{"id":30065,"date":"2018-01-02T16:38:39","date_gmt":"2018-01-03T00:38:39","guid":{"rendered":"https:\/\/www.iths.org\/?p=30065"},"modified":"2018-01-17T09:23:23","modified_gmt":"2018-01-17T17:23:23","slug":"uw-dental-research-team-receives-breakthrough-therapy-designation-from-the-fda","status":"publish","type":"post","link":"https:\/\/www.iths.org\/news\/iths-research-units\/uw-dental-research-team-receives-breakthrough-therapy-designation-from-the-fda\/","title":{"rendered":"UW dental research team receives breakthrough therapy designation from the FDA"},"content":{"rendered":"
[vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_column_text]Early childhood caries, a disease caused by dental decay, is one of the most prevalent illnesses both nationally and globally. Children visit to the dentist regularly to treat and prevent the development of cavities and dental caries. Dr. Peter Milgrom is working with the ITHS Regional Clinical Dental Research Center (RCDRC)<\/a> to test a new technology intended to prevent tooth decay and stop this disease in its tracks.<\/p>\n Making new medical techniques available is the heart of translational medicine and includes testing hypotheses regarding efficacy, ensuring safety, and meeting regulatory requirements. Dr. Milgrom discovered with his research that Silver Diamine Fluoride could have a powerful effect on treating early childhood caries (ECC) and began searching for ways to get this new treatment to communities as quickly as possible.<\/p>\n Bringing a new therapy to market is a slow and expensive process. There are strict regulations which must be adhered to, years\u2019 worth of research data to obtain, and processing fees to be paid. For very promising new treatments, the FDA offers a \u2018fast pass\u2019 lane to expedite the development and review of an intervention in hopes of reaching the patient population as quickly as possible. This \u2018fast pass\u2019 is called breakthrough therapy designation.<\/p>\n In order to be designated a \u201cbreakthrough therapy\u201d the new treatment must address a serious or life threatening condition and have demonstrated a substantially significant improvement to current treatment options in preliminary clinical evidence. Since this path became available through congressional act in 2012, the FDA has only approved cancer and HIV treatments; Dr. Milgrom\u2019s Silver Diamine Fluoride (SDF) is the first breakthrough therapy drug outside of that realm.[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column width=”1\/2″][vc_column_text]Breakthrough therapies have the opportunity to disrupt the standard of care. Currently, ECC is often treated with dental operations to excavate the decay. This is an expensive operation with high risk factors, and moreover it does not treat the cause of the disease, only the symptoms. \u201cAs an academic, I see it as part of my responsibility to help change the paradigm\u201d said Dr. Milgrom, \u201cand provide a more effective alternative\u201d.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″][vc_column_text]<\/p>\n As an academic, I see it as part of my responsibility to help change the paradigm<\/p><\/blockquote>\n [\/vc_column_text][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_empty_space][vc_column_text]Changes in standard care do not happen overnight. Dr. Milgrom and his team faced the challenge of gathering evidence to support the change while simultaneously providing a path for dentists to adopt the new technology in their treatment plans.<\/p>\n In order for the FDA to grant the breakthrough designation, they needed enough data to demonstrate that SDF was a better treatment and safe to use. This data was acquired through a Phase II Stopping Cavities clinical trial supported by the ITHS Regional Clinical Dental Research Center (RCDRC)<\/a>. With the breakthrough designation, Dr. Milgrom was able to work closely and collaboratively with regulatory officers and scientists at the FDA to map out a path towards approval.<\/p>\nWorking with the Food and Drug Administration (FDA)<\/h4>\n
Clinical Trials<\/h4>\n