2020年6月2日 (火) 13:40~18:00｜6月3日 (水) 8:30~17:30
TS1: Practical Strategies for Analytical Method Lifecycle Management for Biological Products
( 研修セミナー1：生物学的製剤に対応する分析法のライフサイクルを管理するための実践的な戦略 )
Nadine M. Ritter, PhD, President & Analytical Advisor, Global Biotech Experts LLC
Introduction/Objective of the Seminar:
Current GMP requirements for test method validation are quite clear: Methods used for GMP product testing must be validated to demonstrate they can produce accurate and reliable results. But FDA and EU guidances are less clear about method 'validation' during product development. On one hand, they indicate method validation is an evolving process, but on the other they state that method validation data should be available upon request at Phase 2 and Phase 3. These guidances also indicate that test methods only need to be qualified for Phase 1 (except safety methods, which do require validation prior to Phase 1). Methods used only for product or process characterization, comparability or similarity also need to be qualified to demonstrate they are scientifically sound. Some of these methods will start out in non-GMP labs, then transfer to GMP labs; others will only ever be used in non-GMP labs. But during development, even data generated in non-GMP studies are critical for making process and product decisions, and are reported in product dossiers as supportive information. Although there is guidance on lab data integrity in GMP labs, there are no current guidance documents on data integrity in non-GMP labs.
The Seminar will cover:
- Overview of ICH, FDA and EU guidance documents associated with method validation and data integrity for in-house and contract testing labs
- Outline of types of test methods typically used with biotech/biosimilar products for characterization, comparability, similarity, release and stability testing
- Illustration of typical method lifecycle events for test methods (optimization, qualification, validation, method changes, method transfer, method replacement)
- Differences in study designs between qualification, validation, verification, tech transfer and bridging for biotech/biosimilar products
- Overview of data integrity expectations for GMP analytical testing labs
- Risks to data from non-GMP R&D labs at each phase of development and for key CMC analytical studies
- Illustration of best practices for lab quality and data integrity for non-GMP R&D labs
- Analysts from R&D (non-GMP) and QC (GMP) laboratories
- Process development scientists conducting process design, QbD, PPQ and CPV studies
- QA reviewers of analytical data from key CMC process and product studies
- RA managers of CMC analytical and stability dossier sections and updates
- CMC project managers for pre- and post-approval activities
- Personnel involved with in-house testing and/or contract testing facilities
Nadine Ritter obtained her master and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 years. She entered the biopharm industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for diagnostic product submissions, responded to FDA comments, and contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of the R&D analytical lab.She then became the Director of the Analytical Services Division of BioReliance (Rockville, MD), a major contract testing organization. There, she led a team of CMC scientists in the design and conduct of method qualification, validation, and transfer, product characterization and comparability studies, and QC release and stability testing. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles. She managed quality and compliance activities for the R&D, GLP and GMP activities conducted in her lab, and implemented Part 11 computer system requirements. In 1999, she created the first public training course specifically focused on biotechnology stability programs, which later grew into an award-winning CMC analytical training course. Since 2002, she has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently as NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA). In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. In 2003, she was one of six industry and two FDA founders of the CaSSS CMC Strategy Forum, which has led to the publication of major industry/regulatory white papers on CMC topics, and is now being held annually in North America, Europe, Asia and Latin America.
2020年6月4日 (木) 8：30~17:15｜6月5日 (金) 8:30~12:30
TS2: Regulatory Requirements across the Product Development Lifecycle
( 研修セミナー2：製品開発のライフサイクル全体に関わる規制の要件 )
Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, Biologics Consulting Group, Inc.
Introduction/objective of the Seminar:
The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This course will include a comprehensive review of the chemistry, manufacturing and controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, good manufacturing practices (GMP) and good laboratory practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.
The Seminar will cover:
- The evolution of drug compliance in the US
- FDA structure and function
- The product development timeline from IND to commercialization
- Special considerations for newer treatment modalities
- Good laboratory practice
- Good manufacturing practice
- Compliance across the product development lifecycle
- The CMC section of the initial IND
- Meetings with FDA during drug development
- The BLA, NDA and beyond
Christina Vessely, PhD, RAC, has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).
Training Seminar Information
Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.