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Webinar

How to Secure Early Stage Development and First-In-Human Studies

Post thumbnail How to Secure Early Stage Development and First-In-Human Studies

We co-organized this digital event with Biopôle Lausanne.

On this Webinar:  

Biopôle presentation (Olivier Philippe)                

Let us get ready for First-in-Human-Study (by VCLS)                

Coralie and Fréderic P. will present the main challenges typically faced by drug developers during this initial stage of development and will discuss how to mitigate the risks and engage with Regulators to de-risk situations which could ultimately lead to a clinical hold.

Xevinapant: A case study (by Debiopharm)              

The Debiopharm team present a case study, based on Xevinapant, a transformative drug for the treatment of patients with locally advanced head and neck cancer. This product originates from the University of Michigan and was initially developed by the small biotech Ascenta Therapeutics. Xevinapant was evaluated by Debiopharm on several occasions during its preclinical development and was finally in-licensed after clearing the US and China IND. Since then, Xevinapant has been explored in several indications and drug combinations in different regulatory territories.

Rosa and Frédéric L. share their experience on the in-licensing and development of this drug to highlight multi-dimensional challenges and solutions to guide early development of promising compounds in oncology.

 

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    Sample of the webinar

    Teaser How to secure early stage development and First In Human Studies

    Featured Speakers

    Frédéric Pailloux
    Frédéric Pailloux, Pharm.D., M.Sc.
    Senior Director, Regulatory Science, Drugs & Biologics
    Frederic has several responsibilities within Voisin Consulting Life Sciences (VCLS). As a Head of Regulatory Science, he provides leadership and…
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    Coralie Hutchison, Pharm.D., M.Sc. thumbnail
    Coralie Hutchison, Pharm.D., M.Sc.
    Head of Swiss Operations & Associate Director Clinical Operations
    Coralie is responsible for the coordination and oversight of all activities related to the planning, conduct and completion of clinical trials, providing leadership and supervision to internal and external cross-functional teams. She has experience of conducting trials in both adult and pediatric populations, across a wide variety of common and rare diseases. She brings to the role 14 years of experience in the management of all phases of international clinical studies and has developed effective working relationship with internal and external partners in North America, Europe, Latin America, Middle East, Russia, Japan.
    Rosa Mouchotte thumbnail
    Rosa Mouchotte
    Global Regulatory Associate Director, Debiopharm
    Frédéric Levy thumbnail
    Frédéric Levy
    Director, Head of Search & Evaluation and Scientific Innovation at Debiopharm
    Olivier Philippe thumbnail
    Olivier Philippe
    Corporate Relations and Business Development Director, Biopôle SA