Session Descriptions
Research and Development TrackMedical Affairs & Markets TrackBio-Agriculture & Industrial Biotech TrackEmerging Business Track"Meet the Press" - Communicating to Media & Investors As You Advance Your Product to Market This session will bring together some of the communications experts in our industry to discuss the challenges and expectations for how companies communicate as they go from an early-stage science-focused company, to a more mature, clinical data-driven, and then product-oriented company. Hear what the investment community looks for from a communications perspective as you develop your pipeline. Gain an appreciation for how the business media values the spectrum of communications from a biotech company. Learn what catches their attention and how to use press releases for free publicity and advertising. Take away strategies to help implement a successful communications strategy, better explain your technologies to other scientists, business investors, and above all, to ordinary people seeking scientific information and greater understanding of the products they consume. Moderator Panelists
Legislative Reform 2007: What Your Life Sciences Company Doesn't Know May Cost You. Sweeping changes are being considered in Congress on a variety of issues that will, or already have begun to affect the biotechnology, pharmaceutical and medical device industries. Get educated on key patent-reform legislation, the latest on follow-on biologics or biosimilars regulation, drug/medical device safety as related to PDUFA and MDUFA reauthorization, SBIR funding and eligibility requirements, drug pricing and R&D tax credits, among others. Hear from an array of legislative and legal experts who are staying on top of this rapidly changing area, and learn what the policy changes will mean for your company. Panelists
The "Other" Pharma - Biologics, Generics & Animal Health The world of pharmaceuticals means more than just synthetic small molecule drugs as human therapeutics. Increasingly, pharmaceutical companies are developing protein therapeutics or biologics as new therapies across a variety of disease states. It seems that big pharma is finding biologics an attractive opportunity to solve their pipeline problems. In addition, generic pharmaceuticals are a huge growth area while posing a significant challenge to traditional pharma companies as they see their highly successful innovator drugs come off patent. Lastly, profound changes are happening in the animal health market where many human pharmaceuticals are being cross-developed as veterinary therapies, in addition to a growing demand for new product development. Michigan is a R&D leader in all three sectors - hear as various company representatives discuss the trends in their respective sectors and what opportunities exist for new technologies and products. Moderator Panelists
Who's Going to Pay For Your Device or Diagnostic? Wrestling with Reimbursements. Who's going to pay for the revolutionary medical devices and diagnostics you're working so hard to develop? Your initial questions are, of course, "Is the science there? Can we prototype it? Can we manufacture it? Will the FDA approve it?" Once these were the most important questions, but these days it's all about affordability to the payer and consumer - whether insurance companies will pay for it and how much of the cost will be transferred to the consumer. How will payer reform affect the financial success of your device or diagnostic? At what point do you need to start planning for insurance coverage for your device or diagnostic? And, who and how do you lobby for appropriate reimbursement? A panel of experts including payer, company and financial representatives will share their expertise on these issues. Moderator
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Finding the "Right" Application (and Market) for Your Technology. For a technology-based biotech company, developing or acquiring innovative technologies is only the first step toward success. A significant challenge lies in finding the right application for these technologies to address real unmet needs. There are usually many approaches to apply a given technology or package a suite of technologies, and most of them may not find a market. Very often, two or more companies have been built around similar technologies, but with different approaches to extract value from these technologies. Some have succeeded, but many have failed. Speakers will draw upon their experiences to help answer how best to apply or identify the right market space for your technology. Moderator Panelists
College Students: Planning For Your Future in the Biosciences These are exciting times for education and careers in biotechnology. Amazing discoveries, inventive products and new applications are happening nearly every day. Due to the multidisciplinary nature of biotechnology and its applications in today’s world, options for students are almost limitless. Come listen and interact with a diverse group of experts from academic and industrial backgrounds. Hear them offer advice on both traditional and non-traditional careers. What educational paths exist and where will they lead to? What do companies look for as they try to meet the demand for skilled biotech employees? These and other questions will be addressed in a session just for undergraduate and postgraduate students. We’ll even throw in lunch! Harmony Bisnett's SlidesKim Shriver's Slides [ back to top ] Medical Devices - Human Factors Engineering & Usability. This session will help medical device companies design intuitive products that enhance patient safety while increasing device company sales and profits. Small firms often do not have the internal expertise or awareness of human factor FDA requirements. Learn how to effectively engage clinicians early in the design process. Basic design principles and methodologies of usability and human factors engineering will be presented. The session will include real life case studies of design process that includes analytical data from clinical users. Panelists
Optimizing & Adaptive Clinical Drug Trial Designs The clinical research enterprise faces numerous challenges like rising development costs, intense competition, regulatory pressures, shortages of qualified professionals and patients, and consumer demands for drug safety and information. As a result, the NIH, FDA and pharma/biotech industry are working together to drive changes in how clinical drug trials are designed, patients recruited, clinical data collected, managed, and disseminated. Experts in clinical trial research and drug development will explore critical issues around implementation and management of trials, pharmaco-vigilance and safety strategies, identifying target populations, integrating patient and trial data more accurately and quickly, improving regulatory compliance, and generally improving the quality and effectiveness of collaborations between stakeholders Moderator Panelists
Biocoatings and Biomaterials: Not Just the Icing on the Cake The successful commercialization of drug-eluting stents has done much to pave the way for a revolution in the discovery of novel biomaterials and development of biocoatings technologies. The use of biomaterials has shown considerable clinical advantages and has been found to be particularly useful in a range of orthopedic applications. It’s projected that demand for biocompatible materials will increase 7% annually to almost $4 billion in 2010. Synthetic and natural polymers will continue to dominate the overall market, but metals and ceramics will spawn niche opportunities in specialty devices such orthopedic and dental implants, pacemaker and defibrillator components, and stents. Advances in bioengineered formulations and nanotechnology both provide a vast growth opportunity for biomaterials R&D, production, and utility. Listen to the experts describe the latest in this burgeoning sector. Moderator Panelists
Show Me Money vs Show Me Data - Alliance Valuation & Strategies The alliance value proposition has come under great scrutiny from all sides. For early-stage biotech companies with minimal business development staff, approaching potential big partners is a daunting prospect. Companies want to know that their increasingly large pre-alliance investments are rewarded. On the other hand, buyer companies need to convince themselves (and top management) that alliance economics make sense. The panel will discuss how alliance terms are set, how these methods are evolving, what information must be in your proposal, how is your proposal evaluated, and what should your expectations be for managing the process. Moderator Panelists
MI's Bio-Economy - Hot Topics, Current Challenges & Future Opportunities The sustainable production and use of renewable biological resources - whether plants, animals and microbes - is a growing area of interest due to the increasing demand for food, feed, therapeutics, and other products generated from these resources. The range of bio-economy is so broad that it's on the verge of leading an industrial revolution. Learn about the latest biotechnology trends in developing bio-based products - everything from genetically modified crops and organisms to plant biotechnology for commercialization into biofuels and therapeutics. Find out what opportunities, as well as challenges, lay ahead for Michigan as it seeks to accelerate the growth of its bio-economy capitalizing on Michigan's potential to connect our strong agricultural, forestry, and natural resource sector with our extensive industrial and manufacturing sector and advance, much less lead, this nationally emerging economic sector. Moderator Panelists
Michigan's Technology, CRO & Commercialization Resources: Helping Companies Innovate & Accelerate Development Increasingly, recognition of the financial and commercial benefits of outsourcing has led to an expansion of the marketplace with a wide range of contract service organizations targeting all aspects of the discovery, development and manufacturing continuum. Outsourcing is viewed as an efficient means to tap into expertise that can expedite development and enhance the chances of regulatory approval. Learn about what’s available right here in Michigan in the way of key academic research-based centers of technology excellence, commercial CROs, and other state-based resources that assist and accelerate commercialization. The panel will discuss their capabilities and programs and what R&D commercialization steps might trigger the need for outside resources. Moderator Panelists
Crossing Borders: EU Regulatory Approval & Implications for the US The challenges faced by biotech companies and universities when attempting to develop, protect and bring to market new products and ideas in an ever-evolving legal and procedural environment are complicated by the having to navigate among differing regulations found across the globe. Europe and Canada have recently seen changes in their regulatory review and approval guidelines. Officials from the EMEA (Europe's "FDA") and Health Canada, along with representatives from drug and device companies, will explain the new rules and provide advice on making the development and marketing of your medicines and devices less of a challenge in those two markets. Moderator
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Convergence of Food, Nutrition, Health & Safety Food and healthcare are moving closer together. New technologies and approaches are playing an important role in this convergence as major food companies reposition themselves with a focus on innovation and health. Consumers are seeing rapid growth and availability of dietary supplements, nutriceuticals, and so-called functional foods as they seek health and nutritional benefits from their food products. Also, food safety has emerged as an important global issue with clear implications for public health, consumer perceptions and food product development. Understand how new technologies are being applied to create sophisticated functional food products, what's new in food and nutrition research, how diet is being integrated into therapeutic treatments, what trends are emerging in food safety, and how the biopharmaceutical and food industries are jointly exploiting human systems biology. Moderator Panelist
Experts Speak: Structuring Biotech M&A Transactions This session will provide an overview of approaches and considerations to structuring biotech M&A transactions. Given the development risk inherent in biotechnology companies, structural approaches including partial equity stakes, put/call options and other contingent value structures have been employed to align incentives and achieve strategic goals between two parties. Investment banking experts, biotech CEOs and biotech-focused M&A lawyers will provide feedback based on experience with structured deals. Moderator Panelists
Future Trends & Technologies In the coming years, the convergence of "-omics", cell therapies, regenerative medicine, bioinformatics, nanotechnology, biomaterials, devices, diagnostics and other life science technologies will pose significant opportunities and challenges in every sector of society. Hear from key technology players as they offer real-world outlooks on the evolving science and emerging sectors. Then, gain an investor's perspective on the realities of commercializing new innovations. Panelists
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