Expert in Medicinal Chemistry/ Synthetic Organic Chemistry-Research and Patent Litigation
Expert ID: 736259 New Jersey, USA
1) Eight years of consulting experience, beginning in Jan. 2012, writing expert reports following patent analysis covering obviousness, claims validation, enablement; depositions given. Cases include an ANDA Hatch Waxman case as expert consultant; a case dedicated to claims validation and enablement that went on for two years, monthly reports; another ANDA case where obviousness was a crucial factor.
2) Seven INDs (investigational new drugs) in oncology, immunology, metabolic and antiinfectives areas during career.
3) Inventor of saxagliptin at BMS that was a breakthrough drug for type II diabetes as a sole therapy.
4) Inventor of lead molecule for bcl-2 inhibitor program venetoclax at Abbott Labs that caused the regression of solid tumors in preclinical oncology studies.
5) As Lexicon director of med chem, led team of 16 medicinal chemists in small molecule effort to IND and Phase IIb clinical trials for rheumatology, arthritis, and psoriasis.
Expert may consult nationally and internationally, and is also local to the following cities: Philadelphia - New York, NY
|Year: 1995||Degree: Postdoctoral||Subject: Synthetic Organic Chemistry||Institution: Princeton University|
|Year: 1992||Degree: PhD||Subject: Synthetic Organic Chemistry||Institution: University of California, Irvine|
|Year: 1986||Degree: BS||Subject: Chemistry||Institution: University of Connecticut|
|Years: 2012 to Present||Employer: Undisclosed||Title: Director||Department: Consulting||Responsibilities: Consultant for pharmaceutical patents for 8 years–claims validation on COM, obviousness, enablement arguments, reports, depositions, testimony. Biotech consulting. Ongoing collaboration with CNS biotech company to test novel CNS library using in vivo phenotypic analysis; filed US Provisional May 2020.|
|Years: 2012 to 2020||Employer: Rutgers University||Title: Assoc. Professor / Director||Department: Chemistry||Responsibilities: At Rutgers–> Expert led MD&S group of 7 chemists to execute programs to obtain preliminary results for NIH R01 grant proposals written. Collaborated with PIs to be awarded six funded R01s, 1 DoD, and 1 R21 in six years where writing proposals with PIs was his main function. Managed CROs SaiLife for PK/PD and Aptuit or Piramal for chemistry support.|
|Years: 2003 to 2012||Employer: Lexicon Pharmaceuticals||Title: Director||Department: Discovery Chemistry||Responsibilities: At Lexicon–> Director of Immunoscience medicinal chemistry: led team of 16 FTE to advance 3 INDs to Phase IIB (LX2931, LX2932) for RA/UC/psoriasis and kinase inhibitor (LX2311) for MS cGLP/GMP through IND enabling studies. Use of biomarkers in mechanistic studies for efficacy from knockouts; Analytical chemistry (NMR, LCMS/MS, HPLC, GCMS, UV-vis); CMC section of INDs written. Phase 1-3 INDs. Managed outsourced chemistry via CROs; Aptuit and SaiLife.|
|Years: 1999 to 2003||Employer: Bristol-Myers Squibb||Title: Principal Investigator||Department: Discovery Chemistry||Responsibilities: • Inventor of ONGLYZA (saxagliptin), FDA Approval 2009 for type II diabetes, J Med Chem 2005, 48, 5025-5037. Expert in Discovery, all aspects; biomarkers, ex-vivo mechanism-based assays for PK-PD.
• Member of BMS Due Diligence team to evaluate biotech research
|Years: 1995 to 1999||Employer: Abbott Labs||Title: Investigator||Department: Discovery Chemistry||Responsibilities: • Inventor of lead acylsulfonamide for bcl-2 inhibitor program that led to acylsulfonamide VENCLEXTA(venetoclax, FDA approval 2015 for CML, cancer) J Med Chem, 2006, 49, 656; Nature, 2005, 435, 677-681.|
|Associations / Societies|
|American Chemical Society, Division of Organic Chemistry, Division of Medicinal Chemistry
American Association of the Advancement of Science
American Society of Pharmacology and Experimental Therapeutics
American Medical Writers Association
|Licenses / Certifications|
|Expert in Organic Chemistry 1992|
|Director of Medicinal Chemistry, Immunoscience, Lexicon Pharmaceuticals
Senior Investigator, Bristol Myers-Squibb Drug Discovery Division
Investigator, Abbott Labs, Drug Discovery Division
|Awards / Recognition|
|Bristol-Myers Squibb Outstanding Investigator-discovery of saxagliptin
NIH Postdoctoral Fellowship at Princeton University Dept of Chemistry (3 years)
Outstanding Undergraduate Research Thesis, UConn
|Publications and Patents Summary|
|Publications: 41 peer-reviewed publications
Discovery of Saxagliptin: A Highly Potent, Long-Acting, Orally Active DPP4 Inhibitor for the Treatment of Type 2 Diabetes
Targeting bone morphogenetic protein receptor 2 was found to sensitize lung cancer cells to TRAIL by increasing cytosolic Smac/DIABLO and by the downregulation of X-linked inhibitor of apoptosis protein -Oncology program targeting BMPR2 Cell Communication and Signaling
Genetic and Pharmacologic Inhibition of MST1 Blocks Lymphocyte Function-Antirheumatic drug that was applied to rheumatoid arthritis and multiple schlerosis, Ann Rheum Dis,
Discovery of a Potent Inhibitor of the Antiapoptotic Protein Bcl-xL from NMR and Parallel Synthesis to identify the lead molecule for the bcl-2 program
An inhibitor of Bcl-2 family proteins (ABT-737) induces regression of solid tumours in mouse models of cancer.
Patents: 35 issued US Patents
Mitochondrial Uncouplers for the treatment of metabolic diseases and cancer United States Patent
MST1 kinase inhibitors-patent describes uses for rheumatoid arthritis, psoriasis and behaves as a classic kinase, United States Patent
Methods of Treating Rheumatoid Arthritis and other autoimmune diseases, United States Patent
Patent that holds the discovery of Venclexta (venetoclax) as a cancer drug that cures solid tumors United States Patent
Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV is the patent that holds the saxagliptin molecule, approved by the FDA for type II diabetes United States Patent
|Expert Witness Experience|
| Expert is open to trial experience. He has been a paid consultant as an expert consultant. Expert was going to be named as expert witness but cases settled before going to court.
4 ANDA cases as expert consultant where obviousness was central to 3 of 4 cases. One ANDA case was based on improved enablement that improved purity profile of drug.
One case where claims validation/enablement were central.
6 cases writing reports/monthly meetings/ 2 depositions
|Other Relevant Experience|
|He assisted attorneys with expert consultation in six patent cases over eight years involving ANDA Hatch Waxman, obviousness, claims violations (and claim validation) and enablement. He has given two depositions. All clients get absolute confidentiality. Expert reads entire patents to gain first rate knowledge of the case.|
Fields of Expertise
pharmaceutical patent, applied organic chemistry, biotechnology, biomedical research and development, active pharmaceutical ingredient, pharmaceutical research, pharmaceutical research and development, biopharmaceutical, airborne volatile organic chemical analysis, alkali-metal chemistry, alkane chemistry, aluminum hydride chemistry, synthetic organic chemistry, antibiotic synthesis, antigen synthesis, monoclonal antibody, catalytic antibody, biotechnology management, bioanalytical chemistry, bioassay, acid dissociation constant, molecular dissociation, affinity chromatography, Paid consulting, expert report, expert testimony, expert witness, agricultural chemistry, patent cases, claim (patent), patent claim construction, patent claim construction brief, defensive patenting, abbreviated new drug application, adverse drug effect, analgesic drug, antirheumatic agent, rheumatic disease, rheumatoid arthritis, ulcerative colitis, molecule, macromolecule, molecular modeling, new drug application, multinuclear nuclear magnetic resonance, multinuclear nuclear magnetic resonance spectroscopy, chiral high-performance liquid chromatography, thermospray HPLC/mass spectroscopy, capillary gas chromatography, capillary gas chromatography application, trial consulting, diabetes insipidus, diabetes mellitus, type 2 diabetes, type I diabetes, gestational diabetes, agonistic drug, oncology, molecular oncology, acute lymphoblastic leukemia, cytotoxic drug, cytotoxic T lymphocyte, cytotoxicity, Ames test, Ames testing, genomics, phenotype, carbohydrate, carbohydrate chemistry, carbohydrate analysis, carbohydrate antigen, aminoglycoside antibiotic, antibiotic, antibiotic resistance, beta-lactam antibiotic, macrolide antibiotic, Hatch Waxman Act, • FDA New Product Registration, Application submissions 510k, activated carbon, carbon 13, proton magnetic resonance, patent infringement, patent interpretation