Expert in Medicinal Chemist Pharmaceutical Expert Witness
Expert ID: 735673 Rhode Island, USA
My services have been retained by a major generic drug company regarding a contract dispute involving pharmaceutical degradation and 21 CFR. I wrote the opening report prior to a settlement being reached.
I have also consulted for H3-Biomedicine, where I 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.
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. Awarded the Heroes of Chemistry Award by the American Chemical Society in August 2019 for my contribution to a new antibiotic, NUZYRA a new antibacterial drug approved by the FDA 10/2/18. I also contributed to the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.
I have 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. I have co-authored a pre-IND proposal that had 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
|Year: 2002||Degree: Ph.D.||Subject: Chemistry||Institution: Brown University|
|Year: 1996||Degree: BA||Subject: Chemistry with a minor in Biology; Awarded Excellence in Organic Chemistry by the American Polymer Society||Institution: Rhode Island College|
|Years: 2014 to Present||Employer: Undisclosed||Title: Consultant||Department:||Responsibilities: Provided a consulting webinar regarding drug product degradation during mail order pharmacy shipments and current US regulations/ industry guidance documents related to the subject.|
|Years: 2018 to 2019||Employer: Generic Pharmaceutical Company||Title: Independent Expert Witness 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: 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: 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: 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: 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: 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: 2014 to Present||Employer: Undisclosed||Title: Professor||Department:||Responsibilities: • Responsible for teaching Organic Chemistry, Forensic Science and other lecture science classes.
|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
• 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: 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: 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
• 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.
|Awards / Recognition|
|Excellence in Organic Chemistry, by the American Polymer Society, I 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|
|Expert Witness Experience|
|4 cases, 2 depositions and one federal trial.|
|Training / Seminars|
|I attended 6 conferences from fall of 2018- 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.
Additionally, I attended Workshops within the conferences mentioned above.