MedImmune-_161015

Affordable Care Act is Here to Stay

10:00 AM - 11:30 AM on Wednesday, Apr 24, 2013


Description: The Patient Protection and Affordable Care Act (ACA) of 2010 includes key provisions that could lead to new and improved treatments, cures and cost savings for patients.  All of these changes...
Event

Assessment of PDUFA and FDASIA Implementation: How the Changes are Impacting the Work of Prescription Drug Regulatory Professionals

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


Description: The FDA Safety and Innovation Act (FDASIA) passed on July 9, 2012 and implementation started on October 1, 2012. Embedded within FDASIA is the Prescription Drug User Fee Act (PDUFA)...
Event

Automatic Substitution of Biologics: Who Decides and with what Criteria?

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


Description: The first approval of a biosimilar product in the U.S. could happen this year, but how this new category of products will be incorporated into the U.S. health care system remains...
Event

Biotech Crops: Tackling Resistance and the Myths

12:00 PM - 1:30 PM on Monday, Apr 22, 2013


Description: All forms of agricultural production have historically endured losses to weeds — and all farmers are challenged with the simple fact that weed control methods have limited life spans. Weeds simply...
Event

Breakthrough Therapies: Navigating the Expedited Development Process

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


Description: Expedited clinical development programs, such as those envisioned under the FDA’s New Breakthrough Therapies designation process, will put Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practices (GMP) considerations on the...
Burrill-Logo--_170758

Burrill State-of-the-Industry Report

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


Description: G. Steven Burrill, CEO of Burrill & Company, a global financial services firm serving the life sciences industry, will discuss trends and hot topics from his new annual report, Biotech 2013:...
Event

Clinical Trials Modernization: Confronting Challenges to Study Start-Up - Avoid Delays, Improve Efficiency, Mitigate Risk

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


Description: Conducting a modern clinical trial requires coordination of a large and diverse group of stakeholders – including patients, clinical investigators, physicians, regulators, and the research sponsors. Studies have suggested that barriers...
Event

Clinical Trials Modernization: The Promises and Challenges of Risk-Based Approaches to Monitoring

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


Description: Monitoring the progress of clinical investigations typically involves frequent visits to each study site. However, general guidelines for Good Clinical Practice (GCP), FDA regulation, and International Conference on Harmonization (ICH) guideline...
Event

Clinical Trials Modernization: Tools for Developing the Clinical Trials of the Future

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


Description: A variety of private-public partnerships focused on regulatory science are dedicated to new drug development tools (DDTs)—biomarkers, aids for patient-reported outcomes, novel clinical trial designs, new statistical approaches for analyzing clinical...
Event

Collaborating For Solutions: Public-Private Partnerships in Agricultural Development for Food Security

9:00 AM - 11:30 AM on Tuesday, Apr 23, 2013


Description: Format: Organizers will host a two-part symposium at BIO 2013 focused on public-private partnerships (PPPs). The first segment will explore three PPP case studies to demonstrate the challenges of scaling up...
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

Corporate Venture Capital in the AgTech Entrepreneurial Ecosystem

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


Description: Major agriculture companies are increasingly looking externally to strengthen their R&D pipelines and develop new products. Corporate venture units within these companies play a vital role in sourcing this innovation and...
Event

Creating Value with Limited Liability Companies and Asset-Centric Investing

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


Description: For decades, start-up companies across industries have been organized as corporations. Most investors insisted on this. However, to keep pace with the challenges facing the biotech industry, a handful of entrepreneurs...
Event

Demonstrating Product Economic and Clinical Value: Know What Investors are Looking For

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


Description: Around the world, cash-strapped public and private payers are just saying "NO" to new products, line extensions and price increases. Even worse, the ability of biotech and pharmaceutical companies to influence...
Event

Demystifying Alzheimer’s Disease

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


Description: Roughly 5 million Americans have Alzheimer’s disease – the most common form of dementia that often steals someone’s memory, cognition and personality. And this number is expected to triple by 2050....
Event

Emerging Markets Heads of Patent Offices Discussion

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


Description: Patent Office Directors in emerging and newly-industrialized countries have unique opportunities to use Patent Office initiatives to foster domestic biotechnology innovation. This panel will discuss initiatives to stimulate both domestic and...
Event

Finding Common Ground: Can Payers and Biopharma Agree on Therapeutic Value?

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


Description: Payers and employers often see corporate R&D as a mechanism for price increases and smart life cycle management. Pharmas just as often see payers and corporate health care buyers as obstacles...
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

Global Regulation of Biosimilars: Issues of Importance in Latin America

10:00 AM - 11:30 AM on Wednesday, Apr 24, 2013


Description: Regulatory agency officials from around the world will be joined by industry representatives to discuss scientific and regulatory issues for biosimilars, including specific requirements for approval of biosimilars, interchangeability and implications...
Event

Going on the Offense: Proactive Strategies to Reduce Uncertainty

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


Description: Bioengineered agricultural and animal products for food and for the production of biofuels have become a focus of opposition groups through frequent litigation, regulatory advocacy and negative media strategies. This...