Thomas BRISSET 12 March 2020 Biological Products and Stability Linear and Nonlinear Modeling Agenda Stallergenes Greer presentation Project Background JMP application Conclusion 2 Stallergenes ID: 1034186
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1. JMP Discovery Summit 2020 - MunichThomas BRISSET – 12 March 2020Biological Products and Stability: Linear and Nonlinear Modeling
2. AgendaStallergenes Greer presentationProject BackgroundJMP applicationConclusion2
3. Stallergenes Greer presentation
4. Our purpose is to enable peoplewith allergies to live normal lives.Our aspiration is to change the treatment paradigm of allergy therapies by delivering curative medicines and innovative tools for patients.
5. Global allergy prevalence: a large and growing health concern1. EAACI: Global Allergy Atlas. 2014. http://www.eaaci.org/GlobalAtlas/GlobalAtlasAllergy.pdf 2. Bousquet J., Van Cauwenberge P., Khaltaev N. et al., Allergic rhinitis and its impact on asthma, ARIA workshop report, J. Allergy Clin. Immunol, 2001, 108 (5) : S147-S334. 3. Ozdoganoglu T, Songu M. The burden of allergic rhinitis and asthma. Ther Adv Respir Dis. 2012;6(1):11-23. Today, allergic diseases affect the lives of more than one billion people worldwide, 13% of the world’s population.1 With an epidemic rise over the last 60 years, prevalence is expected to reach up to four billion people by 2050.1ALLERGIC RHINITIS PATIENTS ARE AT GREATER RISK FOR ASTHMA80%of asthmatic patients suffer from allergic rhinitis23x Patients with allergic rhinitis are three times more likely to develop asthma2500 million people suffer from allergic rhinitis2Less than 1% of patients are treated with allergy immunotherapy3 ALLERIC RHINITIS PATIENTS ACCESS TO AIT IS YET TO BE FULLY UNLOCKED
6. Global commercial and operational footprint2 Core Manufacturing sitesIn Lenoir, NC (U.S.) and Antony (France), out of the 5 manufacturing sites globallyCountriesWith a direct presence; distribution networks in 73EmployeesGlobally in 19 countriesAverage product lead timeCompared to industry average of 2-3 weeksInnovation hubsIn Boston (U.S.) and Paris (France)191,1672 7 daysProduct segmentsCovering sublingual, subcutaneous, veterinary and other products4Manufacturing facilitiesDirect presenceDistributorsHeadquarters
7. Project Background
8. Stability studiesGoal : To study the stability of the pharmaceutical product over time in order to define shelf life and storage conditionIn practice, products in development are studied under different storage condition at different time points in order to evaluate critical parameters evolution over timeModeling of parameters evolution will allow to:Better characterize the productExtrapolate shelf life8
9. Application exampleDescriptive analysisLinear modelingCovariance analysis (ANCOVA)ExtrapolationStability PlatformNon linear modeling9
10. Application in JMP
11. Conclusion
12. Stability data modelingIn the example,3 parameters were studiedParameter 3 modeling allows to characterize the product and predict degradation over 36 monthsTwo possible methodologiesLinear platformStability platformMore generally,Characterization is an essential part of produt development phaseInherent variability of biological products makes modeling difficult in several cases Modeling approach is constrained by pharmaceutical guidelines 12