Kenneth L. Avery Ph.D.
Avery Pharma Consulting LLC
PROFESSIONAL EXPERIENCE:Avery Pharma Consulting LLC
- Consulting in Chemical and Formulation Development.
- More than 20 years experience in Pharmaceutical Development in CMC.
- Experience in small and large pharma with cross functional teams.
- Extensive network of experts.
- Outsourced both the scale up of the API synthesis and a new formulation to support clinical trials for company’s drug asset.
- Outsourced APIs and drug products for clinical and nonclinical studies.
- Directed API and formulation development, manage costs and timelines
- Management of vendors, setting specifications, troubleshooting.
- Member of core project team for new drugs.
- Writing and update of CMC.
- Experienced with polymorphs, solubility and new formulations
- screening of compounds with limited solubilities.
- Technology transfer to overseas manufacturing site.
- Metabolite and impurity synthesis as well as synthetic analytical support.
- Developed HPLC analytical methods for trace analysis of small molecule drugs and metabolites in biological samples.
- Developed highly efficient enzymatic processes for small molecule therapeutics.
- Led collaborative process development projects with several large pharmaceutical companies. Communicated with partners through project proposals and technical reports.
- Established pharmaceutical kilo-lab for production and pilot studies.
- Devised and completed several phases of a new biocatalytic route to one of the world’s largest selling antibiotics. Demonstrated cost effectiveness of process at pilot scale. (Significant IP was developed for the large pharma customer.)
- Developed and scaled a new pharmaceutical chiral intermediate to the multi kilo scale. Performed process development to significantly reduce costs that resulted in a patent application.
- Part of team who developed a new microbial drug metabolite technology platform using high throughput screening techniques.
- Delivered business and technical presentations to various size pharma companies.
- Developed new and economically feasible chemical processes for both core technology compounds and specialty proprietary chemicals. Supported company efforts in nitrile, sulfur and surfactant chemistries. Team leader for new surfactant chemistries. Utilized consultants and external collaborators as needed.
- Developed new chiral reactions for intermediates based on enzymatic and classical routes.
- Key member of a team to develop a new chiral technology platform.
- Scaled products to pilot plant including the production of 300kg of a pharmaceutical intermediate.
- Pilot scale evaluation including daily hands on operation. Process development on pharmaceuticals for human and animal applications following GMP principles and guidelines.
- Developed and scaled a new drug synthesis from pilot plant to semiworks.
