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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
ブログ
Jason Mieding
Senior Director, Logistics
Scientific Expertise:
- Highly experienced in supply chain with a particular focus on sales and operations planning, transportation and logistics management, and system enhancements including SAP
- Certified in production and inventory management (American Production and Inventory Control Society)
- Multi-functional leadership experience in manufacturing, quality, and technical areas within pharmaceutical GMP environments
Focus Area
Logistics
Credentials
Bachelor’s degree in production and operations management from Ohio State
ブログ
Daniel Baskind
Manager, Scientific and Technical Affairs
Focus Area
Biologics (large molecule)
ブログ
Elena Gontarz, PhD
Manager, Scientific and Technical Affairs
Focus Area
Biologics (large molecule)
ブログ
Iain McGroarty
Senior Business Development Executive, API Europe
Focus Area
API (small molecule)
ブログ
Harry Berlanga
Senior Director, Quality, EMEA
Scientific Expertise:
- Steriles
- Biologics
- Solid dose
Focus Area
Clinical trial services
Credentials
Masters in Pharmaceutical Sciences
Chartered biologist
Qualified Person (QP) for clinical and commercial products
ブログ
Janet Williams
Senior Director, Global Supply Chain Management
Focus Area
Clinical ancillary management
Clinical trial services
ブログ
Julie Hoffman
Senior Director of Commercial Strategy and Execution
Focus Area
Clinical ancillary management
Clinical trial services
ブログ
Kevin Shea
Senior Label Program Director
Expertise:
- Clinical supplies, with expertise in clinical labels, label translation and regulatory services
- Customer oversight/maintenance
- Customer liaison
- New business
- Bid defences
- Issue Resolving
- Webinars, Workshops, Presentations, and Whitepapers
- Trade shows
- Escalations
- Technical support
- Training, Quality and Audit support
Focus Area
Clinical label services
Clinical trial services
Credentials
Bachelor's Degree, Hobart College
ブログ
Paul Jorjorian
Vice President and General Manager, Biologics
Focus Area
Biologics (large molecule)
ブログ
Anil Kane, PhD, MBA
Senior Director, Global Technical and Scientific Affairs
Scientific Expertise:
- Product development
- Small molecules
- Pre-formulation, clinical development to lifecycle management
- Scientific strategic planning/problem solving
- Early development
- Clinical supplies
- Technology transfer
- Supporting chemistry, manufacturing, and controls documentation
Focus Area
Formulation and development
Credentials
Doctor of Philosophy from the University of Bombay, India
Master of Business Administration from Richard Ivey School of Business, University of Western Ontario, Canada
Post Doctoral research at the University of Cincinnati
ブログ
Sanjay Konagurthu, PhD
Senior Director, Science and Innovation
Scientific Expertise:
- Product development
- Oral drug delivery
- Drug product development
- Pre-formulation, formulation, process development, scale-up, tech transfer, and commercialization
- Solubility enhancement technologies
- Amorphous solid dispersions by spray-drying
- Hot-melt extrusion
- Size-reduction
- Lipid-based systems
- Complexation
- Oral modified release
- Multiparticulate delivery
- Osmotic delivery
- Taste masking
- Fast-dissolving dosage forms
- Lifecycle management
- Designing novel drug delivery systems
- Nano-milling
- Process miniaturization
- Process development and scale-up
- Novel process design & implementation
- Design of experiments
- Technology transfer
Focus Area
Formulation and development
Credentials
Doctor of Philosophy in chemical engineering from the University of Colorado in Boulder
Bachelor’s degree in chemical engineering from the Indian Institute of Technology Madras (Chennai)
ブログ
Ronald Perry
Senior Manager, R&D
Scientific Expertise:
-
Formulation, technical transfer, and process optimizations for:
- Oral solid dosage forms, tablets, hard shell capsules, and softgels
- Oral liquids (solutions, suspensions, extended release suspension)
- Transdermal systems
- Sterile injectables
- Ophthalmic
- Medical device
- Aerosol products
- Packaging
- Creams and ointments
- Quality assurance experience including site auditing (domestic and international)
- Pharmacy/pharmaceutical consultant services ad libitum
Focus Area
Softgels
Credentials
Pre-med/pharmacy degree from Indiana University South Bend, IN
Bachelor of Science, Pharmacy from Purdue University School of Pharmacy in West Lafayette, IN
Studied diabetes education and anticoagulation therapy
Immunization certified
Registered Pharmacist (R.Ph.)
ブログ
Peter Poechlauer, PhD
Innovation Manager, Small Molecule API
Scientific Expertise:
- Product development
- Small molecules
- Green chemistry
- Process technology
- Continuous manufacturing & analytics
- Process Intensification
- Organic chemistry
- Biocatalysis
Focus Area
API (small molecule)
Credentials
Doctor of Natural Sciences in organic chemistry & pharmaceutical chemistry from Innsbruck University in Austria
ブログ
Richard Snyder, PhD
Vice President, Science and Technology
Scientific Expertise:
- Oral solid dosage forms, tablets, hard shell capsules, and softgels
- Virus biology
- Viral vector development
- cGMP viral vector manufacturing & analytical technologies
- Viral vector mediated gene transfer
- Development of novel viral vector-based human gene therapies
Focus Area
Viral Vector Services
Credentials
Post-doctoral fellow at Johns Hopkins University School of Medicine
Doctor of Philosophy in microbiology from The State University of New York at Stony Brook
Bachelor’s degree in biology from Washington University in St. Louis
ブログ
Kaspar van den Dries, PhD
Senior Director Science and Innovation, Softgels
Scientific Expertise:
- Formulation & process development
- Solid dose formulation (tablets, capsules, and softgels)
- Late stage process development projects
- Technology transfer
- Regulatory filings
- Solubility enhancement
- Biopharmaceuticals
- Lipid-based formulations
- Quality by design
- Risk assessment and experimental designs
- Process analytical technologies (NIR)
- In vitro – in vivo relationships
Focus Area
Softgels
Credentials
Doctor of Philosophy and Master’s degree in pharmaceutical sciences from the University of Utrecht, NL
ブログ
Jennifer A Head, PhD
Manager of Regulatory Affairs, Microbial Manufacturing Services (MMS)
Scientific Expertise:
- Regulatory strategy for marketing of controlled substances, new molecular entities, and new chemical entities
- Regulatory intelligence and interpretation of regulatory guidance
- Developing, editing, and reviewing regulatory submissions
- Cell and gene therapy CMC expert
- Microbiology and immunology
- Viral pathogenesis
- Medical technology
- Central nervous system and oncology pharmaceuticals
Focus Area
Biologics
Credentials
Jean B. Kempner Postdoctoral Fellow and Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant recipient, Doctor of Philosophy in Microbiology and Immunology from University of Texas Medical Branch, Bachelor of Science degree in Medical Technology from University of Texas MD Anderson Cancer Center School of Health Professions, Bachelor of Science degree in Biology from Texas A&M University Corpus Christi
ブログ
Susan Li
Director of Customer Solutions
Scientific Expertise:
- Autologous
- Allogenic cell & gene therapy supply chain solutions
- Clinical trials supplies
- Commercial operation and serialization
- Operations and manufacturing
- Specialty courier services
- Ultra-cold and cryogenic storage and biorepository
- secondary packaging and labeling
- Global cold chain logistics network operation
- Supply chain visibility and real-time monitoring
- Chain of identity and chain of custody
Focus Area
Advanced Therapies
Credentials
MBA from Northwestern University, Kellogg School of Management
MA in Biology from Smith College
BS in Biochemical Engineering from East China University of Science & Technology
ブログ
Clara Ferloni
Sr Manager, EU Regulatory Affairs, Thermo Fisher Scientific
Scientific Expertise:
- Regulatory
- Chemistry, Manufacturing and Controls (CMC)
- Clinical and Commercial products
- EU Regulatory Affairs
Focus Area
Regulatory Affairs, supporting, amongst others, sites specialized in the manufacture of biological products.
Credentials
PhD in enzyme technology
ブログ
Sara Sheriff
VP of Integration/ Engineering Operations Services Optimization Leader
Scientific Expertise:
- Integration
- Engineering Operation Services optimization
- digital platforms
- Operations and manufacturing
Focus Area
Operations/ Supply Chain Excellence and Business Process/Digital Transformation
Credentials
test
ブログ
Panteli Theocharous
Global Vice President, Cell and Gene Therapy Strategy lead at PPD, part of Thermo Fisher Scientific.
Scientific Expertise:
- Cell and Gene therapy
- Cancer Immunotherapy expert
Focus Area
Stem Cell Transplantation,
Cell and Gene Therapies
JACIE – The
Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and
the European Group for Blood and Marrow Transplantation (EBMT) Inspector
Credentials
M.S. in Applied Clinical Hematology ,University of London
Cancer medicine related higher degrees, University of London
ブログ
Michael Cruskie, PhD
Sr. Director and General Manager, API (Small Molecule)
Scientific Expertise:
- Product development
- Small molecule APIs
- Strategy & process development
- Process improvement/optimization
- Operations and manufacturing
- Technology transfer
- Scale-up
- Supply chain
- Outsourcing
Focus Area
API (small molecule)
Credentials
Doctor of Philosophy in organic chemistry from the University of Florida
Bachelor’s degree in chemistry and mathematics from St. Lawrence University
ブログ
Matthew Jones, PhD
Senior Manager, Crystallization
Scientific Expertise:
- Crystallization process development, small molecules and biological macromolecules
- Particle engineering
- Downstream processes (solid-liquid separation and drying)
- Solid state chemistry and solid state analysis
Focus Area
API (small molecule)
Credentials
Habilitation (higher doctorate) in chemical engineering from MartinLuther-University Halle-Wittenberg, Halle (Saale), Germany
Doctor of Philosophy from the University of London, University College, U.K.
ブログ
Keirnan LaMarche, PhD
Senior Staff R&D Manufacturing Scientist
Scientific Expertise:
- Tablet compaction
- Powder flow
- Continuous manufacturing of drug products
- Characterized and model drying processes, unit operators
- Fluid bed driers
- One-pot granulators
- Tablet coaters
Focus Area
Oral solid dose
Credentials
Doctor of Philosophy and Master’s degree in chemical engineering from Rutgers University
Bachelor’s degree in engineering, chemical engineering from The Cooper Union for the Advancement of Science & Art
ブログ
Frank Ritacco, PhD
Director, Scientific and Technical Affairs
Scientific Expertise:
- Highly experienced in the development of cell lines, media, and culture conditions for the production of recombinant proteins and naturalmetabolites, as well as bioreactor operation, scale-up, cGMP manufacturing and technology transfer
- Research experience and skills include both mammalian cell culture and microbial fermentation (bacteria, yeast, filamentous fungi), process development, cellular physiology, and perfusion culture
Focus Area
Biologics (large molecule)
Credentials
Doctor of Philosophy in microbiology and molecular genetics from Rutgers University, NJ
Master of Science in microbiology and molecular genetics from Rutgers University, NJ
Bachelor of Science in biological sciences from Cook College, Rutgers University, NJ