Looking for drug development consulting? Let’s start collaborating and move your project forward.
OUR MISSION
Development of the next generation of pharmaceuticals routinely requires multiple vendors to advance the synthetic process and manufacture GLP and GMP material for preclinical and clinical studies. This can be a complex endeavor and requires expertise and experience. My goal is to guide you through this process as quickly and efficiently as possible.
Let’s work together
I am a Ph.D. synthetic organic chemist with over 30 years of experience in the pharmaceutical industry. I enjoy solving process chemistry problems in a way that allows rapid, cost-effective, reproducible, generation of active pharmaceutical ingredients (APIs) in the purity and quantity needed. My goal is to ensure that availability of drug substance is not the rate-determining step in the drug development process. You should have what you need for analytical development and validation, toxicology studies, preformulation, formulation, drug product manufacture and clinical studies.
About
I am an expert in process chemistry research and drug substance manufacturing.
I have extensive experience in strategic planning and program management. Innovative and disciplined, I pride myself on finding practical and creative solutions to complex problems quickly and efficiently. Potential solutions are vetted rapidly through consistent focus on getting answers to critical questions first. I am adept at developing strong working relationships and delivering superior results. Highlights from my curriculum vitae are below followed by a link to my full CV.
CV Highlights:
View full CV (add link)
-
B.S. Chemistry, University of Wisconsin Madison – Research Advisor Professor Barry Trost
Ph.D. Organic Chemistry, Harvard University – Thesis Advisor Professor David Evans
-
Abbott Laboratories:
Research Scientist with 15 years in process and medicinal chemistry researchCedarburg Pharmaceuticals:
Senior Scientist, Director of Process Research and Development, Chief Scientific OfficerAlbany Molecular Research Inc (AMRI):
Director, Chemical DevelopmentCambrex Inc.:
Director, Process Chemistry and Drug Substance ManufacturingSage Therapeutics:
Director, Chemical Development -
Extensive process development, drug substance scale-up and CMC experience in the pharmaceutical industry.
Demonstrated ability to manage outsourced process development and manufacturing activities in a virtual environment both domestically and internationally.
Strong problem-solving skills and ability to multitask and succeed in a fast-moving and dynamic environment.
Excellent verbal and written communication skills, ability to effectively work across levels, functions, and companies.
Knowledgeable about relevant ICH and health authority guidelines.
Experience in writing drug substance sections for regulatory documents and submissions
CLIENT QUOTE
Insert a client quote here about how great it is to work with you. A testimonial is a great thing to add to the site as a way to break up the sections.
Services & Capabilities by Category
-
Description text goes here
-
Description text goes here
-
Description text goes here
-
Item description
Services & Capabilities
Biotech, Small Pharmaceutical Discovery, Venture Capital Companies
Review and determination of drug substance material needs for preclinical and clinical pharmaceutical development.
Generation of requests for quote (RFQs), vendor evaluation and selection, project oversight. Inspection of CROs/CDMOs/Manufacturing.
Synthetic route selection, technical transfers, optimization, route scouting and proof-of-concept studies. Solutions to complex synthetic chemistry problems.
Identification of the most stable crystal polymorph or salt form.
Management of process research and development, demonstration batches, preclinical (GLP) batches and GMP manufacturing.
Partner closely with analytical and formulation development, nonclinical development, quality assurance, and CMC-regulatory.
Identification of appropriate analytical methods for material release and in-process control.
Raw material evaluation and selection, specification setting for all starting materials, reagents, intermediates, and products.
Establishment of appropriate regulatory starting materials (RSMs).
Impurity control strategies, potential genotoxic impurity (PGI) assessments, nitrosamine risk assessments. Impurity identification and characterization.
CMC author drug substance portion (3.2.S) of investigational new drug application (IND).
Cost of good estimates (COGs) and raw material vendor price negotiations.
Services & Capabilities
Contract Research Organizations (CROs), Contract Development and Manufacturing Organizations (CDMOs):
Evaluation of requests for quote (RFQs/RFPs) and generation of technical strategy, time estimates, and analytical aspects of proposals for clients.
Cost estimates for current processes and recommendations for improvement.
Generation of alternate, novel synthetic routes to valuable materials.
Review of technical capabilities and recommendations for valuable process chemistry, analytical and manufacturing upgrades or expansion.
Technical oversight or full project management of process development and GLP or GMP manufacturing.
Impurity identification through a combination of analysis and knowledge of rection mechanism.
Full impurity characterization (NMR, MS, IR, ROI, ICPMS, XRD, DSC, TGA, IC).
Cost of good estimates (COGs) and raw material vendor price negotiations.
