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Industrial Experience Mark Brian Anderson, PhD.
EXECUTIVE R&D SUMMARY
I bring more than eighteen
years 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 and mentoring talent management essential to program
success, the development and retention of a highly competitive workforce, planning for changing pipeline dynamics interoperating
the corporate vision to tangible deliverables. Also, I have demonstrated a driven talent in setting and managing the scientific
and technical direction; IND development of all invented, existing and/or anticipated products for filling the pipeline
to drive profits. I participate as a translational clinical development team member; work as an international and US
collaborations lead. Working to that end in an advisory capacity I understand the importance of timely
reporting to management boards on the scientific vision and direction of the company. I have been responsible
for the professional development in all aspects of the biology, pathology and chemistry from "principle to practice",
so to encourage the drug development pipeline with the most advanced and patented compounds relative to the
time. I have spent my career targeting highly effective science so to produce a healthy and robust preclinical development
pipeline in pharmaceuticals. Pre-Clinical Phase 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
INDUSTRIAL EXPERIENCE
Novabay Pharma (October 2009 - 2011) Chief
Scientific Officer: Provide senior technical leadership by formulating and advocating a science and technology
vision that complements the business vision as a vibrant up and coming biotech, driving the capability investment strategy,
expanding the technical integration across capability groups to help assure regional, national, and international impact in
the biological, chemical, materials sciences in developing novel therapeutics. Streamline the operating model driving growth
of innovative opportunities and managing multiple business profit driven platforms. Mentor talent, establish and achieve the
strategic goals of the organization in collaboration with the Novabay leadership team by leading the strategic scientific
planning effort, development of critical new science and technology capabilities that are required to build and grow research
programs, attract and anchor effective collaborations and productive partnerships, 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, relevant therapeutic 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 have shepherded preclinical
drug development projects, pathology, chemistry, biology, formulations, understanding toxicology to promote clinical
drug development programs from "principal to practice" that is cost effective and in reasonable time, with entrepreneurial
minded thinking. 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; a vital 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 science and staff. The design, formulation, clinical development and marketing of
novel microRNAs (antagomirs) for the treatment of human pathologies. 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,
which is growth oriented to improve financial conditions reducing over all risk.
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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