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“Helping make new drugs happen… at the speed of science ” “Helping make new drugs happen… at the speed of science Formatech

Marketing II: Indu Isaacs

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Page 1: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

“Helping make new drugs happen… at the speed of science ”

Formatech

Page 2: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

About Us• Lowell: Wannalancit

• Focused on Formulation and Analytical Development for Biologics

Page 3: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

• Pre-Formulation/Formulation Development

• Dosage Form Development• Lyophilization Development• Analytical Development & Validations• Cell Culture Development• Purification Development

Contract Development Services

Page 4: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

About Us

ANDOVER• Construction of CGMP

Aseptic Fill/Finish facility began in 2000 in Andover

• CGMP Aseptic Manufacturing suite March 2001

• 35,000 ft2 Facility & ~ 75 Staff

Page 5: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

• CGMP Manufacture of Aseptic products for clients in US, Canada, Israel, Australia, NZ, UK, Germany, & Japan.– Materials for Toxicological

testing– Clinical Trials (Phases I, II

and III)

Contract Manufacturing Services

Page 6: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Experience

We have assisted clients with projects in all stages of the regulatory

process:• Discovery

• Pre-clinical

• Clinical

• Post Approval

Page 7: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Corporate Objective

• Customer Service, Satisfaction, and Loyalty

• Quality• Productivity/Capabilities/

Efficiency

Page 8: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Mission

“Making a Difference”

Page 9: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Logo

Page 10: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Motto

Doing whatever it takes to build client relationships and ensure repeat business!!!

Page 11: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Goal: Meeting Expectations

Corporate• Time-to-

Clinic

• Time-to-Market

Agency• Consistent

Process

• Stable Dosage Form

Page 12: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Successes!!•FDA inspected GMP Facility May 2003, July 2005 (No 483’s)• MHRA inspected & letter of EU GMP compliance (1st in the US) (3 times)• 200+ manufacturing clients globally•Synagis® and Humira® Development• High antibody concentration formulations• Orally Bioavailable Peptide in a capsule• Solubilization of Insoluble molecules

•IP Spun off as neuMirRx

Corp

Page 13: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Tag line

“Helping make new drugs happen… at the speed of science”

Page 14: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Our Strategic Advantage

• Management Strength and Vision• Manufacturing and Development• Proven Track Record• Strong Global Marketing & Clientele

Page 15: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Contract Services

Out-License Technology

In-License Products

The Golden Key

Management: Vision

Page 16: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

PERFORMANCE

Page 17: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

Performance

Page 18: Marketing II: Indu Isaacs

“Helping make new drugs happen… at the speed of science ”

“Helping make new drugs happen… at the speed of science ”

Formatech