Thursday September 2, 2010 Thursday September 2, 2010
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Course Overview:
The globalization of research and development considering collaborative arrangements among companies for producing biotechnology-derived products often raises product comparability issues which are expected to increase in frequency and complexity. Comparability studies are of major importance in the development of biopharmaceuticals. For new products, such studies may be needed to qualify sources of clinical trial materials following process development, optimization, and scale up as progress through the clinical development phases is made. Comparability studies are also key to the development of biogenerics or biosimilars.
This 2-day course will present practical insights into:
The goal of this course is to provide participants from industry, academia, and regulatory agencies an opportunity to share experiences, learn from each other, and identify issues for future discussions or workshops. In our unique Panel Sessions you will have the opportunity to put your questions and comments to our expert speakers. Guide the direction of the discussion to meet your course needs.
Dr. Steven Kuwahara, Ph.D.
Managing Director
GXP BioTechnology LLC |
Originally from Hawaii, Dr. Kuwahara holds degrees in Biochemistry from Cornell and Wisconsin. After starting as an Assistant Professor of Chemistry, he began his industrial career in the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here he developed expertise in the testing of blood derivatives, viral and bacterial vaccines. He moved to the Hyland division of Baxter Biotech where he was in charge of assay development and quality control. He later became responsible for quality systems for a biological device. After a short period with a contract testing laboratory and another blood fractionator, he became the director of quality control with a gene and cell therapy company. In recent years he has worked as the director of assay validations for a large contract testing laboratory and as a GMP consultant to a start-up cell therapy company. His last position was Director of Quality Control and Assay Development with Titan Pharmaceuticals. He is currently the Managing Director of his company, GXP BioTehnology LLC.
Dr. Kuwahara is an experienced analytical biochemist who has applied his academic knowledge to the areas of clinical chemistry and quality control in the pharmaceutical industry. He work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals.
Dr. Kuwahara has written several papers and book chapters and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.
Dr. Jeanne M. Novak, Ph.D.
CEO and President
CBR International Corporation
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Dr. Jeanne Novak is the founder and principal of CBR International, a scientifically based development company located in Boulder, CO. She is a recognized authority in the areas of biotechnology, vaccine, and pharmaceutical development arenas. She has nearly 20 years of experience in regulatory affairs, clinical program design and strategy, quality program development and CMC process development. Dr. Novak and her company, CBR International Corp., have advised and participated in the development of hundreds of vaccines, therapeutic proteins, monoclonal antibodies, small molecule pharmaceuticals and medical devices in therapeutic indications including infectious disease, endocrinology, oncology, dermatology, and cardiology. Dr. Novak is a lecturer and advisor to industry and government. Dr. Novak has co-authored numerous scientific and regulatory publications, including most recently an article published in BioProcessing Journal entitled, “Product Characterization of Recombinant Proteins and Monoclonal Antibodies,” and a chapter in Vaccines for Biodefense and Emerging and Neglected Diseases (2009, ed. Barrett and Stanberry). She has presented over fifty seminars at international conferences on topics including process development, technology transfer, clinical trial design for various product indications, GCP, cGMP and international regulatory program strategies.
Dr. Novak received her Ph.D. in Experimental Pathology (Cell Biology) in the Department of Pathology from the University of Utah. She served as a Staff Research Scientist at USAMRIID in Frederick, Maryland developing novel vaccines for infectious diseases. In 1993, Dr. Novak accepted a regulatory scientist position at CDRH then CBER at FDA. As a FDA Senior Reviewer in DVRPA, CBER she served as the primary reviewer on countless vaccine and therapeutic product INDs and numerous license applications. Dr. Novak was a credentialed PAI/GMP FDA Investigator while at CBER.
CBR International provides unique and extensive product and program development services to clients around the globe. Dr. Novak and the CBR staff’s partnering and “think outside of the box” style fosters team building, develops client problem solving practices, heightens awareness of cost/time balance and promotes excellent scientific and compliance rigor within client organizations. This unique development approach provides the client with comprehensive scientific, clinical and regulatory tools supporting successful product and program development. The team provides services that include comparability and technology transfer study design, advanced cGMP and GCP training, analytical method development, clinical program oversight, scientific gap analysis, Quality auditing, and strategic regulatory communications. CBR has been pivotal to the approvability of numerous marketing applications worldwide.
Dr. Paula J. Shadle, Ph.D.
Principal Consultant
Shadle Consulting
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Paula Shadle, Ph.D., is a quality and process development consultant who has over 20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, 35 publications and 4 process patents.
Dr. Shadle is on the editorial board of the journal BioPharm International, and often writes about quality and science. She is currently Member-At-Large in the West Coast Chapter of PDA, and Treasurer of the East Bay Chapter of AWIS (Association for Women in Science), an organization that mentors and supports women in the sciences.
Dr. Shadle received her B.S. and Ph.D. in biochemistry at the University of California and postdoctoral training at the Max-Planck Institute in Germany. She worked in technical and quality control/assurance positions of increasing responsibility at Chiron Corporation, Scios Inc., GlaxoSmithKline plc, and Bayer Corporation before founding Shadle Consulting.
Founded in 2001, Shadle Consulting offers consulting services for biotechnology and biopharmaceutical firms in quality, process development, and strategic planning of quality systems. Services provided include internal and external audits, GMP training, QC laboratories, and QA systems. Experienced with clinical trials materials, process validation, and more.
Perspectives on Risk Assessment, Quality by Design, Product Development Timelines and Required Regulatory Submissions
When changes to a process or facility become necessary for a product that has already made significant progress along the development pathway, it is important to develop a robust and comprehensive comparability program to demonstrate that the data collected using the original process are still supportive of the safety and efficacy of the product manufactured using the new process. Operational considerations for the development of these programs will be discussed, beginning with recommendations on how to perform an appropriate risk assessment that will identify the critical parameters to be assessed in the comparability program. Following completion of the risk assessment, planning of the necessary comparability protocols and other impacts on development timelines can be completed. Strategies for obtaining timely regulatory feedback and “buy-in” will also be discussed.
The demonstration of comparability is important when changes are introduced into a manufacturing process for a biological drug, or to a facility, and, if successful, may relieve the manufacturer of the need to repeat preclinical or clinical studies. It is heavily influenced by the ability to manufacture proteins to high levels of purity and the capability of modern analytical techniques to thoroughly characterize them. A thorough characterization of the biologic (drug substance and/or drug product) produced from the revised process conducted in parallel with a re-characterization of the biologic from the earlier process is the most important contribution to the demonstration of comparability. Demonstration that specifications are met and an appropriate re-validation of process steps are also critical. ICH quality documents, especially Q5E, provide guidance relevant to the demonstration of comparability and will be discussed.
The production of a new version of a biologic, by an independent manufacturer, would obviously involve facility changes and a functional change to every step of the manufacturing process. Consequently, manufacturers of “subsequent-entry biologics” (“follow-on” or “biosimilar” products) face considerable challenges in employing the concept of comparability. Nevertheless, this issue is of global interest to patient groups, healthcare providers, industry and regulators. The Canadian regulatory perspective on “subsequent-entry biologics” will be presented.
When are in vivo studies needed for comparability, what type should they be, and how should they be designed?
In the course of an analytical in vitro comparability program, the data may indicate that animal and/or human studies are warranted in order to verify the comparability of pre- and post-change products. Further, certain types of changes will almost certainly trigger requirements for in vivo studies. This session will help you to recognize and predict when each type of trial will be needed and the parameters that should be assessed. We will also discuss study design approaches that will help you minimize impact on product development timelines, contain costs, and get the biggest “bang for your buck” out of these studies.
When the planned change triggering comparability considerations includes the transfer of the process to a new production facility, the burden and risk associated with completion of comparability studies can be significantly reduced through robust process transfer change control. In this session, we will work through a hypothetical case example addressing elements that should be incorporated into the change control process and site transfer plans including:
Managing change across the entire life cycle of a biopharmaceutical product is a key challenge. Changes are associated with increased scientific, safety, and regulatory risks, as well as costs that are usually an investment up front for a future benefit. Often, a licensed process becomes ‘locked-in’, with no changes permitted, as a means of reducing short-term risk. However, in the long term, this strategy will increase the cost of goods and is associated with long-term risk, when the process no longer meets the evolving regulatory standard. During development, changes are easier to implement, however the need to reach market launch as quickly as possible, and limited resources, may mean that many proposed changes are deferred until later. After market launch, making such changes requires substantial cost, complex regulatory filings with long cycle times, and, if something goes wrong, the risk of supply gaps or even product withdrawals.
A firm must develop a product life cycle change strategy, which promotes process improvements, yet times implementation to balance risk and benefit. The comparability protocol is a tool as well as a regulatory mechanism that can be useful in creating and managing a strategy. This talk will analyze typical risks and costs to implement change, and discuss how the comparability protocol can be utilized effectively to reduce the regulatory hurdles.
Regulatory strategy
Analytical assessment of product quality attributes is a critical component of site-to-site comparability exercises. Differences in analytical comparability may necessitate in-depth characterization of manufactured drug substance or drug product. In this case study, we will discuss comparability studies involved in a site-to-site transfer of a monoclonal antibody drug substance manufacturing process, differences observed in charge species monitored using orthogonal techniques, and additional analytical characterization conducted to elucidate the differences.
This presentation will discuss comparability requirements for the situation where test methods are transferred to other laboratories or moved to a new laboratory. The presentation will also touch upon the situation where it is necessary to prove the equivalence of a new or modified analytical test method. The elements that will need to be considered to prove comparability and the procedures for making the proof will be discussed. Areas to be covered will be:
Regulatory needs and guidance for comparability
Method validation parameters that are needed as performance characteristics of the assay method
How to Categorize the Proposed Changes
Selection of Acceptance Criteria for Comparability Studies Throughout the Development Lifecycle
Incorporation of potency assays and binding assays into a comparability program
The Biologics Comparability course will be of interest to professionals working in Pharmaceuticals, Biotechnology as well as Government Officials, and Public Health Advocates who wish to establish or extend their knowledge in this rapidly evolving area with the following responsibilities in:
Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions Policy: CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $250.00 USD per person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.
Holiday Inn
Raleigh-Durham Airport
930 Airport Blvd.
Morrisville, NC 27560
United States
For reservation please contact:
Hotel Front Desk: 1-919-4651910
Hotel Fax: 1-919-4651908
A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IPA to receive the reduced room rate.
