Orange Book Blog

Marcus Evans Conferences will be holding its "5th Product and Pipeline Enhancement for Generics" conference in Washington, DC, on July 18-19.  According to the producer, the conference will help attendees "adopt innovative approaches to strengthen the product pipeline and prepare for regulatory changes to emerge as a global player."  The conference chair is Richard Dicicco, Chairman of Harvest Moon Pharmaceuticals.

The full agenda is as follows:

• Implementing Strategies to Meet Current and Heightened Abbreviated New Drug Application (ANDA) Standards to Gain Product Approval
• Understanding Key Techniques to Ensure Regulatory Compliance
• America Invents Act: Assessing the Impact on Generics
• Understanding Antitrust Concerns When Settling Paragraph IV Litigation and the Analysis of Pay-for-Delay Settlements, by Markus H. Meier, Asst. Director of the Health Care Division, Bureau of Competition
• Analyzing Recent Updates to the Hatch-Waxman Act to Grasp Future Impacts and Challenges
• Developing Key Patent Strategies to Protect Intellectual Property and Ensure Market Sustainability
• Identifying Strategies to Strengthen Paragraph IV Patent Filings and Litigation to Maintain Exclusivity
• Exploring U.S. Healthcare Changes and the Effect on Patent Litigation for Generic Companies
• Adopting Key Techniques to Select, Prioritize and Manage a Generics Portfolio
• Examining Trends in Market Opportunities and Partnerships to Diversify the Company's Portfolio
• Implementing Successful Resource Management Techniques with Limited Resources
• Understanding How At-Risk Product Launches Factor into Portfolio Development
• Identifying Tactics to Improve Strategic API Sourcing
• How Generic User Fees (GDUFA) are Likely to Impact the API Industry
• Studying the Impact of the FDA's Guidance on Biosimilars for the Generics Industry to Ensure Regulatory Compliance
• Global Biosimilars: Differentiating Between the Draft U.S. Biosimilars Guidance and Existing EMA and Japanese Biosimilars Regulations
• Leveraging Novel Drug Delivery Technologies to Drive Innovation and Differentiation
• Understanding the Role and Challenges of a Small Startup Generics Company
• Generics in Emerging Markets: Analyzing the Benefits and Risks of Expanding to New Markets
• Assessing Global Manufacturing Possibilities to Increase Efficiency and Explore Business Opportunities

There will also be a pre-conference workshop on July 17, "Overcoming the Challenges of Global Portfolio Management to Improve Decision-Making."

For more information or to register, please visit the conference website.