West, Kymanox, & Grand River Aseptic Manufacturing tackle hot topics within the pharma and biotech industry
Webinar: Planning for Multiple Product Indications and Presentations
Your company has developed a biological product. Often the “norm” is drugs being studied and developed for one indication, and for administration in acute-care settings, where planning for success is one-dimensional. For many newer drugs, the launch process does not stop or start, with this end goal in mind. Now, products are being studied for multiple indications, either in the same therapy area or in a new one, while also being developed in multiple presentations (e.g. vials, syringes, on-body devices) to adapt to administration in either hospital or non-hospital settings. Planning for success has become multi-dimensional, and organizations must stay launch ready.
In this webinar, we’ll explore multiple scenarios and explore how to leverage experience to achieve a rolling momentum including:
- What is driving the push to develop new drugs in multiple drug delivery/components while still progressing through clinical development?
- How do you prepare for multiple scenarios of products being studied for multiple indications and delivery options?
- With more considerations needed as you build your supply chain and external suppliers, how do you plan for one or multiple CDMOs?
- What are the FDA and regulatory requirements that are impacting approvals for multiple indications and drug delivery platforms?
- How are suppliers/CMOs handling the EU Annex 1 and MDR’s as well as the changes in the compendia requirements around CCS?
Participants:
- Jennifer Riter, Senior Director, Business and Technical Operations, Services and Solutions; West Pharmaceutical Services, Inc.
- Michael Denzer, Vice President – Technical Solutions, Kymanox
- Rebecca Hones, Business Development; Grand River Aseptic Manufacturing
- Julia Douthart, Moderator; Fierce Life Sciences