Agenda
Sunday
Sunday, April 15, 2012
7:30 a.m. – 12:00 noon
6th Annual PDA Golf Tournament at the Wildfire Golf Club
8:00 a.m. – 10:00 am.
PDA 6th Annual Walk/Run (benefiting the Phoenix Children’s Hospital)
Sponsored by Sartorius Stedim Biotech
11:00 a.m. – 4:00 p.m.
Regulatory Affairs & Quality Advisory Board
2:00 p.m. – 3:00 p.m.
Interest Group Leaders Meeting
2:00 p.m. – 6:00 p.m.
Registration Open
3:00 p.m. – 6:00 p.m.
Speaker Ready Room Open
3:00 p.m. – 6:00 p.m.
Meet and Greet Reception
3:00 p.m. – 4:00 p.m.
2012 Program Planning Committee Meeting (Invitation Only)
4:00 p.m. – 5:00 p.m.
Portfolio Steering Committee Meeting
5:00 p.m. – 6:00 p.m.
Interest Group Leaders Meeting
6:30 p.m. – 9:30 p.m.
PDA Awards Dinner (Invitation Only)
Monday
Monday, April 16, 2012
7:00 a.m. – 5:30 p.m.
Registration Open
7:00 a.m. – 8:30 a.m.
PCMO Steering Committee
7:00 a.m. – 8:00 a.m.
Continental Breakfast
7:00 a.m. – 8:00 a.m.
New Member Breakfast
7:00 a.m. – 5:00 p.m.
Speaker Ready Room Open
8:30 a.m. – 8:45 a.m.
Welcome, Opening Remarks and PDA Award Announcements
- Anders Vinther, PhD,Vice President, Quality Biologics, Genentech, Inc., PDA Board of Directors
- Richard M Johnson, President, PDA
- Vince Anicetti, Adjunct Professor, Keck Graduate Institute of Applied Life Sciences
- Marsha Hardiman, Senior Manager, Biological Services, Medtronic, Inc.
| 8:45 a.m. – 10:30 a.m. Opening Plenary Session Moderator: Vince Anicetti, Adjunct Professor, Keck Graduate Institute of Applied Life Sciences |
| Advances in gene and cellular therapy have allowed new treatment approaches and hope for patients with a wide range of serious and life threatening disorders. In this session David Shanahan will present a vision for the future of cancer treatment and the efforts underway at the Mary Crowley Institute to realize that vision. David will share the story of the institute and the belief that a paradigm shift is occurring in cancer care by which personalized medicine will ultimately transform the way patients are treated. With an ultimate goal to cure cancer, the ongoing objective at Mary Crowley is to administer novel agents in innovative ways to transform cancer into a manageable disease. Today Mary Crowley Institute is involved in over 200 FDA approved trials.Stem cell therapy provides new promise for a diverse range of disorders including cancer, spinal cord injuries, and a broad range of human degenerative diseases. Realizing this promise will require fundamental understanding of stem cell biology. The mission of California Institute for Regenerative Medicine (CIRM) is to support and advance stem cell research and regenerative medicine under the highest ethical and medical standards for the discovery and development of cures, therapies, diagnostics and research technologies to relieve human suffering from chronic disease and injury. As a board member of CIRM, Dr. Ted Love will share the promising safety and efficacy results of stem cell therapies to date, but also the challenges ahead in making these therapies widely available. Challenges relating to investigational product development, chemistry, manufacturing and controls (CMC) strategies, product characterization and comparability and evolving regulatory requirements are a few of the challenges that Dr. Love will describe from his view at CIRM. |
| 8:45 a.m. – 9:30 a.m. Future Benefits for Patients: From Discovery to Commercial Products, Cellular and Gene Therapies David Shanahan, President, Mary Crowley Research Center and President, CEO and Founder, Gradalis |
| 9:30 a.m. – 10:00 a.m. The Future of Personalized Medicine – Challenges Ahead Ted Love, MD, Executive Vice President, R&D and Technical Operations, Onyx Pharmaceuticals 10:00 a.m. – 10:30 a.m. Q&A |
10:15 a.m. – 7:00 p.m.
Exhibit Hall Open
10:30 a.m. – 11:15 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall - Sponsored by Catalent
| Poster Presentations on Monday, April 16, 2012 |
|
Quality Management in Production Support Laboratories Rapid, Large-Scale Manufacture of Immunotherapeutics Automation and Monitoring of a Solubilization Process for a Parenteral Solution Product to Eliminate Process Deviations and Improve Process Robustness Observed Challenges during Packing, Qualifying and Conditioning of Hard Silica and Ceramic Chromatography Resins New Silicone Oil Detection Technologies for Autoinjector-Compatible Prefilled Syringes Overcoming Matrix Interference from CHO Harvest Using Sample Enrichment for MycoSEQ TM Mycoplasma Detection Assay PDA Technical Report – Application of Phase-Appropriate CGMP and Quality Systems to the Development of Protein Bulk Drug Substance Terminal Sterilization Proof of Concept Studies to Support Parametric Release of a Re-designed Radiopharmaceutical Elution Device Feasibility Study Using Fluorescence Spectrophotometry for a Sensitive and Robust Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes Evaluation of the MALDI-TOF for Microbial identifications in a QC Microbiology Laboratory Characterization of the Effects of Freezing, Thawing and Shipping on a Bulk Protein Solution Approaches to Biosafety Testing Based on Detection of Novel Viral Sequences in Raw Material Screening of Cyclic-Olefin Copolymer (COC) Syringe Manufacturing Process Parameters on its impact on Syringe Solution Chemistry Characterization of Visible and Sub-visible Particles in Parenteral Products: Using a Forensic Approach Challenging Technical Transfer of a Biopharmaceutical – the Product X Case Study |
11:15 a.m. – 12:45 p.m.
Concurrent Sessions
| Innovation and Productivity in Large Scale Manufacturing | Personalized Medicine/Cellular Therapeutics | Control Strategies for Biopharmaceuticals |
| A – Microbial Control in the Manufacturing Environment: Advanced Aseptic Technology | B – Challenges in Manufacturing and QA/QC Part I | C – Current Practices and Opportunities in Biopharmaceuticals |
| Moderator: Rick Lu, Director of Manufacturing, MedImmune, LLC | Moderator: Marsha Hardiman, Senior Manager, Biological Services, Medtronic, Inc. | Moderator: Philippe Gomez, Key Accounts Manager, Sartorius Stedim Biotech |
| Aseptic processes represent a challenge of their own as controlling microbial contaminants is a matter of probability and risks associated to the process and the environment surrounding it. As we move into the 21st century with increased scrutiny and diligence, managing, controlling and monitoring an aseptic process becomes very costly and potentially inefficient. Alternative methods may also be used to monitor and control the process from potential microbial contaminants. This session will discuss alternative methods for assuring a sterility assurance level suitable for your process and product. The session will discuss innovative technology as well as the implementation strategy using a risk based approach focused on product quality while increasing product output. |
Personalized medicine represents an exciting future direction for the pharmaceutical business. It represents patient specific treatments tailored to each patient's cells and tissues. Current FDA approved personalized medicines are on the market for cancer. Others personalized medicines are in development with aspirations of commercial production in the near future. Along with the manufacturing of these types of products comes interesting and new challenges for both operations and quality departments. The rules for traditional biopharmaceutical manufacturing do not always apply. Compendial and regulatory requirements for aseptic manufacturing and quality testing of sterile products, which were created for traditional pharmaceutical manufacturing, need to be followed, yet often need to be implemented in a different way. In personalized medicine, lot release may need to take place in hours after production versus days, weeks or months after production. Investigations need to be opened, executed and completed in hours, not days to allow for product disposition. This session will expose attendees to real life challenges related to quality control testing, quality assurance and manufacturing of personalized medicine products. | The biopharmaceutical industry remains strong and growing. Pharmaceutical companies continue their efforts to reduce costs and improve internal efficiency, while still continuing to increase their involvement in biopharmaceutical development and manufacture in an attempt to increase the percentage of biopharmaceuticals in their pipeline. This session addresses the current practices, and innovations in the manufacturing processes of biopharmaceuticals, and upstream and downstream opportunities for new as well as for existing established processes. Increasing yield, implementing (or incorporating) new technologies and innovations, scaling up, while maintaining product quality and attributes…are some of the points that will be discussed during this first session of the Biopharmaceutical track. |
| 11:15 a.m. – 11:45 a.m. In-Line, non-thermal Pathogen Inactivation/Sterilization Monochromatic UV Systems Technology for Ophthalmic, Blood Product, Opaque Fluid and Packaged Therapeutic Pharmaceutical Applications Barry Ressler, PhD, Chairman and CEO, Triton Thalassic Technologies, Inc. |
11:15 a.m. – 11:45 a.m. Challenges in QA/QC Greg Whitehead, Director, Corporate Quality Assurance, Dendreon Corporation |
11:15 a.m. – 11:45 a.m. Updating a Legacy Process: Plasma Fractionation Carol L. Anderson, Senior Process Engineer, Grifols, Therapeutics, Inc. |
| 11:45 a.m. – 12:15 p.m. Challenges of Implementation, Validation and Application in BDS Manufacturing and Fill/Finish Operations Ren-Yo Forng, PhD, Site Microbiologist, MedImmune, LLC |
11:45 a.m. – 12:15 p.m. Challenges in Manufacturing John E. Butler, PhD, Global Project Leader, Bayer Innovation GmbH |
11:45 a.m. – 12:15 p.m. Poxvirus Aseptic Process Stephen Brown, PhD, Chief Technology Officer, Vivalis |
| 12:15 p.m. – 12:45 p.m. Q&A |
12:15 p.m. – 12:45 p.m. Q&A |
12:15 p.m. – 12:45 p.m. Q&A |
12:45 p.m. – 1:45 p.m.
PDA Technical Books Committee
12:45 p.m. – 2:15 p.m.
Networking Luncheon in Exhibit Hall
12:45 p.m. – 2:15 p.m.
Science Advisory Board
12:45 p.m. – 2:15 p.m.
Bioburden and Bio-Film Task Force
2:15 p.m. – 3:45 p.m.
Concurrent Sessions
| Innovation and Productivity in Large Scale Manufacturing | Personalized Medicine/Cellular Therapeutics | Control Strategies for Biopharmaceuticals |
| D – Microbial Control in the Manufacturing Environment: Advanced Sterilization Techniques | E – Challenges in Manufacturing and QA/QC Part II – Continued | F – Contamination Control |
| Moderator: Miguel Nogueras, MTD, Manager of QA Microbiology, Abbott Medical Optics | Moderator: Harold S. Baseman, Chief Operations Officer, ValSource, LLC | Moderator: Kurt Brorson, PhD, Staff Scientist, CDER, FDA |
| Terminal sterilization has long been held as the preferred method of sterility assurance for drug products since the drug products are sterilized within their final container closure systems. However, its application has been limited to those products that can withstand the harsh conditions of the sterilization process. With a growing market of biologic products, combination products as well as an existing market of sensitive small molecule products, the industry has pursued advances in terminal sterilization to address these needs. This session will discuss recent developments in terminal sterilization technologies and their application hurdles that provide enhanced sterility assurance for those products have historically been unable to withstand existing sterilization methods. |
Personalized medicine represents an exciting future direction for the pharmaceutical business. It represents patient specific treatments tailored to each patient's cells and tissues. Current FDA approved personalized medicines are on the market for cancer. Others personalized medicines are in development with aspirations of commercial production in the near future. Along with the manufacturing of these types of products comes interesting and new challenges for both operations and quality departments. The rules for traditional biopharmaceutical manufacturing do not always apply. Compendial and regulatory requirements for aseptic manufacturing and quality testing of sterile products, which were created for traditional pharmaceutical manufacturing, need to be followed, yet often need to be implemented in a different way. In personalized medicine, lot release may need to take place in hours after production versus days, weeks or months after production. Investigations need to be opened, executed and completed in hours, not days to allow for product disposition. This session will expose attendees to real life challenges related to quality control testing, quality assurance and manufacturing of personalized medicine products. | Biopharmaceutical products are challenged by a unique spectrum of potential contaminants: process/product related impurities, adventitious agents, and mycoplasma. Control strategies for these have been described in ICH guidance (ICH Q5A, ICH Q6B) as well as recent PDA technical reports (TR 41, 47 and 50). This session will address this unique spectrum of contaminants and strategies firms can implement to address them. |
| 2:15 p.m. – 2:45 p.m. Low Dose Gamma Terminal Sterilization of Biologics Niki Fidopiastis, Director, SteriPro Consulting, Sterigenics |
2:15 p.m. – 2:45 p.m. Industry Perspective: Challenges in Manufacturing of Personalized Medicine Stephen Brown, PhD, Chief Technology Officer, Vivalis |
2:15 p.m. – 2:45 p.m. Update on Technical Report 50 Barbara Potts, PhD, Principal, Potts and Nelson Consulting, LLC |
| 2:45 p.m. – 3:15 p.m. NO2 Sterilization in Place of EtO for Combination Products David Opie, PhD, Senior Vice President, Research and Development, Noxilizer, Inc. |
2:45 p.m. – 3:15 p.m. Challenges in Manufacturing for Personalized Medicine Tom Finn, CMC Reviewer, CBER, FDA |
2:45 p.m. – 3:15 p.m. The MIT Consortium on Adventitious Agent Contamination Michael Wiebe, PhD, President, Quantum Consulting, LLC |
| 3:15 p.m. – 3:45 p.m. Q&A |
3:15 p.m. – 3:45 p.m. Q&A |
3:15 p.m. – 3:45 p.m. Q&A |
3:45 p.m. – 4:30 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall
3:45 p.m. – 4:30 p.m.
Gene & Cell Based Therapy Task Force
3:45 p.m. – 4:45 p.m.
TRI Committee Meeting
4:30 p.m. – 6:00 p.m.
Concurrent Interest Groups
| IG1- Microbiology/Environmental Monitoring | Leader: Jeanne E. Moldenhauer, Vice President, Excellent Pharma Consulting, Inc. | The Microbiology/Environmental Monitoring Interest Group will discuss the issues of fungal contamination in the pharmaceutical process. Jim Polarine of Steris will discuss several of the recent issues with fungal contamination and ways that this can be addressed. Additionally, Brian Hubka and Vladimir Podlipsky of Pegasus Pharmaceuticals will speak on emerging technology to prevent fungal contamination. Following these two presentations, there will be time for discussion among the attendees and speakers.
Brian Hubka, Pegasus Pharmaceutical |
| IG2 – Process Validation | Leaders: Scott Bozzone, PhD, Senior Manager, Global QO Validation, Pfizer, Inc. Harold S. Baseman, Chief Operations Officer, ValSource, LLC |
The Process Validation Interest Group will present the new PDA PCMO Technical Report on Process Validation and Verification. The leaders will discuss the EMA intentions on Process Validation and follow-up on two (2) Concept Papers that were issued in early 2011. The session will also feature feedback on the U.S. FDA Guidance on Process Validation and how it is being received one year after the release. |
| IG3 – Quality Systems | Leader: Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc. | The PDA Quality Systems Interest Group is a network of QA/QC professionals. In this meeting we will discuss FDA's current view on Quality Systems and the role of management as it relates to the Quality System. In ICH Q10 the role of senior management has been specified, and recent Warning Letters and 483 observations shows that the industry in several cases is struggling with ensuring the Quality System is fully appreciated and understood in the company. Examples of how Managem,ent should be involved in the Quality System activities will be discussed. Additionally, there will be a brief summary of the two ICH Q10 workshops that recently were held in US and Europe.
Tom Finn, CMC Reviewer, CBER, FDA |
| IG4 – Prefilled Syringe | Leaders: Thomas Schoenknecht, PhD, Director, Global Key Accounts Management, Schott AG | The Pre-filled Syringe Interest Group will focus in an open discussion forum style on actual topics related to pre-fillable injection system components for drug delivery such as cartridges or syringes and combinations thereof with injection and safety devices. Latest trends and regulatory requirements for primary packaging material, track and trace systems, auto injector requirements on primary containers as well as alternative sterilization methods for material incorporation into isolator systems will be presented and discussed in an open forum. A special focus will be given on recent recalls and their impact on primary packaging material requirements. |
| IG5 – Visual Inspection of Parenterals | Leader: John G. Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer, Inc. | The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products. Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, recent regulatory activity and country specific inspection requirements. This group has also initiated activities to survey industry inspection practices, organize special meetings on visual inspection and to provide scientific guidance on compendial requirements for the inspection of injectable products. |
| IG6 – Lyophilization and Vaccines | Leaders: Edward H. Trappler, President, Lyophilization Technology, Inc
Frank S. Kohn, PhD, President, FSK Associates, Inc |
Lyophilization: As a constantly developing field there are always new perspectives in the science, technology and compliance realms. This interest group provides an open forum for discussions on current topics. Topics are identified at the onset of the meeting for open discussions among participants. This provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices. Vaccines: |
| IG7 – Supply Chain Management | Leader: Lucy Cabral, Director, Supplier and Distribution, Genentech, Inc. | The Supply Chain Management Interest Group offers its members the opportunity to influence the suppliers of the pharmaceutical and biotech industry to develop requirements that meet the needs of the industry in the areas of material quality, continuous improvement efforts, supply chain security, and supplier/customer business partnerships. The Interest Group will use existing information gathered from PDA members, suppliers, other industry groups, and drug manufacturers to document and develop best practices approach for suppliers to meet customer requirements globally. |
5:30 p.m. – 7:00 p.m.
Networking Reception in Exhibit Hall
6:15 p.m. – 7:00 p.m.
Alumni Board Reception (Invitation Only)
7:00 p.m. – 8:00 p.m.
Chairs Reception (Invitation Only)
Tuesday
Tuesday, April 17, 2012
7:30 a.m. – 5:45 p.m.
Registration Open
7:30 a.m. – 5:45 p.m.
Speaker Ready Room Open
7:30 a.m. – 8:30 a.m.
Continental Breakfast
| 7:30 a.m. – 8:30 a.m. Breakfast Session: Career Development Strategies Moderator: Vince Anicetti, Adjunct Professor, Keck Graduate Institute of Applied Life Sciences |
| Strategies and tips for advancing your career will be discussed by three respected and highly experienced experts in biopharmaceutical recruiting and leadership development. The session will use a panel discussion format addressing audience questions. Cheri Spolin is highly accomplished senior HR executive with Genentech who has held senior HR positions in a number of high tech organizations. She will present the perspective of a corporate senior HR manager discussing successful strategies and techniques for internal career transitions and successful navigation of corporate cultures. As a widely respected executive coach, Roy Blitzer has served as a career strategy advisor to many senior executives in the biopharmaceutical industry over the past three decades. He will share his insights on the developing many of the important leadership and networking skills needed to advance from the technical arena into senior management as well as highlighting fatal career derailers to avoid. Dave Fortier is a highly regarded executive recruiter of senior quality, manufacturing and development positions for global biopharma. Dave will share his observations and advice on current trends in biopharmaceutical recruiting, as well as the attributes and experiences most sought after in today's executive job market. Don't miss this opportunity to understand today's demanding job market from some of the industry experts in career and leadership development.
Topics in this session to include:
|
| 7:30 a.m. – 7:50 a.m. Cheri Spolin, Global HR Business Partner, Roche/ Genentech 7:50 a.m. – 8:10 a.m. 8:10 a.m. – 8:30 a.m. |
8:00 a.m. – 9:30 a.m.
Exhibit Space Draw
| 8:30 a.m. – 10:00 a.m. Plenary Session 2 Moderator: Marsha Hardiman, Senior Manager, Biological Services, Medtronic, Inc. |
| What does the future of the biopharmaceutical industry look like? This session will address new trends in the industry. It’s a time of unprecedented opportunity with new medical needs of patients and emerging technologies such as personalized medicine and cell therapies to help meet those needs. In this session, we will look into the future and discuss biologics and manufacturing processes. Come learn about a novel bacterial contaminant in CHO cell culture processes that has implications for the biotech industry at large. |
| 8:30 a.m. – 9:00 a.m. The Future of the Biopharmaceutical Industry David Urdal, Chief Scientific Officer, Dendreon Corporation 9:00 a.m. – 9:30 a.m. 9:30 a.m. – 10:00 a.m. |
9:45 a.m. – 4:30 p.m.
Exhibit Hall Open
10:00 a.m. – 10:45 a.m.
Refreshment Break and Poster Presentations and Passport Raffle Drawing in Exhibit Hall
| Poster Presentations on Tuesday, April 17, 2012 |
|
Detection of Pro-inflammatory Contaminants in Parenteral Drug Products Using a Monocyte Activation Test – A Methods Optimization Approach Enablement of Accurate Dose Administration for a Pre-Filled Syringe Drug Product Implementation of Single Use System in Aseptic Final Filling Process New In-Line Sterilization and Decontamination System for Prefilled Syringes Method Development of a General Method for CCIT Syringe Testing Microbial Hold Time Challenges for Sterile Drug Products After Dose Preparation Improvement of Cell-freezing Technologies and Disposable Bioreactors Allow to Perform Fully Closed USP Process A Fully Integrated Approach to Vaccine Bulk Process Monitoring New Technology for Broad Screening and Identification of Adventitious Agents Automated ATP Bioluminescence System on Evaluation of Sterile Products Evaluation of Real Time Transcription Mediated Amplification and Membrane Based Sample Prep for the Detection of Mycoplasma in Challenging Media Formulations Characterization of a Polymer Prefilled Syringe System with Inserted Needle for Biotherapeutics: Effect of Variable Fill Volume and Solution Viscosity on Performance and Residual Volume Successful Achievement of Quality Status for Pilot Plant to Manufacture DP for GLP Studies Pharmaceutical Manufacturer’s Approach to Qualification of Sing-Use System Innovations in Closed System Sterile Powder Transfer |
10:45 a.m. – 12:15 p.m.
Concurrent Sessions
| Innovation and Productivity in Large Scale Manufacturing | Personalized Medicine/Cellular Therapeutics | Control Strategies for Biopharmaceuticals |
| G – Bioburden and Biofilm Management Strategies | H – Manufacturing Innovation Part I | I – Quality Control/Testing |
| Moderator: Mike Sadowski, Director Sterile Manufacture Support, Baxter Healthcare | Moderator: Christopher Smalley, PhD, Associate Director, BioSterile Validation, Merck | Moderator: Jose Goin, PhD, Associate Director, Quality Control Network Group, Genentech, Inc. |
| Biofilms have recently garnered much attention across our industry and have been frequently highlighted in recalls, warning letters and regulatory inspection citations. A biofilm is a complex aggregate of living microorganisms attached to a substrate in a self-derived structure that is capable of providing advanced protection and proliferation benefits to the microbial residents of this community. Wet pharmaceutical and biopharmaceutical production processes face the threat of biofilm colonization and associated risks to product quality. In this session, recognized experts on biofilms will provide up-to-date background information and share their expertise through a series of case studies to illustrate proper equipment design, detection, control and eradication measures intended to minimize biofilm risks. | This session is part 1 of a two part series on manufacturing innovation. Manufacturing processes need to constantly improve to remain cost effective in a competitive marketplace, and to remain compliant in the face of increasing regulatory expectations. Large scale manufacturing innovation includes an increased use of Single-Use Systems, innovative bioprocessing technologies and outsourcing to contract manufacturing organizations (CMOs). In this session, we will examine two case studies which describe the implementation of Single-Use Systems technology. Examples will be given of careful evaluation of new technologies and an implementation process employed to maximize innovative potential while minimizing disruption to existing operations and relevant elements of the Quality System. Session K will address innovative bioprocesses and the use of CMOs. | The control of analytical methods is a critical part of QC testing operations. This session will focus on the strategies for understanding and managing the analytical method lifecycle, including maintenance, validation and transfer of analytical technologies in the Quality Control laboratory. |
| 10:45 a.m. – 11:15 a.m. Genesis and Detection of Biofilm Marc Mittelman, PhD, Senior Managing Scientist, ExPonent |
10:45 a.m. – 11:15 a.m. Case Study: Implementation of Disposable Systems for Buffer Delivery Claire Frazier, Senior Associate Process Development Engineer, Grifols, Inc. |
10:45 a.m. – 11:15 a.m. The Late-Stage Analytical Method Lifecycle: Risk-based Validation and Maintenance Strategies Stephan Krause, PhD, Principal Scientist/Associate Director, Medimmune |
| 11:15 a.m. – 11:45 a.m. Detection of Biofilm Mark Pasmore, Senior Principle Engineer, Baxter Healthcare Corporation |
11:15 a.m. – 11:45 a.m. Using Single Use Technology at Large Scale Chuck Hart, Director of Upstream Operations Manufacturing Cell Culture, Shire |
11:15 a.m. – 11:45 a.m. Approaches to Ensuring Analytical Method Robustness During Vaccine Product Life Cycle Garry Tackle, Senior Director, Bioanalytics, VMSC, Merck |
| 11:45 a.m. – 12:15 p.m. Q&A |
11:45 a.m. – 12:15 p.m. Q&A |
11:45 a.m. – 12:15 p.m. Q&A |
11:00 a.m. – 12:00 p.m.
Exhibit Committee Meeting
12:15 p.m. – 1:45 p.m.
2013 Annual Program Planning Committee Meeting (Invitation Only)
12:15 p.m. – 1:45 p.m.
Networking Luncheon in Exhibit Hall
12:15 p.m. – 1:45 p.m.
Biotechnology Advisory Board Meeting (Invitation Only)
12:15 p.m. – 1:45 p.m.
Chapter Council Meeting
1:45 p.m. – 3:15 p.m.
Concurrent Sessions
| Innovation and Productivity in Large Scale Manufacturing | Personalized Medicine/Cellular Therapeutics | Control Strategies for Biopharmaceuticals |
| J – Combination Products Challenges and Considerations | K – Manufacturing Innovation Part II | L – Process Control/Validation |
| Moderator: Michele Creech, Quality Operations Manager, Grifols, Inc | Moderator: Ursula Busse, PhD, Head of Project Office, Global Biopharmaceutical Operations, Novartis |
Moderator: Jeffrey Hartman, Validation Manager, Merck |
| With the emergence of new technologies for creating combination products, challenges and opportunities for innovation arise. These "drug delivery systems of the future" are created by combining drugs and devices, drugs and biologics or devices and biologics to create new products. The diversity of the combinations that can be created means that industry and regulators cannot use a "one size fits all" approach when considering these unique entities, especially in the areas of depyrogenation and sterilization. Some of the factors to consider include single-entity vs. co-packaged vs. separately packaged products and whether to address the component parts before or after they are combined. These topics and more will be discussed during this session. | In the second session on manufacturing innovation, we will address improved upstream processing and contract manufacturing as two additional strategies to reduce cost of goods, while increasing efficiency and flexibility. In the first presentation on high yield expression systems you will learn how very high cell densities were achieved to increase product titer, and how downstream processing was modified to purify high titer harvests. The technologies make use of Single-Use Systems and are integrated in the design of DSM's Biologics Plant of the Future, built in Brisbane, Australia. The second presentation on contract manufacturing will analyze and discuss lessons learned from a broad range of biopharmaceutical projects developed successfully at a CMO in collaboration with its contract givers. The focus will be on the key elements of the process leading to successful commercial supply collaboration. | This session will begin with a case study highlighting the validation of a lyophilization cycle for a recombinant protein in a unique drug product device, a dual-chamber cartridge and multi-dose pen injection system. In addition to the development challenges with the novel drug delivery system, the drug formulation and load presented other significant complications. Following this case study, highlights from the new Technical Report on Quality Risk Management for Biopharm manufacturing will be presented. Risk Assessments for typical operations will illustrate the importance and use of this tool in development and helping to proactively address potential processing issues. |
| 1:45 p.m. – 2:15 p.m. Depyrogenation of Combination Products James Cooper, PharmD, Consultant, Endotoxin Consulting Services |
1:45 p.m. – 2:15 p.m. High Titer Production Rolf Douwenga, Vice President, Global R&D, DSM Biologics |
1:45 p.m. – 2:15 p.m. Development of a Dual-Chamber Cartridge and Pen Device for a Lyophilized Therapeutic Protein David Hamilton, Senior Process Engineer, Merck |
| 2:15 p.m. – 2:45 p.m. Radiation Sterilization of Combination Products John Williams, Senior Manager, Baxter Healthcare Corporation |
2:15 p.m. – 2:45 p.m. Key Elements in Successful Outsourcing Morten Munk, Vice President, Business Development, CMC Biologics |
2:15 p.m. – 2:45 p.m. Strategies to Address Cleaning Challenges in Bioreactors with High Cell Density ProcessesRizwan Sharnez, PhD, Principal Engineer, Amgen, Inc |
| 2:45 p.m – 3:15 p.m. Q&A |
2:45 p.m – 3:15 p.m. Q&A |
2:45 p.m – 3:15 p.m. Q&A |
3:15 p.m. – 4:00 p.m.
Refreshment Break and Poster Presentations and Passport Raffle Drawing in Exhibit Hall
4:00 p.m. – 5:30 p.m.
Concurrent Interest Groups
| IG8 – Facilities and Engineering / Pharmaceutical Water Systems | Leaders: Christopher Smalley, PhD, Associate Director, BioSterile Validation, Merck Phil DeSantis, Senior Director, Engineering Systems and Compliance, Merck |
Chris Smalley will introduce the concept of "Green Manufacturing". The session will be a follow-up to the 2011 PDA/FDA Joint Regulatory Conference Interest Group session, which focused on overall green manufacturing, reducing site energy usage, and implementing solar energy. The topic for the Annual Meeting is "Single Use Systems and Green Manufacturing – Can Disposables Be Green?" |
| IG9 – Packaging Science | Leader: Edward J. Smith, PhD, Principal Consultant, Packaging Science Resources |
The Packaging Science Interest Group (PSIG) is a venue for the exchange of knowledge and ideas about pharmaceutical packaging. Members collaborate to develop presentations for PDA programs, organize special meetings on current topics, review USP and FDA proposals and regulations, work on task forces on focused topics, and educate each other. Sessions are held in conjunction with signature PDA meetings. Current E&L Best Practices on Process Materials in North America Current Best Practices Europe: Packaging and E&L Pactices PQRI Activities: Influence on Best Practices in NA and Europe |
| IG10 – Inspection Trends | Leader: Bob Dana, Senior Vice President of Regulatory Affairs and TRI, PDA | The Inspection Trends Interest Group provides a forum for sharing experiences and knowledge in the subject areas. Meeting format varies; we have panel discussions featuring industry and FDA participants, podium presentations on inspection-related activities and programs and an open forum for questions and answers relative to company experiences with government inspections. Data on current inspection findings and trends are presented, as well as discussions on new regulatory and compliance initiatives. |
| IG11 – Quality Risk Management | Leader: Michael A. Long, PhD, Director and Principal Consultant, ValSource, LLC Jeffrey Hartman, Validation Manager, Merck |
Topic: "Mitigating Pharma & BioPharm Equipment Risk Through Human Factors" Companies go to great lengths to ensure that their products and equipment have met various standards, guidelines, technical feasibility and that it leverages the appropriate technology. These same companies institute development design controls and quality management systems to ensure that product requirements have been met and are actualized in the end product. Perhaps, most importantly, a great deal of attention is on mitigating product risk using multiple methodologies such as hazard analyses and failure mode and effects analyses for instance. This same level of rigor, traceability, and risk management is not applied, however, to the human element of the product or equipment. The integration of Human Factors and supporting research is a critical part of developing and maintaining the integrity of user requirements and mitigating any potential use-error risks. This presentation will provide a couple of case studies (e.g. bioreactor, filtration system) in which human factors integration has resulted in equipment design that not only meet product requirements from a technical perspective but also support user requirements in a manner that fosters product compliance while minimizing use-errors. PCMO initiative on Technical Report Update Discussions Christina Mendat, PhD, Director, Research and Human Factors, Radius Product Development |
| IG12 – Filtration | Leader: Russell E. Madsen, President, The Williamsburg Group, LLC | Russ Madsen will dedicate the Filtration Interest Group session to Theodore ("Ted") H. Meltzer, Ph.D., former leader for the PDA Pharmaceutical Water Systems Interest Group. Following a brief tribute to Ted, there will be three (3) fifteen minute presentations from Millipore, Pall and Sartorius-Stedim representatives on the subject of post-sterilization integrity testing. Following those presentations, the session will conclude with a panel discussion with Q&A on pre-filtration bioburden (i.e., the CPMP "requirement" of less than 10 CFU per 100 mL), redundant (serial filtration, and the pros and cons of reusing sterilizing filters.
Maik Jornitz, Senior Vice President, Marketing, Sartorius Stedim Biotech |
| IG13 – Sterile Processing / Blow-Fill-Seal | Leaders: Ken H. Muhvich, PhD, Principal Consultant, Micro-Reliance, LLC Chuck Reed, Director, Sales and Marketing, Weiler Engineering |
An update will be provided regarding the progress that the Task Force has made in transforming the Blow Fill Seal International Operators Association Guidance Document into a formal PDA Technical Report (TR) on "Sterile Manufacturing using Blow/Fill/Seal (BFS) Technology." Task Force members will be identified and key points from the Draft Technical Report will be described. Input from attendees is welcome. In addition, aspects of PDA's updated Aseptic Processing Survey will be discussed. |
| IG14 – Biotechnology | Leader: Vince Anicetti, Adjunct Professor, Keck Graduate Institute of Applied Life Sciences | The topic for the Biotechnology Interest Group session will be "Recommendations of the Bioburden and Biofilm Management Task Force."
Compliance Issues in the Biotechnology Industry and the Evolving Role of the Consultant |
5:45 p.m. – 10:30 p.m.
PDA Annual Meeting Baseball Outing – optional event
Take a 7th inning stretch from the Annual Meeting as the Arizona Diamondbacks take on the Pittsburgh Pirates at Chase Field. Enjoy an evening of baseball with your co-workers, colleagues and family in the heart of downtown Phoenix.
6:30 p.m. – 9:00 p.m.
Dine Around – When the sky turns from sun to stars, there is nothing like dining in Scottsdale
Wednesday
Wednesday, April 18, 2012
7:00 a.m. – 1:00 p.m.
Registration Open
7:00 a.m. – 11:15 a.m.
Speaker Ready Room Open
7:00 a.m. – 8:30 a.m.
Continental Breakfast
7:30 a.m. – 8:25 a.m.
Foundations Breakfast Sessions – Building on the success of the Fundamentals Track at the 2011 Annual Meeting, the Program Committee is pleased to make available three breakfast sessions on topics of interest to the Pharmaceutical/Biopharmaceutical community. Each is based on the science outlined in associated PDA Technical Reports and will provide attendees the opportunity to gain foundational knowledge in the topics at hand. Conference attendees wishing to gain a basic awareness or refresh their knowledge of these topics will find these breakfast sessions of value. For those wishing to delve deeper into the topics presented after the sessions, PDA's Training and Research Institute (PDA TRI) will offer in-depth courses on the subjects later in 2012.
| Technology | Regulatory | Quality |
| M – Cleaning Validation for Biotechnology Products | N – Good Distribution Practices for the Pharmaceutical Supply Chain | O – Evaluation, Validation and Implementation of New Microbiological Test Methods |
| Moderator: Michele Creech, Quality Operations Manager, Grifols, Inc | Moderator: Bob Dana, Senior Vice President of Regulatory Affairs and TRI, PDA | Moderator: Marsha Hardiman, Senior Manager, Biological Services, Medtronic, Inc. |
| This session will describe the essential elements of cleaning validation as they apply to equipment utilized in the manufacture of biotechnology products. Topics such as system design, sampling and analytical techniques, cycle design and establishment of acceptance criteria will be discussed. Principles and techniques to consider for multi-product applications will also be covered. | Knowledge of the impact of environmental conditions on the stability of drug products is essential to the design and control of the supply chain in ensuring the delivery of a quality product to the end user, the patient. This session will focus on the elements important to ensuring the stability of drug products, both small and large molecule, as they move through the distribution chain. | This session will provide a general overview on the introduction of new microbiological test methods in a government-regulated environment. It will discuss ways to ensure the successful evaluation, validation and implementation of new microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. These new methodologies offer significant improvements in terms of the speed, accuracy, precision and specificity with which testing can be performed. |
| 7:40 a.m. – 8:10 a.m. Jenna Carlson, Principal Technical Manager, F. Hoffmann-LaRoche Ltd |
7:40 a.m. – 8:10 a.m. David Ulrich, QA Director/Distribution, Abbott Laboratories |
7:40 a.m. – 8:10 a.m. Michael J. Miller, PhD, President, Microbiology Consultants, LLC. |
| 8:10 a.m. – 8:25 a.m. Q&A |
8:10 a.m. – 8:25 a.m. Q&A |
8:10 a.m. – 8:25 a.m. Q&A |
NEW This Year
7:30 a.m. – 8:25 a.m.
Breakfast Session: Quality and Regulatory Job Market Outlook 2012
Moderator: Ursula Busse, PhD, Head of Project Office, Global Biopharmaceutical Operations, Novartis Pharma AG
The demand for Quality, Manufacturing, and Regulatory professionals is on the rise but also reflects the many dynamics affecting the Pharmaceutical industry today. Increased globalization is changing geographic trends for many parts of the biotechnology and pharmaceutical industries while emerging technologies such as cellular based therapies are creating demand and new hot spots. In addition, the growth of regulatory agencies and overall enforcement climate is creating new opportunities in the consulting and third party support industries. In this session, a panel of executives from biotech companies, consulting firms, and the public sector will discuss in trends they see in job market for manufacturing, quality and regulatory arenas and the hiring profiles they will be looking for in 2012. Don’t miss this unique opportunity to hear from the hiring executives themselves “where the jobs are”!
Topics in this session to include:
- Career strategies for Quality, Manufacturing and Regulatory Professionals
- Hiring trends in the pharma and biotechnology sector
- Hiring trends in the consulting industry and public sector
- Skill sets and hiring profiles in demand
- Skill sets needed for compliance companies
Panelists:
- Steven Lynn, Office Director (acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER, FDA
- Morten Munk, Vice President, Business Development, CMC Biologics
- Claudio Pincus, President, Quantic Group
- Lisa Skeens, PhD, Vice President, Global Regulatory Affairs and Pharmaceuticals, Baxter Healthcare Corporatio
8:30 a.m. – 10:00 a.m.
Concurrent Sessions
| Innovation and Productivity in Large Scale Manufacturing | Personalized Medicine/Cellular Therapeutics | Control Strategies for Biopharmaceuticals |
| P – Extractables and Leachables: Packaging Qualification, Quality Performance, and Best Practices | Q – Supply Chain Control/Distribution | R – Evolving Expectations for Biosimilars |
| Moderator: Wendy Nelson, PhD, Director of Manufacturing, Genentech, Inc. | Moderator: Miguel Montalvo, President, Expert Validation Consulting, Inc. | Moderator: Vince Anicetti, Adjunct Professor, Keck Graduate Institute of Applied Life Sciences |
| Drug product packaging selection and qualification relies not only on an intended delivery system but also on the type of product formulation. Selection of contact materials, fabrication, assembly and qualification of packaging components are key elements of ensuring quality throughout expiry of the drug product. Qualification of the packaging system is essential to ensuring a safe, reliable and effective drug product and quality performance of the packaging system. Packaging qualification and quality performance will be presented as a part of this session. In addition, this session will focus on the need for specific guidance, protocols and extractables and leachables limits for packaging as well as recommendations and best practices from the Product Quality Research Institute (PQRI) | This session will discuss adequate procedures and controls for the selection, evaluation, audit, approval and monitoring of critical suppliers in order to protect our product quality attributes and process requirements and the recent developments on Good Distribution Practices requirements. We will review current legislation and guidance in the making pertaining to supplier evaluation and approval and Good Distribution Practice and securing the supply chain. In particular, recent EU legislation changes (proposed Chapter 5 and 7 of the EU GMPs), the World Health Organization guidance on Good Distribution Practices and the EU concept paper on revision of the GDP regulations in Europe. | In 2009 President Obama signed the Biologics Price Competition and Innovation Act, opening the pathway to licensure of biosimilars in the United States. The European Union had published guidelines in 2005 and approved the first biosimilars as early as 2006. Recently, there has been increasing information exchanged within the industry and in the press about the coming of copies of previously approved biologicals. There is an expectation that the US FDA will publish its own guidance soon, probably before the PDA Annual Meeting.Because of their complex structures, biological molecules cannot be presumed to be exactly the same as their targeted original versions. Seemingly minor differences in structure might have a significant affect on therapeutic properties. The question becomes “How similar is similar enough?” Therefore, the path to approval for these generics will be much more difficult than their small-molecule generic counterparts. Despite the potential time and expense involved in bringing biosimilars to market, the anticipation is that it can be done in a manner which will make these drugs more available and affordable to a broader patient population. Therefore, many companies, both large and small, have thrown their hats into the ring. This session will explore biosimilars from both an industry and a regulatory perspective. As biologics continue to replace small molecules on the list of largest-sellers, where will biosimilars fit in? |
| 8:30 a.m. – 9:00 a.m. E&L Current Best Practices for Packaging and Processing Injectables Ed Smith, PhD, Principal, Packaging Science Resources, LLC |
8:30 a.m. – 9:00 a.m. API Evaluation Audit, Approval and Monitoring Sofia Ribeiro, Head Supplier Quality Management for Americas Region, Genentech, Inc |
8:30 a.m. – 9:00 a.m. From First Generation Biosimilar EPO’s And G-CSF’s To Biosimilar MAbs – How To Deal With Increasing Levels Of Complexity Thomas Schreitmueller, Head of Technical Regulatory Policy and Strategy Biologics, F. Hoffman-LaRoche Ltd. |
| 9:00 a.m. – 9:30 a.m. Drug Product Contact Materials: Stage Appropriate Assessments for Quality Performance Diane Paskiet, Associate Director of Scientific Affairs, West Pharmaceutical Services |
9:00 a.m. – 9:30 a.m. Good Distribution Practices Karen Ginsbury, CEO, Pharmaceutical Consulting Israel, Ltd. |
9:00 a.m. – 9:30 a.m. Worldwide Regulatory Experience with Biosimilars Mark McCamish, MD, PhD, Head Global Biopharmaceutical Development |
| 9:30 a.m. – 10:00 a.m. Q&A |
9:30 a.m. – 10:00 a.m. Q&A |
9:30 a.m. – 10:00 a.m. Q&A |
10:00 a.m. – 10:30 a.m.
Refreshment Break
| 10:30 a.m. – 12:00 p.m. Closing Plenary Session Moderator: Harold S. Baseman, Chief Operations Officer, ValSource, LLC |
| The health care product industry is facing changes and challenges as a result of innovative products, new technologies, expanded supplier networks, and the growing needs of public health. “Tried and true” traditional methods may not offer the optimal approach to process design, manufacturing, process control, quality assurance, and regulatory compliance. New approaches will be needed. How will the industry and regulators change current approaches in order to meet these new challenges? How can industry and regulators work together to make these changes and develop these new approaches? How can industry and regulators anticipate the challenges they may face and the changes needed to meet those challenges in the future? These and other related issues will be addressed by our distinguished speaker and panel. |
Discussion Points:
|
| 10:30 a.m. – 11:00 a.m. How FDA will apply a Risk Based Approach to Science and Quality Systems Steven Lynn, Office Director (acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER, FDA 11:00 a.m. – 11:30 a.m. 11:30 a.m. – 12:00 p.m. 11:45 a.m. – 12:15 p. m. Panelist: Tor Graberg, Chair of PIC/s and Head of Inspection, Medical Products Agency (MPA) |
12:15 p.m.
Closing Remarks and Adjournment
12:15 p.m. – 2:00 p.m.
Technical Report 33 Meeting
12:30 p.m. – 3:00 p.m.
Mycoplasma Task Force Meeting
12:30 p.m. – 5:00 p.m.
PDA Board of Directors Meeting
PDA Single Use Systems Workshop
PDA Single Use Systems Workshop
Knowledge Enables Implementation – A Consensus Approach
April 18 – 19, 2012 | Phoenix, Arizona
Downloads
Overview
Single-use (disposable) technology is a proven alternative solution for the biopharmaceutical industry offering several significant advantages over standard reusable stainless steel systems: by reducing cross contamination risk, cleaning and associated cleaning validation, capital investment and potentially reducing facility start up time. However, this new technology also offers several challenges which must be overcome for a successful implementation. This workshop will help guide participants through these challenges by helping them to ask the right questions when considering SUS implementation.
The PDA Taskforce for Single-Use Systems is completing a Technical Report on the implementation of Single-Use Systems and would like to invite you to attend the PDA Single Use Systems Workshop being held April 18-19, 2012 in Phoenix, Arizona.
The workshop will showcase and encourages the philosophies championed in the Technical Report and offer a different approach, presenting science and risk-based concepts which are flexible and can be applied in many different situations and organizations.
Learning Objectives
At the completion of this program, participants will be able to:
- Implement a risk-based decision making process for the use of Single Use Systems
- Describe the value of a partnership relation between Suppliers and End Users
- Understand the need for a flexible approaches for implementing Single Use Systems for your specific business
- Demonstrate an awareness of regulators' expectations on the application, use and validation of Single Use Systems
Who Should Attend
This workshop will be of significant value to: SUS suppliers, plastic manufacturers, end users, suppliers, regulatory or anyone who is currently frustrated by the current state of SUS's.
Single Use Systems offer unique challenges for both senior management and the shop floor technician. This work shop will help all organizational levels understand the right questions to ask to when trying to overcome SUS challenges and ensure the right decisions are made.
Specifically, pharmaceutical and biopharmaceutical professionals with the following responsibilities are encouraged to participate: anyone in a position to influence or change the way their organization operates | Procurement/Purchasing | Process Development | Senior Management | Regulatory | Quality | Operations.