Re-posted by Houston Lawyer and Law News - American Conference Institute invites you to join your peers and colleagues at the 2nd edition of its Biosimilars conference. Brian Malkin from FLH will be presenting at this timely industry-leading forum where counsel and advisors for brand name and generic companies will discuss positioning strategies in light of the FDA's current stance on the biosimilar pathway, in addition to some of the most pressing and recent controversies surrounding implementation of the pathway:
Determining what level of clinical data biosimilar applicants must provide to prove safety and efficacy
Demonstrating interchangeability and proving or disproving similarity based upon the heightened statutory standard
Preparing for the inevitability of biosimilar patent litigation
Evaluating the impact that the 12-year exclusivity period will have on competition and research and development
Scrutinizing the success of biosimilars globally so far and comparing various regulatory models which may influence the FDA
Assessing the financial viability of biosimilars in light of potential regulatory hurdles and forecasting potential profit margins
This event -- which is the definitive forum on dissecting the science, the law, the regulatory, commercial and international framework for biosimilars and which also serves as the annual meeting place for the "who's who" of biosimilars players -- is now the single forum on which industry leaders wishing to blaze a biosimilar trail can rely for answers during this turbulent time in which the balance of power between traditionally branded companies and generic companies may completely unravel. Come to this conference and get the up-to-the minute information that you need to strategically situate your company and protect and increase market share in anticipation of the attacks on IP and litigation sure to come.
Do not miss your opportunity to enhance your learning and networking experience by attending one or both of our hands-on, informative and practical workshops:
Biologics Science 101:Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilars- At this primer, leading scientists and academics will translate the technical and scientific complexities behind biosimilars into useable data to factor into your business plan.
In-Depth Breakdown of the Biosimilar Framework in the EU- At this Master Class, leading EU practitioners will delve into the commercial and regulatory specifics of the already-launched EU biosimilar framework. In addition to providing a nuanced look into EU law for companies launching a biosimilar abroad, our expert faculty will give best practices from actual launches to incorporate into U.S. biosimilar strategies. [ACI Biosimilars Conference on June 7-8, 2011 in New York City - http://www.fdalawyersblog.com]
Re-posted by Houston Lawyer and Law News
Determining what level of clinical data biosimilar applicants must provide to prove safety and efficacy
Demonstrating interchangeability and proving or disproving similarity based upon the heightened statutory standard
Preparing for the inevitability of biosimilar patent litigation
Evaluating the impact that the 12-year exclusivity period will have on competition and research and development
Scrutinizing the success of biosimilars globally so far and comparing various regulatory models which may influence the FDA
Assessing the financial viability of biosimilars in light of potential regulatory hurdles and forecasting potential profit margins
This event -- which is the definitive forum on dissecting the science, the law, the regulatory, commercial and international framework for biosimilars and which also serves as the annual meeting place for the "who's who" of biosimilars players -- is now the single forum on which industry leaders wishing to blaze a biosimilar trail can rely for answers during this turbulent time in which the balance of power between traditionally branded companies and generic companies may completely unravel. Come to this conference and get the up-to-the minute information that you need to strategically situate your company and protect and increase market share in anticipation of the attacks on IP and litigation sure to come.
Do not miss your opportunity to enhance your learning and networking experience by attending one or both of our hands-on, informative and practical workshops:
Biologics Science 101:Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilars- At this primer, leading scientists and academics will translate the technical and scientific complexities behind biosimilars into useable data to factor into your business plan.
In-Depth Breakdown of the Biosimilar Framework in the EU- At this Master Class, leading EU practitioners will delve into the commercial and regulatory specifics of the already-launched EU biosimilar framework. In addition to providing a nuanced look into EU law for companies launching a biosimilar abroad, our expert faculty will give best practices from actual launches to incorporate into U.S. biosimilar strategies. [ACI Biosimilars Conference on June 7-8, 2011 in New York City - http://www.fdalawyersblog.com]
Re-posted by Houston Lawyer and Law News
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