avara corporate capabilities presentation 11-8-16
TRANSCRIPT
Avara Capabilities Presentation
Experience At Your Side
October 2016
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Contents
Experience Avara• Introduction
• Leadership Team
The Avara Promise
Experience The Difference
Avara's Capabilities • Overview
• Primary Manufacturing
• Secondary Manufacturing
• Packaging
Customer Profile
Avara's Locations
• Arecibo, Puerto Rico
• Shannon, Ireland
• Norman, Oklahoma
• Avlon, United Kingdom
• Norwalk, Connecticut (headquarters)
Avara and You
Thank You
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Experience Avara
We are led by a highly experienced management team comprised of industry veterans
Our company mission is to consistently deliver on our commitments
We offer a global network of world-class facilities with proven commercial records
We put value on people to retain long-tenured staff so institutional expertise remains embedded at our facilities
We are flexible to your needs, merging the agility of a nimble provider with the qualities of a large company
Avara Pharmaceutical Services is a CDMO set up specifically to focus on customers and deliver a world-class outsourcing experience.
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Experience Our Team
Tim Tyson – Chairman & CEOOver 35 years leading pharma businesses and contract providers – instrumental in bringing more than 50 medicines to market.
Jim Scandura – Director & COOManaged three major manufacturing network change programs, over 30 site audit and operational improvement efforts, and integration of an R&D center and manufacturing sites.
Keith Lyon – Director & CFOCareer experience with several buyouts, three public offerings, and C-Suite or Treasurer roles including Nestlé, First Chicago Bank, Duracell, and Estée Lauder.
Bill Pasek – Chief Commercial Officer25 years of experience in sales leadership including GSK, Sunovion, and Quintiles
Don Britt – Chief Quality Officer40 years of experience in quality / regulatory, including GSK, Abbott Labs, Bayer, and Sanofi-Aventis
Rick Mark – Chief HR OfficerLed Human Resources in 5 industries, with HR due diligence resulting in $1B in acquisitions
Avara was founded and is run by a team of industry veterans who have been on both sides. We know how to deliver an exceptional CDMO experience to you.
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The Avara Promise
One of the CDMO market’s most experienced leadership teams
Systemic commitment to on-time, in-full delivery at a fair price
World-class facilities, proven commercially to meet the highest quality and reliability standards
Long personnel tenure at all facilities, delivering experience, institutional knowledge and consistency
Flexibility based on intently listening to customers, and the agility to respond quickly
Transparency in communications, and overall integrity that drives trust
We will provide a world class, customer-oriented CDMO experience and deliver on our commitments. The foundation of this mission is based on:
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Experience The Difference
Flexible manufacturing footprint across Europe and North America, comprising a portfolio of commercially-proven facilities
Operational excellence and a compliance-oriented quality program based on Lean Six Sigma methodologies
Regulatory support and delivery covering more than 100 international markets
Commitment to listening to customers’needs and the flexibility to align with them and deliver on our commitments
Optimization through industry best practices including continuous improvement
We offer primary and secondary manufacturing with integrated packaging, supplying drug substance and drug product from world-class facilities
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Capabilities Overview
cGMP development, scale-up and supply of APIs, including hazardous materials
Clinical and commercial-scale supply of solid dose drug product, including high potent capabilities
Integrated packaging & supply chain support
Development support – process optimization, analytical methods, and release / stability testing
GRANULATIONBroad experience with tech transfers, commercialization and product launches
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Primary Manufacturing
Multiple cGMP API facilities / capabilities
Center of Excellence for drug substance
Dedicated small-scale production / Kilo Lab (60 L – 75 L reactors)
Large-scale production (1m3 to 32m3 capacity)
Specialization in hazardous / complex chemistry
Process scale-up and optimization
Multi-product potential
Avara has two sites that develop, scale up and manufacture APIs for some of the market’s leading drugs
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Primary Manufacturing
Centrifuge & Nutsche Filter Isolation
Alkylation
Nitration
Grignards
Hydride Reduction
Hydrogenation
Cryogenic Processing
Milling & Blending of APIs
Avara has two sites that develop, scale up and manufacture APIs for some of the market’s leading drugs
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Secondary Manufacturing
Two global multi-product facilities provide secondary manufacturing services
Clinical and commercial-scale manufacturing and packaging
High containment capabilities for potent products
Broad experience with tech transfers
Global compliance-oriented quality program based on Lean Six Sigma methodologies
Regulatory support across more than 100 countries
Avara manufactures multiple blockbuster drugs, serving some of the world’s leading pharmaceutical companies
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Secondary Manufacturing
Milling
Spray Drying
Granulation (High Shear, Roller Compaction, Fluid Bed)
Blending
Compression
Coating
Tablet Printing
Capsule Filling
Avara manufactures multiple blockbuster drugs, serving some of the world’s leading pharmaceutical companies
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Packaging
Blisters• 100-300 blisters per minute• Form, fill and seal• Automated cartoning and inspection• 150 cartons per minute• Laser printing, automated inspection
Bottles• Capsules and tablets• 75cc and 120cc bottles• High-speed lines, 100-300 bottles
per minute• Slat filling technology• Laser printing & automated inspection
Serialization• To international requirements
Integrated packaging capabilities to optimize costs and increased efficacies.
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Commercial Products
Avara has manufactured APIs and finished dosage forms for multiple blockbusters
Betanis®
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Client Relationships
Avara has served and currently serves some of the world’s leading pharmaceutical companies
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Arecibo, Puerto Rico
ARECIBO, PUERTO RICO
Facility Overview
Acquired from Merck & Co.
Over 35 years of site experience
Continual investment by Avara
Secondary manufacturing and integrated packaging
Manufactures multiple commercial products, including blockbusters
Granulation, coating, blending, encapsulation, compression & drying
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Shannon, Ireland
SHANNON, IRELAND
Facility Overview
Acquired from UCB
Over 40 years of site experience
Primary manufacturing
API scale-up from lab to commercial scale (8,000 L)
Multi-product flexibility
High containment capabilities
cGMP
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Norman, Oklahoma
NORMAN, OKLAHOMA
Facility Overview
Acquired from Astellas Pharma
Over 35 years of site experience
Secondary manufacturing and integrated packaging
Manufactures six commercial products, including blockbusters
Clinical and commercial-scale supply
Milling, spray drying, granulation, blending, compression coating, tablet printing
Development support
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Avlon, United Kingdom
Facility Overview
Acquired from AstraZeneca
Over 45 years of site experience
Worldwide Pharmaceutical Services Center of Excellence
Primary manufacturing
API manufacture for Crestor®
and Seroquel®
High containment capabilities
Separate tech transfer / small-scale facility and large-scale facility
AVLON,UNITED KINGDOM
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Avara and You
Committed to delivering an exceptional customer experience
Company culture to deliver on our commitments
Transparency in all operations and communication
Flexibility to your priorities and the agility to respond quickly
Integrity in everything we do to earn your trust
Avara is committed to being easy to do business with. When you engage with us, you will immediately witness our drive to deliver a world-class customer experience.
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Experience More
We are grateful for your time and the opportunity to make this presentation.
We’d like to listen to your needs to understand how Avara’s approach can exceed your expectations with a world-class outsourcing experience.
Please visit www.avara.com
Thank You