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Drug Development Services

Medicinal Chemistry CMC / Scale up and Process Chemistry Analytical Methods ADME/PK Bioanalytics

Medicinal Chemistry

The Medicinal Chemistry department is lead by Dr. Prakash Jagtap (Ph.D.) Vice-President of Chemistry , a veteran medicinal chemist with 25 years of experience, who has played leading roles at several biotechnology and pharmaceutical firms resulting in the advancement of his patented technologies to the clinical stage of development.

The Salzman Group offers an experienced medicinal chemistry team for all aspects of hit optimization and clinical candidate selection. This includes expansion of new chemical scaffolds and pharmacophores around rational SAR design by empirical and computational and crystallographic approaches. We optimize your hits for potency, ADME/PK, and toxicology and provide consultancy and guidance to solve your developmental challenges or need for optimization, e.g. to generate new intellectual property, or to reduce cost of goods via more efficient synthetic routes. 


CMC / Scale up and Process Chemistry

The Salzman Group offers expertise and in-house capability in bringing milligram syntheses to the kilogram level, including process development to redesign syntheses tailored to your needs. This is supported comprehensively by our analytical team. Our analytical chemists excel at the design of quality control (QC) assays for the release of starting materials, synthetic intermediates, and final active pharmaceutical ingredients (API). Our manufacturing plant is well equipped with reactors at various sizes, up to thousands of liters, ready  for any production task.


Formulation Development

Head – Dr. Garry Southan, Ph.D., Executive Vice-President of Research.

Dr. Southan is a nationally-renowned pharmaceutical development leader with 25 years of professional experience in Synthetic Chemistry and Biochemistry who led numerous pharmaceutical projects from invention into Phase 2 clinical trials. Former Executive Vice-President of Chemistry at Inotek Pharmaceuticals Corporation, Dr. Southan has broad experience in the pharmaceutical development process and leads senior chemists and biologists to identify, discover, in-license, and develop innovative life science technologies.

The Salzman Group can expertly develop a variety of formulations, ranging from simple to complex, including formulations for parenteral, oral, dermal, ocular, and inhaled dosing. The desired route of dose administration will consider the target site, bioavailability, disposition, and pharmacokinetics of the therapeutic entity. We can screen for excipients, solubility, stabilization, and container compatibility supported by deep analytical capabilities.


Analytical Methods

Head - Dr. Yousif Sahly, Ph.D., Director of Analytical Chemistry and ADME/PK.

Dr. Sahly has over 23 years of experience in large and emerging pharmaceutical companies in USA and Israel, amongst, worked at Pfizer as a Director of Drug Metabolism and Pharmacokinetics (DMPK), at Merck as a Senior scientists in the DMPK department and at Teva as senior Director, Head of analytical Research and Development.

The Salzman Group provides state-of-the-art infrastructure and comprehensive analytical methodologies (LC-MS/MS, LC-MS/TOF, NMR, FTIR, GC-MS, DSC, UV/fluorescent spectroscopy, HPLC, microscopy), enabling solubility and stability testing, salt screening, morphology studies, formulation, and pro-drug evaluation.




ADME/PK

Head - Dr. Edwin Garner, Ph.D., Vice-President of Drug Development.

Dr. Garner has over 20 years of experience in pharmacokinetics and metabolism and has published numerous publications in pharmacokinetics and toxicokinetics. Dr. Garner’s previous tenure with three major pharmaceutical companies included direction of preclinical DMPK. Dr. Garner is responsible for developing novel PK and PK/PD models to support discovery and development of small and large molecules.

The Salzman Group offers broad capabilities for determining the absorption, distribution and for the use of novel delivery, tracer, and analytical approaches to resolve dosimetric and metabolic questions. We combine leading-edge bioanalytical chemistry, in silico ADME/PK modeling, and radioanalytical capabilities with expertise in exposure, biochemistry, toxicology, and pathology to optimize the pharmaceutical efficacy and select laboratory species most predictive of human responses. 


Bioanalytics

Head – Dr. Garry Southan, Ph.D., Executive Vice-President of Research.

The Salzman Group has the experience and tools to develop or transfer methods on small molecules, proteins, or peptides to support pharmacokinetics, toxicokinetics, metabolism studies, and immunoaffinity assays. Methods can be validated in accordance with GLP. For biomarker discovery we employ specialized metabolomics, time-of-flight spectroscopy, and MassHunter software.



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