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Potential for Apps in
Pharmaceutical Development
Steve Hutson
Potential for Apps in
Pharmaceutical Development
Steve Hutson
www.virtualpv.co.uk www.virtualpv.co.uk
Potential for Apps in
Pharmaceutical Development
Steve Hutson
Potential for Apps in the
National Health Service
www.virtualpv.co.uk
• 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%).
DoH - National Mobile Health Worker Project
Final Report
Clear trend in time taken for new technology to reach 50% Market Penetration
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It is estimated that tablets will take just 5 years to reach 50% market penetration
Google glass may take just 2.5 years to reach 50% market penetration
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• Other sectors close to pharma development
are adopting Apps
– HCPs
– public
– Regulators
• Different divisions within pharma are adopting
Apps
– Sales
– Marketing
• 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
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• 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
Mobile Apps and HCPs
• 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 Functionality of Mobile Apps in the HCP Community
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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
1 - Apps in General
2 - Apps in Pharma
Manufacturer and Type of device Number of Apps available iPhone 236 iPad 75 Android 32 Blackberry 11 Nokia/Symbian 1 Windows mobile 0
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2 - Apps in Pharma
Functional Category Number of Apps
Examples
Branded
107
Get Bladder Fit from Astellas Alli Food Planner, GSK
General
177
Disease awareness e.g. VisionCheck, Allergan
Disease calculators e.g. Pegatron Dosage calculator, Merck
Patient diaries e.g. Crohn’s diary, Centocor, MyAsthma, GSK Medical Education 18 COPD, Nycomed, Psoriasis, Janssen Treatment Tracker 10 HeliTrax, CSL Behring FactorTrack, Bayer Healthy Living 11 Plan Q, Pfizer GoMeals, Sanofi Clinical Trials 6 Cancer Trials, GSK
Oncology Clinical Trial Resource, Lilly
*No Apps specifically for Pharma Development e.g. clinical or AE data gathering
Software development is tightly controlled
–ICH recommendations
–GCP regulations
–21CFRpart11 - Validation
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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
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm
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
Number of Setbacks
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• For these three reasons very few mobile apps
have been produced for pharma
development.
• 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
3 - Apps in Pharma Development
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• Collecting clinical trial data
– Phases I, II, III
• Collecting adverse event data
– Clinical and spontaneous AEs, PASS
• Collecting DUS and QoL data
Replacing Paper and/or Web
in
Pre and post Approval
– handheld analysers and monitors
– simple analysers used to test
blood gases, electrolytes,
coagulation, pregnancy
assessment and drugs of abuse
testing.
Apps and Point of care testing devices
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• Educating patients and
HCPs
• Prescribing guidance
.
• Information on what to
do if you experience an
adverse event
Apps in Risk Minimization
Direct patient reporting of outcomes particularly adverse events is a
growing trend but mainly using paper and web tools.
Apps and Patient Reported Outcomes
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3 - Apps in Pharma Development
Potential Benefits Portability Quality Assurance Speed Access to data Decisions Updates Convenience Patients and HCPs Connectivity WiFi, GPS Mobile
Thank you
Questions
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https://www.gov.uk/government/uploads/system/uploads/attachment_data/ file/127437/mhwp_final_report.pdf.pdf
