IriSys Profile Presentation widescreen V.2.3
- 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 1/24/2017 IRISYS, LLC 2
- 3. From Preclinical to Commercial Formulation Development Analytical Methods Development Regulatory and Drug Development cGMP Clinical Supply Manufacturing Commercial Manufacturing 1/24/2017 IRISYS, LLC 3
- 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 1/24/2017 IRISYS, LLC 4
- 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) 1/24/2017 IRISYS, LLC 5
- 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 1/24/2017 IRISYS, LLC 6
- 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 1/24/2017 IRISYS, LLC 7
- 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 1/24/2017 IRISYS, LLC 8
- 9. cGMP Clinical Trials Manufacturing • Vials • Sterile fill syringes • Bottles • Over encapsulation • Blister packaging • Bulk packaging • Bulk labeling • Sachets • Powder in bottle Packaging & Labeling 1/24/2017 IRISYS, LLC 9
- 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 1/24/2017 IRISYS, LLC 10
- 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 1/24/2017 IRISYS, LLC 11
- 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 1/24/2017 IRISYS, LLC 12 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 1/24/2017 IRISYS, LLC 13
- 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 1/24/2017 IRISYS, LLC 14
- 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 1/24/2017 IRISYS, LLC 15 Protocol development, execution and review Standard Operating Procedures Manufacturing batch records Specifications development Final product release Compliance audits
- 16. Facility Layout 1/24/2017 IRISYS, LLC 16 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 1/24/2017 IRISYS, LLC 17
- 18. cGMP Commercial Manufacturing Facility 1/24/2017 IRISYS, LLC 18
- 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 1/24/2017 IRISYS, LLC 19
- 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 1/24/2017 IRISYS, LLC 20
- 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 1/24/2017 IRISYS, LLC 21
- 22. IRISYS, LLC1/24/2017 22 Thank You! 6828 Nancy Ridge Drive, Suite 100 San Diego, CA 92121 P 858.623.1520 F 858.623.1525 www.irisys.com