2. Opportunity
A new paradigm in drug discovery.
By outsourcing to access capabilities, maximize flexibility,
and improve cost‐effectiveness, universities, research
institutes, start‐ups, and biotech companies may optimize
small molecule drug leads and retain control of intellectual
property rights, while maximizing the value of their
discoveries. This can be done
with complete anonymity and confidentiality
without the need to establish chemistry, biology,
pharmacokinetic/drug metabolism, in vivo pharmacology,
process and toxicology infrastructures
…without needing to seek the support of a pharma partner.
3. Challenges
Driving rapid advancement of science, understanding, and biological activity.
Making the most of available funds in a manner acceptable to sources.
Developing a plan of action, knowing what to make, how to make it, where to
produce it, what to do with it, how to evaluate it, & prioritizing where to go next.
Establishing early Proof‐of‐Concept evidence at the cellular and in vivo level.
Enhancing the quality of the invention.
Generating relevant, reliable, quality data to drive decision making, especially in
unfamiliar or unexplored areas.
Intelligent benchmarking against competition and navigating around prior art.
Identifying potential issues, generating of key data to justify continued
investment, and adjusting focus to address concerns.
Determining when the product meets criteria for commercialization and
assembling an attractive, compelling, supporting data package
Protecting your interests with the broadest possible patent filings.
Realizing the maximal value and potential of the discoveries.
Maintaining involvement, control, and security of your intellectual property
throughout the process.
4. Collaboration without compromise
Advantages
Direct involvement of a successful drug discoverer
…with over 20 years of proven contributions in Pharma industry, with
extensive experience in:
Computational, synthetic & medicinal chemistry, structure‐activity
relationships (SAR)
Virtual screening, protein production & crystallography, structure‐
based drug design (SBDD)
Parallel synthesis & high speed purification
Compound library assembly, assay development, High‐throughput
screening, HTS “Hit” analysis
Lead compound assessment & Lead optimization
Enzymology, signal transduction, biochemistry, cell biology,
pharmacology
Proof‐of‐concept studies using biological and small molecule agents
5. Collaboration without compromise
Advantages
extensive experience in…
Preclinical pharmacokinetics, PK/ADME, Toxicology, Safety
Pharmacology
Identification and Synthesis of metabolites
Early Clinical development strategy
Surrogate biomarker studies
Intellectual property evaluation, strategies & protection
Expert testimony & technical support for attorneys
Infrastructure design and implementation
Staff selection and mentoring
Due diligence/opportunity analysis
6. Collaboration without compromise
Advantages
Proven integrity
Focused attention to the needs of your research effort to achieve specified goals
Reliable, flexible, scalable support through management of outsourcing
Intelligent design, synthesis and evaluation
Practical yet creative experimental design insights
Extensive network of resources, competent CROs, and information sources
Management of external activities according to agreed specifications
Timely, cost‐effective execution of plans
Delivery of high quality chemical matter and data
Maximal return by enlisting a US company to manage offshore CRO activities
Appropriately conducted studies in accordance with accepted US standards
Facile transition to large scale production and experimentation
Confidentiality & Anonymity in external interactions
Interactive local creation and management of intellectual property,
…limiting overseas disclosures, maximizing confidentiality, protecting interests,
and enabling typical strategies to maximize patent life
All IP contributions remain the property of the client.
7. Collaboration without compromise
Effective Management of Outsourcing needs is accomplished through
established relationships for:
Synthesis from mg to kg scale
Virtual screening
Protein cloning, expression, & production
Crystallography, structure & fragment‐based drug design
Screening, assay development, pharmacology
Selectivity assessments & receptor binding
In vitro ADME & measurement of physicochemical properties
hERG determinations and Cardiovascular safety assessments
In vivo PK, ADME, Toxicology, and Safety Pharmacology studies in rodents,
dogs, monkeys
Genetic Toxicology
Metabolite identification and synthesis
Salt selection, Preformulation, Polymorph analyses & characterization