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• Clinical Phases 1-3 clinical development team member driving  to NDA
• Clinical chemistry panel review, translational research, adverse drug-drug interactions, personalized medicine discussions, and chemical toxicology
• Formulations for small molecules, heterocycles, natural products, proteins, and antisense RNA compounds etc
• Polymorphs, salt forms, prodrugs, DSC, TGA, pre-IND API stability studies, C-of-A's, and Top-quality technology transfer packages enabling bench-to-CRO API syntheses
• Business acumens, TPP and IND preparation, INN/USAN proprietary names, and ATC Codes
• International and US joint collaborative research committees (JCRC); board meetings; steering committees; and strategic think tanks; and provided scientific expertise on in-licensing opportunities
• New technology evaluations and review
• Confidential M&A discussions
• Pharmacology (pharmacokinetics/ADME, pharmacodynamics, pharmacotherapeutics, & Toxicology) in SXR matrix
• Track record of building and mentoring fully integrated chemistry drug discovery engines (e.g. CFU/H2L, In Silico Chemistry/SBDD, Analytical, Medicinal/Chemical Biology/Chemical Proteomics, In Silico Sciences, SBDD, pre-formulations, early API stability, and bench top-to CRO scale-up and technology transfer packages, Chemical Toxicology)
• Predicting blood-brain barrier (BBB) permeable compounds
• Direct international and US multidisciplinary CRO's/CMO's.
• Track-record of leadership, scientific vision, problem solver, timelines, IND's, budgets, etc
• Track record of small molecules, heterocycles, natural products, proteins, carbohydrates, antisense RNA, etc
• Track record in strategic disease areas of cancer/oncology, infectious disease, neurodegeneration /neurology (Alzheimer's), HIV, thrombosis, inflammation, etc
• Track record of important targets kinases, genetic disease links, metabolic, bacterial, fungal, endocrine, cardiovascular, pulmonary, cell adhesion, tubulin agents, ischemia-reperfusion inhibitors, etc
• Track record of driving ideas into the clinic, being a passionate leader, drug hunter, mentoring talent, inventor, team player, and creating fun top-quality high-performance teams

OVERVIEW OF INTELLECTUAL PROPERTIES: 90+ US & international issued and pending patent applications covering novel therapeutic agents, HIV maturation inhibitors, novel agents for treating HIV, novel antiviral (HIV) agents, blood brain barrier permeable anti-cancer agents, methods for treating brain cancer, novel anti-tumor agents, caspase activators and inducers of apoptosis, prodrugs, Alzheimer's disease (neurodegeneration), non-peptide GnRH agents, kinases, etc., additional IP pending. The end result is a history of agents in the clinic.  

PUBLICATIONS HIGHLIGHTS: 50+ publications on novel agents with potent anti-maturation activity against HIV-1, discovery of novel agents for treating brain cancer, SAR of novel anticancer agents, experimental therapeutics, new methodologies, etc., additional publications are in progress. Examples: 2008 review on vascular disrupting and vascular targeting agents (in press), 2003 Annual Reports in Medicinal Chemistry, Burger's Medicinal Chemistry Chapter 22 (1994), ACS and international symposia posters, and many international collaboration presentations.

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BIOTECH PHARMA SOLUTIONS (MARCH 2009 - PRESENT) OFFICES IN BOSTON, MA AND SALT LAKE CITY, UT. http://www.biotechpharmasolutions.com/

Services: As a consulting chief scientific officer (CSO) I can help you shepherd your preclinical drug development projects, formulations, and clinical drug development programs through to fruition at a cost you can afford and in a reasonable timeframe and much more. In the role as a consulting CSO in multiple therapeutic areas, I have been responsible for advancing the company's product pipeline; setting and managing the scientific and technical direction; IND track development of all invented, existing or anticipated products in the pipeline; formulation strategies; clinical development team member; international and US collaborations lead; advising the board and management on the scientific vision and direction of the company; and responsible for the professional development of the scientific staff.  Furthermore, I have developed highly effective business acumens that help direct the creation of a healthy robust prioritized preclinical IND pipeline in a reasonable timeframe.

Drug Discovery
Preclinical Drug Development
Formulation Development
CRO Selection and Management
Pharmaceutical Drug Development
Quality Assurance/GMP Assistance
Pharmaceutical Regulatory Affairs/CMC CRO Management
Confidential In-Licensing and M&A discussions
Invention Generation
Document Writing
Management and Talent Mentoring
Competitive Landscaping
INN/USAN & ATC Codes
Evaluating Research Tools (e.g. equipment, chemical proteomics, chemical biology, chemical toxicology)
Think Tank and Personalized Medicine Discussions;
Help with 21 & 37 Codes of Federal Regulations
Focused Change Management and more.

Examples: Cancer (brain, melanoma, etc), Infectious disease (bacterial & fungal); HIV infection; Neurodegenerative (Alzheimer's & Parkinson's); Cell Adhesion mediated diseases (inflammation, cancer metastasis, etc); Genetic disease (antisense RNA); and therapeutic agent types: small molecules; natural products; heterocycles; peptides and proteins; antisense RNA; agents targeting metalloenzymes; complex carbohydrates; and chemical combinations to form novel hybrids.

MYRIAD GENETICS & MYRIAD PHARMACEUTICALS (DEC. 2003 - MARCH 2009, 5.5 YEARS) SALT LAKE CITY, UTAH.

Vice President of Chemistry: Responsible for setting and managing the overall scientific, technical direction, and IND track development of all invented, existing or anticipated products in the pipeline; clinical development team member; and responsible for: the professional development of the scientific staff. The results were to put five compounds into clinical development. The most advanced and patented compounds target brain cancer, metastatic cancers and HIV (vide infra patents).

Clinical Pipeline: Azixa^TM (MPC-6827) Non-Small-Cell Lung Cancer Phase 2; Azixa^TM (MPC-6827) Melanoma Phase 2; Azixa^TM (MPC-6827) Glioblastoma Phase 2; Vivecon^TM (MPC-9055) HIV Maturation Phase 1; MPC-2130 Metastatic & Blood Cancers Phase 1; MPC-0920 Thrombosis Phase 1; MPC-3100 for Cancer; and work on Flurizan^TM (tarenflurbil) for Alzheimer's. Composition of matter, clinical use patents, and IND's to fully enable the pipeline (vide infra patents).

Preclinical Pipeline: Responsible for the chemistry drug discovery engine and program management to produce IND-Ready agents. Examples: MPI-0443803 (drug resistant cancers and brain cancer; including prodrugs); MPI-451936 HIV (HIV fusion inhibitor) and MPI-461359 HIV (Maturation); MPC-2130 (chemical MOA); backup for MPC-0920; follow on agents for MPC-3100 ( in clinical development); MPI-442690( backup for Alzheimer's Disease); prodrugs for treating neurodegenerative disease agents; novel compounds and novel drug combinations for neurodegenerative disease programs including prodrugs and formulations; blood-brain-barrier predictions; chemical proteomic programs and strategies; and numerous oncology, antiviral, and kinase targets that are clinically-relevant and clinically-important; novel drug-drug combinations for treating diseases; drug delivery formulations; and numerous invention disclosures for novel agents and therapeutic targets and enzymes (vide infra patents).

Intellectual Properties (IP): Track record of a close, effective, and productive relationship with the IP department. In addition, a recent review on VDA's and VTA's is published.

In-Licensing & Collaborations: Member of the joint collaborative research committee with Abbott; and a member of Myriad's in-license acquisition teams for the in-licensing of potential research (idea to IND) and/or drug agents suitable for clinical development (IND to NDA).

Track record: Effective leadership and management business acumens; multiple program portfolio management resulting in compounds in the clinic; multidisciplinary program  management; worked closely with pharmacology/ADME TOX and discovery biology; medicinal chemistry chemical biology; exploitation of pharmacology and biologic results for the SXR chemical drug design matrix; a fully integrated chemistry department (medicinal, analytical, structure-based drug design, chemistry follow up/hit-to-lead, pre-IND scale up); chemical proteomics with coordination of chemistry & biology teams; share management responsibilities for the site as a member of the senior management team; numerous patents, invention disclosures and expert relationship with the intellectual property department; active discussions in personalized medicine; translational research/medicine; 1-5 year budgets; hiring; annual reviews; and 21 & 37 codes of federal regulations. The result is a fun, innovative, fast-paced, results-driven, strategic, and team-oriented drug discovery engine with a clear focus on the programs and corporate objectives. The return on the R&D investment is multiple drug agents in the clinic.

Examples of chemical structures such as small molecules, heterocycles, natural products, prodrugs, peptide analogs, chelators, etc. can be reviewed from the patents and applications vide infra.


ELITRA PHARMACEUTICALS INC. (JUNE 2002 - NOV. 2003, 1.5 YEARS) SAN DIEGO, CA.

Senior Director of Drug Discovery Chemistry R&D: Share management responsibilities for the site as a member of the senior scientific staff, mentored the microbiology teams, and manage a large portfolio of projects focused on discovering, developing, and commercializing novel small molecule drugs for the treatment of drug resistant infectious diseases with high unmet needs.

Clinical Pipeline: Evaluate potential in-license opportunities for clinical development (IND to NDA), ensuring that the potential in-licensing IND package was complete, feasible, and a reasonable estimate for moving towards a successful NDA;

Preclinical pipeline: Responsible for the chemistry drug discovery engine and program management to produce IND-Ready agents from internal efforts and with multiple international and US collaborations. Elitra's drug discovery collaborations included Merck & Co. (US), LG Life Sciences (Korea), BioLeads (EU), Kaken (Japan), and deCODE genetics (Reykjavik, Iceland and US facility). Designed the chemistry drug discovery plans for SBIR grants (e.g. chemical compound design for Yersinia pestis a Gram-negative rod-shaped bacterium belonging to the family Enterobacteriaceae); and reviewed the competitive landscape of bacterial and fungal drugs.

Track-record of mentoring top-performing teams by ensuring the capture of ideas and intellectual properties (Idea to IP); member of multiple joint collaborative research committees (JCRC's); the utilization of genetic, biologic, pharmacokinetic (ADMET), safety, and pharmacodynamic (PD) data into the matrix of medicinal chemistry drug design; member of in-license acquisition teams for in-licensing of potential drug agents for the clinic (IND to NDA); development of effective business acumens; and familiar with WHO/INN/USAN, and ATC codes.

Simultaneously managed multi-phased and multi-focused collaborations (JCRC's); experienced manager of CRO's/CMO's; and experienced in the design and development of new therapeutic agents exploiting Elitra's proprietary bacterial and fungal genetic targets. These proprietary platforms were highly valued for drug discovery and chemical biology to elucidate the molecular pathways that are fundamental in cellular, developmental, and the biology of diseases of novel and established drugs.

Mentor talent in Microbiology and Cell-Based assays (6); Pharmacology (ADMET and Pharmacodynamic) team (4); and the Analytical team (2); managed the drug discovery chemistry with LG (8) and deCODE (8), worked with CRO's.

Plan and execute multiyear budgets for multiple departments (chemistry, bioanalytical, microbiology, pharmacology/ADMET and pharmacodynamics groups). Maintain high scientific standards (>95% HPLC purity); developed business acumens for the internal analog progression of preclinical agents towards IND-ready candidates; collaboratively work with screening, informatics, biology, analytical chemistry, microbiology, joint collaborations, and CROs. Review HTS and UHTS screening hits; scientifically contribute to SAR and SXR (DMPK/ADMET) of collaborations; de novo drug discovery; managed the Microbiology and Cell-Based assays (6), ADMET and Pharmacology team (4), Analytical (2). Chemistry (LG 8 and deCODE 8), CROs. Work closely with human resources for recruiting, hiring and annual reviews.

Genetic and therapeutic targets for the discovery of new agents for the treatment of bacterial infections as a high priority as many know pathogens show resistance to know antibacterial agents. The medical need is for antibacterial agents for Gram-positive, Gram-negative and/or broad spectrum agents and to investigate agents for drug resistant infectious bacterial induced disease. The focus was the discovery and development of novel antibacterial and antifungal drug candidates identified by proprietary screening technologies of the bacterial and fungal genomes (functional genomics), with internal and collaborative chemistry drug discovery programs. Elitra identified more than 6,000 essential genes in eleven bacterial and fungal pathogens and were discovering new classes of compounds utilizing its internal high throughput screening capabilities. The approach was enabling true functional genomics on a genome-wide scale and to identify all of the essential genes directly in the key pathogenic organisms. The technology also elucidated known and potential new targets of established clinically used bacterial and fungal drugs. 2004 Elitra's assets acquired by Rx3 now Trius and Mycota now Merck.

PFIZER LA JOLLA LABS, AGOURON PHARMACEUTICALS (OCT. 1997 - JUNE 2002, 5 YEARS).

Associate Director of Medicinal Chemistry: share management responsibilities for the department as a member of the senior scientific staff.

Winner of the Agouron Pharmaceuticals President's Award in drug discovery research (January 1999). Associate Director of Medicinal Chemistry Duties: Foster a team-oriented approach in chemistry and projects; worked with upper management to maintain a focus on corporate needs and the corporate pipeline. Project leader (GnRH), and project member of several drug discovery projects and directly contributed to multiple patent applications. Direct line management on average of more than 20 PhD/MS chemists, and 4 students. Focus on teamwork and drug candidate compounds for GnRH, cancers related to kinases, and ideas for novel anti-virals. Additional contributions: microwave syntheses; combinatorial chemistries; and actively participated in the oncology and viral discovery groups.

Clinical pipeline: Familiar with Pfizer's protocols for moving into first in human studies and beyond.

Preclinical Pipeline: Participated in numerous drug discovery projects, one candidate compound awarded, and responsible for the project leadership of the GnRH project, and the progression of candidate for IND/Clinical considerations, directly contribute to the chemical lead discovery and lead optimizations, and developed the small molecule antagonist project from the initial HTS screening hits, through the novel molecular rearrangement to give the key lead series, through a full medicinal chemistry team lead SAR optimization including early DMPK/ADMET, Safety, biomarkers, and pharmacodynamic data integration into further lead optimizations, to the presentation of several potent viable lead series exhibiting metabolic stability, sufficient Cmax, long T1/2, etc. as potential drug development candidate compounds. Additional project considerations included: verification of medical need, marketing and commercial considerations in collaboration with the global management teams.

Project teams consisted of ~ 11 PhD/MS chemists, ~5 PhD/MS pharmacologists, ~2 PhD/MS DMPK specialists, ~6+ PhD/MS biologists including assorted marketing and development teams, etc. In addition to the GnRH project, I had the pleasure of participating in several kinase structure-based-drug-design projects and in multiple combinatorial chemistry projects. As an associate director and scientist, I personally contributed to the design, and submission, of many new ideas into the Pfizer idea bank for new drug core structures and combinatorial library expansion opportunities.

Associate Director and scientific duties activities: Foster a team-oriented approach in the department and in projects; conducted team meetings (as the project leader) and action item follow up for lead optimization to candidate compound projects; participated in cross-site Pfizer scientific meetings in medicinal chemistry and in combinatorial discussions; attend departmental meetings and senior staff meetings. Responsible for line management of several PhD/MS chemistry teams in the medicinal chemistry department. Conceive, design and execute on novel chemical series for active research projects; actively support all intellectual property needs related to associated projects, and directly contribute scientifically to patent filings. Actively support all aspects of medicinal chemistry in the department and directly contributed chemical agents for screening and medicinal chemistry lead optimization. Participated in SBDD (structure-based drug design) kinase teams and in targeted/combinatorial drug design strategies for hit and lead optimizations; personally contributed to novel synthesis ideas and opportunities for developing the new Pfizer screening libraries; team member of the Pfizer La Jolla oncology discovery advisory group (project leaders & internal experts).

Local and Groton ADMET testing results within the project settings; worked closely with biology and pharmacology colleagues for the advancement of projects and fostered open discussion of the biological results; worked with upper management to maintain a focus on corporate needs, compound advancement criteria, and critical path discussions.

Microwave-accelerated chemical lead series optimizations, microwave cyclization methods, microwave nitrations, and novel exploratory microwave chemistry experiments (PersonalChemistry, CEM, Mars, Milestones); made proposals in supercritical fluid synthetic chemistries; coordinate with computational colleagues to develop pharmacophores and pharmacophore designed targeted libraries for the GnRH and other projects; contributed to budgets and capital equipment.

LIGAND PHARMACEUTICALS - GLYCOMED INC. (APRIL 1992 - SEPT. 1997, 5.5 YEARS).

Senior Research Scientist and International Project Leader reporting directly to John Musser, Ph.D. Chief Scientific Officer / Chief Operating Officer. A demonstrated ability to define and drive the vision for scientific growth and demonstrated the ability to effectively plan, implement, and manage a diverse portfolio of research projects.

International Collaborations: Sankyo-Glycomed (Japan-USA) international collaboration leader and member of the joint collaborative research committee in the discovery of novel agents to treat, cancer, cell adhesion, inflammation, pulmonary disease, and diseases related to aberrant cell adhesion. Established drug candidate selection criteria for advanced preclinical and clinical studies. Extensive international collaboration with the Canadian Alberta Research Council (ARC).

Extensive collaborations with: Johns Hopkins Asthma and Allergy Center, Baltimore, MD.; The University of Michigan Medical School Department of Pathology for in vivo lung injuries; The University of Michigan Medical School Department of Pharmacology for ex vivo and in vivo cardiac ischemia/reperfusion injuries, rat model of pulmonary Granulomatous Vasculitis, and a new in vitro cell-based membrane attack complex assay for the selection and research evaluation of selectin inhibitors; The MD Anderson Cancer Center in Houston Texas for the use of cell adhesion / anti-inflammatory agents in cancer; and finally The University of Michigan at Kalamazoo (cytokine release related to cell adhesion). Selected experiments were carefully controlled, appropriate, and fully monitored in mice, rats, rabbit, Guinea Pigs, and some primates. Main therapeutic areas included: Cancer, Asthma, Cardiac Ischemia-Reperfusion injury, Granulomatous Vasculitis, Inflammation, and Cell Adhesion (E-, L-, and P-Selectins). GM acquired by LGND 1995.

Senior Research Scientist/Project Leader activities included: Find and optimize R&D hit to lead and lead to potential IND opportunities; patenting agents with specific and dual pharmacophobic activities; utilized de novo pharmacophore designs; solid-phase (resin) syntheses; discrete parallel methodologies (Advanced ChemTech 496-MOS); approaches using Chiron Mimotope (PIN) technologies; solid-phase medicinal chemistry directed combinatorial technology (resins focusing on spatially-addressable systems), and peptidomimetics. Maintain high scientific standards; worked within the established matrix management and line management systems to supply agents for testing and collaborations. Was responsible for the design, synthesis and characterization of several novel chemical analogs and series of agents, identified natural products as cell adhesion inhibitors, developed new molecular hybrids and small molecules to act as glycomimetics of Sialyl Lewis^x and Sialyl Lewis^a to inhibit cell adhesions related to disease and cancer; and directly contributed to the developing patent estates. Developed the structure activity relationships for key chemical series, utilized the data from additional cell-based cell adhesion assays and drug metabolism data to further develop potential drug candidates. Worked with outside CROs to perform scale-up modifications for agents that were potential candidates for development consideration. Worked closely with screening, cell-based assays, and cell-based rolling assay, cancer cell adhesion assay, and in vivo adhesion model teams to obtain data and discuss the scientific results. Additional work was performed by making novel sulfatoids and sulfates as sialic acid mimics. Was promoted to Senior Research Scientist from Scientist III (July 1994).

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Key Words: chemistry, medicinal chemistry, business acumen, Harvard, Purdue, University of Minnesota, drug design, small molecule, drug discovery, chemical proteomics, Director, Senior Director, Vice President, CHEMISTRY, MEDICINAL CHEMISTRY, BUSINESS ACUMENS, DRUG DESIGN, ADMET, SMALL MOLECULE, INTELLECTUAL PROPERTIES, PATENTS, CANCER, INFECTIOUS DISEASE, HIV, ANTIVIRAL, ALZHEIMERS DISEASE, ALZHEIMERS, BLOOD BRAIN BARRIER, VASCULAR DISRUPTING AGENTS, VASCULAR TARGETING AGENTS, vascular targeting agents, prodrugs, PRODRUGS, , kinase, KINASE, CASPASE, drug design, admet, infectious disease, apoptosis, APOPTOSIS, patents, cancer, endocrine, antiviral, gnrh, GNRH, Selectin, cell adhesion, glycomimetic.

References

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