July 2010

i n s i d e

Enabling business success in the life sciences.

®

new approaches to working with diabetic patients. His address is titled “Treatment Fit in Diabetes – The Next Frontier.”

The Innovations in Diabetes Summit will highlight unmet needs of this growing population and feature some of the most promising technologies and approaches aimed at prevention, treatment, and cures. It will also serve to both introduce attendees to the scientific and business leaders who are driving innovation and stimulate networking throughout the community to help participants discover new partners and build valuable relationships. Further, it will kick off a working group that will meet quarterly to continue connecting key players and supporting new developments in the field of diabetes.

For more information and to register: https://www.lifesciencealley.org/programs_events/detail.aspx?id=514.

OMember News p2

In-Transition LifeScience Alley Membership p2

Education Programs – E-mail Marketing and Print Sponsorship Support 2010 p3

Contribution – Pens Needed for LifeScience Alley Programs & Events p3

21st Annual Alley Institute Scholarship Golf Tournament p4

Decision Makers Invited to Explore Critical Thinking Through August 19 Workshop p8

Annual UEL BBQ – 2010 p8

Following an Entrepreneur to Market p9

Alley Chats Boat Cruise & 2010 Update p9

New Member Corner p10

2010 Minnesota Tekne Awards p10

Women Leaders in Life Sciences and Health Care Come Together p10

BioSpace – BioMidwest Campaign p10

Business Referral Update for May 2010 p11

Women’s Golf Clinic p11

Featured Job Postings p11

News Bytes p12

Calendar p13

n July 14, the International Diabetes Center

at Park Nicollet will host a full day LifeScience Alley Crossroads Series event called Innovations in Diabetes Summit – Leveraging Excellence in the Upper Midwest. Experts from such leading health organizations as Mayo Clinic, the University of Minnesota, Medtronic, Cargill, UnitedHealthcare and Merck will provide high-level overviews of their advances in research and clinical care in the field of diabetes prevention, treatment and cure.

This event will also feature a panel of Type I and Type II diabetes patients who will share what it’s like to live with diabetes and offer their suggestions of what is needed, from a patient’s perspective. In addition, there will be separate panels focused on recent advancements in scientific research, clinical care and therapeutics, plus a special

panel showing some of Minnesota’s infrastructural expertise which provides critical support to the health care industry as well as the medical device and biopharmaceutical industry. The depth of knowledge in – for example – legal, clinical research, regulatory, reimbursement and marketing services in Minnesota helps give our region the edge in successfully developing new therapeutics and bringing them to patients.

A special mid-day keynote by Mayo Clinic endocrinologist Victor Montori, MD, will explore

Thirty Leaders in Diabetes to Showcase Regional Excellence in Minnesota at Summit on July 14

Victor Montori, MD

m e m b e r n e w s

r e n e w i n g m e m b e r s

Access Genetics LLCwww.access-genetics.comScott Kelly, VP Sales and Marketing

Antares Pharma, Inc.www.antarespharma.comPeter L. Sadowski, VP, Devices Group

Avnet Electronics Marketingwww.avnet.comFred Chu, Regional Technical Manager

Bayer Healthcarewww.bayerhealthcare.com/scripts/pages/en/index.phpCraig Mischo, Sr. Regional Manager, State Government Affairs

City of Blainewww.ci.blaine.mn.usCurt Larson, Economic Development Specialist

Closys Corpwww.closyscorp.comGervaise Wilhelm, President & CEO

Consulate General of Canadawww.canadainternational.gc.ca/minneapolisPaul Hansen, Trade Commissioner

Devicix, LLCwww.devicix.comRick W. Stein, VP Busines Development

Genentechwww.roche.comScott Setzepfandt, Senior Regional Manager, SGA

Gray Plant Mootywww.gpmlaw.comKermit Nash, Attorney

Greater Fargo Moorhead Economic Development Corporationwww.gfmedc.comBrian Walters, President

HealthEast Care Systemwww.healtheast.orgRoger Green, VP Strategy, Policy & Communications

Immunochemistry Technologies, LLCwww.immunochemistry.comSally A. Hed, Vice President, Marketing

Joglekar Associates, Inc.www.joglekarassociates.comAnand Joglekar, Founder & President

Katz Analytical Serviceswww.katzanalytical.comBill Katz, President

ASIC Systems, Inc.www.asicsystems.comJoseph Pagliolo, Manager

BARD Advertisingwww.bardadv.comJoseph C. Horvath, Account Director of New Business

CMC Consulting Groupwww.cmc-co.netTim Oswald, Partner

Exos Corporationwww.exosmedical.comFariborz Boor Boor, President

MEDTOX Scientific, Inc.www.medtox.comRichard J Braun, President, CEO, Chairman

Northstarwww.northstaraerospace.comJohn Eagleton, CEO

R8Scan www.r8scan.comRoger Jensen, CEO and CFO

KMI Diagnostics, Inc.www.kmidiagnostics.comMark Kowal, President & CEO

Medical Device Resource Groupwww.mdrg.orgCharlie Jones, President

MedInvent, LLChttp://nasoneb.com/William Flickinger, CEO

Metro Mold & Design, Inc.www.metromold.comDave J. O’Brien, Director of Sales

Minneapolis Heart Institute Foundationwww.mplsheartfoundation.orgJames Toscano, President

Minnesota State Colleges & Universities (MnSCU)www.mnscu.eduDr. Gail C. O’Kane, System Director for Education-Industry Partnership

MPI Researchwww.mpiresearch.comJoan Manners, Director of Marketing

Muvewww.muveinc.comJames Meyer, Chief Operating Officer

NAI Welshwww.welshco.comEric Dueholm, Vice President Corporate Services

Neuromics, Inc.www.neuromics.com Brett J. Schroeder, Director of Operations

Nimlok Minnesota/ABF Display Companywww.nimlok-minnesota.comSteven A. Miller, Exhibit Consultant

Olsson, Frank and Weeda, P.C.www.ofwlaw.com Neil F. O’Flaherty, Principal

PlaCor, Inc.www.placorinc.comDr. Bill S. Haworth, President & Chief Technical Officer

Principal Financial Groupwww.principal.com Alyssa J. Kreutzfeldt, Marketing Director

n e w m e m b e r s

Ridgewater Collegewww.ridgewater.edu Jenni Swenson, Dean of Liberal Arts and Sciences

Rockwell Automationwww.rockwellautomation.comSidney J. Solazzo, Life Sciences Business Development Manager

Shatin Associates, LLCshatin-associates.comDr. Deborah Shatin, Principal

Start Recruitingwww.startrecruiting.comLee Waldron, President

Surgical Technologies, Inc.www.scanlangroup.comTimothy Scanlan, President & CEO

Twin Star Medical, Inc.www.twinstarmedical.comJim Stice, President

Uroplasty, Inc.www.uroplasty.comSusan Hartjes Holman, Chief Operating Officer

Vital Images, Inc.www.vitalimages.comKim Tucker, Marketing Director

In-Transition LifeScience Alley MembershipIn light of the challenging job market we know many of you are facing, LifeScience Alley is extending a six month In-Transition Membership to individuals formerly employed with member companies. We hope that this will help keep you connected to our strong network.

The In-Transition Membership allows many of the traditional membership benefits, including access to the online member directory and the ability to register for all education programs at the member rate.

If you are interested in becoming an in-transition member, please submit your name and contact information to lsteffel@lifesciencealley.org.

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ifeScience Alley is offering a new sponsorship to help

support our Shared Interest Group (SIG) education programs. Our Education department produces 80+ SIG programs each year currently focused on topics in:

• Biotechnology

• Clinical Studies

• Manufacturing/Quality

• Marketing

• Regulatory Affairs

• Reimbursement

• Research & Development

• And other Featured programs

These programs are designed to keep life science professionals up-to-date on policies, regulations, and technology advances that help them to better perform their jobs and contribute to the success of their organizations.

Sponsorship Details

All of our education programs are marketed to a diverse group of life science

professionals and decision makers via e-mail, and most programs include printed handouts of speaker presentations available to all attendees. Sponsors will receive the following benefits and exposure:

• “E-mail Sponsored by: ‘Hyperlinked organization name’ ” (URL of sponsor’s choice) placed prominently in weekly Program Calendar e-mails (distributed every Tuesday) – sent to over 12,000 life science professionals in MN and Midwest

• “Printing Sponsored by: ‘Organization name’ ” and logo to appear in black & white on front page of all printed presentation handouts available onsite at education programs – our 40+ programs are held in a 6-month period, with 25 – 150 attendees, depending on the program

Target Audience

Program attendees typically represent middle management and above in medical devices, diagnostics, biotechnology, pharmaceuticals, academia, and health care delivery.

Available Options

Sponsorships are available for 6-month periods; the next available period is July – December 2010. Sponsorships are NOT industry category exclusive. All Sponsorships are available on a first-come, first-served basis and can

only be reserved with a signed reservation form and payment.

• One $4,000 sponsorship (earns exclusivity for 6 months*)

OR

• Up to three $1,500 shared sponsorships are available per 6-month period

Questions

Contact Ryan Baird, Communications Manager, at 952-746-3818 or rbaird@lifesciencealley.org to find out more.

Education Programs – E-mail Marketing and Print Sponsorship Support 2010

L

Contribution – Pens Needed for LifeScience Alley Programs & Events

LifeScience Alley would like to thank member companies Intertek, Kablooe Design, and Kluge Design Inc. for providing pens to be used at our programs and events.

We are always in need of pens for our programs, so if you or your organization is interested in an opportunity to help our education department and to raise the profile of your business, please send pens to:

LifeScience Alley Attn: Sharon Hollister 1550 Utica Avenue South, Suite 725 St. Louis Park, MN 55416

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MedCity News. Your Next Generation News Source.

MedCity News is your source for news

that brings together the business,

innovation and influence of health care.

With in-depth insight and a robust reader

community, MedCity News covers health

care by reporting on topics and starting

conversations.

Find us online at www.medcitynews.com,

Facebook, Twitter, YouTube and on your

Kindle today!

Join us this year for a fabu-lous day of golf in support of a good cause on one of the premier courses in Minnesota! The tournament sponsorships raise funds for students interested in careers in the life sciences.

This year, the tournament will be held at the Golden Valley Golf & Country Club, providing a challenging experience for players while helping a good cause. We use a scramble format so players of all abilities can participate, and the day

concludes with an awards banquet where players can network together.

Playing in the Tournament

The Player Registration Early Bird deadline is July 30, so register online now to save. Players may sign up individually or in foursomes. View registration details online.

Sponsorships

A variety of sponsorships are available, ranging from $500 – $5,000. See more details online.

Thank You to Our Sponsors To-Date

Medpoint, LLC, Lommen, Abdo, Cole, King & Stageberg, P.A., Pace Analytical Life Sciences, Patterson Thuente, Kluge Design Inc., Adolfson & Peterson Construction, Scales Advertising, and The BioBusiness Alliance of Minnesota.

Questions? Call Michelle Holker at 952-746-3822 or e-mail mholker@lifesciencealley.org.

About Alley Institute

Alley Institute is committed to provide actionable solutions to help increase the awareness of career options in the life sciences, and to help ease the work force shortage in these specialized fields. Raising funds through the Scholarship Golf Tournament is a tangible way to make a difference in this effort.

21st Annual Alley Institute Scholarship Golf TournamentSeptember 13, 2010 – Golden Valley Golf & Country Club

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Register Online— Enter code LSAMEM to receive $100 off the current registration price!

CardioTec is the first and only conference dedicated to cardiovascular device manufacturers and will explore manufacturing issues through a specialized agenda and line-up of speakers.

CardioTec launches: September 15, 2010

The Northland Inn & Conference Center

Minneapolis, Minn.

In one day, you’ll benefit from the showcase of a select group of suppliers, ample networking and quality, relevant conference sessions including topics such as:

• Lean Manufacturing in Today’s Environment• Avoiding Common Stumbling Blocks of Effective Product Transfer • FDA Regulations and Phases I-III of Device Development• Maintaining Quality While Tackling Pricing Pressures• Tactics to “Fast Track” Product Release and Commercialization

CardioTec is a Medical Product Outsourcing event — Leaders in providing information and networking to medical device manufacturing professionals.

A Medical Product Outsourcing Event

A Medical Product Outsourcing Event

A Conference Offering Opportunities & Solutions for Cardiovascular Device Manufacturers

For sponsorship and speaking opportunities, contact Howard Revitch 201-880-2243 | howard@rodpub.com

Register Today —

www.cardiotec.com

September 15, 2010 • The Northland Inn & Conference Center • Minneapolis, Minn.

SPONSORS

Get real-time updates on this Medical Product Outsourcing event.

Find us on:

SUPPORTING COMPANY

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Visit the conference website: www.LifeScienceAlleyConference.org

Seminar Tracks:

Therapeutics

Diagnostics

Health IT

Market Development

Finance

International

Talent & Management

DECEMBER 8, 2010Minneapolis Convention Center Minneapolis, Minnesota

What is the future of health care innovation?

Innovators from research organizations, start-ups, established companies, and health care organizations will present their visions of new technologies and delivery models, with a focus on disease prevention, diagnosis, and intervention.

2009 ATTENDANCE

1,400 People33 States8 Countries650+ Organizations

Many of the University of Minnesota’s research centers and institutes look forward to the Annual LSA Conference & Expo as a unique and valuable opportunity to meet and exchange ideas and information with the life science community. There is no other place that can compare to the effectiveness of the University’s participation in the LifeScience Alley Conference & Expo for meeting and sharing information with like-minded professionals.”

Elaine NissenThe Of ce of Business RelationsUniversity of Minnesota

“

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Visit the conference website: www.LifeScienceAlleyConference.org

Exhibit Hall has SOLD OUT the Past Five Years!

Sponsorship OpportunitiesPlease visit the conference website for the most current listing of available sponsorship opportunities.

SPONSORS as of 6/22/10

Sponsor trademarks are the sole property of the sponsoring company or organization and their use here does not imply endorsement of the sponsoring company or organization or any of its subsidiaries.

A range of high-impact sponsorship opportunities are available to t every budget

Expanded Expo Hall oor offers new

premium booth spaces

Premium Closing Booth Reception Sponsor

Don’t miss your opportunity to maximize your exposure — reserve your space today!

Sign Up Today! Contact The Event Group, Incorporated at

(763) 548-1307 or sponsorshipsales@eventshows.com for additional information and pricing.

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Our lives are filled with important decisions – both personal and professional. Many are low-risk, but some – especially in the bioscience and health fields – have much more serious implications. To make better decisions and increase our odds of a good outcome, we need to develop our ability to think critically.

With experienced leaders as our guides, it is possible

to learn how to recognize and assess the influences that get in the way of good decision making and make a shift away from biased actions and reactions. This starts with paying attention to our behavior even as we are in the process of think-ing.

The ‘’Critical Thinking for Decision Makers’’ class – led by a highly respected senior scientist/engineer

from Medtronic and an organizational educator with deep experience at Fortune 500 firms – is being offered for the first time through LifeScience Alley to help participants build their abil-ity to think critically based on three perspectives:

1) Brain-wiring: predictable ways that our brains process and interpret information

2) Personal: influences that come from personal experience, education and culture

3) Group dynamics: unique influences that emerge when we work together in groups to solve problems and make decisions.

Learning Outcomes:

After attending this highly engaging and interactive workshop, participants will be able to:

• Recognize and learn to avoid common influences that can result in poor decisions

• Assess bias in self and others

• Manage group interactions to improve the decision-making process and drive toward more successful outcomes

To register: https://www.lifesciencealley.org/programs_events/detail.aspx?id=523.

Decision Makers Invited to Explore Critical Thinking Through August 19 Workshop

Let’s cut to the quality.Let’s cut to the quality.

FULLY AUTOMATED: | CAPA | Nonconformances | Complaint Handling| eMDR| Supplier Quality | Audits & Findings| Change Control | Risk Management| & More

1.888.9.ASSURX • www.assurx.com

No hype. No buzzwords. Just quality done right.

When you want a quality and compliance management system that reaches as far as your business does; provides the

control to guarantee every issue is being solved no matter where its source; and performs perfectly for even the most

complex processes—cut straight to AssurX.

Annual UEL BBQ – 2010

University Enterprise Laboratories is holding its annual BBQ on July 21, 2010, from 3 – 7 p.m.

It will be held at the UEL campus: 1000 Westgate Drive, St. Paul, MN 55114

To attend, please RSVP by July 9th to info@uelmn.org or call Donna at 651-641-2804.

8

n early 2009, LifeScience Alley News featured a story on product design-

er and entrepreneur Tracy D. Sigfrid. At the time, Tracy was in the early stages of developing several medical products, one of which is a novel technology used in tracheotomies.

Now, over a year later, Tracy has taken on a new chal-lenge by successfully launch-ing two companies in the past six months. Today she is President of both Ventum, Inc., and Product Technolo-gies Design (Ptech Design).

She started with the incor-poration and launch of Ventum, Inc., in November of 2009, and quickly moved forward to establish an advi-sory board for the company. Taken from the Latin word for “wind”, Ventum aptly describes this respiratory company. One of Ventum’s medical products – the Trach-Tapeze – was recently evaluated by the Medical Industry Leadership Insti-tute (MILI) Valuation Lab at the University of Min-nesota Carlson School of Management. The product was issued a 510K Device Exemption by the FDA and is patent pending. The Ventum Advisory Board is currently seeking angel investors to raise seed capi-tal. The company is plan-ning to license the product to an established respiratory company to produce and market the product.

In February of 2010, Tracy launched her second com-pany, Product Technologies Design (Ptech Design). This multi-faceted company has grown quickly and has expanded to include an “incubator group” for other product developers. The list includes a variety of clients from both Minnesota and out of state. Ptech Design has built an outstanding management team and staff by attracting a variety of top talent, increasing the team from one to twelve mem-bers as of June 2010. For more information on the Ptech Idea Team, log on to www.ptechdesign.com.

Ptech recently launched a new product – Custom Comfort Pads – that is gain-ing recognition and strong support from participants in a cross-section of individual and team sports markets. These high performance pads are a solution to replace band-aids, “mole skin”, carpet padding, cos-metic sponges or any other make-shift item athletes typically use – in any kind of shoe, helmet or other type of sports equipment. This professional-grade prod-uct features an industrial

strength adhesive, sturdy Latex-free closed cell foam and a unique top layer that wicks away moisture. For more information on the pads visit: www.Custom-ComfortPads.com.

Ptech also collaborates with alliance partners to assist clients with product devel-opment, including patents and commercialization. The company has formed an alli-ance with colleagues from other companies – including medical device companies – to work with Ptech clients in the U.S. Ptech is also

collaborating with exporter Tushar Gupta, President of Sanguine International, as a future pathway to market products in India. The com-pany is currently seeking angel investors to raise capi-tal for continued marketing of products in the U.S. and abroad. The company has several products for licens-ing and IP sale.

Tracy D. Sigfrid is the President of Ventum, Inc., and Ptech Design, and can be reached at tracy@ptechdesign.com or 763-754-9801.

Following an Entrepreneur to Market

I

Tracy D. Sigfrid

Alley Chats Boat Cruise & 2010 Update

Only 3 Alley Chats remain for 2010:

July 15 Boat Cruise (Mississippi River) – registration opens early June ($65 to attend)

September 16 Minnetronix ($25 to attend)

November 11 Medtronic – CRDM Headquarters ($25 to attend)

LifeScience Alley has hosted these valuable “Knowledge Bridging” events over the past five years to help link life science industry resources. Nowhere else can engineering, regulatory, clinical, marketing, product development, busi-ness development, facilities and people from MANY other disciplines get together to discuss areas of shared interest.

For this reason, we describe Alley Chats as: “A networking event engaging LifeScience Alley members to collaborate in sharing resources, discussing topics of mutual interest, and improving the status of the industry.”

We would like to thank our Boat Cruise sponsors – Consul-ate General of Canada, Amphenol Medical, and Underwrit-ers Laboratories for making the July 15 event possible.

All hosting and sponsoring opportunities for 2010 are SOLD OUT. If your organization is interested in host-ing or sponsoring a 2011 Alley Chats Networking Recep-tion, please visit us online for more info, or contact Frank Jaskulke, Member Services Manager, at 952-746-3814.

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n e w m e m b e r c o r n e r

ASIC Systems, Inc.www.asicsystems.com

Main Contact: Joe Pagliolo, PresidentPhone: 763-586-0820E-mail: info@asicsystems.comYear Founded: 1996Headquarters: Minneapolis, MN

Key Products/Services:

ASIC Systems, Inc.(ASI) was founded 14 years ago to provide support and design services for the development of mixed-mode (mixed-signal) application specific integrated circuits (ASIC’s). ASI’s particular technical expertise is in the area of low voltage, low power (and micro-power) analog integrated circuits (IC’s) and custom digital cells.

Organization Overview:

ASI was founded with the goal of making the capabilities of custom integrated circuits (IC’s) accessible to small and midsize companies. Custom IC’s are not just for large companies with high product volumes any longer. The maturity of full-custom and semi-custom IC technology, and the resulting reduction in cost and development risk, has made the competitive advantages of IC’s available to companies that may not have previously considered this approach feasible. To accomplish our goal, ASI has developed services that can guide companies though all stages of an IC development project, from initial feasibility analysis and planning, to production support.

LifeScience Alley’s annual summer Women’s Leader-ship Luncheon will be held at the Golden Valley Golf and Country Club on August 12, offering excellent net-working opportunities. It will also provide participants with an overview of the LifeScience Alley’s Women’s Leadership Roundtable program – which will launch its 4th circle in the fall.

In today’s health care and life science business environment, having a strong and diverse network is especially important. Greater connectivity leads to a better understanding of the shifting landscape and

Women Leaders in Life Sciences and Health Care Come Together

provides a source of inno-vation across interrelated industries. Beyond that, cultivating a close group of ‘’go to’’ people and mentors on whom to rely as a sound-ing board for professional advice is a key ingredient among women leaders who thrive. This luncheon offers an opportunity to build new bridges with exceptional people.

Space at the luncheon is limited to 100 attendees. For more information and to register, please visit: https://www.lifesciencealley.org/programs_events/detail.aspx?id=521

BioMidwest: Put your company ON THE MAP

BioSpace is excited to announce that we will be launching the next edition of the BioMidwest branding and marketing campaign this July. Join the BioSpace community of 400,000+ industry professionals, executives and investors via the BioMidwest 2010 branding and marketing campaign. Reach this vast and targeted audience with your news, recruitment, partnering/licensing, product/service and investor message. Visit www.biospace.com/biomidwest and contact Ryan Guensch at 732-746-2283 or ryan.guensch@biospace.com for details.

2010 Minnesota Tekne Awards

APPLICATION DEADLINE EXTENDED: JULY 9, 2010

The Minnesota Tekne Awards honor companies, innovations and individuals that positively impact Minnesota’s technology-based economy. The Tekne Awards began in 2000, and are presented by the Minnesota High Tech Association, in partnership with the BioBusiness Alliance of Minnesota, LifeScience Alley and Enterprise Minnesota.

Applying for a Tekne can bring extensive visibility to an organization and provides great opportunities to celebrate and promote products and leaders within an organization. Apply here.

For more information, visit www.tekneawards.org.

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Featured Job Postings

Principal Design Assurance EngineerAGA Medical Corporation

Sr. Quality EngineerAcist Medical Systems, Inc.

Sales Engineer, Medical (Minneapolis)Sciemetric Instruments

Principal Reimbursement Analyst – SQDMMedtronic, Inc.

Job Board – A Workforce Development Tool The job board is an excellent tool for recruiting highly-skilled talent to fill positions in the Twin Cities and surrounding areas. It is also the 2nd most highly-trafficked area on our website.

Details• All organizations signing up for membership or renewing

membership in 2009 and beyond will receive one free posting to be used at any time

• Postings are only $50 for members and $75 for non-members

Please take advantage of this opportunity to extend the reach of your organization’s name to our life sciences students and job-seekers.

Visit the job board at www.lifesciencealley.org/careers.

We have documented over 250 referrals for the month of May. These connections include helping member companies to identify key business partners and ser-vice providers necessary to their business initiatives.

In May, we:

• Referred a large medical device company to an engineering consultant to assist in new product development

• Referred a start-up diagnostics firm to a potential strategic partner

• Referred an academic researcher to an industry contact for commercial support

How We Can Help YouIf you or anyone else in your organization is looking for partners or solution provid-ers, please contact a Life-Science Alley staff member and make a request.

Business Referral Update for May 2010

What sort of help can we provide?

• Identify researchers who can assist in specific projects from academic institutions, health care settings or private industry.

• Identify available talent for hire or resource providers that can assist in the process.

• Identify vendors and solution providers in IT, Operations, HR, Finance and specialized areas of the life

sciences such as clinical research, regulatory, reimbursement, product development and more.

• Identify potential strategic partners for product development.

What sort of help won’t we provide?

• We will not provide contact information of members for the purposes of solicitation.

For more information, contact Frank Jaskulke at 952-746-3814 or fjaskulke@lifesciencealley.org. Women’s Golf Clinic

Thank you to all of the women who participated in LifeScience Alley’s first Women’s Golf Clinic on Wednesday, June 30, at the Brookview Golf Club. Also, a big thank to our friends at Scales Advertising for all of their help and support in producing this event.

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n e w s b y t e sScientists reveal the mystery of sudden cardiac deathThe pioneering research, using detailed computer models, could help save lives through preventative treatment of those most at risk from a form of heart rhythm disorder called sick sinus syndrome. This occurs when the activity of the heart’s pacemaker, the sinoatrial node, is impaired. Up to now, no-one has been able to work out why this happens. R&D Magazine

CMS, FDA sign MOU, paving the route for devices to get to market fasterA new memorandum of under-standing (MOU) between the FDA and Centers for Medicare & Medicaid Services (CMS) could eventually accelerate the regulatory route for PMA devices. The agreement, which was signed last week and will go into effect next month, will allow the FDA and CMS to share confidential information about a submission on a more regular basis. The MOU could lead to a dual-approval process for PMA devices between the agencies in which the FDA would make the safety and efficacy decision while CMS determines whether to reim-burse for the device. Devices & Diagnostics Letter

Burdensome regulation is barrier to investigatorsThe regulatory environment in the U.S. and Western Europe is largely responsible for a decline in the number of physi-cians willing to participate in clinical trials in those regions, according to a survey. Seventy percent of U.S. and Western

European physicians participat-ing in the survey, conducted by the Association of Clinical Research Organizations and the Academy of Pharmaceuti-cal Physicians and Investiga-tors, said the current regulatory environment – including medi-cal liability, conflict-of-interest rules and disclosure require-ments – is making clinical trials difficult to manage. Clinical Trials Advisor

Finding a funding ally in Defense Dept.Small businesses turn to the Defense Department for money now that angel invest-ments and venture capital are weaker. Entrepreneur David Reamer is looking for fund-ing for his business, which is developing sensors to detect dangerous gases as far as a kilometer away. But he’s not asking angel investors or ven-ture capital firms for money. Instead, Reamer is courting the U.S. Defense Department. Star Tribune

Senator urges FDA to improve orphan drug developmentTo spur orphan drug develop-ment, the FDA should develop a system to prioritize the top 100 rare diseases, Sen. Sam Brownback (R-Kan.) said dur-ing a Senate subcommittee hearing. The FDA needs to collaborate with industry, aca-demia and federal agencies to “quarterback” therapies under an accelerated review process, Brownback said. The agency is already addressing this need, FDA Deputy Commissioner for Science and Public Health Jesse Goodman said, pointing to a Rare Disease Repurposing

Database of 235 FDA-approved treatments that might be use-ful in treating orphan diseases. Drug Industry Daily

FDA, NIH aim to cultivate personalized medicineFDA Commissioner Margaret Hamburg and NIH Direc-tor Francis Collins said their agencies are working together to advance personalized medicine, which includes gene therapy and diagnostic tests. The initiative includes a regula-tory pathway for gene tests and treatments as well as research centers specializing in such products. Reuters

Medtronic to unveil Patient Care Center program in ChinaMedtronic will introduce on Aug. 8 its Patient Care Center pilot program in Beijing to discuss the benefits and cost of cardiovascular implantation procedures with prospective patients free of charge, said Jean-Luc Butel, group presi-dent of the firm’s international unit. Butel said the initiative can help spare patients from waiting in long lines at outpa-tient clinics of their providers. Medical Devices Today/The Gray Sheet

MOJO Minnesota agitates for startupsA group of entrepreneurs, investors, attorneys and other business leaders have come together to launch a new organization called Mojo Minnesota. The group, which held its official launch party last month, wants to drum up excitement and generate self confidence among the state’s startups and policy makers, with a mix of community-building events and grass-roots activism. Part of the group’s role will be to advocate for public-policy changes that sup-

port innovation. Members lob-bied in support of the recently passed angel-investor tax credit. The law awards angel investors a tax credit worth 25 percent of their investment in a Minnesota startup company. Minneapolis/St. Paul Business Journal

Pfizer announces creation of rare disease research unitPfizer Inc. recently announced the creation of a new Research Unit focused on rare diseases. This new unit will significantly expand Pfizer’s presence in rare disease research with the goal of discovering novel, life-saving medicines for diseases affecting less than 200,000 patients. Its creation within Worldwide Research and Development represents a further step in Pfizer’s strategy to apply our strong science and technology base to find innovative new treatments for patients with large unmet medical needs. Bioresearch Online

EnteroMedics stock jumps 108%The Roseville company says its anti-obesity medical device has promising results in two patient studies. Shares of EnteroMedics Inc. soared 108 percent on June 22 on positive news about the unique obesity-fighting medical device. Two patient studies indicated that the company’s Maestro System “shows our technology works and we’re here to stay,” said Chief Financial Officer Greg Lea. EnteroMedics has developed an implanted pace-maker-like device that sends intermittent electrical impulses to the vagus nerve, which tells the brain when the stomach is empty. The technology blocks impulses that make people overeat. The Star Tribune

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The Issue of Ethics – Clinical Trial Design Ethics, to be exact

July 20 8 – 9:30 a.m.Presented by: Regulatory Affairs SIG

Speaker: Jeffrey Kahn, PhD, MPH, Director, Center for Bioethics, University of Minnesota

Location: DoubleTree Park Place Hotel

Adverse Events Reporting: Fun, Fact, Fantasy or Fiction?

July 21 8 – 9:30 a.m.Presented by: Clinical Studies SIG

Speaker: Debbi Lindgren-Clendenen, RN, MN, GNP-BC, Principal Consultant, CME Consulting, LLC

Location: Hamline University Minneapolis – St. Louis Park, MN

c a l e n d a rInnovation in Diabetes Summit

July 14 8 a.m. – 4:30 p.m. (luncheon included)

A LifeScience Alley Featured Program

Lead Sponsor: Dorsey & Whitney LLP

Sponsored by: American Diabetes Association, The BioBusiness Alliance of Minnesota, and MedCity News

Speakers: View a full list of speakers online

Location & Host: International Diabetes Center at Park Nicollet Clinic – St. Louis Park, MN

Alley Chats Boat Cruise (Members Only)

July 15 6 – 9 p.m.Presented by: LifeScience Alley

Sponsored by: Amphenol Medical Solutions, Underwriters Laboratories, and the Consulate General of Canada

Location: Boom Island Park, Downtown Mpls

All programs are posted to the website approximately one month in advance. All events are subject to change. lifesciencealley.org

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Women’s Leadership Summer Luncheon

August 12 11 a.m. – 1 p.m.

A LifeScience Alley Featured Program

Speaker: Sue Horvath, CMA, Chief Financial Officer, VP Operations and HR, Hemosphere, Inc

Location: Golden Valley Golf & Country Club

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Applications and Benefits of Printed Electronics in the Life Sciences

July 27 8 – 9:30 a.m.Presented by: R&D SIG

Speaker: John M. Heitzinger, PhD, Vice President of Technology, Soligie, Inc.

Location: Hamline University Minneapolis – St. Louis Park, MN

WebMD’s Best Practices for Engaging Patients and Physicians Online

July 29 8 – 9:30 a.m.Presented by: Marketing SIG

Speaker: Steve Peck, Director of Strategic Accounts, WebMD Corporation

Location: Hamline University Minneapolis – St. Louis Park, MN

Member Breakfast July 2010

July 30 8 – 9:30 a.m.Presented by: LifeScience Alley

Location: Risdall Marketing Group – New Brighton, MN

Critical Thinking for Decision Makers Workshop

August 19 8 a.m. – 5 p.m.

A LifeScience Alley Featured Program

Speakers: Darrel F. Untereker, PhD, VP Corporate Research & Technology, Medtronic, Inc.; Richard R. Gillen, PhD, Organizational Educator & Consultant, Benay Group LLC

Location: Hamline University Minneapolis – St. Louis Park, MN

21st Annual Scholarship Golf Tournament

September 13 11 a.m. – 7 p.m. (shotgun start at 11:30 a.m.)Presented by: Alley Institute

Location: Golden Valley Golf & Country Club

Players register before Friday, July 30, to receive Early Bird rates

LifeScience Alley News is published by LifeScience Alley 12 times per year. Its primary purpose is to provide life sciences industry and association news of interest to our membership. The deadline for editorial, advertising, and event information is the 10th of the month prior to publication.

For information on advertising in LifeScience Alley News or for address corrections, call 952.542.3077 or e-mail info@lifesciencealley.org.

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