Global Drug Development Services

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Global Drug Development Services
Frontage Laboratories, Inc. 105 Great Valley
Parkway Malvern, PA 19355 www.frontagelab.com (610
) 232-0100
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Who We Are
A Contract Research Organization providing global
drug development services for pharmaceutical and
bio-tech industries

• Started operation in 2002 One of the most
  rapidly growing private-held companies in
  PA/NJ/DE (2006, 2007 and 2008 by Philadelphia
  100)
• Dedicated Experienced Team employed more than
  200 experienced scientists in USA and China
• Seven state-of-the-art facilities and equipment
  (GLP/GMP/GCP compliance) providing high quality
  services to our global clients and collaborators

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Where We Are Located
3 sites in China
2 sites in PA, USA
2 sites in NJ, USA
Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
4
Our Team

• More than 90 chemists, pharmacists, chemical
  engineers and biologists in US-PA facilities --
  60 of them have advanced degrees
• Pharmaceutical development experiences gained at
  Pfizer, Wyeth, GlaxoSmithKline, Aventis, Elli
  Lilly, Novatis, AstraZeneca, Johnson Johnson,
  and more
• Our teams have worked in every phase of drug
  development discovery, development,
  preclinical, clinical, NDA and ANDA filing,
  process validation and launch for branded and
  generic products
• Our scientists have experience in the development
  of small molecule drugs and biologics

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Our Services

• Bioanalytical/DMPK Services
• Pharmaceutical Analysis
• Formulation Development
• API / Organic Synthesis
• Regulatory Affairs
• Preclinical research
• Clinical studies
• In vitro ADME
• Bioassay Services
• cGMP manufacture

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Operation Systems

• Quality system (GMP/GLP/GCP)
• Training system
• Project management system
• Sample tracking system
• Data handling and archiving system

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Quality System

• Quality Assurance Unit operates as an independent
  group reporting to the CEO
• SOPs generated to reflect clients needs as well
  as Frontages expanding service areas
• Comprehensive GMP/GLP/GCP training curricula and
  hands-on technical training program for
  qualification of scientists
• Successful FDA audits (2004, 2006, 2007 and 2008)
• Frequent client audits (3-4 times/month)

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
8
Bioanalytical Services

• 25 LC/MS/MS systems (API 4000, API 5000 and
  Q-Trap), 19 in US lab and 6 in China Lab
• Specializing in the development and validation of
  very sensitive methods and methods for unstable
  drugs/metabolites
• Fast turn around (10,000 samples QA reviewed
  within 4 - 6 weeks of receipt)
• Provide support for preclinical and clinical
  studies

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
9
Pharmaceutical Analysis

• Method development/validation
• API and finished product release testing
• Pre-formulation testing solubility, stability,
  log P
• Stability studies of API and finished products
• Dissolution testing
• Reference standard qualification
• Forced degradation studies
• Unknown impurity identification
• USP/EP/BP/JP testing

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
10
Stability Studies and Capacity

• Stability chambers are fully compliant with ICH
  guidelines
• 7 walk-in stability chambers with 3,900 total
  cubic feet
• Smaller chambers and Photostability chamber for
  special requirements
• Emergency back-up power generator for continuous
  operation

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Formulation Development

• Pre-formulation screening and measurement of
  physical / chemical properties
• Expertise in various liquid and solid dosage
  forms
• RD / Pilot scale equipment
• Clinical study compounding for customized dosing
  of finished products
• Experience in successful technology transfer for
  manufacturing
• cGMP manufacture for clinical trial supplies
  (Solid dose and injectable)

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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API and Organic Synthesis/Sourcing

• Fully functional organic synthesis laboratory
• HEPA filtered supply air
• Kilo lab GMP capacity DMF filing in 2005
• Automated flash chromatography for impurity
  identification and reference standard
  preparations

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Clinical Studies

• A 72-bed clinical research center capable for BE
  clinical pharmacology and Phase I and II
  studies
• A experienced Clinical Research Organization
  for Phase I IV clinical trials
• Clinical study designing and monitoring
• International project management
• Clinical data management, biostatistics and
  regulatory submission
• Clinical operation in China

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
14
Preclinical Research

• All species and dosing routes
• Fast turn around, high quality and significant
  low cost
• Conducting studies either in the US or China
  upon clients preference
• Preclinical Services
• PK/PD/ADME (microsomes and hepatocytes)
• General toxicology and immunogenecity
• Safety pharmacology (cardiovascular, CNS)
• Efficacy studies (CV, oncology, inflammation,
  metabolic disorders)
• Customized animal model development

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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BioAssay Services

• Assay development and sample analysis for
  biomarkers and biologics for drug safety and
  efficacy, diagnostics, disease modeling and
  clinical studies
• Working with the protocol you provide or the
  protocol we design for you based upon your
  requirement
• Techniques available for target validation

• Immunoassays with commercially available kits
• Immunoassays with customized detection systems
• Immunoblotting/WB
• Genotyping
• LC/MS/MS techniques
• GC techniques

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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Operations in China

• Frontage (Shanghai) Laboratories, Inc.
• US European trained leaders and local recruited
  scientists
• Successful inspection/audit by our global clients
  and sponsors
• Bioanalytical, Analytical, Formulation
  Development, ADME and Bioassays
• Frontage (Suzhou) Preclinical Center
• Large species animal resources
• Specialized on non-clinical studies in large
  species including NHP, dogs and minipigs
• Frontage (Beijing) Clinical Services
• Data management and biostatistics
• Clinical trial monitoring, coordinating and
  management

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com
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• Thank you for allowing us to share in your
  mission!

Frontage Laboratories, Inc. Telephone
[phone] Fax [phone]
www.frontagelab.com