Contract Pharma: Tell me about SGS's offerings in the vaccine space.
Jeff Ryel: SGS Life Science Services offers Phase I-IV Clinical Research services, including data management, statistics, pharmacovigilance and regulatory consultancy. For the vaccine space, SGS recently opened a viral challenge unit. On the lab services side, SGS can assist in product characterization, biosafety testing, cell line characterization, host cell impurity testing, molecular biology tests and a variety of assays such as cell-based, cross reactivity, potency, and neutralization.
CP: What are the biggest areas of opportunity?
JR: In general, there’s a lot of attention on vaccines for oncology, rare diseases and infectious diseases; that includes influenza, HIV, malaria and Dengue fever.
From the vaccine developers’ perspective, there's currently a big emphasis on influenza.
CP: Are there significant differences in protocols from U.S. to EU, in terms of requirements?
JR: For protocols, they're largely the same; however, there may be additional documentation needed from one region to another. But, because most clients are covering their bases for future marketing, manufacturers try to comply with regulations for both markets. There are occasional quirks. For example, a country may want additional language added to their protocol. Then, we can make a country-specific change, but generally it's already well harmonized.
CP: How significant is this business for SGS?
JR: We have a lot of experience in infectious diseases, which is the unit that encompasses vaccines. Most of this work is in Phase I/II, and in flu. That being said, we've also performed a lot of HIV treatment studies. SGS got started in that area, and we're seeing the focus shift from treatment of that disease to prevention.
Here's a snapshot of our vaccine studies. By phase, it's 37% in Phase I, 18% in IIa, 9% in IIb, 27% in Phase III, and 9% in Phase IV/post-approval. By disease condition, 54% of our studies are in influenza, 23% in therapeutic vaccines, 8% in hepatitis, 8% in other viral areas, and 7% in bacterial.
CP: How concerted of a push have you made in vaccine services?
JR: In the past year, we’ve added viral challenge capabilities to our facility in Antwerp, which is our Phase I unit where we do all of our early phase studies. Presently, we can perform these studies on three viruses: influenza, rhinovirus, and respiratory syncytial virus (RSV). In general, the service involves performing a vaccination with the candidate vaccine on healthy volunteers representing a target demographic, and then inoculating with the virus — one of the three mentioned above — via intranasal delivery. The subject is then placed in isolation and monitored for symptoms and using diagnostic tests for infection or resistance. The service is unique and there are relatively few providers on the market.
CP: What's the client base for you?
JR: For the most part, we see more interest from smaller biotech companies. We also tend to fit in as a niche CRO for some of the larger companies, because we have capabilities that larger CROs don't have.
CP: Can you get much of that large pharma business, or would it involve changing the structure and scale of what you do well?
JR: We have the infrastructure for our large pharma clients and compete for studies with large CROs. However it's not our goal to be a large CRO. For instance, while there are few other CROs able to provide viral challenge capabilities, SGS, as a partner, can further help in their vaccine development by a more complete service offering.
On the Laboratory Services side of the business, clients can benefit from a range of expertise from one provider. From the SGS M-Scan sites within the network, clients can obtain full protein characterization, glycosylation analysis, and determination of higher order structures. SGS Vitrology can perform virology testing, adventitious agent and mycoplasma testing services to ensure that vaccines are free of contaminants.
Furthermore, within our SGS-owned laboratory network, SGS also offers bioanalysis along with the range of assays I previously mentioned. Additionally, we expanded a department within our bioanalytical lab in Poitiers, France with immunoassay capabilities by adding equipment and bringing in high-level experts in that area. That site also has a Biosafety Level 2 suite, which only one other site in Europe has.
By adding certain services like this, we can put together a unique set of solutions for an early-phase approach. This gives clients more clarity as to whether candidate vaccines should proceed in development or not. This combination can help expedite timelines for clients in the early stages of product development.
CP: How important is the vaccine market to SGS?
JR: We're focusing on this because of its potential. From a market point of view, it's quite small right now. According to data from the WHO in 2010, vaccines represent 2% to 3% of pharmaceutical market. Although small, it has a very good growth rate — 10% to 15% — compared to 5% to 7% for the overall pharma market. That's a pretty compelling story.
In addition, it’s definitely an SGS focus, fitting perfectly into our analytical and clinical capabilities. By understanding the market, we can build a complete service offering to meet client needs for vaccines. Based on this approach, vaccines (like biosimilars) are a strategic segment for us. Very few companies can address the market in the same way.
Jeff Ryel has 17 years of experience in Clinical Research. He joined SGS in 2004 as a project manager and currently serves as project director for Infectious Diseases. Prior to SGS, Mr. Ryel worked at Human Genome Sciences in Washington, DC and Pfizer Pharmaceuticals in La Jolla, CA. He received a Bachelor of Science in Nursing from George Mason University in Fairfax, VA and is a licensed Registered Nurse.
Gil Roth has been the editor of Contract Pharma since its debut in 1999.