Pharmaceutical Executive Europe - February 2008 - (Page 14) 14 R&D: Innovation February 2008 Pharmaceutical Executive Europe research translates to the human situation. An example is the Alzheimer’s vaccine. We try to make the human body make antibodies against beta amyloids. Well, at the same time we are now testing for safety, we are also testing that proof of concept. Previously, that would have been done much later in the process. For several years, we have been systematically doing that for all of our drugs going into the clinic. Actually, even during the selection criteria — if the development and research teams cannot come up with a scientific readout that indicates that the working hypothesis translates to the human situation, these drugs now have a lower priority than the ones that do have such a concept. This is a very important go/no-go criteria for full development before it costs the hundreds of millions that it does in Phase IIs and IIIs. If I can put the drug in people, I should see this or that enzyme go up or down, and if it doesn’t happen, then the drug is dead then and there. PE: In terms of toxicology and safety studies, are there any new ways of testing early on that are going to be particularly applicable? PH: Yes. First, a lot of things that used to be done only in animals can now be done earlier in vitro. So there are quite a number of in vitro assays developed that can predict prohibitive side effects in people. Second, just like we do expression patterns of drugs with the clinical studies, the toxicologists are generating databases of drugs that fail for toxic reasons and seeing if there’s a typical genetic fingerprint and other commonalities. For example, the family of genes that would lead to liver failure. Now, if you could do that earlier, possibly in animals or even in in vitro situations, rather than waiting until you are in expensive human studies, you could eliminate drugs that have a lower probability of survival because of these side effects. There is a big European programme that we are discussing to share those databases — they are proprietary and they are the historical experience of that company with particular drugs. The question arises, if these drugs are not going to be competitive because they cannot be translated into real medicine, could companies be convinced to pool this data and thereby find common genetic patterns that are predictive of toxicology much faster than if each company does it on their own? That is one of these things that people are thinking about. Novartis is already starting to contribute some drugs with expression patterns, and several other companies are also signing on. PE: So it’s moving forward. PH: Yes, hopefully. Of course, the scientific question that’s still open is, Will we find sufficiently predictable patterns to really be able to say with some level of confidence that one drug should not be further developed, while that one is OK? But these methods all need to be validated and confirmed. And what will be great is if we can get a sufficient level of reliability that the regulatory authority accepts these methods. That might help to reduce the number of animals used in safety studies. It’s still too early to call. As usual, we will learn by experience that there are some classes of drugs for which it works very well and others much less. Especially for completely new mechanisms, it will be more difficult. PE: How is this similar to FDA’s Critical Path Initiative that’s encouraging companies to share information? PH: Oh, this is very similar, but it is under the auspices of the European Union. PE: So it really does seem that the future of R&D can be one of collaboration at certain points. PH: Oh, yes. Novartis was one of the companies that started the SNP Consortium of cross-company collaboration, a joint venture between Wellcome Trust, the Sanger Institute, the Whitehead Institute, the Genome Sequencing Center, Cold Spring Harbor, Stanford University, and 10 major pharmaceutical companies. It was the first time that several pharma companies pooled their resources to make this map as fast as possible, and they made it available both to academics and to themselves to get more predictable drug discovery. The initiative we just talked about in safety goes along the same lines. PE: It’s interesting that in the neglected disease area, collaboration and partnership is standard, with a whole range of public–private partnerships. But that idea seems to be translating into the for-profit world. PH: Well, there are different kinds of collaborations. For the SNP safety databases we said, “If each of us does it alone, we will not have the answer because we don’t have enough data to compare. And it’ll be so expensive, we’ll ruin ourselves. So let’s do it together.” Now, the neglected disease area has another aspect that makes collaboration easier: It’s mostly not-for-profit. So there is no commercial competition. As you know, the Drugs for Neglected Diseases initiative and Medicines for Malaria Venture all have the not-for-profit concept as part of their business model. They are not allowed to make money with these drugs that they develop. The commercial competition that is traditional between pharma companies does not appear. Since the money that pharmaceutical companies allocate to neglected diseases will not generate returns, by definition it has to be limited because our shareholders want to have returns. They accept that we invest some part of our resources into noncommercial neglected diseases, but there are limits. So it is even more important that the resources that we can allocate to these big diseases of the developing world are used in the most efficient way possible. Therefore, we want to avoid redundancies and share as much information as possible.
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - February 2008 Pharmaceutical Executive Europe - February 2008 Contents From the Editor News and Analysis Brussels Report Calendar R&D: Innovation - Learning to Share Drug Launch - The Preparation Game Q&A - Getting a Head Start Regulatory Compliance - Credible Compliance Clinical Trials - Establishing Trials in China The Mix - Relevant ROI Comment - Taming the Trader Last Word - Under the Microscope Pharmaceutical Executive Europe - February 2008 Pharmaceutical Executive Europe - February 2008 - Pharmaceutical Executive Europe - February 2008 (Page 1) Pharmaceutical Executive Europe - February 2008 - Pharmaceutical Executive Europe - February 2008 (Page 2) Pharmaceutical Executive Europe - February 2008 - Contents (Page 3) Pharmaceutical Executive Europe - February 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - February 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - February 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - February 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - February 2008 - Brussels Report (Page 8) Pharmaceutical Executive Europe - February 2008 - Brussels Report (Page 9) Pharmaceutical Executive Europe - February 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 11) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 12) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 13) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 14) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 15) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 16) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 17) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 18) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 19) Pharmaceutical Executive Europe - February 2008 - Q&A - Getting a Head Start (Page 20) Pharmaceutical Executive Europe - February 2008 - Q&A - Getting a Head Start (Page 21) Pharmaceutical Executive Europe - February 2008 - Regulatory Compliance - Credible Compliance (Page 22) Pharmaceutical Executive Europe - February 2008 - Regulatory Compliance - Credible Compliance (Page 23) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 24) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 25) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 26) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 27) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 28) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 29) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 30) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 31) Pharmaceutical Executive Europe - February 2008 - Comment - Taming the Trader (Page 32) Pharmaceutical Executive Europe - February 2008 - Last Word - Under the Microscope (Page 33)
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