Collaboration without compromise

OpportunityOpportunityA 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.

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.

AdvantagesDirect 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

Advantagesextensive 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

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

AllAll IP contributions remain the property of the client. IP contributions remain the property of the client.

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

Lee D. Arnold, Ph.D. DiscoverDiscoverElucidationsElucidations, LLC55 Chestnut Street, Mt. Sinai, NY 11766631-403-4176 (office); 631-662-5281(cell)laphdad@aol.com