www.corerxpharma.com
CoreRx, Inc Overview Our Core Business <ul><li>CoreRx, Inc. is a Dosage Form Development company specializing in formulati...
Our Core Focus <ul><li>Complete client satisfaction </li></ul><ul><li>Highest quality science  </li></ul><ul><li>Consisten...
Why CoreRx? <ul><li>People and Expertise </li></ul><ul><li>It all boils down to people and trust..  </li></ul><ul><li>Comm...
Why CoreRx…? <ul><li>Oh yes… and Location </li></ul>
Executive/Scientific Team <ul><li>Todd R. Daviau, Ph.D. - Chief Executive Officer </li></ul><ul><ul><li>25+ years of pharm...
Executive/Scientific   Team <ul><li>Mark J. Licarde, Vice President - Manufacturing </li></ul><ul><ul><li>28+ years in pha...
History <ul><li>Founded in 2006 </li></ul><ul><li>Started with 5 employees </li></ul><ul><li>Now at 26 employees </li></ul...
Convenient Location Tampa, Florida <10 minutes to Tampa Airport (TPA) cGMP Compliant FDA/FL DOH Registered DEA Licensed Sc...
And In 2012: Convenient Location Clearwater, Florida ~15 minutes to Tampa Airport (TPA) cGMP Compliant FDA/FL DOH Register...
New 2012 CoreRx Facility Overview <ul><ul><li>Approximately 35,000 square feet </li></ul></ul><ul><li>19 Manufacturing sui...
New Location Formulation Suites Analytical Labs Warehouse cGMP Manufacturing Area Admin areas
Core Competencies by Business Unit <ul><li>Preformulation Services </li></ul><ul><ul><li>Drug substance characterization <...
Additional Capabilities <ul><li>CoreRx is committed to adding innovation where we see a client need </li></ul><ul><ul><li>...
Project Management/Logistics <ul><li>Project Manager is assigned to manage: </li></ul><ul><ul><li>Project planning and Exe...
SERVICES
Preformulation
Preformulation Characterization <ul><li>Solid and/or Solution Characterization can be Conducted Utilizing the Following In...
Analytical Services <ul><li>Experienced Professionals in Analytical Chemistry </li></ul><ul><ul><li>Method Development, Qu...
Analytical Services <ul><ul><li>Analytical Support for Formulation Development </li></ul></ul><ul><ul><li>Stability and QC...
Formulation Services <ul><ul><li>Solids </li></ul></ul><ul><ul><ul><li>Tablets, Capsules, Modified Release, Coatings </li>...
Formulation Services <ul><li>Solid Oral Capabilities </li></ul><ul><ul><li>API in Bottle/Capsule </li></ul></ul><ul><ul><l...
Contract Manufacturing Services <ul><li>Manufacturing </li></ul><ul><ul><li>API in Capsule/Bottles </li></ul></ul><ul><ul>...
Stability <ul><li>ICH Conditions </li></ul><ul><ul><li>25 o C/60%RH, 30 o C/65%RH, 40 o C/75%RH </li></ul></ul><ul><ul><li...
Why CoreRx…? <ul><li>Quality First Focus </li></ul><ul><ul><li>Numerous audits reinforcing compliance </li></ul></ul><ul><...
Faster to Clinic with Xcelodose  ®  or Quantos ® <ul><li>Manufacturing </li></ul><ul><ul><li>Advanced neat drug dosing dir...
… and now even Faster to Clinic with ClinicFirst SM  60Day Guarantee <ul><li>The CoreRx ClinicFirst program is designed fo...
Introducing SuiteView TM … <ul><li>Formulation & Manufacturing </li></ul><ul><ul><li>Real-time video feed (Pan, Tilt & Zoo...
Choose CoreRx <ul><li>The projects we work on may change.... </li></ul><ul><li>  </li></ul><ul><li>our values won't... </l...
www.corerxpharma.com
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CoreRx, is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.

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CoreRx presentation

  1. 1. www.corerxpharma.com
  2. 2. CoreRx, Inc Overview Our Core Business <ul><li>CoreRx, Inc. is a Dosage Form Development company specializing in formulation development, analytical development and clinical manufacturing of various dosage forms </li></ul><ul><li>Drug Characterization </li></ul><ul><li>Preformulation </li></ul><ul><li>Formulation Development </li></ul><ul><li>Analytical Development </li></ul><ul><li>Clinical Trial Materials Manufacturing </li></ul>
  3. 3. Our Core Focus <ul><li>Complete client satisfaction </li></ul><ul><li>Highest quality science </li></ul><ul><li>Consistent and effective communications </li></ul><ul><li>Strong timeline management </li></ul><ul><li>Full attention to client goals at all levels </li></ul>
  4. 4. Why CoreRx? <ul><li>People and Expertise </li></ul><ul><li>It all boils down to people and trust.. </li></ul><ul><li>Communication </li></ul><ul><li>Effective, Scientist-to-Scientist communication is the cornerstone to every CoreRx™ project’s success. </li></ul><ul><li>Flexibility </li></ul><ul><li>CoreRx™ scientists, management, and systems ensure flexibility and agility, allowing for direction changes without inflexible systems and bureaucratic hassles. </li></ul><ul><li>Speed </li></ul><ul><li>CoreRx™ understands that developing innovative solutions for improved patient care, combined with the bottom line, revenues and profitability, are tied to getting your product on the market as quickly as possible. </li></ul><ul><li>Quality systems </li></ul><ul><li>Documentation, quality, and operational systems are a necessity in a GLP/cGMP environment. Quality & timeliness must go hand in hand. </li></ul>
  5. 5. Why CoreRx…? <ul><li>Oh yes… and Location </li></ul>
  6. 6. Executive/Scientific Team <ul><li>Todd R. Daviau, Ph.D. - Chief Executive Officer </li></ul><ul><ul><li>25+ years of pharmaceutical experience </li></ul></ul><ul><ul><li>Director of the Analytical Group for MDS Pharma Services </li></ul></ul><ul><ul><li>Guilford Pharmaceuticals </li></ul></ul><ul><li>Brian McMillan, Vice President - Formulation Development </li></ul><ul><ul><li>20+ years of experience in pharmaceutical formulation development </li></ul></ul><ul><ul><li>MDS Pharma Services </li></ul></ul><ul><ul><li>Bausch and Lomb Pharmaceuticals </li></ul></ul><ul><ul><li>Roxane Laboratories </li></ul></ul>
  7. 7. Executive/Scientific Team <ul><li>Mark J. Licarde, Vice President - Manufacturing </li></ul><ul><ul><li>28+ years in pharmaceutical manufacturing </li></ul></ul><ul><ul><li>MDS Pharma Services </li></ul></ul><ul><ul><li>Mylan Pharmaceuticals </li></ul></ul><ul><ul><li>Bristol Myers Squibb </li></ul></ul><ul><li>Jim Davis, M.S., Vice President </li></ul><ul><ul><li>15+ years of pharmaceutical experience </li></ul></ul><ul><ul><li>MDS Pharma Services </li></ul></ul><ul><ul><li>Bausch and Lomb </li></ul></ul>
  8. 8. History <ul><li>Founded in 2006 </li></ul><ul><li>Started with 5 employees </li></ul><ul><li>Now at 26 employees </li></ul><ul><li>Grown from 3300 sq. ft. to over 10,000 sq ft. </li></ul><ul><li>New 35,000 sq ft. facility purchased in December 2010 – now undergoing a $5 million facility expansion </li></ul>
  9. 9. Convenient Location Tampa, Florida <10 minutes to Tampa Airport (TPA) cGMP Compliant FDA/FL DOH Registered DEA Licensed Schedule II - V
  10. 10. And In 2012: Convenient Location Clearwater, Florida ~15 minutes to Tampa Airport (TPA) cGMP Compliant FDA/FL DOH Registered DEA Licensed Schedule II - V Insert new map
  11. 11. New 2012 CoreRx Facility Overview <ul><ul><li>Approximately 35,000 square feet </li></ul></ul><ul><li>19 Manufacturing suites </li></ul><ul><ul><li>13 cGMP – including 1 for cytotoxic projects </li></ul></ul><ul><ul><li>6 Non-GMP – formulation development </li></ul></ul><ul><li>Manufacturing capacity – up to ~500kg </li></ul><ul><li>Expanded laboratory space: </li></ul><ul><ul><li>Formulation Development </li></ul></ul><ul><ul><li>cGMP Manufacturing </li></ul></ul><ul><ul><li>Stability storage testing </li></ul></ul><ul><ul><li>Analytical </li></ul></ul><ul><ul><ul><li>R&D </li></ul></ul></ul><ul><ul><ul><li>cGMP </li></ul></ul></ul><ul><li>  </li></ul>
  12. 12. New Location Formulation Suites Analytical Labs Warehouse cGMP Manufacturing Area Admin areas
  13. 13. Core Competencies by Business Unit <ul><li>Preformulation Services </li></ul><ul><ul><li>Drug substance characterization </li></ul></ul><ul><li>Analytical Services </li></ul><ul><ul><li>Method Development and Validation </li></ul></ul><ul><li>Formulation Development </li></ul><ul><ul><li>Liquids, Semi-solids and Solids </li></ul></ul><ul><li>Manufacturing, Packaging & Labeling </li></ul><ul><ul><li>API in Capsule or in Bottle </li></ul></ul><ul><ul><li>Liquids, Semi-solids and Solids </li></ul></ul><ul><ul><li>Matching Placebo manufacture </li></ul></ul><ul><ul><li>Blinding of reference product (over-encapsulation) </li></ul></ul><ul><li>Stability Program Management </li></ul><ul><ul><li>ICH or customized stability parameters </li></ul></ul>
  14. 14. Additional Capabilities <ul><li>CoreRx is committed to adding innovation where we see a client need </li></ul><ul><ul><li>API in capsule/bottle services </li></ul></ul><ul><ul><ul><li>Xcelodose ® </li></ul></ul></ul><ul><ul><ul><li>Quantos® </li></ul></ul></ul><ul><ul><li>Multi-layer tablet (up to 3 layers) </li></ul></ul><ul><ul><ul><li>FlexiTab ® </li></ul></ul></ul><ul><ul><li>Liquid in capsule services </li></ul></ul><ul><ul><li>Multi-particulate capsules </li></ul></ul><ul><li>CoreRx licensed with DEA </li></ul><ul><ul><li>Controlled substances (II – V) </li></ul></ul><ul><li>Overencapsulation services – comparator or “blinding” studies </li></ul>
  15. 15. Project Management/Logistics <ul><li>Project Manager is assigned to manage: </li></ul><ul><ul><li>Project planning and Execution </li></ul></ul><ul><ul><li>Team leadership with integration of technical </li></ul></ul><ul><ul><li>Manage all CoreRx-Client communications </li></ul></ul><ul><li>Project Teams are made up of subject matter experts which represent their respective disciplines: </li></ul><ul><ul><li>Project Management/Logistics </li></ul></ul><ul><ul><li>Analytical Chemistry </li></ul></ul><ul><ul><li>Formulation Development </li></ul></ul><ul><ul><li>Manufacturing </li></ul></ul><ul><ul><li>Quality Assurance </li></ul></ul>
  16. 16. SERVICES
  17. 17. Preformulation
  18. 18. Preformulation Characterization <ul><li>Solid and/or Solution Characterization can be Conducted Utilizing the Following Instrumentation/Procedures: </li></ul><ul><ul><li>Thermal evaluation </li></ul></ul><ul><ul><ul><li>DSC, TGA, Hot-stage microscope </li></ul></ul></ul><ul><ul><li>FTIR </li></ul></ul><ul><ul><li>X-ray Diffraction </li></ul></ul><ul><ul><li>Particle size/morphology </li></ul></ul><ul><ul><li>Polarized microscopy </li></ul></ul><ul><ul><li>Moisture content </li></ul></ul><ul><ul><ul><li>KF, moisture analyzer </li></ul></ul></ul><ul><ul><li>Moisture sorption profile </li></ul></ul><ul><ul><li>pH solubility </li></ul></ul><ul><ul><li>Partition coefficient </li></ul></ul><ul><ul><li>Photostability </li></ul></ul><ul><ul><li>Intrinsic dissolution </li></ul></ul>
  19. 19. Analytical Services <ul><li>Experienced Professionals in Analytical Chemistry </li></ul><ul><ul><li>Method Development, Qualification and Validation </li></ul></ul><ul><ul><ul><li>HPLC, uPLC, Dissolution, etc. </li></ul></ul></ul><ul><ul><li>Raw Material Testing (select) </li></ul></ul><ul><ul><li>Stability Sample Analysis </li></ul></ul><ul><ul><li>Dissolution Testing </li></ul></ul><ul><ul><li>Chiral Analysis </li></ul></ul><ul><ul><li>Cleaning Analysis/Verification </li></ul></ul><ul><ul><li>CMC Technical Packages </li></ul></ul>
  20. 20. Analytical Services <ul><ul><li>Analytical Support for Formulation Development </li></ul></ul><ul><ul><li>Stability and QC Release Testing </li></ul></ul><ul><ul><li>API/Reference Standard Characterization </li></ul></ul><ul><ul><li>Isolation and Identification of Impurities </li></ul></ul><ul><ul><li>Physical Chemistry </li></ul></ul>
  21. 21. Formulation Services <ul><ul><li>Solids </li></ul></ul><ul><ul><ul><li>Tablets, Capsules, Modified Release, Coatings </li></ul></ul></ul><ul><ul><li>Semi-Solids </li></ul></ul><ul><ul><ul><li>Creams, Gels, Ointments, lotions, etc. </li></ul></ul></ul><ul><ul><li>Dispersed Systems </li></ul></ul><ul><ul><ul><li>Emulsions & Suspensions </li></ul></ul></ul><ul><ul><li>Liquids </li></ul></ul><ul><ul><ul><li>Oral, Ophthalmic, Parenteral </li></ul></ul></ul>
  22. 22. Formulation Services <ul><li>Solid Oral Capabilities </li></ul><ul><ul><li>API in Bottle/Capsule </li></ul></ul><ul><ul><li>Excipient Compatibility </li></ul></ul><ul><ul><li>Oral Drug Delivery </li></ul></ul><ul><ul><ul><li>Tablets, Capsules, Powders, Pellets, Mini-Tablets </li></ul></ul></ul><ul><ul><ul><li>Solutions, Suspensions, Emulsions, Powders for Reconstitution </li></ul></ul></ul><ul><ul><li>Solid Dispersions </li></ul></ul><ul><ul><li>Lipid Formulation Delivery for Poorly Soluble/Bioavailable APIs </li></ul></ul><ul><ul><li>Multi-Phasic, Extended and/or Delayed Release Drug Delivery </li></ul></ul><ul><ul><li>Highly Potent Compounds </li></ul></ul>
  23. 23. Contract Manufacturing Services <ul><li>Manufacturing </li></ul><ul><ul><li>API in Capsule/Bottles </li></ul></ul><ul><ul><li>Tablets, Capsules, Pellets, Mini-Tablets </li></ul></ul><ul><ul><li>Liquid in Capsule </li></ul></ul><ul><ul><ul><li>Solutions, Suspensions, Emulsions </li></ul></ul></ul><ul><li>Over-Encapsulation, Reference Product Blinding </li></ul><ul><li>Packaging & Labeling </li></ul><ul><li>Other Services </li></ul><ul><ul><li>Matching Placebo Manufacturing </li></ul></ul><ul><ul><li>Technology Transfer </li></ul></ul>
  24. 24. Stability <ul><li>ICH Conditions </li></ul><ul><ul><li>25 o C/60%RH, 30 o C/65%RH, 40 o C/75%RH </li></ul></ul><ul><ul><li>Custom conditions also available </li></ul></ul><ul><li>Protocol design </li></ul><ul><li>Report generation </li></ul><ul><li>Stability software management system </li></ul><ul><ul><li>SLIM/SLIMStat </li></ul></ul><ul><li>Sample analysis </li></ul><ul><li>Secure storage </li></ul>
  25. 25. Why CoreRx…? <ul><li>Quality First Focus </li></ul><ul><ul><li>Numerous audits reinforcing compliance </li></ul></ul><ul><li>Responsiveness </li></ul><ul><ul><li>Flexible manufacturing model </li></ul></ul><ul><ul><li>Unique project management team structure with client-centric focus </li></ul></ul><ul><ul><li>Cross training program for employees </li></ul></ul><ul><li>Technology </li></ul><ul><ul><li>Investment in new equipment and expertise as they become available </li></ul></ul><ul><li>Expertise </li></ul><ul><ul><li>Ability to attract top-level talent with high-level benefits package </li></ul></ul><ul><li>Reliability </li></ul><ul><ul><li>Leveraging our company’s size to your advantage </li></ul></ul>
  26. 26. Faster to Clinic with Xcelodose ® or Quantos ® <ul><li>Manufacturing </li></ul><ul><ul><li>Advanced neat drug dosing directly into capsule or bottle </li></ul></ul><ul><ul><li>Decreases lab to clinic development </li></ul></ul><ul><ul><li>Decreases API requirements </li></ul></ul><ul><ul><li>Decrease risk of stability </li></ul></ul><ul><ul><li>Minimizes API waste </li></ul></ul>
  27. 27. … and now even Faster to Clinic with ClinicFirst SM 60Day Guarantee <ul><li>The CoreRx ClinicFirst program is designed for clients requiring rapid supply of clinical trial materials for First-in-Man (Phase I) clinical studies. </li></ul><ul><li>API in Capsule </li></ul><ul><li>Blend in Capsule </li></ul><ul><li>API in Bottle </li></ul><ul><li>Blend in Bottle </li></ul>
  28. 28. Introducing SuiteView TM … <ul><li>Formulation & Manufacturing </li></ul><ul><ul><li>Real-time video feed (Pan, Tilt & Zoom) </li></ul></ul><ul><ul><li>Remote/IP access </li></ul></ul><ul><ul><ul><li>Password controlled </li></ul></ul></ul><ul><ul><li>Two way communication </li></ul></ul><ul><ul><ul><li>Reduce travel time/costs </li></ul></ul></ul>
  29. 29. Choose CoreRx <ul><li>The projects we work on may change.... </li></ul><ul><li>  </li></ul><ul><li>our values won't... </li></ul><ul><li>  </li></ul><ul><li>quality, reliability, value, integrity </li></ul>
  30. 30. www.corerxpharma.com

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