Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit

Regardless of the pharmaceutical development company, therapeutic area or regulatory pathway taken to get a drug onto the market, at some point there is a need to validate the business and scientific/regulatory case in a “proof-of-concept” clinical trial. If the development program supporting a proof-of-concept trial is done well, then it is up to the drug to demonstrate an acceptable risk-benefit profile.

In this audio conference, our speaker examines the framework necessary to maximize the chance of a successful proof-of-concept trial for a new chemical entity (the hardest case). The session also includes a discussion and case histories of the supporting nonclinical safety program, pharmacokinetic and pharmacodynamic evaluations, maximum tolerated dose issues, study design and endpoints in the context of a regulated industry.

Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit is being presented by Dr. Scott Oglesby, Director, Scientific Consulting, with Beckloff Associates, a Cardinal Health Company and airs on Tuesday, January 19, 2010. For more details or to register, please visit our site at www.fxconferences.com

The Art and Science of Drug Product Regulatory Submissions

Collectively, pharmaceutical drug products include a surprisingly wide variety of possible dosage forms and functions. No matter the dosage form, there are requirements that must be met in manufacturing and testing. A high-quality, organized CMC submission should be organized based on the CTD format, and contain information that will aid in a positive review and a quality drug product for patients. Fortunately, there are many similarities across this wide variety of dosage forms, including general product development principles which can be utilized throughout the life of any drug product.

This session provides an overview of the similarities -- and some unique differences -- of manufacturing, analysis and regulatory expectations. Our speaker explains how these similarities can fit together to produce a high-quality submission to the FDA for marketing approval, as well as regulatory maintenance after approval.

The Art and Science of Drug Product Regulatory Submissions is being presented by Dr. Andrew Trammel, Director, Executive Consultant, with Beckloff Associates and airs on Tuesday, December 8, 2009. For more details or to register, please visit our site at www.fxconferences.com

Managing the Shift to Electronic Submissions

The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.

The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.

Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com

Regulatory and Scientific Considerations for API Drug Development

The establishment of a robust Active Pharmaceutical Ingredient (API) development program is an integral part of drug development. A well-planned API development program that is properly integrated with the drug product, clinical, non-clinical and marketing programs is essential to prevent delays that can result in lost time, revenues and market life cycle.

This audio conference provides an overview of the scientific, regulatory and compliance requirements of API development at the various phases of development. The speaker also discusses special considerations associated with API development such as APIs manufactured from biological sources, the use of DMFs, and the management of manufacturing contractors.

Regulatory and Scientific Considerations for API Drug Development is being presented by Dr. William Putnam, Director, Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. (a Cardinal Health company) and airs on Wednesday, August 26, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

The "Why" and "How" of eCTD Conversions

Effective January 1, 2008, all electronic submissions submitted to FDA in the United States must be in eCTD format. This deadline is forcing organizations within the pharmaceutical industry to evaluate the transition from submitting paper documents to submitting electronic documents to global regulatory agencies.

The transition from paper documents to electronic documents encompasses many areas within an organization and integrates technology with regulatory requirements for submission and regulatory document preparation. This presentation highlights the things sponsors, CROs, testing facilities, and medical writers need to know about the impact of the eCTD on the industry and on their businesses.

The "Why" and "How" of eCTD Conversions was presented by Gina Ross, Director, Managing Consultant Regulatory Publishing Services, with Beckloff Associates a Cardinal Health Company and aired on 2008-01-31. For more details or to download this conference, please visit our site at www.fxconferences.com