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U.S. Army Medical Materiel Development Activity

Spotlight: Division of Investigational New Drugs for Force Health Protection

Marianne Erlichman
Marianne Erlichman, product manager IND-FHP, provides annual Good Clinical Practices training.

The U.S. Army Medical Materiel Development Activity works to develop and deliver quality medical solutions to protect, treat, and sustain the health of our service members. The medical needs of our service members are vast and ever-changing. In order to provide the most comprehensive and highest quality medical solutions, it takes a team of specialists in all areas. USAMMDA uses five Project Management Offices and four Divisions to execute its mission. One division in particular has the job to anticipate our service members' needs during the most critical situations. This task is one that is performed all over the globe to assist all of our U.S. Forces with meeting their needs. The Division of Investigational New Drugs for Force Health Protection uses unique capabilities to provide urgent medical response to attacks on our service members.

The Division of IND-FHP provides an urgent diagnostic, therapeutic or preventative treatment capability using investigational countermeasures to protect U.S. Forces against deliberate or natural threats when no U.S. Food and Drug Administration-approved drugs exist or fail.

Lt. Col. Travis Watson, IND-FHP director, described the work that IND-FHP does which contributes to the USAMMDA mission. Under DODI 6200.02, which provides the authority to use IND products to support force health protection, IND-FHP works to make products demonstrated to be safe in advanced development available for use under appropriate controlled protocols before they have received FDA clearance or approval.

"Although our division does not perform any advanced development, we support the USAMMDA mission by providing a treatment capability that would otherwise leave U.S. Forces vulnerable to deliberate or endemic disease threats," said Watson.

IND-FHP focuses on preparedness for harmful situations that may arise against our U.S. Forces. It is imperative to have groups like this, so that when/if we do face crisis, there will be solutions already in place. It takes years to get a product licensed by the FDA, but IND-FHP works to have products available for our troops when and where they are most needed, when no other options are available.

Watson described the main priority of IND-FHP as having the correct diagnostic, treatment or preventative IND medical countermeasure at the right place at the right time.

"This means we must ensure that we have the most relevant portfolio of IND medical countermeasures in the hands of treating physicians to meet the actual or anticipated needs of the Force," said Watson. "This requires being strategic and connected to our collaborating partners and the medical planners throughout the DoD; it requires having a regulated and responsive plan to field these capabilities under an IND or emergency use authorization; it requires focused timely training for implementation; and it requires strategic positioning of the medical countermeasures to ensure timely treatment."

Recently, IND-FHP partnered with Walter Reed National Military Medical Center and Meiji Pharma, LTD, to provide the drug Arbekacin as a new option to treat soldiers with multi-drug resistant infections. This FDA-regulated study will provide an alternative antibiotic to cure infections.

IND-FHP also acquired Heptavalent Botulinum Antitoxin, which is a safer and more effective product than past products, for post-exposure treatment of botulinum toxin exposure. They also have provided IV Ribavirin in several instances to treat soldiers with Viral Hemorrhagic Fevers, a life-threatening disease for which there are no FDA-approved vaccines or drugs. Additionally, IND-FHP is working on a treatment for smallpox or other serious orthopox virus infections, to treat our U.S. Forces.

IND-FHP also provides a specialized team to assist in homeland or OCONUS CBRN responses. The Specialized MEDCOM Response Capabilities Investigational New Drug Team is managed by IND-FHP to provide support to lead medical units in employing investigational countermeasures against a chemical, biological, radiological, nuclear or terrorist incident. According to Watson, some of the key tasks the SMRC-IND team prepares to perform are: Rapidly establish a protocol site; Train supporting medical staff on the use of the medical product; Ensure FDA and DoD regulatory requirements are met; Provide the investigational countermeasure to the treating organization(s).

Partners of IND-FHP include, but are not limited to, the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention, the Joint Program Executive Office for Chemical Biological Defense and the U.S Army Medical Research Institute of Infectious Diseases.

USAMMDA is truly armed with a tremendous asset in the IND-FHP Division. In order to maintain the highest level of quality, in the widest area of expertise, it requires specialized divisions such as IND-FHP. From Investigational New Drugs, to the SMRC-IND team, IND-FHP delivers solutions to the service member, when and where they are most critical. The specialized knowledge of the individuals in this group contributes not only to USAMMDA but also to the entire U.S. Forces, and its work will benefit our troops for years to come.

Last Modified Date: 12/04/2017