2010 Sessions and Speakers

Tuesday, October 26

Registration Open: 7:30 a.m. - 7:00 p.m.  Sponsored by: Kalexsyn, Inc.

8:00 a.m. - 1:00 p.m. - Biosciences Facilities Tours
This year's Expo tours include Aastrom Biosciences, Accuri Cytometers, Enzo Life Sciences (formerly Assay Designs), Essen BioScience, the Michigan Life Science Innovation Center, Terumo, the University of Michigan Medical Innovation Center, and Xoran Technologies.

10:00 a.m. - 5:00 p.m. - Business Partnering Meetings
Meet one-on-one with business development representatives from larger pharma and medical device companies to establish relationships, explore partnerships and gain valuable advice.
Note: Business parterning is open to MichBio Members only.

10:00 a.m. - 5:00 p.m. - Michigan Emerging Biosciences Showcase
Preview the next wave of Michigan bioscience companies in this jam-packed fast-paced program. The morning session is comprised of “emerging” or “pre-seed” companies, those evolving out of universities via technology transfer offices or otherwise formed and taking their first steps along the commercialization pathway. The afternoon will highlight seed or early-stage companies that are conducting their proof-of-concept research or are further along in executing their business and product development plans. Gain quick insights into up and coming companies and their technologies. In addition hear from two panels on topics relevant to all start-up companies – IP and finance. 
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Keynote Address
James Kuo, MD, MBA, President and CEO, Adeona Pharmaceuticals

Panel #1: Capitalization of the Venture
Hear a panel of experts discuss the latest investment trends, company formation principles, and the quest for capital to launch companies with a model that is sustainable.  Learn about the variables that influence the valuation of emerging companies in an uncertain investment environment.

Panel #2:  What Every Biotech Start-Up Needs to Know About IP Protection
The winds of change are swirling in every direction when it comes to intellectual property protection - from patent reform to PTO rule modifications and recent court cases.  Hear about the basics of IP rules from seasoned veterans to avoid costly mistakes and protect your business interests before you’re even out of the formation gate.
Sponsored by: Great Lakes Entrepreneur's Quest

12:00 - 7:00 p.m. - Exhibit Hall Open
                                  Innovations Poster Session
The poster session showcases the most promising technologies and discoveries coming out of labs at Michigan universities and research institutions.  Areas of focus can be pharmaceuticals, medical devices, equipment, diagnostics, informatics, bio-based technologies, industrial biotech and clinical research. 
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12:00 - 5:00 p.m. - Manufacturing Supplier Track
A Regulatory Primer for Prospective Medical Device Manufacturing Suppliers
Thinking about diversifying into the medical device sector because your current technology and manufacturing capabilities seem well-positioned to be transferrable?  It may not be as simple as that, given the medical technology space is highly regulated. Small manufacturers and suppliers need to understand the scope of FDA authority, essentials of regulatory rules, quality system regulations, compliance procedures, and available sources of help and information. A diverse group of speakers from the FDA, industry and suppliers will provide an overview of the basics.

Beyond Technology - What you Need to Succeed as a Supplier to the Medical Device Industry
Technology and manufacturing prowess won’t be enough to guarantee a successful transition into the lucrative medical device industry.  If you want to play in this arena you will have to develop a compelling product message and find a way to deliver it to a much broader, geographically diverse audience. No one will do it for you. This session will explore the strategies successful companies employ to establish a medical device market presence, how small medical companies achieve big financial results and the reasons why one Michigan company’s effort to enter the medical device industry failed despite a $100,000,000 technology investment.

12:15 - 1:15 p.m. - Networking Lunch - Exhibit Hall

2:45 - 3:15 p.m. - Networking Break - Exhibit Hall

5:00 - 7:00 p.m. - Expo Opening Reception - Exhibit Hall

7:00 - 9:00 p.m. - CEO Dinner Forum -  “Changing Times for the Bio-Industry”
The session will bring together key industry leaders in big pharma and biotechnology.  They will discuss the challenges every R&D executive is facing, especially given economic and policy uncertainty – from reigning in the high costs of R&D to declining research productivity and pipelines, pricing pressures and regulatory constraints, future trends in R&D innovation, outlooks for corporate partnering, and of course, the changing landscape in healthcare delivery.  Don’t miss a great opportunity to hear perspectives from the “big boys” and network with your CEO peers, invited business development representatives, and other select guests. 
NOTE: This is an invitation-only event for CEOs of bioscience companies.  For MichBio member companies only. Space is limited.

Wednesday, October 27

Registration Open: 7:00 a.m. - 3:00 p.m.

8:00 a.m. - 12:45 p.m. - Exhibit Hall Open

8:00 - 9:00 a.m. - "Legislator of the Year" Award/Breakfast Policy Forum
This Forum for the first time will feature Michigan’s gubernatorial candidates who will discuss their ideas and plans for advancing the state’s bioscience industry.  The session will begin in a moderated fashion with questions developed by MichBio’s Policy and Legislative Affairs Committee.  An open Q&A period will follow.  Leaders of the state’s research institutions, entrepreneurs, CEOs of biosciences companies, economic development organizations, investors, policymakers, and others are sure to gather and offer their perspectives to the candidates.  Those serious about making Michigan a center for biosciences activity must attend and be heard at this program.   

9:15 - 10:15 a.m. - Concurrent Track Sessions
Medical Devices:  Changing Times in FDA Enforcement: What’s a MedTech Company to Do?
The FDA is flexing new enforcement authority as evidenced by an increase in punitive actions for non-compliance.  Warning letters, CIAs, product seizures, and consent decrees are all on the rise but with no real predictability and transparency.  The panel of experts will review current FDA enforcement priorities and trends, discuss how to respond and communicate with the agency over issues of non-compliance, regulatory do’s and don’ts are highlighted with examples of real enforcement actions to help you lessen the risk for your company.
Pharma:  Quality Systems for Emerging Biotech/Pharma Companies: What’s Needed and When
Start-up companies and others in the early phases of drug and biologics development face a variety of issues and pitfalls.  Besides obtaining financing and having a strong strategy to meet milestones, compliance to regulations from the FDA is a MUST. At a minimum, the company must pay attention to three regulatory areas, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).  This session will cover the history, the when, the why, and pointers to consider on how to comply with "The G's" to keep your company compliant as you achieve success.
Ag/Bio-based Technologies:  Swallowing Health: Convergence of Food, Nutrition and Pharma
Consumers are increasingly taking a more proactive approach to managing their health.  Prevention of lifestyle diseases is an attractive market that is growing dramatically through the convergence of food, nutrition and pharmaceuticals.  This next-generation of disease prevention and personalized health products are evolving through technology advances in areas like functional and nutrient-dense foods, nutritional supplements, medical foods, and pharmaceuticals “grown” in crop plants – a vast, largely untapped consumer health marketplace.  Speakers will describe such issues as the opportunities for commercialization and market growth, access to intellectual property and capital investment, regulatory challenges, and technology advances and trends.
Emerging Business:  Transformation in the Workforce: What Every Bio Company Needs to Know
Strategic workforce requirements by large pharma, device and other bio companies are shifting due to continued challenging markets.  In the past, talent development was planned from within. Large companies now are focused either on hiring talent that can jump from one position to the next and/or are relying on third-party providers to provide staffing on a “just in time” basis, essentially “plugging and playing” personnel as the development cycle progresses. The use of contingent workers is becoming the norm - a viable solution previously thought only for controlling labor costs in a post recession environment. This session will outline emerging bioscience workforce trends and why bio-companies may be well suited for adopting the new velocity process-focused/contingent labor talent solutions to their own R&D efforts.

10:15 - 10:45 a.m. - Networking Break - Exhibit Hall

10:45 - 11:45 a.m. - Concurrent Track Sessions
Medical Devices:  Healthcare Reform and Legislative Issues: The Coming Tsunami for MedTech Companies
Beginning in 2013, device manufacturers will be assessed a 2.3% tax on sales of their products. It’s likely that smaller, more innovative companies will be more adversely affected than the large device manufacturers, and could see their R&D budgets decimated as a result.  In addition, trickle down effects of imposed cost reductions by hospitals and tighter reimbursement rates, will be felt by device manufacturers who will be pressured to lower product costs, and furthermore on vendors to reduce component or supply costs. Hear from device companies, legislators and other experts about what the likely impacts will mean for your company, development and business priorities, and legislative efforts being taken to repeal the excise tax and otherwise relieve some of the expected burden on device firms.
Pharma:  Clinical Trials 2.0: The New Rules for Engagement
Regulatory and legislative policy reform, technology advances in predictive diagnostics, and evidence-based medicine are reshaping the way clinical trials are conducted.  This, coupled with competitive pressures, are reshaping the clinical development strategies of many biopharma and biotech companies.  Hear from experts about the latest trends in clinical trials and impending impact of comparative effectiveness research requirements.
Ag/Bio-based Technologies:  Biobased Technologies – ‘CleanTech’, ‘Green’ and ‘White’ – A Potential Growth Industry for Michigan
The burgeoning sector of technologies and products geared towards replacing or supplementing petroleum-based products have enormous commercialization and economic potential.  Michigan, with its existing feedstock, chemical and industrial technology infrastructure, along with an established advanced manufacturing and logistics network is well poised to grow this sector.  Learn as industry experts, investors and executives from companies commercializing renewable chemical, biofuel, bio-materials and other bio-based technologies, discuss the status of the industrial biotechnology sector, latest trends in commercialization, market acceptance and unmet needs, and evolving government policy.
Emerging Business:  Providing Health Insurance to Your Employees: What Now?
The high cost of health insurance is a huge burden on American businesses large and small, stunting their ability to grow, innovate, compete, hire American workers, and ultimately rebuild the American economy.  This session is designed to provide the employer with information you need on how healthcare reform affects company’s health benefit plans.  Learn your obligations and when you need to comply; understand how this new legislation interacts with state laws; become current with the latest legal and legislative developments, and lastly, understand the penalties and how they could apply to you

11:45 a.m. - 12:45 p.m. - Networking Lunch - Exhibit Hall

12:45 - 1:45 p.m. - Concurrent Track Sessions
Medical Devices:  Unique Device Identification for Medical Devices: Emerging New Standards
The FDA is in the midst of establishing a mandated unique device identification (UDI) system and regulations for medical devices to be fully implemented by 2013.  In addition, the possible establishment of a National Medical Device Registry, a provision included in the health reform legislation, is being considered.  UDI is likely to be applied at all levels of packaging, down to the lowest level of patient or unit use, including direct part marketing for some devices.  Draft guidelines for the UDI program are likely in the fall 2010.  Hear about the latest developments, what standards and technologies are being contemplated, and what the pending regulations will mean for your device company’s R&D and manufacturing efforts.
Pharma:  How Healthcare, Patent and CMS Reform May Affect Drug Development
Healthcare reform is in the early stages of implementation, wholesale changes to patent rules are still pending in Congress but poised for passage, and new leadership at CMS will have a big say on what drugs will make it to market and how.  All of this and more may have dramatic impact on how biotech and biopharma companies conduct R&D.  Learn how these changes may affect pipeline considerations and development plans, what impacts we might expect on drug innovation, and how companies and institutions can assess risk in their development efforts.
Ag/Bio-based Technologies:  Farm to Fork - Food and Environmental Diagnostics To Insure Consumer Health
The growing incidence of food safety and environmental contamination scares along with inadequate product inspection has undermined consumer and Congressional confidence.  This has put pressure on implementing tighter quality assurance measures. Thus, the food and environmental diagnostics subsector is growing rapidly and offers great opportunities for commercialization of new products.   The session will focus on the latest in bio-detection and analytical technologies, evolving performance and certification standards and certification, investment trends, and the changing regulatory landscape.
Emerging Business:  Going Global? Considerations for Entering Foreign Markets and Sourcing
Economics, regulations and politics are making offshoring an increasingly attractive option for biobusinesses.  Whether it’s searching for foreign investment, developing a business strategy, outsourcing R&D, finding distributors/partners, sourcing and manufacturing, or looking for acquisitions and licensing, companies need to know the opportunities, regulations, legalities and pitfalls of doing business overseas.  Hear from speakers well-versed in emerging and foreign markets about how to do your homework right by using the correct business strategy from the outset.

1:45 - 3:00 p.m. - "Innovator of the Year" and "Good to Great" Awards
                                Keynote Address:  Dr. Jeffrey E. Shuren, Director, FDA Center for Devices and
                                Radiological Health

3:00 p.m. - Closing Reception