Find an Expert
Biotech/Pharma; Marketing Rare Disease and Specialty Products
After graduating with a Master in Biotechnology and Business Administration and a career in molecular diagnostics and medical devices, Expert redirected his marketing career in Biopharma 12 years ago. He has been driving the global marketing strategy of drugs in…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Non-operative and Operative Management of Spinal Disorders
Board-certified neurosurgeon fellowship trained in treatment of spinal disorders. Excellent expert and witness with 20 years of experience. RESEARCH FOCUS: 1. Complex spinal disorders 2. Bone Morphogenetic Protein 3. Resorbable polymers 4. Disc arthroplasty 5. Stem cell technology 6. PRP…
Vaccines, IVD, Animal Health, Coronavirus Virus and Vaccine Models
Expert has excelled in the animal vaccine field for over 21 years. He has directed licensing for over 40 U.S. and 55 international registrations for avian, bovine, canine, equine, feline and ovine species. Expert has consulted with the world's leading…
in vitro diagnostic assay designing, development and troubleshooting
Experthas developed and participated in assay development and troubleshooting for variety of target molecules with special skill in development of ELISA on different platforms (spectroscopy, luminescence and electrochemical). He has also acquired very good grasp on nanoparticles based rapid assays.…
Oncology, Hematology
ACADEMIC BIO SKETCH: Expert holds the rank of Professor of Hematology/Oncology, is a 33 year veteran of academic medicine, a key opinion leader and skilled principal investigator of over 200 clinical trials and has published over 100 peer-reviewed articles in…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Medicinal Chemistry, Drug Discovery, Organic Chemistry, Antibody-Drug Conjugates
Accomplished project leader with strong experience as R & D medicinal chemist in advancing projects from inception to Phase I clinical trials in ocular, inflammation, diabetes and neuroscience areas. Skilled in medicinal chemistry, organic chemistry, small molecule and peptide lead…
Endocrinology, Human Physiology, Heart Disease, Diabetes, Obesity, and Clinical Trials
Expert. Expert is clinically trained as an Endocrinologist, and performs research in human physiology and clinical trials. The basis of his work is in moving discoveries from the concept stage into human testing, often undertaking first-in-human studies or early stage…