American Conference Institute (ACI) will be holding a conference on Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process on November 28-29, 2012 in Boston, MA. The conference will allow attendees to:
• Understand and
comply with the FDA's current regulations and policies to gauge the legitimate
medical plausibility of a population;
• Prepare an airtight orphan-drug designation request and advocate for orphan status in gray area situations;
• Develop global regulatory and patent strategies to maximize international market share and learn best practices from successful global orphan development;
• Determine the financial viability of orphan drugs and explore new strategic alliances and alternative partnerships to facilitate development;
• Overcome routine stumbling blocks in the designation process to proactively combat designation rejections; and
• Adapt a practical approach to incorporate orphan drugs into your current patent portfolio strategy and brace for the coming wave of orphan drug patent challenges.
• Thinking outside
the pillbox: Exploring successful orphan drug partnerships, collaborations, and
• Demystifying the designation submission process: Best practices for working cooperatively with the FDA;
• Orphan drugs around the world: Working within the orphan drug framework in major global markets;
• Keynote address: State of the market: Evaluating the commercial viability and opportunity in orphan drug development;
• Mastering the intricacies of the orphan drug designation process: A step-by-step guide to navigating the pathway;
• Overcoming hurdles in the orphan drug designation process: Insider insights into what works and what doesn't;
• Factoring orphan drugs into your broader patent portfolio and life cycle strategies; and
• Protecting orphan drug designation and proactively guarding against potential liability downstream.
A pre-conference boot camp entitled: "Intensive Deep-Dive into the Orphan Drug Act: Demystifying the Designation Process and Discovering the Accompanying Incentives" will be offered from 8:30 to 11:30 am on November 28, 2012. A post-conference master class entitled: "Overcoming Clinical Trials Challenges and Proving Safety and Efficacy for Orphan Drugs" will be offered from 3:00 to 5:30 pm on November 29, 2012.
The agenda for the Orphan Drugs and Rare Diseases conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee is $2,295 (conference plus pre-conference boot camp or post-conference master class) or $2,895 (conference, boot camp, and master class). Those registering on or before September 27, 2012 will receive a $300 discount and those registering by October 26, 2012 will receive a $200 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of ACI's Orphan Drugs and Rare Diseases conference.