Vice President

Science & Technology
Medtronic

Thomas Gunderson
Moderator

Sr. Research Analyst
Piper Jaffray

101

Biofuels Central: What’s Cooking in the Upper Midwest

This region is considered one of the world’s hotbeds of bio-fuel research and development, as well as ethanol and bio-diesel production. Hear from researchers, biofuel producers and those who provide support services to this dynamic industry. Their real-life examples will reinforce how the Upper Midwest is poised to lead the world in the development of commercially viable bio-based energy sources.

~ Randall Doyal, Chief Executive Officer, Al-Corn Clean Fuels

~ Lawrence Wackett, Ph.D., Professor, Biotechnology Institute, University of Minnesota

~ Robert Walker, President and Chief Executive Officer, Bixby Energy

~ Robert Elde, Ph.D., Dean, College of Biological Sciences, University of Minnesota

102

The Changing Tide in Post-Market Reporting

The FDA is scrutinizing post-market reporting and surveillance now more than ever before. We will discuss how this change in the tide will affect manufacturers’ regulatory strategies going forward. This will include: the impact on research & development and quality systems, off-label use, what’s being looked at now, the FDA process and triggers for their in-depth investigations.

~ Sue Danielson, RAC Regulatory Affairs / Quality Director Medical/Surgical Division, 3M

~ Jennifer Marrone, Executive Vice President, Regulatory & Clinical Research Institute, Inc

103

Best Practices for Managing Clinical Trial Contracts

This session will address important legal issues raised when sponsors are contracting with doctors and hospitals, including: subject recruitment, HIPAA, indemnification, fraud and abuse, site selection, publication, and determining the responsible party in a dispute. A hypothetical case study will be used to illustrate these legal issues and generate discussion. 

~ Bob Klepinski, Attorney, Fredrikson & Byron, P.A.

104

Convergence Technology Partnerships: Big Steps Towards Big Cures

This region is internationally recognized leading the convergence of devices with pharmaceuticals and biologics, beginning with the famous example of the drug-eluting coronary stent. Leading device manufacturers understand the value of embracing a combination approach. This requires intense collaboration, most often with technologies outside their zones of expertise. Case studies of these partnerships will illustrate the new dimensions that convergent technologies are generating.

~ Aron B. Anderson, Ph.D., Vice President, Chief Scientific Officer, SurModics

~ Kalpana Kamath, Ph.D., Boston Scientific

~ Thomas Vasicek, Ph.D., Medtronic

~ Rod Greder, Ph.D., New Productivity Group, LLC

105

Running a Tight Ship From a Messy Desk: Lean Manufacturing Meets Creative Innovation

Can a company pursue operational excellence while keeping a spirit of creativity and innovation?  Many would argue that you can only support one approach or the other and that lean manufacturing stifles innovation. With the right balance, it is possible to creatively fill the product pipeline while keeping costs in line.  Hear from industry experts who will provide case studies in support of both theories.

~ Thomas W. Burns, Technical Support Manger, Medical Molding & Assembly, Phillips Plastics Corporation

~ Jacquie Hart, New Product Development Manager, Smead

~ Michael Larsen, Design for Lean Sigma Deployment Leader, Medtronic

~ Susan Paquette, Commercialization Services Director, 3M

106

New Ways of Doing Business: Learn from the Leaders

Learn from the leaders and get insight from four business perspectives affecting life sciences. Leaders with medical device, provider, legal and industry backgrounds share their insights into the new ways of navigating today's landscape. This panel will discuss codes of conduct, implications of consumer-driven health care, error reduction and transparency relating to the life sciences industry.

~ Kathy M Cooney, Executive Vice President and Chief Administrative Officer,  HealthPartners

~ Peter L. Gove, Retired, St. Jude Medical Executive

~ Steve Young, Global Executive Director, Caux Round Table

~ Michael McCormick, Partner, Dorsey& Whitney LLP

107

Start-Up Strategies: Building Blocks for Success

Priorities are everything when you have limited resources. Hear lessons learned by seasoned business people about the most important elements to consider as you build on the foundation of your company. In addition, hear their advice about when to stick with your original plans and when to adapt your strategy to capitalize on emerging opportunities.  Let the experts be your guide.

~ Michael Chambers, President and Chief Financial Officer, Aldevron

~ Phil Messina, Chief Operating Officer, Gel Del

~Tom Mozer, Ph.D., President and Chief Executive Officer, Nerites

~Joel Marcus, Chief Executive Officer and Founder, Alexandria Real Estate Equities, Inc

201

The New Generation of Industrial Biotechnology: Bio-Based Innovations for the Future

Hear industry leaders discuss the newest generation of products made from renewable resources - such as bio-based textiles, food packaging products, industrial lubricants and building materials. In addition to sharing their views on opportunities and challenges in this growing field, these seasoned industry members will suggest best practices for marketing the diverse range of new bio-based products that are being developed in our region.

~ Chris Ryan, Ph.D., Chief Technology Officer, NatureWorks LLC

~ Mark Stowers, Ph.D., President and Chief Executive Officer, MBI International

~ Marc von Keitz, Ph.D., Associate Director, BioTechnology Insitute, University of Minnesota

~ Peter Ekberg, Partner and Co-Chair of Emerging Companies Practice, Faegre & Benson LLP

202

What’s New in the EU?

Keeping up with all the new and revised regulations can be a challenge.This session will provide you with the latest updates – including European Union (EU) regulation issues, the hazardous substances ban, and implications of moving from a Class IIB to a Class III designation under the new guidelines.  

~ Paul Brooks, Vice President, BSI Americas

~ Chris Scavotto, Director of Quality Assurance, CHF Solutions  

~ Dr.Sandeep Shah, Managing Director, Tarilian Consulting

Post-market clinical trials provide an opportunity to meet FDA surveillance requirements, gather data for reimbursement claims, assess long-term outcomes, and generate critical data for marketing and sales. Industry is now using registries and these trials as a means of securing competitive accounts while gathering data for claims. This session will outline recommendations for some of the gray areas of post-market trial compliance requirements while also highlighting strategies to mitigate risk.

~ Sarah Moeller, Chief Executive Officer, The Greenlight Group LLC

~ Suzanne Sullivan, RN, CCRA, Manager, Clinical Research Services, Alquest, Inc.

~ Teri Takle-Flach, M.S., Clinical Business Alliance Manager, Boston Scientific Corp.

Explore recent patent infringement cases in the life science and technology fields. Hear industry experts discuss emerging concepts such as patenting naturally-occurring biological processes. How will you protect your intellectual property assets by anticipating and avoiding challenges to your patents?

~ Jim Petell, Ph.D., Director of Technology Transfer and Commercialization, University of North Dakota

~ Konrad Sechley, Ph.D., Senior Life Science Patent Attorney, Gowlings

~ Bruce Vrana, J.D., Senior Patent Attorney, Syngenta

~ Phil Goldman, J.D., Fredrikson & Byron, P.A.

Hear the success stories of manufacturers in the region that were successful in other mature industries, and then elected to enter the hot life science market. Learn how these manufacturers made their decisions to cross over and how they adapted their manufacturing practices to meet the demands and opportunities of a whole new – and especially lucrative – market.

~ Elizabeth Abraham, CEO, Top Tool Corporation

~ Jim Lande, CEO, Quadion Corporation

~ Christina Temperante, President, BioMeasurement Division, Hutchinson Technology Inc.

~ Andrew D. LaFrence, Partner, KPMG

Corporate leaders constantly scan the business landscape for new management strategies aimed, for example, at lowering costs, fostering innovation and improving quality. The most effective leaders are those who can predict which techniques are most likely to work in their company and who know how to successfully adapt an approach to fit their unique corporate culture. This session will provide actual examples of companies that have succeeded and failed as they’ve attempted to reshape their processes through widely recognized as well as more innovative management techniques.

~ Tim Laske, Ph.D., Senior Program Director, Medtronic

~ Alison Page, Vice President, Patient Safety, Faiview Health Services

~ David Stassen, Managing Director, Split Rock Partners

~ Jeff Pauley, Chief Executive Officer, Magelian Executive Resources

207

Sourcing Capital to Fuel Growth: Gaining and Maintaining Your Investor Base

As an emerging business, one of your most important responsibilities is to secure financing for your innovations.  The next step is to manage expectations and relationships with your investors. Industry experts share best practices and practical, productive techniques for successfully managing this critical balancing act.

~ Wally Danielson, Chief Executive Officer and Founder, ImPres Medical, Inc.

~ Robert Hansen, Co-Founder, Chairman and Chief Executive Officer, Electromed

~ B. Kristine Johnson, Managing Partner, Affinity Capital

~ Barbara Lano Rummel, Partner, Lindquist & Vennum PLLP

Dr. Leroy Hood is one of the world’s leading scientists in molecular biotechnology and genomics. He is widely considered the “Father of Systems Biology” – an approach to health care that views the human body in its entirety by analyzing complex expression patterns of genes and proteins. Systems Biology promises – over the next 10 to 20 years – to enable scientists and doctors to:

While Dr. Hood believes that Systems Biology is an idea whose time has come, he acknowledges that it will require a new culture which integrates biology, technology, computation and medicine that, frankly, is not possible in many places. Crucial to the Systems Biology approach is a full integration of the Life Science and IT industries with K-12 and higher education curricula. Dr. Hood’s thought-provoking presentation will outline what a region – such as the Upper Midwest – must consider if we choose to succeed in driving predictive, preventive and personalized medicine.

Thought leaders in the food and health market will explain the theory and recent developments of this exciting field.  Learn what drives those in academia who are taking basic nutritional research to the next level. In addition, treat yourself to hearing the trends and challenges of global companies that are involved in product development as they search to bring improved health and personalized nutrition to the market.

~ Charles Muscoplat, Ph.D., Vice President for Statewide Strategic Resource Development, University of Minnesota

~ Peter Vitulli, President and Chief Executive Officer, Sciona

~ Steve Snyder, Vice President, Sales and Marketing, Cargill Health & Food Technologies

302

Asian Submission Issues and Lessons Learned

As manufacturers move into Asian markets with their products, they encounter submission roadblocks, such as timeline uncertainties, language and cultural barriers and other situations that can make the process cumbersome. Experienced regulatory professionals will discuss how to successfully navigate those roadblocks for a faster and more efficient submission process.

~ Ames Gross, President, Pacific Bridge Medical

~ Mike Winegar, Vice President of Regulatory Affairs, Clinical & Quality, Enpath Medical

~ Chip Whitacre, Director, Corporate Regulatory & Clincial Affairs, Medtronic

~ Ruilin Li, Attorney, Fredrikson & Byron, P.A.

As the cost of conducting clinical trials continues to rise, so does the pressure to make sure you’ve included all your measurable endpoints. Increasingly, this has also come to mean endpoints for not only clinical data, but also marketing and CMS reimbursement data.

~ Bonnie Handke, R.N., Senior Manager, Health Policy & Payment, Metronic Inc.

~ Monica Schultz, Principal Advisor, Reimbursement, Regulatory & Clinical Research Insititute, Inc.

~ Beth Hahn, United BioSource Corporation (UBC) Center for Pricing & Reimbursement (CPR)

~ Judith Hickey, MBA, President, Princeton Reimbursement Group

Where do you find your new product ideas?  How do you select and nurture the most promising ones? Hear best practices from companies that are known for their success in innovation, as well as from specialists who advise others on how to bring new ideas to commercial success.

~ Heidi Emanuael, Director of Strategy & Innovation, Research & Dvelopment, General Mills, Inc.

~ Gerald W. Timm, Ph.D., Professor, Urologic Surgery, UMN

~ Daniel Titcomb, Principal, Pulse Innovation

~ Paul Rothweiler, Aspen Research Corporation

Quality demands have created new relationships between manufacturers, patients, and everyone involved in the process. New wireless technologies have enabled tighter controls and mountains of data to sort. Where is surveillance leading and how has the environment changed? What does it all mean for manufacturers?

~ David M. Frazee, Ph.D., Technical Director, 3M Corporate Research - SEMS Labortory

~ Joel Jorgenson, Ph.D., Chief Executive Officer, Packet Digital

~ Nora C. Vernon, RN, Clinical Affairs Manager, Patient Safety, Fairveiw-University Health Services

~ Diane Davies, MD, Consultant, University of Minnesota

How do we educate and – more importantly - inspire the next generation of scientists, mathmeticians and engineers in the life sciences? Hear what leading companies in the region are doing to help develop the life science workforce of the future. In addition, learn of creative ways for your organization to enrich the experiences of your current scientists, engineers, technicians and life science managers through two-way mentorship programs. Explore this critical issue from various angles, learn who’s doing what in scientific workforce development and engage in a lively dialogue.

~ Wayne Freese, DVM, President and Chief Executive Officer, Prairie Holdings Group and Newport Laboratories

~ Phil Gerlach, Senior Director of Manufacturing Services, PDL BioPharma

~ Norman Lee, Coordinator, Mindset/Manitoba Network for Science & Technology

~ Gail O'Kane, Ph.D., Project Manager, Strategic Partnerships, Minnesota State Colleges and Universities, MNSCU

307

Building A Strong Network: Leverage the Expertise Around You

The Upper Midwest is home to leading research institutions, private industry service providers, government specialists and life science companies large and small that offer great collaboration and networking opportunities.  This session will help you understand how to successfully build an effective network of contacts and partners in order to fuel your company’s growth.

~ Laura Dierker, Market Segment Manager - Life Sciences, Sciemetric

~ Jeff Mirviss, Vice-President Marketing, Boston Scientific Corp

~ Randy Olson, General Manager, University Enterprise Laboratories (UEL)

~ Dale Wahlstrom, Board Chair, BioBusiness Alliance of Minnesota