GROUND TRUTH


into Phase 3 planning, which in turn allows the PM to plan better for the EMD phase. Successful Phase 3 clinical trials depend on ironing out all issues (for example, dosing and procedure) before initiation; this, in turn, can yield signifi- cant cost savings.


CONSIDER DEPOT CAPABILITIES


SGT Mike Burrell, left, Stacy Klemke, SPC Daniel Steinbruckner, Darlene Navarra, SPC Zachary Dehn and Pamela Eisenhauer inspect and assemble radio transmitter components before final testing at Tobyhanna Army Depot, PA. The Soldiers are members of the Communication and Electronics Repair Section of the 322nd Support Maintenance Company, Arden Hills, MN. Klemke, Navarra and Eisenhauer are electronics mechanics. The ALLP indicates that Army depots like Tobyhanna can offer the same development and production capabilities as contractors, with the potential for considerable cost savings. (Photo by Steve Grzezdzinski, U.S. Army Communications-Electronics Command)


LL_251: The U.S. Army Center for Health Promotion and Preventive Medicine (CHPPM) should be involved early on to allow tailoring of testing to meet the center’s needs for specific information, in order to provide a positive statement of support of Type Classified – Standard.


Background CHPPM typically


does not have an


opportunity to observe tests or influence the type of tests conducted; usually its only opportunity to review test reports is at their completion.


Recommendation


Te PM should consult with CHPPM when drafting the test and evaluation master plan to ensure that the testing provides for the center’s informational requirements. Te PM should also invite CHPPM to participate in test planning meetings to discuss detailed test plan.


execution of the


LL_637: Use indefinite-delivery, indefinite-quantity (IDIQ) contract vehicles for medical countermeasure development contracts.


MITIGATING RISK


Dr. John M. Dye Jr., Viral Immunology Branch chief for the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in Frederick, MD, leads a study of the drug ZMapp, an experimental treatment for Ebola patients. The FDA typically requires multiple clinical trials before it will grant licensure, and lessons learned data indicate that initiating Phase 2 clinical trials before Milestone B can mitigate the risk of an acquisition program baseline deviation during the EMD phase. (USAMRIID photo)


Background During the development of a medical countermeasure, the FDA required the drug developer to complete additional studies based on the emerging results. To maintain the overall program sched- ule, these additional studies had to be


36 Army AL&T Magazine January–March 2015


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133  |  Page 134  |  Page 135  |  Page 136  |  Page 137  |  Page 138  |  Page 139  |  Page 140  |  Page 141  |  Page 142  |  Page 143  |  Page 144  |  Page 145  |  Page 146  |  Page 147  |  Page 148  |  Page 149  |  Page 150  |  Page 151  |  Page 152  |  Page 153  |  Page 154  |  Page 155  |  Page 156  |  Page 157  |  Page 158  |  Page 159  |  Page 160  |  Page 161  |  Page 162  |  Page 163  |  Page 164  |  Page 165  |  Page 166  |  Page 167  |  Page 168  |  Page 169  |  Page 170  |  Page 171  |  Page 172  |  Page 173  |  Page 174  |  Page 175  |  Page 176  |  Page 177  |  Page 178  |  Page 179  |  Page 180  |  Page 181  |  Page 182  |  Page 183  |  Page 184