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Industrial Experience Mark Brian Anderson, PhD.
EXECUTIVE R&D SUMMARY
I bring more than seventeen years of drug discovery experience from the biotechnology and pharmaceutical industry
directing numerous R&D programs. In these roles, 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; 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. The results were to put five compounds into the clinical development pipeline for Myriad Pharmaceuticals
with the most advanced and patented compounds targeting brain cancer, metastatic cancers and HIV; a healthy and robust preclinical
development pipeline; and the delivery of potential IND candidates for other companies.
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
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)
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
INDUSTRIAL EXPERIENCE
Novabay Pharma (October 2009 - Present) Chief
Scientific Officer: Provides senior technical leadership by formulating and advocating a science and
technology vision that complements its business vision, drives the capability investment strategy, and provides technical
integration across capability groups to help assure regional, national, and international impact in the biological, chemical,
materials sciences in developing novel therapeutics as salable drug candidates. Establish and achieve the strategic
goals of the organization in collaboration with the Novabay leadership team by leading the strategic scientific planning effort
and by managing the development of critical new science and technology capabilities that are required to build and grow research
programs, attract and anchor effective collaborations, maintain a competitive market position, and deliver highly impactful
science in key areas as outlined by the board of directors and scientific advisory board. Manage scientific staff in all areas
of discovery and development in biology, chemistry, pathology and clinical development as they relate to the team development
in the pursuit of novel drug targets in novel, relavent theraputic areas.
BIOTECH PHARMA SOLUTIONS (MARCH 2009 - September 2009) OFFICES IN BOSTON, MA AND
SALT LAKE CITY, UT.
Consulting 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: AzixaTM (MPC-6827) Non-Small-Cell Lung Cancer Phase 2; AzixaTM
(MPC-6827) Melanoma Phase 2; AzixaTM (MPC-6827) Glioblastoma Phase 2; ViveconTM (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 FlurizanTM
(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 Lewisx and Sialyl Lewisa 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). AWARDS, PERSONAL INTERESTS,
AND OTHER
Professional Associations: American
Chemical Society New York Academy of Sciences Association
for Molecular Pathology American Society for investigative Pathology
Awards: Agouron Pharmaceuticals President's Award in drug discovery (January 1999). Associations: Harvard University Club; Harvard Boston Club Member, Harvard San Francisco
Club Member
Strathmore's Who's Who in Leadership and Achievement (2003).
United Who's Who of Executives
and Professionals (2003). Multiple Continuing Education Certificates (CE).
Personal
Interests: Golf, Fly Fishing, Skiing, Travel, Languages (Swedish, German, French, Spanish), Art, Literature, etc.
Useful Software: MS Word, Front Page, PowerPoint, Adobe, ISIS, Excel, SciFinder, Spotfire, Pipeline Pilot, Group resource
and modeling software Beilstein, ISIS base, Accelrys, Schrodinger, etc.
REFERENCES
Industrial: Alex Polinsky Ph.D. (owner of Apolco, in Massachusetts) alex.polinsky@gmail.com and John Musser, Ph.D. (COO at Pharmagenesis) jmusser@pharmagenesis.com
Academic: Professor Yoshito Kishi, Ph.D. kishi@chemistry.harvard.edu at Harvard University http://www.harvard.edu/ and Professor Phil. Fuchs, Ph.D. pfuchs@purdue.edu at Purdue University http://www.purdue.edu/
Additional references available on request.
Professional Character Recommendations:
LinkedIn http://www.linkedin.com/in/markbanderson Printable CV: http://www.markbriananderson.com/
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