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.
In particular,
ACI's faculty will offer presentations on the following topics:
• Thinking outside
the pillbox: Exploring successful orphan drug partnerships, collaborations, and
acquisitions;
• 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 [email protected] 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.
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