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The Future Of Clean Thermal Technologies: Technology Developments, Key Costs And The Future Outlook-Aarkstore Enterprise

Robert — Sun, 22 Aug 2010 18:37:17 +0000

This report investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via fixed dose combinations. The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to provide a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world. An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
This report explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs.
The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to give the reader a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world.
An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.

Key findings
Drug manufacturers must make the best strategic use of the patent-protected lifespan of a drug, or else risk losing the profit incentives they perceived at the start of the project.
In light of the increasing complexity of biopharmaceutical patenting, the ‘freedom to operate’, i.e. to commercialize the invention, is coming under increasing scrutiny.
The US Congress’ emerging stance on data exclusivity provisions for biologics will define the length of time a biotechnology company can keep out generic competition in new indications. The biotech industry’s stance is that the current provisions do not provide for enough time to profit from their post-approval R&D investments.
The potential for post-approval label expansion is much greater for biologics in comparison to small molecule pharmaceutical drugs. Most biologics on the market today can expect to add significant revenue streams via new indications, and potentially extend their commercial lifespan.
Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.
If an FDC is launched close to the loss of exclusivity date of the constituent brand, it may be interpreted as a marketing tactic to limit post-LoE revenue losses. If launched early, it may show intent to cater to a genuine unmet need, or to legitimately maximize the potential of the parent molecule(s).

Scope of the report
In-depth case studies explore the real-world execution of the issues and challenges discussed in the report.
Analysis of historic drug approval data provides the reader with contextual reference points.
Case studies on Vytorin, Advair and BiDil illustrate the strategies employed by three leading FDC brands.
Brand histories of Yaz, Remicade and Seroquel show how label expansion is fundamental to successful lifecycle management.
Where applicable, these strategies are discussed with reference to specific therapeutic areas or geographies.
Issues related to biologics are highlighted to indicate where they differ from small molecule drugs.

Use this report to
Gain an understanding of legal provision for patent protection and data exclusivity. Understand their role in the context of product lifecycle management
Utilize the historical data on NDA approvals to identify trends and build assumptions into competitive landscape forecasts.
Understand the stance of key stakeholders and implications of off-label drug usage.
Understand the role of FDCs in optimizing the commercial potential of a product asset, and the main challenges in their commercialization
Juxtapose historic sales performance with the timing of indication expansion and FDC based strategies to assess the success or failure

The Intel 80386 Business Case

Robert — Wed, 26 May 2010 18:08:32 +0000

[Recorded: January 26, 2009] Under the leadership of Andy Grove and Gordon Moore, the personal computer market changed in October 1985 with the launch of the Intel 80386 microprocessor. Today, no one will dispute that Intel is a world-leading company, but few recall that Intels path to becoming a technology giant was solidified by an unprecedented business strategy. In this lecture Harvard Business School Professor and CHM Board Member Richard S. Tedlow presents and reviews Intels sole-source supplier business strategy. Learn how Intel forever changed the landscape of the computing industry with its decision in the mid-1980s to act as the sole source for its revolutionary 80386 microprocessor. Prior to this risky and unorthodox move, companies would second-source products by licensing their technology to competitors the way it was always done. The 386 microprocessor marked the end of second-sourcing and the beginning of Intels leadership as a components-supplier in the personal computer market. But why was this significant and what did it mean to the future of the microprocessor and the future of personal computers? Professor Tedlow presents the business case, as taught in his Harvard Business School classes, to describe how these important decisions were made and what valuable lessons we can learn from Intels industry-changing business choices.

Zija – Marunggay, Moringa & Team DYNASTY

Robert — Mon, 19 Apr 2010 02:52:59 +0000

tinyurl.com Russ Bianchi, formulator of the Zija beverage and is one of Zija’s product development consultants. Mr. Bianchi is the founder and Managing Director of Adept Solutions, Inc., a global product development, formulation, creation, and existing brand conversion firm. He is an expert in nutritional bioavailibity and a highly respected formulator of many recognized nutritional branded products worldwide. He is also an acclaimed speaker and author of food technology and nutritional articles, and has been extensively quoted in the media. Monica Marcu, researcher and technical advisor for Zija. Monica holds 2 Ph.Ds in Botanical Pharmacology. Author of Miracle Tree, Marcu’s background as an expert on the nutrient-rich Moringa is impressive. She has worked in clinical pharmacies and in biomedical research laboratories at the University of Ottawa and the National Institute of Health (NIH)-National Cancer Institute (NCI). She has also conducted extensive pharmacological and biological research, authored patents, and is credited with more than 60 articles and chapters in scientific journals and publications. She has been the recipient of numerous awards and honors from the American Association for Cancer Research, NIH, and the NCI, as well as recognition from other organizations. In addition to numerous professional affiliations, she is an associate of the National Geographic Society as well as the Nature Conservancy. Besides her two Pharmacology degrees, Monica also has a …

Technology Management Program UCSB: Entrepreneurship

Robert — Sat, 03 Apr 2010 15:44:57 +0000

Tina Seelig of the Stanford Technology Ventures Program addresses the question of whether innovation and entrepreneurship can be taught to students. This is part of the Winter 2007 series: Technology: Change and Challenge. Series: Technology Management Program [5/2007] [Business] [Show ID: 12486]