Are You Really Ready?

By Jon Rhodes, M.S.
Senior Scientific Advisor
ABC Laboratories

www.abclabs.com

It’s very easy to build an argument that investing time and other resources in developing and nurturing a relationship between your organization and a new CRO development partner is essential to the success of both organizations. It’s very hard to actually identify and implement the steps necessary to make that success a reality. The landscape is littered with examples of less than successful attempts at building fully functioning, collaborative and engaged partnerships that stand the test of time.

Most organizations, whether they like to admit it or not, are very reluctant to loosen their grip on knowledge, skills, and experience and freely share and disseminate such things in a transparent manner. That’s why it’s essential to create a crystal clear vision about what success looks like, how it can be achieved, and what the rewards will be. It’s about creating a culture of enthusiasm and anticipation. The right processes and the right people are essential to creating this culture of success and this should come first, before actual knowledge and technology is transferred.

Marrying the best discovery engine and product pipeline with the best applied science and registration support isn’t strictly science – communication, collaboration, and transparency are everything.

Metabolite Profiling: More Than Just Detective Work

By Jim Schmidt
Sr. Scientific Advisor
ABC Laboratories
www.abclabs.com

Time flies!  It’s been just over a year since my first posts on this blog. One of my early posts, back in September 2014, concerned a chapter on metabolite profiling I was writing for a forthcoming book of invited essays.  I submitted the chapter in late spring of this year and the book - New Horizons in Predictive Drug Metabolism and Pharmacokinetics (published by the Royal Society of Chemistry), with about two dozen contributors – is set to be released in just a few weeks.

I performed metabolite profiling of one kind or another for most of my nearly thirty-year career at the bench; even though I’m not in the lab, presently, it’s still a passion and interest, and with good reason: metabolite profiling is a very intellectually satisfying exercise, owing in no small part to its interdisciplinary nature. The “detective work” of metabolite profiling contributes to medicinal chemistry, enzymology, pharmacology, toxicology, mechanistic chemistry, analytical chemistry, and many other fields. Among the more satisfying and exciting results of metabolite profiling is the discovery of novel and/or unexpected metabolites.

Apart from the satisfying “detective work,” there are some other very important and practical reasons for performing metabolite profiling early and often, including but not limited to:

Drug Attrition - The most practical reason for pursuing metabolite profiling efforts as early and as diligently as possible is to mitigate attrition in the drug discovery process. Owing in no small part to an increased focus on metabolite profiling in drug design, attrition attributed to poor pharmacokinetic  (PK) behavior decreased from 40% in the early 1990s to <10% in 2000 (in one recent study, poor PK behavior represented as little as 3% of drug failures in preclinical evaluation). In fact, metabolite profiling can support troubleshooting of other aspects of drug attrition and should not be limited simply to improving PK behavior.

The Law - The aphorism applied to highway speed limits and (cheekily) applied to gravity—“It’s Not Just a Good Idea. It’s the Law”—can also be applied to metabolite profiling. Guidance documents, including—but not limited to—those from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)/ICH, have formalized the regulatory framework and decision-making of metabolite profiling.

Due Diligence - Another important rationale is the due diligence process that is associated with the process of acquisition of intellectual property and/or drug portfolios. While limited funding may result in a temptation to delay or minimize metabolite profiling efforts, that temptation should be ignored: scientific due diligence is every bit as essential as financial analysis and important questions about metabolites and pathways help minimize poor choices in investment decisions; likewise, groups should be prepared to answer these questions to improve chances for desired investment.

Stay tuned to this blog for more thoughts on metabolite profiling.

What are you doing to pay more (and earlier) attention to metabolites in the drug discovery and development process?

Download ABC's 3 Presentations from AAPS 2015

Below are recent presentations by ABC at this year's AAPS in October.

Don’t Leave Method Transfers to Chance

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.

To download this presentation, click here.

 

The Critical Role of CMC in your IND Submission

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.

To download this presentation, click here.

Are Extractables & Leachables Going Phase-Appropriate?

Not long ago, it was more or less conventional wisdom that E&L studies should be performed late in the development cycle—even after the final container/closure system is known. But current regulatory trends suggest that, like many things GxP, expectations for early E&L data are on the rise. In recent years, many drug sponsors have been required to address E&L questions as early as phase I/II. It isn’t just CTM containers causing concern; questions often involve the equipment used in manufacturing and dosing devices. Phase-appropriate E&L program design can help you avoid related clinical holds and unplanned expense.

To download this presentation, click here.

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

Show in My Time Zone

---

"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.

Register Now