EXPLORING OPPORTUNITIES TO PARTNER TOWARD CURES FOR PD. Chicago Clinical Research Fair June 11, 2016

Transcription

1 EXPLORING OPPORTUNITIES TO PARTNER TOWARD CURES FOR PD Chicago Clinical Research Fair June 11, 2016

2 HOW DO WE LEARN MORE ABOUT PARKINSON S DISEASE? Patient-reported data Diagnosis and clinical symptoms Progression Response to available treatments 2

3 HOW DO WE GET TO CURES? Explore opportunities at the Resource Fair to Help Speed a Cure. 3

4 TURNING RESEARCH PARTICIPATION INTO NEW PD TREATMENTS 1960 s 1970 s 1980 s 1990 s 2000 s 2010 s» Levodopa FDA approved» Sinemet» 1 st DA Bromocriptine approved» Eldepryl» Sinemet CR» Mirapex Requip» Tasmar» Comtan» Stalevo» Deep brain stimulation» Neupro» Parcopa» Apokyn» Azilect» Northera» Duopa» Rytary» Nuplazid and MORE in clinical testing! With so many treatments in clinical testing today, your participation in research paves the way for even more PD therapies to be available tomorrow. 4

5 WHAT TYPES OF TRIALS ARE IN THE CLINIC TODAY?» Parkinson s disease clinical trials assess the safety and effectiveness of new ways to diagnose, treat, and ultimately cure PD» There are two kinds of trials: INTERVENTIONAL TRIALS test the impact of a drug, device or medical procedure, or changes to participants behavior such as diet or exercise OBSERVATIONAL TRIALS monitor participants in their natural state over a period of time to provide researchers with data on the disease 5

6 WHAT TYPES OF INTERVENTIONAL TRIALS ARE RECRUITING IN THE CHICAGO AREA? Trials Testing Drugs That May Slow PD: Disease Modifying Interventions That May Treat The Motor symptoms of PD Interventions for the non-motor symptoms of Parkinson s SURE-PD 3 (Inosine) Reducing OFF time and motor fluctuations DBS trials Improving gait and reducing falls Reducing dyskinesia Reducing orthostatic hypotension Managing cognitive changes Information on these trials and more can be found at the Resource Fair. 6

7 WHY EXPLORE ALL RESEARCH OPPORTUNITIES?» Researchers design studies with specific volunteers in mind to best answer scientific questions Symptoms Disease duration» Trial participation is linked with study eligibility criteria and your interests Current medications» There are 35 unique studies or trial sites at today s fair! Trial Eligibility Talk to trial team representatives today to find studies that are right for you. 7

8 OBSERVATIONAL STUDY: Parkinson s Progression Markers Initiative (PPMI) Background:» A biomarker to better track disease progression would transform clinical therapeutic development for PD Goal:» Collect clinical data, imaging data, and biospecimen for PD progression biomarker research Study Design:» Looking for people of Ashkenazi Jewish decent with and without Parkinson s» Genetic testing and counseling available at no cost Talk to a site representative here today to learn more. 8

9 I M INTERESTED, WHAT COMES NEXT?

10 NAVIGATING EARLY STEPS IN RESEARCH PARTICIPATION 1. Screening Process: Helps the study team determine if you are eligible to participate May involve phone or in-person screening 2. Eligibility Criteria: Requirements to be included in a study Ensures that volunteers are similar to each other and gives researchers greater confidence in study results 3. Informed Consent: Gives important information about the trial, including possible risks and benefits and schedule of activities Agreement to participate 10

11 RECOMMENDATIONS FROM A RESEARCH PARTICIPANT VETERAN» What do you gain from participation in a clinical study?» How do you know the right research opportunities for you? Clinical trial participation» What questions should you be asking of trial teams during screening?» How can volunteers make the most of the Resource Fair? Talk with site representatives at the Resource Fair to learn more about available studies and determine which are right for you. 11

12 HOW CAN YOU SPEED RESEARCH? Fox Insight: Virtual Research Hub» Collects data from surveys and online profile» Study Parkinson s variability and trends» Prioritize most pressing patient needs» People with PD and an Android phone can receive a free smartwatch for participation in a wearable/mobile application sub-study Fox Trial Finder» Over 55,000 volunteers registered» Over 450 recruiting studies listedan y 12

13 QUESTIONS?

14 THANK YOU! Trial Exhibition Open Until 1:00 PM

15 APPENDIX

16 HOW DO WE GET TO CURES?» It typically takes $1 billion and decades to develop a new therapy» Clinical trials are costly with time-intensive steps in the drug development process Target Discovery Preclinical Clinical Research Phases I/II/III FDA Review Phase IV/ Outcomes PHASE I PHASE II PHASE III» Testing a new drug or treatment in a small group of people to evaluate safety and dose range» Drug or treatment is given to a larger group of people to see if it is effective» Treatment is given to large groups of people to confirm its effectiveness, monitor side effects, and compare it to other therapies Recruiting individuals with and without Parkinson s is a rate limiting step in drug development. No amount of funding can overcome a lack of volunteers. 16

17 ONLY PATIENTS CAN TEACH US ABOUT DISEASE AND TEST NEW THERAPIES» Hundreds, sometimes thousands, of volunteers are needed for studies» The standard recruitment rate for a trial is one volunteer per site per month What would happen if that was sped up? The more volunteers enroll in studies, the sooner we will have new treatments, new insights and ultimately, a cure. 17