overview of the keys to successful commercialization gerald j. siuta, ph.d. president siuta...
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Overview of the Keys to Successful Overview of the Keys to Successful CommercializationCommercialization
Gerald J. Siuta, Ph.D.President
Siuta Consulting, Inc.
Tucson, ArizonaOctober 18, 2001
What Are the Keys to theWhat Are the Keys to theCommercialization of Technology?Commercialization of Technology?
• Marketable technology
• A commercialization partner
Siuta Consulting, Inc.
Setting the Stage for LicensingSetting 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?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 PotentialAssess 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 Technologies with Reduced MarketabilityMarketability
• 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 Enhancing the Value and Increasing the Chance For Commercializationthe 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 PartnersPotential 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 LicenseeFinding a Licensee
• Faculty colleagues• Pharmaprojects• Physician’s Desk Reference• Annual reports• Technology transfer databases• Personal industrial contacts
Siuta Consulting, Inc.
Initial Presentation of the Data:Initial Presentation of the Data:The Executive SummaryThe 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:Initial Presentation of the Data:The Executive Summary (continued)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:Initial Presentation of the Data:The Executive Summary (continued)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 AvoidPitfalls 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 SuccessProbability 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.