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HomeMy WebLinkAbout10/04/2004 Study Session MinutesMINUTES OFSTUDY-SESSION REGARDING_INSTITUTE FAR GLOBAL PI~ARMACEYJTICAL `DEVELOPMENT ANl'I THE'T'©WN COCi`NCIL IIANDBQOK . 1VIARANA''T'+CIWN HA~.L E OCT013E12 204' PLACE AND DATE Marana Town Hall, October 4, 2004 I. CALL TO ORDER By Mayor Sutton at 5:35 p.m. The Mayor announced that Vice Mayor Kai and Council Member Comerford would be arriving late. He added that the meeting would begin with Item #2 regarding the Council Handbook. II. GENERAL ORDER OF BUSINESS 2. Presentation: Council Handbook Ms. Bronson addressed the Council and explained that the draft handbook distributed to the Council had been modeled after a City of Flagstaff example provided to the Arizona Municipal Clerks' Association. She said that she envisioned the completed handbook to be a compilation of the Town Code, the Land Development Code, personnel policies, and various Town procedures that might be of value to a Council member when dealing with inquiries from Marana residents or other interested parties. Ms. Bronson asked that the Council members study the table of contents for items they wished to include in Marana's version and said that, if the Council was interested in this project, she anticipated having a completed handbook ready by March 2005. Council Member Honea asked if the example had been taken solely from the City of Flagstaff s handbook. Ms. Bronson replied yes and that she had not made many changes to the example. She pointed out that the City of Flagstaff was a charter city while Marana was not and explained that there would be inconsistencies between the two jurisdictions. Mayor Sutton remarked for the record that Council Member Comerford and Vice Mayor Kai had arrived at the meeting. The time was 5:40 p.m. The Mayor commented that the handbook was a valuable project and that something of this nature was needed. The Town Clerk concluded her presentation by stating her appreciation of the Mayor's direction and inviting the Council members to participate in the formation of the handbook. She pointed out that the manual could become a useful tool for Town staff as well. 1 M1NUTEw` OF STUDY SESSION ~ a REGARDING 1NS~'ITUTE FOR GLOBAL PHARR7ACEUTICAL `DE'~EL{~PMENT AN7l THE TOWN COUNCCL HANI~BOfJK I~'IARANA ~'+OWN DA1.L flCT4l3EIt 4 20p4 1. Presentation: Institute for Global Pharmaceutical Develo ment Mr. Reuwsaat conducted the next portion of the study session. He said that the proposal for the Institute for Global Pharmaceutical Development (IGPD) was a three-way partnership between the University of Arizona (UA), the SRI International (formerly known as the Stanford Research Institute), and the United States Food and Drug Administration (FDA). He asked for the Council's direction on this matter and provided them with a letter of support from the Pima County Administrator, Chuck Huckelberry, stating the County's willingness to contribute $375,000 annually for five years toward this project. The letter, which contained eight conditions for approval, has been made a permanent part of this record. He introduced Dr. Raymond Woosley, Vice President for UA Health Sciences, to the Council and explained that Dr. Woosley would continue the study session with a slide presentation. A copy of the slide presentation has also been made a permanent part of this record. Dr. Woosley outlined the project's background. He distributed an informational folder containing a white paper titled Innovation or Stagnation?, authored by the FDA. The folder also contained a fact sheet about the IGPD and a draft proposal for it's creation. These materials have been made a permanent part of the record. He pointed out that one of the biggest concerns facing the nation was the rising costs of medications and health care coverage. He said that the pharmaceutical industry was one of the major industries in the United States and that this country led the world in providing new medications. He explained that the FDA approval process was where the largest delays occurred in the development of new drugs and that the FDA recognized this problem so cut the review timeframe from two years to one year. He noted that, even though the National Institutes of Health Sciences' budget doubled last year for research and development of new medical therapies, the medical product development process was not keeping pace with basic scientific innovation. He related that the average drug approved today was estimated at a $1.7B cost with an average of 10 to 12 years in the approval cycle. He said that the increase in the development time was because of the clinical development cycle. He explained that a U.S. patent for a drug lasted 17 years and was issued at the beginning of the drug study. He pointed out that this timeframe left only two to five years for drug companies to recoup the initial $1.7B investment plus any profits. He cited the fast track approach that was used with the development of various AIDS drug and used this process as an example that the development phase did not have to take so many years. 2 1YIINUTFS OF STUDY SESSION g REGARDING INSTXTUTE FOR Gt+O~AL PHARA9ACEUT~CAL DEVELOPMENT ANI~ THE TO'~VN CflUNCXL HANDBOOK 1~'IARANA TO'V4rN HALL OCTOBER ~, 2004 Dr. Woolsey continued by giving a brief synopsis of the proposal for the creation of the Institute for Global Pharmaceutical Development in Tucson. He said that the IGPD would focus on streamlining drug development in order to provide better, less expense drugs. Mayor Sutton inquired about the difference in the drug costs after the development phase was reduced to a three year turnaround. Dr. Woolsey replied that it was difficult to estimate because of the differences in the various drugs being developed but that data indicated the results were equal. He said that if the development time was cut in half then the cost was estimated to be cut in half as well. Mayor Sutton commented that he was initially concerned that the drug companies would be tied to the process and he was relieved to find that this proposal was in neutral ground with the FDA onboard. He said that patients would obviously benefit by receiving critical drugs earlier and possibly survive serious illnesses. He asked about the funding process and noted that it was risky relying on the federal government for project funding. Dr. Woolsey said that he agreed with the Mayor and that the problem was if monies were accepted from private drug companies then the FDA had to leave the process. He commented that all of the players involved in this proposal wanted to create an independent organization with federal funding. He noted that, once established, he believed that the IGPD would be able to receive "no- strings attached" endowments from the drug industry. Mayor Sutton stated that he did not want to see this project manipulated and that he was behind the effort to bring the Institute to the area. Dr. Woolsey pointed out that the IGPD would not be developing any drugs itself but would be developing the process that would allow other entities to speed up the development pace overall. He said that this proposed project would be a partnership with the FDA to develop the tools for drug development. Council Member Escobedo inquired if there were commitments from other jurisdictions and entities besides Pima County. 3 MINUTES-OF STUDI' SESSION CARDING INSTITtJ'I"E ~'flR GLCIBAL PHARMA~CEUTIOAL '` DE'1~~LOPMR~iT AND THE TOWN COUNCIL I~ANDBOOK ~~N~ TOWN HALL OCT+D$E12.4, 204 Dr. Woolsey replied that, at this time, he was asking for commitments not checks or money. He said that the group was seeking support so that when negotiations began with the three partners to develop a business plan then they could come back to the community supporters for the critical core funding. He said that over the next three months a work plan and business plan would be developed. He said that after this task was accomplished then the partnership would go back to those who had indicated that they would entertain a request for funding and get checks after incorporation of the nonprofit organization in January 2005. He noted that there were nineteen entities interested in contributing to this effort including four families, all wishing to remain anonymous, who have committed $100,000 for five years. He said that the City of Tucson and Pima County had both committed $375,000 per year, with the Greater Tucson Realty and the Multi-Listing Service partnering on a commitment of $100,000 per year. He continued by saying that the new car dealerships in the metropolitan Tucson area pledged to give $50,000 for five years. He noted that the nineteen different organizations all had the understanding that the plans were not completed at this time. He promised that this information would be provided prior to asking for checks and that a 501(C)(3) nonprofit organization would be in place for tax deductions. He said that there would be open books and that everyone involved would be able to see the plan and the operations. He added that there would be a Board of Directors made up of community members so that there would be accountability and a voice in how the Institute was operated. Council Member Escobedo asked about employment opportunities that the Institute for Global Pharmaceutical Development would bring to the area. Dr. Woolsey answered that an estimate of 60 to 80 positions would be created and that the work plan would define those positions more concretely. He said that the general consensus was that the IGPD's work would bring in millions of dollars in related work for the University of Arizona and that the community would benefit from the other jobs created as a spin off from this effort. He said that although it could not be promised it was also widely believed that the pharmaceutical industry would want to be located nearby in southern Arizona as well. He reported that SRI had said that if this Institute was created in Arizona that they would like to put their drug development programs here, too. 4 MINUTES OF STDDY SESSION 'REGARDING INSTITUTE FOR GLfJBAL PAARMA.CEUTICAL ..DEVELOPMENT AND THE TOWN C01JN~IL HANDDQOK MARA,NA:~'4~'VN HALL, OCTC)l3ER 4, 2004 Dr. Woolsey said that the group had met with Governor Napolitano this morning and that she had expressed strong interest in the long term plan of these buildings being built by the State on a pay back plan where the State would get its money back but they would also be investing in creating the bricks and mortar for the IGPD. He said that with the availability of surrounding open properties then there would be other companies wanting close proximity to that environment. He related that this would create high paying jobs and a clean knowledge-based economy, mainly a think tank where various people were brought together to analyze data and make decisions about how better to develop drugs. Council Member Escobedo asked about the October 1St deadline and if this had been extended. Dr. Woolsey said that a meeting had been held with the presidents of SRI and UA as well as the Deputy Commissioner of the FDA last Saturday night and that a decision to go forward was made even lacking the full funding at this time. He said that there was no official commitment from the City of Tucson or from Pima County but that the leaders of the two jurisdictions had voiced their interest and plans to take the proposal before their Supervisors and Council members. He remarked that the UA and the other partners were planning to go ahead and develop a business plan based on the level of support they had received so far. He added that they were eager to continue to get commitments of support because it was not all locked up. $1.5M per year is a minimum budget. They think this is credible and it will be a good startup. Mayor Sutton asked if Marana was on the list for the location of the institute. Dr. Woolsey replied that Southern Arizona was definitely on the list and the location would be somewhere near the university not at the tech park. The board would look at the various potential sites. Want to be close to the university because of the science, close to the interstate and airport, and other criteria that would be established. He said that when the science spins out of that environment that this will spill over into Marana in terms of residences for the job force, etc. Mayor Sutton commented that if Dr. Likins wants to move the UA out to Marana that the Town had "all that other stuff!" 5 1~IINUTES OF STUD.' SESSION REGARDING INSTITUTE F4R GI..OBAL PIIATt3~7AC'EUTICAL DEYELOI'xVIENT AND THE TOE CC)UNCIL HANllBUOK M~IRANA` TO WN FALL OCTOBER 4, 2004 Council Member McGorray remarked that, as everyone knew, her son was a quadriplegic, and when he was injured and helicoptered in to UMC, Dr. Hamilton tried very hard to obtain a drug that was legal in Italy and it could not be brought into the US. She emphasized that it was vital to speed up the process of drug development and availabity. Mr. Reuwsaat said that the community was coming together on this effort and that the direct benefit to Marana would be home ownership, employment, and secondarily, the spin off job development stand point would locate close to our airport and close to the interstate as this is where the Town was setting up for industry development. He recommended that a range of $10,000 to $25,000 per year for five years be considered for next year's budget. He said that the Town would continue to work with Pima County and others such as Oro Valley to see what they are doing. He said that the county was asking for a fifteen year stay, disclosure of all information, confirmation of viability. He said that it was hoped that like the optics cluster that perhaps Marana could be a place for the pharmaceutical cluster. Council Member Escobedo said that he would like to see the business plan and make the commitment to go forward at that point. Mr. Reuwsaat said that, at the Council's pleasure and with their direction, he could develop a letter similar to the County's and have this proposed monetary commitment considered in next year's fiscal budget. Dr. Woolsey said that once the work plan and the business plan were developed then the group could present the stakeholders with an economic impact prediction. He said that was the intent. Mayor Sutton asked if there was any opposition to the Town Manager's suggestion for commitment. There was none. Mr. Woolsey introduced three representatives of the Greater Tucson Economic Council (GTEC) who had accompanied him to the study session. This group included Colleen Mathis, the Director of Corporate Services, Kym Adair, the Manager of Investor Relations, and Steven Kelley, the Vice President of Marketing and Corporate Relations. He said that GTEC had been outstanding in their support of this effort. He commented that the GTEC Board of Directors' Chair, Francie Merryman, had been especially helpful in getting the accurate word out about this opportunity. 6 MINUTES.OF STUD' SESSION REGARDING INSTITUTE FOR G~,OBAL PIIAR~49ACE~TICAL DEVELOPMENT AND 'I`HE `TC7WN COUNCIL HANDBOOK 11i~1.R:A,I~A TOWN HAi,L OCTOBER ~, 2004.:: a A Mr. Reuwsaat mentioned that Dr. Woolsey was fairly famous and well known in his own right and that this fact played into the equation of the location for the institute. XI. ADJOURNMENT Upon motion by Council Member Escobedo, seconded by Council Member Blake, the study session was adjourned at 6:27 p.m. CERTIFICATION I hereby certify that the foregoing are the true and correct minutes of the Marana Town Council study session held on October 4, 2004. I further certify that a quorum was present. celyn B son, Town Clerk 7