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

21st Century Cures Act – Is It Truly Progress?

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

Dr. Francis Collins, Director of NIH, has stated that it takes “around 14 years and $2 billion or more “to develop a new drug. Based on statements like these, Congress has come to the conclusion that the drug approval process is too onerous and lengthy and is the primary impediment to the discovery and approval of new drugs. In response they have passed the 21^st Century Cures Act with nearly unanimous, bipartisan approval. But is this a fallacious assumption? Some argue that the FDA review and approval process is the fastest and most streamlined in the world and that accelerating the approval process may impact patient safety.

In an editorial in the New England Journal of Medicine, Dr. Jerry Arvon states ”The bill would also encourage the FDA to rely more on biomarkers and other surrogate measures rather than actual clinical end points in assessing the efficacy of both drugs and devices.” While surrogates have previously been utilized as endpoints by the FDA to support accelerated approvals, this was only for drugs intended to treat life threatening illnesses.  Dr. Arvon goes on to state that biomarkers “may not always predict the drug’s capacity to improve patient outcomes “. The literature has many examples of cancer drugs approved utilizing these criteria that not only do not extend life, but have side effects.

While the argument regarding expedited drug approval continues, one aspect of the new law has unanimous support; an additional $8.75 billion in funding for NIH over the next 5 years.  According to a study published in Health Affairs, federal funding of basic research played a major role in the origin of transformative drugs approved between 1984 and 2009.

Analytical Method Transfer Delays Not Part of Your Game Plan? (Upcoming ABC Webinar - July 23rd, 2pm EST)

Upcoming Webinar:

Analytical Method Transfers: Practice and Pitfalls

Thursday, July 23rd, 2 pm EST

When planning your development timeline, the transfer of analytical methods is rarely more than a blip on your radar. But when a method doesn’t perform as expected, it can take precious days of investigative work to find the problem, and even more to correct 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.

Speaker:

 
Wayland Rushing, Ph.D. 
Senior Scientific Advisor
ABC Laboratories 

Dr. Wayland Rushing is a technical expert in Chemistry Manufacturing and Controls (CMC) program design, analytical development and regulatory submissions. Over his career, he has led CMC development programs for a wide array of biopharmaceuticals, including parenterals, inhalation drugs, and other pharmaceuticals with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. He currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects and was a co-author of the PDA Technical Report No. 65 – Technology Transfer.

Sponsored by:  Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.

Visit the Event Page for this ABC Webinar to get more info and find out how to sign up!

ABC Webinar Archive: "Evolving CMC Analytical Techniques for Biopharmaceuticals: Obsolete methods have you feeling on the hook?"

Presented by Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories

Originally produced in association with Contract Pharma
on Thursday, May 28th, 2 pm EST

Regulatory expectations for understanding product impurities and degradants in biopharmaceuticals continue to increase, and many biopharmaceutical developers are finding their “current” CMC methods are quickly becoming obsolete. New, highly sensitive and specific technologies are now emerging from R&D into the QC lab and are becoming the “new normal.” But how do you address heightened regulatory expectations while managing the risk associated with mid-course changes to methods?

To view an archive of the webinar on ABC Laboratories' website, click here.