Pace Analytical Life Sciences

https://www.pharmtech.com/pt/lipophilic_drugs


This presentation focuses on the development of non-aqueous liquid formulations for highly lipophilic compounds. Experts from Pace® Life Sciences dive into lipophilicity and its chemical and biopharmaceutical consequences; formulation strategies to allow oral dosing in both pre-clinical and clinical studies; and analytical differences between these types of molecules.
However, please be aware that non-aqueous formulations for other routes of administration (e.g., injection or topical) will not be covered in this presentation.




Attendees will gain an understanding that:

The formulation challenges provided by highly lipophilic compounds can be managed using non-aqueous liquid vehicles

The same drug/vehicle formulation can be administered directly into animals or filled into capsule shells for human dosing

There can be some analytical challenges with this type of formulation

Research and development (R&D) scientists


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

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.

Developing Liquid Formulations for the Oral Dosing of Lipophilic Drugs

This discussion will center on peptide formulation approaches and the key properties of peptides that result in opportunities and limitations for peptide formulations. Key strategies will be discussed for rapid entry into early clinical development followed by considerations for final drug product dosage form design, and finally, an overview of potential options for peptide product life cycle management.

Peptide properties and relevance to dosage form design strategy

Formulations for rapid entry into the clinic

Strategies for final dosage form selection and development

Attendees should come away with an understanding of:

Peptide properties relevant for dosage form design and selection

Formulation options for peptides in early development versus strategies for final dosage for design

Formulation options and routes of delivery that may represent life cycle options

Associate Scientist, Scientist, Principal Scientist, Assoc Director, Director, Senior Director, Executive Director, VP for the following:

CMC, formulation, pharmaceutical sciences, drug delivery sciences, process development, pharmaceutical and chemical development, product development, pharmaceutical development, pharmaceutical research and development


Vice President, Scientific Affairs
Pace Life Sciences


Tuesday, Nov. 30, 2021 at 2pm EST | 1pm CST | 11am PST

On demand available after final airing until November 30, 2022.

**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.***


Peptide Formulation: Initial Clinical Development, Final Dosage Forms and Life Cycle Management

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

Compendial verification is a regulatory requirement in various phases of drug development. The technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory is often overlooked.

This webcast will discuss a series of case studies that illustrate the importance of performing robust compendial verification in your laboratory. Experts will describe the technical challenges encountered, while evaluating a variety of active pharmaceutical ingredients and excipients and explaining how those challenges were resolved.

Sample preparation methodology that led to ruptured vials

High-purity reference standards unavailable from commercial sources

Reference standards of uncertain purity or potentially contaminated

Standard preparation methods that may be hazardous or present safety concern

Understand the value added by performing compendial verification to demonstrate suitability under the actual conditions of use in your laboratory.

Assess why compendial verification data is needed to ensure potential technical and safety issues are identified.

Identify analytical details and techniques that may not be included in the compendial procedure but are essential for a robust method.

Thursday, May 27, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

*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* 

Challenges with Verification of Compendial Chromatographic Methods 

Determining the polymorphism of a drug—the propensity of a molecule to crystallize in different crystalline arrangements, to form crystalline salts and/or non-salt cocrystals—allows for rational selection of the proper solid form/polymorph for further development. In this webcast, learn about the basic concepts of the physical phenomenon of crystalline polymorphism in drug molecules and the techniques used to discover and characterize polymorphs. Explore the effects that different polymorphs may have during drug dissolution and solubilization in the body and resultant bioavailability levels. The benefits of understanding possible polymorphs from a commercial business and risk reduction standpoint will be explored.

Review the definitions of drug solid form, polymorphism, crystallinity, and amorphicity.

Understand the physical nature of polymorphism and the techniques used to find polymorphs, salts, and cocrystals.

Develop an appreciation of the importance of profiling polymorphism in drugs for the following factors:

As a key component of selecting the proper solid form for development

As a necessary inclusion in key regulatory filings

As an asset for intellectual property filings, which can prevent competitors from legally formulating your drug using a polymorph not under patent protection.

 Steven Johnston, Director Pharmaceutical Development, Pace Analytical Life Sciences

: Thursday, Oct. 15, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after final airing until Oct. 15, 2021

*** 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***

Understanding Polymorphism to De-Risk Drug Development

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

As biopharmaceutical drug product development continues to grow, so do new regulations on packaging and container closure components associated with delivery of the drug product to the patient. This webcast will present a brief introduction to extractables and leachables (E&L), followed by a discussion of relevant 

 and ISO guidelines and practical considerations when planning an extractables and leachables project. A case study demonstrating a typical extractables and leachables project, including the design, extraction, analysis, and reporting of extractables and leachables data for single-use IV bags used for bioprocessing purposes will be presented. Learn best practices for an extractables and leachables program and how to analyzing materials for biologics drug projects.

Review results and analysis of an E&L case study of biopharmaceutical single-use bag systems

Gain an overview of the process, procedures, and approaches for biopharma E&L studies

Understand analytical capabilities and expertise needed to conduct effective studies

Daniel Abate, Ph.D., Principal Chemist, Pace Labs

Hannah Tims, PhD, Principal Chemist, Pace Labs

 Thursday, Sept. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Sept. 24, 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

Extractables and Leachables of Biopharmaceutical Container Closure Systems

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

The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. Discriminating, stage-appropriate, analytical and biophysical tools are key to fully characterizing and understanding routes of degradation that are unique to each drug substance on the path to producing a stable product and meeting rigorous safety guidelines. This webinar will provide insights into:

Characterizing aggregates to control stability and purity

Stability challenges faced during formulation and process development

Integrating analytical results for a complete picture of quality

Recognize the relationship between chemical degradation and physical instability of therapeutic macromolecules and how to address this through formulation

Review the CMC requirements for gene therapies

Observe a demonstration of analytical methods to assess gene therapy quality attributes

Benjamin Buer, Ph.D., Associate Director, Pharmaceutical Development, Pace Analytical Life Sciences

Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Aug. 20, 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


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