Engaging with FDA for Better Lung Cancer Treatments. August 6, 2013 American Lung Association
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1 Engaging with FDA for Better Lung Cancer Treatments August 6, 2013 American Lung Association
2 Agenda Background on FDA s initiative Patient & survivor views How can you share your thoughts? Other opportunities Lung cancer research Q&A
3 Background Erika Sward Assistant Vice President, National Advocacy
4 Supporters
5 Project Origins Prescription Drug User Fee Act Patient Focused Drug Development Initiative
6 Patient-Focused Drug Development Initiative (PFDDI) Designed to provide a more systematic approach to obtaining patient perspective on the disease severity and the currently available treatments for a set of disease areas. September 2012: FDA releases a request for comments on which diseases the Initiative should focus
7 Patient-Focused Drug Development The Lung Association: Initiative Reached out to patients, family members and advocates, who submitted 1800 comments (thank you!) Filed national comments Behind-the-scenes meetings with FDA Testified at public meeting
8 Patient-Focused Drug Development Initiative Chronic Fatigue Syndrome HIV Lung Cancer Narcolepsy Alpha-1 antitrypsin deficiency Breast cancer Chronic Chagas disease Female sexual dysfunction Fibromyalgia Hemophilia and other heritable bleeding disorders Idiopathic pulmonary fibrosis Irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease with persistent regurgitation symptoms on proton-pump inhibitors Neurological manifestations of inborn errors of metabolism Parkinson s disease and Huntington s disease Pulmonary arterial hypertension Sickle cell disease
9 June 28 Meeting at FDA Included panel of FDA staff, 2 panels of current or former lung cancer patients Discussed FDA questions You can watch a recording here: stry/userfees/prescription DrugUserFee/ucm htm
10 Questions for Lung Cancer Patients Disease symptoms and daily impacts that matter most to patients Patients perspectives on current approaches to treating lung cancer When thinking about your overall goals for treatment, how do you weigh the importance of prolonging your life vs. improving the symptoms you experience because of your lung cancer? What factors do you take into account when making decisions about using treatments to help reduce or control the spread of your lung cancer?
11 Let s hear from some of the patient panelists! Denise Susan Kathleen
12 How Can You Participate? Participate in a survey Deadline - August 15 th
13 How Can You Participate? Submit comments to the public docket Deadline: August 26, 2013
14 How Can You Participate? Spread the word! Share with family, friends Share with your cancer support group Share on social media #lungcancer
15 Other Opportunities for Lung Cancer Survivors & their Families Carly Hamburger Manager, Adult Lung Health Education
16 Lung Association Resources
17 Lung Association Resources connection.lung.org Call the Lung HelpLine at LUNGUSA or
18 Lung Cancer Research Susan Rappaport Vice President, Research and Health Education
19 Breaking News: U.S. Preventive Services Task Force Draft Recommends Annual CT Screening for Those at High Risk Screening may lead to a 14% reduction in lung cancer mortality
20 Lung Cancer Screening High risk defined as those: 55 through 79 years old, and current or former smokers who have quit within the past 15 years. Smoking at least 30-pack years a pack year is smoking an average of 1 pack of cigarettes per day for 1 year.
21 The American Lung Association Supports Lung Cancer Research Lung Cancer Discovery Award Supporting investigators focusing on novel approaches to improving clinical methods for the early detection of lung cancer developing novel medical treatments advancing current treatment options
22 Lung Cancer Discovery Award $850,000 in research expenditures Nine current awardees throughout the country Studies currently being funded include: validating biomarkers to determine who will respond to lung cancer treatment; improving personalized treatment for lung cancer identifying the mechanisms by which tobacco leads to lung cancer
23 Supporters
24 Questions? Comments? Ideas?
25 We will breathe easier when the air in every American community is clean and healthy. We will breathe easier when people are free from the addictive grip of cigarettes and the debilitating effects of lung disease. We will breathe easier when the air in our public spaces and workplaces is clear of secondhand smoke. We will breathe easier when children no longer battle airborne poisons or fear an asthma attack. Until then, we are fighting for air.
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