Reports & Publications - IMI Conference Presentations

The benefits of Orphan Drugs status, such as early entry, less expensive clinicals, and other major beneficial conditions are defined in this presentation. In cancer, it defines the segments of cancers that would come under Orphan Drug and the rationale. It illustrates the cancer market and discusses the various therapeutic segments as well as the world sales for pharmaceutical companies. It describes the blockbusters as well as identifies those companies with Orphan Drug status. It also defines what an Orphan Drug is and the general qualifications required to be recognized as an Orphan Drug. It also compares the benefits of the Orphan Drug registration vis-à-vis the EU, U.S.A., Japan and Australia.

This presentation illustrates, why forecasting in oncology may require more than high-tech IT and financial skills. It is not intended to teach, but to warn of the experience and knowledge required for this field. Oncology as a therapeutic pharmaceutical segment does require respect and years of experience. It is a must reading even for the experts. Even Roche asked for a copy.

This presentation illustrates what we believe to be the best practice seven habits. The author by identifying the seven habits illustrates the diligence within each one of these that is required to truly achieve best practice in pharmaceutical business development. It also clearly shows the depth of knowledge required per indication and quotes “The Art of Valuing Science”, a Scrip magazine article, that best analyzes how to conduct valuation. It also illustrates the success rates of new chemical entities by their individual clinical development stage. The presentation brings humour into play and illustrates that a great deal of analysis is necessary in valuating and deal structure creation. Benchmarking is illustrated and some benchmarks are also given. Last but not least the negotiations best practice and tactics are illustrated and as simplistic as these appear, they do bring truths to the table from a different perspective.

This presentation uses a case history of the Buprenorphine brands, Temgesic® and Subutex®, which draws upon the experience of taking this drug from analgesia to drug-maintenance treatment. This is a remarkable success story based on all the uses of the product life-cycle management industry tools and practice. In this example, it is clearly shown how proper use of a life-cycle management tools, including Drug Delivery Systems, provides major longevity and insulation against generics. In addition, the presentation identifies the common strategies against generic encroachment. It is excellent reading for companies seeking to defend their products from generic encroachment, especially those near the product’s patent expiration date. A long list of examples of products using these tactics has also been provided.

This presentation helps illustrate the importance of Business Development in a pharmaceutical corporation especially from the standpoint of the CEO. It also illustrates the pharmaceutical industry’s “forces-at-work” and what are the pressures affecting the industry? It explains how important it is to develop a short-, mid- and long-term perspective of where the industry is going, as well as the forces and pressures eradicating change. In a way, it illustrates that Business Development and Corporate Development are in fact one and that a vision must be developed, shared and executed for the business to succeed. “The Seven Habits of Highly Effective Business Developers” illustrates the recommended practice for any executive wishing to develop and not only climb the corporate latter but also support his/her company in succeeding by bringing in new products and technologies.

This presentation addresses the importance of the corporate culture drivers from national, environmental to internally led factors. There are references to the McKinsey 7-s analysis as a way of understanding corporations. The presentation also defines key nationality groups and their potential differences. The book “The transplanted Executive” is analyzed. This presentation refers to the differences in paternalistic versus federalist societies, self-focused versus group-focused societies and it helps break-down the differences between legal structures, ownership structures, financial and accounting systems, management structures/rewards and leadership style. It also analyzes the reason for alliances failure.

A series of attorneys and Business Development experts specialized on Life-Science transactions both in Europe and the USA were interviewed requesting identification of the most difficult Intellectual Property issues facing these types of transactions. The results are varied and fascinating. There are some key lessons learned such as Competition Law, IP reexamination and IP due diligence.