No one wants to miss an opportunity for success, particularly in drug development. When pharmaceutical companies reach out to Revvity Omics only at a later stage in their drug development, they miss out on the deep expertise Revvity Omics brings to the early-stages of drug creation and delivery.
Companies who work with Revvity Omics early in the drug development process reap the benefits of close evaluation of the product and its intended use. This proactive approach also involves the development of a strategic plan for partnership and collaboration throughout the entire drug development life cycle.
Assay development
Revvity Omics can create the many different types of novel assays pharmaceutical companies need. In broad terms, biochemical assays are analytical procedures that detect and quantify cellular processes or metabolic reactions. They can be used, for example, to measure if an enzyme replacement therapy is effective. Biochemical assays can also be used as biomarker assays at predefined intervals or repeatedly over time during preclinical or clinical testing to provide researchers with information on the effects of a drug. Molecular tests validate biochemical assay results in clinical labs using PCR amplification or next-generation sequencing (NGS) to quantify DNA or RNA.
Such molecular assays can be used, for example, to evaluate the presence or absence of single nucleotide variations (SNV) that have been identified via genome-wide association studies (GWAS) to be clinically important. Pharmaceutical companies with gene therapy programs may also, for example, desire a molecular assay to test for clearance of the adeno-associated virus (AAV) vehicle as well as the presence of the delivered gene. Many assays can also be employed post-drug approval to assist patients and physicians in the diagnosis of rare diseases, which may be treatable with the help of such a newly available drug.
Once developed and validated, pharmaceutical companies often use assays to obtain analytical data necessary for drug development.
Three ways pharmaceutical companies can partner with Revvity Omics to obtain data for drug development.
- Companies can use the Revvity Omics laboratories that are spread throughout the world in India, China, Sweden, the UK, and the US. Revvity Omics can work within the culture of a variety of countries to reach patients who may typically be difficult to access.
- If a pharmaceutical company wants to perform analytics in different countries other than those listed above, Revvity Omics can license assay kits to 3rd-party laboratories in countries where such laboratories would perform the clinical testing.
- Revvity Omics also offers the option of creating a lab-in-lab, whereby Revvity Omics establishes a laboratory on the premises of the pharmaceutical company.
Support
No matter what its use, once an assay has been developed, the novel assay will need to be validated. Pharmaceutical companies can turn to Revvity Omics for support at any stage of that validation process. Validation includes performing clinical trials with a specified number of subjects to demonstrate safety as well as effectiveness. Revvity Omics has the capability to advise on and/or perform these trials and aid with regulatory approval of the assays.
Regulatory
The current complicated regulatory landscape means that drug development requires early identification of the desired outcome as well as identification of the steps required to achieve that outcome. Included in this is the need for a global regulatory submission strategy. If a pharmaceutical company can create this strategy early in drug development, then the company will likely reduce the need to retrospectively perform redundant work. Revvity Omics can help create a regulatory submission strategy and work with a pharmaceutical company to implement the plan which will likely include multiple timelines with different costs associated with those timelines.
The need for a regulatory submission strategy often comes a need for a strategy to obtain reimbursement, either from a country, region, or health insurance company. It is only through such a reimbursement strategy that a drug becomes available to patients. The creation of a strategy requires a global examination of the intended marketplace for the drug and an evaluation of the local regulatory requirements.
Revvity Omics can guide pharmaceutical companies to these local requirements which may, in many cases, dictate product design. In the case of the US Food and Drug Administration (FDA), for example, Revvity Omics works in tandem with FDA, seeing them as partners instead of gatekeepers. This approach means that Revvity Omics works with FDA throughout the drug discovery process to identify and, hopefully remedy, potential problems as early as possible.
A programmatic approach
Revvity Omics brings to its partnerships an overarching vision for a drug development program created through a series of interconnected projects under common objectives. This programmatic approach leverages the expertise within both Revvity and Revvity Omics to create the best possible product for a global marketplace.
While Revvity Omics can be consulted at any point of drug development, their value begins at the earliest stages, and they thus encourage pharmaceutical companies to engage with them in the first months of the process to create a plan for collaboration and partnership throughout the entire drug development life cycle.
