Pharma Expert Witnesses

Pharmaceutical Research, Chemistry & Chemicals - API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism

HIGHLIGHTS • Twenty-eight years of industrial experience in all aspects of chemical development • Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities • Eighteen years of experience in devising and executing integrated CMC development programs • Hands-on, results-oriented leadership of CMC development and multidisciplinary teams • Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting. • Expertise in technology transfer and oversight of chemistry from the research laboratory to kilo labs, pilot plants and multipurpose plants at contract development and manufacturing organizations • Experience in the development and manufacture o...

Pharmaceutical Research, Chemistry & Chemicals - Drug Formulation, Biotechnology, liquid formulation, formulation, medicinal chemist, organic chemist, pharmacokinetics, stability studies, dietary supplements, tetracyclines, synthetic biology, drug tests

EXPERT WITNESS CONSULTING Dr Abato has been involved in 8 cases, been deposed 5 times and has testified at trial in 4 cases. Dr Abato has testified in high stakes litigation cases at the International Trade Commission and federal courts for major players in the pharmaceutical industry. He has experience with ANDA, trade secret, trademark infringement, patent infringement and contract law cases relating to pharmaceuticals. Upload Dr Abato’s CV, which includes a complete list of case numbers and Law Firms that he has represented. PHARMACEUTICAL EXPERIENCE Dr. Abato is a Medicinal Chemist. His expertise includes drug research, medicinal chemistry, organic chemistry, drug formulation for; IT, IV, IP, ICV, IN, IM and oral dosing routs, stability studies, extensive structure-activity relationships, efficacy, pharmacokinetics, as well as all pre-clinical testing required for IND submission to the FDA. Dr Abato was awarded the prestigious “Heroes of Chemistry Award” by the Amer...

Oakland , California

HIPAA - Healthcare Futurist, HIPAA, data, Consultant, EHR, Pharma, Health Systems, HIEs

Omar Shaker, MD, MBA is a physician turned clinical data visualization expert, with 3 years of patient care at Tufts and abroad, and a 10-year track record of EHR, decision making, and interoperability consulting. People-focused with exceptional ability to lead emotionally. Extensive clinical data analytics practice working with a wide variety of clinical datasets from payers, health systems, pharma, and HIEs. Successful track record in delivering health data products based on data generated from user research and using design thinking methods. Named one of HIMSS Future 50, and published author and presenter on FHIR at HL7 Roundtables, and AHIMA on clinical data integrity and burnout. Active advisor and angel investor in early-stage digital health startups. Published author and confident speaker, with extensive healthcare network. Omar has 10+ years of experience in consulting US Payers and Providers to improve healthcare using data science and data visualization. Over his career, ...

Las Vegas, Nevada

Pain Management - Medicine, Medical Devices - Failed back, chronic pain, Complex Regional Pain Syndrome (CRPS), Practice guidelines and standards, Nerve Injury, Injections, Opioids, Addiction, Fraud, IME, Independent Medical examinations, patents, intellectual property, pharma, medical billing, pill mill, spinal cord stimulators, ablation

Fellowship trained pain physician. Experienced expert witness with excellent communication skills. Co-author of international pain practice guidelines. Active clinical practice after recovering from a disabling spine injury. Pharma and medical device experience. Inventor of a patented system and method for objectively verifying internal disc disruption. Former master instructor for International Spinal Injection Society. Performs pain procedures including: Spinal cord stimulators, radio frequency ablations, stellate ganglion blocks, epidural injections, steroid injections, spinal nerve root injections, facet injections, and nerve blocks. Licensed in Arizona, California, and Nevada