Coordinating Research Results and Workflows When Developing Combination Therapeutics
Combination therapeutics are increasingly common, but efficient research and manufacturing operations for these products requires open channels of communication. Modern information sharing platforms can provide the solution. Image Credit: Flickr use List_84
More than ever, scientists are embracing the development of combination therapeutics. Not only is this more convenient for patients, since they may be able to use a single combinatorial product instead of juggling a series of medications, but it can also improve the effectiveness of therapeutics for previously intractable diseases.
One recent example is the three-drug combinatorial therapy that a major biopharma company submitted to the FDA for approval for the treatment of chronic obstructive pulmonary disease (COPD) in November 2016. In order to treat the airway obstruction associated with COPD, the researchers developed an inhalable powder consisting of fluticasone furoate, a corticosteroid; umeclidinium, a muscarinic receptor antagonist; and vilanterol, a beta-2-adrenergic receptor agonist.1
Also in November 2016, another promising combination therapy was described in the New England Journal of Medicine. These scientists found an effective combination therapy for patients with advanced-state estrogen receptor-positive/HER-2-negative breast cancer. By treating patients with both palbociclib, a CDK4 and CDK6 inhibitor, and letrozole, a traditional anti-estrogen therapy, they were able to reduce the risk of disease progression by 42 percent compared to treatment with letrozole alone, without adverse side effects.2 Similarly, palbociclib was previously shown to be more effective when used in combination with another anti-estrogen drug, fulvestrant.3 As more pharmaceutical companies work to design and manufacture combinatorial drugs like these, modern software platforms can help facilitate a free flow of information that can improve research efficiency and product quality.
Ensuring the Free Flow of Data Throughout the Research Process
When looking for potential drug combinations and running tests on the safety and efficacy of promising therapeutics, ensuring that all interested parties have access to relevant information is critical. Modern cloud-based software solutions are making this much easier. Here are a few reasons this technology is particularly useful for researchers and organizations exploring combinatorial therapeutics:
- Accessing information for personal use
In the early stages of the research process, when scientists are choosing which combinations of drugs to pursue, they must efficiently sort through drug combination possibilities, targeting the best candidates and dismissing therapeutics that are less likely to work. The easier it is to locate the results of relevant experiments conducted by the organization in the past, the more scientists can avoid running repeat preliminary experiments. It also important to be able to facilitate access to a wide variety of searchable databases, so necessary information about each drug is always readily available.
- Transferring information across the company
Especially when developing combination therapies that involve multiple drugs, there can be several research groups within the company working on a single project. In large pharmaceutical companies, these groups may not even be based at the same location. Sharing data in real-time is a necessity to researchers who need to stay up-to-date with each other’s progress, no matter where in the world they are located.
- Sharing data with scientists at other organizations
When the UCLA researchers were running the clinical tests on the palbociclib/letrozole combination therapy, they collaborated with investigators in 17 different countries. To ease the transfer of data in disparate studies like this one, it’s extremely helpful to be able to integrate data no matter what sharing application each research group uses, even if it’s a unique in-house application.
- Opening communication with contract research organizations (CROs)
An increasingly common business strategy in the pharmaceutical industry is to contract the research out to CROs. All interested parties should have access to the data they need to fulfill their research responsibilities.
Sharing Protocols With Contract Manufacturing Organizations
Once a combination therapy has been approved, a pharmaceutical company may contract out some of the manufacturing to a contract manufacturing organization (CMO). The CMO may be responsible for some or all of the manufacturing of one or more drugs in the therapeutic, so it essential to ensure that their operations are consistent with the pharmaceutical company’s in-house procedures. Simplification of the process of online protocol creation and transfer between groups is key: scientists with little or no programming experience can use GUI interfaces to draw up a workflow and make it immediately available to scientists at a CMO. Key analytical procedures can even be automated, further reducing the risks of inconsistencies between in-house and CMO-based manufacturing operations.
Whether your pharmaceutical company is looking to discover new combination therapies or improve the quality and efficiency of the manufacturing of an approved drug combination, BIOVIA ScienceCloud can provide the information-sharing capabilities you need for success in today’s globalized scientific community, while BIOVIA Discoverant can offer a self-service, on-demand to process and quality data for manufacturing. Contact us today to learn more about this technology, as well as our other innovative software offerings.
- “GSK seeking FDA approval for ‘triple combination’ COPD therapy,” November 21, 2016, http://www.bizjournals.com/philadelphia/news/2016/11/21/gsk-fda-approval-innoviva-triple-inhaler-copd.html?ana=yahoo ↩
- “Drug combination therapy for estrogen-receptor-positive breast cancer passes critical step for worldwide approval,” November 17, 2016, https://www.sciencedaily.com/releases/2016/11/161117115439.htm ↩
- “Palbociclib for previously treated hormone-dependent breast cancer,” May 9, 2016, https://medivizor.com/blog/SampleLibrary/breast-cancer/palbociclib-for-previously-treated-hormone-dependent-breast-cancer/ ↩