Event

Market Access in Europe – Pricing in Germany and its Impact on Other Countries

2:15 PM - 3:00 PM on Tuesday, Apr 23, 2013


Description: Increasingly, EU member states are looking for ways to reduce their health care budgets. In 2011, Germany introduced a new AMNOG system based on an early benefit assessment and mandatory price...
Event

Massive Health Care Consolidation and Its Impact on Biotech

10:30 AM - 11:30 AM on Tuesday, Apr 23, 2013


Description: In the wake of the Patient Protection and Affordable Care Act of 2010, many provider organizations (e.g., hospitals and physician groups) have responded to the changing health care delivery environment by...
Event

Medical Countermeasures: Partnering with the FDA for Successful Product Development

9:00 AM - 10:15 AM on Tuesday, Apr 23, 2013


Description: The FDA plays a critical role in the nation’s effort to prepare for a public health emergency. In 2010, the agency launched its Medical Countermeasures Initiative (MCMi) to facilitate the development...
Event

Money Ball: Winning Venture Strategies

10:30 AM - 11:30 AM on Tuesday, Apr 23, 2013


Description: Investors with novel investment strategies and a proven track record of returns continue to raise significant capital. However, traditional life science venture capital is being challenged, and several firms are closing...
Event

Multi-Party and Cross-Border Patent Issues Affecting Biotech Businesses

9:00 AM - 10:15 AM on Tuesday, Apr 23, 2013


Description: Recent developments in U.S. case law may dramatically affect an innovator's ability to protect technologies that competitors may seek to copy and divide among multiple parties and/or in multiple countries. An...
Event

Myriad, Mayo, and Beyond: Developments in the Law of Patentable Subject Matter

10:30 AM - 11:30 AM on Tuesday, Apr 23, 2013


Description: The question of what products and processes are eligible for patent protection, and in particular the scope of the exception for laws of nature, has been the subject of recent scrutiny...
Event

National Alzheimer’s Planning

10:30 AM - 11:30 AM on Wednesday, Apr 24, 2013


Description: In 2012, the cost of caring for Americans with Alzheimer’s totaled approximately $200 billion, and Medicare and Medicaid picked up a hefty portion of this bill. This number is expected to...
Event

Navigating the Special Challenges of Commercializing Biologics for Rare Diseases: Distribution, Partnership, Reimbursement

3:45 PM - 5:00 PM on Tuesday, Apr 23, 2013


Description: Manufacturers of biologics for rare diseases face unique commercialization challenges at odds with the model of low-cost, bulk product distribution. Information is key down the line: patients and advocates need guidance...
Event

New Defenses Against Old Enemies: Vaccines and Biotherapies for Bacterial Infection

9:00 AM - 10:15 AM on Tuesday, Apr 23, 2013


Description: As many bacterial infections become tougher to treat with available drugs, new vaccines and antibodies are urgently needed. Novel biotherapeutics may have to master an immunological juggling feat: foil the pathogen’s...
Event

Next-Generation Biomanufacturing Facilities: Beyond Compliance to Process Excellence

3:45 PM - 5:00 PM on Tuesday, Apr 23, 2013


Description: Business dynamics and regulatory forces are driving significant changes in biopharmaceutical manufacturing. Innovation in the way facilities are designed and fabricated is focused on the need for speed in both process...
Event

Open Innovation: Transforming the Model of Biopharmaceutical R&D

2:30 PM - 3:30 PM on Tuesday, Apr 23, 2013


Description: Pharmaceutical companies are exploring new strategies and alliance models to address the industry’s innovation gap. One approach is ”open innovation”—defined as “a paradigm that assumes that firms can and should use...
Event

Opportunities and Challenges in Developing Innovative Stem Cell Therapies

3:45 PM - 5:00 PM on Monday, Apr 22, 2013


Description: Stem cell-based therapies are rapidly emerging as a promising new class of treatment for a wide range of diseases. Few have been marketed and some have reached clinical trials with many...
Event

Orphan and Rare Diseases: Closing Distances in Understanding Larger Disease Mechanisms

10:30 AM - 11:45 AM on Tuesday, Apr 23, 2013


Description: Research on rare diseases can shed light on mechanisms and therapeutic opportunities for common diseases. Better tools and improved support models have helped mitigate the special risks of research for rare...
Event

Orphan Disease Forum

9:00 AM - 5:00 PM on Tuesday, Apr 23, 2013


Description:
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Orphan Disease Forum Welcoming Remarks

8:45 AM - 9:00 AM on Tuesday, Apr 23, 2013


Description:
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Orphan Drug Development: Normal Rules Don’t Apply

2:30 PM - 3:30 PM on Wednesday, Apr 24, 2013


Description: Building a company focused on orphan drug development is not an easy task. Investors hesitate to invest due to the complexity of the technologies. Diseases are often not widely known. Preclinical...
Event

Panacea or Pain: Collaboration in Personalized Medicine

3:45 PM - 5:00 PM on Tuesday, Apr 23, 2013


Description: When it comes to advances in personalized medicine, is collaboration among diagnostic, therapeutics, and life science companies a panacea or the problem? How do companies with competing interests each capture their...
Event

Partnering for Effective Drug Development: 90% Joy, 100% Misery or 110% Synergy

3:45 PM - 5:00 PM on Tuesday, Apr 23, 2013


Description: Finding and applying synergies among industry, academia, patients and non-profit foundations can significantly minimize the risk of failure and increase the probability of success in drug discovery and development. In...
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Partnering in the Cloud - Can Pharma Drive Innovation through Big Data?

2:00 PM - 3:30 PM on Tuesday, Apr 23, 2013


Description: Outcomes-based healthcare reform is pushing traditional big data analyses to more expansive levels. Accessing new data sources (such as payer information to evaluate outcomes with biochemical and genetic information), collaborating with...
Event

Personalized Medicine and Diagnostics Forum

9:00 AM - 5:00 PM on Tuesday, Apr 23, 2013


Description: Co-organized by BIO and the Personalized Medicine Coalition Personalized medicine is poised to transform healthcare by offering the possibility of improved health outcomes and the potential to make healthcare more cost-effective....