Pharmaceutical Medicinal Chemist Drug Development, Drug Formulations Expert

Expertise

• Discovery and development of novel human therapeutics for: Anti-infective, anti-inflammatory and neurodegenerative diseases.
• Development of antibacterial clinical candidates, and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.
• Drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formulation and the management of CROs to support pre-clinical testing.
• Chemical analysis of pharmaceutical and nutraceuticals products.
• Drug formulation and drug stability studies.
• Design, synthesis and purification of drugs.
• Drug development in the areas of inflammation, spinal muscular atrophy, multiple sclerosis and anti-bacterial.
• Formulating drugs for stability, solubility and bioavailability studies. Designed protocols for IP, IV, ICV, IT and oral dosing studies.
• Cross couplings, transition metal catalysts, formylation, Iodination and peptide coupling reactions
• TLC, IR, 1H NMR, 13C NMR, 2D NMR, HPLC and LCMS.
• HPLC and Flash chromatography.

Expert Witness Experience

• All aspects of drug research and development.
• Patent infringement, provided chemical analysis of disputed products.

Experience

Undisclosed Company, Independent Expert Witness Consultant, 2016 - Present

• Provide professional consulting and expert witness services to the undisclosed client through legal counsel pertaining to patent infringement.
• Coordinate and oversee the chemical analysis of the defendant's contested products.
• Preparing expert reports regarding the infringement of contested products over the asserted claims.

Mylan Pharmaceuticals, Independent Expert Witness Consultant, 2016

• Provided professional consulting and expert witness services to Mylan Inc. through legal counsel in connection with opposing ANDA patent infringement litigation in the area of pharmaceutical technology.
• Prepared expert reports regarding the invalidity of Pfizer patents concerning the reformulation of one of their products.
• Provided compelling arguments based on examples within the prior art, of why it would have been obvious to a person skilled in the art to at least try the formulation in the contested patents with a reasonable expectation of success.
• Prepared reply reports in response to Plaintiff experts' responsive reports, reconfirmed presented arguments as well as highlighted Opponents experts' contradictions and misrepresentations of the prior art.
• Participated in a 7 hour deposition.
• Involved with the pre-trial preparation.

Salve Regina University, Newport RI, Professor, 2014 - Present

• Responsible for teaching Organic Chemistry lab and lecture science classes.

Cemotics LLC, Providence, RI, Consultant, 2014 - 2016

Project: Biotech developing therapeutics for cancer and malaria

• Developed Arysphosphonium Salts (APS) as anti-cancer agents. Responsibilities include design of novel compounds, development of screening cascade and medicinal chemistry lead optimization efforts.
• Interacted with vendors to facilitate whole cell screening, toxicity, in vivo efficacy and ADME.
• Developed a novel treatment for malaria that circumvents resistance, generation of preliminary data through outsourcing with vendors.

Paratek Pharmaceuticals, Boston, MA, Principal Scientist, 2002 - 2013

Principal Scientist and Project Coordinator, 2009 - 2013

• Biotechnical development of tetracycline therapeutics for anti-infective, anti-inflammatory and neurodegenerative diseases.

Project Coordinator-Lab, 2009 - 2013

Project 1

• Coordinated the efforts of the Spinal Muscular Atrophy (SMA) program in preclinical development.
• Responsible for design and development of intrathecal (IT) and intracerebroventricular (ICV) continuous and bolus dosing protocols for mice, rat and monkey studies.
• Designed and conducted stability studies and formulation studies for continuous dosing efficacy studies to be compatible with Alezet osmotic pumps.
• Worked with cross-functional teams in cell-biology, pharmacology, process chemistry and vendors that supported in vivo efficacy studies, DMPK and GLP toxicity studies.
• Responsible for synthesis of new compounds and lead optimization of medicinal chemistry efforts for SMA.
• Outsourced and managed preclinical efficacy/PK testing of three compounds at multiple CROs to facilitate pre-clinical toxicity and further PK analysis of our clinical candidate in mice, rat and monkey.
• Contributed to grant writing for NIH and FSMA grants.

Project 2

• Developed a new antibacterial for bacterial resistant respiratory infections in cattle for Elanco.
• Delivered an efficacious antibacterial compound for subcu bolus dosing which would not tissue stain.
• Managed one direct reports.

Senior Scientist and Project Coordinator-Lab, 2006 - 2009

• Worked on areas of anti-inflammation and functioned as the project coordinator for SMA.
• Responsible for synthesis of new derivatives, lead optimization, analysis of results from outsourced and in house in vitro studies, whole cell, pharmacology and in vivo studies.
• Worked with cross-functional teams in cell-biology, pharmacology, process chemistry as well as vendors that supported in vitro and in vivo efficacy studies.
• Developed HPLC purification methods for large-scale (6" diameter column) epimer separation of novel tetracycline derivatives previously not possible.
• Managed one direct reports.

Scientist II, 2003 - 2005

• Discovered and developed novel tetracyclines for the treatment of multiple sclerosis (MS) in collaboration with Serono. Delivered three validated pre-clinical tetracycline leads for MS.
• Developed formulation procedures that reduced tolerability issues when dosing IP and IV and enabled a wider therapeutic window with which to compare compounds in experimental autoimmune encephalomyelitis (EAE) mouse efficacy studies.
• Responsible for synthesis of new derivatives, lead optimization and analysis of results from in vivo efficacy
• Worked with cross-functional teams in cell-biology, pharmacology and process chemistry.
• Built a micro reactor to developed an oxidation assay to elucidate the structure activity relationship for tetracycline oxidation/tissue staining, a potentially negative aspect of some tetracyclines. The assay's results correlated with tissue staining in vivo.

Scientist I, 2002 - 2003

• Contributed to the development of pre-clinical candidates for hospital and community acquired severe bacterial infections.
• Optimized synthetic methods and developed purification protocols for two key tetracycline intermediates on a 100g scale. This work removed a huge bottleneck in the production of tetracycline derivatives.
• One lead compound is currently in phase III trials (Omadacycline) and a second has completed Phase I.

Eikos Inc., Franklin, MA, Scientist I, 2002

• Oversee biotechnical and material science co development of anti malaria drugs and incorporation of carbon nanotubes into polymers.
• Managed all aspects of chemistry at Eikos. Conducted Polymer production reactions using a 50L reactor.
• Developed a solid phase organic synthesis protocol for the production of aminoquinoline antimalarials in support of an SBIR grant.
• Managed three direct reports.

Brown University, Providence, RI, Graduate Researcher, Department of Chemistry, 1996 - 2002

• Studied protease inhibitors and developed a novel enzymatic assay for screening catalysts for asymmetric reactions.
• Optimized a novel class of protease inhibitors based on a cyclohexanone core
• Developed a protocol for the synthesis of cyclohexanone-based protease inhibitors on solid support.
• Designed and synthesized a 400-member library of these cyclohexanone inhibitors on solid support.
• Developed an enzymatic assay for high-throughput screening of catalysts for asymmetric reactions.
• Developed methodology to conduct assays in a 384 well format to assess inhibition constants for a library of peptidomimetic compounds against cathepsin B, plasmin, papain, trypsin, thrombin and kallikrein.
• Monitored reactions by TLC, IR, 1H NMR, 13C NMR, and HPLC.
• Purification by flash chromatography, crystallization, distillation, separation of diastereomers by HPLC and enantiomers by both chiral-GC and chiral-HPLC.
• Analysis of final compounds 1H NMR, 13C NMR, 2D NMR and MS.
• Proficient with enzymatic assays and jell electrophoresis.

Honors & Publications

Credentials

• Computer skills: Microsoft word, Excel, PowerPoint, Photoshop

Awards

• Excellence Award: Organic Chemistry by the American Polymer Society

Publications and Patents

• Author and Co-Author of publications: Peer reviewed journals, posters and abstracts
• Inventor and Co-Inventor, 9 patents: World, U.S., Canada (with focus to tetracycline compounds)

Education

• Ph.D. Chemistry, Brown University, Providence, RI
• B.S. Chemistry, Rhode Island College, Providence, RI