Pace Analytical Sciences

This presentation focuses on the development of suspension formulations of an NCE for oral administration.

Starting with the simple formulations used in safety studies, moving through the multi-dose product used for clinical programs and onto the advanced, long shelf-life product that is commercialized. Both formulation and analytical aspects will be covered.

Suspensions for other routes of administration, e.g., IM or SC injections and eye drops, are outside of the remit of this presentation.

Attendees will gain an understanding that:

The formulation complexity increases during development of a compound

Analytical testing requirements also increase during development

Multiple aspects of API characterization need to be considered


Vice President of Scientific Affairs
Pace® Life Sciences


Dave graduated with a degree in pharmacy from The School of Pharmacy, U. of London (“The Square”). After completing a year’s pharmacy internship, he returned to The School of Pharmacy to undertake a Ph.D. in Pharmaceutical Sciences.

Dave then joined Pfizer’s R&D division in Sandwich, England and for the next 13 years worked on developing drug products of locally discovered molecules, from early pre-formulation through scale-up and transfer into production sites in Europe and the US.

In 2001, with the acquisition of Parke-Davis, Dave moved to Ann Arbor to complete the construction and commissioning of the new Pharmaceutical Sciences building (550/TDF). Upon the successful start-up of the facility, he moved to the Clinical Trial Materials department managing activities across the Ann Arbor, Kalamazoo and Groton, CT sites.

In 2008, with the closure of the Ann Arbor facility, Dave teamed up with Gerry Cox to set up Velesco Pharmaceutical Services which provides formulation and analytical development services for small to medium sized pharma companies as well as the provision of small scale, non-sterile cGMP supplies for early stage clinical studies.

In 2021 Velesco became a part of the Pace® Life Sciences laboratory network. Dave is now Vice President of Scientific Affairs at Pace® Life Sciences in Wixom, MI.

Webcasts

Thursday, April 14, 2022 at 11 AM EDT | 8 AM PST | 3 PM GMT
Suspension formulations – simple or complex?  As with many things the answer is “it depends”.  This presentation will address the development of suspensions from simple, initial animal study products through complex commercial products.

The Evolution of an NCE’s Suspension Formulation, from pre-GLP Studies to the Pharmacy Shelf

https://www.pharmtech.com/pt_w/formulation_strategies

Formulation strategies for orally administered small molecules can vary widely for early-phase clinical studies and are not always optimal for the program. Sponsors should consider a wide range of formulation options as they develop program strategies, weighing level of effort versus clinical needs for the short and long term.

This webcast will discuss formulation strategies and their appropriateness depending on drug properties, dosing requirements, and corporate strategy.

Understand various formulation approaches and the situations for which each is best utilized.

Balance formulation level of effort vs. clinical needs (or wants)

Identify common issues, traps, and unforced errors in formulation development.

Rob Tuohy, Vice President, Pharmaceutical Development, Pace Analytical Life Sciences

: November 12, 2020, 11am EST| 8am PST| 4pm GMT| 5pm CET

On demand available after final airing until Nov. 12, 2021

***Live: November 12, 2020, 11am EST| 8am PST| 4pm GMT| 5pm CET***Formulation strategies for orally administered small molecules can vary widely for early-phase clinical studies and are not always optimal. Sponsors have a wide range of formulation options as they develop program strategies. This webinar will discuss formulation strategies and the advantages that may depend upon drug properties, dosing requirements, and corporate business strategy.*** On demand available after final airing until Nov. 12, 2021.***


Formulation Strategies for Early-Phase Clinical Studies

http://www.pharmtech.com/pt_w/molecule_drugs


	Preformulation studies play a significant role in developing approaches to analytical and formulation development based on the physicochemical properties of small-molecule pharmaceuticals. Data collected during pre-formulation informs:

		Understanding of the feasibility of drug product development

	This webcast will provide insights into the preformulation phase of drug development and will illustrate common issues encountered.

		To identify the typical experiments performed in preformulation of small molecules

		To recognize how physicochemical properties will affect the choice of dosage form

		To spot potential formulation issues that could have been prevented by pre-formulation activities

Frank Koppenhagen, Ph.D., Vice President, Pharmaceutical Development, Pace Analytical Life Sciences

Thursday, Jun. 18, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after final airing Jun. 18, 2021

Preformulation studies play a significant role in developing approaches to analytical and formulation development based on the physicochemical properties of small-molecule pharmaceuticals. This webinar will provide insights into the preformulation phase of drug development and will illustrate common issues encountered.

Live: Thursday, Jun. 18, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing Jun. 18, 2021

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