Skip to main content
Premium Trial:

Request an Annual Quote

Molecular Health Rebrands Ahead of 2016 Early-Access Launch of Drug Safety Software

Premium

NEW YORK (GenomeWeb) – Molecular Health is rebranding its product portfolio as it prepares to begin offering a series of clinical genome interpretation solutions starting early next year. The company is also preparing to run an early-access program for its drug safety software that will start in January and last for about six months.

Because "we are starting a series of new products that will come out in the next year ... we decided to come to a consistent branding and messaging," Lutz Voelker, Molecular Health's president and CEO, explained to GenomeWeb. "What we are planning is ... a whole diagnostic platform [for] the clinical market and a platform for clinical decision support."

At the core of the company's portfolio is Engineus, a newly minted comprehensive biomedical data warehouse that integrates and harmonizes information on protein-protein interactions, cancer indications, clinical trials, drugs, and scientific literature from multiple sources. The database will be offered as a standalone solution in addition to supporting other products in the company's portfolio. That list of products includes EngineusGuide, which provides pipelines for analyzing and interpreting genomic data based on the information contained in Engineus and reporting the results to requesting clinicians.

Also available are EngineusProfile and EngineusProfile+, which provide cancer diagnostic testing and treatment decision support services to European and US-based clinicians, respectively. These products used to be called TreatmentMap, and use Molecular Health's targeted gene panel that tests for over 600 genes as well as the Engineus database.

Last month, the company began recruiting participants for an EAP for EngineusEffect — previously called SafetyMap — which is the company's software for analyzing drug-induced adverse events and for predicting possible safety issues of new drug candidates. It hopes to test the software ahead of a full commercial launch currently planned for the second half of 2016.

Molecular Health recently entered into a commercial license to provide EngineusEffect to the FDA where it's being used to assess drug safety issues pre- and post-approval. But it is also planning to commercialize the platform more broadly targeting pharmaceutical companies, systems pharmacologists, and clinical professionals who are involved in researching, developing, and managing therapies and treatments. It hopes to further hone and improve the system through the EAP, which officially kicks off on Jan. 1 — although testers had access to the software starting Dec. 1 — and will run until the end of June after which the tool will be released commercially, Scott DePriest, the company's vice president of biopharma strategic development, told GenomeWeb in a recent interview.

The company has yet to determine the exact pricing for the product, but does plan to offer the web-based software under an annual subscription model where customers pay for named user licenses. It is open to entertaining other licensing models as well as possibly offering a locally installed option for customers who request it, he added.

DePriest said that the company is actively discussing the EAP with a number of pharma and biotech companies and intends to recruit about five customers who will have a chance to test-drive the system on specific applications or projects, for example retrospectively analyzing clinical trial data from an adverse event perspective or predicting how a class of drugs might produce an specific adverse event. Molecular Health told GenomeWeb this week that the company is on track to meet its goal of recruiting five EAP partners.  

During the earlier interview with GenomeWeb, DePriest said that the company is seeing interest in the system from users working in early-stage drug discovery and computational toxicology, as well as from safety and surveillance groups. "In our discussions with folks, we have tried to keep the discussion in terms of application for the early-access period to be around a specific project or application, for instance," DePriest said. That might be a client who wants to do a retrospective analysis of clinical trial results to understand the cause of adverse events. Another client might use the software to explore how a specific class of drugs produces a given adverse event, or to use information contained in the EngineusEffect database to anticipate or mitigate adverse events that might be associated with a compounds as part of a drug discovery and development project.

The EngineusEffect is an upgraded version of the company's Molecular Analysis of Side Effects (MASE), DePriest said. Molecular Health initially launched MASE in 2012 and that same year, the US Food and Drug Administration begun evaluating the software as part of a collaborative research effort aimed in part at further developing and improving the product. Much of the same infrastructure underlies both products — for example, the underlying algorithms are largely unchanged — but EngineusEffect features much broader functionalities than its predecessor and boasts an improved user interface that makes the software simpler to use, DePriest said.

Probably the single largest change to the system is that it now has a much deeper well of data to draw from. While MASE relied largely on information from the FDA's Adverse Event Reporting System (AERS), EngineusEffect covers not just the information in that database but also expands to include information from scientific literature and clinical data as well as data on biomarkers and pathways that the company has collected and curated internally, he said.

Specifically, the current iteration of the database and computational modeling system integrates clinical information from more than 5 million reports from AERS with information about drug targets, drug mode of action, and disease pathways to identify safety interactions and adverse events related to specific drugs, drug classes, diseases, and molecular targets and pathways. Users can explore relationships between scientific findings or events of various types, as well as confirm relationships between drugs, toxicity mechanisms, patient susceptibility, and clinical effects.

On the interface side, the company has made a number of enhancements including adding a tool called query builder which lets users craft and execute specific queries on EngineusEffect's underlying database. With the earlier iteration of the software, users needed to have some level or expertise such as knowledge of the Anatomical Therapeutic Chemical classification system — used to classify drugs' active ingredients — in order to query the database effectively, DePriest explained. Query builder, on the other hand, guides users through the query creation process step by step, allowing them to select the bits of information along the way that are crucial to the specific question they are trying to ask.

For example, if a user wants to find a cohort of female patients between the ages of 40 and 60 that have breast cancer and have been taking the drug Herceptin and reported hypertension as an adverse effect, the tool provides a straightforward mechanism for building a query based on the particular patient profile, drug, indication, and adverse event, he said.

"Understanding and effectively managing treatment selection and the inherent safety profile of those treatments can alleviate considerable cost to the healthcare system," CEO Voelker noted in a statement at the time the EAP was announced. According to Laura Housman, global head of Molecular Health's therapeutics business, each year in the US there are approximately 700,000 emergency department visits and 120,000 hospitalizations that are due to adverse events and more than $3.5 billion is spent on associated medical costs. "We are eager to offer a solution to this growing problem and to provide EAP users with the opportunity to provide feedback for further customizing [EngineusEffect] during and following the early-access period," she said in a statement.  

Recently the company raised $26.8 million in a private financing round led by current investor Dievini, which it will use to continue building out its commercial platform and to drive product adoption. Specifically, Voelker told GenomeWeb that the company will use the funds to grow add another 80 to 100 employees to its US staff based in its offices in Boston, Houston, and San Francisco. This will include a new chief financial officer and a new chief scientific officer. Some funds are being invested in improvements to the company's technology that will enable it integrate more data into its platform, Voelker said. The funds will also support efforts to build out Molecular Health's international presence — it is planning market launches in France and the UK in the first and second quarters of 2016.

The Scan

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.