Pushing Through the Uncertainty: New in vitro Analytic Tools to Help Keep Your Development Projects on Track

Pushing Through the Uncertainty: New in vitro Analytical Tools to Help Keep Your Development Projects on Track

DATE & TIME:
 Wednesday May 27, 2020

9:00 am, New York, USA EDT

2:00 pm, London, UK BST | 6:30 pm, New Delhi, India IST | 9:00 pm, Beijing, China CST

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PRESENTERS
Alberto Correia, VP Technical Services
Linda Liao, Senior Field Applications Scientist

Drug development costs are reported to exceed $1B USD, with daily revenues ranging from $1-3M. Shortening the time to market is critical to maximize return and secure a competitive advantage. Strategies that increase efficiencies and reduce cost are paramount.

For generic drug development in the OINDP space, striving toward a waiver of clinical endpoint testing is a route many are exploring. The FDA has shown commitment to this approach with its release of a product-specific guidance document highlighting alternative in vitro tests to demonstrate bioequivalence.

Innovator drug developers can also benefit from the data generated using these novel techniques to help guide key decisions early on regarding device selection, formulation development, and IVIVC.

In this webinar we will review the current landscape and discuss new tools and techniques that can be used to accelerate your development projects. We will demonstrate the importance of employing new in vitro analytical methods early on in your OINDP development projects in order to gain valuable insight and reach approval faster than you thought possible.

DETAILS AND REGISTRATION

Proveris Laboratories offers OINDP development expertise to biopharmaceutical companies, including contract services using new innovative techniques. Register to gain access to scientific data demonstrating how these novel tools are being used by Proveris to assist in maintaining projects and accelerating development.

Key takeaways:

  • How Proveris can assist in maintaining your projects or accelerating development
  • Overview of the major challenges in OINDP development
  • Discover a combination of new analytical techniques for comprehensive product insight which can be used to demonstrate in vitro bioequivalence and IVIVC
  • Understand the importance of applying alternative in vitro approaches early on in drug development
  • Learn more about updates to the regulatory guidance and the new landscape for generic drug development
  • Combine strategies to accelerate your development project and increase chances of successful approval

Who will benefit from attending:

  • Analytical R&D Scientists
  • R&D Directors
  • Lab Managers
  • Device Development Engineers
  • Formulation Development Scientists
  • Product Development Teams
  • Regulatory Managers and Directors

Recipharm invests in its US inhalation development service

The newly acquired system was installed alongside an environmental controlled aerosol collection chamber for inhalation testing and a metered dose inhaler (MDI) and dry powder inhaler (DPI) pilot process lab.

SprayVIEW® is a primary instrument for the characterisation of aerosols or sprays emitted from MDIs, soft mist inhalers and nasal sprays through the measurement of spray pattern and plume geometry. Both are important factors that affect spray performance and SprayVIEW® is an important tool that can visualise changes in other critical quality attributes (CQAs) of inhaled and nasal products.

Commenting on the investment, Lei Mao, Director Inhalation Science and Product Development at Recipharm said: “By employing the SprayVIEW® system and expanding our expertise in this technique, we are strengthening our capabilities in inhalation and nasal product development and manufacturing.”

Read news reported by: Recipharm…