Parexel's Josef von Rickenbach On Phase I Activity
Parexel recently expanded its early phase operations in three of its phase I facilities. The move brings the company’s global phase I bed capacity to one of the largest in the industry, at 550.
Parexel also has phase I services in India through a partially owned venture with Synchron Clinical Research’s Ahmedabad-based facility, which has 86 beds. Last month, Parexel increased its ownership stake in that venture from 19.5% to 31% at a cost of $5 million. At the same time, Parexel sold its France-based bioanalytical and biomarker testing laboratory facility—owned since 1999—to a subsidiary of Synchron for approximately $6.7 million. The unit will now be called Synexel Research International and will stay within Synchron’s operational network.
ClinicalTrialsToday recently asked Josef von Rickenbach, Parexel's chairman and chief executive officer, to provide some additional insight into the CRO's recent moves within the burgeoning phase I market.
Here's a look at that in-depth Q&A:
Why did you decide to expand your capacity at these units?
With expanded capacity at our international clinical pharmacology research units, we are able to accommodate the increasing client demand for Phase I and Proof of Concept studies. Additionally, with our global locations, we are able to provide clients with the ability to conduct multi-site studies and access specialized patient populations.
How do you perceive the phase I market now and in the future, as far as market opportunity?
There is an abundance of molecules moving into early drug development due to advances in bioinformatics and pharmacogenomics. Our international clinical pharmacology team is addressing this growing complexity.
Additionally, biopharmaceutical companies are also increasing the number of expertise-based Phase I studies they are conducting, and we are working with them to help identify and select the most promising compounds earlier, based on demonstration of safety and efficacy.
How big are the expansions and will there be staff increases there?
The expansions are focused on increasing bed capacity at the units, increasing the amount of clinical space, and adding more state-of-the-art technology and equipment, especially for specialized studies.
PAREXEL continually attracts expertise across our business. We have recently appointed several leading clinical pharmacology experts in our global clinical pharmacology business.
What are some of PAREXEL’s future phase I expansion plans, that you can talk about?
PAREXEL is committed to meeting our clients’ needs. To do so, we continually seek opportunities to expand our services and capabilities.
What were the reasons for divesting your bioanalytical facility?
PAREXEL originally purchased the bioanalytical lab in 1999, which is located in Poitiers, France, however since the specific location was not ideal for our business, especially in terms of attracting the staff required, the lab wasn’t fully optimized.
Overall, PAREXEL still offers bioanalytical services as part of our early phase clinical development services.
Increasing your ownership share of Synchron seems to indicate you see good things happening there and are optimistic about its future?
Synchron and PAREXEL believe that there is an excellent match between the two companies. Both companies offer Phase I-IV clinical research services and with PAREXEL’s extensive expertise across the development and commercialization continuum, we are one of the leading biopharmaceutical services organizations in India providing such an extensive portfolio of offerings.
This is an opportunity for clients to conduct clinical research in India, and to include India in global clinical studies. Clients can expect the same high quality standards, operating procedures, systems and infrastructure in India similar to what we provide in any of our global locations.
What’s the future for Parexel's relationship with Synchron?
There has been significant demand from a range of clients, including small and emerging bio/pharmaceutical companies, medical device companies, and large pharmaceutical companies, requesting clinical research services in India, one of the high growth emerging economies.
Recent reforms in the regulatory system in India have increased approval rates of studies. Additionally, India will become an even more attractive location for clinical research as other systems and laws are implemented, such as the patent system and data exclusivity laws.
PAREXEL and Synchron are dedicated to creating growth opportunities for India’s bio/pharmaceutical industry by providing India-based companies with ways to access global markets, including the U.S. and Europe. PAREXEL is currently working with several companies, ranging from smaller bio/pharmaceutical companies based in India to large international companies with locations in India, who are looking for global clinical development capabilities.