Manage interactions with agencies e.g., IRS, FDA, EMA, DoD, and CROs. Contribute pharmacological advice on current and future projects.

Advise start-up Biotech/Pharmaceutical companies in early stage drug discovery and development. Consultant for strategic planning, due diligence, and executing steps ranging from lead authentication to Safety/Toxicology and IND submission. Identifying and negotiating protocols and contracts with CROs offering bio-analytical, in-vivo, and in-vitro services. Assist with NIH and DOD Grant submissions.

Principal Investigator of a Phase II SBIR with responsibility for preclinical testing of delta selective opioid receptor agonists for treatment of chronic neuropathic pain, advancing to IND-enabling studies. The base platform of Biousian Biosystems, Inc. involves synthetic glycosylation which improves the pharmacological properties of endogenously active peptides, e.g., Delta Opioid and GLP-1 agonists. • Managed out-sourcing of DMPK, Safety, Toxicology, and pre-formulation studies to CROs.• Assisted collaborators in the direction of preclinical efficacy and safety studies. • Communication with NIH grants management, e.g., annual reports and reallocation of grant funding.

Developed databases and statistical procedures for in vivo electrophysiology studies in rats engaged in food or drug reinforced operant behavior. Utilized knowledge of Unix, MySQL, Perl, Excel VBScript, Systat, and Graphpad Prism.

Responsible for non-clinical Safety/Toxicology testing of nornicotine and norketamine in addition to clinical studies of the VMAT2 inhibitor, lobeline. Researched and wrote Pharmacology/Toxicology Modules of INDs and a successful NDA submission for VALCHLOR™ (mechlorethamine) gel, a major closing condition for the acquisition of Ceptaris Therapeutics, Inc by Actelion Ltd in 2013.• Managed cGMP drug substance manufacturing and IND-enabling Safety/Toxicology studies for two Phase I candidates. Negotiated contracts, monitored genotoxicity, in-life toxicology, analytical, and bioanalytical studies for FDA/ICH compliance. • Directed cGMP manufacture of a semi-solid drug product for a pivotal clinical trial of VALCHLOR™. Audited batch records, stability protocols, and compiled CMC documentation for regulatory submissions. • Prepared regulatory pharmacology/toxicology sections for Investigator's Brochures, 1571s and other FDA correspondence, INDs and an NDA for VALCHLOR™ . • Principle Investigator of a Phase II SBIR with responsibility for a clinical trial of Lobeline for Attention Deficit Hyperactivity Disorder (ADHD).• Managed Yaupon’s Medicinal Chemistry laboratory at the University of Kentucky and Yaupon sponsored STTRs with University of Kentucky investigators. Directed synthetic and analytical/bioanalytical chemistry and development of semi-solid, transdermal, and sustained release Drug Product formulations.• Contributed to projects involving treatment of methamphetamine addiction, smoking cessation, neuropathic pain, Tourette syndrome, inflammation, and T-cell mediated disorders such as Cutaneous T-cell Lymphoma (CTCL) and psoriasis.

Successfully led a team conducting in vivo pre-clinical studies leading to the discovery of 1) a novel series of potential antipsychotic compounds combining potent dopamine D2 receptor antagonist and serotonin 5-HT1A receptor agonist properties in the same molecule and 2) a series of extremely high efficacy 5-HT1A biased agonists for depression, anxiety and neuropathic pain.• Managed pivotal in vivo studies in animal models of depression, schizophrenia, and anxiety, identifying more than six new chemical entities which entered into clinical development. • Assisted in the discovery of highly effective mixed D2 antagonist/5HT1A agonists, a new class of atypical antipsychotics with a low propensity to cause extrapyramidal side-effects. • Played a critical role in identifying high efficacy 5-HT1A agonists with superior antidepressant activity.• Equipped one of the largest computer integrated behavioral pharmacology laboratories in Europe, with 48 mouse, rat, and pigeon operant chambers, acoustic startle chambers, locomotor activity monitoring, and facilities for recording/scoring behavioral observations of rats, mice, and non-human primates.

Co-PI on a Center Grant from NIDA which funded the Drug Abuse Research Center. Studied the reinforcing and discriminative stimulus effects of cocaine in nonhuman primates, identifying targets for the treatment of cocaine abuse. A highly recognized discovery was that dopamine D1 receptors mediated both subjective and reinforcing effects of cocaine.• Showed that chronic cocaine differentially altered D1 and D2 receptors in rat brain. • Characterized neurotoxic properties and structure-related activity of amphetamine-related compounds, e.g., the anorectic fenfluramine, contributing to the FDA decision to revoke marketing approval.