I am a qualified pharmaceutical professional, with 25 years of experience in large and small molecule integrative early phase drug discovery/translational research, nonclinical pharmacokinetics, drug metabolism, GLP toxicokinetics/toxicology and clinical pharmacology/bioequivalence/pharmacokinetic (study design, operations and pharmacokinetic analysis).
Xyzagen has worked with over 40 different clients since its founding in 2018 within the fields of ophthalmology, neurology, anti-infectives, addition, pain and autoimmune diseases; as well as other therapeutic areas. Xyzagen is a small, focused, contract bioanalytical small molecule LC/MS/MS lab with a rodent vivarium and drug development consultancy expertise, organized to support early stage biotechs in their nonGLP discovery in vivo PK and PK/PD studies. We are able to support client product development through IND and initial clinical trials with GLP TK support and Nonclinical ADME and Clinical Pharmacology consulting services. Xyzagen offers within one organization the capability to formulate a new chemical entity, dose, collect fluids and tissues for concentration analysis, develop bioanalytical methods to quantitate the drug, and then analyze the concentration data for pharmacokinetic interpretation in a cost effective nonGLP setting. Xyzagen’s consultants have supported IND and NDA submissions of small molecules, biologics such as mAb and enzymes, and gene therapies.
Clients include large, midsize and small pharmaceutical companies as well as biotechnology, veterinarian companies and CROs. Other clients include private equity groups, investment banks and business consultancies. Activities include strategic and scientific due diligence, formulate and refine product pharmaceutics strategies, safety assessment plans and clinical development programs. I have specifically supported specific Phase 1/2A clinical operations, pharmacokinetic analysis, medical writing and nonclinical/clinical expert input for regulatory activities associated with IND, ANDA and (s)NDA preparation and review.
1st Order Pharmaceuticals (1OP) was a clinical development-stage pharmaceutical company focused on advancing 1OP-2198, an IND-ready small molecule potassium channel opener (KCNQ2/3), for unmet medical, medically important and orphan indications in neurology and pain management.
Clinical Pharmacology and nonclinical development consultant
Reported directly to Global Head of R&D and member of R&D leadership team from 2010-2011 and member of CMO’s leadership team from 2012-2013. As department head within a lean organization was also responsible for the Alliance Management lead on multiple projects with numerous companies (GSK, J&J, Lundbeck, Sanofi) thus was responsible for the strategic/scientific direction, financial management and operational success of the projects within my department and at times across the North American organization.
Received increasing responsibilities within the organization with regard to drug development programs and built out the core laboratory ADME capabilities and Clinical Pharmacokinetics functions. These responsibilities afforded interaction across a fully integrated organization from the bench top scientists through clinical and commercial where I was responsible for internal and external nonclinical ADME/Clinical Pharmacokinetic studies, writing and/or review of all regulatory documents for FDA, EMEA, Health Canada under CTD sections 2.6.4-5 and 2.7.1-2 in the therapeutic areas of Cardiovascular, Pulmonary and Ophthalmology.
Responsible for writing summaries for CTD module sections 2.6.2 through 2.6.5 (pharmacology and pharmacokinetics) for molecules in therapeutic areas of Sickle Cell Anemia and Epilepsy and conducting nonclinical pharmacology and ADME research in the CNS and pain therapeutic areas.
Responsible for new molecular entity research in a variety of therapeutic areas. The core focus of the group was in vitro and in vivo kinetics, drug metabolism and metabolite ID utilizing analytical technology such LC/MSn, robotics and combinatorial chemistry in the lead optimization process.
Responsible for the conduct of GLP acute, chronic and oncogenic inhalation nonclinical safety studies on a variety of systems of atmosphere generation; vapors, dusts, gases and liquid aerosols.
Thesis: Development Plan for Vulvar Vestibulitis Syndrome
Left program for job opportunity
Left program due to relocation to N.C
Lead technical expert on the international patent families associated with Valeant’s KCNQ potassium channel opener program as well as lead technical expert on patent applications associated with retigabine formulation development. Provided technical support and consultant and review for Valeant North America’s intellectual property team.