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必要な情報を、カテゴリー／エキスパート別に検索してください。
ブログ
Monica Commerford, PhD
Head of Viral Vector Services Regulatory Affairs
Scientific Expertise:
- Cell and gene therapy CMC expert
- Microbiology and molecular genetics
- Microbial control, Product Quality microbiology, and Sterility Assurance for investigational new drug and marketing applications
- Developing, editing and reviewing regulatory submissions, including reviews as a health authority assessor
- Regulatory intelligence and interpreting regulatory guidance
Focus Area
Viral Vector Services
Credentials
Sallie Rosen Kaplan Post-Doctoral Fellow, National Cancer Institute, National Institutes of Health
Doctor of Philosophy in Microbiology and Molecular Genetics from Harvard University
Bachelor’s degree in Biochemistry and Molecular Biology from Michigan State University
ブログ
Christy Eatmon
Senior Staff Scientist, R&D
Scientific Expertise:
- Extensive experience in pre-clinical to early phase formulation development of sterile products
- Process engineering expertise to enable technology transfer and scale up of parenteral formulations
- High level knowledge of all phases from drug discovery to commercial manufacturing and commercial launch
- Extensive experience with both small and large molecules, including small molecule formulation for controlled release of poorly water-soluble drugs
Focus Area
Steriles
Credentials
Bachelor’s degree in chemistry from Moravian College in Pennsylvania
ブログ
Douglas Hausner, PhD
Senior Manager, Continuous Manufacturing
Scientific Expertise:
- Continuous manufacturing
- Process analytical technology
Focus Area
Commercial manufacturing
Credentials
Doctor of Philosophy in physical chemistry from Temple University
Bachelor’s degree in chemistry from the University of Delaware
ブログ
Jeff Hou, PhD
Director and Site Head, Scientific & Technical Affairs
Scientific Expertise:
- Biologics development
- Cell line development
- Process development
- Tech transfer
- GMP manufacturing
- Cell biology
- Lead candidate discovery
Focus Area
Biologics (large molecule)
Credentials
Doctor of Philosophy in biotechnology from The University of Queensland
Bachelor’s degree in advanced sciences from the University of New South Wales
ブログ
Gordon Hutton, PhD
Materials Science Lead
Scientific Expertise:
- Organic chemistry
- Crystallization processes for commercial applications
- Materials science expert
- API development
- Commercial manufacturing
Focus Area
API (small molecule)
Credentials
Doctor of Philosophy in synthetic organic chemistry from the University of Cambridge, U.K.
Bachelor’s degree in pure & applied chemistry from Strathclyde University in Glasgow, U.K.
Expert
Kevin Kane, PhD
Senior Staff Scientist, R&D
Scientific Expertise:
- Oral drug delivery
- Drug product development
- Pre-formulation, formulation, process development, scale-up, tech transfer, commercialization
- Phase appropriate dosage forms for preclinical and clinical studies
- Solubility enhancement technologies
- Amorphous solid dispersions by spray-drying, hot-melt extrusion and complexation
- Size-reduction and lipid-based systems
- Oral modified release
- Multiparticulate and osmotic delivery
- Matrix tablets
- Lipid modified release
- Injectable drug delivery
- Formulation development for solution and lyophilized vials for small molecules
- IV and depot formulations
- Powder-filled vials
- Technology transfer
Focus Area
Commercial manufacturing
Credentials
Doctor of Philosophy in inorganic chemistry from Ohio University
Post-doctoral Fellow and Visiting Assistant Professor of chemistry at the University of Idaho
Master’s and Bachelor’s degrees in chemistry (polymer and materials) from Texas State University
