R&D Directions: These are certainly exciting and daunting times in R&D for the pharmaceutical industry. Weighing all the positives (new innovations/technologies, increase in R&D investment) and negatives (high cost of trials, sagging FDA approval rate), how would you define the current state of drug discovery?
Moncef Slaoui: It’s challenging, but then it always has been. Importantly, there is no shortage of scientific opportunity — in some areas it is greater than it has ever been — which is encouraging and it means that, despite all the pressures, there is still a huge amount of potential. Companies need to work out how to take advantage of it.
R&D Directions: Do you feel investment in R&D is where it needs to be? Is the reported increase in corporate spending toward research necessarily equating to more productivity in the field?
Moncef Slaoui: R&D is the engine of the business and GlaxoSmithKline recognizes that by its continuing investment in this area. R&D has repaid that faith — our latest pipeline report shows that we have 149 projects in the clinic. In 2001, it was 50. We have also built the capability to continue “reloading” the pipeline with potential medicines to follow those progressing to late-stage development. So in GlaxoSmithKline our productivity has increased. Our challenge is to deliver that pipeline by progressing more medicines through Phase III and regulatory submissions.
R&D Directions: What are ways companies such as GlaxoSmithKline would prefer to get the greatest return on their R&D investment?
Moncef Slaoui: The best return on investment is to have a strong pipeline. In support of that we will continue to invest internally in drug discovery and at the same time, set up alliances and collaborations with partner companies, recognizing that GlaxoSmithKline does not have the monopoly on good ideas in-house. We are also aware that in countries like China and India there is a growing science base. In China we have already announced that we have created an independent R&D organization located in Shanghai.
R&D Directions: How would you describe GlaxoSmithKline’s approach when it comes to R&D: aggressive or more on the cautious side?
Moncef Slaoui: I don’t think you can use one adjective to sum up such a diverse business. We have taken bold steps to restructure R&D by setting up the Centres of Excellence for Drug Discovery, we have established an R&D base in China, and we acquired a domain antibody business to support our growing biopharmaceutical operations. [Those are] just a few examples where we have led the industry. In other areas, it’s appropriate to be more moderate. The smart R&D organizations are the ones that adapt to different circumstances and opportunities with speed and insight in equal measure.
R&D Directions: How is GlaxoSmithKline altering its business strategies to deal with the influx of generic competition as some of its top products face patent expirations?
Moncef Slaoui: Increased generic competition is an issue for the industry. But you cannot change your whole R&D because of generics; we have an obligation to develop medicines that patients need. So industry must work on the issue with government so that innovation is protected, otherwise the survival of an industry that delivers for patients — and which ironically keeps the generic companies in business — will be threatened. At the same time, patents have a finite lifespan, so in R&D, in GlaxoSmithKline we continue to mine new science and invest in novel and effective new treatments for diseases. As we learn more about the fundamental basis of disease, we are seeing a break down of larger diseases into clusters of smaller ones. As a result of this increased understanding, we will see more products for smaller indications, with smaller revenue streams. Eventually companies will be less reliant on two or three big products.
R&D Directions: GlaxoSmithKline recently won an injunction to temporarily block new rules at the U.S. Patent and Trade Office from taking effect. What is your major objection to the changes and what needs to be done to make sure companies can maintain adequate protection for their intellectual property?
Moncef Slaoui: Our long development period — 10 to 12 years on average — means that we learn more about our compounds as we take them through the process, and we regularly seek to patent that new knowledge and invention along the way, gaining coverage for those inventions from the first date of filing of the original patent. The new rules would limit our ability to claim all those new inventions, and impact the roughly 100 patent applications that we have at the PTO, as well as those of other pharmaceutical companies. It is in the public interest to ensure that changes to the patent system do not cause a disincentive to GlaxoSmithKline to bring more lifesaving drugs to market.
R&D Directions: How confident are you that even with possible changes in U.S. patent law, innovation will remain the top priority?
Moncef Slaoui: We are a world-leader in bringing innovative new medicines to patients and we will strive to continue to do so.
R&D Directions: What is GlaxoSmithKline’s hope now for Avandia in the wake of FDA’s decision to revise the black box warning on the drug to include information on myocardial ischemia? Does the fact FDA has not found enough evidence to indicate there is any more cardiovascular risk associated with Avandia compared with other type 2 diabetes treatments offer encouragement that the drug may rebound in 2008?
Moncef Slaoui: Avandia remains a safe and effective treatment for type 2 diabetes patients when used appropriately. Although Avandia is not for everyone, we believe that Avandia is and will continue to be an important treatment option for type 2 diabetics, many of whom often need to use two or three medicines to help maintain their blood sugar levels. Importantly, Avandia has been shown to control blood sugar for longer than the two most commonly used oral anti-diabetic medicines — up to five years. As such, GlaxoSmithKline is committed to continuing our support of Avandia, including investigating new forms and uses for the medicine, and continuing to study Avandia in ongoing large, long-term clinical trials. We believe that data from ongoing and future clinical trials will provide additional scientific support for the safety and benefit of Avandia.
R&D Directions: What are some of GlaxoSmithKline’s pipeline products that the company is most excited about?
Moncef Slaoui: There are as many as 30 potential medicines that we are very excited about, however, to mention a few:
Promacta for idiopathic thrombocytopenia, which is a disorder of low blood-platelet counts and puts patients at risk of serious bleeding, as well as ongoing research on the use of Tykerb for additional indication, including brain metastases in breast cancer. We have also started trials on the monotherapy trial of rosiglitazone XR in Alzheimer’s disease. Finally, darapladib, our LppLA2 inhibitor program currently in clinical trials, may well become the first new anti-atherosclerosis medicine since the discovery of statins.
R&D Directions: GlaxoSmithKline has 33 key assets currently in Phase III development and 71 drugs in the mid and late stages overall. How has the company been able to maintain and increase the strength of its mid-stage and late-stage pipelines?
Moncef Slaoui: The recently published Cowen study is the ultimate benchmark study comparing all pipelines of all major companies, and that report concludes that GlaxoSmithKline has the best mid-to-late-stage pipeline — Phase II/Phase III filings. We have achieved that by a combination of excellent in-licensing activity and collaborative ventures, and by filling the pipeline after the creation of the Centres of Excellence for Drug Discovery. What was an early-stage pipeline is now maturing.
R&D Directions: Are there any new therapeutic areas that GlaxoSmithKline is targeting?
Moncef Slaoui: We have recently created two new Centres of Excellence in immunoinflammation (II) and infectious diseases and an increased investment in biopharmaceuticals. In particular, we think II offers a lot of potential for new treatments initially in smaller diseases. But much of what we learn we expect to be applicable across a wider range of therapy areas.
R&D Directions: How have some of GlaxoSmithKline’s recent alliances (M.D. Anderson Cancer Center, Tolerx, Synta, Anacor) helped bolster the company’s efforts in drug discovery and development?
Moncef Slaoui: Alliances allow us to share risk but often they also give GlaxoSmithKline access to ideas and expertise, improving diversity of scientific insight over what we have in-house.
R&D Directions: What specific disease areas do you think the industry will focus more on in the coming years?
Moncef Slaoui: I can only speak for GlaxoSmithKline. We will increasingly focus on oncology and neurosciences, and across disease areas we are developing in biopharmaceuticals and vaccines. |
