蛋白質程序管理會議 - Day 1

短期研討會 | Day 1 | Day 2

議程 (PDF : English)

透過與程序管理專家對話，您可以掌握成功的策略和實際方法，同時還能學習到寶貴的實際經驗。相信本會議將有助於您順利邁向產品開發的下一個階段。

Thursday, January 10

7:00am - 3:00pm Registration Open 

7:30am Morning Coffee

8:15 Chairperson�fs Opening Remarks 

Opening Keynote Presentation

8:20 Balancing Quality, Speed and Value Across A Bioproduct Portfolio William Heath, Ph.D., Executive Director, Bioproduct Research & Development, Eli Lilly & Co. By their very nature, biotherapeutics present unique challenges to the industry. They often make the transition from lead to clinical candidate in very rapid order compared to traditional synthetic organic molecules, compressing the timeline and forcing tough strategic choices on investment. This speed theme and timeline compression continues to be felt as the molecules move through clinical development. In addition, their downstream complexity moving towards regulatory submission and commercialization provide for fewer opportunities to close technical gaps and requires that decisions around drug product presentation, global submission strategy and manufacturing options be made long before certain critical data are available. On the surface this would appear to be an inconsistent set of challenges yet the industry as a whole has managed over the years to deliver using a range of approaches that span the spectrum of �ebrilliance coupled with good luck�f to sheer brute force. As our bioproduct portfolio has grown, we have evolved a paradigm that seeks to balance investment choices with risk and speed with downstream commercial robustness - a �epay to play/play to win�f concept.

Featured Presentation

9:05 What if You are Right! An aggressive Facilities and Quality Systems Approach for Developing Biopharmaceutical Manufacturers R. Barry Holtz, Principal, Holtz BioPharma Consulting Biotechnology has developed extremely powerful descriptive tools such as genomics, proteomics and metabolomics, making the promise of creating patient-specific therapies for cancer and other diseases closer to becoming a reality. As the flood of information is turned into new strategies for treating disease, the opportunities may soon outstrip our abilities to provide these treatments commercially to larger patient populations. Early-stage companies must get products to the clinic so that proof of principle in human trials will catalyze the necessary funding to move forward toward licensure. We also have to consider that as biotechnology really starts this maturation phase and moves from research and development to product manufacture, we will be "right" more often and at a higher percentage of success. The necessity to start human clinical trials early in the development cycle of these companies, has focused the development of pilot facilities that can operate under cGMP compliance. Many of these facilities have been and are extensions of the laboratory. However, new generations of facilities are being constructed to provide robust production of materials for clinical trials. As these therapies start to show success in clinical trials, there is the potential for rapid regulatory approval of therapies, especially in cases of unmet medical need. To maximize the benefit to the patient population and the value of the company going forward, a more robust early stage manufacturing platform must be developed that can lead to rapid commercialization. This of course has to be tempered with the continued lack of ready capital for early-stage companies. This talk outlines specific strategies for accelerating the commercialization process as far as possible with resources typical of an early-stage biotherapeutics company. Case studies highlight the specifics of how an aggressive approach to quality systems development, building high-level, scalable facilities. and engineering planning and modeling can deliver a platform for rapid commercialization in a capital conservative environment.

9:45 Designing Developabiltiy in Biopharmaceuticals by Targetting Protein Aggregation and Stability
Jesus Zurdo, Ph.D., Head of Advanced Protein Technologies, Lonza Biologics plc
Protein stability and aggregation are major issues affecting the developability of biopharmaceuticals, their cost of production and even their safety profile (i.e. immunogenicity, etc.).  The industry spends a considerable ammount of effort in tackling aggregation through the modification of production and purification proceses and the development of formulations that would stabilise biopharmaceuticals, but also regulators are taking a hard stance on aggregation in an increasing effort to tackle safety in biopharmaceuticals. Lonza is applying pioneering technologies in predicting aggregation in proteins before it occurs, opening ways to select optimal sequences for development or designing processes before practical issues appear, but also creating ways of modify polypeptides to increase their stability in solution or even design specific stabilisers when protein engineering is not an option.

10:15 Coffee Break in the Exhibit Hall

11:15 Risk Management -- A Practical Approach
Courtland R. LaVallee, Director, Development Project Management, Genentech, Inc.
This talk will discuss managing risk in a biopharmaceutical environment, including:

• The case for risk management 
• Risk management basics 
• A practical approach to qualitative risk management methodology 
• Tips for successful implementation 

11:45 Change Management A Regulatory Requirement
Peter D. Smith, Vice President, Pharmaceutical Compliance, PAREXEL Consulting
Change Management, or Change Control, is a significant element of regulatory compliance. Control of changes, including proper evaluation of change impact on drug products, is an important Quality System GMP requirement. Management of changes with regard to regulatory submissions (for example, NDA or BLA) and appropriate agency approvals is an important element for regulatory compliance. This presentation will discuss FDA requirements for Change Management, some common Change Control problems, and the elements for a compliant and efficient Change Management Program.

12:15pm Close of Morning Session

12:30 Luncheon Workshop or Lunch on Your Own

1:45 Chairperson�fs Remarks

1:50 Process Analytical Technology Implications for Bioprocessing 
Beth Junker, Ph.D., Senior Director, Fermentation and Development Operations, Merck Research Laboratories
Process Analytical Technology has broad implications for bioprocessing efficiency based on several robust past and numerous potential future applications. Key to its successful application is identifying the correct analytical opportunity in terms of feasibility, cost, and impact. The extent of novel PAT methods currently incorporated in bioprocessing has been limited owing to technical, regulatory, and sensor development challenges. This presentation reviews drivers for PAT efforts focused on improving process understanding, reducing process variability, and overall continuous process improvement.

2:20 Advances that Will Impact PAT for Process Characterization
Melvin Koch, Ph.D., Director, Center for Process Analytical Chemistry, University of Washington
The need for improved process understanding in the pharmaceutical and biotechnology industries has been a driver for the advancement of measurement tools to support efforts for improved process monitoring and control. A key part of these advances has been in miniaturization technology, where the development and application of micro-analytical tools in high through put experimentation, process optimization, and process monitoring will have a large impact. These micro-analytical tools, combined with advances in process sampling and sensor platforms will be described as a valuable approach for implementing Process Analytical Technology (PAT).

2:50 The Roles of Design Space and Process Knowledge in Implementing Process Improvements
Michael Lennick, Ph.D., Associate Director, Purification Technology, Global Biologics Supply Chain, Centocor

3:20 Technology Spotlight

3:35 Refreshment Break in the Exhibit Hall

4:30 Program Management for an Exploding Pipeline - The Wyeth BioPharma Model
Steven Max, Ph.D., Development Project Leader, Business Operations and Program Management, Wyeth BioPharma
A modified program management strategy has been developed utilizing Operational Excellence tools to improve the planning and oversight of activities and resources in response to the overwhelming number of Phase 0 projects entering the Development pipeline. Drivers for this initiative will be presented as well as an overview of the new program management model as it relates to cross-functional activities, governance structures and modes of communication underlying Wyeth�fs platform development strategy.

5:00 The Role of Lean Six Sigma in the Complex Bio-pharmaceutical Industry
Victor Awafo, Ph.D., Manager, Process Improvement Sciences, sanofi pasteur

5:30 Manage Your Process or Your Process Will Manage You
Diana Bartlett, Director of Corporate Partnerships, Keck Graduate Institute of Applied Life Sciences
What can process management in an academic setting tell us about managing processes in the �greal world�h? Plenty. First and foremost, academic experiences in dealing with protein expression, development of peptide-based therapeutics, bioprocessing, etc. educates us about the need to manage the process before the process manages us. 
Issues will include: Identify steps for successful management of key development and production processes; Capture and implement �gbest practices�h in process management within biotech functions and organizations; Develop goals, milestones and metrics to assist in managing processes; Create and deliver effective communications; Identify, classify, and manage risk; Productively manage individuals and teams; Generate and use dynamic scheduling; Successfully develop and manage budgets and forecasts

6:00 Reception in the Exhibit Hall