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Building Ideas In
To Solutions 
From Principle To Practice The business of directing the science,
mentoring people & building
value to move Cell Phone: 510.219.5188 | markanderson@biotechpharmasolutions.com Drug
Discovery & Development
Technological
changes in preclinical drug development have dramatically changed the path to IND. I bring a depth of preclinical experience that
will facilitate change and foster a faster positive growth for your team.
My expertise is in moving drug-discovery programs
from idea to securing intellectual property space (Idea to IP); moving ideas to leads and leads to the point of preparing
for initiating GLP (Good Laboratory Procedures) studies. A cohesive presentation will be required for building your agent's
IND for regulatory filings (IP to IND). You will eliminate wasted time and energy by infusing my expertise at
critical junctures as a consultant.
As part of your team I can help you to evaluate ideas and develop a matrix for what should
be considered for intellectual property space within your corporate vision. Moving from Idea to IP is a critical milestone
in establishing and/or building a robust discovery pipeline. Expertise expedites your time in a very cost effective manner
and facilitates change.
My expertise will help leverage your
intellectual property (IP) to accomplish your needs; develop your therapeutic agents, develop collaborations with other companies,
or to sell your assets that are outside of your therapeutic focus.
We can develop initial project research plans and consider an initial target
product profile that is important for establishing a focus and building your teams for the discovery pipeline and as a format
for discussing the clinical development pipeline. For this I have build business acumens that aligns the research efforts
with the clinical development efforts.
Once we have mapped out your pipeline we need to do the work and determine as we progress the Go/No Go junctures. These can
be ensuring that: 1) hits are elucidated and leads are identified; 2) series and leads are transformed into potential drug
candidates; 3) scale-up and technology transfer packages are established; 4) CRO's/CMO's are identified and your new agent
is ready for advanced preclinical studies; 5) GLP studies are planned and ready to initiate (often about 9 months are needed
for assays and final reports) provided that sufficient test materials and initial testing formulations were ready; we will
call this being IND-Ready.
Our next critical step will be transforming
the plethora of information and data into a finalized IND suitable for submission to the FDA. Writing and submitting an IND
requires a tremendous amount of coordination, dedication, and attention to details. Let's start early in the process once
we have established robust in vivo efficacy. Oversight of CMC
regulatory interactions and collaboration with regulatory affairs on all communications with the US FDA other regulatory agencies
is the next step. I can work with your teams on all of this.
Call for your consultation today.
Key Words:
drug discovery, drug development, drug design, drug discovery stratergies, drug discovery methods, cancer targets, cancer,
oncology, neurology, neurodegenerative, neurodegeneration, Alzheimer's, infectious diseases, 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, cardiovascular, CONSULTANT, CONSULTING, 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
clinical, chemical pharmaceutical development, lead optimization, IND, NDA, clinical, blood brain barrier, team leader, BLOOD
BRAIN BARRIER
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