Industry Insights From PAREXEL Chief Operating Officer Dr. Goldberg

By Rob Wright, Chief Editor, Life Science Leader magazine

Over the past several years, the biopharmaceutical industry has been preparing for many blockbusters to come off patent. Facing the difficulty of replacing that revenue stream the industry's focus in the emerging niche-buster era has centered on how to make R&D more efficient, including in the management of R&D dollars. As the biopharmaceutical industry evolves to meet the demands of a changing global marketplace, companies of all sizes are embracing new approaches to accelerate time to market, reduce costs, and expand their reach into markets around the world. These new approaches rely on integrated, long-term relationships with a small number of outsourced providers to create a strategic, cost-effective blend of internal and external resources.

PAREXEL, founded 30 years ago, is one of the industry's leading global biopharmaceutical services organizations—with over 11,000 employees and more than 70 locations throughout more than 50 countries around the world. One of the company's leaders is Mark A. Goldberg, M.D., chief operating officer (COO). Dr. Goldberg has helped lead the expansion of PAREXEL's operations globally to serve client needs, as well as the integration of its technology and service offerings to bring greater productivity to the clinical development process.

During a recent event, Dr. Goldberg shared some of his insights about the industry with Clinical Leader. Here is what Dr. Goldberg had to say.

Clinical Leader (CL): What are your major concerns within your market over the next three years?
Dr. Goldberg: One of the key areas of concern for the industry over the next three years will relate to how to capitalize on the huge market opportunity in Asia. A lot of companies are trying to move their research and development to India and China. At the same time, there's been some instability in the regulatory environment. For example, in India some of the rules and regulations that have been instituted have somewhat challenged industry. As a result, the actual number of trial starts in India recently declined. China is another example of a huge opportunity, but also where there are some challenges; for example, the government in China certifies every investigator site. Unless a site has been government certified, it can't be used in a clinical trial. Presently, there are only about 400 certified sites in China. Given the vast opportunity that China represents from a market standpoint, a lot of our customers are trying to determine how to handle the challenge presented by regulatory hurdles. Companies like PAREXEL have the local knowledge and global capabilities to assist our clients in successfully navigating these important and rapidly changing regulatory environments.

CL: Why do you think that the trials declined in India?
Dr. Goldberg: Relatively long approval timelines in India contribute to the trend toward fewer trials being conducted there currently. However, India has experienced a change in its regulatory leadership and processes are being reworked. In India there is a focus on using more outside reviewers as experts. That being said, there does not seem to be enough bandwidth to deal with the number of applications. If it takes a relatively long time for a country to approve a clinical trial start, then sponsors will consider conducting the trial in another geography.

CL: Given the challenges and roadblocks you've been seeing in China and India, where are some other opportunities for executing trials?
Dr. Goldberg: Other markets that have been attracting clinical trials activity include Eastern Europe, Latin America (including Argentina and Brazil), and other countries in Asia, such as Korea. When you look at Asia, a lot of countries are relatively small in terms of potential patient populations and other market factors compared to India and China. Taiwan, for example, has an established clinical trial infrastructure, however there is a limit to the number of potential sites and available patients.

CL: Among the challenges that the industry is facing, which do you see as being mission critical?
Dr. Goldberg: What is most mission critical for the industry is to bring drugs to market less expensively in a more streamlined way. Right now, the cost of bringing new drugs to market is unsustainable. The blockbuster era—where drugs would generate billions of dollars in revenue—is really over. The transition from this old R&D model is a reason that we are seeing the disaggregation of the activities which were taking place within a pharmaceutical company toward more of an outsourced model. A key focus now is on innovating around how the trials are actually executed and on how to bring down the costs. In the new, so called "niche-buster," era, drugs will be increasingly developed for targeted populations. So the cost for bringing these types of drugs to market has to be less, because the market size will be less. From my perspective, the industry needs to figure out how products that will serve smaller populations can be brought to market at a sufficiently lower cost to create an economically viable model.

CL: What do you see as being one of the most innovative solutions being implemented?
Dr. Goldberg: Scientifically, certainly the use of the genome is one of the most interesting areas. From a trial execution standpoint, I think some of the innovative ideas around adaptive designs are very interesting, with a focus on figuring out how you can get more done faster and at lower cost. We're also starting to see some flexibility in thinking about how monitoring is executed at the trial sites. What matters is that you're doing things with high quality not that you are simply following a cookbook approach. This creates an opportunity to decrease some cost in the process.

CL: From your perspective, what trend is growing in importance and why?
Dr. Goldberg: A trend that has continued to grow in importance over the last several years is strategic partnerships between sponsor companies of all sizes, and CROs. This is a direct reflection of the challenges and the pressure on sponsor companies to bring products to market as efficiently as possible. It simply doesn't make sense to maintain the fixed cost of development, when you can hire that on an as-needed basis. It really doesn't make sense to build a global development infrastructure if you can leverage a CRO's infrastructure. Companies are completely reinventing what they do from a development standpoint, and what and how they choose to outsource. This really represents a "once in an industry" transformation.

It's not just about hiring a service provider to do the work for you, it's about how that relationship is constructed—so a lot of the creativity is going into ways to make those relationships more productive. This means focusing on improving communication, gaining more insight into the sponsor company's pipeline, participating in the trial design. It is not just being handed a protocol, but also creating a collaboration where the service provider has the opportunity to bring true expertise to the table. Governance structures are being created that allow companies to work well together and to ensure that issues get escalated when appropriate, and that they get resolved, so that teams function well together. These are all things that have to be brought to a much more sophisticated level than was ever done historically, given that you are now effectively the development arm of a partner. While large pharmaceutical companies have moved to the strategic partnership model first, we are seeing increased interest from the biotechnology and emerging companies to form strategic partnerships with PAREXEL for many of the same reasons.

CL: What trends are decreasing in importance, and why do you think that is?
Dr. Goldberg: Certain early phase activity has been decreasing partly due to the pressure that's being created by the patent cliff. This drives companies to invest their dollars in whatever way they possibly can to drive revenue in as near a timeframe as possible. So, if there were compounds that were in the pipeline, the decision will be to drive compounds across the finish line, as opposed to taking the next new idea into the beginning of the pipeline. I do worry a little bit that at some point, innovation may not move as fast as it could, because there is such a focus on later stage development. I believe this will change, and I think it's a function of the patent cliff. That being said, there is a focus on identifying and selecting the most promising compounds early in the development process–with the goal of avoiding late phase failures. So, effective early phase development is focused on a better and faster decision-making process.

CL: What do you perceive as being the biggest issue pharm and bio execs need to stay on top of?
Dr. Goldberg: The biggest issue for biopharmaceutical industry executives is to be able to drive their innovations into the marketplace as fast and inexpensively as possible. I think that what's clear is that the industry needs to focus on innovative approaches in terms of staffing, processes, and technologies. The industry can't expect to have a different or meaningful outcome, if things are largely done the same way.