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Your 24x7 Gateway to Minnesota MedTech & HighTech

 





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The MedSuds™ Report ©

The January 1, 2005 Issue: 

May 9-11, 2005
Bloomington, MN
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Re-sending of this newsletter to any number of colleagues is encouraged provided you also cc: report@medsuds.com.  In return, we will invite recipients to subscribe.  Any other unauthorized re-distribution is a violation of copyright law.

Subscribe to the MedSuds Report at http://www.netsuds.net/mail.htm. You can get the web versions of these reports at http://www.medsuds.com/report/.


In this Issue:

        1.0   Minnesota Business and Technology Forums
        2.0   Jobs in the Medtech, Biotech and Life Sciences Market
        3.0   Calendar of Events
        4.0   Tidbits (Devoted to the Minnesota Business and Technology Forums this month only)
               4.1    Registration For The Minnesota Business and Technology Forums
               4.2    California Stem Cell Project Energizes Other States to Act

               4.3    Illinois May Tax Nip & Tuck Surgery
               4.4    The Ones That Got Away
               4.5    New Wisconsin University Program to Aid Start-up Firms
               4.6    Grow Iowa Values Fund
               4.7
   Phoenix Biotech
               4.8   
Wisconsin News
               4.9    Embryonic SCR Word Games
               4.10  Wisconsin Biotech Initiative Faces Opposition
               4.11  2005 MN VC Conference Investors
        5.0   MedSuds Email Advertising
        6.0   MedSuds CEO Roundtable - www.medsuds.com/ceo/
        7.0   MedSuds Executive Search - www.medsuds.com/search/
        8.0   Building A Medical Data Network
        9.0   Common-Sense Valuation Improvements
        10.0  How California Proposition 71 Was Born
        11.0  California Proposition 71 Faces Quagmire
        12.0  Guest Writers for this Report


1.0   Minnesota Business and Technology Forums

The Minnesota Business and Technology Forums are useful for many purposes.  In order to view the information on the web forums, you do not need to register.  To post information, you must create an account.  There are many reasons to create a free account.  In order to fully participate as a "MedSudser" in the Minnesota medtech community, you should create an account and use it to full advantage.

The Minnesota Business and Technology Forums - http://www.masvf.com/forums/index.php

Upcoming Events - http://www.masvf.com/forums/forumdisplay.php?f=4

MedTech Companies - http://www.masvf.com/forums/forumdisplay.php?f=21

People On The Move - http://www.masvf.com/forums/forumdisplay.php?f=15

Press Releases - http://www.masvf.com/forums/forumdisplay.php?f=16

Why email only to your small email list of associates when you can post this information on Minnesota Business and Technology Forums and have access to 2700+ MedSudsers. 


2.0 Jobs in the "medtech, biotech and life sciences" Market

Click on http://www.masvf.com/forums/forumdisplay.php?f=30 for a list of available MedTech Jobs in Minnesota.

We encourage you to post available jobs for medtech professionals in Minnesota.  You must identify which company you represent.  If your company is already listed, please do not create a duplicate thread.  Instead, post to the same thread.  If you are a recruiter, you must identify yourself as such.


Thank you for the support many of you have shown to the MedSuds recruiting association with the American Consulting Company.  We have developed a quality and impressive MedSuds candidate database.  We always appreciate the opportunity to discuss how we might help in locating candidates for your open positions.   And, we've added an association with OnCall Staffing - www.oncallstaffing.com.

If you are a hiring manager, you are invited to review our process, our commitment to ethical standards and diversity recruiting, and other areas of interest at: www.americanconsultingcompany.com.  When you identify yourself as a member of the MedSuds association, we will offer you a discounted rate to assist in locating candidates for your company.  And remember, you never pay a fee unless you hire one of our candidates. 

If you are a candidate, visit the ‘Candidate Kit’ at www.americanconsultingcompany.com.  You will find valuable tools to help in your job search.  When you send us your resume, be sure and mention your association with MedSuds.

Renowned entrepreneur and local resume-writing expert Kevin Donlin - www.gresumes.com - is available to assist you in writing a powerful, effective resume.  Kevin can also help you with cover letters and job search coaching.  Contact Kevin at guaranteed.resumes@netsuds.com and tell him Matt Noah referred you.
Hi Matt -

Thanks for posting our job opening in the NetSuds monthly.  The number of "good" people we had respond to our position is a direct reflection of the exposure received thru NetSuds.  I do not have a quantitative measurement but having posted the same job just 45 days earlier thru the 'normal' means provides a pretty accurate comparison.  The only thing we did differently was use the NetSuds site. 

We have filled the position so the posting can be removed.  Thanks again -

Bradd Strelow
Director of Technology and Innovation. Dakota County Technical College



3.0  Schedule of Events

The calendar for medtech and hightech events in Minnesota is scattered all over in print, email and online publications.  Up until now, there has been no single definitive calendar.  NetSuds and MedSuds has created the first and only online calendar for all hightech, medtech, biotech and life science events in Minnesota.

Calendar of Events - http://www.masvf.com/forums/calendar.php?

You can use the online calendar to post your organization's events.  We will even allow the posting of events which compete with NetSuds and MedSuds events.  The calendars are free to use for both tracking events and for posting your own events.

Non-Minnesota companies conducting events in Minnesota will not be allowed to post events for free, even if they are teaming up with a Minnesota company.  Non-Minnesota companies or organizations should contact matt@netsuds.com to discuss the fees associated with posting such events. 

1/18-19   MedSuds Think On Your Feet® Workshop
http://www.medsuds.com/workshop/toyf/
5/9-10   Minnesota Venture Capital Conference
http://www.mnvcc.com/
5-11   Minnesota Association of Seed & Venture Funds Conference
http://www.masvf.com/


4.0   Tidbits

4.1  Registration For The Minnesota Business and Technology Forums

Visiting http://www.masvf.com/forums/index.php allows one to visit the Minnesota Business and Technology Forums and observe what is available.  However, in order to become a member of the community, one must register.  Registration is simple and has several advantages.  First, you can search for other members in the community using names, IDs and keywords related to industries.  Second, you can identify yourself to the community through the use of keywords and interests.  Third, you can subscribe to certain "threads" and receive email when these threads experience activity.  You may also unsubscribe from any thread at any time.  Fourth, you can post to the Forums.  This is extremely powerful.  Members can post their opinions, information and engage in online discussions.  Jobs can be posted.  Events can be posted.

MedSuds encourages members to choose usernames which readily identify one's self to the community.  For example, the username "johnsmith" identifies the member as John Smith (or at least we hope!).  Use of IDs to hide one's identity is not encouraged in these Forums.  Remember, this is a professional Web Forum and not some adolescent, rumor-spreading chatroom.

Even after you register you can alter your user profile in the "CP" section along the top of the Forum webpage.

4.2  California Stem Cell Project Energizes Other States to Act

The following story was taken from the NASVF November 24 Newsletter http://www.masvf.com/forums/forumdisplay.php?f=27

As California moves quickly toward setting up a $3-billion embryonic stem cell research agency, other states are scrambling to prevent their top researchers from being raided. The lure is clear: $300 million a year for embryonic stem cell research in California for the next decade, more than 10 times the yearly federal funding available and free of the Bush administration's tight restrictions on what research can be conducted with federal money. Megan Garvey of the Los Angeles Times examines what's happening as a result of the California incentive: http://www.latimes.com/news/local/la-me-stemcell22nov22,0,6718071.story?coll=la-home-headlines

But Scott Rothschild of the Lawrence Journal World writes that while California and other states are upping the ante in the high-stakes game of stem-cell research, Kansas appears ready to stand pat, a bad move, according to Mary Faith Marshall of the Kansas University Medical Center in Kansas City: http://ljworld.com/section/stateregional/story/188273

4.3  Illinois May Tax Nip & Tuck Surgery

The following story was taken from the NASVF November 24 Newsletter http://www.masvf.com/forums/forumdisplay.php?f=27

Days after state legislators voted down a largely symbolic measure supporting privately funded stem-cell research, politicians and medical leaders Tuesday announced plans to ask those same lawmakers to support an even broader initiative to publicly fund the promising but controversial medical research. It asks the General Assembly to approve placement of a referendum question on the general election ballot in 2006 asking voters to add a 6 percent levy on face-lifts, breast augmentation, Botox injections and other elective plastic surgery procedures--supporters called it the nip/tuck tax--to fund $1 billion in grants and loans for Illinois researchers over 10 years http://www.chicagotribune.com/news/local/chi-0411240193nov24,1,7557074.story?coll=chi-news-hed

4.4  The Ones That Got Away

http://www.ovp.com/industry_deals.html

4.5  New Wisconsin University Program to Aid Start-up Firms

The following story was taken from the NASVF November 24 Newsletter http://www.masvf.com/forums/forumdisplay.php?f=27

The UW-Madison Office of Corporate Relations announced that it will start a program next year to help create, support and sustain start-up companies that are based on research and technology developed at the UW, reports Madison's Capital Times: http://www.madison.com/tct/business//index.php?ntid=18529&ntpid=12

4.6   Grow Iowa Values Fund

Central Iowa business leaders will focus their legislative lobbying efforts on getting permanent funding for the state's premier business incentive program, the Grow Iowa Values Fund. Officials of the Greater Des Moines Partnership said Friday that continuing the seven-year economic development program is one of the most important issues that will come before the Iowa Legislature, which starts its 2005 session on Jan. 10: http://www.desmoinesregister.com/apps/pbcs.dll/article?AID=/20041211/BUSINESS04/412110312/1029/

4.7  Phoenix Biotech

With a new for-profit company and new headquarters opening next week, the Translational Genomics Research Institute is making headlines these days. But it is not necessarily making money. The downtown Phoenix institute, seen as the key to the state's effort to create a biotech industry, recorded $16 million in revenue for the fiscal year that ended June 30: http://www.azcentral.com/business/articles/1212tgen12.html#

4.8   Wisconsin News

Wisconsin Start-Ups Need Help Sooner

Put another way, the funnel through which deals flow is backward in Wisconsin, says Lane Brostrom, managing director of TechStar, an organization created to accelerate start-ups in the Milwaukee area. By putting too much emphasis on venture capital and not enough on the early stages of business creation, he believes, the state puts itself at a disadvantage:  http://www.jsonline.com/bym/news/dec04/283144.asp

Wisconsin lags neighboring states in funding for new companies, but efforts are under way to encourage more "angel" investors to help launch businesses here, the state's top financial regulator said Monday.  http://www.jsonline.com/bym/news/dec04/283846.asp

4.9  Embryonic SCR Word Games

http://www.lifenews.com/bio622.html

IMAGINE the difficulty of engaging in a political debate in front of an audience that didn't speak your language. Empirical analysis would mean nothing: What use would be the marshaling of facts and evidence when your audience wouldn't be able to understand what you were saying? And as for the art of persuasion, forget about it. No matter how brilliant your argument, to your audience, it would just be confusing noise. ...

4.10  Wisconsin Biotech Initiative Faces Opposition

The response has been less than overwhelming to Governor Jim Doyle's proposal to invest nearly $750 million in public and private money in Wisconsin's biotechnology future. Budget-conscious members of the Legislature have choked on the price tag, opponents of stem-cell research have once again protested, and Milwaukee politicians have asked if they're being shortchanged in favor of Madison. Tom Still responds in the Wisconsin Technology Network's newsletter:: http://www.wistechnology.com/article.php?id=1440

4.11  2005 MN VC Conference Investors

The list of committed investors - www.mnvcc.com/agenda/speakerprofiles/2005.htm - for the 2005 MN VC Conference is growing quickly.  Investors can apply for a complimentary registration.  The early early-bird registration deadline is December 31, 2004 so register today at www.mnvcc.com/register/.


5.0     Email Advertising

The NetSuds (5700+) and MedSuds (2800+) email lists reach 8500+.  The NetSuds email lists are double-opt-in and concentrated on professionals in the communications, IT and Internet markets.  The MedSuds email lists are double-opt-in and concentrated on professionals in the medtech, biotech and life sciences markets.  So, rather than spend your advertising dollars on any other email lists in the Twin Cities, consider the NetSuds and MedSuds lists.  Contact matt@medsuds.com or 612.605.5252.  For current ad rates, visit www.netsuds.com/adrates.htm.


6.0   MedSuds CEO Roundtable - www.medsuds.com/ceo/

MedSuds is opening up another group of CEO Roundtables in January 2005.  If you are a hightech or medtech CEO and want to join us, (the first session is free), contact matt@medsuds.com.  A synopsis of the CEO Roundtable can be found at www.medsuds.com/ceo/  It is repeated here as well.

MedSuds CEO Roundtable

Membership  Only CEOs of tech and medtech companies are allowed to join the MedSuds CEO Roundtable.  If you are a VP, CxO or President, you are not welcome unless you also hold the CEO title.  If you are interested in becoming a member, contact matt@medsuds.com.  Membership is not automatic.  There must be an available spot open in the roundtable.  You must have employees.  Your company must be incorporated.  Your company must be a tech (communications, IT, software, Internet) or medtech (medtech, biotech, life sciences) company.  You must pay a yearly fee of $1200 in advance.  You may not send substitutes to the Roundtable. 

Roles  Unlike the days of knights, kings and Camelot, there is no king of the MedSuds CEO Roundtable; only a facilitator; Matt Noah, CEO of NetSuds.com, Inc.  Knights are replaced by CEOs and the table won't be quite round.

Schedule  The Roundtable will meet at least 10 times per calendar year.  We meet the last Tuesday of every month.  Each meeting lasts between 2 hours starting at 7 am.  A facility convenient to the majority of Roundtable members is used.  A continental breakfast is served.

Our next introductory session (free) has been scheduled for January 25, 2005.  Attendance will be limited to just CEOs.  Contact matt@medsuds.com if you want an invitation.

Purpose  CEOs need resources to assist them in executing their duties and leading their companies.  Boards of Directors and upper management are not always the best or most independent resources upon which to draw.  The CEO Roundtable exists to provide CEOs with an independent resource of wisdom and shared experience.  Your key 'take-aways' from the Roundtable will be accelerated learning - so as to avoid common and uncommon pitfalls -, an expanded network of advisors and colleagues and tools to enhance the productivity and value of your enterprise.

Content  First, networking among the CEO members of a Roundtable is the best and richest content.  Second, the Roundtable facilitator will schedule subject matter experts of interest to the CEOs.  Examples include intellectual property, branding, sales, engineering, marketing, finance, compensation, human resources, M&A, etc. 

Format  Meetings consist primarily of 2 elements.  First, "content" will be presented and discussed.  Second, "discussion" of common problems and solutions will take place.  The facilitator will lead both elements or assign elements to certain CEOs.

Confidentiality  Roundtable meetings are completely confidential.  Nothing said in a roundtable discussion, short of illegal activity, leaves the meeting.  This allows each CEO to feel comfortable discussing issues and subjects he may not feel comfortable speaking about with others.


7.0   MedSuds Executive Search - www.medsuds.com/search/

See the following URL for more information on our executive search service - www.medicalsuds.com/search/.  


8.0   Building A Medical Data Network

The following article appeared in the November 22, 2004 New York Times - www.nytimes.com - and was forwarded to our attention by Kathy Hagen, kathylhagen@aol.com

By STEVE LOHR

In health care, the most exhilarating technology always seems to be on the clinical side of medicine - sophisticated scanners that can peer inside arteries, gadgets that enhance life-saving microscopic surgery and biotechnology that promises to cure disease and extend life.

But medical experts are also talking with excitement about what might appear to be boring back-office technology - electronic health records.

At a conference last week at Rockefeller University, sponsored by I.B.M., a panel of health care experts discussed the innovations that promised to be the most intriguing and the most necessary over the next decade or so. They chose one grand pursuit in clinical care - the probable rise of "predictive medicine." The idea is that advances in genetics would make it possible to know from birth a person's genetic predisposition for, say, obesity, heart disease or cancer, and that knowledge could be used to tailor treatment or alter personal behavior.

Yet the panel spent more time on the need to bring patient records and prescriptions out of the ink-and-paper era and into the computer age. "The problem I see is that we have so much information and we need to be able to translate that information into care," said Dr. Edward D. Miller, dean of the Johns Hopkins University medical school.

Last week's dialogue was a brief chat in a larger national discussion about how to make the transition to electronic health records and the implications of such a move. To date, the impetus for bringing information technology to health care has centered somewhat narrowly on reducing administrative costs and medical errors - both of which are huge problems.

An estimated 31 percent of this year's total national health care bill of $1.79 trillion is spent on administration. Electronic record-keeping would eliminate enormous amounts of paper-shuffling, which could save hundreds of billions of dollars and many lives. An estimated 45,000 to 98,000 people die each year from medical errors, including those attributable to misunderstood handwritten prescriptions and hospital charts, or lost laboratory test results.

But digital patient records are merely a first step toward a broader vision. Those records could become building blocks in a nationwide biomedical computer network for assembling and distributing up-to-the-minute epidemiological studies. The network could show researchers and physicians what treatments work for people with similar characteristics, ailments and, eventually, gene markers. To protect privacy, personal identifiers would be stripped out of the national network.

There are plenty of technical obstacles and privacy concerns that would have to be overcome. Yet such a network is part of the 10-year plan being promoted by the National Institutes of Health, among others. "The dream is that every physician will be able to tap into that national biomedical network from his or her desktop computer," said Dr. Eric Jakobsson, who heads the Biomedical Information Science and Technology Initiative at the National Institutes of Health.

The presumed benefits would be improved quality and higher standards of health care. But such a network would also provide the basis for far more efficient markets in health care - and would have the potential to shake up both the pharmaceutical and health insurance industries.

Big insurers like UnitedHealthcare, Aetna and Cigna insist that they have moved beyond being insurers to become experts in managing health care. But in large part they still operate as the middlemen, tussling with doctors and hospitals over reimbursements for visits, tests and operations. In a digital network, the rules for approval and nearly all transactions could be automated, drastically reducing the middleman's role.

"We're going to get rid of insurance companies, at least insurance companies as we know them," said Neal Patterson, chief executive of Cerner, which produces software for health care automation.

The pharmaceutical business could also be in for a shock. Doctors often get most of their information about drugs from the drug makers. Obtaining genuinely objective information about the effectiveness of drugs requires close tracking of academic studies, particularly those not funded by the drug industry. Kaiser Permanente, a health maintenance organization, is big enough to field its own drug information team to review the available research and study the treatment results of its 8.3 million members.

The work of the Kaiser researchers has influenced, for instance, the company's approach to the use of statins, a family of cholesterol-lowering drugs. The researchers compared the efficacy of lovastatin, which went off patent in 2001, to newer statins like Pfizer's Lipitor and Merck's Zocor. Lovastatin is less potent per milligram than the newer drugs. But the researchers found that many people could get the same cholesterol-lowering effects, without an increase in side effects, by taking higher doses of lovastatin. As a generic drug, lovastatin costs much less than brand-name patented drugs like Lipitor. The estimated cost saving to Kaiser from substituting lovastatin was $80 million over the last two years.

The company's drug information unit, said Dr. Sharon Levine, a director in Kaiser's medical group, is intended to combat "the total failure of the market for information in pharmaceuticals."

A digital medical network like the one envisioned by the National Institutes of Health would make studies such as Kaiser's, though with even larger data sets, available to doctors and patients across the nation. An open system for information on drugs and their effectiveness might just make obsolete the sales visits to physicians' offices and the television pitches for drugs.

What's needed is are basic standards for patient information and its transfer over the Internet. Hospitals, medical centers and insurers would keep their private networks, but they would share information, using open standards. That would require the equivalent of a free trade agreement for the exchange of health information and communication.

The person in the position to negotiate such agreements is Dr. David J. Brailer, the Bush administration's national coordinator for health information technology. While the end game may be more efficient health care markets, the standards-setting step will require a deft and forceful government role - as even the most avowed free-market enthusiasts acknowledge.

"Everybody should be integrated, and that will not happen by random, gradual evolution," said Newt Gingrich, the former House speaker who is the founder of the Center for Health Transformation, which champions market-based health care policies. "That's Brailer's biggest and toughest challenge."
 


9.0  Common-Sense Valuation Improvements

By MedSudser D.J. (Del.) Richter, Drichter566@cs.com, CFO Initiatives, 763-498-0047 

During the current changing economic climate, many books and publications include articles about improving a business for sale through merger and acquisition or for entering the IPO market.  As many investment bankers will tell you the IPO market today is not the panacea it was in the 1990’s. For most small businesses an IPO is not the best “exit strategy”.  

As noted in a recent article by Gabor Garai in Business Week (BW), merger and acquisitions (M&A) have out stripped the IPO market in 2003 and are scheduled to do so in 2004. Garai stated “According to research outfit Mergerstat, middle-market M&A rebounded from a low of 251 transactions, valued at $26.9 billion, during the first quarter of 2003, to 331 transactions, worth more than $42 billion, during the fourth quarter of 2003.  This year, more than 250 middle-market transactions were announced in January, 2004, alone.” 

Many companies are now in a buying mood due to increased profits, the need to fill out marketing gaps in their product lines and interest rates remaining historically low.  In addition there is a large amount of cash on the sidelines that may need to be invested as the economy continues to grow. 

As a result, companies that are anticipating an M&A transaction should provide time to get their house in order.  With the current regulations, this may take twelve months to two years. As noted in the BW article above and in books and publications by noted M&A experts, there are several important steps that must be taken to improve the value of the company and make it more salable at a price acceptable to the owner and investors. 

During more than 25 years as a CFO with hands-on M &A experience, the following suggestions have been effective for maximizing value: 

1)     Put your financials in order and think about what buyers want.  An ideal IPO requires accelerated growth rates which may not need strong operating earnings. However, acquirers want steady profit growth, healthy margins and predictable cash flows.  Improve your market niche and run the company from the buyer’s point of view for at least one year.

2)     Clearly articulate near term goals.  Buyers are interested in rigorous business plans that spell out how you will achieve your goals over the next 12 -18 months.

3)     Fill out your key management team with seasoned professionals.  CEO’s and CFO’s are often considered expendable, since an acquirer may want to put their own people in these roles.  But the operating management team is seen a key to ongoing growth and development.

4)     Present a strong case for unexploited opportunities.  Buyers are looking for products and services that can complement their offerings and access existing distribution systems. To the extent that you show you can take advantage of these opportunities with the buyer’s leverage, the more attractive your company will become.

5)     Demonstrate your ability to leverage financial strength.  Because most buyers will be making the acquisition with borrowed funds, they will respect your ability to make things happen through leverage.

6)     Hire an investment banker (M&A expert) in the beginning to help you through the entire process.

7)     Get the best accountant available.

a)     Get at least one year audited financial statements

b)     Put in strict financial controls

c)     Pay off personal loans

d)     Write off uncollectible accounts receivables and obsolete inventory

e)     Clear up tax issues

f)      Prepare restated financial statements that adjust for non-recurring items and owner “perks”.  But remember, restated earnings are not as valuable as reported earnings.

8)     Find an attorney, other than your current legal consul, who is an M&A expert.

a)      Settle all pending litigation

b)      Review environmental issues

c)      Do a mock due diligence walk through

9)     Document key relationships and essential procedures.

10) Sarbanes-Oxley requirements should be determined early so compliance can be met as necessary. 

As you position your company for an M&A exit it is important to remember that the process may take longer than anticipated.  For best results, acquire outside advisors early in the process. Early ground work can only work to your benefit and enhance the overall value of your company.  Following the above common-sense practices can help you achieve a successful conclusion when the time is right to complete the deal.


10.0   How California Proposition 71 Was Born

http://www.signonsandiego.com/uniontrib/20041219/news_1n19stemcell.html

California Stem Cell Research and Cures Act was work of eclectic group that included film director, finance expert, Republican and researcher

STAFF WRITER

December 19, 2004

Two years ago last weekend, a determined state legislator met with a group of scientists to talk about an idea eavesdroppers might have thought was far-fetched.

Over dinner at the trendy Esquire Grill in Sacramento, the group discussed putting together a coalition of patient advocates and scientists to sponsor a state bond initiative that would provide money for stem cell research.

President Bush had signed a bill a year earlier limiting the embryonic stem cell work scientists could pursue with federal dollars, and some conservatives in Congress wanted to criminalize the research.

The group at the dinner in Sacramento wanted to make California the global center for the work, which many scientists believe will one day lead to therapies for devastating diseases.

Sen. Deborah Ortiz, a Sacramento Democrat and the legislator who was at the dinner, had just failed in an attempt to get the state Legislature to commit a few million dollars a year to studying stem cells.

However, she had been successful three months earlier in getting the Legislature to approve a bill that made stem cell research legal in California.

Now she wanted to do something more ambitious. "Let's take this to the voters," Ortiz suggested to her dinner partners. A public bond initiative would be the vehicle for securing the funding that the scientists at the table thought was vital.

Out of that discussion grew Proposition 71, the bond issue voters approved last month that will make $300 million a year available for scientists in California to pursue stem cell research over the next decade.

The independent citizens' oversight committee that will govern the effort met for the first time Friday, and its goal is to start distributing the money by May.

The path from that first dinner in Sacramento to Friday's meeting of the oversight committee was an arduous one, as a core group of a few people built a network of supporters and raised millions of dollars to promote their vision.

From the beginning, the idea was for the faces of the initiative to be those of parents with sick children, people with a personal stake in helping support science that could one day lead to cures for diseases such as diabetes, Parkinson's, Alzheimer's and cancer.

Meet the Zuckers

Three months after the first dinner, a group that included such parents gathered in the Brentwood home of movie director Jerry Zucker and his wife, Janet. The Zuckers' 16-year-old daughter, Katie, was diagnosed with juvenile diabetes when she was 11.

During the previous two years, the family had logged hundreds of hours on Capitol Hill and in politicians' offices across the country lobbying for stem cell research as part of Cures Now, a patient advocacy group. They also had been active in the Juvenile Diabetes Research Foundation.

Ultimately, the Zuckers and two other affluent and politically savvy families took the lead in funding, organizing and campaigning for Proposition 71, the California Stem Cell Research and Cures Act. They spent millions of dollars on polling, lawyers and consultants before they were even assured that enough Californians would support the measure to put it on the ballot.

The three families – which also include millionaire Bakersfield home developer Tom Coleman and his wife, Polly, and Bay Area real estate finance expert Robert Klein – have widely divergent political and religious beliefs. But all have a child with juvenile diabetes.

"These families have dedication, passion and an ability to articulate to the people of California the simple hope, like all parents, to see their children into adulthood," Ortiz said.

The first meeting at the Zucker home attracted an eclectic mix.

Janet Zucker had worked the telephone, as she's known to do, inviting friends, patient advocates and nationally recognized scientists. The group of more than 30 included Zucker's friend Sherry Lansing, the head of Paramount Motion Pictures and an advocate for cancer research; Lucy Fisher, a Hollywood producer who along with her husband, Doug Wick, also were active in Cures Now; and renowned stem cell researchers such as Larry Goldstein of University of California San Diego and Irv Weissman of Stanford.

Tom Coleman, a Republican and a Catholic, remembers sitting in that first meeting at the Zuckers' home and deciding immediately that he wanted to join the effort.

His eldest child, Sarah, 28, was diagnosed with juvenile diabetes when she was 5. Despite the name of the disease, it is a lifelong affliction that can cause limb loss and organ failure and shorten life expectancy.

Bush had approved the limitations on embryonic stem cell research because the work requires the destruction of embryos, collections of 100 to 200 cells that are formed days after fertilization. The Roman Catholic Church and conservative Christian groups oppose the science because they believe the embryos are human life that should be protected.

Coleman said it is not the first time he has disagreed with the church.

"It became a very easy decision for me," he said. "Either you throw away an embryo with no designation as a human being or use it to help another human being. I don't think that violates Christian principles of the Catholic church."

Science vs. politics

The Zuckers, who are Jewish, also did not struggle with the moral issues of embryonic stem cell research.

They recalled when their daughter was first diagnosed with juvenile diabetes. She had lost about 20 pounds and was listless. Then, after an injection from a tiny glass vial, she was smiling and bounding down the halls of Children's Hospital in Los Angeles.

They say such experiences underscore the value of medical research.

"You can't help but take a minute and have gratitude for the people who invented this stuff and worked so diligently to find it," Jerry Zucker said. "The more we got into this, the more we realized how scientists really have to struggle against politics, and often religion, and small-minded people who always think (the scientists) have gone too far whether it's organ transplants or recombinant DNA. The next new thing always seems ghoulish or scary.

"But when these cures become commonplace, we are all lining up to take them," he said.

The Zuckers and the Colemans paid for early polling and political consultants to help them wade through the start-up of a voter initiative.

The early polls showed voters would embrace a bond initiative, though not by a landslide. It also showed that the more people understood stem cell research, the more likely they would be to vote to fund it, Tom Coleman said.

From the beginning, the families decided the campaign would be straightforward and educational.

"We saw that some people just didn't understand stem cell research, particularly embryonic stem cell research," Jerry Zucker said. "Some people think an embryo is a fetus. And they don't realize embryos are being discarded when they could be used for research."

While the direction of the campaign was clear, how to write a bond initiative was not.

Janet Zucker recalled talking to Peter Van Etten, president of the Juvenile Diabetes Research Foundation, about the possibility of a voter initiative. She knew she and her husband could handle the lobbying and probably the fund raising the initiative would require.

"But I thought that this bond initiative – actually writing this thing – was going to be a daunting task. Where would we start?" she said during a recent interview in the family's home.

Van Etten told Zucker about Klein, a Palo Alto-based real estate finance expert who served on the Juvenile Diabetes Research Foundation's board of directors. Klein, who also is a lawyer, wrote the California Housing Finance Act more than 20 years ago.

Janet Zucker remembered picking up the telephone to cold-call Klein, whose interest in stem cell research is a result of his son Jordan's struggle with juvenile diabetes.

"We spent three or four hours talking about it," she said. "Then he was on the phone again the next day."

Drafting the initiative

When Klein first heard about the initiative, he knew its structure would have to be creative. It needed to take into account that the state was fighting a deficit. And it needed to be structured so the bonds didn't have to be repaid until the research had time to generate scientific advances that would bring in revenue for the state.

Many people have come to think of Klein as the author of the initiative. It is not a notion he is quick to dispel.

"The initial conceptual plan took about two weeks, but actually writing the initiative took 30 drafts and about eight months," he said.

The Zuckers and the Colemans said the measure never would have been as successful without Klein's involvement. He was its voice during the last intense months of the campaign. He also formed a nonprofit organization to help appoint the citizens' oversight committee that will administer the grants.

But writing the initiative was definitely a group effort.

There were several writing sessions, consecutive days when a group that included the Zuckers, Colemans, Klein, political consultants, Goldstein and lawyers from some of the state's top firms hunkered down and hashed out the wording.

The first session, during which the group set its initial principles, produced the skeleton of what would become Proposition 71. The next several months were filled with conference calls and meetings where the families, the lawyers, the consultants and the scientists vetted every word and every statement.

Was a sentence politically sound? If so, was it legally sound?

There were complicated issues to debate – how should repayment of the bond be structured, considerations about science and intellectual property issues to address, and rules for avoiding conflicts of interest.

"We could have maybe 50 issues on the table," Tom Coleman said. "We put them in some kind of priority, but as each piece changes, all the issues related to it change. As time progressed, each detail was dealt with in much greater detail."

One of those issues was the price tag.

There was discussion about how much it might cost to create a cure for a disease like polio, Coleman said. And there was discussion about how much the National Institutes of Health spends on a particular disease.

"But you also have to look at what kind of money a particular university might need," he said. "And there was a conversation about how much we need to attract the top scientists in the world to come here, knowing that there's funding for 10 years. You can quickly reach that $3 billion figure."

The members of this group commissioned a financial analysis, which found that the initiative could easily pay for itself even if it contributed to only small advancements in health care.

Proposition 71's passage

The Zuckers, Colemans and Klein still afford themselves a few brief moments to relish the success of Proposition 71, which 59 percent of voters supported.

Jerry Zucker remembers the strength of so many people suffering from so many diseases.

"I remember seeing Christopher Reeve in Washington when we were both lobbying," he said. "I'd be getting off a plane and going to the Capitol to a lunch to make a speech or my pitch. And then there (Reeve) is. For him, every single breath was an effort. It was just so courageous for him to come and do that and speak in this way. For so many people who are suffering like that, there really is no place to turn but science."

Asked if they would like to tackle another initiative, the Zuckers and Tom Coleman laughed heartily. They will be watching closely as the independent oversight committee begins to create standards and then dole out grants. But they have no designs on serving on the committee or any of its working groups.

Klein, however, is front and center.

Long considered the front-runner for the position of chairman of the committee that will oversee spending of the $3 billion, he was the only candidate nominated for the post. The Democrat even won the endorsement of Gov. Arnold Schwarzenegger, to whose campaign he never contributed.

The 27 appointed members of the oversight committee unanimously voted him into the post at their first meeting Friday.

Klein's interest in stem cell research is a result of his 14-year-old son Jordan's battle with juvenile diabetes.

"Jordan's growing about a half inch a month right now, and the human growth hormone really throws blood sugar levels out of whack," he said during a recent interview.

"How can I turn my back on this?" asked Klein, whose father died of heart disease and whose 88-year-old mother developed Alzheimer's a decade ago.

"It's a privilege to commit yourself to something that has the potential to do as much for medicine and human suffering as stem cell research has the potential to do."

Terri Somers: (619) 293-2028; terri.somers@uniontrib.com


11.0   California Proposition 71 Faces Quagmire

from the December 20, 2004 edition - http://www.csmonitor.com/2004/1220/p03s01-uspo.html

Woes for California's stem-cell experiment

Regulation and ethical battles swirl ahead as the state figures out how to spend its $3 billion initiative.

By Mark Sappenfield | Staff writer of The Christian Science Monitor

OAKLAND, CALIF. - The debate over stem-cell research has been stirred again - this time by the unlikeliest of sources.

For months, state Sen. Deborah Ortiz has been the strongest political voice in favor of California's bid to earmark $3 billion for stem-cell research. From southern California to the halls of Washington, she took part in public forums and bandied words with the Bush administration to promote Proposition 71, the initiative that eventually passed last month.

So when she recently said the plan was so flawed that it needed to be corrected by legislative decree, Senator Ortiz gave rise to a perplexing question: What has California gotten itself into?

Only half-joking, some scientists say California is set to become NIH West - a Pacific Coast counterweight to the federal National Institutes of Health. The concern is that no state has ever attempted a scientific venture of this magnitude and complexity, and some wonder if the state can handle it.

As other states from Wisconsin to New Jersey rush to counter California's massive investment by setting aside stem-cell money of their own, California is reprising a familiar role. As the biggest and the boldest, California will most clearly delineate the promises and perils of stem-cell science for the rest of the nation, showing the limits of federalism by its success or its failure.

"There isn't a precedent for doing biomedical research independent from the federal government," says Jeffrey Kahn, director of the Center for Bioethics at the University of Minnesota in Minneapolis. "[California is] starting from a different place than anyone else."

The challenges are immense. During the past 50 years, NIH has essentially invented the protocols that govern medical study in the United States - from peer review to ethical guidelines to patient protections. Not only does California have to come up with its own set of rules and regulations, but it also must create them for a scientific field that has never existed in the US.

When President Bush decided that the federal government should not fund the creation or study of new stem-cell lines, he largely squashed a new field of scientific study - as well as the ethical questions that came with it. Now, California must meet them both head on.

"They are going to have to make up from scratch things that don't exist," says Dr. Kahn.

Even in a perfect scenario, the 29 board members of the program that will disburse some $300 million in grants each year would have a difficult job. They will have to choose which projects to fund, picking from among different areas of stem-cell research carried out by universities and biotechnology firms - all the while keeping an eye on the ethics of cloning human embryos. (While the proposition bans cloning humans for reproduction, it allows cloning so that embryos can be used to devise therapies.)

Those decisions lie ahead, however. The template for how to proceed has already generated concern. The template is the text of the ballot initiative itself, and it spreads across nine pages of the California voter's handbook. Only now, more than a month after the election, are analysts and politicians finally unraveling its intricacies, and not all like what they see.

Ortiz first pushed the idea of a stem-cell-research ballot measure, but she is troubled by some of the text. One section says that the legislature cannot amend the initiative for three years, and then only with a 70 percent supermajority. Board members who run the program aren't held to state requirements for disclosure of potential conflicts of interest. And protections for women who donate eggs - a potentially dangerous procedure - are left open.

Although Ortiz says she still supports the initiative, she is trying to pass legislation on these issues - despite the initiative's ban. She calls the measure the product of "an imperfect means of government."

Others are more critical: "This is not the sort of thing that should be done by initiative," says Marcy Darnovsky of the Center for Genetics and Society here. "How many voters went through all that fine print?"

Even supporters of Proposition 71 agree that the scientific process is often not served best by a ballot. But they suggest that the Bush administration left them with no choice. Nearly all agree that it would have been better for the federal government to pick up this work, mostly because NIH can fund the best research in the country - not just the best research in one state. In fact, some scientists suggest California might have difficulty finding enough good in-state ventures to spend $300 million a year wisely.

Yet now that the Bush administration has bowed out of ambitious stem-cell research, California's effort is an attempt to make the best of the situation. And it's a good place to start. "California is not just another state," says Robert Lanza of Advanced Cell Technology in Worcester, Mass. "It's like a country investing in scientific research."

Moreover, the processes for making good decisions are in place. The newly created California Institute for Regenerative Medicine might not be NIH, but the model is well known, and many of the people involved in California have been a part of it.

"There are no intrinsic difficulties that arise because it is a state and not the federal government," says Ira Black of the New Jersey's Stem Cell Institute in New Brunswick. "Through the peer-review mechanisms honed by NIH, there are clear guidelines in terms of proceeding."

What gives some ethicists pause, though, is the authority vested in the board members that run the California Institute of Regenerative Medicine. For instance, Prop. 71 was written in such a way that very few people other than the author Robert Klein were qualified to be nominated as chairman. Earlier this month, he was nominated.

Most observers say they still think the Institute will do its job well, and they note the importance of freeing science somewhat from the vagaries of public policy. But if California's experiment goes awry, either as a perceived money grab or as an ethical disaster, it is uncertain what anyone could do to stop it.

"It's not to say [the board] will not put [good rules] in place, but they don't have to," says Dr. Darnovsky. "This is important enough that there should not be a choice."

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