Experienced in Target Validation and Lead Discovery Through Nomination of Compounds for Preclinical Development and due diligence evaluation for in-licensing opportunities.Drug Discovery: Target discovery and validation, assay development, High-Throughput Screening (HTS), hit-to-lead and lead optimization.In vivo pharmacology: Disease modeling, neurodegeneration and neuroscience, efficacy testing, biomarker discovery.Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD).Project management.Laboratory design and streamlining laboratory operations.Business: Strategic planning and decision matrix evaluation, scientific due diligence, I...

DABT Toxicologist and Scientist with Applied Industrial Experience Specific to IND and NDA Submissions to the FDA and Global Equivalents.DABT Toxicologist and Scientist, Department Head with over 12 years applied industrial experience, supporting and directing interdisciplinary teams to both IND and NDA submissions to the FDA and global equivalents.Management, budgetary and scientific skills include discovery, investigative, and regulatory drug safety assessment with an excellent foundation in toxicology, pharmacology, physiology, biochemistry and DMPK.Therapeutic areas supported are anti-infectives, cancer, immune regulation, diabetes, CN...

Consultant for drug development for cardiovascular therapeutics and heart failure; experienced as an expert witness.Drug development, specializing in cardiovascular therapeutics.Expert witness and the evaluation of cardiovascular drugs.Drug safety.Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).Product support-promotional review and medical information.Evaluation of previously monitored clinical studies.Principal Investigator in the following areas:Vasodilator and inotropic drugs.Vasodilator therapy for acute myocardial infarction.Nitrates and hydralazin...

Neurobiologist Consultant: Central Nervous System, Spinal Cord Injury, Hemostasis, Thrombosis and Autoimmune DiseasesEight (8) years of experience in biotherapeutic drug discovery and development with a focus on neurobiology, hemostasis, thrombosis and autoimmune diseases.Drug discovery research for hemophilia and in critical bleeding indications.Development of therapeutics for spinal cord injury, multiple sclerosis and other central nervous system disorders.Experienced with molecular and cellular pharmacology, cell-based assays with central nervous system (CNS) and immune cell types, immunohistochemistry and thrombosis pathology, animal m...

Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development; IND Filing, Support of Phase I & II Clinical TrialsSynthetic and medicinal chemistry.The integration of all aspects of drug discovery, from early-stage research in chemistry and biology, through patent protection, pre-clinical development, CMC, IND-filing and support of Phase I and II clinical trials.Indication areas of experience: Inflammation, cancer, neurological and neurodegenerative diseases, age-related macular degeneration, and diabetic retinopathy.18 years o...

Expertise in designing, planning and executing in vitro and in vivo molecular, cell biological, biochemical, immunological and toxicological research studies in compliance with funding agencies' GLP.Demonstrated leadership and versatility in directing multi-disciplinary research teams to investigate the molecular mechanisms, identifying pathways and bio-markers involved in developmental and reproductive biology and neurodegenerative diseases using genomic and proteomic approaches.Practical and demonstrated experience in one or more of the following areas: Neurobiology, toxicology, molecular biology, genomics, proteomics, transgenic technol...

Regulatory Expert in the Fields of Food and Feed Additive Safety Assessment, GRAS Notifications, Food Additive Petitions, Quality, Hazard Analysis and Good Manufacturing PracticeRegulatory support in the fields of food and feed additive safety assessment, GRAS notifications, food additive petitions, quality, hazard analysis and good manufacturing practice.GRAS Notifications for CFSAN and CVM, and FSMA compliance.Broad knowledge of the fermentation-derived enzyme, food ingredient, food and feed additive, and dairy culture fields.Additive, ingredient or product safety assessment, preparation and submission of GRAS notifications or additive p...

FDA Regulatory Statistician Experienced in all phases of Clinical Trial Design, Analysis, and BiostatisticsBiostatistics: Regulation of drugs, drug devices and biologics.Clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.Expert regulatory statistician (FDA designation).Areas of application include clinical trial design and analysis, interim analyses, multiple imputation, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity stud...

Biotechnology Expert with Extensive Domestic and International Product and Process Development Experience in Pharmaceutical, Biofuel, Chemical, Agricultural and Nutraceutical IndustriesConducting and directing product, process and manufacturing development activities for biologically-derived materials used in the pharmaceutical, biofuel, chemical, agricultural and nutraceutical industries.Production of biosimilars, monoclonal antibodies and industrial recombinant proteins. Activities include research, development, production, biocomparability, technology management in CMOs, FTO landscape critical for biosimilars, licensing, business deve...

Forensic Toxicology Expert with Considerable Experience with Criminal Cause of Death Investigations and Impairment Related to Alcohol, Pharmaceuticals, and Drugs AbuseToxicologist with forensic board certifications in medicine and forensic examinations.Toxic exposure investigations, including analytical protocol, referral of autopsy material for analyses, environmental and occupational health risk assessments and site assessment and causation determination.Toxic tort defense or plaintiff evaluations, reports, affidavits and expert testimony.Chemical causation assessments with written reports based upon scientific, peer-reviewed methodology...