1. Gerald Yakatan, Ph.D.
Chairman, CEO & Founder
gyakatan@irisys.com
T 858.281.7939

2. Who We Are
• Founded 1996 to focus on pharmaceutical science and industrial pharmacy
• Highly qualified and experienced technical staff – over 20 Ph.D. and M.S.
• Successful track record with therapeutic agents of all classes and physicochemical properties
• Demonstrated expertise and compliance with cGMP regulations
• State-of-the-art facility, FDA and FDB (CA) inspected in 2015 – no 483s
• GMP commercial manufacturing experience and capacity
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3. From Preclinical to Commercial
Formulation Development
Analytical Methods Development
Regulatory and Drug Development
cGMP Clinical Supply Manufacturing
Commercial Manufacturing
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4. Why Clients Come to IriSys
Experience and Breadth of Understanding
• 150+ years of experience from discovery to commercialization
• Scientists expert in their fields
• Understand the value of meeting client timelines
• Direct communication with scientists working on your project
• Client focus accommodates change
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5. Wide Range of Clients,
Partners and Collaborators
Domestic and International (Japan, China, Korea, Australia, Russia)
Small Biotech & Big Pharma
National Institutes of Health (NIH)
• Therapeutics for Rare and Neglected Diseases (TRND)
• National Center for Advancing Translational Sciences (NCATS)
• Bridging Interventional Development Gaps (BrIDGs) Program
• National Cancer Institute Developmental Therapeutic Program (DTP)
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6. Expertise that Distinguishes IriSys
Strong intellectual core
• Extensive expertise in industrial pharmacy, drug discovery and development
Vision to understand the big picture
• Consider both technical issues and their impact on the development program and regulatory
strategy
Expertise that covers the entire development path
• Formulations, clinical manufacturing, FDA interactions, IND filings and clinical development
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7. Formulation R&D
Pre-formulation Studies
Analytical methods development, qualification and validation
Formulation development, all stages
• Non-GLP animal studies
• GLP Toxicology studies
• cGMP NCE Phase I/II
• Generic Drugs, 505b2
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8. cGMP Clinical Trials Manufacturing
Excipient Selection, Process Selection and Development
Dosage Forms
• Tablets (immediate, extended and delayed release)
• Liquid-filled capsules
• Powder-filled capsules (immediate, extended and delayed release)
• Oral liquids
• Ointments, creams, gels
• Injectables, including lyophilization
Volumes up to 10,000 units
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9. cGMP Clinical Trials Manufacturing
• Vials
• Sterile fill syringes
• Bottles
• Over encapsulation
• Blister packaging
• Bulk packaging
• Bulk labeling
• Sachets
• Powder in bottle
Packaging &
Labeling
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10. Specialized Technologies for
Formulation Development
• Moving from multiple daily doses to once daily
• Controlled release of highly water soluble drugs
• Immediate release of highly lipophilic drugs
Oral
• Increased bioavailability
• Enhanced stability
• Optimized viscosity
• Optimized polymer network for high electrolyte content
Topical
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11. Specialized Technologies for
Formulation Development
• Increased circulating half-life, optimized bio-
distribution
• Improved safety and efficacy
• Decreased immune recognition
• Targeted delivery
• Discriminative release (location and
environment)
• Pharmacodynamically optimized formulations
• Long-acting formulations
Parenteral
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12. Technologies
Proprietary Formulation
Technologies
Lipid based formulations
Liquid-filled hard gelatin caps
Controlled release solid dosages
Micro and nanoparticles
Liposomes and solubilization
Formulations to enhance
intellectual property portfolios
Small organic molecules
Peptides and biologics
Proteins
Synthetic polymers
Inorganic compounds
Cytotoxic and potent
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Applications

13. cGMP Commercial Manufacturing
FDA Inspected August 2015
• Full commercial level inspection: no 483s
• CA FDB inspected
Capabilities for oral tablets, capsules, liquids
Current Projects
• Single source products
• ANDAs
• Rare disease and orphan drugs
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14. cGMP Commercial Manufacturing
Services
• Formulation and process optimization of drug product
• Scale up from R&D to commercial cGMP batch manufacturing
• Process validation
• Technology transfer
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15. Complete QC/QA Services
QUALITY CONTROL
Analytical methods transfer and
development
Release testing of bulk API and drug
product
In-process testing
Microbiology
Certificates of Analysis
Stability study protocols and programs
according to ICH Guidelines
QUALITY ASSURANCE
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Protocol development, execution and
review
Standard Operating Procedures
Manufacturing batch records
Specifications development
Final product release
Compliance audits

16. Facility Layout
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CLINICAL SUPPLIES
DEVELOPMENT & MFG.
COMMERCIAL
MFG.
OFFICES
QC

17. Product Development
and GMP Suites
1. Nanoparticle formulation
2. Tablet/powder compression
3. Blending, capsule filling – GMP processing
of solid dosage forms
4. Formulation and analytical development
5. Nanoparticles, liposomes size analysis
6. Liquid filling
7. Formulation development – solid/liquid
dosage forms
8. Analytical lab – HPLC, dissolution
9. Ointment/cream processing
10.Sterile lyophilization
11.Sterile processing, Class 100, Class 1000
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18. cGMP Commercial
Manufacturing Facility
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19. Drug Development &
Regulatory Strategy
Drug development guidance at all stages
FDA strategic planning
Pre-IND FDA meetings
• Meeting package and presentation prep
• Meeting participation and follow-up
CMC sections and filing INDs
• Data generation and reports
• Preparation for submission
Organization and supervision of Phase I/II clinical trials
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20. Special Services for
International Clients
Bring client’s products into the U.S.
• Strategy and guidance throughout the U.S. FDA approval process
• Meet at the client’s location or host representatives at IriSys
• Provide translations
• Educate client’s personnel about FDA regulatory requirements
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21. Leadership & Management
Gerald J. Yakatan, Ph.D., Founder, Chairman & CEO
Bob Giannini, Ph.D., Chief Scientific & Technical Officer
Louis Scotti, Vice President Business Development
Jean Wang, Ph.D., Vice President, QA & QC
Charlie Cavallino, Executive Director Manufacturing Operations
Brooke Yakatan, Director Quality Assurance and Regulatory Affairs
Igor Nikoulin, Ph.D., Director Research and Development
Kevin Xie, Controller
Victoria Smith Karpinski, Director HR and Administration
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Thank You!
6828 Nancy Ridge Drive, Suite 100
San Diego, CA 92121
P 858.623.1520
F 858.623.1525
www.irisys.com