Nancy A. Gillett, D.V.M., Ph.D., is the corporate executive vice president and president, Global Preclinical Services, at Charles River Laboratories. In her role, Dr. Gillett drives the strategy for the company's global preclinical business operations. We conducted an e-mail exchange to discuss CRL's views on the biopharma marketplace. —GYR
Contract Pharma: What does the marketplace look like through the eyes of a CRO?
Nancy Gillett: With next year’s patent expirations on the horizon, we are seeing continuous shifts within the pharma and biotech marketplace. Pharma is going through a constant process of looking inward at their infrastructure, determining what has to be done internally and what can be done externally as we continue to see big clients redefine themselves.
As part of that continuous self-examination process, pharma is looking closely at price, changing and re-changing their infrastructures and scrutinizing their pipelines. Some of the large drug companies have begun to outsource work that was historically not available. We anticipate that, over time, there will be more companies following suit in order to compete effectively, particularly since the patent cliff looms in the next year.
It’s a fact that our client base is undergoing significant change and their efforts to create a new more efficient drug development model will involve increased outsourcing. The ability to utilize CRO expertise and infrastructure instead of investing in their own will enable them to redeploy assets to more productive initiatives and to replenish their drug development pipelines with therapies to advance human health.
CP: How are the marketplace dynamics impacting CROs and Charles River?
NG: Our clients want it all — superior scientific expertise, accelerated timelines, and quality — at a competitive price. We understand their price sensitivity and are working with clients so they can benefit from our high-quality and scientific expertise at a competitive price.
We are continuously evaluating our portfolio of products and services to ensure it meets the evolving needs of our customers. In addition, we’ll continue to identify opportunities to work with clients more effectively both to advance their processes and at the same time drive our growth.
CP: What do the pharma/biopharma industry’s transformations look like from a CRO’s perspective?
NG: We are seeing more and more clients evaluate their core competencies and partner with CROs to provide the expertise they do not have internally. This is creating a model where CROs are now considered an extension of their clients’ team.
CP: What are the growth drivers for the industry and how is CRL positioning itself in these areas?
NG: We are seeing an increased interest from our clients for support with their biosimilar development. In addition, we are also seeing increased interest in the area of biobetters, which are new molecules that are derived from an existing biologic product but have been deliberately modified to improve stability, efficacy or safety.
Companies are considering the potential return on investment required to bring a biosimilar to market and, in many instances, are not finding the numbers to their liking. Biobetters allow them to target an established mechanism, safety and efficacy profile but gain the benefit of sales of a new molecular entity. The costs are the same as developing a new biological product, but the chances of successful registration are significantly higher.
We are supporting our clients by developing testing programs for originator biological products and are using this experience to help biobetter developers tailor their testing to their product. We have developed product-specific testing programs for biosimilars where regulatory guidance is available, but recognize the complexities of new and better biological products and provide guidance for maximizing the regulatory impact of the studies performed.
In addition, a specific area of increased demand is in our cell-based and stem cell services. Our clients rely on us for stem cell therapy guidance and regulatory support in this growing area of drug discovery. To meet client demand, we were the first CRO to start a Cell Product Toxicology Program. The Program is staffed with experts in animal research models, molecular biology, veterinary pathology, immunology, regulation and pharmacology. We were also the first CRO to form a Stem Cells Research Oversight committee (S-CRO), an institution-wide review board that oversees the ethical conduct of cell therapy research — this is a requirement for running cell research funded by California (CIRM) and a number of other states.
CP: In your opinion, who and what are driving innovation in the industry?
NG: As an industry we are continuously looking for the best ideas and sources of innovation. Big pharma continues to be a source of innovation and also fueling innovation throughout the industry. As part of a growing trend, big pharma is providing funding to the academic market, which is a future source of innovation. We are also seeing big pharma fund some of the innovation in biotech as well.
CP: What do you think accounts for the (relative) failure of large-scale R&D models?
NG: I don’t believe failure is the right word. We are targeting very complex disease areas, such as cardiovascular, CNS, inflammation and oncology, which require very complex treatments using combination therapies. The drug development process is very complex.
Gil Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at gil@rodpub.com.
Contract Pharma: What does the marketplace look like through the eyes of a CRO?
Nancy Gillett: With next year’s patent expirations on the horizon, we are seeing continuous shifts within the pharma and biotech marketplace. Pharma is going through a constant process of looking inward at their infrastructure, determining what has to be done internally and what can be done externally as we continue to see big clients redefine themselves.
As part of that continuous self-examination process, pharma is looking closely at price, changing and re-changing their infrastructures and scrutinizing their pipelines. Some of the large drug companies have begun to outsource work that was historically not available. We anticipate that, over time, there will be more companies following suit in order to compete effectively, particularly since the patent cliff looms in the next year.
It’s a fact that our client base is undergoing significant change and their efforts to create a new more efficient drug development model will involve increased outsourcing. The ability to utilize CRO expertise and infrastructure instead of investing in their own will enable them to redeploy assets to more productive initiatives and to replenish their drug development pipelines with therapies to advance human health.
CP: How are the marketplace dynamics impacting CROs and Charles River?
NG: Our clients want it all — superior scientific expertise, accelerated timelines, and quality — at a competitive price. We understand their price sensitivity and are working with clients so they can benefit from our high-quality and scientific expertise at a competitive price.
We are continuously evaluating our portfolio of products and services to ensure it meets the evolving needs of our customers. In addition, we’ll continue to identify opportunities to work with clients more effectively both to advance their processes and at the same time drive our growth.
CP: What do the pharma/biopharma industry’s transformations look like from a CRO’s perspective?
NG: We are seeing more and more clients evaluate their core competencies and partner with CROs to provide the expertise they do not have internally. This is creating a model where CROs are now considered an extension of their clients’ team.
CP: What are the growth drivers for the industry and how is CRL positioning itself in these areas?
NG: We are seeing an increased interest from our clients for support with their biosimilar development. In addition, we are also seeing increased interest in the area of biobetters, which are new molecules that are derived from an existing biologic product but have been deliberately modified to improve stability, efficacy or safety.
Companies are considering the potential return on investment required to bring a biosimilar to market and, in many instances, are not finding the numbers to their liking. Biobetters allow them to target an established mechanism, safety and efficacy profile but gain the benefit of sales of a new molecular entity. The costs are the same as developing a new biological product, but the chances of successful registration are significantly higher.
We are supporting our clients by developing testing programs for originator biological products and are using this experience to help biobetter developers tailor their testing to their product. We have developed product-specific testing programs for biosimilars where regulatory guidance is available, but recognize the complexities of new and better biological products and provide guidance for maximizing the regulatory impact of the studies performed.
In addition, a specific area of increased demand is in our cell-based and stem cell services. Our clients rely on us for stem cell therapy guidance and regulatory support in this growing area of drug discovery. To meet client demand, we were the first CRO to start a Cell Product Toxicology Program. The Program is staffed with experts in animal research models, molecular biology, veterinary pathology, immunology, regulation and pharmacology. We were also the first CRO to form a Stem Cells Research Oversight committee (S-CRO), an institution-wide review board that oversees the ethical conduct of cell therapy research — this is a requirement for running cell research funded by California (CIRM) and a number of other states.
CP: In your opinion, who and what are driving innovation in the industry?
NG: As an industry we are continuously looking for the best ideas and sources of innovation. Big pharma continues to be a source of innovation and also fueling innovation throughout the industry. As part of a growing trend, big pharma is providing funding to the academic market, which is a future source of innovation. We are also seeing big pharma fund some of the innovation in biotech as well.
CP: What do you think accounts for the (relative) failure of large-scale R&D models?
NG: I don’t believe failure is the right word. We are targeting very complex disease areas, such as cardiovascular, CNS, inflammation and oncology, which require very complex treatments using combination therapies. The drug development process is very complex.
Gil Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at gil@rodpub.com.
