AAPS National Meeting- ABC Laboratories' Presentations

By Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com

I always look forward to the AAPS National meeting. It is the one time of year in which I can re-connect with old colleagues, clients and other friends in the industry. It never ceases to amaze me the inter-connectedness of the industry and shows that it is truly a small world. The conference presents multiple opportunities to hear about the latest developments in the field, but also to present our own data. I have the privilege of participating in a number ABC laboratory presentations.

On Tuesday, October 27, Exhibitor Seminar Room 4

·       Analytical Method Transfer: Practice and Pitfalls

Dr. Wayland Rushing and Dr. Glenn Petrie

This seminar will outline how to plan and execute a successful method transfer. This process is oft times not given proper attention and is seen as a “check box” activity. However, there are multiple hazards arising from this attitude that can result in a tremendous loss in time and money. Dr. Rushing and I will discuss method appropriate best practices, as well as several case studies.

·       The Critical Role of CMC in Your IND Submission

Dr. Glenn Petrie and Dr. Wayland Rushing

Submitting an IND is a tremendous task, particularly the CMC section. This seminar will cover various aspects of CMC including:

o   General requirements

o   Minimal requirements and safety

o   The CMC continuum

o   Risk and Reward: Analytical, formulation and Stability

The goal is to provide information to optimize your CMC section in terms of time and money, resulting in a successful IND submission.

On Thursday, October 29, 10:30-11:30 AM, Exhibit Hall WA3

I will be presenting Poster R6208 “Development and Validation of a Polysorbate 20 Assay in a Therapeutic Antibody Formulation by RP-HPLC and Charged Aerosol Detector (CAD).

o   Polysorbate 20 is a key excipient utilized in biotherapeutic formulations. This poster examines the validation data for an accurate and precise method for assay of Polysorbate 20 in the presence of a high concentration of monoclonal antibody.

Be sure to stop by ABC Laboratories at Booth #1825!

Upcoming Presentation: "CMC in your IND: Getting it Right"

Early stage drug developers generally have their sights firmly set on the initiation of clinical trials, focusing on toxicological and pharmacological studies. Often, the importance of Chemistry, Manufacturing and Control (CMC) data is underestimated. But the CMC package is critical to IND approval, and meeting all FDA requirements demands careful planning and sound execution. This discussion will cover the risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation; as well as potential pitfalls and ways to streamline the entire development process.

Don’t miss this important technical presentation at AAPS!

The Critical Role of CMC in your IND Submission
Presenter: Glenn Petrie, Ph.D.
Tuesday, October 27, 11:00-12:00
Exhibitor Seminar Room #4

Upcoming Presentation: "Don’t Leave Method Transfers to Chance" (See you at AAPS)

When planning your development strategy, you probably didn’t give much thought to method transfers. But when an analytical method doesn’t perform as expected, it can take precious days of investigative work to find the problem, and even more to resolve it. Learn about common pitfalls that cause method transfer failures, how to decide what type of method transfer makes sense for your study, and how to implement a fail-safe communication plan that will help put your outsourcing relationship on the right course.

Don’t miss this important technical presentation at AAPS!
 

Don’t Leave Method Transfers to Chance
Presenter: Wayland Rushing, Ph.D.
Tuesday, October 27, 9:00-10:00
Exhibitor Seminar Room #4

AAPS 2015 - See us at booth #1825

Upcoming ACS-AGRO Webinar: "Reflections on select insecticide discoveries, toxicological problem approaches, and enjoying the unexpected"

Wed, Oct 14, 2015 11:00 AM - 12:00 PM CDT

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"Reflections on select insecticide discoveries, toxicological problem approaches, and enjoying the unexpected"

ACS International Award for Research in Agrochemicals – Award Presentation

Dr. Keith Wing, Keith D Wing Consulting LLC

Abstract: There isn't much rational debate as to the benefits that modern Agrochemicals deliver, but there is still debate and multiple approaches to their discovery and optimization. Many Agrochem companies run compounds "through a process" which provides a framework with which to characterize/prioritize agriculturally active leads quickly and efficiently. However every lead compound series poses different and unique problems on the commercialization path, and the ability of the team to expeditiously solve those problems, some of which may fall outside of ongoing processes, can determine ultimate success. This talk will reflect on 3 insecticide classes which teams were able to discover, chemically optimize and eventually register as commercial products. It is hoped that this presentation and the associated symposium on applying "ADME-like studies" to agrochemical discovery will stimulate reflection on how to go about finding novel, valuable new crop protectants in the future.

Bio:
Dr. Keith Wing, recently retired from DuPont, is the recipient of the 2015 ACS International Award for Research in Agrochemicals. Dr. Wing received this award for his research and exceptional accomplishments in metabolism, bioavailability, and formulations
research. Dr. Wing is a co-inventor or author on a number of insecticide and enzyme technology patents and publications. He has led/worked on teams which used a variety of biochemical/chemical technologies to discover and commercialize new products, leading to positive agricultural business outcomes. He is currently a consultant in industrial biochemistry and strategic planning, specializing in agricultural and renewable chemical areas.

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