• Assess the most recent FDA proposals regarding biosimilars development and user fees for generic companies;
• Develop key strategies to balance and diversify a company's global portfolio;
• Instill more innovative approaches for the drug pipeline to heighten a competitive edge;
• Implement techniques to sustain product portfolios and increase a company's bottom line; and
• Understand regulatory nuances of global markets and how to frame and prepare for potential expansion.
In particular, the conference will offer presentations on the following topics:
• Implementing strategies to meet current and heightened Abbreviated New Drug Application (ANDA) standards to gain product approval;
• Evaluating the impact of the proposed FDA Generic Drug User Fee Act (GDUFA) to dictate preparation and implementation strategies;
• America Invents Act: Assessing the impact on generics;
• Adopting techniques and regulatory compliance strategies to ensure global competitiveness in the generics market;
• Analyzing recent updates to the Hatch-Waxman Act to grasp future impacts and challenges (intellectual property/patent track);
• Developing key patent strategies to protect intellectual property and ensure market sustainability (intellectual property/patent track);
• Identifying strategies to strengthen Paragraph IV patent filings and litigation to maintain exclusivity (intellectual property/patent track);
• Identifying tactics to improve strategic API (active pharmaceutical ingredient) sourcing;
• Identifying approaches to help overcome the drug shortage and deliver products to consumers;
• Studying the impact of the FDA's guidance on biosimilars for the generics industry to ensure regulatory compliance;
• Leveraging novel drug delivery technologies to drive innovation and differentiation;
• Generics in emerging markets: Analyzing the benefits and risks of expanding to new markets; and
• Assessing global manufacturing possibilities to increase efficiency and explore business opportunities.
A pre-conference workshop, entitled "Overcoming the Challenges of Global Portfolio Management to Improve Decision-Making," will be offered from 3:00 to 5:00 pm on July 17, 2012.
A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, and list of speakers can be requested here. Registration information can be obtained by e-mailing Michelew@marcusevansch.com or by calling 312-540-3000 ext. 6625.
Patent Docs is an official conference blogger of marcus evans' 5th Product and Pipeline Enhancement for Generics conference.