Accelerating Development                         Ron Connolly                        October 1, 2012CORPORATE OVERVIEW
Frontage Snapshot-An Integrated R&D outsourcing company                         Headquartered in Exton, Pennsylvania, U.S...
US and China: Round-the-Clock Operations                                                                                  ...
CPSA 5-MINUTE INTRO   Making discoveries that accelerate development   1. LC/MS/MS quantification of mAb (MW ~126K)   2. D...
LC/MS/MS QUANTIFICATION OF ANTIBODY IN SERUM AND CSFA Humanized IgG1 mABdeveloped as a potentialtherapeutic agent forAlzhe...
ALTERNATIVE LC-MS/MS ASSAY STRATEGY   Solution   Developed LC/MS/MS method with selected surrogate    peptides (LC/MS/MS ...
FORMULATION DEVELOPMENT FOR INSOLUBLE DRUGS Challenge More compounds in development with poor solubility  • Roughly 65% of...
CLINICAL - INTEGRATED OPERATIONS WITH FAST TURNAROUNDCase Study: Open-label single-dose, two-period crossover study toasse...
FRONTAGE ACCELERATES SOLUTIONS    DISCOVERS solutions to tough technical challenges    DELIVERS high quality data on-tim...
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27 accelerating development ron connolly - frontage labs

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27 accelerating development ron connolly - frontage labs

  1. 1. Accelerating Development Ron Connolly October 1, 2012CORPORATE OVERVIEW
  2. 2. Frontage Snapshot-An Integrated R&D outsourcing company  Headquartered in Exton, Pennsylvania, U.S.A. (Established 2001) Locations  New Jersey, Shanghai, Beijing, Zhengzhou, Changchun  Preclinical through clinical-stage • DMPK, Service Offerings • Biologics & Bio-analytical Services drug development and clinical services: • CMC - drug development • Clinical studies and biometrics  Over 200 customers (>85% returning) mainly in the US, EU, Japan and China: Customers • Global Top 10, mid-size and virtual pharmaceutical and biotech firms, • Government agencies and public health concerns (NIH, BARDA, NIAID, foundations) • Leading Chinese generic and innovative drug companies Employees  280+ employees - Close to 70% of scientist team with advanced degrees  US: • 80,000 sq.ft. Bioanalytical / DMPK lab and Animal Facility in Exton, PA (AAALAC) • 26,500 sq.ft. CMC services operation including API synthesis lab, analytical, formulation development, and GMP manufacturing of clinical trial materials (CTM) Facilities • 15,000 sq.ft., 88-bed Phase I-II clinical research facility in Hackensack, NJ  China: • 16,000 sq.ft. bioanalytical lab, one of the largest in Shanghai • 30,000 sq.ft. CMC lab and GMP CTM facility in Beijing • Clinical facilities in Zhengzhou (120 beds), Changchun (82), and Nanjing (50) CORPORATE OVERVIEW
  3. 3. US and China: Round-the-Clock Operations Beijing, PRC • Clinical Services • Regulatory Affairs • CMC Services • GMP Consulting Shanghai, PRC • Bioanalytical • Biologics • DMPKExton, PA (2 locations) • Analytical Services• Headquarters• Bioanalytical/Biologics• DMPK• CMC Services Hackensack, NJ Hospital based Phase I-IIa units (API, Analytical, PRD, CTM mfg) • 88-bed Phase I-IIa Clinic 120-bed Zhengzhou University• Regulatory Affairs • Late phase clinical studies 82-bed The First Teaching Hospital of Jilin University• GMP Consulting • Data management/support 50-bed Nanjing City First HospitalCORPORATE OVERVIEW 3
  4. 4. CPSA 5-MINUTE INTRO Making discoveries that accelerate development 1. LC/MS/MS quantification of mAb (MW ~126K) 2. Developing a formulation for a "brick" material that is insoluble 3. Performing dose escalation study arms in 5 days CORPORATE OVERVIEW
  5. 5. LC/MS/MS QUANTIFICATION OF ANTIBODY IN SERUM AND CSFA Humanized IgG1 mABdeveloped as a potentialtherapeutic agent forAlzheimer disease (AD)ChallengeELISA assay sensitivity(LLOQ of 6 ug/mL), IgG1 mABprimary Ab was limited.Target LLOQ:Serum assay = 500 ng/mL,CSF assay = 5 ng/mL CORPORATE OVERVIEW
  6. 6. ALTERNATIVE LC-MS/MS ASSAY STRATEGY Solution  Developed LC/MS/MS method with selected surrogate peptides (LC/MS/MS optimization)  Developed a sample processing procedure using enrichment approach and digestion  Determined best IS approach (Antibody analog vs deuterated surrogate peptide) Results  Client successfully utilized LC/MS/MS method in Phase I studies and moving to Phase II CORPORATE OVERVIEW
  7. 7. FORMULATION DEVELOPMENT FOR INSOLUBLE DRUGS Challenge More compounds in development with poor solubility • Roughly 65% of discovery compounds have solubility <100 µg/mL Solutions • Solid amorphous dispersion • Pharmaceutical co-crystals • Self-emulsifying and self-microemulsifying drug delivery systems, • Suspension or Emulsion Parenteral Dosage Form Results • Utilizing Quality by Design principles to create robust formulations • Enhanced drug permeability and delivery in-vivo CORPORATE OVERVIEW
  8. 8. CLINICAL - INTEGRATED OPERATIONS WITH FAST TURNAROUNDCase Study: Open-label single-dose, two-period crossover study toassess BE of test and reference formulations Contract signing to BA/PK data in less than 5 weeks; 60 subjects and nearly 3000 samples • Two-in-one method developed and validated within 2 weeks Contract signed: 14 Nov of contract signing (8 calendar days including Thanksgiving!). IRB submission: 15 Nov • 2949 samples analyzed Dec 15-19. No run failures occurred IRB approval: 21 Nov Subject screening: 22 Nov • 10 LC/MS/MS systems, 10 chemists, 34 runs FPFV: 03 Dec LPLV: 13 Dec • QC’d data Dec 21; QA’d data Dec 29. Samples Shipment: 14 Dec • Preliminary Bioequivalency Evaluation included with QC data BA/PK data to sponsor: 21 Dec TLFs to sponsor: 06 Jan • ISR– 300 analyzed with only 1 sample for analyte-1 and 7 samples for analyte-2 falling outside of the criteria (Guidance allows 15%). • Final Report to the client within agreed upon timeline and consistent with CLIENT’s STYLE GUIDE. CORPORATE OVERVIEW
  9. 9. FRONTAGE ACCELERATES SOLUTIONS  DISCOVERS solutions to tough technical challenges  DELIVERS high quality data on-time and on-budget  DEDICATES experienced personnel to projects for efficient execution www.frontagelab.com 1-610-232-0100 CORPORATE OVERVIEW

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