MMJ/FDA Designation of a Drug

The FDA Drug Act provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. For a drug to qualify for approval both the drug and the disease or condition must meet certain criteria specified in the FDA’s implementing regulations. FDA approval qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received FDA designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.

Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of a designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

On December 23, 2015, the DEA eased some of the regulatory clinical requirements impose by the Controlled Substance Act (CSA) for those who are conducting FDA-approved trials on cannabidiol (CBD), an extract of the cannabis plant. These modifications will facilitate the exploration of CBD, a compound which has already shown significant medicinal promise, and which has generated compelling interest in exploring its therapeutic potential.

Allowing the Department of Veterans Affairs to use Cannabis as Healthcare Treatment

Late in 2015, the US Senate passed the FY2016 Military Construction and Veterans Affairs Appropriations Bill, which included language to allow VA doctors to recommend medical cannabis to their patients in states where medical cannabis is legal. Although the approved language was ultimately removed from the final omnibus spending bill, its passage through the senate was a strong indicator of growing congressional support for allowing veterans access to medical cannabis.

Got a big data problem?

The University at Buffalo can help.

Through the Buffalo Institute for Genomics and Data Analytics (BIG), UB’s supercomputing experts have developed a tool that enables researchers and companies to sift through, query and analyze enormous amounts of digital information.

The technology, called the Genomics Data Warehouse, stores and queries vast quantities of data efficiently — a challenging computational task, says project manager Adrian Levesque, MBA, a senior programmer/analyst with UB’s Center for Computational Research.

UB built the tool to accelerate genomics-based research, but the technology can be used to solve big data problems in any field, from drug discovery to materials development and supply chain management.

The warehouse is available for use by UB researchers without a fee, and by industry users with rates dependent on the nature of the project.

“What we’ve created through the Genomics Data Warehouse is a simple method of managing a vast amount of information,” says Brian McIlroy, PhD, executive director of BIG. “It’s an important technology: Researchers and businesses are often able to collect huge amounts of digital information, but lack the technological infrastructure to analyze this data and leverage it in meaningful ways. Our new tool bridges this gap.”

The technology supports the mission of BIG, which is a part of UB. The institute aims to drive innovation and job creation in New York State by advancing genomic medicine, a field that uses information on an individual’s genetic make-up to improve his or her clinical care.

BIG is a key component of a $100 million genomic medicine initiative announced by Governor Andrew M. Cuomo that partners UB with the New York Genome Center in Manhattan to translate research advances in the field into clinical care in partnership with industry to drive economic growth.

The new Genomics Data Warehouse furthers this mission by facilitating solutions to big data problems in genomics. The technology was developed in collaboration with UB’s genomic core, a facility that offers genome sequencing technology. Genomic data from the core can be transferred seamlessly to the genomic data warehouse, where the data can be stored for subsequent analysis.

Already, UB researchers are using the Genomic Data Warehouse to analyze information generated by genome sequencing projects, with the goal of identifying genetic variants that may be associated with disease. The technology gives researchers access to a wide range of genomics analysis tools for applying their data, and facilitates collaboration by providing investigators with the ability to grant secure access to data to collaborators.

In addition to Levesque, the team that developed the Genomics Data Warehouse includes Jianxin “Jason” Wang, PhD, a bioinformatics computational scientist, and Mohammad Zia, PhD, a bioinformatics programmer, both part of the Center for Computational Research, UB’s supercomputing center.

Researchers and companies interested in using the Genomics Data Warehouse can contact Adrian Levesque at [email protected] for information on the technology and industry user fees. Queries are welcome from users working in genomics and other fields that feature big data problems.