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Strategic
Consulting Services 
From Principle To Practice The business of directing the science, mentoring people & building value
to move Cell Phone: 510.219.5188 | markanderson@biotechpharmasolutions.com
I am a consulting chief scientific officer (CSO). Do you have the scientific
leadership and management skills needed to 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? Do you really have the
time to search for and find a CSO to lead your teams while your programs stall, falter and precious money is being spent?
Isn't it time you hired a consultant CSO?
I bring more than eighteen years of successful experience in drug
discovery, formulations, drug development, and now CSO consulting for biotechnology and pharmaceutical companies needing expert
experience in preclinical drug development; formulations development; CRO selection and management; clinical pharmaceutical
drug development assistance; and much, 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 candidates, completing
the medical writing existing for 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. As a member of your team I can help explore and expand your drug discovery and development platforms. As
a consultant I will drive research with the end in mind; as a result oriented engine. Chemistry Experience: small molecule syntheses,
heterocycles, natural products, prodrugs, carbohydrates, oligosaccharides, peptides, carbon glycosides, etc. Therapeutic Experience: Cancer, Cancer
Targets, Viral, Antiinfectives (bacterial and fungal), Neurodegeneration (Alzheimer's), kinases, Vascular Disrupting
(VDA) and Vascular Targeting Agents (VTA), Cell Adhesion, Chelation Agents, Coagulation, Blood-Brain-Barrier, etc. Design new research opportunities Formation of project teams Technical assessment Project management Research planning and budgeting Chemical Biology & Chemical Proteomics
Departmental
organization and management (biology, chemistry, ADMET) Building an interactive framework in the preclinical pipeline Vendor relations and management (CRO's &
CMO's) Development
of strategic drug development plan and budget Assistance with pre-IND letter, package and Pre-IND meeting Strategic plan finalization Molecular Medicine & Translational Medicine
Managing The Preclinical Science
Managing
the science, mentoring people, and helping your company to discover and market novel therapeutic agents to treat human diseases
by building equity through Biology/Chemistry/ADMET/PD supported by the intellectual properties to drive the branding mechanism
to enable the corporate vision is what I do. I have managed national and international collaborations.
My experience has been that many drug-discovery
teams can be easily and unintentionally redirected by trying to provide presentation materials for investor meetings which
in turn they appear to miss critical milestones required for ensuring that programs become successful. The reality is that
you need to "build-in selling points" in every discovery & development project with clear transition "talking
points" so as to minimize unintentional redirections. This also includes ensuring that patents are submitted as well
as seminal papers and posters exemplifying your discoveries. This means that we must have a plan and that all three critical
preclinical components are involved in the coordination process. My experience in all aspects of chemistry drug discovery
(hit-to-lead, medicinal chemistry, structure-based drug design, targeted & combinatorial libraries, screening file enrichment,
analytical chemistry, In Silico chemistry, and pre-IND scale-up chemistry). I have also successfully lead ADMET/PD
teams as part of the drug discovery process.
In smaller companies some or all of the critical parts of the discovery engine may be outsourced
until the components can be constructed internally. As part of your team I can manage the outsourcing and help integrate the
components of this pipeline and if needed direct the design and scale up of agents to supply the emerging pipeline. In larger
companies I can help by mentoring the team structure, providing executive oversight, and strategic problem solving.
As part of your team I help integrate
the three important pillars of early discovery and preclinical research, namely biology, chemistry and ADMET/PD.
Platform For Success
As a member of your team I can help you achieve your vision on multiple
platforms. Drug discovery and development is entering a new era of requiring cross-functional experts. I have worked with
biologists to understand chemistry, with chemists to understand biology and pharmacologists to understand chemistry. With
the internet the world is truly flattened. Solving today's medical needs requires new thinking and my multiple therapeutic
area experience provides me with the skills to combine what is "tried and true" with new venues. Call to set up your consultation
calendar with me today. Bringing clarity to your research is half the battle. A new eye on your work may be just what
you need to solve problems. Developing the research utilizing solid building blocks, optimizing new vision drives teams together
and saves time. As a consultant I can save you money and move your organization in the best direction for success.
Preclinical & Drug Development
The road from idea to IND (Investigational New Drug) and IND to NDA (New Drug Application) is an exhilarating
venture with real world timelines. Many early-stage drug-discovery teams, particularly at small startups and in academic programs,
have not had the time to build internal experience on how to best travel this road, so as to get to a high quality IND-Ready
agent and file an IND as fast as possible, with controlled expenditures, and with a compound that has the best chance of successful
entry into the clinic and beyond. These teams can benefit tremendously from the advice and leadership of an experienced drug-discovery
and drug-development consultant.
From Idea to IND as part of your team I can help you
in developing chemical biology, chemical proteomics, target selection, target validation, screening file enrichment, hit-to-lead
teams, targeted and combinatorial library analysis and design, intellectual properties, utilizing contract research and contract
manufacturing organizations, medicinal chemistry SAR/SXR, analytical teams, integration of biological data, integration of
pharmacokinetic data (ADME), toxicology data, safety data, formulations, API, pharmacodynamic data, target product profiles,
business acumens, and pre-IND materials.
From IND to NDA I can help you in drug manufacturing
organization contacts, drug product discussions, SOP's, 21CFR's, INN/USAN/ATC considerations, and my experiences pertaining
to focusing on the pre-clinical task at hand.
My participation in your team will be to
streamline efforts, contribute to the intellectual property when needed, and help move ideas to IND's and IND's to an NDA;
moving from concept to reality in moving "from principle to practice".
Specialtes and Key
Words: drug discovery, drug development, drug design, drug discovery strategies, drug discovery methods, cancer targets,
oncology, neurology, neurodegenerative, neurodegeneration, Alzheimer's, infectious diseases, anti-infectives, cardiovascular,
anti-infective, cell adhesion, blood brain barrier, pulmonary, adverse drug reactions, kinase, viral, antiviral, HIV, genetic,
epigenetic, metabolic, targets, competitive landscaping, antibacterial, antifungal, thrombosis, endocrine, inflammation, cell
adhesion, pulmonary, chemical biology, chemical proteomics, vascular disrupting agents, vascular targeting agents, tubulin
agents, ischemia-reperfusion, inhibitor, GnRH, apoptosis, medicinal chemistry, CRO, Contract Research Organization,
consulting, consultant, biochemistry microbiology, natural products, total synthesis, project management, preclinical, discovery
preclinical, pharmaceutical, lead optimization, IND, NDA, clinical, blood brain barrier, small molecule
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