Archive for July, 2007
American Conference Institute’s National Forum on Strategic and Practical Pharmacoeconomics
July 8th, 2007
in Pharmaceuticals / Biotech / Life Sciences |
Gain expert insight and practical strategies on how to –
• DETERMINE the most cost-effective strategies for product development
• UNDERSTAND the relationship of FDA and CMS in product development and approval relative to government payor programs
• DEMONSTRATE value and efficacy of new products
• ACHIEVE successful formulary placement
• BENCHMARK your company’s strategies against others from the health economics and outcomes arena
Featuring expert speakers from:
• AlchemiPharma
• Hoffmann-La Roche
• Johnson & Johnson Pharmaceutical Services
• The Sanofi-Aventis Group
• Schering-Plough Corporation
• and many more…
The statistics are well-known and staggering. $800 million to research and develop a single new medicine; one in 1,000,000 potential new drugs ever make it to the pharmacy; and only 3 out of 10 medicines make enough profit to
cover average research and development costs.
In an effort to make the most out of your investment, you must undergo expensive, timely, and complex trials. You also must ensure that, once approved for use, a product can be paid for at a reasonable rate to recoup investment costs and serve as a benefit to the company and the public. As manufacturers of pharma and/or biotech products, you have an opportunity to define how
value and efficacy can and should be measured when attempting to secure placement on a formulary. To do so, you must remain informed on the latest economic data and efficacy studies. You must also understand the new roles that the FDA and CMS play in the development and approval of your products vis-à-vis government payor programs.
American Conference Institute’s inaugural National Forum on Strategic and Practical Pharmacoeconomics will provide the necessary and practical information and analysis for all those attempting to fairly determine the
value and efficacy of a drug or biotech product. It is critical that companies sustain their lifeblood, not only by developing safe and effective drugs, but by successfully and efficiently achieving another critical element to success: Obtaining placement on formularies.
Learn from pharmaceutical and biotechnology leaders about successful strategies for:
• Using the latest comparative effectiveness techniques
• Mastering the FDA/CMS interface in new product development and approval
• Demonstrating value pricing and efficacy to prospective payors
• Navigating the CMS coding maze
• Minimizing the impact of the Part B/Part D divide on development decisions
• Setting price and value when confronted with PDLs and preferred sources
• Designing development programs to collect data needed to support valuation
• Overcoming the economic challenges of personalized medicine
Tags: Biotech, CMS, FDA, Legal conferences, PDLs, Pharma
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8th Annual MAXIMIZING PHARMACEUTICAL PATENT LIFE CYCLES
July 8th, 2007
in Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
The definitive Hatch-Waxman event for brand names and generics
Preeminent patent counsel and advisers to leading brand name and generic pharmaceutical companies, as well as representatives from key government agencies, will provide insights on the latest Hatch-Waxman challenges and help you:
• SEE how a new legal paradigm for pharmaceutical patent life cycles
is emerging
• EXPLORE new legislative developments affecting pharmaceutical IP, including
the FDA Revitalization Act and the Patent Reform Bill and related PTO Rules
• EVALUATE the impact of KSR on secondary pharmaceutical patents
• UNDERSTAND how the evolution of declaratory judgment provisions and standards from the MMA to MedImmune to Teva v. Novartis is impacting Orange Book listings and Paragraph IV litigation
• LEARN how recent developments in the courts and Congress will affect the future of brand name/generic patent settlements
• NAVIGATE the intricacies of the latest developments affecting patent
and non-patent exclusivity
• COMPREHEND the vital role of the safe harbor in linking R&D to portfolio
management and life cycle management
• EXAMINE how the decisions of the Roberts Court are having a profound effect on pharmaceutical patent life cycle strategies
• ASSESS the cumulative impact of TRIPS, other trade agreements, and EU Roche-Bolar on US pharmaceutical patents
Before 2017, drug companies will suffer patent losses of $140 billion. In light of this startling figure, 2007 is a pivotal year for pharmaceutical companies – both brand name and generic – to rethink patent strategies not only in terms of this
impending economic reality, but also in terms of the dramatic political, legislative, judicial, and regulatory metamorphoses currently under foot.
The air is replete with change on every front – in Congress, at the PTO, and in the courts – some prime examples, so far include:
In Washington …
• The passage of the Kennedy-Enzi bill (FDA Revitalization Act) and the status of the following:
- PDUFA renewal
- pediatric exclusivity
- follow-on biologics
• Congressional hearings and proposed legislation on authorized generics and other matters impacting the legality of brand name/generic settlements
• PTO rule changes
• The fate of the Patent Reform bill
At the Supreme Court and the CAFC…
• A reexamination of the MMA’s declaratory relief provision via the iconoclastic holdings
of MedImmune and Teva v. Novartis
• A questioning of the validity of secondary pharmaceutical patents as the courts adopt new standards for obviousness in Norvasc and KSR
In this tumultuous and volatile time, it is imperative that you – as counsel to either a brand name or generic pharmaceutical company – have a complete understanding of the latest legal and regulatory developments and their
implications for your company’s patent life cycle strategies. It’s time to come to the one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies’ current strategies and tactics against competitors in both camps.
The eighth American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry-leading
conference. An outstanding faculty of in-house pharmaceutical counsel and expert attorneys for both brand names and generics, as well as government representatives, will provide insights on all the latest legal and regulatory developments affecting patent life cycle management.
In addition, our in-depth Master Classes for brand names and generics on:
• New strategies for obtaining pharmaceutical patent extensions post-KSR; and
• Updated drafting guidelines for Paragraph IV certifications and notice letters
will offer hands-on practical advice on some of the most critical day-to-day concerns for both sides of the pharmaceutical industry.
Tags: Follow-on Biologics, Legal conferences, MMA, Patent Reform Bill, PDUFA, Pharmaceutical, PTO
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