Overview of the Keys to Successful Commercialization Gerald J. Siuta, Ph.D. President Siuta Consulting, Inc. Tucson, Arizona October 18, 2001

What Are the Keys to the Commercialization of Technology? Marketable technology A commercialization partner Siuta Consulting, Inc.

Setting the Stage for Licensing When to seek a partner: When you have A patentable invention Commercial potential When you require Financial support Development capabilities Marketing assistance Siuta Consulting, Inc.

What Do Companies Want? New chemical entities Demonstrated biological activity In vitro activity In vivo activity Novel mechanism of action Improved therapeutic index New drug targets Patented technology Siuta Consulting, Inc.

Assess Commercial Potential Therapeutic indication Chronic vs. acute therapy Mode of administration and dosing schedule Market size and sales potential Advantages over competitive products Product price and profit margin Development timeline and costs Patent status Siuta Consulting, Inc.

Technologies with Reduced Marketability New uses For an old compound For a currently marketed drug Combination product Preventives vs. treatments Me-too product Large molecules Peptides and proteins Siuta Consulting, Inc.

Enhancing the Value and Increasing the Chance For Commercialization Get broad patent coverage Perform well designed experiments Assay reliability Quality vs. quantity Use suitable controls Avoid quick and dirty No anecdotal clinical data Siuta Consulting, Inc.

Potential Partners Target Companies that: Market similar products Have research programs in the same area Have the capability to develop the product Are seeking to enhance their pipeline Are committed to technology transfer Siuta Consulting, Inc.

Finding a Licensee Faculty colleagues Pharmaprojects Physicians Desk Reference Annual reports Technology transfer databases Personal industrial contacts Siuta Consulting, Inc.

Initial Presentation of the Data: The Executive Summary Title Summary paragraph Brief description of the invention Potential therapeutic indications Identify inventor Background Scientific rationale for the technology Siuta Consulting, Inc.

Initial Presentation of the Data: The Executive Summary (continued) Detailed description of the invention Summary of available data Stage of development Potential advantages Comparison to known drugs Publications Scientific journals Meeting presentations Siuta Consulting, Inc.

Initial Presentation of the Data: The Executive Summary (continued) Patent status What is claimed Where have patents issued Where have applications been filed Licensing status What is being sought from a partner Siuta Consulting, Inc.

Pitfalls to Avoid Pursue licensing before technology is sufficiently developed Publish before filing patent applications File patent applications too early Fail to file patent applications worldwide Mistake new use for new chemical entity Overestimate the value Siuta Consulting, Inc.

Probability of Success 10,000 compounds synthesized 1,000 will reach animal studies 10 will reach Phase I 5 will reach Phase II 1 will reach Phase III 0.9 will achieve FDA approval Siuta Consulting, Inc.