ONCommit support academic institutions, biopharmaceutical and medical devices companies to bring new medicines to patients quicker

1. Lilian Leclerc
Founder and Consultant
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2. Table of contents
A. About ONCommit
B. Our expertise
C. ONCommit services
D. Value proposition
E. Case studies
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3. A. About ONCommit
Company founded in Dec. 2013 based in Switzerland
MISSION:
To provide efficient, flexible, and
high quality services
To academic institutions,
biopharmaceutical and medical
device companies
In the management of
translational and clinical research
projects
VISION:
To become a leading partner for academic
institutions, biopharmaceutical and
medical device companies to help them
bring new medicines to patients quicker.
VALUES:
Commitment, Trust, Openness
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4. A. About ONCommit
• Master in Biological Sciences (Aix-Marseille University -
France)
• 3 years experience in academic lab research
• Over 12 years experiences in clinical research in the
industry (affiliates and headquarters in France, UK,
Switzerland)
• Site, Country and Global levels expertise
• 7 years experiences in Oncology (Clinact CRO, Chiron,
Roche)
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My background and experiences:

5. B. Our expertise
THERAPEUTIC AREAS
CLINICAL TRIAL METHODOLOGY
PROJECT MANAGEMENT
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6. B. Expertise in various TA
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7. B. Expertise in Oncology
Phase Number of
studies
Indication Responsibilities/Services
I 4
Melanoma
Breast cancer
Colorectal cancer
AML
Global and country project
management
Sites monitoring
II 2 Breast cancer
NHL
Sites monitoring and global
project management
III 3 Breast cancer
CLL
Global project management
Non-
interventional
2 Breast Cancer
Lung Cancer
Global and country project
management
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8. B. Examples of early phases studies
A Phase I Dose Escalating Study to Evaluate the Safety, PK and PD of X in patients
with Acute Myeloid Leukemia.
A Phase I open-label, excretion balance, pharmacokinetic and metabolism study
after a single oral dose of 14C-labeled X in previously treated and untreated patients
with metastatic melanoma
A Phase I Single-Center, Randomized, Double-Blind, Multiple-Dose, Placebo-
Controlled, 2-way Cross-over Study to Investigate the Effects of X and Sodium
Intake on the Renal Hemodynamics following Oral Administration in Healthy
Subjects.
A phase I single-centre, randomized, double-blind, placebo-controlled, study to
investigate the safety and tolerability of sublingual immunotherapy tablets of X in
adolescents with house dust mite-associated allergic rhinitis.
A Phase II Randomized, Open Label, Controlled Trial of the addition of 8 weeks SC
Administration of X to 4 weeks IV Administration of Rituximab in the Treatment of
Rituximab Naïve Subjects with Follicular Non-Hodgkin’s Lymphoma, Refractory or
Relapsed after Previous Chemotherapy
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9. C. ONCommit Services
CLINICAL TRIAL FULL SERVICES through collaborations with academic
institutions experts, consultants and CROs:
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10. C. ONCommit Services
Examples of CLINICAL TRIAL FUNCTIONAL SERVICES at different levels of the
team organization and different phases of the trials:
Global
Country
Site
Full planning Risk Management CSR review
Lead study team
Writing study docs Investigators meeting Budget reconciliation
Submissions IEC/HA
Sites selection and (Co)-monitoring Audit preparation
contracting
Set-up Conduct Close-down
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11. C. ONCommit Services: 4 key success factors
ONCommit provides you with customized project management tools
to support the organization of the team and delivery of the project
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12. D. The competitive advantages
Multiskilling resourcing model
Strong expertise in clinical project management
Specialized in Oncology and early phases
Global collaborations
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13. D. The added value
Fast communication and prompt decision making
Optimization of resources and cost/time reduction
Flexibility and quality in execution
One point of contact through the entire project
ONCommit ensure a faster and less costly
initiation and delivery of the projects
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14. E. Case study I: an oncology AME study
Phase I Mass Balance study after a single oral dose of 14C labelled
X in patients with metastatic melanoma
Challenges: deliver an innovative study for first IND/CTA submission
(NME / first-in-class).
Innovation, complex planning and stretched timelines, high volume
of data per patient, large international cross-functional team.
Skills: entrepreneurial, leadership and project management skills.
Outcome: study performed in 1 year (Synopsis to CSR). High quality
results delivered on time. (IND to Launch = 5 years)
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15. E. Case study II: study set-up
A multi-country retrospective chart review analysis of
patients with ALK-positive non-small cell lung cancer
Challenges: selection and contracting with investigators sites
/ timelines study set-up.
Skills: expertise in country level regulations (France) /
interpersonal and project management skills.
Outcome: 8 sites selected and initiated / despite delay at
country level data delivered on time for global DB lock and
publications.
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16. THANK YOU FOR YOUR ATTENTION
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