Expert Details
Medicinal Chemistry and Pharmaceuticals
ID: 735673
Rhode Island, USA
Expert's services have been retained by a major generic drug company regarding a contract dispute involving pharmaceutical degradation and 21 CFR. He wrote the opening report prior to a settlement being reached.
Expert has also consulted for H3-Biomedicine, where he oversaw radio-labeled syntheses, of active pharmaceutical ingredients (API) for pharmacokinetic studies as well as the design of stability studies and formulation of the API in support of CMC.
Expert is a Ph. D. Medicinal Chemist with over 25 years of experience in the discovery and development of novel human therapeutics in the areas of cancer, anti-infective, anti-inflammatory and neurodegenerative diseases. He has been awarded the Heroes of Chemistry Award by the American Chemical Society in August 2019 for his contribution to a new antibiotic and new antibacterial drug approved by the FDA in 2018. He also contributed to the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.
Expert has been involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug formulation, stability studies and the management of CROs. He has co-authored a pre-IND proposal that enjoyed a favorable review by the FDA.
SKILLS AND TECHNIQUES
• Expert Witness Consulting: Report writing, Deposition experience and pre-trial preparation experience.
• Medicinal Chemistry: Discovered multiple clinical candidates
• Drug Formulation: Developed stable formulations from hundreds of drugs for preclinical testing.
• Synthetic Organic Chemistry: Extensive work with tetracycline natural products pioneering mild reaction conditions suitable for this class of compounds. Cross couplings, transition metal catalysts, formylation,
Iodination and peptide coupling reactions to name a few
• Analytical: TLC, IR, 1H NMR, 13C NMR, 2D NMR, HPLC and LCMS.
• Purification: Analytical and preparative HPLC and Flash chromatography
• Computer skills: Microsoft word, Excel, PowerPoint, Photoshop
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2002 | Degree: Ph.D. | Subject: Chemistry | Institution: Brown University |
| Year: 1996 | Degree: BA | Subject: Chemistry with a minor in Biology | Institution: Rhode Island College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2014 to Present | Employer: Undisclosed | Title: Consultant | Department: |
Responsibilities:Among other achievements as Consultant at his eponymous firm, Expert has provided a consulting webinar regarding drug product degradation during mail order pharmacy shipments and current U.S. regulations/ industry guidance documents related to the subject. |
|||
| Years | Employer | Title | Department |
| Years: 2018 to 2019 | Employer: Generic Pharmaceutical Company | Title: Independent Expert Witness and Consultant | Department: |
Responsibilities:• Provide professional consulting and expert witness services (opening report) relating to a contract dispute.• Corroborated pharmaceutical manufacturing documents with 21 CFR to show compliance. |
|||
| Years | Employer | Title | Department |
| Years: 2018 to 2018 | Employer: Generic Pharmaceutical Company | Title: Independent Expert Witness Consultant | Department: |
Responsibilities:• Provided professional consulting and expert witness services relating to an ANDA case.• Provided a Declaration regarding how a person skilled in the art would define specific claim terms |
|||
| Years | Employer | Title | Department |
| Years: 2016 to 2018 | Employer: Thorn Research | Title: Independent Expert Witness Consultant | Department: |
Responsibilities:• Deposed for 7h.• Gave trial testimony for a trial by jury. • Advised counsel on 2 in progress depositions. • Provide professional consulting and expert witness services pertaining to patent infringement. • Coordinated the search for and vetted other experts for the case. • Coordinated and oversee the chemical analysis of the defendant’s contested formulation. • Preparing expert reports regarding the infringement of contested products over the asserted claims. |
|||
| Years | Employer | Title | Department |
| Years: 2017 to Present | Employer: Undisclosed | Title: Pharmaceutical development Consultant | Department: |
Responsibilities:Coordination of a radiolabeled compound synthesis, stability studies and formulation used in pharmacokinetic studies.Assist with CMC of clinical trial material and the intricacies of drug allocation |
|||
| Years | Employer | Title | Department |
| Years: 2016 to 2016 | Employer: Mylan | Title: Independent Expert Witness Consultant | Department: |
Responsibilities:• Provided professional consulting and expert witness in connection with Hatch-Waxman ANDA patent infringement litigation in the area of pharmaceutical technology.• Prepared expert reports regarding the invalidity of plaintiff’s 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 in which I reconfirmed my arguments as well as highlighted plaintiff’s experts’ contradictions and misrepresentations of the prior art. • I was deposed by the plaintiff’s counsel for 7 hours. • I was also involved with the pre-trial preparation up until the parties settled. |
|||
| Years | Employer | Title | Department |
| Years: 2014 to 2016 | Employer: Cemotics LLC, | Title: Pharmaceutical Development Consultant | Department: |
Responsibilities:• Development of Arysphosphonium Salts (APS) as anti-cancer agents. Responsibilities include design of novel compounds, development of screening cascade and medicinal chemistry lead optimization efforts.• Interact with vendors to facilitate whole cell screening, toxicity, in vivo efficacy and ADME. • Developing a novel treatment for malaria that circumvents resistance, generation of preliminary data through outsourcing with vendors. |
|||
| Years | Employer | Title | Department |
| Years: 2014 to Present | Employer: Undisclosed | Title: Professor | Department: |
Responsibilities:• Responsible for teaching Organic Chemistry, Forensic Science and other lecture science classes. |
|||
| Years | Employer | Title | Department |
| Years: 2002 to 2013 | Employer: Paratek Pharmaceuticals | Title: Principal Scientist/ Project Coordinator | Department: |
Responsibilities:Biotech developing tetracycline therapeutics for anti-infective, anti-inflammatory and neurodegenerative diseases.Project 1: Project Coordinator for Spinal Muscular Atrophy (SMA) program in preclinical development • Co-authored a pre-IND application for the intrathecal administration of our clinical candidate for Spinal Muscular Atrophy (reviewed by the FDA 1/23/13). • Responsible for design and development of intrathecal (IT) and intracerebroventricular (ICV) continuous and bolus formulations and 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 subcutaneous bolus dosing which would not tissue stain. • Worked on additional projects as needed. • Managed one direct report Sr Scientist (Project Coordination/Lab work ~ 30%/70%) 01/06 – 01/09 • 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 report. Scientist II 01/03 – 01/05 • 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 drug formulation procedures that reduced tolerability issues when dosing IP and IV thereby enabling a wider therapeutic window with which to compare compounds using 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 08/02 – 01/03 • 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. |
|||
| Years | Employer | Title | Department |
| Years: 2002 to 2002 | Employer: Eikos Inc. | Title: Scientist I | Department: |
Responsibilities:Biotech/material science, developing 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. |
|||
| Years | Employer | Title | Department |
| Years: 1996 to 2002 | Employer: Brown University | Title: Graduate Researcher, Department of Chemistry | Department: |
Responsibilities: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 (see EMDee publication below). • Developed methodology to conduct assays in a 384 well format to assess inhibition constants for a library of peptidomimetic compounds against various proteases such as cathepsin B, plasmin, papain, trypsin, thrombin and kallikrein • Monitored reactions by TLC, IR, 1H NMR, 13C NMR, 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. |
|||
Career Accomplishments
| Licenses / Certifications |
|---|
| Awarded Excellence in Organic Chemistry by the American Polymer Society. |
| Awards / Recognition |
|---|
| Excellence in Organic Chemistry by the American Polymer Society. Scored in the 96th percentile on a National Exam. Heroes of Chemistry Award by the American Chemical Society, for my contribution to the development of NUZYRA, a new antibacterial drug to combat drug resistant bacteria, approved by the FDA in 2018. |
| Publications and Patents Summary |
|---|
| Publications and Patents: 14 |
Additional Experience
| Expert Witness Experience |
|---|
| 4 cases, 2 depositions and one federal trial. |
| Training / Seminars |
|---|
| Expert attended 6 conferences from fall of 2018 to summer 2019. 2 ACI PIV Disputes conferences in New York and Chicago ACI's Drug and Medical Device Litigation in NYC King and Spaulding conference in NYC ACI's Dietary Supplements- Legal, Regulatory and Compliance in NYC ACI's FDA Bootcamp- Legal and Regulatory aspects in Boston. He also attended workshops within the conferences mentioned above. |