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DiscoverElucidations Focus Presentation


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DiscoverElucidations Focus Presentation

  1. 1. Collaboration without compromise
  2. 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. 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. 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. 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. 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. 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
  8. 8. Collaboration without compromise Lee D. Arnold, Ph.D.   DiscoverElucidations, LLC 55 Chestnut Street, Mt. Sinai, NY 11766 631‐403‐4176 (office); 631‐662‐5281(cell)