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  • 1. ® Enabling business success in the life sciences. July 2010 Thirty Leaders in Diabetes to Showcase Regional inside Excellence in Minnesota at Summit on July 14 Member News p2 O n July 14, the new approaches to working In-Transition LifeScience Alley Membership p2 International with diabetic patients. His Diabetes Center address is titled “Treatment Education Programs – E-mail at Park Nicollet will host Fit in Diabetes – The Next Marketing and Print Sponsorship Support 2010 p3 a full day LifeScience Frontier.” Alley Crossroads Series Contribution – Pens Needed The Innovations in Diabetes for LifeScience Alley Programs & event called Innovations Summit will highlight Events p3 in Diabetes Summit – unmet needs of this Leveraging Excellence in the 21st Annual Alley Institute growing population and Scholarship Golf Tournament p4 Upper Midwest. Experts feature some of the most from such leading health Decision Makers Invited to Explore promising technologies organizations as Mayo Critical Thinking Through August 19 Victor Montori, MD and approaches aimed at Workshop p8 Clinic, the University of prevention, treatment, and Minnesota, Medtronic, panel showing some of Annual UEL BBQ – 2010 p8 cures. It will also serve to Cargill, UnitedHealthcare Minnesota’s infrastructural both introduce attendees to Following an Entrepreneur to and Merck will provide expertise which provides Market p9 the scientific and business high-level overviews of critical support to the leaders who are driving Alley Chats Boat Cruise & 2010 their advances in research health care industry as Update p9 innovation and stimulate and clinical care in the field well as the medical device networking throughout New Member Corner p10 of diabetes prevention, and biopharmaceutical the community to help treatment and cure. industry. The depth of 2010 Minnesota Tekne Awards p10 participants discover new knowledge in – for example Women Leaders in Life Sciences and This event will also feature partners and build valuable – legal, clinical research, Health Care Come Together p10 a panel of Type I and Type relationships. Further, it regulatory, reimbursement II diabetes patients who will kick off a working group BioSpace – BioMidwest Campaign and marketing services p10 will share what it’s like to that will meet quarterly to in Minnesota helps give live with diabetes and offer continue connecting key Business Referral Update for our region the edge in their suggestions of what players and supporting new May 2010 p11 successfully developing new is needed, from a patient’s developments in the field Women’s Golf Clinic p11 therapeutics and bringing perspective. In addition, of diabetes. them to patients. Featured Job Postings p11 there will be separate For more information panels focused on recent A special mid-day News Bytes p12 and to register: https:// advancements in scientific keynote by Mayo Clinic Calendar p13 www.lifesciencealley.org/ research, clinical care and endocrinologist Victor programs_events/detail. therapeutics, plus a special Montori, MD, will explore aspx?id=514.
  • 2. 2 member news renewing members Access Genetics LLC Devicix, LLC KMI Diagnostics, Inc. Ridgewater College www.access-genetics.com www.devicix.com www.kmidiagnostics.com www.ridgewater.edu Scott Kelly, VP Sales and Rick W. Stein, VP Busines Mark Kowal, President & CEO Jenni Swenson, Dean of Liberal Marketing Development Arts and Sciences Medical Device Resource Group Antares Pharma, Inc. Genentech www.mdrg.org Rockwell Automation www.antarespharma.com www.roche.com Charlie Jones, President www.rockwellautomation.com Peter L. Sadowski, VP, Devices Scott Setzepfandt, Senior Regional Sidney J. Solazzo, Life Sciences MedInvent, LLC Group Manager, SGA Business Development Manager http://nasoneb.com/ Avnet Electronics Marketing Gray Plant Mooty William Flickinger, CEO Shatin Associates, LLC www.avnet.com www.gpmlaw.com shatin-associates.com Metro Mold & Design, Inc. Fred Chu, Regional Technical Kermit Nash, Attorney Dr. Deborah Shatin, Principal www.metromold.com Manager Greater Fargo Moorhead Dave J. O’Brien, Director of Sales Start Recruiting Bayer Healthcare Economic Development www.startrecruiting.com Minneapolis Heart Institute www.bayerhealthcare.com/scripts/ Corporation Lee Waldron, President Foundation pages/en/index.php www.gfmedc.com www.mplsheartfoundation.org Surgical Technologies, Inc. Craig Mischo, Sr. Regional Brian Walters, President James Toscano, President www.scanlangroup.com Manager, State Government HealthEast Care System Timothy Scanlan, President & CEO Affairs Minnesota State Colleges & www.healtheast.org Universities (MnSCU) Twin Star Medical, Inc. City of Blaine Roger Green, VP Strategy, Policy www.mnscu.edu www.twinstarmedical.com www.ci.blaine.mn.us & Communications Dr. Gail C. O’Kane, System Jim Stice, President Curt Larson, Economic Immunochemistry Technologies, Director for Education-Industry Development Specialist Uroplasty, Inc. LLC Partnership www.uroplasty.com Closys Corp www.immunochemistry.com MPI Research Susan Hartjes Holman, Chief www.closyscorp.com Sally A. Hed, Vice President, www.mpiresearch.com Operating Officer Gervaise Wilhelm, President Marketing Joan Manners, Director of & CEO Vital Images, Inc. Joglekar Associates, Inc. Marketing www.vitalimages.com Consulate General of Canada www.joglekarassociates.com Muve Kim Tucker, Marketing Director www.canadainternational.gc.ca/ Anand Joglekar, Founder & www.muveinc.com minneapolis President James Meyer, Chief Operating Paul Hansen, Trade Commissioner Katz Analytical Services Officer www.katzanalytical.com NAI Welsh new members Bill Katz, President www.welshco.com ASIC Systems, Inc. Eric Dueholm, Vice President www.asicsystems.com Corporate Services Joseph Pagliolo, Manager Neuromics, Inc. BARD Advertising www.neuromics.com www.bardadv.com Brett J. Schroeder, Director of In-Transition LifeScience Alley Membership Operations Joseph C. Horvath, Account Director of New Business In light of the challenging job market we know many Nimlok Minnesota/ABF Display CMC Consulting Group Company of you are facing, LifeScience Alley is extending a six www.nimlok-minnesota.com www.cmc-co.net Tim Oswald, Partner month In-Transition Membership to individuals formerly Steven A. Miller, Exhibit Consultant Exos Corporation employed with member companies. We hope that this will www.exosmedical.com help keep you connected to our strong network. Olsson, Frank and Weeda, P.C. Fariborz Boor Boor, President www.ofwlaw.com The In-Transition Membership allows many of the Neil F. O’Flaherty, Principal MEDTOX Scientific, Inc. www.medtox.com traditional membership benefits, including access to the PlaCor, Inc. Richard J Braun, President, CEO, www.placorinc.com online member directory and the ability to register for all Chairman Dr. Bill S. Haworth, President & education programs at the member rate. Chief Technical Officer Northstar www.northstaraerospace.com If you are interested in becoming an in-transition member, Principal Financial Group John Eagleton, CEO www.principal.com please submit your name and contact information to Alyssa J. Kreutzfeldt, Marketing R8Scan lsteffel@lifesciencealley.org. Director www.r8scan.com Roger Jensen, CEO and CFO
  • 3. 3 Education Programs – E-mail Marketing and Print Sponsorship Support 2010 L ifeScience Alley professionals and decision Target Audience only be reserved with a is offering a new makers via e-mail, and Program attendees signed reservation form and sponsorship to help most programs include typically represent middle payment. support our Shared Interest printed handouts of speaker management and above • One $4,000 sponsorship Group (SIG) education presentations available to in medical devices, (earns exclusivity for 6 programs. Our Education all attendees. Sponsors diagnostics, biotechnology, months*) department produces 80+ SIG will receive the following pharmaceuticals, academia, programs each year currently benefits and exposure: and health care delivery. OR focused on topics in: • Up to three $1,500 shared • “E-mail Sponsored Available Options sponsorships are available • Biotechnology by: ‘Hyperlinked • Clinical Studies organization name’ ” Sponsorships are available per 6-month period (URL of sponsor’s choice) for 6-month periods; the • Manufacturing/Quality placed prominently in next available period is Questions • Marketing weekly Program Calendar July – December 2010. Contact Ryan Baird, • Regulatory Affairs e-mails (distributed Sponsorships are NOT Communications Manager, • Reimbursement industry category exclusive. every Tuesday) – sent to at 952-746-3818 or rbaird@ • Research & Development All Sponsorships are lifesciencealley.org to find over 12,000 life science • And other Featured available on a first-come, out more. professionals in MN and programs first-served basis and can Midwest These programs are • “Printing Sponsored by: designed to keep life science ‘Organization name’ ” and professionals up-to-date on logo to appear in black policies, regulations, and & white on front page of technology advances that help all printed presentation them to better perform their handouts available onsite jobs and contribute to the at education programs success of their organizations. – our 40+ programs are Sponsorship Details held in a 6-month period, with 25 – 150 attendees, All of our education depending on the programs are marketed to a program diverse group of life science 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
  • 4. 4 21st Annual Alley Institute Scholarship Golf Tournament September 13, 2010 – Golden Valley Golf & Country Club Join us this year for a fabu- concludes with an awards Thank You to Our About Alley Institute lous day of golf in support banquet where players can Sponsors To-Date Alley Institute is committed of a good cause on one network together. Medpoint, LLC, Lommen, to provide actionable of the premier courses in Abdo, Cole, King & solutions to help increase Minnesota! The tournament Playing in the Tournament the awareness of career Stageberg, P.A., Pace sponsorships raise funds The Player Registration Early Analytical Life Sciences, options in the life sciences, for students interested in Bird deadline is July 30, Patterson Thuente, Kluge and to help ease the careers in the life sciences. so register online now to Design Inc., Adolfson & work force shortage in save. Players may sign up Peterson Construction, these specialized fields. This year, the tournament individually or in foursomes. Scales Advertising, and Raising funds through will be held at the Golden View registration details The BioBusiness Alliance of the Scholarship Golf Valley Golf & Country Club, online. Minnesota. Tournament is a tangible providing a challenging experience for players while way to make a difference in Sponsorships Questions? Call Michelle this effort. helping a good cause. We Holker at 952-746-3822 A variety of sponsorships use a scramble format so or e-mail mholker@ are available, ranging from players of all abilities can lifesciencealley.org. $500 – $5,000. See more participate, and the day details online. 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!
  • 5. 5 Register Online— Enter code LSAMEM to receive $100 off the current registration price! A Medical Product Outsourcing Event A Conference Offering Opportunities & Solutions for Cardiovascular Device Manufacturers A Medical Product Outsourcing Event September 15, 2010 • The Northland Inn & Conference Center • Minneapolis, Minn. 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. SPONSORS 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. Register Today — www.cardiotec.com For sponsorship and speaking opportunities, contact Howard Revitch SUPPORTING COMPANY 201-880-2243 | howard@rodpub.com Get real-time updates on this Medical Product Outsourcing event. Find us on:
  • 6. 6 Seminar Tracks: Therapeutics Diagnostics Health IT Market Development Finance International Talent & Management “ Many of the University of Minnesota’s DECEMBER 8, 2010 research centers and institutes look forward to the Annual LSA Conference Minneapolis Convention Center & Expo as a unique and valuable Minneapolis, Minnesota opportunity to meet and exchange ideas and information with the life science community. There is no other place What is the future that can compare to the effectiveness of health care innovation? of the University’s participation in the LifeScience Alley Conference & Expo for Innovators from research organizations, meeting and sharing information with start-ups, established companies, and like-minded professionals.” health care organizations will present their visions of new technologies and delivery Elaine Nissen models, with a focus on disease prevention, The Ofce of Business Relations diagnosis, and intervention. University of Minnesota 2 0 0 9 AT T E N D A N C E 1,400 People 33 States 8 Countries 650+ Organizations Visit the conference website: www.LifeScienceAlleyConference.org
  • 7. 7 Exhibit Hall has SOLD OUT the Past Five Years! 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. Sponsorship Opportunities Please 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. Visit the conference website: www.LifeScienceAlleyConference.org
  • 8. 8 Decision Makers Invited to Explore Critical Thinking Through August 19 Workshop Our lives are filled with to learn how to recognize from Medtronic and an Learning Outcomes: important decisions – both and assess the influences organizational educator with After attending this highly personal and professional. that get in the way of good deep experience at Fortune engaging and interactive Many are low-risk, but decision making and make 500 firms – is being offered workshop, participants will some – especially in the a shift away from biased for the first time through be able to: bioscience and health fields actions and reactions. This LifeScience Alley to help – have much more serious starts with paying attention participants build their abil- • Recognize and learn to implications. To make better to our behavior even as we ity to think critically based avoid common influences decisions and increase our are in the process of think- on three perspectives: that can result in poor odds of a good outcome, we ing. decisions 1) Brain-wiring: predictable need to develop our ability • Assess bias in self and The ‘’Critical Thinking for ways that our brains to think critically. others Decision Makers’’ class – process and interpret With experienced leaders led by a highly respected information • Manage group as our guides, it is possible senior scientist/engineer interactions to improve 2) Personal: influences that come from personal the decision-making experience, education process and drive Annual UEL BBQ – 2010 toward more successful and culture University Enterprise Laboratories is holding its annual BBQ outcomes on July 21, 2010, from 3 – 7 p.m. 3) Group dynamics: unique influences that emerge To register: https://www. It will be held at the UEL campus: lifesciencealley.org/ when we work together in 1000 Westgate Drive, St. Paul, MN 55114 programs_events/detail. groups to solve problems To attend, please RSVP by July 9 th to info@uelmn.org or call and make decisions. aspx?id=523. Donna at 651-641-2804. Let’s cut to the quality. FULLY AUTOMATED: | CAPA | Nonconformances | Complaint Handling | eMDR | Supplier Quality | Audits & Findings | Change Control | Risk Management | & More 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. 1.888.9.ASSURX • www.assurx.com
  • 9. 9 Following an Entrepreneur to Market I n early 2009, LifeScience strength adhesive, sturdy collaborating with exporter Alley News featured a Latex-free closed cell foam Tushar Gupta, President of story on product design- and a unique top layer that Sanguine International, as er and entrepreneur Tracy D. wicks away moisture. For a future pathway to market Sigfrid. At the time, Tracy more information on the products in India. The com- was in the early stages of pads visit: www.Custom- pany is currently seeking developing several medical ComfortPads.com. angel investors to raise capi- products, one of which is tal for continued marketing Ptech also collaborates with a novel technology used in Tracy D. Sigfrid of products in the U.S. and alliance partners to assist tracheotomies. abroad. The company has clients with product devel- In February of 2010, Tracy several products for licens- Now, over a year later, Tracy opment, including patents launched her second com- ing and IP sale. has taken on a new chal- and commercialization. The lenge by successfully launch- pany, Product Technologies company has formed an alli- Tracy D. Sigfrid is the ing two companies in the Design (Ptech Design). ance with colleagues from President of Ventum, Inc., past six months. Today she This multi-faceted company other companies – including and Ptech Design, and is President of both Ventum, has grown quickly and has medical device companies can be reached at tracy@ Inc., and Product Technolo- expanded to include an – to work with Ptech clients ptechdesign.com or gies Design (Ptech Design). “incubator group” for other in the U.S. Ptech is also 763-754-9801. product developers. The list She started with the incor- includes a variety of clients poration and launch of from both Minnesota and Ventum, Inc., in November out of state. Ptech Design Alley Chats Boat Cruise & 2010 Update of 2009, and quickly moved has built an outstanding Only 3 Alley Chats remain for 2010: forward to establish an advi- management team and staff sory board for the company. July 15 Boat Cruise (Mississippi River) – by attracting a variety of top Taken from the Latin word registration opens early June ($65 to attend) talent, increasing the team for “wind”, Ventum aptly from one to twelve mem- September 16 Minnetronix ($25 to attend) describes this respiratory bers as of June 2010. For November 11 Medtronic – CRDM Headquarters company. One of Ventum’s more information on the ($25 to attend) medical products – the Ptech Idea Team, log on to Trach-Tapeze – was recently www.ptechdesign.com. LifeScience Alley has hosted these valuable “Knowledge evaluated by the Medical Bridging” events over the past five years to help link life Industry Leadership Insti- Ptech recently launched science industry resources. Nowhere else can engineering, tute (MILI) Valuation Lab a new product – Custom regulatory, clinical, marketing, product development, busi- at the University of Min- Comfort Pads – that is gain- ness development, facilities and people from MANY other nesota Carlson School of ing recognition and strong disciplines get together to discuss areas of shared interest. Management. The product support from participants in a cross-section of individual For this reason, we describe Alley Chats as: “A networking was issued a 510K Device and team sports markets. event engaging LifeScience Alley members to collaborate Exemption by the FDA and These high performance in sharing resources, discussing topics of mutual interest, is patent pending. The pads are a solution to and improving the status of the industry.” Ventum Advisory Board is currently seeking angel replace band-aids, “mole We would like to thank our Boat Cruise sponsors – Consul- investors to raise seed capi- skin”, carpet padding, cos- ate General of Canada, Amphenol Medical, and Underwrit- tal. The company is plan- metic sponges or any other ers Laboratories for making the July 15 event possible. ning to license the product make-shift item athletes typically use – in any kind of All hosting and sponsoring opportunities for 2010 are to an established respiratory SOLD OUT. If your organization is interested in host- company to produce and shoe, helmet or other type of sports equipment. This ing or sponsoring a 2011 Alley Chats Networking Recep- market the product. tion, please visit us online for more info, or contact Frank professional-grade prod- uct features an industrial Jaskulke, Member Services Manager, at 952-746-3814.
  • 10. 10 Women Leaders in Life Sciences and Health Care Come Together new member corner LifeScience Alley’s annual provides a source of inno- summer Women’s Leader- vation across interrelated ASIC Systems, Inc. ship Luncheon will be held industries. Beyond that, www.asicsystems.com at the Golden Valley Golf cultivating a close group of and Country Club on August ‘’go to’’ people and mentors Main Contact: Joe Pagliolo, President 12, offering excellent net- on whom to rely as a sound- Phone: 763-586-0820 working opportunities. It ing board for professional E-mail: info@asicsystems.com will also provide participants advice is a key ingredient Year Founded: 1996 with an overview of the among women leaders who Headquarters: Minneapolis, MN LifeScience Alley’s Women’s thrive. This luncheon offers Key Products/Services: Leadership Roundtable an opportunity to build new program – which will launch bridges with exceptional ASIC Systems, Inc.(ASI) was founded 14 years ago to provide its 4 th circle in the fall. people. support and design services for the development of mixed- mode (mixed-signal) application specific integrated circuits In today’s health care Space at the luncheon is (ASIC’s). ASI’s particular technical expertise is in the area of and life science business limited to 100 attendees. low voltage, low power (and micro-power) analog integrated environment, having a For more information and to circuits (IC’s) and custom digital cells. strong and diverse network register, please visit: https:// is especially important. www.lifesciencealley.org/ Organization Overview: Greater connectivity leads programs_events/detail. ASI was founded with the goal of making the capabilities to a better understanding of aspx?id=521 of custom integrated circuits (IC’s) accessible to small the shifting landscape and 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. 2010 Minnesota Tekne Awards APPLICATION DEADLINE EXTENDED: JULY 9, 2010 BioMidwest: Put your company ON THE MAP The Minnesota Tekne Awards honor companies, innovations BioSpace is excited to announce that we will be launching and individuals that positively impact Minnesota’s the next edition of the BioMidwest branding and marketing technology-based economy. The Tekne Awards began in campaign this July. Join the BioSpace community 2000, and are presented by the Minnesota High Tech of 400,000+ industry professionals, executives and Association, in partnership with the BioBusiness Alliance of investors via the BioMidwest 2010 branding and marketing Minnesota, LifeScience Alley and Enterprise Minnesota. campaign. Reach this vast and targeted audience with Applying for a Tekne can bring extensive visibility to an your news, recruitment, partnering/licensing, product/ organization and provides great opportunities to celebrate service and investor message. Visit www.biospace.com/ and promote products and leaders within an organization. biomidwest and contact Ryan Guensch at 732-746-2283 or Apply here. ryan.guensch@biospace.com for details. For more information, visit www.tekneawards.org.
  • 11. 11 Business Referral Update for May 2010 We have documented over • Referred a start-up What sort of help can sciences such as clinical 250 referrals for the month diagnostics firm to a we provide? research, regulatory, of May. These connections potential strategic partner reimbursement, product • Identify researchers who include helping member development and more. • Referred an academic can assist in specific companies to identify key researcher to an industry projects from academic • Identify potential strategic business partners and ser- contact for commercial institutions, health partners for product vice providers necessary to support care settings or private development. their business initiatives. industry. How We Can Help You What sort of help won’t In May, we: • Identify available talent for we provide? If you or anyone else in your • Referred a large medical organization is looking for hire or resource providers • We will not provide device company to an partners or solution provid- that can assist in the contact information engineering consultant ers, please contact a Life- process. of members for the to assist in new product Science Alley staff member • Identify vendors and purposes of solicitation. development and make a request. solution providers in For more information, IT, Operations, HR, contact Frank Jaskulke at Finance and specialized 952-746-3814 or fjaskulke@ areas of the life Women’s Golf Clinic lifesciencealley.org. Thank you to all of the women who participated Featured Job Postings in LifeScience Alley’s first Women’s Golf Clinic on Principal Design Assurance Engineer Wednesday, June 30, at the AGA Medical Corporation Brookview Golf Club. Also, Sr. Quality Engineer a big thank to our friends Acist Medical Systems, Inc. at Scales Advertising for all of their help and support in Sales Engineer, Medical (Minneapolis) producing this event. Sciemetric Instruments Principal Reimbursement Analyst – SQDM Medtronic, 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.
  • 12. 12 Database of 235 FDA-approved port innovation. Members lob- treatments that might be use- bied in support of the recently ful in treating orphan diseases. passed angel-investor tax new s byte s Drug Industry Daily credit. The law awards angel investors a tax credit worth 25 FDA, NIH aim to cultivate percent of their investment in Scientists reveal the mystery of European physicians participat- personalized medicine a Minnesota startup company. sudden cardiac death ing in the survey, conducted FDA Commissioner Margaret Minneapolis/St. Paul Business The pioneering research, using by the Association of Clinical Hamburg and NIH Direc- Journal detailed computer models, Research Organizations and tor Francis Collins said their could help save lives through the Academy of Pharmaceuti- agencies are working together Pfizer announces creation of preventative treatment of those cal Physicians and Investiga- to advance personalized rare disease research unit most at risk from a form of tors, said the current regulatory medicine, which includes gene Pfizer Inc. recently announced heart rhythm disorder called environment – including medi- therapy and diagnostic tests. the creation of a new Research sick sinus syndrome. This cal liability, conflict-of-interest The initiative includes a regula- Unit focused on rare diseases. occurs when the activity of rules and disclosure require- tory pathway for gene tests and This new unit will significantly the heart’s pacemaker, the ments – is making clinical trials treatments as well as research expand Pfizer’s presence in sinoatrial node, is impaired. Up difficult to manage. Clinical centers specializing in such rare disease research with to now, no-one has been able Trials Advisor products. Reuters the goal of discovering novel, to work out why this happens. Finding a funding ally in life-saving medicines for R&D Magazine Medtronic to unveil Patient Defense Dept. diseases affecting less than Care Center program in China 200,000 patients. Its creation CMS, FDA sign MOU, paving Small businesses turn to the route for devices to get to Medtronic will introduce on within Worldwide Research the Defense Department for market faster Aug. 8 its Patient Care Center and Development represents a money now that angel invest- pilot program in Beijing to further step in Pfizer’s strategy A new memorandum of under- ments and venture capital are discuss the benefits and cost to apply our strong science standing (MOU) between the weaker. Entrepreneur David of cardiovascular implantation and technology base to find FDA and Centers for Medicare Reamer is looking for fund- procedures with prospective innovative new treatments & Medicaid Services (CMS) ing for his business, which is patients free of charge, said for patients with large unmet could eventually accelerate developing sensors to detect Jean-Luc Butel, group presi- medical needs. Bioresearch the regulatory route for PMA dangerous gases as far as a dent of the firm’s international Online devices. The agreement, which kilometer away. But he’s not unit. Butel said the initiative was signed last week and will asking angel investors or ven- can help spare patients from EnteroMedics stock jumps go into effect next month, will ture capital firms for money. waiting in long lines at outpa- 108% allow the FDA and CMS to Instead, Reamer is courting tient clinics of their providers. The Roseville company says share confidential information the U.S. Defense Department. Medical Devices Today/The its anti-obesity medical device about a submission on a more Star Tribune Gray Sheet has promising results in two regular basis. The MOU could Senator urges FDA to improve patient studies. Shares of lead to a dual-approval process MOJO Minnesota agitates orphan drug development EnteroMedics Inc. soared for PMA devices between the for startups To spur orphan drug develop- 108 percent on June 22 on agencies in which the FDA A group of entrepreneurs, ment, the FDA should develop positive news about the unique would make the safety and investors, attorneys and a system to prioritize the top obesity-fighting medical device. efficacy decision while CMS other business leaders have 100 rare diseases, Sen. Sam Two patient studies indicated determines whether to reim- come together to launch a Brownback (R-Kan.) said dur- that the company’s Maestro burse for the device. Devices new organization called Mojo ing a Senate subcommittee System “shows our technology & Diagnostics Letter Minnesota. The group, which hearing. The FDA needs to works and we’re here to stay,” Burdensome regulation is held its official launch party said Chief Financial Officer collaborate with industry, aca- barrier to investigators last month, wants to drum up Greg Lea. EnteroMedics has demia and federal agencies to excitement and generate self developed an implanted pace- The regulatory environment in “quarterback” therapies under confidence among the state’s maker-like device that sends the U.S. and Western Europe an accelerated review process, startups and policy makers, intermittent electrical impulses is largely responsible for a Brownback said. The agency is with a mix of community- to the vagus nerve, which tells decline in the number of physi- already addressing this need, building events and grass-roots the brain when the stomach is cians willing to participate in FDA Deputy Commissioner for Science and Public Health activism. Part of the group’s empty. The technology blocks clinical trials in those regions, Jesse Goodman said, pointing role will be to advocate for impulses that make people according to a survey. Seventy to a Rare Disease Repurposing public-policy changes that sup- overeat. The Star Tribune percent of U.S. and Western
  • 13. 13 All programs are posted to the website approximately one month in advance. All events are subject to change. lifesciencealley.org calendar Innovation in Diabetes The Issue of Ethics – Applications and Benefits of Member Breakfast July 2010 july Summit Clinical Trial Design Ethics, Printed Electronics in the Life July 30 8 – 9:30 a.m. July 14 8 a.m. – 4:30 p.m. to be exact Sciences Presented by: (luncheon included) July 20 8 – 9:30 a.m. July 27 8 – 9:30 a.m. LifeScience Alley A LifeScience Alley Featured Presented by: Presented by: Location: Program Regulatory Affairs SIG R&D SIG Risdall Marketing Group – 2010 Lead Sponsor: Speaker: Speaker: New Brighton, MN Dorsey & Whitney LLP Jeffrey Kahn, PhD, MPH, John M. Heitzinger, PhD, Vice Sponsored by: Director, Center for Bioethics, President of Technology, Soligie, American Diabetes Association, University of Minnesota Inc. The BioBusiness Alliance of Location: Location: Minnesota, and MedCity News DoubleTree Park Place Hotel Hamline University Minneapolis – Speakers: St. Louis Park, MN View a full list of speakers online Adverse Events Reporting: Location & Host: Fun, Fact, Fantasy or Fiction? WebMD’s Best Practices International Diabetes Center at for Engaging Patients and Park Nicollet Clinic – St. Louis July 21 8 – 9:30 a.m. Presented by: Physicians Online Park, MN Clinical Studies SIG July 29 8 – 9:30 a.m. Speaker: Presented by: Alley Chats Boat Cruise Debbi Lindgren-Clendenen, Marketing SIG (Members Only) RN, MN, GNP-BC, Principal Speaker: July 15 6 – 9 p.m. Consultant, CME Consulting, LLC Steve Peck, Director of Strategic Presented by: Location: Accounts, WebMD Corporation LifeScience Alley Hamline University Minneapolis Location: Sponsored by: – St. Louis Park, MN Hamline University Minneapolis – Amphenol Medical Solutions, St. Louis Park, MN Underwriters Laboratories, and the Consulate General of Canada Location: Boom Island Park, Downtown Mpls Women’s Leadership Summer Critical Thinking for Decision 21st Annual Scholarship Golf august Luncheon Makers Workshop Tournament August 12 11 a.m. – 1 p.m. August 19 8 a.m. – 5 p.m. September 13 11 a.m. – 7 p.m. A LifeScience Alley Featured A LifeScience Alley Featured (shotgun start at 11:30 a.m.) Program Program Presented by: Speaker: Speakers: Alley Institute Sue Horvath, CMA, Chief Darrel F. Untereker, PhD, VP Location: Financial Officer, VP Operations Corporate Research & Technology, Golden Valley Golf & Country Club and HR, Hemosphere, Inc Medtronic, Inc.; Richard R. Gillen, Players register before Friday, July Location: PhD, Organizational Educator & 30, to receive Early Bird rates Consultant, Benay Group LLC 2010 Golden Valley Golf & Country Club Location: Hamline University Minneapolis – St. Louis Park, MN 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.