LifeScience Alley Programs & Events

Using Recall Data to Analyze the 510(k) System

Sat, 01 Jan 2000 08:00:00 GMT

Professor Ralph Hall of the University of Minnesota Law School and counsel to the firm of Baker & Daniels has recently completed the first major study assessing the 510(k) system from a safety perspective. Hall's work is being presented to the IOM committee reviewing the 510(k) system and to various congressional offices. At this LSA program, Hall will review his research and the message his research has for potential changes to the 510(k) system.

Substantial time and energy has been devoted to debating changes to the 510(k) system. However, there had been no systemic, data based assessment of whether the 510(k) system has permitted some inordinate number of products onto the market. This seminal study provides vital guidance for decision makers.

Women's Leadership Summer Luncheon

Sat, 01 Jan 2000 08:00:00 GMT

LifeScience Alley & Leadership Solutions invite you to a special summer luncheon for women leaders in life sciences & healthcare:

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 provides a source of innovation across interrelated industries. Beyond that, cultivating a close group of ''go to'' people and mentors on whom to rely as a sounding board for professional advice is a key ingredient among women leaders who thrive.

Our annual summer Women's Leadership Luncheon is an opportunity to meet with others in the life science and health care fields and hear from a few of our roundtable members who will share the valuable professional and personal outcomes they've experienced by helping other women in the industry. This is a way for you ''try on'' LifeScience Alley's Women's Leadership Roundtable to see how it might be of help to you in the year ahead.

Whether you are in a position to commit to our 9-month long roundtable (which will launch in the fall) or you just want to expand your network, we invite you to this engaging event. We expect you'll find common ground with many interesting leaders in the room.

Personalized Medicine - Partnerships in the Region

Sat, 01 Jan 2000 08:00:00 GMT

With some projects, it is clear that you can't go it alone - especially to reach your highest potential. Minnesota has elite capabilities in bioinformatics, computer hardware, microfluidics, microelectronics, medical device manufacturing, a highly sophisticated infrastructure of service firms and virtually all it takes to create a world-class Diagnostics industry. This session will examine successful partnerships between large and small organizations and, in some instances, uncommon collaborators. What did they look for in a successful partner? What were their goals? What were the dealbreakers? What were the drop-dead points? What worked/what didn't/why with these and other collaborations? This session is part of the Midwest Personalized Health Framework series.

University full-time faculty, staff, and students may register free of charge. Please enter ''GOPHER'' as the validation code to disable fees.

Thank you to LifeScience Alley's Midwest Personalized Health Framework Founding Lead Sponsor: Faegre & Benson, LLP and Founding Supporting Sponsor: The University of Minnesota Academic Health Center.

Critical Thinking for Decision Makers Workshop

Sat, 01 Jan 2000 08:00:00 GMT

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 thinking.

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 ability 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

''After a time of reflection on the awesome content of your Critical Thinking class, it appeared clear to me I had been exposed to an invaluable learning: good decision making could be systematic because it is possible to systematically identify and remove elements of bad decision making.''

''What made your class even more special was its approach as an exploratory seminar rather than a prescriptive course. The work is brilliant.''

Target Audience:
• Senior Management
• Technical Leaders and Staff
• Human Resources and Operational Managers
• Marketing and Business Development Professionals

Please note: Lunch will be provided for attendees.

The Impact of Healthcare Reform on Minnesota's Healthcare Industry

Sat, 01 Jan 2000 08:00:00 GMT

In March, President Obama signed into law the most sweeping healthcare reform since Medicare. The law, known as Patient Protection and Affordable Care Act, will be implemented in phases over the next five to ten years.

Even though many of the most sweeping changes won't be implemented until 2014, it's important for our entire community - providers, payers, vendors - to thoroughly understand what this law says, what impact it will likely have on us, and how to ensure that we all thrive long into the distant future.

Please join us for an information packed half-day seminar on August 23rd. Senator Amy Klobuchar will provide the opening keynote to begin the morning. Leaders from all major healthcare delivery systems will be present to discuss the posible impact on the provider community. Donna Zimmerman, VP of Government and Community Relations at HealthPartners, will talk about the likely impact on the payer community, and industry will also be represented.

21st Annual Alley Institute Scholarship Golf Tournament

Sat, 01 Jan 2000 08:00:00 GMT

Early Bird deadline extended to August 18th!
For two decades, the Scholarship Golf Tournament has provided a terrific opportunity for team building, networking, and fund-raising. Join us this year for a fabulous day of golf in support of a good cause on one of the premier private courses in Minnesota! This year's tournament will be held at the Golden Valley Golf & Country Club. The tournament sponsorships raise funds for students pursuing careers in the life sciences.

Tournament is a scramble format so players of all abilities are encouraged to participate! Driving range opens at 9:30 a.m. Tournament begins with a shotgun start at 11:30 a.m. (lunch served on the course). The day concludes with dinner, awards and plenty of networking.

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.

Playing in the Tournament
Players may sign up individually or in foursomes.
Download player registration form.

Thank you to our sponsors:
Medpoint, LLC, Lommen, Abdo, Cole, King & Stageberg, P.A., Pace Analytical Life Sciences, Patterson Thuente, Adolfson & Peterson Construction, Kluge Design Inc., Quality Tech Services, Inc. (QTS), Scales Advertising, and The BioBusiness Alliance of Minnesota.

Interested in sponsoring?
Sponsorships range from $750 - $5,000, and are a tax-deductible contribution.
View Sponsorship Packages.
Download Sponsorship Reservation Form.

Questions? Call Michelle Holker at (952) 746-3822 or email mholker@lifesciencealley.org

FDA Establishment Registration and Listing: Live Demonstration by FDA Expert

Sat, 01 Jan 2000 08:00:00 GMT

The ''FDA Unified Registration and Listing System'' (FURLS) is the on-line tool that companies must use to complete the annual Establishment Registration and Medical Device Listings for their firm. The FURLS system introduced in October 2007 proved to be a challenge to use in the early days but has evolved over the years and there are some new updates that will improve the process.

With the registration window between October 1 and December 31 of each year, this program is timed to get you the information you need to quickly and efficiently complete the process. If you are involved in managing FDA information and/or directly registering your company and products you should not miss this chance to hear directly from an FDA expert on the FURLS program and how to register all of your facilities and product listings. This program will feature a ''Live on-line Demonstration'' by FDA on how to use the fee payment process and FURLS and DRLM (Device Registration and Listing Module) systems.

This is a key part of your companies compliance program and profile within the FDA system so getting it right is critical to how FDA views and manages your companies pre and post market activities. This program will include the ''how to steps'' and ''practical tips'' to use in successfully completing your Establishment Registration AND Medical Device Listings using the FURLS systems.

Design of Experiments (DOE)

Sat, 01 Jan 2000 08:00:00 GMT

This is a two-day seminar for technical people from R&D, manufacturing, quality, engineering, supplier management, and regulatory affairs departments.

Screening Experiments
Product and process development requires the identification of key factors that control product and process performance. Screening experiments efficiently identify key factors and interactions; provide a way to optimize product and process designs, and to troubleshoot manufacturing. They help shorten development cycle time and reduce cost.
1. Why design experiments?
2. Factorial designs
3. Key success factors
4. Fractional factorial and Plackett-Burman designs
5. Applications using software

Optimization Experiments
DOE approach to product and process design is a two step approach: screening followed by optimization. When effects are not linear, optimization experiments are necessary to optimize product and process designs. Both formulation and process optimization are considered.
1. Sequential assembly of designs
2. Central composite and Box-Behnken designs
3. Mixture designs
4. Model building and response surface optimization
5. Applications using software

Robust Design Method
Robust designs result in small variability. Robust design method, developed by Dr. Taguchi, provides tools to make product and process designs robust against the impact of noise factors. The key to robustness and ways to design and analyze the necessary experiments are considered.
1. Basic principle to achieve robustness
2. Control and noise factor experiments
3. Signal to noise ratio and other analyses
4. System simplification
5. Applications using software

Statistics for Managers

Sat, 01 Jan 2000 08:00:00 GMT

Statistics for Managers is a one-day seminar geared toward technical managers in industry - supervisors, managers, directors, vice presidents and other technical leaders - from research and development, manufacturing, quality, engineering, supplier management, and regulatory affairs departments.

To guide effective implementation of statistical methods, managers need to know what the key statistical tools accomplish, their pros and cons, when to use which tool, and what questions to ask to promote the timely and effective use of statistics. This seminar communicates the key concepts of practically useful statistical methods and how they apply to the various stages of R&D and manufacturing - research, product design, process design, validation, manufacturing and continuous improvement.

The purpose of this seminar is to provide practical guidance on how to effectively guide and implement statistical methods, by answering questions such as:

1. Why not to use a t-test and what to replace it with?
2. Size matters - how much data to collect?
3. Why design experiments - is it not going to cost too much and take too long?
4. What is the key to designing robust products and processes?
5. Setting specifications - arbitrary or is there a method to it?
6. What must you know to properly design process validation studies?
7. One minute process management - how to use an at-a-glance-display?
8. Is my measurement system acceptable - and how to improve it?

Reimbursement Realities - The Untold Story

Sat, 01 Jan 2000 08:00:00 GMT

CMS and private payor reimbursement - especially in an era of heightened Comparative Effectiveness Research - is a critical determinant of a bioscience company's success or failure. Even when all the critical milestones are met, including CMS approval - it's not a ''done deal'' until payors reimburse. Hear insights and experiences from seasoned entrepreneurs and advisors who will share the lay of the land and discuss hidden pitfalls in reaching these endpoints. CEOs will have an opportunity to network with other life science industry leaders in this protected ''by invitation only'' meeting. [Note: This program is exclusively for entrepreneurs heading emerging core life science companies.]

For questions regarding eligibility please contact Dana Boyle at 952-746-3820 or dboyle@lifesciencealley.org.

Thank you to our Small Business Leaders' Forum sponsors:
Faegre & Benson, Dymedex Consulting, and Argenta Reimbursement Advisors, and BioBusiness Alliance of Minnesota.

Diabetes Working Group

Sat, 01 Jan 2000 08:00:00 GMT

Please join our Diabetes Working Group that will meet quarterly to continue connecting key players and supporting new developments in the field of diabetes. (More detailed description coming soon)

Diabetes Working Group

Sat, 01 Jan 2000 08:00:00 GMT

Please join our Diabetes Working Group that will meet quarterly to continue connecting key players and supporting new developments in the field of diabetes. (More detailed description coming soon)

A View from the Captain's Chair - CEO All-Star Panel

Sat, 01 Jan 2000 08:00:00 GMT

Seasoned medtech/biotech CEO's share their insights on surviving and thriving in this market for the benefit of their peers and the next-generation life science company leaders. This annual session is a chance for them to reflect on their achievements and offer advice that they've learned along the way. Minnesota's vibrant life science culture is well-respected, even in such hotbeds as Silicon Valley. The Small Business Leaders' Forum speaks to the well-connected, ''willing to give back to others'' community that exists here. As always this program will provide time to network with other life science industry leaders in a protected ''by invitation only'' setting. [Note: This program is exclusively for entrepreneurs heading emerging core life science companies.]

For questions regarding eligibility please contact Dana Boyle at 952-746-3820 or dboyle@lifesciencealley.org.

Thank you to our Small Business Leaders' Forum sponsors:
Faegre & Benson, Dymedex Consulting, and Argenta Reimbursement Advisors, and BioBusiness Alliance of Minnesota.