Potential for Apps in Pharmaceutical Development. Steve Hutson Co-founder Virtual PV

Transcription

1 Potential for Apps in Pharmaceutical Development Steve Hutson Co-founder Virtual PV

2 Potential for Apps in Pharmaceutical Development Steve Hutson Co-founder Virtual PV

3 Potential for Apps in Pharmaceutical Development Steve Hutson Co-founder Virtual PV

4 Potential for Apps in the National Health Service

5 DoH - National Mobile Health Worker Project Final Report Significant increases in productivity can be achieved e.g. contact activity up 142% Significant increases in time spent with patients following deployment of mobile devices (up to 104%) Journeys can be reduced, even where clinical activity is increased (down 11%) Time spent travelling can be reduced (down 33%) Data duplication can be reduced significantly, freeing up clinical time (up to 92%) Number of access visits can be reduced significantly (up to 50%) Significant saving in referrals can be achieved (up to 34%) Significant savings in admissions can be achieved (up to 91%).

6 1 - Apps in General Clear trend in time taken for new technology to reach 50% Market Penetration

7 1 - Apps in General It is estimated that tablets will take just 5 years to reach 50% market penetration

8 1 - Apps in General Google glass may take just 2.5 years to reach 50% market penetration

9 1 - Apps in General Other sectors close to pharma development are adopting Apps HCPs public Regulators Different divisions within pharma are adopting Apps Sales Marketing

10 Merseyside Healthcare trusts 300 community staff are using mobile apps to gather clinical data at the point of care. The apps are running on smartphones and tablets and are fully integrated with existing clinical systems. There are also plans to use mobile devices to replace paper-based forms on the wards at Aintree University Hospitals Foundation Trust

11 1 - Apps in General Mobile Apps and HCPs 80%+ of U.S. doctors (27%+ in Europe) use smartphones and medical apps 56% said they expedited decision-making As of today, there are 40K+ medical and healthcare apps available for smart phones and tablets 88%+ of physicians would like their patients to use apps track and/or monitor their health at home weight blood sugar levels vital signs

12 1 - Apps in General Functionality of Mobile Apps in the HCP Community Reference Medscape, Epocrates, Skyscape Monthly Prescribing Reference (MPR) PubMed Mobile Pdf collector Evernote Medical calculator Calculate by QxMD Medical News MedPage Today Harvard School of Public Health

13 1 - Apps in General Apps in the General Community The public are increasingly using mobile apps for: Researching their disease Investigating their medication Counting calories Planning nutrition Calculating body mass index, Quitting smoking Medical diary Sharing their experience

14 2 - Apps in Pharma Within Pharma Apple devices are the most popular Manufacturer and Type of device Number of Apps available iphone 236 ipad 75 Android 32 Blackberry 11 Nokia/Symbian 1 Windows mobile 0

15 2 - Apps in Pharma Apps in Pharma currently focus on supporting products Functional Category Branded General Medical Education Treatment Tracker Healthy Living Clinical Trials Number of Apps Examples Get Bladder Fit from Astellas Alli Food Planner, GSK Disease awareness e.g. VisionCheck, Allergan Disease calculators e.g. Pegatron Dosage calculator, Merck Patient diaries e.g. Crohn s diary, Centocor, MyAsthma, GSK COPD, Nycomed, Psoriasis, Janssen HeliTrax, CSL Behring FactorTrack, Bayer Plan Q, Pfizer GoMeals, Sanofi Cancer Trials, GSK Oncology Clinical Trial Resource, Lilly *No Apps specifically for Pharma Development e.g. clinical or AE data gathering

16 3 - Apps in Pharma Development Software development is tightly controlled ICH recommendations GCP regulations 21CFRpart11 - Validation

17 3 - Apps in Pharma Development Draft guidance on mobile medical apps (medical devices) has been produced by the FDA If your App is considered a medical device you will need to: Register the device Pre-market approval Verify and validate the app to ensure the safe and effective use of the device

18 3 - Apps in Pharma Development Number of Setbacks 1. October 2011 Pfizer was forced to pull its Rheumatology Calculator iphone and Android app after errors were found in its calculation formulas. 2. A number of Apps have been shown to be inconsistent e.g. Pedometers. This was possibly due to: Lack of medical/scientific involvement in development Poorly developed and badly tested prior to launch

19 3 - Apps in Pharma Development For these three reasons very few mobile apps have been produced for pharma development.

20 3 - Apps in Pharma Development However, the potential for apps is significant Replacement of paper or Web based systems for data gathering Linkage with point of care (POC) devices Implementing risk management plans Risk minimization activities Supporting patient reported outcomes Adverse events Improving patient compliance

21 3 - Apps in Pharma Development Replacing Paper and/or Web in Pre and post Approval Collecting clinical trial data Phases I, II, III Collecting adverse event data Clinical and spontaneous AEs, PASS Collecting DUS and QoL data

22 3 - Apps in Pharma Development Apps and Point of care testing devices handheld analysers and monitors simple analysers used to test blood gases, electrolytes, coagulation, pregnancy assessment and drugs of abuse testing.

23 3 - Apps in Pharma Development Apps in Risk Minimization Educating patients and HCPs Prescribing guidance. Information on what to do if you experience an adverse event

24 3 - Apps in Pharma Development Apps and Patient Reported Outcomes Direct patient reporting of outcomes particularly adverse events is a growing trend but mainly using paper and web tools.

25 3 - Apps in Pharma Development Potential benefits from implementing apps Portability Quality Assurance Speed Access to data Decisions Updates WiFi, GPS Mobile Connectivity Potential Benefits Convenience Patients and HCPs

26 Apps in Pharma Development Thank you Questions

27 file/127437/mhwp_final_report.pdf.pdf