Steve J Bannister
- Role
- President and Principal Consultant at Hightower Pharma Services
- Location
- Tampa, FL, US
- LinkedIn followers
- 500 followers
About Steve J Bannister
Experienced pharmaceutical-development scientist and leader; more than 30 years of…
Experience
President and Principal Consultant
Nov 2008 — Present
General Description Hightower 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 Level Assist 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) reformulations Project Level Data analysis to develop real understanding; modification of dissolution and transport behavior; selection and technical supervision of contract laboratories Task Level Problem solving, e.g, in investigations of release-control failures and technical transfer problems; experiment planning and interpretation Litigation Support Engaged as a consulting or testifying expert by counsel for plaintiffs or defendants, provides data analysis and opinion on technical issues as described above Recent Project Under 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.
Skills
- Formulation Chemistry
- Clinical Development
- V&V
- R&D
- Clinical Trials
- Biopharmaceuticals
- Glp
- Gmp
- CRO
- Pharmaceutics
- Due Diligence
- Laboratory
- Drug Development
- Formulation
- Drug Delivery
- Organic Chemistry
- Life Sciences
- Oncology
- Solubility
- Pharmacokinetics
- Chromatography
- Pharmacology
- Purification
- Fda
- Chemistry
- Nanoparticles
- Bioanalysis
- Regulatory Affairs
- Technology Transfer
- Ind
- Commercialization
- Hplc
- In Vivo
- Management
- Dissolution
- Medicinal Chemistry
- Analytical Chemistry
- Leadership
- Pharmaceutical Industry
- Lifesciences
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