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Company Introduction

Company Introduction. THE FRONTAGE ADVANTAGE. Attention, Efficiency, and Expertise. Who is Frontage Laboratories?. We are an early phase drug development company Started in 2002 Currently 225 people We have grown organically and through acquisition (clinical)

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Company Introduction

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  1. Company Introduction

  2. THE FRONTAGE ADVANTAGE Attention, Efficiency, and Expertise

  3. Who is Frontage Laboratories? • We are an early phase drug development company • Started in 2002 • Currently 225 people • We have grown organically and through acquisition (clinical) • selected as one of the fastest growing companies in the Philadelphia region – 4 years in a row • Facilities in US and China

  4. Working with Frontage:Advantage #1 – Expediting your development program • ACCOMPLISH MORE WITH ONE SERVICE SUPPLIER • Frontage has all that you need to move your compound from preclinical development through Phase I – II clinical studies and beyond • API synthesis • Preclinical / ADME Services • Dosage form development • GMP manufacturing • Clinical study execution via 72-bed CRU • Bioanalysis & Biomarker / Immunology • Regulatory filing and support

  5. Working with Frontage:Advantage #2 - 100% Attention • WHAT SETS FRONTAGE APART?? • Every project is on the front burner – 100% attention • Communications are easy to manage, coordinated, and routinely scheduled • Our project management leaders each have a minimum 15 years experience in the industry – You receive the best project leadership possible • Cross functional project teams allow for smoother working process and less administration • WE WORK HARD TO MAKE SURE YOUR COMPOUND IS FRONT AND CENTER !!!

  6. Working with Frontage:Advantage #3 – Top Scientific Team • YOUR DRUG DEVELOPMENT PROGRAM REQUIRES THE BEST TALENT • Frontage has a significant number of advanced-degree scientists – >60% of our team • Extensive personal experiences in all phases of drug development – from discovery to clinical, from laboratory to commercial launch • Involved in numerous preclinical, first-in-man, late stage clinical, generic and OTC development projects

  7. Working with Frontage: Advantage #4 – Frontage US –China Operation • QUALITY • Globally managed, centralized data (all sites WATSON LIMS) • Globally managed Quality System • SCIENCE • Frontage has the best training system in the industry • Management team has international experience • Scientists receive international training, working hands-on at US facilities • Uniform testing platforms and ability to pool resources to ensure best scientific coverage • Established method transfer procedures • LOGISTICS • Continuity of Service is guaranteed by Frontage – if there are any potential shipment issues to China, US laboratory will serve as back-up facility

  8. FRONTAGE - BACKGROUND Service Offerings

  9. Our Locations

  10. Our Clients More than 200 clients around the world: US, EU, JP, China Global top 10, mid-size and virtual pharmaceutical and biotech firms Chinese generic and innovative drug companies Frontage has had successful FDA inspections (10+) and numerous client inspections and audits for both our US and China facilities

  11. DMPK Preclinical ServicesOverview • WORLD-RENOWNED LEADERSHIP • Accomplished team of professionals • Thought leaders in drug metabolism - over 100 years of collective experience in DMPK and ADME support and published research • DMPK Services • Support for discovery pharmacokinetic studies • Discovery-stage in-vitro studies metabolism evaluations • Discovery-stage ADME studies • Drug development stage DMPK support and metabolic evaluations • EFFICIENT SYSTEMS • Technical leadership allows for quick completion of studies • Price leadership • Capabilities in US and China

  12. Discovery DMPK Services:PK Studies DT Exploratory Discovery Pre-Selection Lead Candidates PK in Pharmacology Model(s) Help with POC, MED exposure In-Life and Non-GLP Bioanalytical • PK/PD Biomarker Assessment • PK in Other Species including Rodents and Non-Rodents(As Needed) • PK in Non-Rodent • Target Tissue Exposure(Total and Free) • High-dose Pharmacology Support • Salt Selection • Linearity Assessment • Renal/Biliary Clearance(As Needed) • Ascending Dose PK Rodent andNon-Rodent • TK and Formulation Support • Additional Species PK • Food Effect • Interspecies Scaling

  13. Discovery DMPK Services:In-Vitro DMPK Studies DT Exploratory Discovery Pre-Selection Lead candidates • Metabolite Profiling/ • Structure Elucidation • - metabolic soft spots • - structure optimization • Metabolic Stability • (microsomes / hepatocytes) • Metabolism in human • plateable hepatocytes • Metabolic pathways • elucidated • Cross-species metabolism • (microsomes/hepatocytes) • Identification/isolation of • major human metabolites • Plasma Profiling/ • - pharmacology species • - PK and tox species • (rodents, dogs, monkeys) • Intrinsic Clearance • CYP IC50/MBI • Plasma/Microsomal Protein Binding • Blood/Plasma ratio • CYP Reaction Phenotyping • P-gp Transport/ Inhibition • CYP Induction(PXR/Human Hepatocyte) • Caco-2/MDCK permeability

  14. Drug Development Phase DMPK:Metabolite Studies Phase 2 to Post-NDA POC NDA Phase 0 IND Phase 1 SAD & MAD • In vitro metabolism - [14C] compound • Single dose 14C metabolism and mass balance (rodent andnon-rodent) • Multiple dose metabolite profiles from IND enabling studies • Enzyme induction(ex vivo), if needed • Mechanistic studies to support safety assessment(as needed) • Metabolite profiles from SAD/MAD studies • Determination of exposure of major human metabolites in tox species • DDI support and kinetic assessment of metabolite formation [14C] in vitro • Tissue distribution, brain penetration/target tissue uptake • 3H mass balance and tissue distribution • Human [14C] ADME study • Metabolism support of clinical studies (DDI, pediatric, elderly, hepatic/renal, QTc, etc.) • Placental transfer, milk excretion

  15. Discovery ADME Studies • Metabolic stability (2 time points) – microsomes / hepatocytes • Intrinsic clearance – microsomes / hepatocytes • In-vitro metabolite identification for structural optimization • Cross-species metabolite profiles across species – microsomes / hepatocytes • CYP-450 inhibition – LC/MS/MS based assays (available May 2010) • CYP reaction phenotyping – cDNA • Plasma protein binding

  16. Discovery ADME Studies • Plasma metabolite profiling • Plasma/blood partitioning studies • Isolation and characterization of metabolites • In-Life PK studies (in-life conduct through partners – internal small mammal capabilities available June 2010) • CACO-2 / MDCK permeability studies (available July 2010) • Quantitative LC/MS analysis (non-GLP) from PK studies

  17. Development DMPK Studies • Reaction phenotyping (cDNA & chemical inhibition) • Metabolite profiling and identification – Tox/FIH studies • Isolation and characterization of metabolites • Delineation of metabolic pathways • CYP inhibition studies. Definitive IC50 & k1 determinations (April 2010) • CYP induction in livers of rodents, canines & primates (June 2010)

  18. Development ADME Studies • Synthesis of metabolites and stable-labeled materials • The Frontage team has specific expertise for development of Metabolites In Safety Testing (MIST) packages. • Identification of metabolites • Quantitation of metabolites • AUC determinations (using non-radiolabeled compounds) • Mass balance studies in rodents – 14C and 3H and tissue distribution studies will come on line second half of this year

  19. DMPK Leadership Team • Abdul Mutlib: Twenty years of experience in pharmaceutical industry, • (PhD) DuPont-Merck, Pfizer, Hoechst-Roussel (Aventis), Wyeth • Five years post-doc in academia, 60+ publications, patents • Editoral Board: Chemical Research in Toxicology • Jack Wang: • Jim Burleigh: Experienced technical supervisor with over 25 years of experience • (BS) in conducting ADME studies in laboratory animals • Peter Liu: Experience in developing, validating and implementing complex (MS) LC/MS/MS assays for the quantitation of drugs in biological matrices in a GLP, GLP-like and non-GLP environments. Twenty • years experience in bioanalysis.

  20. DMPK Leadership Team

  21. DMPK Leadership Team continued:

  22. Bioanalytical Services • INDUSTRY - LEADING TECHNICAL CAPABILITIES • Highest ratio of advanced degreed scientists working on the bench • From data management and sample handling to analysis platforms, Frontage has invested in state-of-art technology, including global Watson LIMS system • Streamlined method development - typically completed within 1 week • Analyte stabilization techniques help Frontage to overcome tough technical challenges – prevents degradation of analytes • One of the largest laboratories on the East Coast, USA and China • EFFICIENT PROJECT MANAGEMENT • Global study support • Over 35,000 samples analyzed per month in US and China

  23. Bioanalytical Services • LC / MS / MS

  24. Bioanalytical Services • GC & LC/MS/MS METHOD DEVELOPMENT & VALIDATION • Demonstrated success in developing methods for compounds requiring high sensitivity measurements (picogram / mL) • Small and large molecule analysis • One of the most proficient labs in US and China – tackling technically challenging projects globally • IMMUNOASSAY DEVELOPMENT & VALIDATION • MSD Electrochemiluminescence Platform • ELISA • Antibody and platform development • BIOMARKER ASSAY DEVELOPMENT & VALIDATION

  25. State-of-Art Equipment and Processes • 17 LC/MS/MS systems in USA (10 API 4000, 3 API 5000, 3 4000 API Q-trap, API365), • 6 LC/MS/MS in China (4 API 4000, 1 API 5000, 1 API 4000 Q-trap) • More than 30 HPLC systems • 3 MSD Electro-chemilluminescence Instruments • Watson LIMS system – centralized data for US and China • Tomtec and Tecan Liquid handling systems • Ultrasonic Tissue Processing Equipment • Emergency Power Back up • Monitoring system for storage freezers

  26. State-of-Art Equipment and Processes High Throughput Sample Preparation

  27. State-of-Art Equipment and Processes Electrochemiluminescence – Large Molecule Analysis

  28. State-of-Art Equipment and Processes Covaris Ultrasonic Extractor – Tissue Processing

  29. Exton CMC Facilities • Analytical Labs– 8,000 Sq Ft • GMP Analytical Instrumentation • ICH Stability Storage • Formulation Development & GMP Area ( 10,000 Sq Ft) • Solids R&D • Liquids / Creams / Ointments R&D • Potent Compounds suite (GMP) • Solids Dosage Manufacturing (GMP) • Liquids / Creams / Ointments (GMP) • Sterile Compounding (GMP)

  30. CMC Services - Analytical • GMP & GLP ANALYTICAL SERVICES • Method Development, Validations and Transfers • HPLC (25 systems), UPLC, GC, LC/MS/MS, GC/MS • ICH Stability Evaluations – over 4,500 cubic feet of storage • Standard and Custom Conditions • Dissolution Testing • Comparator Study Capability with On-line HPLC & UV • Unknown Impurity Identifications • Fraction Collection, Purification, Synthesis, ID by MS & NMR • Finished Product Release Testing & Customer Complaint Investigations – CTM and Commercial Products • Particle Size Analysis and Wet Chemistry

  31. Analytical Equipment • 25 HPLC Systems – UV/PDA, CAD, Refractive Index, Fluorescence • Three vendor platforms for ease of method transfer / robustness (Waters, Agilent, Shimadzu) • UPLC Systems – PDA and MS • 3 GC Systems – FID with Headspace • Ion Chromatography (Dionex) • LC/MS/MS and GC/MS - Impurity ID • 10 Dissolution Systems • with on-line HPLC and UV analysis • Particle Size Analysis & Wet Chemistry (KF, Titrations)

  32. CMC Services - Stability • Stability Chambers Are Fully Compliant With ICH Guidelines • 7 Walk-in Stability Chambers And 5 Reach-ins With Over 4,500 Total Cubic Feet • Smaller Chambers And Photo stability Chamber For Special Studies • Lab Watch Monitoring System • Emergency Back-up Power Generator for continuous operation

  33. CMC Services - Formulations • FORMULATION DEVELOPMENT • Rational Development Processes (CTD / QBR formats) • Pre-formulation characterization and screening • Physicochemical evaluations • Excipient compatibility • Immediate and Controlled Release Development Expertise • Oral Solid Dosage Forms – Immediate and Controlled delivery systems • Sterile – Parenteral, Lyophilized, & Ophthalmic Forms • Creams, Ointments and Gels • Nasal Sprays (including characterization – droplet size, geometry • High Potency Suites • Proof of Concept Studies in Animals via China facilities • Process Optimization and Improvements

  34. Clinical Manufacturing • Phase I –II Scale • Full Range of Capabilities • Oral Solids -High Shear, • Encapsulation, Compression, • Tablet Coating, Fluid Bed • Sterile manufacturing • utilizing disposable bag system • Semi Solids • Liquids capabilities to 100 L • High Potency Suites

  35. CMC Services • GMP CONTRACT MANUFACTURING – CLINICAL TRIAL MATERIALS • Oral Solid Dosage Forms • API filling in Capsules – Accurate Dosing System • Standard Tablet and Capsule filling • Tablet in Tablet technology (Tri-layer Tablet Press) • Liquid – filled Capsules • Enteric Coating • Sterile Dosage Forms • Aseptically-filled vials using disposable mixing and filling technology • Nasal Sprays • Suspensions • Topical Dosage Forms • Creams, Ointments, Gels • API’s via chemical synthesis

  36. CMC Services • API SYNTHESIS AND RESEARCH CHEMISTRY • GMP Synthesis of Small Molecules – up to 5 kg scale • Reference Standard Synthesis • Metabolite Synthesis & Cold Labeling • Impurity Identification and Purification Projects • Process Development & Optimization • Sourcing & Scale-up to Commercial

  37. Collaborations • BEIJING PHARMACEUTICALS GROUP • Large Scale, FDA-inspected GMP manufacturing • PIERRE FABRE (FRANCE) • Patented Nanotechnologies for enhancing bioavailability of low permeability / low solubility drugs • Taste masking of bitter API’s • HERAEUS (GERMANY) • Cytotoxic API Manufacturing via chemical synthesis and fermentation • SINCLAIR RESEARCH (MISSOURI) & CALVERT LABORATORIES (PA) • GLP Preclinical research centers • PRECLINICAL RESEARCH CENTERS IN CHINA • Frontage - supervised studies for non-GLP evaluations

  38. Biomarkers & Biologics • Frontage Laboratories will provide a full range of technology platforms, flexibility and customization to meet all your Biomarker and Biological Analytical requirements across various stages of preclinical & clinical development • Our collective experience ranges from all phases of drug development • Our team can provide guidance on issues that range from assay development, validation to biomarker, Pharmacokinetics and Immune response analysis • Comprehensive portfolio of technology platforms to accommodate virtually all of your biomarker testing requirements • Flexibility in choosing from assays commercially available or previously developed. We also work with you to develop and validate custom assays • 21CFR Part 11 compliant (adherence to 21 CFR Part 58 GLP)

  39. Biomarker and Biologics

  40. Immunoanalytical Testing (Ligand-Binding Assays)

  41. Specialized Assays & Services

  42. Biologics: Assays & Services

  43. Biologics: Assays & Services CELL-BASED ASSAYS (PRE-CLINICAL AND CLINICAL) • Potency assay • Cytotoxicity and Proliferation assays • Immune function assays • Flowmetric assays • Tissue processing/staining for IHC • Custom assay development for client needs USA AND CHINA • Frontage provides these services at both facilities • Possible expansion to other countries

  44. US Clinical Research Center: Background • Founded in 1994 – 16 year track record of service excellence • 72-bed unit located in Hackensack, New Jersey • On-site, full-time principal investigator with 20 years of emergency medicine experience • Phase 1 and 2a studies • On-site pharmacy (temperature controlled, limited access) for study drug storage, packaging / labeling and retention • Extensive subject database (healthy volunteers / special populations) and dedicated recruiting staff • Local clinical laboratory with 24-hour turn-around • Central IRB (rapid review process)

  45. Clinical Research Centers:Phase 1 and 2 Studies • PHASE 1 AND 2A STUDY EXPERIENCE • First-in-human • Pharmacokinetics • Single dose escalation / repeated dose • Absolute and relative bioavailability • Bioequivalence studies (pilot, pivotal, fed, fasted) • Drug-drug interaction (DDI), drug-alcohol and drug-food interaction studies • Oral, injectable, inhaled, intranasal NCEs, peptides, hormones • Thorough QT (TQT) study evaluations • PD assessments / Biomarkers Safety and tolerability assessments

  46. Clinical Research Centers:Subject Recruitment • Proactive recruitment planning & execution • Extensive volunteer database (5000+ subjects) • Wide-ranging media options – newspapers and local publications, employment guides, local flyers and postings, radio • Local networking – schools, businesses, health fairs • Dedicated recruiting staff

  47. Clinical Research Centers:Proof-of Concept Studies • Proof of concept studies • Cardiovascular – endothelial dysfunction, HTN, early CV disease (Endo-PAT vascular compliance devices) • Metabolic – Type 1 and 2 DM, obesity, metabolic syndrome, dyslipidemias (dietician, on-site Hologic Dexascanner) • Gastroenterology – sigmoidoscopies, colonoscopies, gastroesophageal reflux, irritable bowel syndrome, diarrhea • Women’s health – pre- and postmenopausal women, osteoporosis, hormone replacement, sexual dysfunction • Men’s health – testosterone replacement, osteoporosis, sexual dysfunction • Dermatologic – acne, actinic keratosis, psoriasis • Inflammation – osteoarthritis, rheumatoid arthritis • Ophthalmologic assessments • Cognitive assessments • Excellent access to specialty physicians as needed

  48. Clinical Research Centers:Study Time Lines • Rapid IRB submission process (Central IRB) • Study-specific approval typically within 8 business days of submission • Able to begin screening immediately with IRB-approved generic ICF • Dosing within 3 weeks of contract execution • Same-day shipment of plasma samples from CRC to Frontage BioA laboratory • Prompt (within 48 h) report of preliminary PK/BE results

  49. Clinical Research Centers:Study Metrics Since 2006, we have performed: • Over 25 bioequivalence studies (pilot and pivotal) • 2-way and 3-way cross-over • Fed and Fasted • Over 700 healthy male/female volunteers enrolled • Enrollment rate >98% • Completion rate >90% • Over 25 Phase 1 studies • Over 1000 healthy male/female volunteers and special populations enrolled • First-in-human, single and multiple dose, bioavailabilty, formulation, DDI, PK, safety/tolerability • Enrollment rate >98% • Completion rate >93%

  50. Clinical Services Moving Forward • New US clinic to be constructed • 160-bed state-of-the-art Phase 1 clinic • Northern New Jersey location • Access to public transportation and diverse subject population • Ability to run 3 separate 24/36 subject panels simultaneously • Separate area with hospital beds • Operational 24 hours per day / 7 days per week • On-site pharmacy (storage/preparation/retention) • Flexible site use / expanded recreation & dining areas • Expected to be operational Q2/Q3 2010 • 2009: 120-bed clinic became operational in Zhengzhou, China

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