LifeScience Alley Programs & Events

Statistics for Quality, Part 2 - Screening Experiments - The Heart of DOE

Fri, 29 Feb 2008 08:00:00 GMT

Statistics for Quality is a sequence of programs geared toward technical individuals who deal with data and make decisions based upon data. This audience includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistic green belts and black belts will both benefit from this series of programs. Each program stands alone and is not a prerequisite for the next program in the series. A LifeScience Alley Statistics for Quality Certificate will be issued for those who complete the six-part series.

Program 2: Screening Experiments - The Heart of DOE

Product and process development requires identification of key factors that control product and process performance. Screening experiments efficiently identify key factors and interactions. They provide a way to optimize product and process designs, and to troubleshoot manufacturing. Screening experiments are the most important class of designed experiments (DOE), and help shorten development cycle time and costs.

Unfortunately, much product and process development proceeds using one-factor-at-a-time or other ad-hoc experimentation strategies - approaches that provide less information at higher cost. On the other hand, there are any number of examples where screening experiments, properly applied, have resulted in - making a better cake, brewing a better beer, improving drug formulations, reducing development cycle times, designing robust measurement systems, and improving the accuracy and consistency of ammunition.

The purpose of this seminar is to provide practical guidance on the effective use of screening experiments, by answering questions such as:

1. Why design experiments?
2. What are factorial designs?
3. What to think about to make the screening experiment successful?
4. How to evaluate a large number of factors with a fractional factorial design?
5. How to design robust products and processes?
6. How to easily implement screening experiments using software?

Statistics for Quality, Part 5 - Managing and Improving Processes

Fri, 28 Mar 2008 07:00:00 GMT

Statistics for Quality is a sequence of programs geared toward technical individuals who deal with data and make decisions based upon data. This audience includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistic green belts and black belts will both benefit from this series of programs. Each program stands alone and is not a prerequisite for the next program in the series. A LifeScience Alley Statistics for Quality Certificate will be issued for those who complete the six-part series.

Program 5: Managing and Improving Processes

Control charts are implemented in manufacturing with the hope of improving manufacturing processes. But control charts can deliver on this promise only if the manufacturing process meets certain criteria. Capability and performance indices can be used as an at-a-glance-display to rapidly determine whether the process meets these criteria, namely, where control charts may be the effective process management tool and where other statistical tools need to be used. Variance components analysis is one such statistical tool that provides the detailed information necessary to make cost effective process improvements.

Using the ideas presented here the manufacturing department of one company was able to quickly develop and implement a focused quality improvement plan. The quality department of another company reduced their voluminous quarterly quality reports while simultaneously getting greater management attention to the true quality issues. Yet another company changed the type of control chart to reduce frustrating and unproductive intervention by production operators. The west coast operation of a company made a dramatic turn around from having lost a major customer to being declared the financially most successful operation within the company.

The purpose of this seminar is to provide practical guidance on the use of statistical tools to cost-effectively manage and improve processes by answering questions such as:
1. What is the logic behind control charts and how to select the proper chart?
2. What are the four process capability and performance indices?
3. How to use these indices as an at-a-glance-display to manage and improve processes?
4. How to use variance components analysis to estimate the % of variability caused by each cause?
5. How to target variance reduction efforts most cost-effectively?
6. How to use software to implement this methodology?

The Not so Subtle Art of Marketing YOU

Thu, 28 Aug 2008 07:00:00 GMT

Registration for this program is full. If you wish to be added to the waiting list, or would like to receive information regarding a possible encore presentation, please email Lauren Steffel

It's not what you know, It's who you know.
In today's frenzied landscape of communication mediums, understanding the impact of social networking to effectively communicate your message has never been more important. However, for many of us, making meaningful connections isn't something that comes easy.

We are thrilled to have Stevie Ray from Stevie Ray's Improv Company and Gary Jader from Ideas on the Wall, join us on August 28th to lead us through what they call The Networking Tango. This workshop is designed to help you learn new networking skills without having to sit through another PowerPoint presentation.

The Networking Tango, and according to Stevie Ray, unlike anything previously offered through LifeScience Alley, is a fun and interactive workshop that will help you:
- Establish personal goals for an event
- Identify good prospects
- Make contact, not just contacts
- Move freely from one interaction to another
- Have something to say about any subject
- Smoothly enter conversations, whether in groups or pairs
- Leave an impression that will have people asking for your card

Who should attend?
EVERYONE (Marketers, Sales Professionals, Executives, Product Managers and technical experts) who would benefit from understanding how to better represent themselves and their organization in various social situations (tradeshows, networking events, technical conferences, etc.).

19th Annual Scholarship Golf Tournament

Mon, 08 Sep 2008 07:00:00 GMT

For two decades, the Scholarship Golf Tournament has provided a terrific opportunity for team building, networking, and fund-raising. The Alley Institute Scholarship Golf Tournament is designed to raise money to help students pursue life sciences careers. We use a scramble format so players of all abilities can participate, and the day concludes with an awards banquet where players can network. 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.

The 2008 Scholarship Golf Tournament will be held September 8 at the Golden Valley Golf and Country Club.

Thank you to our sponsors to date:
Mayo Clinical Trial Services
AllOut Marketing, Inc.
Boston Scientific
Patterson, Thuente, Skaar & Christensen, P.A.
Schwegman, Lundberg & Woessner, P.A.
Tegra Group
Fish & Richardson
RCRI, Inc.
Smiths Medical MD, Inc.
The Integra Group - Clinical & Preclinical Research

View sponsorship information and Player Registration Form.

Achieving Short-Term Revenue Goals While Building the Value Proposition for Payers

Tue, 09 Sep 2008 07:00:00 GMT

Most device and diagnostics manufacturers have FDA approval, and can launch their product commercially, long before reimbursement policy for their technology is well established. This challenging period of early commercialization is an opportunity to operate below the payer radar and test the fundamentals of the payer strategy. Specifically, it is an opportunity to identify physician champions, gain experience with claims submissions and payer responses, and evaluate possible commercialization support services for physicians that may be necessary to secure favorable reimbursement from payers. Ms. Renbaum will describe a plan to build market share and sales growth, while working toward a stable and consistent payer strategy in the US.

Mini Master of Medical Technology Management

Tue, 09 Sep 2008 07:00:00 GMT

Designed to provide a neutral forum to discuss the needs of the medical technology industry, the Mini Master of Medical Technology Management addresses a broad range of topics that benefit anyone engaged in health care technology. Gain the skills needed to address today's problems and position yourself more effectively to respond to the changing needs of the marketplace.

Visit the University of St. Thomas site for more information.

Ideal Learner
This program benefits innovative thinkers who want to develop their understanding of the medical technology business. Participants may include those interested in developing, financing, or leading a medical technology start up or anyone responsible for an organization's new or second-generation product development. Whether you are a doctor who has developed a concept for a new medical product, an engineer creating a new product line, an investor interested in medical technology, a functional manager responsible for a new or existing product, or someone interested in increasing your knowledge in this area, you will benefit greatly from this program.

What You Will Learn
- Assessing the Medical Technology Market
- Assembling a Management Team
- Product Marketing Assessment
- Financing
- Managing Your Intellectual Property
- Device Design and Manufacturing
- Management Considerations in the Design of Clinical Studies for Medical Products
- Regulatory Affairs
- The Reimbursement Pyramid: Challenges and Considerations
- Exit Strategies

Strengthening Your Supply-Chain Relationships

Wed, 10 Sep 2008 07:00:00 GMT

Join us for this special education program in St. Cloud! As pressures continue to mount on OEMs and suppliers in the LifeScience industry, both are recognizing that speed and flexibility are the keys to reducing supply chain risk. Come learn about a supplier development initiative designed to build on continuous improvement processes - Accelerate!

John Connelly, director of product management for Enterprise Minnesota, will share his expertise about the Accelerate! system - a powerful process where OEMs and suppliers are working together to better manage their supply chain.

The Accelerate! system helps build a better, collaborative relationship between supplier and OEM. Improving this relationship leads to a better supply-chain, increased productivity and reductions in inefficiencies. OEMs and suppliers have realized shorter cash-to-cash cycles, reduced inventories, increased asset utilization, and optimized cash flow because of the model. Average improvements among the 160 small-to-midsize suppliers that have participated include:
- Fifty percent reduction in Manufacturing Critical-path Time (MCT)
- Ten-fold increase in inventory turns
- Significant cost savings

For Harley-Davidson, flexibility and responsiveness are becoming more and more critical in our business. We have seen phenomenal results from Accelerate, and I am particularly encouraged by the level of permanence the approach has: culture and performance are both changing for the better.
-Matt Levatich, Vice President Materials Manufacturing, Harley-Davidson Motor Company, Inc.

If you wish to attend St. Cloud Alley Chats networking event (which immediately follows this program) at no additional cost, please follow the bundle link above.

St. Cloud Alley Chats

Wed, 10 Sep 2008 07:00:00 GMT

The purpose of Alley Chats is to invite life science industry members to engage one another in order to collaborate in sharing resources. This is accomplished by sustaining a welcoming environment of open communication, sharing thoughts and expertise. Alley Chats is not an event for the marketing of products and services, other than those of its sponsors who enable the event; it is intended to be an attractive opportunity to network with colleagues in the life science industry. St. Cloud Alley Chats is open to both members and non-members.

This event is a great opportunity to meet other companies in your life science community. Here is a sample of who is located in St. Cloud:
• DCI
• MicroBioLogics
• NeuroMEDx

Registrants are invited to ride the bus to the first of two new Alley Chats Networking Events outside the Twin Cities. A bus will be departing from the LifeScience Alley office in St. Louis Park on September 10th for our event in St. Cloud, and on October 8th in Rochester (departure time TBD). There is no extra fee beyond the $20 event registration fee to ride the bus thanks to our sponsors! So leave the driving to us while spending extra networking time with your fellow LifeScience Alley members to and from these events. To secure your seat on the bus, please email info@lifesciencealley.org with your name and contact information.

Many thanks to our sponsors:
Bus Sponsors: St. Cloud State University and St. Cloud Technical College
Event Sponsors: Gray Plant Mooty and Science Initiative of Central Minnesota

Preceding the Alley Chats Networking Event, LifeScience Alley and Enterprise Minnesota, are co-hosting a program from 3:00 - 4:00 p.m. on Strengthening Your Supply-Chain Relationships. If you wish to attend this program, followed by Alley Chats at no additional cost, please click on the bundle link above. (Note that the bus ride is not available for attending this earlier portion of the events in St. Cloud).

Managing Restricted Substance Programs Leveraging Emerging International Standards

Thu, 11 Sep 2008 07:00:00 GMT

With escalating Restricted Substance regulations worldwide and individual requirements, there is an urgent need for companies to have the ability to design compliance programs that facilitate the re-use of critical materials information to keep costs to a minimum. This impacts medical equipment as they become subject to additional regulations such as RoHS (Restriction of Hazardous Substances) and REACH (Note: medical equipment is already within scope of China RoHS). Product producers and their supply chains must understand the often subtle requirements of these regulations and to implement Restricted Substance Control programs that demonstrate confidence in compliance. The industry is using industry standards to help meet these challenges.

This presentation will provide the attendee with:
- An overview of key emerging regulations such as RoHS and REACH
- Expectations of RoHS Compliance Assurance
- Awareness of Industry Standards as a Toolkit to Support Environmental Compliance and how they may be leveraged to streamline the flow of materials data in an environment of global supply chains, global markets, and escalating regulations
- Insight to future industry trends based on the direction of International Standards
- A method to plan and implement a Restricted Substance Control program consider.

Biotech Company in a MedTech Town: Attracting a Talented Workforce with Biotech Skill Sets

Fri, 12 Sep 2008 07:00:00 GMT

This session is aimed especially at high-level biotech executives, as well as HR managers in biotech companies. It will feature a panel - moderated by Rod Greder - of four or five biotech leaders who can talk about their challenges and best practices in attracting the right people to their organizations. Beckman Coulter, Kingfisher Biotech, and MGI Pharma will be represented on the panel with others to be announced.

Midwest Personalized Health Framework - September Meeting

Tue, 16 Sep 2008 07:00:00 GMT

Join this working group of leaders in genomics-based medicine. This initiative will draw together those experts throughout the Midwest who are working in the field of Personalized Medicine, including academic researchers, health care organizations, medical device manufacturers, biopharmaceutical companies and service firms working in the areas of:
• Biomarker Identification
• Pharmacogenomics
• Laboratory Services
• Molecular Diagnostics

The primary goals of the Midwest Personalized Health Framework are to connect key players in the region, discuss industry trends, explore case studies in the field of personalized medicine, consider funding and partnering opportunities, and identify ways to develop needed products in personalized medicine for the benefit of current and new organizations working in this field. This will strengthen the fabric of the region's bioscience industry, draw attention to it and foster a more diversified bio-economy that is more in tune with the future of medicine.

LifeScience Alley is conducting this effort with the advisory assistance and direction of Leomics Associates, the Mayo Clinic's Center for Individualized Medicine, led by Dr. Frank Prendergast and the University of Minnesota. Other regional life science/bioscience industry associations as well as research universities in the Midwestern United States and Central Canada are also invited to be partners in the development of this Midwestern cluster.

Thank you to our Founding Sponsor: Faegre & Benson LLC

Founding Sponsorships are still available. If interested, please contact Dana Boyle at dboyle@lifesciencealley.org for more information.

Leomics Associates (www.leomics.com) is a strategic advisory group focused on catalyzing the advancement of molecular diagnostics and personalized medicine fields. Leomics Associates was founded by Dr. Jorge Leon, a molecular diagnostics pioneer and previously co-founder and VP of the molecular diagnostics business at Quest Diagnostics. Leomics has helped start and advance to commercialization several important initiatives in the field and generously shares its global experience with the members of The Midwest Personalized Health Framework.

Click here for more information about December's Midwest Personalized Heath Framework meeting.

The Science of Market Development

Tue, 16 Sep 2008 07:00:00 GMT

This 2.5-day course will provide an in-depth, hands-on experience intended to provide a clear understanding of the roadmap to standard of care for medical technologies. It is designed to deliver key insights and practical tools that participants can use immediately to help accelerate market adoption and growth over the short and long term. The concepts and tools will be discussed in the context of both U.S. and international markets and their unique (and common) barriers. This course content is applicable to all medical technologies whether they are at concept, newly released, struggling to grow, seemingly fast tracking, or mature.

Agenda:
September 16th Registration 7:30-8:00 am, Program 8:00-5:00 pm
September 17th, Program 8:00-5:00 pm
September 18th, Program 8:00-12:00 pm

View Detailed Program Agenda

Expected outcomes:
- Common language, proven approach, and standard measures of Market Development
- Clear understanding of the roadmap to standard of care for medical technologies
- Clear understanding of the barriers, typical pitfalls/challenges and best practices
- Practical tools and methods to accurately size the opportunity and forecast adoption and growth rates
- Clear understanding of the 5 market development stages and what is required to move from stage to stage
- Practical tools and methods to help you assess your existing technology, understand the priority barriers, and develop high impact strategies and tactics

The intended audience for this program includes, seasoned medical device marketing and market development professionals and leaders, senior leaders of small or medium size medical device companies, and anyone interested in gaining a better understanding of the elements and process of taking a medical technology to standard of care.

Consumer-Driven Health Care: Rewarding Valued Care

Wed, 17 Sep 2008 07:00:00 GMT

LifeScience Alley's Crossroads Series will delve into payment reform that takes its cues from the Consumer-Driven Health Care movement. The September 17 program Rewarding Valued Care will feature a keynote address by Tony Miller, CEO of Carol - a disruptive health care technology company based in Minnesota.

This subject is attracting a great deal of attention and momentum, as health consumer advocates, policy makers and the public in general look to turn the tables on how financial rewards should be realigned. The new paradigm, in their eyes, will provide incentives for preventive health, transparency and a focus on the whole person. In order for such a change to occur, it will take a multi-faceted approach with a shared goal involving committed leaders in our life science and health care community.

Following Miller's keynote presentation, a panel of experts - including leading employers, health care providers, insurers and policy makers - will discuss what it will take to get the ball rolling in Minnesota and make it stick. This will have implications for the manufacturers of therapeutics - devices and drugs - as well as payers, health care providers, patients and public policymakers. Most of all, it promises improvements in patient health.

Lead Sponsor: Larsen Design
In-Kind Sponsor: Travelers Insurance

Program Location: Jackson Room - Travelers Insurance Headquarters (Downtown St. Paul)
Ramp parking within 2 blocks

Women's Leadership Roundtable for Life Science Professionals - Introductory Luncheon

Thu, 18 Sep 2008 07:00:00 GMT

Join executives in the life science and health care community to hear Lois Quam, Managing Director - Alternative Investments at Piper Jaffray, speak about the value of engaging with peers outside your organization. Learn, too, about our new leadership circles which will begin meeting in October.

LifeScience Alley's Women's Leadership Roundtables will be facilitated by professional leadership coaches. These professional development sessions will meet for 3 hours each month. As a roundtable participant, you can expect to grow your go to network in the life sciences and health care community, share valuable insights with others in the industry, benefit from diverse viewpoints and develop your own leadership skills.

For more information on the Women's Leadership Roundtable for Life Science Professionals - the annual cost to participate in monthly meetings, as well as the goals and logistics - please click on this link.

Competitive Intelligence

Fri, 19 Sep 2008 07:00:00 GMT

This full-morning program will begin with an introduction of competitive intelligence (CI). The second part of the program will focus on the application of competitive intelligence principles to business practices with examples. A panel of health care executives will be involved in the discussion. This program will be applicable for a broad spectrum of businesses from services to providers to payors to manufacturers. The following topics will be addressed:

- What is CI?
- Why does a company need to practice CI?
- How do you get started with CI?
- Examples of how CI is being applied.

Members of SCIP (Society of Competitive Intelligence Professionals) may register at the LifeScience Alley member rate.

New Member Breakfast September 2008

Fri, 19 Sep 2008 07:00:00 GMT

As a new LifeScience Alley member, you are invited to attend the New Member Breakfast on September 19, 2008. This is a great way for you to meet with LifeScience Alley staff, other members, and representatives from our Group Purchasing Program partners to learn how to get the most from your membership.

Renewing members are welcome to attend and learn more about their membership or bring questions as well.

Working Together to Prevent Perceptions from Clouding Reality

Tue, 23 Sep 2008 07:00:00 GMT

The focus of the SIG is to examine how perceptions often create the fog of innovation. All too often time and money are wasted on ideas that cannot work and truly innovative ideas are ignored or eliminated. Perceptions based on memory, biases, or faulty information can hinder or completely inhibit the capacity of people to accurately see the true value of an idea.

Revenue Growth depends on the ability of a company to deliver desirable innovative products to the market. Most companies intend to excel at this expertise. Yet, unwittingly their best intentions are unraveled when unproven perceptions drive the decisions which select and fund new ideas. All too often managers and R&D personnel are at odds with one another over which ideas to resource and pursue. This leaves many people feeling like they are in the same company as Dilbert.

Highlights of the Perception Versus Reality Analysis will be discussed. The Perception Versus Reality Analysis provides a tool to help everyone recognize and control the negative influences of perceptions. Managers, R&D personnel, discovery teams, and development teams can learn to accurately see the true reality/value of ideas faster.

Accurately seeing the true value of ideas not only saves time and money, but also reduces the frustration, and increases the engagement of everyone involved in product development. This interactive process eliminates ideas that cannot work and focuses people on high potential ideas faster. The discussion fosters the necessary team effort to deliver both incrementally improved and highly innovative products that drive today's and tomorrow's revenues.

Want to Solve the IDE Mystery? Learn How to Make the Pre-IDE Process Work for You

Wed, 24 Sep 2008 07:00:00 GMT

This program will cover the mechanics of how to effectively utilize the FDAs Pre-IDE process to help your company interact with FDA early in the IDE process. This approach provides an opportunity for your company to understand FDA requirements and to also familiarize FDA with your technology and proposed study design which can help speed the regulatory process and minimize delays.

Practical tips will be shared on how to best navigate the process and request meetings, prepare the submission, and document the results. The information provided at this meeting serves as a nice compliment to the FDA guidance documents associated with this interactive approah dealing with agency. Don't miss this opportunity to hear from an expert so you can begin using this process on your next IDE.

Who should attend:
Clinical, Regulatory, Program Management, Research professionals and others involved in the design and development of medical devices and clinical trials.

The Golden Egg - How to Both Share and Protect Your Intellectual Properties

Wed, 24 Sep 2008 07:00:00 GMT

The LifeScience Alley Small Business Leaders Forum provides those heading up small scientific businesses with peer-to-peer networking that supports them in building their companies. It can be a lonely and difficult journey to take a scientific concept to commercialization or grow a bioscience business in the midst of a world-leading cluster of giants.

This monthly breakfast forum brings experienced as well as emerging entrepreneurs together to explore best practices, share ideas and build a critical network. What do you do to develop your leadership skills in today's ever-shifting world? Make this commitment to invest in your business by investing in yourself.

September 24th: The Golden Egg - How to Both Share and Protect Your Intellectual Properties
Sponsored by Dorsey & Whitney LLP

Please note that this program is not open to consultants and other service providers.

For those organizations that provide valuable support to small and emerging scientific companies, LifeScience Alley has structured unique sponsorship opportunities within the Small Business Leaders Forum. If you would like more information, please contact Dana Boyle, Vice President of Business Development at dboyle@lifesciencealley.org or (952) 746-3820.

Aligning Marketing and Sales: The Delicate Dance for Success

Thu, 25 Sep 2008 07:00:00 GMT

Marketing and Sales are essential to any successful business. In this session, we will discuss the special relationship, challenges and opportunities between marketing and sales for companies engaged in the lifesciences.

Agenda:
7:30-8:00am: Registration and Continental Breakfast

8:00-9:00am
Kevin McArdle - Get In Step With Sales: New Roles For Marketing In Sales Force Enablement
View presentation description.

9:00-9:15am: Break

9:15-11:30am
Diane Emo - Customer Message Management: Increasing Marketing's Impact Selling
View presentation description.

Raising the Bar on Medical Sales Training: Accelerating Sales

Wed, 01 Oct 2008 07:00:00 GMT

If you are a CEO, Board Members, VC, SVP or VP who has responsibility for top line revenue for your company, this program is for you. Today's Senior Executives face many demands and are continually asked to do more with less. Regardless of how well your sales were last year, one thing you can count on is for your sales goal to increase.

Successful sales training is linked to business strategy and produces results. Traditionally however, in the medical device market, many companies focus simply on product training. Due to the technical nature of the medical devices, companies typically hire Nurses, Techs or Clinical personnel to design and run their sales training. While they have great clinical expertise, they don't always have sales, sales management, formal education in training, professional training expertise or a business background.

With this in mind Susan Lund developed a sales training program to help a local medical device company turnaround their sales training to achieve business results. They had grown rapidly, had multiple products and they had previously had a clinical person oversee all of their sales training which was not meeting their business objectives. The resulting training program was a high impact learning system that led to accelerated sales for new hires, increased productivity an incremental $1000/day per Territory Manager or $300,000 more pre year, and developed and retained top sales performers.

By raising the bar on medical sales training it was clear that sales training can be linked to business results. Whether your company has $50M in revenue or $750M + in revenue, it is possible for you to accelerate your revenue via effective sales training. Learn how sales challenges were addressed, how results were achieved, and how these same strategies and systems can apply to you and your company to accelerate sales.

SIG Plus! Phillips Plastics Corporation

Fri, 03 Oct 2008 07:00:00 GMT

Agenda
1:30 - 2:30pm Registration with welcome reception
2:30 - 4:00pm Program and Tours (Engineers and scientists at stations in tech center to show processes and outputs)
4:00 - 5:00pm Reception and Networking

Statistics for Managers

Fri, 03 Oct 2008 07:00:00 GMT

Statistics for Managers is a 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 16 practically useful statistical tools 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 and acceptance sampling plans?
7. Controlling processes - does my process have fever?
8. One minute process management - how to use an at-a-glance-display?
9. Getting lucky - how to find causes of variability by just looking systematically?
10. Is my measurement system acceptable - and how to improve it?

Members of AACC (American Association of Cereal Chemists) may register at the LifeScience Alley member rate.

Rochester Alley Chats

Wed, 08 Oct 2008 07:00:00 GMT

The purpose of Alley Chats is to invite life science industry members to engage one another in order to collaborate in sharing resources. This is accomplished by sustaining a welcoming environment of open communication, sharing thoughts and expertise. Alley Chats is not an event for the marketing of products and services, other than those of its sponsors who enable the event; it is intended to be an attractive opportunity to network with colleagues in the life science industry. Rochester Alley Chats is open to both members and non-members.

This event is a great opportunity to meet other companies in your life science community. Here is a sample of who is located in Rochester:
• Mayo Clinic
• COMPASS International
• Rochester Medical
• Medical Laboratory Surgical Services, Inc.
• Domaille Engineering LLC
• Medical Innovations International
• Ortho Innovations

Registrants are invited to ride the bus to the second of two new Alley Chats Networking Events outside the Twin Cities. A bus will be departing from the LifeScience Alley office in St. Louis Park on October 8th (departure time TBD). There is no extra fee beyond the $20 event registration fee to ride the bus thanks to our sponsors! So leave the driving to us while spending extra networking time with your colleagues to and from these events. To secure your seat on the bus, please email info@lifesciencealley.org with your name and contact information.

Many thanks to our sponsors:
Bus Sponsor: StoneArch Creative
Hosted by: Mayo Clinical Trial Services
Event Sponsor: Fish & Richardson P.C. and Merck & Co., Inc.

Introduction to Adaptive Design Methods in Clinical Trials: Efficient Use of Clinical Research Resources

Thu, 09 Oct 2008 07:00:00 GMT

Adaptive designs range from internal pilot study or sample size re-estimation, group sequential, to changing the treatment allocation based upon current trial results (outcome-adaptive). These designs are desirable to medical research professionals because they more accurately reflect medical practice in the real world, i.e. they adapt to data as it accrues. They can be designed to allocate more patients to the best performing treatment strategies. Because of the adaptation to data as it accrues, adaptive designs can be designed to stop as soon as the question the study was designed for is answered. Thereby, adaptive designs are efficient and expose fewer patients to ineffective therapy.

Adaptive designs utilize clinical research resources efficiently. They can ensure that enough patients are enrolled to show a statistical significant result, and can allow for the expansion or termination of the trial as needed. During interim looks at the data, the probability that the trial will be successful given the data observed to date in the trial can be calculated. It's possible this limited information could be utilized to increase investor confidence in the product or to help marketing and manufacturing decide how best to use their resources. Knowledge of this information, however, does not come without the risk of introducing bias into the trial. This can be done with minimal or no increase to the overall cost of the trial, and in some cases can shorten the trial reducing the overall cost.

This presentation will introduce adaptive design concepts and discuss the benefits of using an adaptive design. It will review where they are currently being used and challenges associated with their implementation. Lastly, the presentation will review case studies where innovative adaptive trial designs have been implemented with success.

Target Audience:
The target audience is clinical, regulatory, research and marketing professionals interested in understanding how adaptive designs can be applied to clinical trials to efficiently use research resources. This presentation will discuss various adaptive designs and how they might mitigate business risks associated with clinical trials. NOTE: The presentation will NOT be a statistical how-to.

Open Innovation in Biotechnology - Leveraging the World to Stretch Your Scientific Capabilities

Fri, 10 Oct 2008 07:00:00 GMT

This session is aimed particularly at R&D professionals and executives from biotech companies of all sizes, and speaks to process.

Clinical Trial Monitoring Master Class

Tue, 14 Oct 2008 07:00:00 GMT

This engaging and highly interactive program includes a brief review of the FDA regulations and guidance related to clinical trial monitoring. The majority of the day will include hands-on exercises, from informed consent reviews to regulatory binder document compliance assessments. We will use a sample protocol, medical records and a template monitoring report to learn and practice monitoring skills and talk through different approaches to enforcing compliance while fostering strong customer relationships. Attendees will participate in role-playing both as a coordinator and a monitor, in order to understand the challenges of medical record review, data and adverse event reporting, query resolution, and sponsor-site relationships. Additional role playing with a mock physician and eventually a mock FDA inspector will help attendees put concepts into practice, learning to understand the process of monitoring from paper to people.

Instructor Sarah Moeller, M.S., of The Greenlight Group, LLC, will coach attendees through exercises that were personally developed by The Greenlight Group team. Our well-known instructor excels at keeping dry material interesting and fun while ensuring a deep dive into the complex world of monitoring.

Building Brand Through Your Most Important Channel - Your Employees

Thu, 23 Oct 2008 07:00:00 GMT

Internal brand building is a powerful innovation that resides at the nexus of marketing and human resources and is transforming organizations' relationships with their customers.

Are you or your organization facing:
- A limited marketing budget that is inhibiting your ability to build a stronger brand?
- Fast growth making it difficult to maintain alignment around the organization's vision and what's important to customers?
- A leadership team that is skeptical about the importance of allocating resources for brand building?
- A challenge with employee engagement?

Research has shown, that engaged employees are more productive and can have a big impact on a company's overall positioning. Marketers bring your HR colleagues and training officers, because internal brand building is a collaborative effort. The internal brand building process contains innovations in brand building and organizational development, that will strengthen overall positioning and productivity.

Karl D. Speak, the leading global expert on internal brand building, will share his insights and experiences about what companies can do to more effectively develop this important relationship.

Statistics for Variance Reduction, Part 1: Finding Causes of Variation

Fri, 24 Oct 2008 07:00:00 GMT

Statistics for Variance Reduction is a program geared toward technical individuals in industry: scientists, engineers, and personnel from research and development, manufacturing, quality, engineering, supplier management, and regulatory affairs departments. Green belts and black belts will also benefit.

Members of AACC (American Association of Cereal Chemists) may register at the LifeScience Alley member rate.

Program 1: Finding Causes of Variation
Considerable effort in industry is directed toward reducing variability. Variability is caused either by changes in control factors or by changes in uncontrolled or noise factors. Cost effective variance reduction strategy can be implemented by (a) understanding the extent and consequences of variability, (b) identifying key causes of variability and (c) estimating the contribution of each cause to the overall variability. Without such an assessment, it is difficult to properly target variance reduction efforts. For example, if the moisture content of the final product varies, it is necessary to know the percent of variability in moisture caused by batches of purchased raw material, by the in-house manufacturing process and by the moisture measurement system. Without such an understanding it would be difficult to say whether the variance reduction efforts should be focused on the supplier, the manufacturing process or the measurement system. As another example, engineers at a major company thought that the old in-house equipment was responsible for product variability. Implementation of the methodology presented in this seminar resulted in the identification of the real cause, saving over half-million dollars in unnecessary capital expenditures.

The purpose of this seminar is to provide practical guidance on how to efficiently find the key causes of variation, by answering questions such as:
1. How to quantify variability and its economic consequence?
2. What data to collect to identify key causes of variability?
3. How to analyze the data to estimate the contribution of each cause to the overall variability?
4. How to plan cost-effective variance reduction efforts?
5. How to easily implement the methodology using software?

Breakthrough Series: Frontiers in Heart Failure

Mon, 27 Oct 2008 07:00:00 GMT

The topic of this Breakthrough Series event is Heart Failure, presenting important academic research into prevalence and incidence, cardiac remodeling and heart failure, and advanced and emerging therapies. Eighteen leading researchers and speakers from the University of Minnesota are confirmed for this full-day program.

Breakthrough technology calls for Breakthrough collaboration between the University of Minnesota and the member organizations of LifeScience Alley. LifeScience Alley has joined with the Office of Clinical Research at the University of Minnesota in this educational partnership.

This program will be highly interactive. Presentations and panel discussions will add intellectual depth to our understanding of current and future research directions, and will look at emerging interventions. Question-and-answer periods will give everyone opportunities to interact with presenters and with each other. The purpose is to enhance Minnesota-based leadership in new technology. This topic will not be sufficiently covered in one day. We intend to address heart failure again in a subsequent program emphasizing industry initiatives. Don't miss this spotlight on academic breakthroughs, and watch for more.

Statistics for Variance Reduction, Part 2: Designing Robust Products and Processes

Fri, 31 Oct 2008 07:00:00 GMT

Statistics for Variance Reduction is a program geared toward technical individuals in industry: scientists, engineers, and personnel from research and development, manufacturing, quality, engineering, supplier management, and regulatory affairs departments. Green belts and black belts will also benefit.

Members of AACC (American Association of Cereal Chemists) may register at the LifeScience Alley member rate.

Program 2: Designing Robust Products and Processes
One important objective in industry is to design and develop products and processes that are robust - that deliver on-target performance in the presence of large variation in raw material and process factors and customer usage conditions. Such robust designs achieve high quality at low cost by permitting wide tolerances for purchased material and manufacturing conditions. They also increase market share by permitting wider customer usage conditions. However, building robustness in product and process designs requires a different approach to product and process development - in terms of the strategy of experimentation and methods of data analysis.

The purpose of this seminar is to provide practical guidance on how to design robust products and processes, by answering questions such as:
1. What is the key principle of achieving robustness?
2. How to structure control by noise factor experiments?
3. How to analyze the data to design robust products and processes?
4. Two major examples: How to build robustness with known and unknown noise factors?
5. What changes to the product development process are necessary to implement the methodology?
6. How to easily implement the methodology using software

What Biotech Products Bring to a MedTech Cluster - Convergent Technology Opportunities in the Region

Fri, 14 Nov 2008 08:00:00 GMT

This session is aimed at scientists, R&D professionals and leaders of biotech companies, particularly those in the human health sector, and speaks to products. It plays on the needs that the biotech industry has for targeted, controlled delivery of their molecules and how medical devices can offer effective platforms for drug delivery.

Cardiac Valves: Past, Present, and Future

Mon, 08 Dec 2008 08:00:00 GMT

The Second Annual Bakken Surgical Device Symposium will be held December 8-9, 2008, spotlighting Cardiac Valves. This program will explore the early innovations and current practice with an eye to future developments in cardiac valve design and technique. Alley Institute and the Minnesota Medical Foundation fund this continuing series thanks to your tax-deductible contribution**. A substantial portion of registration fees support our annual spotlight on device development and innovation.

**$300 of the Full Conference Registration rate is tax-deductible, or $200 of your Day One or Day Two Conference Registration rate is tax-deductible.

The Bakken Surgical Device Symposium is presented by the University of Minnesota and supported by LifeScience Alley and Alley Institute

Agenda: December 8, 2008
8:00 am - Welcome
Selwyn M. Vickers, M.D and Jay Phillips, Professor and Chair, Department of Surgery, University of Minnesota

8:15 am - Welcome
Frank B. Cerra, M.D. Senior Vice President for Health Sciences, Academic Health Center, University of Minnesota

8:30 am - Welcome - Earl Bakken

9:00 am - Plenary Talk
Speaker: John Mayer, M.D.

10:00 am - Coffee Break

10:30 am - History of Cardiac Valve Development at the University of Minnesota
Richard W. Bianco, Program Director Experimental Surgical Services, Associate Professor of Surgery, University of Minnesota

11:00 am - Session I A: Development of Mechanical Heart Valves
Moderator: Herbert Ward, M.D.
Speakers: Jack Bokros, M.D.; Robert Emery Jr., M.D.; Robert Gallegos, M.D.

12:00 - Lunch (box lunches provided)

1:00 pm - Session I B: Development of Mechanical Heart Valves
Moderator: Herbert Ward, M.D.
Speaker: James Cox, M.D.

2:00 pm - Session II: Development of Tissue Heart Valves
Moderator: Sara Shumway, M.D.
Speakers: W. Eric Jamison, M.D.; James St. Louis, M.D.; Hertzell Schaaf, M.D.

3:30 pm - Coffee Break

4:00 pm - Session III A: Device Development: From Bench to Bedside
Moderator: Paul Iazzio, M.D., Ph.D.
Speakers: Ajit Yoganathan, PhD; Fred Schoen, M.D., Ph.D.

5:00 pm Adjourn

AGENDA: December 9, 2008
9:00 am - Session III B: Device Development: From Bench to Bedside
Moderator: Paul Iazzio, M.D., Ph.D.
Speakers: Robert Levy, M.D.; Uli Stenseifer, Ph.D.

10:00 am - Coffee Break

10:30 am - Session IV A: Looking to the Future - Techniques and Technology
Moderator: Dan Garry, M.D.
Speakers: Robert Wilson, M.D.; Rusty Phillips, Ph.D.; Paul Iazzio, M.D., Ph.D.

12:00- Lunch

1:00 pm - Session IV B: Looking to the Future
Moderator: Dan Garry: M.D.
Speakers: Doris Taylor, Ph.D. (unconfirmed); Rakesh M. Suri, M.D., Ph.D. (unconfirmed)

2:30 pm - Coffee Break

3:00 pm - Closing Plenary - Cardiac Surgeons and Cardiologists on Future Directions in Cardiac Valve Replacement

7th Annual Conference & Expo

Wed, 10 Dec 2008 08:00:00 GMT

7th Annual LifeScience Alley Conference & Expo
December 10, 2008
Minneapolis, MN Convention Center

This event brings together life science leaders from Minnesota and around the world. Attendees of this annual conference represent the medical device, health care, pharmaceutical, biopharma, agricultural and industrial biotechnology and renewable energy sectors.

This conference showcases widely respected speakers, world renowned companies and research institutions, new technologies, and juried poster sessions. It provides access to top industry leaders, opportunities to build your business or research through education and networking, with insights into current trends, regulations, research and emerging technologies. Based on past history, this year's conference is expected to draw more than 1,500 attendees from over 25 states and a dozen countries.

Conference Highlights:

Four general keynote sessions
Seven concurrent tracks/21 educational seminars
New Technology Showcase
Innovation & Collaboration Center with meeting rooms
Exhibit Hall featuring 190 exhibitors
Juried poster session
Holiday Alley Chats Networking Reception in the Expo Hall

Sponsorships and exhibit space are selling out fast! See who has already signed up!

A registration brochure is available to download. Visit the conference website for more information and to register.

Midwest Personalized Health Framework - December Meeting

Thu, 11 Dec 2008 08:00:00 GMT