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From Discovery to Clinic: Getting Ready for Phase I – Biological Products

Catalent

Tuesday, March 20, 2018 from 9:00 AM to 3:30 PM (CET)

From Discovery to Clinic: Getting Ready for Phase I –...

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Event: From Discovery to Clinic: Getting Ready for Phase I – Biological Products
Location: 3-5 Impasse Reille, 75014 Paris, France
Date: Tuesday20th March 2018

Les entreprises de biotechnologie d'aujourd'hui font face à une pression importante pour accélérer le développement de leurs produits en clinique. Une telle pression peut souvent conduire à adopter une stratégie à court terme et négliger les réalités en aval du développement de médicaments. La complexité du développement de produits biologiques nécessite en effet une conception stratégique de l’ensemble des étapes de développement et de production afin d’une part d’optimiser le time-to-clinic et d’autre part, garantir l’élaboration d’un dossier d’autorisation d’essai clinique solide. La pertinence des stratégies de développement sélectionnées pourra également positivement influencer les investisseurs et les sociétés pharmaceutiques lors des phases de levée de fonds et d’out-licensinget ainsi permettre à un candidat médicament de se démarquer.

Cette conférence, francophone et gratuite, portera sur un certain nombre de considérations clés pour amener les produits biologiques de la découverte à la phase I, depuis le développement de lignées cellulaires jusqu’à la production cGMP en passant par les besoins de formulation, les études de toxicologie et pharmacologie et incluant une revue des exigences réglementaires. L’objectif de ce workshop sera de partager les compétences et l'expérience des experts présents et permettre aux participants d’échanger activement sur leurs projets dans le cadre de sessions interactives.

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Today’s biopharmaceutical companies face significant pressure to accelerate their products from discovery to the clinic. Such pressure can often lead them to adopt short-term thinking and overlook the downstream realities of drug development. The complexity in developing biological products requires strategic design of production aspects, drug formulation, demonstration of mode of action and efficacy, together with customised toxicology and safety pharmacology studies to ensure a robust clinical trial application and fewer problems down the line such as escalating timelines, costs, and regulatory issues.

This free francophone conference will focus on a number of key considerations for transitioning biological products from discovery to phase 1 readiness including production aspects, formulation development, toxicology, pharmacology and regulatory requirements. We aim to leverage the skills and experience of experts and connect the dots between competencies to help companies minimise the risks and improve the odds of success for the development of their biologic products.

 

Time

Agenda Item

Presenter

09:00

Registration/Coffee

09:30

Introductions

Arnaud Bathelier, Catalent

09:40

Regulatory aspects of early stage therapeutic development – Biological Products

  • Regulatory landscape (EU/US)
  • What do all these abbreviations mean?
  • Regulatory guidance, one hat does NOT fit all
  • What makes up a high quality clinical trial application?

Nathalie Muller & Vincent Dubois, Leads to Development

10:20

Implications of technology integration to speed up clinical development of protein & mAb candidates – Mammalian system case study

  • Importance and key features of a good cell line development platform
  • Current process and analytical development strategies for Phase I programmes
  • Concrete examples of accelerated timelines from cell line development to PI GMP manufacturing

Christelle Dagoneau, Catalent

11:00

Coffee/networking

11:30

Improving the industrial potential of a biologic therapeutic candidate in early development phases

  • What to do and when?
  • Case study: development of an antibody fragment
  • Specificities of a development plan for recombinant protein expressed in microbial systems

Claire Untereiner, PX Therapeutics

12:10

Preclinical safety studies for biological products

  • General considerations to be evaluated before starting GLP studies
  • Designs of preclinical Toxicity studies
  • Specific endpoints and biomarkers

Olivier Foulon, Emilie Grosdidier & Philippe Ancian, CiTox Lab

12:50

Networking Lunch

1:1 Private Consultancy Appointments

13:45

Round table – Focus on

  • Recombinant proteins
  • Vaccines
  • Antibodies

 

 

 

 

During the networking lunch, private no-obligation discussions on specific programmes and challenges are available.

Please contact Amy Glekas (amy.glekas@catalent.com) if you have questions or specific dietary or building access requirements.


 

Useful Contacts:

 

Christelle Dagoneau

Director, Business Development – Biologics – Europe

M +33 6 37 44 49 07| E Christelle.Dagoneau@Catalent.com

 

Arnaud Bathelier

Account Director – Drug Delivery Solutions – Development & Analytical Solutions at Catalent

M +33 6 84 40 62 33 | E Arnaud.Bathelier@Catalent.com

 

Jonathan Kearsey

Director of Pharmacology & Business Development at Leads To Development

M +33 6 89 34 57 32| E JKearsey@LeadsToDevelopment.com

 

Olivier Foulon

Managing Director, Director of operations at CiToxLAB

M +33 7 88 10 31 01 | E Olivier.Foulon@fr.citoxlab.com

 

Alexandre Chevallier

Business Development Manager at CiToxLAB

Ealexandre.chevallier@fr.citoxlab.com

 

Claire Untereiner

COO at PX Therapeutics

M +33 6 27 15 20 99 | E claire.untereiner@px-therapeutics.com

Have questions about From Discovery to Clinic: Getting Ready for Phase I – Biological Products? Contact Catalent

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When & Where

3-5 Impasse Reille
75014 Paris
France

Tuesday, March 20, 2018 from 9:00 AM to 3:30 PM (CET)


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Organizer

Catalent

Catalent is the #1 industry partner for advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise and the broadest portfolio of superior technologies to bring more customer products to market faster, enhance product performance and ensure reliable clinical and commercial product supply. Our team of over 10,000 people, located at over 30 sites on five continents, produces +70 billion doses of +7,000 products for more than 1,000 customers from 87 of the top 100 global pharmaceutical marketers, to 24 of 25 biological marketers, to 21 of 25 leading consumer health marketers, to thousands of small innovators globally. Our passion is to help unlock the full potential of your product.

www.catalent.com

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