CORPORATE OVERVIEW

Ron ConnollyOctober 1, 2012

Accelerating Development

CORPORATE OVERVIEW

Frontage Snapshot-An Integrated R&D outsourcing company

Service Offerings Preclinical through clinical-stage

drug development and clinical services:

• DMPK, • Biologics & Bio-analytical Services • CMC - drug development • Clinical studies and biometrics

Employees 280+ employees - Close to 70% of scientist team with advanced degrees

Facilities

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)• 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)

Customers Over 200 customers (>85% returning) mainly in the US, EU, Japan and China:

• 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

Locations Headquartered in Exton, Pennsylvania, U.S.A. (Established 2001) New Jersey, Shanghai, Beijing, Zhengzhou, Changchun

CORPORATE OVERVIEW

STRATEGIC LOCATIONS

3

US and China: Round-the-Clock OperationsBeijing, PRC• Clinical Services• Regulatory Affairs• CMC Services• GMP Consulting

Shanghai, PRC• Bioanalytical • Biologics• DMPK• Analytical Services

Hospital based Phase I-IIa units 120-bed Zhengzhou University 82-bed The First Teaching Hospital of Jilin University 50-bed Nanjing City First Hospital

Hackensack, NJ• 88-bed Phase I-IIa Clinic• Late phase clinical studies• Data management/support

Exton, PA (2 locations)• Headquarters• Bioanalytical/Biologics• DMPK• CMC Services

(API, Analytical, PRD, CTM mfg)

• Regulatory Affairs• GMP Consulting

CORPORATE OVERVIEW

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

LC/MS/MS QUANTIFICATION OF ANTIBODY IN SERUM AND CSF

ELISA assay sensitivity

(LLOQ of 6 ug/mL),

primary Ab was limited.

Target LLOQ:

Serum assay = 500 ng/mL,

CSF assay = 5 ng/mL

A Humanized IgG1 mAB developed as a potential therapeutic agent for Alzheimer disease (AD)

IgG1 mAB

Challenge

CORPORATE OVERVIEW

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)

ALTERNATIVE LC-MS/MS ASSAY STRATEGY

Solution

Results

Client successfully utilized LC/MS/MS method in Phase I studies and moving to Phase II

CORPORATE OVERVIEW

FORMULATION DEVELOPMENT FOR INSOLUBLE DRUGS

More compounds in development with poor solubility•Roughly 65% of discovery compounds have solubility <100 µg/mL

Challenge

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

CLINICAL - INTEGRATED OPERATIONS WITH FAST TURNAROUND

• Two-in-one method developed and validated within 2 weeks of contract signing (8 calendar days including Thanksgiving!).

• 2949 samples analyzed Dec 15-19. No run failures occurred

• 10 LC/MS/MS systems, 10 chemists, 34 runs

• QC’d data Dec 21; QA’d data Dec 29.

• Preliminary Bioequivalency Evaluation included with QC data

• 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.

Contract signed: 14 Nov

IRB submission: 15 Nov

IRB approval: 21 Nov

Subject screening: 22 Nov

FPFV: 03 Dec

LPLV: 13 Dec

Samples Shipment: 14 Dec

BA/PK data to sponsor: 21 Dec

TLFs to sponsor: 06 Jan

Case Study: Open-label single-dose, two-period crossover study to assess BE of test and reference formulations Contract signing to BA/PK data in less than 5 weeks; 60 subjects and nearly 3000 samples

CORPORATE OVERVIEW

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