Presentation China And Usa July 2011

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Frontage Laboratories - CRO - Labs in USA and China - July 2011

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Presentation China And Usa July 2011

  1. 1. Full Service US Based global CRO (973) 934-1171<br />
  2. 2. Fully integrated GLOBAL CRO<br /><ul><li>Combinatorial</li></ul> chemistry<br /><ul><li>Structure-based</li></ul> drug design<br /><ul><li>In vitro, ex vivo &</li></ul> in vivoscreening<br /><ul><li>HTS screening
  3. 3. Traditional</li></ul> medicinal<br /> chemistry<br /><ul><li>Rational drug</li></ul> design<br /><ul><li>In silico</li></ul> drugdesign<br />- Efficacy<br />- GMP Supplies<br />- Regulatory<br />- CMC consult<br />- Tech Transfer<br />- Pharmacology<br /><ul><li>Medicinal </li></ul> chemistry<br /><ul><li>Rational drug </li></ul> design<br />- Fast PK evaluation<br /><ul><li>Bioavailability
  4. 4. Systemic exposure
  5. 5. Absorbance
  6. 6. Clearance
  7. 7. Distribution
  8. 8. Expression</li></ul> analysis<br /><ul><li>In vitrofunction
  9. 9. In vivovalidation
  10. 10. Bioinformatics</li></ul>- Safety<br />- GMP Supplies<br />- Regulatory<br />- CMC consult<br />EARLY PHASE & BEYOND<br />Accomplish more with one service supplier<br /><ul><li>API Synthesis/Manufacturing
  11. 11. Preclinical / DMPK Services
  12. 12. Dosage Formulation Development
  13. 13. CTM Manufacturing
  14. 14. Clinical Study Execution in US and China
  15. 15. Bioanalysis & Biomarker / Immunology
  16. 16. Regulatory filing, GMP Consulting and Support</li></ul>Commercial<br />Launch<br />Drug<br />Development<br />Candidate<br />(ADMET)<br />Target<br />Discovery &<br />Validation<br />HTS<br />Screening<br />Lead<br />Optimization<br />Registration<br />Phase I<br />Hits to Leads<br />Phase II<br />Phase III<br />
  17. 17. FRONTAGE Milestones<br />Expanded Analytical Services & CTM Mfg <br />moved to Exton, PA<br />Launched Clinical Service Center in Beijing<br />Acquired ABR CRO<br />Expanded Operations <br />in Malvern, PA <br />(Bioanalytical, Analytical, PRD and API/Organic Synthesis)<br />Initiated<br />Operations in NJ<br />Investment – <br />Clinical Services with ABR (CRO-1994)<br />Launch of<br />Beijing CMC Center<br />2002<br />1 employee<br />2004<br />2006<br />2007<br />2008<br />2009<br />2011<br />~250 employees<br />2010<br />Launched<br />DMPKOperations<br />AAALAC Certification<br />2009 Launched <br />Zhengzhou Clinical Center<br />Launched <br />Shanghai Facility<br />(Bioanalytical, Analytical Services)<br />
  18. 18. Our Locations<br />Two Countries One Quality System<br />Beijing, PRC<br /><ul><li>Clinical Services
  19. 19. Regulatory Affairs
  20. 20. CMC Services</li></ul>(Analytical, CTM<br /> Manufacturing, PRD)<br />Shanghai, PRC<br /><ul><li>Bioanalytical
  21. 21. Biomarkers
  22. 22. DMPK
  23. 23. Analytical Services</li></ul>Malvern / Exton, PA<br /><ul><li> Bioanalytical Services
  24. 24. DMPK / Biomarkers
  25. 25. CMC Services</li></ul> Hospital based Phase I-IIa units<br /><ul><li>120-beds Zhengzhou University
  26. 26. 80-beds The First Teaching Hospital of Jilin University
  27. 27. 80- beds at Henan TCM University Hospital - Q3 11
  28. 28. 80 - bed at Zhongshan University Hospital - Q1 12</li></ul>Hackensack, NJ<br /><ul><li>72- bed Phase I-IIa Clinic
  29. 29. Late phase clinical studies
  30. 30. Data management/support</li></ul>4<br />
  31. 31. A Fully Integrated GLOBAL CRO <br />KEY Service areas<br />CMC Drug Development<br />Preclinical/Bioanalytical<br />Clinical<br />Bioanalytical<br />DMPK<br />Biological / Immuno Assays<br />Biomarker Assays<br />API / Organic Synthesis<br />Pharmaceutical Analysis<br />Formulation Development<br />Clinical Manufacturing<br />GMP & CMC Consulting<br />Clinical Studies Phase I/IIA<br />Data Analysis<br />Regulatory Affairs<br />GLP<br />GCP<br />GMP<br /> Multiple Successful (10+) FDA Inspections<br /><ul><li>Helping US, EU and Chinese companies to introduce new products to the US marketplace, from IND submissions to NDA / ANDA filings
  32. 32. Helping US and EU companies to introduce products to China</li></li></ul><li>CMC Services <br />API /Organic synthesis<br /><ul><li>GMP Synthesis of Small Molecules
  33. 33. Reference Standard Synthesis
  34. 34. Metabolite ID and Synthesis
  35. 35. Impurity Identification and Purification Projects
  36. 36. Process Development & Optimization
  37. 37. Sourcing & Scale-up to Commercial</li></ul>GMP CONTRACT MANUFACTURING - CLINICAL TRIAL MATERIALS<br /><ul><li>Oral Solid Dosage Forms
  38. 38. Sterile Dosage Forms
  39. 39. Topical Dosage Forms
  40. 40. API’s via chemical synthesis</li></ul>PHARMACEUTICAL ANALYSIS<br /><ul><li>GMP Analytical Services
  41. 41. >200 Method Development/Validation since 2008
  42. 42. Impurity Identification and Characterization</li></ul>FORMULATION<br /><ul><li>Pre-formulation characterization/screening
  43. 43. Immediate and Controlled Release </li></ul> Development Expertise<br />
  44. 44. Clinical Services Clinical Pharmacology Unit<br />Overview<br /><ul><li>16 years of operational experience
  45. 45. Facilities in US and China
  46. 46. Full-time Principle Investigator with Emergency Medicine background
  47. 47. BLS and ACLS trained staff
  48. 48. Close proximity to major medical center</li></ul>Types of studies<br /><ul><li>First in HumanSingle &multiple ascending dose
  49. 49. Absolute and Relative BA, fed /fasted BE, food effect, PK/PD studies
  50. 50. Drug / drug interaction (DDI) and drug / alcohol interaction studies
  51. 51. Thorough QT (TQT) and other cardiovascular evaluations (Holter Gateway, etc)</li></li></ul><li>United States<br />One of the largest Phase I research facilities in the NJ/NY metropolitan area <br />72-bed (hospital-type) facility<br /> China <br />Two SFDA certified hospital-based clinical centers, operated according to US <br />standards <br />120-bed Chinese clinical center on the campus, The First Affiliated Hospital of Zhengzhou University (>4000 beds)<br />80-bed clinical center within The First Teaching Hospital of Jilin University with focus on phase I for oncology drugs (>3000 beds)<br />Coming this Q3 2011 and Q1 2012 respectively<br />80- beds at Henan TCM University Hospital<br />80-beds at Zhongshan University Hospital with focus on diabetic disorders and oncology (>3000 beds)<br />Clinical services _ Global facilities<br />
  52. 52. Clinical Services CRO SERVICES FOR PHASE I-IIA TRIALS<br /><ul><li>Study Protocol Design
  53. 53. Project Management
  54. 54. Clinical Data Management (Oracle Clinical)
  55. 55. Biostatistical & Pharmacokinetic Analysis
  56. 56. SAS Programming
  57. 57. Medical Writing
  58. 58. Regulatory submissions</li></ul>Clinical Study Reports<br />PK Summaries<br />IND, IDE, NDA (505b1 and b2), PMA, ANDA<br />
  59. 59. Clinical and regulatory consulting _ case studies<br />Successful completion of the clinical pharmacology and biopharmaceutics sections of an NDA for a pharmaceutical company in Europe <br />• Provided clinical pharmacology and regulatory consulting for a specialized U.S. pharmaceutical company <br />• Contributed to discussions with the FDA review division to waive a TQT study for an NDA <br />• Contributed to the preparation of meeting package and discussions at an EOP2 FDA meeting <br />Ongoing work with two major Chinese pharmaceutical companies for their respective first NME drug development in the United States <br />• Including consulting for the IND preparation (CMC, Pharmtox and clinical protocols), U.S. FDA interactions from pre-IND meeting, IND filing and clinical development programs <br />Recent ANDA approval of AmlodipineBesylate for Beijing Second Pharmaceutical Co., Ltd. <br /><ul><li> Frontage was responsible for CMC development, bioequivalence studies, GMP Consulting, Facility Qualification, Quality System development, and regulatory filing for this ANDA project </li></ul>Ongoing work with a startup biotech company in U.S. on its first biosimilar drug product indented for FDA submission <br />
  60. 60. DMPK Services<br />In vitro studies <br /><ul><li>Metabolic Stability, Protein Binding, MDCK, CYP inhibition etc</li></ul>In vivo studies (rats and mice) – FAST PK<br /><ul><li>AAALAC Certified Vivarium
  61. 61. In-life + Bioanalytical Support + PK Report Using WinNonLin) with a Turnaround time of 5 days after receipt of compound.  </li></ul>Mass balance studies<br /><ul><li>(C14 and tritium)</li></li></ul><li>Bioanalytical services<br />One of the largest laboratories in the East Coast, USA and <br />China<br /><ul><li>28 LC/MS/MS Bioanalytical systems linked to Watson LIMS system
  62. 62. Industry-leading staff with advanced degrees
  63. 63. GLP and non-GLP Analysis</li></ul>In 2010<br /><ul><li>Over 90,000 Samples Analyzed (GLP/Regulated)
  64. 64. Over 80 Methods Developed (GLP/non-GLP)
  65. 65. 80% Repeat Customers</li></li></ul><li>Bioanalytical capabilities<br />Method Development/Validation and Sample Analysis in Compliance with FDA and GLP Guidance.<br /><ul><li>Track record of developing and validating difficult, highly sensitive methods
  66. 66. Development of stabilizing procedures for analyte with stability issues for sample collection
  67. 67. Fast turnaround for preclinical and clinical sample analysis for TK, PK and BE studies
  68. 68. Biomarker and immunogenicity method development/validations, PK, TK, PD sample analysis</li></ul>Integrated Services Between our Phase I Clinic and Bioanalytical labs<br />
  69. 69. BIOLOGY SERVICES _ Large Molecules<br />EQUIPMENT LIST<br /><ul><li>PCR (AB 7900HT-Real Time PCR System)
  70. 70. MSD 6000
  71. 71. Spectramax
  72. 72. Abbott AxSYM System
  73. 73. Packard: Multiprobe II ex robotic liquid handling system
  74. 74. Tomtec: Quadra-3-SPE
  75. 75. Tecan: Genesis freedom 200
  76. 76. Watson LIMS Ver. 7.3
  77. 77. BIORAD CHEMI-Doc (quantitation of SDS-PAGE/WB)
  78. 78. GLP Labs
  79. 79. Assay Development / Transfer / Validation
  80. 80. Clinical / Pre-clinical Sample Testing
  81. 81. ADA – Anti Drug Antibody Assays (Immunogenicity)
  82. 82. PK/TK – Pharmacokinetics Assays
  83. 83. NAB – Neutralizing Antibody Assays
  84. 84. Cell Based Assays
  85. 85. Biomarker Assays</li></li></ul><li>Frontage China introduction<br />
  86. 86. Frontage China _ Overview<br />China operations (established 2006): <br /><ul><li>Shanghai, laboratories
  87. 87. Beijing, clinical services and regulatory affair, CMC center
  88. 88. Zhengzhou, clinical center</li></ul>China services:<br /><ul><li>Bioanalytical, DMPK
  89. 89. Product development (formulation and pharmaceutical analysis)
  90. 90. Early and late phase clinical trials, clinical data management and regulatory affairs </li></li></ul><li>People and facility<br />OVER 80 STAFF IN CHINA<br /><ul><li>Over 70% laboratory staff with advanced degrees (PhD, MD, Master)
  91. 91. All Director levels and above are trained either in the US or EU </li></ul>EXPERIENCED MANAGEMENT TEAM WITH DIVERSE BACKGROUND <br /><ul><li>Pfizer, GSK, JNJ, Schering-Plough, etc.</li></ul>STATE-OF-THE-ART FACILITY AND EQUIPMENT<br /><ul><li>6 LC/MS/MS, MSD-6000
  92. 92. 10 HPLC, GC, IR, UV-VIS, dissolution
  93. 93. 5 stability chambers
  94. 94. Tablet press/coater, capsule filler, etc.
  95. 95. Clinical Research Center with over 300 beds </li></li></ul><li>Bioanalytical/DMPK<br />SUPPORT DMPK AND TK STUDIES FOR DRUG DISCOVERY, PRE-CLINICAL, <br />CLINICAL AND BIO-EQUIVALENCY (BE) STUDIES<br />METHOD DEVELOPMENT AND VALIDATION FOLLOWING FDA, OECD, ICH <br />GUIDELINES (2-3 WEEKS); CROSS METHOD TRANSFERRING AND VALIDATION <br />BETWEEN US AND CHINA<br />ANALYZE SAMPLES IN DIFFERENT BIOLOGICAL MATRICES PLASMA, URINE, <br />BLOOD AND TISSUES<br />BIOASSAYS TO SUPPORT LARGE MOLECULE DRUG DEVELOPMENT; <br />BIOMARKER FOR DRUG SAFETY AND EFFICACY, DIAGNOSTICS, DISEASE <br />MODELING AND CLINICAL STUDIES<br />
  96. 96. Pharmaceutical Analysis<br />SUPPORT DRUG DEVELOPMENT FROM EARLY EXPLORATORY TO FULL <br />DEVELOPMENT STAGES<br />WORK CLOSELY WITH CLIENT TO DEFINE<br /><ul><li>Stage oriented method development and validation
  97. 97. Stability testing strategy</li></ul>ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND TESTING<br /><ul><li>For API, Drug Product, In-Process control
  98. 98. Experience in small molecules, peptides and proteins</li></ul>STABILITY STUDY<br /><ul><li>Qualified stability chambers with 24/7 monitoring</li></ul>REFERENCE STANDARD QUALIFICATION AND STRUCTURE ELUCIDATION<br />
  99. 99. Formulation Development<br />FORMULATION DEVELOPMENT AT ALL STAGES: FROM INITIAL CONCEPT TO <br />COMMERCIALIZATION<br /><ul><li>Pre-formulation and formulation for preclinical, clinical, and ANDA studies</li></ul>VARIOUS DOSAGE FORMS<br /><ul><li>Solid: tablets, capsules
  100. 100. Liquid: solution, suspension, emulsion for oral and parenteral administration</li></ul>RELEASE PROFILE: IMMEDIATE, DELAYED, EXTENDED COATING: FILM, ENTERIC, <br />CONTROLLED RELEASE<br />cGMP CLINICAL TRIAL MATERIAL MANUFACTURING (SOLID AND STERILE DOSAGE <br />FORMS)<br />
  101. 101. Clinical Services<br />CLINICAL TRIAL MANAGEMENT UNDER GCP GUIDELINES<br /><ul><li>Two SFDA certified hospital-based clinical centers, operated according to US standards </li></ul>120-bed Chinese clinical center on the campus, The First Affiliated Hospital of Zhengzhou University (>4000 beds)<br />80-bed clinical center within The First Teaching Hospital of Jilin University with focus on phase I for oncology drugs (>3000 beds)<br /><ul><li>Coming this Q3 2011 and Q1 2012 respectively</li></ul>80- beds at Henan TCM University Hospital<br />80-beds at Zhongshan University Hospital with focus on diabetic disorders and oncology (>3000 beds)<br />DATA MANAGEMENT AND BIOSTATISTICS<br /><ul><li>Oracle, SAS programming, ECTD, EDC applications, web-based study tracker Regulator strategy and filings
  102. 102. Regulatory filings for new drug application
  103. 103. Import product registration (IDL, CPP),drugs, medical devices, diagnostic kits</li></ul>MEDICAL WRITING, STUDY FEASIBILITY, MARKETING REVIEW<br /><ul><li>Medical writing
  104. 104. Feasibility and marketing review for foreign products registration for China market</li></li></ul><li>Quality System<br />TWO COUNTRIES, ONE QUALITY SYSTEM WITH CONTINUOUS IMPROVEMENT, <br />WORK UNDER GLP/GMP/GCP/ICH GUIDELINES<br />ONGOING TRAINING PROGRAM AND INTERNAL AUDIT PROGRAM<br />CONTROLLED DOCUMENTATION SYSTEM, MATERIAL HANDLING SYSTEM, <br />INSTRUMENT QUALIFICATION/CALIBRATION SYSTEM<br />SUCCESSFUL INSPECTIONS BY CLIENTS SINCE 2006 <br />(US FDA AUDITED MARLVEN SITE MORE THAN 10 TIMES)<br />
  105. 105. Strength of Frontage China<br />UNIQUE BUSINESS MODEL<br /><ul><li>Services provided in China are the routine services provided in the US </li></ul>TWO COUNTRIES ONE SYSTEM<br /><ul><li>Using same quality system, same SOPs and same management system</li></ul>CROSS METHOD VALIDATION<br /><ul><li>Controlled cross validation in support of multicenter clinical studies</li></ul>FULLY SUPPORTED BY US TEAM<br />
  106. 106. Thank You<br />Roseann Affinito<br />Business Development Manager – NJ<br />Phone: (973) 934-1171<br />

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