Download - Presentation China And Usa July 2011
CORPORATE OVERVIEW
FULL SERVICE US BASED GLOBAL CRO (973) 934-1171
CORPORATE OVERVIEW
FULLY INTEGRATED GLOBAL CRO
EARLY PHASE & BEYOND
Accomplish more with one service supplier• API Synthesis/Manufacturing • Preclinical / DMPK Services• Dosage Formulation Development • CTM Manufacturing • Clinical Study Execution in US and China• Bioanalysis & Biomarker / Immunology• Regulatory filing, GMP Consulting and Support
TargetDiscovery &Validation
HTSScreening Hits to Leads
LeadOptimization
DrugDevelopment
Candidate(ADMET)
RegistrationPhase I Phase II Phase III
•Expression analysis•In vitro function•In vivo validation•Bioinformatics
•Combinatorial chemistry•Structure-based drug design•In vitro, ex vivo & in vivo screening•HTS screening
•Traditional medicinal chemistry•Rational drug design•In silico drug design
•Medicinal chemistry•Rational drug design- Fast PK evaluation
•Bioavailability•Systemic exposure•Absorbance•Clearance•Distribution
- Safety- GMP Supplies- Regulatory- CMC consult
- Efficacy- GMP Supplies- Regulatory- CMC consult- Tech Transfer- Pharmacology
CommercialLaunch
CORPORATE OVERVIEW
FRONTAGE MILESTONES
20021 employee
2004 2006 2007 2008 2009 2011~250 employees
2010
Launch ofBeijing CMC Center
Launched Shanghai Facility
(Bioanalytical, Analytical Services)
LaunchedDMPK
Operations
AAALAC Certification
Expanded Analytical Services & CTM Mfg moved to Exton, PA
Launched Clinical Service Center in BeijingAcquired ABR CRO
Investment – Clinical Services with
ABR (CRO-1994)
Expanded Operations in Malvern, PA
(Bioanalytical, Analytical, PRD and API/Organic Synthesis)
InitiatedOperations in NJ
2009 Launched Zhengzhou Clinical
Center
CORPORATE OVERVIEW
OUR LOCATIONS
4
Two Countries One Quality SystemBeijing, PRC• Clinical Services• Regulatory Affairs• CMC Services(Analytical, CTM Manufacturing, PRD)
Shanghai, PRC• Bioanalytical • Biomarkers• DMPK• Analytical Services
Hospital based Phase I-IIa units 120-beds Zhengzhou University 80-beds The First Teaching Hospital of Jilin University 80- beds at Henan TCM University Hospital - Q3 11 80 - bed at Zhongshan University Hospital - Q1 12
Hackensack, NJ• 72- bed Phase I-IIa Clinic• Late phase clinical studies• Data management/support
Malvern / Exton, PA• Bioanalytical Services• DMPK / Biomarkers• CMC Services
CORPORATE OVERVIEW
API / Organic Synthesis
Pharmaceutical Analysis
Formulation Development
Clinical Manufacturing
GMP & CMC Consulting
Bioanalytical
DMPK
Biological / Immuno Assays
Biomarker Assays
CMC Drug Development
GLP
Preclinical/Bioanalytical Clinical
GCP
Clinical Studies Phase I/IIA
Data Analysis
Regulatory Affairs
GMP
Multiple Successful (10+) FDA Inspections
KEY SERVICE AREAS
A FULLY INTEGRATED GLOBAL CRO
•Helping US, EU and Chinese companies to introduce new products to the US marketplace, from IND submissions to NDA / ANDA filings
•Helping US and EU companies to introduce products to China
CORPORATE OVERVIEW
CMC SERVICES
API /ORGANIC SYNTHESIS• GMP Synthesis of Small Molecules• Reference Standard Synthesis• Metabolite ID and Synthesis• Impurity Identification and Purification Projects• Process Development & Optimization• Sourcing & Scale-up to Commercial
GMP CONTRACT MANUFACTURING - CLINICAL TRIAL MATERIALS•Oral Solid Dosage Forms
•Sterile Dosage Forms
•Topical Dosage Forms
•API’s via chemical synthesis
PHARMACEUTICAL ANALYSIS• GMP Analytical Services
>200 Method Development/Validation since 2008• Impurity Identification and Characterization
FORMULATION•Pre-formulation characterization/screening• Immediate and Controlled Release Development Expertise
CORPORATE OVERVIEW
CLINICAL SERVICES CLINICAL PHARMACOLOGY UNIT
Overview• 16 years of operational experience• Facilities in US and China• Full-time Principle Investigator with
Emergency Medicine background• BLS and ACLS trained staff• Close proximity to major medical center
Types of studies• First in Human
Single &multiple ascending dose• Absolute and Relative BA, fed /fasted BE,
food effect, PK/PD studies• Drug / drug interaction (DDI) and drug / alcohol
interaction studies• Thorough QT (TQT) and other cardiovascular
evaluations (Holter Gateway, etc)
CORPORATE OVERVIEW
United StatesOne of the largest Phase I research facilities in the NJ/NY metropolitan area
• 72-bed (hospital-type) facility
China Two SFDA certified hospital-based clinical centers, operated according to US standards
• 120-bed Chinese clinical center on the campus, The First Affiliated Hospital of Zhengzhou University (>4000 beds)
• 80-bed clinical center within The First Teaching Hospital of Jilin University with focus on phase I for oncology drugs (>3000 beds)
Coming this Q3 2011 and Q1 2012 respectively• 80- beds at Henan TCM University Hospital• 80-beds at Zhongshan University Hospital with focus on diabetic disorders and
oncology (>3000 beds)
CLINICAL SERVICES _ GLOBAL FACILITIES
CORPORATE OVERVIEW
CLINICAL SERVICES CRO SERVICES FOR PHASE I-IIA TRIALS
• Study Protocol Design• Project Management• Clinical Data Management (Oracle Clinical)• Biostatistical & Pharmacokinetic Analysis• SAS Programming• Medical Writing• Regulatory submissions
• Clinical Study Reports• PK Summaries• IND, IDE, NDA (505b1 and b2), PMA, ANDA
CORPORATE OVERVIEW
CLINICAL AND REGULATORY CONSULTING _ CASE STUDIES
Successful completion of the clinical pharmacology and biopharmaceutics sections of an NDA for a pharmaceutical company in Europe • Provided clinical pharmacology and regulatory consulting for a specialized U.S. pharmaceutical company • Contributed to discussions with the FDA review division to waive a TQT study for an NDA • Contributed to the preparation of meeting package and discussions at an EOP2 FDA meeting
Ongoing work with two major Chinese pharmaceutical companies for their respective first NME drug development in the United States • 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
Recent ANDA approval of Amlodipine Besylate for Beijing Second Pharmaceutical Co., Ltd. • Frontage was responsible for CMC development, bioequivalence studies, GMP Consulting, Facility Qualification, Quality System development, and regulatory filing for this ANDA project
Ongoing work with a startup biotech company in U.S. on its first biosimilar drug product indented for FDA submission
CORPORATE OVERVIEW
DMPK SERVICES
IN VITRO STUDIES • Metabolic Stability, Protein Binding, MDCK, CYP inhibition
etc
IN VIVO STUDIES (RATS AND MICE) – FAST PK• AAALAC Certified Vivarium• In-life + Bioanalytical Support + PK Report Using WinNonLin)
with a Turnaround time of 5 days after receipt of compound.
MASS BALANCE STUDIES• (C14 and tritium)
CORPORATE OVERVIEW
BIOANALYTICAL SERVICES
In 2010• Over 90,000 Samples Analyzed (GLP/Regulated)• Over 80 Methods Developed (GLP/non-GLP)• 80% Repeat Customers
One of the largest laboratories in the East Coast, USA and China
• 28 LC/MS/MS Bioanalytical systems linked to Watson LIMS system
• Industry-leading staff with advanced degrees• GLP and non-GLP Analysis
CORPORATE OVERVIEW
BIOANALYTICAL CAPABILITIES
Method Development/Validation and Sample Analysis in Compliance with FDA and GLP Guidance. • Track record of developing and validating difficult, highly sensitive methods • Development of stabilizing procedures for analyte with stability issues for
sample collection• Fast turnaround for preclinical and clinical sample analysis for TK, PK and BE
studies• Biomarker and immunogenicity method development/validations, PK, TK, PD
sample analysis• Integrated Services Between our Phase I Clinic and Bioanalytical labs
CORPORATE OVERVIEW
BIOLOGY SERVICES _ Large Molecules
• GLP Labs• Assay Development / Transfer /
Validation• Clinical / Pre-clinical Sample Testing • ADA – Anti Drug Antibody Assays
(Immunogenicity)• PK/TK – Pharmacokinetics Assays• NAB – Neutralizing Antibody Assays• Cell Based Assays• Biomarker Assays
EQUIPMENT LIST• PCR (AB 7900HT-Real Time PCR System)• MSD 6000• Spectramax• Abbott AxSYM System • Packard: Multiprobe II ex robotic liquid handling
system• Tomtec: Quadra-3-SPE • Tecan: Genesis freedom 200 • Watson LIMS Ver. 7.3• BIORAD CHEMI-Doc (quantitation of SDS-PAGE/WB)
CORPORATE OVERVIEW
FRONTAGE CHINA INTRODUCTION
CORPORATE OVERVIEW
FRONTAGE CHINA _ OVERVIEW
China operations (established 2006): • Shanghai, laboratories• Beijing, clinical services and regulatory affair, CMC center• Zhengzhou, clinical center
China services:• Bioanalytical, DMPK• Product development (formulation and pharmaceutical analysis)• Early and late phase clinical trials, clinical data management and
regulatory affairs
CORPORATE OVERVIEW
PEOPLE AND FACILITY
OVER 80 STAFF IN CHINA• Over 70% laboratory staff with advanced degrees (PhD, MD, Master)• All Director levels and above are trained either in the US or EU
EXPERIENCED MANAGEMENT TEAM WITH DIVERSE BACKGROUND • Pfizer, GSK, JNJ, Schering-Plough, etc.
STATE-OF-THE-ART FACILITY AND EQUIPMENT• 6 LC/MS/MS, MSD-6000• 10 HPLC, GC, IR, UV-VIS, dissolution• 5 stability chambers• Tablet press/coater, capsule filler, etc.• Clinical Research Center with over 300 beds
CORPORATE OVERVIEW
BIOANALYTICAL/DMPK
SUPPORT DMPK AND TK STUDIES FOR DRUG DISCOVERY, PRE-CLINICAL, CLINICAL AND BIO-EQUIVALENCY (BE) STUDIES
METHOD DEVELOPMENT AND VALIDATION FOLLOWING FDA, OECD, ICH GUIDELINES (2-3 WEEKS); CROSS METHOD TRANSFERRING AND VALIDATION BETWEEN US AND CHINA
ANALYZE SAMPLES IN DIFFERENT BIOLOGICAL MATRICES PLASMA, URINE, BLOOD AND TISSUES
BIOASSAYS TO SUPPORT LARGE MOLECULE DRUG DEVELOPMENT; BIOMARKER FOR DRUG SAFETY AND EFFICACY, DIAGNOSTICS, DISEASE MODELING AND CLINICAL STUDIES
CORPORATE OVERVIEW
PHARMACEUTICAL ANALYSIS
SUPPORT DRUG DEVELOPMENT FROM EARLY EXPLORATORY TO FULL DEVELOPMENT STAGES
WORK CLOSELY WITH CLIENT TO DEFINE• Stage oriented method development and validation• Stability testing strategy
ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND TESTING• For API, Drug Product, In-Process control• Experience in small molecules, peptides and proteins
STABILITY STUDY• Qualified stability chambers with 24/7 monitoring
REFERENCE STANDARD QUALIFICATION AND STRUCTURE ELUCIDATION
CORPORATE OVERVIEW
FORMULATION DEVELOPMENT
FORMULATION DEVELOPMENT AT ALL STAGES: FROM INITIAL CONCEPT TO COMMERCIALIZATION
• Pre-formulation and formulation for preclinical, clinical, and ANDA studies
VARIOUS DOSAGE FORMS• Solid: tablets, capsules• Liquid: solution, suspension, emulsion for oral and parenteral
administration
RELEASE PROFILE: IMMEDIATE, DELAYED, EXTENDED COATING: FILM, ENTERIC, CONTROLLED RELEASE
cGMP CLINICAL TRIAL MATERIAL MANUFACTURING (SOLID AND STERILE DOSAGE FORMS)
CORPORATE OVERVIEW
CLINICAL SERVICES
CLINICAL TRIAL MANAGEMENT UNDER GCP GUIDELINES• Two SFDA certified hospital-based clinical centers, operated according to US standards
• 120-bed Chinese clinical center on the campus, The First Affiliated Hospital of Zhengzhou University (>4000 beds)
• 80-bed clinical center within The First Teaching Hospital of Jilin University with focus on phase I for oncology drugs (>3000 beds)
• Coming this Q3 2011 and Q1 2012 respectively• 80- beds at Henan TCM University Hospital• 80-beds at Zhongshan University Hospital with focus on diabetic disorders and oncology (>3000
beds)
DATA MANAGEMENT AND BIOSTATISTICS• Oracle, SAS programming, ECTD, EDC applications, web-based study tracker Regulator strategy and
filings• Regulatory filings for new drug application • Import product registration (IDL, CPP),drugs, medical devices, diagnostic kits
MEDICAL WRITING, STUDY FEASIBILITY, MARKETING REVIEW• Medical writing• Feasibility and marketing review for foreign products registration for China market
CORPORATE OVERVIEW
QUALITY SYSTEM
TWO COUNTRIES, ONE QUALITY SYSTEM WITH CONTINUOUS IMPROVEMENT, WORK UNDER GLP/GMP/GCP/ICH GUIDELINES
ONGOING TRAINING PROGRAM AND INTERNAL AUDIT PROGRAM
CONTROLLED DOCUMENTATION SYSTEM, MATERIAL HANDLING SYSTEM, INSTRUMENT QUALIFICATION/CALIBRATION SYSTEM
SUCCESSFUL INSPECTIONS BY CLIENTS SINCE 2006 (US FDA AUDITED MARLVEN SITE MORE THAN 10 TIMES)
CORPORATE OVERVIEW
STRENGTH OF FRONTAGE CHINA
UNIQUE BUSINESS MODEL• Services provided in China are the routine services provided in the US
TWO COUNTRIES ONE SYSTEM• Using same quality system, same SOPs and same management system
CROSS METHOD VALIDATION• Controlled cross validation in support of multicenter clinical studies
FULLY SUPPORTED BY US TEAM
CORPORATE OVERVIEW
Thank YouRoseann Affinito
Business Development Manager – NJ
Phone: (973) 934-1171