1. We’ve started hearing the term “precision medicine” more and more. What capabilities must a service provider have to enable clients to pursue precision medicine?
Achieving precision medicine requires the integration of clinical and molecular data in the drug development process. Precision medicine is partnered with personalized medicine, or the subsequent measurement of numerous pieces of genetic, epigenomic, environmental data in order to develop a molecular signature of the patient. This combination of molecular signatures helps to define the molecular basis of disease, individual disease patterns and consequently the most efficacious and safe drugs to treat the individual. Numerous analytical tools are necessary to collect this information--be it a rewired signaling circuit, the drug interaction within a particular cell signaling pathway or genetic event which could ultimately define the impact of the disease and drug for that patient.
Service providers help clients deliver on the precision medicine paradigm by understanding, recommending and conducting the appropriate tests to build a molecular understanding of the disease which can then be combined with clinical data to create a fuller understanding of the condition. The number of potential assays and data resulting from these measurements are significant and contract service providers must have expertise in a variety of biomarker detection methods and assay development schemes as well as an inherent knowledge of how to interpret the data.
EMD Millipore’s history lies in a deep understanding of cellular, protein and multiplex assays for purposes of evaluating biomarkers. Our depth of expertise puts us in a prime position to support clients focused on large molecule discovery and development and those who do not have the internal expertise or available resources for cellular or protein-based assays that they may need for the large molecule drug that they are developing.
Beyond our expertise in cellular and protein assays and biomarkers, we are now initiating genomic and tissue-based biomarker assay services. We will be able to provide our clients with a collection of genetic and protein biomarker data from blood, serum, tissue and other fluids from each patient sample, assessed on a variety of platforms. Connections between these data sets will provide the client with information regarding disease biology and potential drug safety and efficacy for specific patient profiles.
2. How do years of experience in Pharma Services help a provider like EMD Millipore deliver on the paradigm of precision medicine?
Because of our nearly 10 years of experience working with a variety of Pharma clients on numerous drug molecules, we have an in-depth understanding of the applicable assays and regulatory requirements that are necessary for the client to assess the molecule within the appropriate system. We have anticipated the changes in drug discovery and development as they relate to precision medicine, based on the types of biomarker studies that our clients are requesting and have asked us to help them with. We understand the information our clients are getting out of each test--not only are we looking at the data, but also helping interpret the data so we can inform clients what other types of tests they may want to consider that will give them the pertinent information about the drug they are developing.
Some clients transfer assays to us and perform their own downstream analysis on the data we provide. However, just as often, clients want some consultation on the types of assays that are required or that could give them the next data that will help them take the next step in the development of the drug, especially when they’re doing earlier-stage testing. It’s in the early stages that clients often ask, “Is this the right assay to provide me with the information that we need to make the best decisions about the molecule?” The right type of information can save clients huge amounts of time and money, while an inconclusive approach could be incredibly costly. That’s where our years of experience can provide insight.
3. EMD Millipore is unique in the marketplace as being both a reagents supplier as well as a service provider. What value does this combination bring to clients?
This is an incredible advantage because we have access to EMD Millipore’s large portfolio of tools, kits, reagents and instrumentation systems. With our collective experience, we’re positioned to provide our clients with advice based on our access to the best technologies available. If you look at EMD Millipore’s broad strategy, it’s all about designing tools and reagents that help reveal how biological systems interact and change. These, in turn, can help reveal the potential for a new therapeutic candidate and may thereby reveal what impact the drug will have in the patient.
We’re not just sitting on the sidelines waiting for these innovations to come out on the market and get integrated into Pharma; we understand what these technologies can offer far ahead of the time they may be on the market. Moreover, many of EMD Millipore’s assays and technologies are used in drug development and validation, have been on the market for several years and are well adopted in Pharma. We employ the majority of the technologies that our clients have already validated in their own labs and have developed rigorous assays around these platforms.
It’s exciting to think about how much innovation we’re able to take to our customers—platforms and technology to which other CROs may not have early access. For example, EMD Millipore’s new CellASIC™ microfluidic cell culture and analytical platform and the new FlowSight® and ImageStreamX® imaging flow cytometers are fabulous tools for predictive model system development and cellular analysis, potentially helping clients establish an understanding of biological molecular mechanisms as well as the potential drug safety, toxicity and efficacy earlier in the discovery process. Not only do we have early access to these cutting-edge tools, but we can also help our company develop these products, because we have insight into what challenges our Pharma clients face and the type of data they are looking for. Finally, we have an “insider” supply chain as compared to other CROs – because we have access within the company to many of the kits and reagents we need every day to perform the assays needed by our clients.
4. In the coming years, CROs are likely to be called upon to support more and more biosimilars projects. Regulatory agencies have not provided very much guidance on how similar is “similar enough”. How can service providers best help clients get biosimilars approved?
Service providers, like EMD Millipore’s Discovery and Development Solutions, that are accustomed to the assays used to assess the innovator drugs on animal and patient specimens have an advantage. We’ve already had experience designing assays and conducting testing for the innovator drugs. This puts us in a great position to help a client developing a biosimilar drug. Our experience with a variety of assays used for innovator drugs has also enabled us to develop pre-qualified services for biosimilars clients.
Ultimately, with the help of service providers, biosimilars clients can go to the regulatory agencies with the testing strategies and data, which can help continue the dialogue toward creation of the regulatory guidelines. We are already providing bioanalytical and characterization services for several biosimilars clients that have come to us because of our experience and expertise in large molecule assay development and testing services.
About EMD Millipore:
EMD Millipore Discovery and Development Solutions is a leading provider of outsourced discovery and bioanalytical services, focusing on the development of biotherapeutics. EMD Millipore is the Life Science division of Merck KGaA of Germany and supports our customers' success in research, development and production of biotech and pharmaceutical drug therapies. For more information, please visit www. emdmillipore.com/CRO.
Christina Shasserre, M.S., M.B.A, is Vice President of Discovery and Development Solutions at EMD Millipore. Prior to the integration of EMD Chemicals and Millipore, she led EMD Chemicals’ Bioscience business, bringing the company’s biotechnology-based capabilities and technology platforms to customers in pharmaceutical, biopharmaceutical and academic research industries. Highlights of Shasserre’s extensive experience include senior leadership positions in marketing, business development and licensing at Sigma-Aldrich, Marketing and Product Development at Vysis (now Abbott Molecular) and a variety of positions in research and clinical laboratories.