Steve J Bannister Email & Phone Number

Tampa, Fl, Us

General DescriptionHightower Pharma Services is a pharmaceutical-development consultancy which assists client firms turn discoveries into products. Hightower focuses on investigating the physical chemistry of active and inactive ingredients in drug substances, drug products, and biological milieu in order to develop an understanding of formulations and drug delivery sufficient to develop effective technology. Program LevelAssist executives with technical due diligence in the acquisition of drug-development projects; screen candidate technologies, e.g., delivery and targeting systems, for new chemical entities and 505(b)(2) reformulationsProject LevelData analysis to develop real understanding; modification of dissolution and transport behavior; selection and technical supervision of contract laboratoriesTask LevelProblem solving, e.g., in investigations of release-control failures and technical transfer problems; experiment planning and interpretationLitigation SupportEngaged as a consulting or testifying expert by counsel for plaintiffs or defendants, provides data analysis and opinion on technical issues as described aboveRecent ProjectUnder contract from the National Instiitute on Drug Abuse (NIDA) and in collaboration with a design engineering firm developed and characterized a standardized electronic nicotine delivery system (ENDS) for use in electronic cigarette clinical research. Investigated the influence of hardware design, nicotine-containing liquid (e-liquid) composition, and power-control parameters on the delivery of nicotine and harmful and potentially harmful constituents (HPHCs). Monitored the stability of the e-liquid in the packaged assembly. Prepared a drug-device combination product Drug Master File (DMF) in Common Technical Document (CTD) format for reference by investigator-initiated Investigational New Drug (IND) applications.

While continuing my Hightower consulting practice I am actively involved as a member and as a scientist in the start-up Cloaked Therapeutics.Cloaked is developing TumorSelect® technology which combines:- proprietary prodrugs of approved, clinically effective anticancer agents:- nanotechnology; and- knowledge of human physiologyAnticancer drugs are selectively delivered into tumor cells with the assistance of physiological processes of both the human body and the tumor cell. Cloaked Therapeutics’ designer prodrugs are assembled within nanoparticles which are not extensively distributed into healthy tissue but are carried to tumor tissues where they are actively taken into cells and transformed rapidly into the cancer-killing active drug. This approach increases drug effectiveness while reducing the severe side-effect toxicities associated with current cytotoxic chemotherapy therapy.

Tampa, Fl, Us

Product development and CMC consultingSelection and management of outsourced servicesConsulting and testifying expert in litigation

King Of Prussia, Pennsylvania, Us

Product development and CMC consultingSelection and management of outsourced servicesConsulting and testifying expert in litigation

Tampa, Fl, Us

Consultancy supporting product development planning and execution, technical due diligence and intellectual property protection.

Denver, Colorado, Us

Served as outside thesis committee member; lectured on natural products in drug development; supervised a postdoctoral fellow in the development of sensitive and specific enantioselective bioanalytical separations complex stereoisomer mixtures

• Section 16-reporting corporate officer• Accountable for drug R&D, process development, and manufacturing technical services• Member of corporate technical due diligence team• In-house subject-matter expert in the crafting and review of formulation patent defense strategiesDepartment accomplishments include: • Approval of paclitaxel ANDA;• Development of proprietary oral delivery systems for natural-product drugs;• Design and synthesis of small focused libraries of proprietary modified natural products with specifically enhanced pharmacology;• Development and installation of semisynthetic paclitaxel manufacturing process meeting or exceeding targets for cost, yield, purity, and impurity profile;• Development and installation of extraction, isolation and purification processes for natural products from multiple biomass sources; and• Numerous analytical methods, especially chromatographic, capable of specific determination of components in complex natural product mixtures7/99-9/00 Senior Director, Product and Analytical Development. Formed new department combining internal resources for the development of sterile and oral formulated products with those of central analytical services. 9/98-7/99 Director New Product Development. Recruited from former development partner based on problem-solving performance and effective leadership of corporate technical interactions

9/97-9/98 Director, Preformulation Development, 3/97-9/97 Associate Director, Analytical Research and Development, 6/95-3/97 Section Head, Analytical Research and Development.Lead multidiscipline analytical unitDeveloped methods to characterize new-drug and generic immediate and extended-release oral solid dosage forms and used data in collaborative product optimization.Reinforced technical performance of central R&D analytical department. Member of the Research & Development Committee (CSO’s executive control of drug development), and the corporate New Technology Review Committee, evaluating licensing opportunities and joint-venture proposals. • Raised technical performance of Section and Department through the implementation of rational tools and techniques in analytical method development and optimization. • Increased the level of collaboration of Section and Department with other development and regulatory units of Company. • Assertively lead CMC collaboration between Ivax and partners NaPro BioTherapeutics (API supplier) and Faulding (product manufacturing). • Increased effective utilization of department resources to complete a zero-deficiency Paxene NDA CMC section within project plan despite significant department staff reductions.• Team developed proprietary solutions for formulation stability problems, and deformulated and characterized competitor products

Basel, Basel-Stadt, Ch

Lead two laboratory units responsible for chromatographic methods applied to drug-safety and pharmacokinetics studies. US and Global Drug Safety representative on US and international product-management teams. Communicated effectively and persuasively with FDA on substantive technical issues. Permanent member of the US Drug Safety Management Committee (VP’s senior staff), and permanent DS liaison to Pharma Development VP’s staff. Project leader in international projects leading to global data-manipulation and data-management tools, and to harmonized reports.

Recruited as part of expansion of Rochester NY discovery and development. Major task was to help with an orderly elimination of the department as the company collapsed under the weight of compliance failures in major UK manufacturing facilities.

Developed department from 7 to 22 professionals as part of expansion of US development resources. • Analytical Services – Product and substance analytical methods and clinical supplies release;• Bioanalysis- Methods for analysis of fluids and tissues for drugs and metabolites; and • Pharmacokinetics – Bioavailability, bioequivalence, dose-proportionality, and drug-drug interaction studies were designed, interpreted and reported. Projects included Augmentin®, Paxil®, Bactroban®, and Relafen®. The department prepared portions of PK and CMC sections of US and European investigational, new-drug, generic-drug and veterinary product registrations. Guided integrated implementation of new analytical and data-management technologies.

Formed Key's first central analytical resource for drug-delivery product R&D. Products included TheoDur, an extended release oral solid delivering theophylline, KDur, an extended-release oral solid delivering potassium chloride, and the drug-in-adhesive NitroDur nitroglycerin transdermal. Analytical methods development and services applied to:• Drug substance and drug product testing;• Drug release control characterization and release-mechanism elaboration;• Collaborative optimization of formulation and process to achieve in-vitro and in-vivo release targets;• In-vitro transport experiments;• Product stability assessment;.Served as liaison between R&D and engineering during specification, design and renovation of 70,000 sq.ft. factory - on-time and within budget – into laboratories for R&D use and as facility manager after construction.

Ms, Phd, Pharmaceutical Chemistry

Bs, Pharmacy