DiscoverElucidations Focus Presentation


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DiscoverElucidations Focus Presentation

  1. 1. Collaboration without compromise
  2. 2. <ul><li>Opportunity </li></ul><ul><ul><li>A new paradigm in drug discovery. </li></ul></ul><ul><ul><li>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 </li></ul></ul><ul><ul><ul><li>with complete anonymity and confidentiality </li></ul></ul></ul><ul><ul><ul><li>without the need to establish chemistry, biology, pharmacokinetic/drug metabolism, in vivo pharmacology, process and toxicology infrastructures </li></ul></ul></ul><ul><ul><ul><li>… without needing to seek the support of a pharma partner. </li></ul></ul></ul>
  3. 3. <ul><li>Challenges </li></ul><ul><ul><li>Driving rapid advancement of science, understanding, and biological activity. </li></ul></ul><ul><ul><li>Making the most of available funds in a manner acceptable to sources. </li></ul></ul><ul><ul><li>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. </li></ul></ul><ul><ul><li>Establishing early Proof-of-Concept evidence at the cellular and in vivo level . </li></ul></ul><ul><ul><li>Enhancing the quality of the invention. </li></ul></ul><ul><ul><li>Generating relevant, reliable, quality data to drive decision making, especially in unfamiliar or unexplored areas. </li></ul></ul><ul><ul><li>Intelligent benchmarking against competition and navigating around prior art. </li></ul></ul><ul><ul><li>Identifying potential issues , generating of key data to justify continued investment, and adjusting focus to address concerns. </li></ul></ul><ul><ul><li>Determining when the product meets criteria for commercialization and assembling an attractive, compelling, supporting data package </li></ul></ul><ul><ul><li>Protecting your interests with the broadest possible patent filings. </li></ul></ul><ul><ul><li>Realizing the maximal value and potential of the discoveries. </li></ul></ul><ul><ul><li>Maintaining involvement, control, and security of your intellectual property throughout the process. </li></ul></ul>
  4. 4. <ul><li>Advantages </li></ul><ul><li>Direct involvement of a successful drug discoverer </li></ul><ul><li>… with over 20 years of proven contributions in Pharma industry, with extensive experience in: </li></ul><ul><ul><ul><li>Computational, synthetic & medicinal chemistry, structure-activity relationships (SAR) </li></ul></ul></ul><ul><ul><ul><li>Virtual screening, protein production & crystallography, structure-based drug design (SBDD) </li></ul></ul></ul><ul><ul><ul><li>Parallel synthesis & high speed purification </li></ul></ul></ul><ul><ul><ul><li>Compound library assembly, assay development, High-throughput screening, HTS “Hit” analysis </li></ul></ul></ul><ul><ul><ul><li>Lead compound assessment & Lead optimization </li></ul></ul></ul><ul><ul><ul><li>Enzymology, signal transduction, biochemistry, cell biology, pharmacology </li></ul></ul></ul><ul><ul><ul><li>Proof-of-concept studies using biological and small molecule agents </li></ul></ul></ul>
  5. 5. <ul><li>Advantages </li></ul><ul><li>extensive experience in … </li></ul><ul><ul><ul><li>Preclinical pharmacokinetics, PK/ADME, Toxicology, Safety Pharmacology </li></ul></ul></ul><ul><ul><ul><li>Identification and Synthesis of metabolites </li></ul></ul></ul><ul><ul><ul><li>Early Clinical development strategy </li></ul></ul></ul><ul><ul><ul><li>Surrogate biomarker studies </li></ul></ul></ul><ul><ul><ul><li>Intellectual property evaluation, strategies & protection </li></ul></ul></ul><ul><ul><ul><li>Expert testimony & technical support for attorneys </li></ul></ul></ul><ul><ul><ul><li>Infrastructure design and implementation </li></ul></ul></ul><ul><ul><ul><li>Staff selection and mentoring </li></ul></ul></ul><ul><ul><ul><li>Due diligence/opportunity analysis </li></ul></ul></ul>
  6. 6. <ul><li>Advantages </li></ul><ul><ul><li>Proven integrity </li></ul></ul><ul><ul><li>Focused attention to the needs of your research effort to achieve specified goals </li></ul></ul><ul><ul><li>Reliable, flexible, scalable support through management of outsourcing </li></ul></ul><ul><ul><li>Intelligent design , synthesis and evaluation </li></ul></ul><ul><ul><li>Practical yet creative experimental design insights </li></ul></ul><ul><ul><li>Extensive network of resources, competent CROs, and information sources </li></ul></ul><ul><ul><li>Management of external activities according to agreed specifications </li></ul></ul><ul><ul><li>Timely, cost-effective execution of plans </li></ul></ul><ul><ul><li>Delivery of high quality chemical matter and data </li></ul></ul><ul><ul><li>Maximal return by enlisting a US company to manage offshore CRO activities </li></ul></ul><ul><ul><li>Appropriately conducted studies in accordance with accepted US standards </li></ul></ul><ul><ul><li>Facile transition to large scale production and experimentation </li></ul></ul><ul><ul><li>Confidentiality & Anonymity in external interactions </li></ul></ul><ul><ul><li>Interactive local creation and management of intellectual property , …limiting overseas disclosures, maximizing confidentiality, protecting interests, and enabling typical strategies to maximize patent life </li></ul></ul><ul><ul><li>All IP contributions remain the property of the client. </li></ul></ul>
  7. 7. <ul><li>Effective Management of Outsourcing needs is accomplished through established relationships for: </li></ul><ul><ul><li>Synthesis from mg to kg scale </li></ul></ul><ul><ul><li>Virtual screening </li></ul></ul><ul><ul><li>Protein cloning, expression, & production </li></ul></ul><ul><ul><li>Crystallography, structure & fragment-based drug design </li></ul></ul><ul><ul><li>Screening, assay development, pharmacology </li></ul></ul><ul><ul><li>Selectivity assessments & receptor binding </li></ul></ul><ul><ul><li>In vitro ADME & measurement of physicochemical properties </li></ul></ul><ul><ul><li>h ERG determinations and Cardiovascular safety assessments </li></ul></ul><ul><ul><li>In vivo PK, ADME, Toxicology, and Safety Pharmacology studies in rodents, dogs, monkeys </li></ul></ul><ul><ul><li>Genetic Toxicology </li></ul></ul><ul><ul><li>Metabolite identification and synthesis </li></ul></ul><ul><ul><li>Salt selection, Preformulation, Polymorph analyses & characterization </li></ul></ul>
  8. 8. Lee D. Arnold, Ph.D. Discover Elucidations , LLC 55 Chestnut Street, Mt. Sinai, NY 11766 631-403-4176 (office); 631-662-5281(cell) [email_address]