We are pleased to announce a powerful new add-on service to BioMedTracker that could substantially enhance your competitive intelligence and investment analysis process. The new service, Thought Leader Opinions (TLO), provides you direct access to the latest expert opinions in the disease areas that you follow. The service currently provides subscribers with over 700 recent interviews from

• 300 medical/clinical Thought Leaders
  
• 30 Practice Specialties
  
• 90 Indications

These interviews provide in-depth analysis on the following issues which are crucial to understanding the competitive landscape within a given market:

1. Whether a late stage drug will be approved by the FDA and/or EMEA.
2. Whether that drug's approval will affect current prescription practice.
3. What market implications the recent results of a key trial will have.
4. What mechanisms of action and targets show promise for earlier stage drugs in a particular indication.
5. How recent safety concerns will affect how a doctor prescribes a particular drug or class of drugs.
6. How the pricing of a new medicine will impact its uptake in the market.

Examples of how Thought Leader Opinions have predicted the direction of FDA Panel Decisions include:

1. Brilinta for Acute Coronary Syndrome

Cardiologist Thought Leader says on January 13, 2010:

And then of course at ESC you had the ticagrelor PLATO data presented, which is really a pretty impressive trial result showing a reduction in mortality. That is going to be very, very difficult to argue against. My understanding is that drug may be approved as early as third or fourth quarter 2010. So I think that ultimately we are probably going to have three choices in antiplatelet therapy; clopidogrel, conventional dose or high dose depending on what you believe in, ticagrelor and then prasugrel. If I had to guess I would say that the loser out of all this is probably going to be prasugrel. I think people are going to be trying to decide between high dose clopidogrel and ticagrelor. Ticagrelor has got some limitations; it is twice a day, although we have got a lot of drugs that are twice a day, it has got some dyspnea associated with it that patients may not tolerate or may keep coming back into the hospital complaining of and that is going to make people sort of nervous about whether or not their stent is closing or they are having another ACS potentially. I think there are going to be some challenges to it, but I think it is going to be a very, very strong competitor to clopidogrel ultimately.

Result on July 26, 2010 - the Cardiovascular and Renal Drugs Advisory Committee recommends by a vote of 7-1 that Brilinta should be approved for the treatment of Acute Coronary Syndrome. Because the overall data was so strong, including a mortality benefit, the panel felt there was a sufficient possibility that an unfavorable hazard ratio versus clopidogrel was due to chance that they were uncomfortable keeping Brilinta from the market.

2. Qnexa for Obesity

Endocrinologist Thought Leader says on December 19, 2007:

I think certainly the combination of phentermine and topiramate makes a significant amount of sense. There are two things about it that I think that combination is important. One is they're reformulated in such a way that they get less peaks and valleys and more of a sustained effect of topiramate and they have changed the phentermine to a more slow release preparation and they have gotten very good weight loss in their initial 24 week trials. It just seems to me that is likely to be a potentially fortuitous combination. The only thing one worries about is the same problems that J&J found with it at a higher dose of topiramate which was neuropathy and cognitive changes; memory loss. So whether that will occur with time I don't know and that is the big question mark of that combination.

Result on July 14, 2010 - the FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommends by a vote of 10-6 that Qnexa should NOT be approved for the treatment of Obesity. Cognitive changes were cited as one of the main factors in the panel's rationale behind recommending against the drugs' approval.

3. Daxas for COPD

Pulmonologist Thought Leader says on November 13, 2009:

What would be needed her is an anti-inflammatory treatment. As you know, roflumilast is being developed as an anti- inflammatory treatment. So that would be the right sort of compound but I think the problem with roflumilast is that it has a lot of side effects and that limits the dose to a very low dose that hardly has any effect. So probably roflumilast wouldn't be the most suitable drug because of the risk of side effects. And I think this is where you do need new drugs that are going to be safe and effective as anti-inflammatory treatment.

Results on April 7, 2010: The FDA's Pulmonary-Allergy Drugs Advisory Committee Panel Votes 10-5 that Daxas should NOT be approved for the treatment of COPD. While there was not one overriding safety issue that led to the "no" approval vote, at least 4 members indicated that given the potential safety issues, they would have liked to see data that the drug was better than other available drugs or provided a benefit when added on to standard of care treatment, especially inhaled corticosteroids

When you are doing pipeline searches on BioMedTracker, you can easily see all of the drugs, targets, trials and indications that have these expert opinions available as those profiles now include a Thought Leader Opinion section highlighting those reports. For instance, you can see which recent interviews are available for Osteoporosis at the top of its Profile here. You can also quickly search for any specific Thought Leader Opinions by using the intuitive search tool here.

With these Thought Leader Opinions, you can quickly dig deeper into your analysis of a particular drug or mechanism of action you are exploring by seeing exactly what experts are saying about them. This is the first time that a comprehensive drug database has been combined with this level of expert opinion, making this information easier to manage and your workflow more efficient.

If you would like to sample how the Thought Leader Opinion service works, we are currently offering limited free trials. If you would like to access this free trial and find out how to gain permanent access to this service, please contact us by email or at 858-200-2390.

About MedPredict
The Thought Leader interviews in this database are being provided through an exclusive partnership with MedPredict Market Research.

MedPredict has established long-standing, peer-to-peer relationships with medical researchers and thought leaders across many therapeutic categories. Their experienced analysts capitalize on these relationships to uncover deep insights into commercial and research activity, as well as near- and long-term category trends.