The document discusses a mobile application-based solution for improving clinical trial data collection. It aims to significantly improve data quality while decreasing costs by collecting patient-reported outcomes and physiological data through mobile devices. This allows for more flexible trial protocols, real-world evidence collection, and improved compliance monitoring compared to traditional trials. The solution offers customized mobile apps, questionnaires, and data collection for each trial protocol while ensuring regulatory compliance and data security.

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2. OUR GOAL : REVOLUTIONIZE CLINICAL DATA COLLECTION
Our technology and expertise significantly improve the quality of clinical trials’ data while radically decreasing its costs 2
Mobile technology
Real life data
Flexible & scalable
Cost efficient

3. CHALLENGES OF CURRENT DRUG DEVELOPMENT PARADIGM
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Ever- changingregulations
Increasedcomplexity
Resource intensive process
Difficulty in acquiring real-life data through refined measures such as QoL, behavior assessments, direct & indirect costs
Insufficient degree of flexibility and granularity of trial protocols to demonstrate the added value of new treatments
Excessive development costs due to inconsistent treatment compliance leading to avoidable hospitalizations

4. OUR SOLUTION : A MOBILE APPLICATION BASED SOLUTION
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Data collection by the patient (ePRO*) & physiological captors in his environment
*electronic Patient-Reported Outcome
Each application is customized to a specific protocol

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A mobile app matching the newly generated protocol is automatically created for the patients
Ex features for questionnaires design
•Open questions
•Multiple choice questions
•Visual analogue scales
•Photos
•QR & data matric codes
Ex features for study design
•Fixed or event based questions
•Delayed questioning
•Branching of the questions
•Specific or conditional answers
•Turn on/off notifications
Protocol drafting with the help of Ad Scientiam’sexpertise (protocol strategy, sample size etc.)
Building of the questionnaires by the researcher via Ad Scientiam web interface
A web portal is created for the investigators to administer the protocol
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Step 3 -Data collection
Step 2 -Recruitment
Step 1
PROTOCOL DESIGN

6. STUDY AND PROTOCOL DESIGN
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Step 3 –Data collection
Step 2
Step 1 –Protocol Design
RECRUITMENT PHASE
Easy to manage
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Easy to adapt
Easy to use web portal
Fast patient inclusion via portal or email
Iterative protocol development between the promoter and Ad Scientiam

7. STUDY AND PROTOCOL DESIGN
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Step 3
Step 2 -Recruitment
Step 1 –Protocol Design
DATA COLLECTION PHASE
Patient download a free application on their own smartphone
Works on iOS, Android, and Windows phones
Automatic time zone and language recognition
Highly ergonomic user interface
Integrated tutorial and help at every step of protocol
Data collection available offline
Compliance to protocol is monitored
Protocol can be modified during the trial
Preliminary data analysis
Real-time data access
Identification of sub-groups
Preliminary results analysis
For the patient
For the investigator

8. A POWERFULCOMPLIANCE SYSTEM
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•Each questionnaire and protocol step is associated with a tutorial and a FAQ
•Administration of the right product at the right time is guaranteed by a code reader before each administration
For the patient
For the investigator
•Protocol compliance can be individually monitored
•Alert thresholds for non-compliant patients available
•Push notifications to patient if needed

9. INTEGRATIONOF WEARABLECONNECTEDDEVICES
The rapidly growing wearable technologies market increases the potential of our system to cover a larger scope of clinical trials
A large set of validated medical devices from several makers are already at our disposal (blood pressure monitor, pulse oximeter, glucose monitor, scale, actimeter, spirometer, etc.)
A partnership with iHealth, the world leader in wearable connected devices, allows us to include cutting edge devices
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10. COMPLIANTWITHPRIVACYAND REGULATORYSTANDARDS
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Data can only be accessed by authorized people
Data are encrypted directly on the device
Encrypted data are stored on a secure server
Compliant with 21 CRF part 11 FDA guidance

11. SPECIFIC ADVANTAGES FOR PHARMACEUTICALS
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Additionalvalue for regulators
Innovative protocols
Reduced costs
Real life data is a new requirement for regulatory approval and post marketing studies
Direct & indirect costs analysis adds value during the pricing and reimbursement process
High security and privacy standards match the regulatory framework
Complex protocols can be implemented using our highly customizable system
Secondary endpoints based on QoLand behavioral data are now possible
Improved relationship with classic clinical research teams and CRO
Phase III trials & post marketing studies can be partially or totally implemented in a homecare setting
High protocol compliance is achieved by automatic monitoring thus decreasing group size requirements

12. OUR STANDARD OFFERING CAN BE FULLY CUSTOMIZED TO MEET THE STUDY’S NEEDS
Research
AdS*
Clinical AdS*
Advanced AdS*
Premium AdS*
Custom AdS*
Mobiletechnology
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Real-life data datacollection
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Medical expertise
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Study design expertise
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Regulatory compliance
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Real time-data access
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Double arms study
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Patients randomization
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Connected wearabledevices
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Compliance module
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Statistical data analysis
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Patient recruitment system
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*Ad Scientiamtechnology

13. PHASE III STUDY OF A NEW IRREVERSIBLE ANTI-VEGF INHIBITOR IN THETREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER
Hypotheses after publication of intermediate results
•Primary endpoint (OS) will be missed
•Secondary endpoints (PFS and OR) will be achieved
•HR will decrease with a better side effect profile
Problematic
•Premium pricing strategy is conditional to cost-effectiveness evaluation in major markets
•Other oncology products with similar results were already rejected by the NICE
AdScan measure more precise data in a sub group or ad hoc study
•Close monitoring of specific side effect and symptom frequency (nausea, asthenia, etc.)
•Real-life QoLevaluation with validated scales
•Direct and indirect cost monitoring
AdScan realize an advanced pharmaco-economic analysis
•Use real life input instead of transferring conservative inputs from the literature to calculate costs and QALY
•Take into account more parameters than traditional approaches 13
Case study 3
Case study 2
Case study1

14. STUDY AND PROTOCOL DESIGN
Situation
•Failure to meet both primary and secondary endpoints
•Significant number of patients’ caregivers continue to claim that the drug is highly beneficial
•No additional investment in the drug candidate is planned in the future
Problematic
Can a small scale study qualify and quantify the caregivers’ claims with enough granularity to reevaluate the drug candidate at a minimal cost?
AdScan measure unconventional data
•Caregivers’ care time, involvement and QoL
•Symptoms and incidents measured with high granularity (duration, severity)
•Introduction of new measures based on caregivers’ feedback
AdShas a strong expertise in unconventional and real-life data analysis
•AdSmodelling techniques allow a close analysis of the patient environment
•Faster discovery of hidden patterns
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Case study III
Case study II
Case study1
FAILURE OF AN ALZHEIMER DRUG CANDIDATE DURING PHASE III

15. STUDY AND PROTOCOL DESIGN
Situation
•Approval conditional to the realization of a large post marketing study to demonstrate a real life efficacy and safety profile
•Competitive market with many generic drugs
•High economic burden of the disease with relatively high unmet medical needs
Problematic
•A large phase post marketing study can become very expensive
•Low compliance to chronic treatments can undermine the efficacy measure
•Accurate real-life physiological measurement are hard to collect
•Circadian variation of PEF and FEV1
•Memory biases in capacity to exercise reporting
AdScan measure QoL, physiological data, and ensure a good compliance
•The use of a connected spirometer allows measures several times per day
•Symptoms are measured by event-triggered open questions
•High compliance is insured by our compliance module
•The use of mobile technology decreases significantly the monitoring costs
AdShas a recognized expertise in unconventional and real-life data analysis
•AdSmodelling techniques allow a close analysis of the patient environment
•Statistical significance of up-to-now hidden patterns crucial for the disease management can now be revealed by data analysis. 15
Case study III
Case study II
Case study I
AFTER A SUCCESSFUL PHASE III, A NEW COPD DRUG WAS APPROVED BY THE FDA WITH A PAC* AND IS WAITING FOR THE EMA REVIEW
*Post-approval commitment

16. A MULTIDISCIPLINARYTEAM
Dr Benjamin Pitrat
MD, MPH
Dr Cécile Monteil,
MD
Dr Samir Medjebar
PharmD, MBA
Pr. Sebastien Montel
PhD psychology (USA based)
MedicalTeam
Daniel Vial
Senior pharmaceutical advisor
Liouma Tokitsu,
CEO
Térence Brochu,
Ergonomist & designer
Amaury Larreur,
Software developer
François de Berry,
Software developer
TechnicalTeam
Emilie Pons, PhD
PhD, algorithmic research director (UK based)
Dr. Jean-Pierre Lehner
MD, senior medical advisor
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17. OUR PARTNERSHIPSIN CLINICALRESEARCH
Parkinson disease: Pr Corvol(ICM), Dr Yelnik(ICM)
Psychiatry: Sainte-Anne hospitalresearchgroup (Pr Krebs)
Periodicparalysis: Dr Vicart(Pitié-Salpêtrière hospital)
Sleepmedicine: Pr Arnufl(Pitié-Salpêtrière hospital)
Eyetracking: eyeBrain(ICM)
Theory of Mind: Dr Daunizeau(ICM)
Cardiology: Pr Isnard (institut de cardiologie / ICAN)
Endocrinology: Pr Oppert(ICAN)
…
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18. AD SCIENTIAMIPEPS-ICM, INSTITUT DU CERVEAU ET DE LA MOELLE ÉPINIÈREHÔPITAL DE LA PITIÉ-SALPÊTRIÈRE47, BD DE L'HÔPITAL75013 PARISFRANCE 18
WEBSITE:ADSCIENTIAM.COM
PHONE :+33(0)1 57 27 41 94
MAIL :INFO@ADSCIENTIAM.COM