Pace Analytical Life Sciences

How to Craft a Successful Orphan Drug Designation

Oligonucleotides are a class of biotherapeutics presenting complex challenges in the development and commercialization of gene therapies. Download our paper and learn how to move your project forward.

Webinar Date/Time: Wed, Jun 21, 2023 2:00 PM EDT

Webinar Date/Time: Wed, May 24, 2023 2:00 PM EDT

Peptide modification via salts is a way to change properties of the API to make it more advantageous to the desired release profile.

A long-acting injectable improves the patient’s experience by only requiring a once weekly, or monthly injection as opposed to a daily dosing regimen. The gel depot formulation is simple to manufacture, and easy to tune to the desired release duration and dose.

Tuesday, October 4, 2022 at 11am CDT |12pm EDT | 9am PDT Is developing formulations of highly lipophilic compounds worth the effort? With today’s excipients and technologies, the answer is a definite yes. This presentation will showcase the issues presented by lipophilic compounds and ways to address them.

**Tuesday, Nov. 30, 2021 at 2pm EST | 1pm CST | 11am PST*** Formulation options for peptides in early development versus strategies for final dosage for design, keeping all options open. Peptide formulation strategies for rapid entry to the clinic. *** On demand available after final airing until November 30, 2022.***

*Live: Thursday, May 27, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST* Compendial verification is a regulatory requirement. Often overlooked are the technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory. Experts will share experiences gained over years of evaluating hundreds of methods to help you avoid similar obstacles and delays in your laboratory. *On Demand Until May 27, 2022*

*** Live: Thursday, Oct. 15, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST *** Polymorph screening of small-molecule drug candidates enables rational selection of the proper solid form/polymorph for further development. Learn the elements and techniques of polymorph screening is and why performing it thoroughly will help de-risk drug development effort. ***On demand available after final airing until Oct. 15, 2021***

Learn how to navigate the regulatory requirements for extractables and leachables testing for new biologic drug products. Review the essential steps to for study design, extraction, analysis, and reporting of extractables and leachables data in this webcast. Live: Thursday, Sept. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 24, 2021

The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. This webcast will provide insights into characterizing viral and non-viral gene therapies to ensure quality. Live: Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 20, 2021