Karine Corcelle Email & Phone Number

Geneva, Switzerland

Expand role and actions to :- Enable LMICs to meaningfully participate in joint-regulatory assessment and build respective capacity and expertise. Develop regulatory strategies and advocate for the use of facilitated registration pathways (i.e. EU M4All, Swissmedic MAGHP...).- Joining forces with WHO (GAP-f), academic partners/ research institutes, and like-minded organizations (“PDPs” Product Development Partners) to close Paediatric R&D gaps.- Full support to responses to funding proposals, interviews and reporting to donors.

Genève, Suisse

Lead/ Co-lead with partners all regulatory strategies to optimize neglected patient access to DNDi product portfolio under development in Leishmaniasis, Sleeping Sickness, HIV-Cryptococcal Meningitis.- Fexinidazole registration in rhodesiense Human African Trypanosomiasis patients through EU M4All.- Many consultations with regulators, and stakeholders on innovative proposals for medicines development/ registration addressing lack of global regulatory guidance and limited regulatory capacity in endemic settings.

Bâle, Suisse

- Drive regulatory strategies for Global Health Flagship Programs (Malaria and Leprosy) with the goal of ensuring high patient reach and access to medicines.- Regulatory leadership on Novartis Adaptive Development initiative to improve access to medicine, safety and efficacy, to vulnerable patient groups (incl. children, women, elderly).- Co-develop a Medscape Medical program educating physicians on risks-related to the use ofMycophenolates in pregnancy.

Basel Area, Switzerland

Regulatory Lead for global programs (NCEs & biologics) from early development to registration. Frequent Scientific Advice/ regulatory interactions: EMA, Swissmedic, French ANSM, Singapore SFDA,.- Registration of Myfortic® as a treatment for Lupus Nephritis in Asia and Middle-East based on Real-World Data.- Extension of Diovan® for use in hypertension in younger children (1 to 5 years) in EU.- Regulatory strategy extending Coartem® for uncomplicated malaria in neonates and infants.- Collaboration with WHO for the prequalification of Coartem® high strength and Lamprene® in DR-TB.- Post-trial Access strategy for Sebivo® in children and adolescents (2 to 17 years) with Compensated Chronic Hepatitis B Virus Infection.Partnership:- Close collaboration with Sandoz on life-cycle strategies for shared molecules and authorized generics.- Regulatory recommendations to partnership agreement and management of out-licensing/ divestments (incl. waiving post-approval commitments).

Basel Area, Switzerland

- Management of all submission of Early Development and Global Health Units,- Novartis representative at EFPIA eSubmission Working Group from 2010 to 2014 (previously TiGes) developing strategies, standards and best practices to drive the eCTD roadmap in EU.- Off-shoring of submission management activities in India.

Basel, Switzerland

- Lead cross-functional teams of scientist through the preparation of EU/US MAA/NDA registrations (i.e. Respiratory: Tobi® Podhaler; Oncology: Signifor®, Jakavi®...) and participated to EMA MAA pre-submission meetings.- Technical lead of various workstreams/ pilots adapting the organization to new EU regulatory framework: (1) overall modernization/ simplification of the registration process through eSubmissions, (2) new requirements from the orphan and paediatric legislation.

Basel Area, Switzerland

- Development of several innovative drug delivery systems for ophthalmic diseases, skin conditions and oncology. Prepared regulatory documentation for CMC Modules submission.. Responsible for assessing in-licensing opportunities of new formulation principles/ excipients/ devices. Patents/ Inventions: WO2008074853A1 (WIPO (PTC)) Ophthalmic rebamaipide solution: 2008-06-26 WO2011009852A2 (WIPO (PTC)) Topical pharmaceutical compositions: 2011-01-27

Évreux, Normandy, France

- Set-up a laboratory for the technical evaluation of inhalation devices and led method transfers from UK facility.- Help Altran Group to create and develop their portfolio of new pharmaceutical services.

Lyon Area, France

- Explore and characterized novel vaccine adjuvants for HIV and Hepatitis B.- Mobilize researchers' expertise and develop in-vitro methods for the early assessment of the immune-modulatory effect of vaccine adjuvants for preclinical POC.

Master'S Degree, Law And Policies Of The European Union: Health Products Law

Advanced Master'S Degree, Pharmaceutical Development And Drug Product Engineering