20–21 September 2010
Hyatt Regency New Brunswick
New Brunswick, NJ
Lead Faculty:
Lani Cammack, director, Global Pharmaceutical Regulatory Affairs CMC, Abbott
David Ziering, PhD, director, Regulatory CMC, Bristol-Myers Squibb Co.
Additional Faculty:
Lynn Gold, vice president, CMC services, Camargo Pharmaceutical Services
John Groskoph, director new products CMC, global CMC at Pfizer, Inc.
Deanna Murden, president, ePharmaCMC, LLC
Edward A. Narke, principal, Design Space InPharmatics
Andrew Papas, RAC, PhD, MBA, senior director of CMC global regulatory affairs, Shire HGT
Ken Phelps, president, Camargo Pharmaceutical Services
Ambarish K. Singh, PhD, associate director, global regulatory sciences-CMC, Bristol-Myers Squibb Co.
Chand Sishta, PhD, RAC, senior principal scientist, Global CMC, Pfizer Inc.
Tracy L Verciglio, associate director, CMC, Global Pharmaceutical Regulatory Affairs, Abbott
| Monday, 20 September 2010 |
| 7:30–8:30 am |
Registration & Breakfast |
| 8:30–10:00 am |
CTD Modules 2 & 3
Lynn Gold, vice president, CMC services, Camargo Pharmaceutical Services
Ken Phelps, president, Camargo Pharmaceutical Services
The Overall Summary and Chemistry, Manufacturing, and Control (CMC) sections (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the US Food and Drug Administration (FDA) will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the International Conference on Harmonisation (ICH) guideline, M4: The Common Technical Document, is instrumental to that process. The task starts with bridging the research and development programs and ends at the desk of the reviewer. Recognizing reviewers have a short time to digest an entire program, the objective of this presentation is to outline the variations that can occur from application to application depending upon the dosage form, drug product and type of file under construction, with the goal of providing coherent Quality and Overall Summary Modules. |
| 10:00–10:30 am |
Break |
| 10:30–11:30 am |
The Impact of eCTD for the CMC Professional
Deanna Murden, president, ePharmaCMC, LLC |
| 11:30 am–12:30 pm |
Boot Camp for CMC Initiatives for Biotech and Specialty Pharma
Edward A. Narke, principal, Design Space InPharmatics
ICH has introduced manufacturing and product quality initiatives designed to modernize the regulation of drug development. Practically, however, investment in extensive development data, especially in the early stages, is an added expense that can only be justified by lowering the risk of the regulatory process or when business benefits can be established. This session will consider implementation of ICH initiatives, particularly for biotech and specialty pharma, looking at the key elements of Quality by Design, i.e., development of a design space and control strategies. Effective communication and translation of product knowledge into effective regulatory submission documents will also be discussed. |
| 12:30–1:30 pm |
Lunch |
| 1:30–2:30 pm |
Quality by Design: The Coming Regulatory Expectation for Development and Commercialization of Drugs
John Groskoph, director new products CMC, global CMC at Pfizer, Inc.
Based in part on the ICH guidances Q8, Q9 and Q10, increasingly, leading Health Authorities are expecting the applicant to demonstrate process understanding, risk assessment and quality systems to ensure quality has been built into the product, and not merely tested in. Inevitably, Quality by Design (QBD) will be Good Manufacturing Practice. This session focuses on the essentials to understand QBD, and the key regulatory considerations in developing marketing applications that utilize QBD in the development, manufacture and control of new drug substances and products. |
| 2:30–2:45 pm |
Break |
| 2:45–3:45 pm |
Quality Module Insight: Ensure Your CTD Module 3 Will Pass Review
Edward A. Narke, principal, Design Space InPharmatics
The information required in Module 3 of the Common Technical Document, and how that information is organized, is carefully specified in guidance documents. However, sponsors have latitude in how data are presented and important messages are formatted in the compilation of an application. Hear best practices derived from work with agency thought leaders and based upon recent filings: the many documents that should or should not make up the filing; the steps to take from day one to create a compliant and conforming filing; setting appropriate boundaries for data; and documenting this in anticipation of gaining a “contract” with the regulatory agencies. |
| 3:45–4:30 pm |
Application of QbD Principles and PAT to Enable Real-time Release Testing
Ambarish Singh, PhD, associate director, CMC, Bristol-Myers Squibb Co.
While application of QbD principles is not new to non-pharmaceutical industries, recent years have seen an explosion of discussion on elements of QbD (such as, critical quality attributes, critical process parameters, quality risk management etc.), PAT application and control strategies in pharmaceutical conferences. Many pharmaceutical companies have embraced QbD principles in drug development. This presentation will discuss key elements of QbD and how these elements in conjunction with application of PAT could help develop a cogent overall control strategy to justify reduced end-product testing (real-time release testing).
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| Tuesday, 21 September 2010 |
| 8:00–8:30 am |
Breakfast |
| 8:30–9:15 am |
CMC RA Business Partner: Mergers and Major Supply Agreements
Lani Cammack, director, Global Pharmaceutical Regulatory Affairs CMC, Abbott
The CMC regulatory professional plays a critical role in identifying financial implications, compliance issues and time lines associated with mergers, acquisitions and drug product supply agreements. Understanding the scope and objective of the merger is key to providing the management team with the appropriate recommendations.
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| 9:15–10:00 am |
Engaging the Regulatory CMC Colleague in the Business of Product Development
Chand Sishta, PhD, RAC, senior principal scientist, Global CMC, Pfizer Inc.
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| 10:00–10:15 am |
Break |
| 10:15–11:45 am |
Continuous Manufacturing: Considerations for Submissions
Tracy L Verciglio, associate director, CMC, Global Pharmaceutical Regulatory Affairs, Abbott
Absorb a case study of a project to move a product from batch manufacturing to continuous manufacturing as a postapproval change. Leverage the application of this information to recognize potential regulatory challenges associated with advancing technology. Next, engage in a review of agency interactions and lessons learned and identify potential opportunities to maximize regulatory flexibility through appropriate regulatory submission content.
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| 11:45 am–12:45 pm |
Lunch |
| 12:45–1:45 pm |
CMC Considerations for Biologics
Andrew Papas, RAC, PhD, MBA, senior director of CMC global regulatory affairs, Shire HGT
While biologics span a wide range of products, this presentation will focus on both CMC considerations and regulatory requirements of both recombinant proteins and monoclonal antibodies. Because specific considerations for these fundamental differences need to start early in development, expectations presented will encompass preparation for first-in-man clinical studies through development and registration. Expectations for global postapproval changes will be presented that include critical comparability studies that ensure the change has no impact on product safety and efficacy.
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| 1:45–2:45 pm |
CMC Considerations for Combination Products
Andrew Papas, RAC, PhD, MBA, senior director of CMC global regulatory affairs, Shire HGT
Examine the US regulatory definition of combination products, along with examples of combinations that do or do not meet this definition. The next step will be the designation of the primary mechanism of action (PMOA), which has a significant impact to an organization on many fronts. There are many CMC consequences to the PMOA designation which will be presented in both general terms and for a case study of an approved biologic/device combination.
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| 2:45–3:30 pm |
Genotoxic Impurities: A New Challenging CMC Area for Drug Regulatory Scrutiny
David Ziering, PhD, director, Regulatory CMC, Bristol-Myers Squibb Co.
While the ICH guidances are clear about levels at which an ordinary impurity needs to be identified and assessed for safety, they do not specify what limits should apply to more onerous impurities, i.e., those with the potential to cause cancer. The EU has issued a final guidance on the control of these genotoxic impurities (GTIs) and the US FDA has issued draft guidance on the topic. As there may be multiple potential GTIs in an active pharmaceutical ingredient (API), there now is a dramatic increase in the technical challenges for the analytical and chemical-process development groups, the commercial manufacturing sites and the in-process and release laboratories. This session will provide you with a basic understanding of the regulatory considerations for genotoxic impurities, and approaches to successful technical-regulatory GTI control strategies. |
| 3:30 pm |
Wrap-up and Adjourn |