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Forming EDSP Screening Consortia. GLENN S. SIMON, PH.D., DABT Director of Toxicology September 10, 2009. Forming EDSP Screening Consortia. OUTLINE. Why Form/Join Consortium? Why Not? Who Should/Can Join? Manager/Support - Internal vs. External? Cost Sharing Formula? - PowerPoint PPT Presentation
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CHALLENGING BOUNDARIES
Forming EDSP Screening Consortia
GLENN S. SIMON, PH.D., DABTDirector of Toxicology
September 10, 2009
CHALLENGING BOUNDARIES2
Forming EDSP Screening Consortia
•Why Form/Join Consortium?
•Why Not?
•Who Should/Can Join?
•Manager/Support - Internal vs. External?
•Cost Sharing Formula?• (THE SECRET REVEALED!!)
OUTLINE
CHALLENGING BOUNDARIES3
Forming EDSP Screening Consortia
WHY FORM/JOIN A CONSORTIUM?
•Share the $$ cost (evenly or not)• May be able to leverage lab study costs
•Share the sweat equity
•Share the risk
•Industry has one voice in front of EPA• EPA perceives this as advantageous
•Ensure data utility for other purposes• REACH, others
CHALLENGING BOUNDARIES4
Forming EDSP Screening Consortia
WHY NOT FORM A CONSORTIUM?
•Additional Costs (but shared costs)• Time required to get started and with testing
• Adminstrative Fees, Consultants Experts
• Legal Fees• Helps avoid anticompetitive claims
• Accounting/bookkeeping fees
• Travel time and costs for meetings
•Unequal sharing of sweat equity
•Discontent with consortium’s decisions
•Must provide for data preservation
CHALLENGING BOUNDARIES5
Forming EDSP Screening Consortia
WHO WOULD JOIN CONSORTIUM?
•Any company covered by rule
•Any other interested companies• More companies, more $$ sharing
• Must avoid anti-competitive behaviors
• All members will own data
CHALLENGING BOUNDARIES6
Forming EDSP Screening Consortia
WHO TO MANAGE CONSORTIUM?
•Internal management• Unequal distribution of sweat equity• Issues/appearance of preferential/anticompetitive treatment
•External management• Legal Firm• Consulting/Management Firm
• Administrative only?• Technical expertise?• Bookkeeping/accounting?
CHALLENGING BOUNDARIES7
Forming EDSP Screening Consortia
BEST COST-SHARING FORMULA?
EASY ANSWER…………
CHALLENGING BOUNDARIES8
Forming EDSP Screening Consortia
COST-SHARING CONSIDERATIONS
•Equal shares or classes of costs• Arbitrary shares for consortia of <3 companies
• Producers vs. Others – different costs
•Cost based on:• Production volume*
• Sales*
• Production capacity*
•Hybrid of above
*May require sharing of confidential info,
necessitating external management
CHALLENGING BOUNDARIES9
Forming EDSP Screening Consortia
BEST COST-SHARING FORMULA?
EASY ANSWER…………
CHALLENGING BOUNDARIES10
Forming EDSP Screening Consortia
BEST COST-SHARING FORMULA?
THE ONE EVERYONE AGREES TO