Research (2013), 30(1), 203-217. Crystal structure prediction of a flexible molecule of pharmaceutical interest with unusual polymorphic behavior. Crystal Growth & Design (2013), 13, 581−589. Compression-induced crystallization of amorphous indomethacin in tablets - characterization of spatial heterogeneity by two-dimensional X-ray diffractometry. Molecular Pharmaceutics (2015), 12(1), 253-263. Assessment of the Amorphous Solubility of a Diverse Group of Drugs Using New Experimental and Theoretical Approaches. Molecular Pharmaceutics (2015), 12(2), 484-495.
Discovery of physical forms of active compounds and selection of form for development; salts, co-crystals, and polymorphs. Prepare regulatory submissions and construct sections of patent applications. Consult legal teams evaluating patents.
Responsible for directing research activities conducted in three laboratories at Eli Lilly and Company; salt discovery and selection, single crystal X-ray diffraction, and X-ray powder diffraction laboratories. Interact with discovery chemistry, process development chemistry and formulation scientists to screen compounds, during lead optimization and development stages, for chemically stable and bioavailable crystalline salt forms. Hits are validated and chemistry scaled to sufficient size for physical and chemical characterization prior to candidate selection. Responsible for Eli Lilly and Companies small molecule X-ray crystallography laboratory. Serve as corporate resource for growth and solution of small molecule crystal structures and generation of crystallographic data for Confirmation of Structure (COS) reports for all IND and NDA submissions. Responsible for X-ray powder diffraction laboratory. Work involves the application of powder diffraction methods for the characterization of the solid-state forms. Commonly determine crystal structures by powder diffraction (using simulated annealing/genetic algorithms) to understand crystallographic packing influence on morphology in cases where single crystals cna not be grown with sufficient size or quality for single crystal methods. Use area detectors andf 96 well-plate formats for High throughput screening of forms, Use variable temperature and humidity to study phase transformations and phase relationships of crystal forms.
The Pharmaceutical Development Leader (PDL) for the Dairy team is responsible for the development of veterinary drugs (small and large recombinant produced molecules) for food-producing animals. The team focuses on the early development stages of the pipeline with formulation development, dose determination and completion of chemistry process development as key goals. As a member of the multi-disciplinary Food Animal Development team, the PDL is responsible for all aspects of the CMC program from the early stage pre-formulation and formulation development up to production of material for clinical trials. The PDL plays a central role in this process by interacting with members of the FAR Team, Pharmaceutical Science and Technology (PST) functions, TS/MS Commercialization, Regulatory Affairs and external partners.