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PAREXEL's Alberto Grignolo, PhD, Comments on Key Trends at DIA 2014

June 18, 2014
The major topics discussed at DIA today, at this particular annual meeting, I have found to be rather patient-centered. In other words, the voice of the patient is becoming louder and more insistent having to do with a desire for the entire healthcare ecosystem to produce more and better medicines for patients who are waiting. The keynote speaker at the annual meeting Jamie Heywood, who heads PatientsLikeMe made a very impassioned appeal for the industry and regulators and the entire system to actually bring more drugs to patients who need them. In fact, he made an interesting aspirational statement wishing that someday we will see the approval of 1,000 drugs every year, which I find a little bit of an analogy to what Steve Jobs said about placing 1,000 songs in your pocket when he launched the iPod. I think Mr. Heywood made a very important call to action to the audience, essentially encouraging everyone to hurry up because the patient is waiting. Another thing that I picked up at the annual meeting has to do with drug development success. Frankly, there are challenges in bringing new medicines to patients but there are also very encouraging signs that this is going to become a much more positive development. One sign is precision medicine. There are major scientific advances today and we see that, in fact, companies and scientist are advancing what we know about the human genome and are applying that knowledge to new therapeutic entities and modalities, medicines that are precisely targeted at disease and, in particular, cancer. We also see the regulators actually approving these precision medicines more rapidly. The FDA and the oncology group at FDA, in particular, has been in a position to approve medicines rather rapidly for several types of cancer and making them available to patients that much more rapidly. The major issues and opportunities that face drug developers today are several. I would pick three or four. One is the rate of success of drug development and the rate of success of clinical trials in particular. About half of Phase III clinical trials fail due to failure to demonstrate efficacy or safety or both and this is an expensive problem facing drug developers which precision medicine may help address in leveraging better science and therefore leading to more precise trials. Another issue is clinical sites themselves. Of course drug developers are using thousands or tens of thousands of clinical sites. Seven of ten clinical sites are actually "one and done," as people say here at the convention. Namely, they do one clinical trial and they don't do a second one. This is not an efficient use of those resources. There are also manufacturing issues. The global supply chain is now exposed, to some extent, to non-compliance and this effects global drug supply and local drug supply in specific countries. Another issue that I might point out is that global project management skills are becoming more and more critical as drug development and clinical development, in particular, have become global. The skill set of project managers have got to become much more global and there are several sessions here at DIA that address this issue. I would also point out a couple of opportunities, however. One is the accelerated approval pathways that agencies like the FDA and the EMA have put in place for the benefit of sponsors and therefore patients. Finally, I will mention one country in particular: Japan, where the regulatory agency, the PMDA, has become more efficient, more open to innovation, both from within Japan and outside Japan. Many people don't realize that this is the right time to go to Japan with their innovative products. At PAREXEL, as a global company, we think of drug development as a journey and, in fact, we think of this as "Your Journey. Our Mission." Your being you, the client and us being us at PAREXEL, making our mission to help facilitate your journey. It's a complex journey. It's one that takes years and a lot of financial and human resources. Our aim, frankly, is to simplify the journey for our clients and ultimately for the patients who are eagerly awaiting the medicines that our sponsors create and that we help them develop and take to the market. We think of drug development with reimbursement in mind to try to make sure from the earliest stages of drug development that, in fact, there will be a pathway to the market, a pathway to the payers, a pathway to the patient and the bedside.
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