Event

Allies in Innovation: Biologics and Cell Therapy Manufacturers Think Small for Big Value

2:30 PM - 3:30 PM on Monday, Apr 22, 2013


Description: As biologic and cell therapies that open the door to more personalized and targeted medicine gain momentum, the bioprocessing and cell therapy industries are advancing more cost-effective and flexible technologies for...
Event

Big Problems Need Big Solutions - Fixing the Health Care System Using Big Data

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


Description: Companies like Google have changed the way we live and interact with the world. The biopharma industry started realizing the potential of big data as genomics companies quietly began using it...
Event

Circulating Tumor Cells (CTC): From Enumeration to Comprehensive Molecular Characterization

2:30 PM - 3:30 PM on Monday, Apr 22, 2013


Description: Inexpensive, minimally-invasive diagnostics tests are important for the effective development of targeted cancer therapies because they can be used repeatedly throughout the course of disease to assess the effect, and even...
Event

Companion Diagnostics: Demonstrating Value and Delivering Success

10:15 AM - 11:30 AM on Tuesday, Apr 23, 2013


Description: With a number of new partnership announcements between pharma and diagnostic companies, the companion diagnostics (CDx) field appears ripe to deliver. However, a number of strategic and technical pitfalls still need...
Event

Finding Innovation in Emerging Markets

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


Description: While biotechnology companies and academic institutions in established markets remain important sources of innovation for pharmaceutical companies looking for licensing deals and partnerships, emerging markets are becoming increasingly attractive. This is...
Event

Finding Your Niche

10:15 AM - 11:30 AM on Monday, Apr 22, 2013


Description: Rising regulatory and reimbursement hurdles are putting pressure on biopharma’s commercial engines, and redefining the term "blockbuster." Part of the industry’s response has been to embrace more niche indications, where lower...
Event

How IP Issues Impact Innovations in Biomarker Diagnostics & Personalized Medicine

10:15 AM - 11:30 AM on Monday, Apr 22, 2013


Description: Advances in personalized medicine and diagnostic technologies have been made possible by innovators who have done the difficult work to assess and clinically validate which biomarker measurements are relevant to disease...
Event

It’s a Small World After All: Development of Global Pediatric Plans

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


Description: The pediatric provisions within the 2012 FDA Safety and Innovation Act (FDASIA) have a significant impact on the management of pediatric studies both inside and outside the U.S. Now is an...
Event

Lithuanian Biotech - Innovations in Health

9:00 AM - 9:45 AM on Monday, Apr 22, 2013


Description: The Lithuanian government is focused on life science innovation as a cornerstone for promoting competitiveness and growth of the country. Key areas include: biotechnology, pharmaceuticals, medical devices, and related fields. The...
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

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

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

Personalized Medicine and Diagnostics Regulatory Fireside Chat

1:00 PM - 2:15 PM on Monday, Apr 22, 2013


Description: This fireside discussion will explore the current landscape of regulatory issues impacting the personalized medicine industry. Panelists will address pre- and post-market topics, from companion diagnostics to the regulation of laboratory-developed...
Event

Personalized Medicine Forum Opening Remarks

9:15 AM - 9:30 AM on Monday, Apr 22, 2013


Description:
Event

Policy Changes to Advance Personalized Medicine

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


Description: This panel will explore policy barriers to the advancement of personalized medicine, and discuss potential solutions to foster innovation and continued progress in this area.  Panelists will discuss challenges relating to...
Event

Say It Ain't So, You Can Now IPO

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


Description: Private biotech companies require access to significant capital to develop their pipelines. The IPO market adds a desperately needed source of capital and can increase the intrinsic value of biotechs overall....
Event

The Changing Landscape for Companion Diagnostic Deals

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


Description: Both diagnostic and pharmaceutical companies have been struggling to structure research collaborations to develop of companion diagnostics. Current reimbursement policies do not appropriately reward quality and innovation in diagnostic tests. As...
Event

Using NIH Resources to Help Advance Biomedical Technology and Drug Projects to Industry Adoption

9:00 AM - 10:15 AM on Wednesday, Apr 24, 2013


Description: Biotechnology companies and university researchers urgently need additional funding and research resources to move technologies and therapeutic programs to industry adoption (i.e. investor funding and corporate partnerships). During the last year,...