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2015 PDA Annual Meeting Manufacturing Innovation and Efficiency: Achieving Quality Performance in Sterile and Biopharmaceutical Operations March 16 – 18, 2015 | Red Rock Casino Resort and Spa | Las Vegas, NV As of February 23, 2015 Sunday, March 15, 2015 8:00 a.m. ‐ 10:00 a.m. 9th Annual Walk / Run Event (Optional Event) Benefiting Cure 4 the Kids Foundation On your mark, Get set, Go...to the PDA 9th Annual Walk / Run Event. Set off on your choice of a 5k run or 3k walk through the outdoors of Las Vegas. Start your week with a fresh breeze and light workout with colleagues, family, and friends. There will be prizes for the 1st, 2nd and 3rd place winners of the walk and run and a good time for all. Cure 4 the Kids Foundation ‐ Cure 4 The Kids Foundation was organized in April 2007 solely for charitable, educational, and scientific purposes to address the specialized health care needs of children in Nevada and the surrounding region; more specifically to encourage and support clinical research and the application of that research seeking to control, cure, and prevent all types of childhood diseases. 9:00 a.m. ‐ 12:00 p.m. Regulatory Affairs & Quality Advisory Board (Invitation Only) 12:00 p.m. – 1:00 p.m. Advisory Board Mix & Mingle (Invitation Only) 1:00 p.m. ‐ 4:00 p.m. Science Advisory Board (Invitation Only) 3:00 p.m. ‐ 4:00 p.m. 2015 PDA Annual Meeting Program Planning Committee Meeting (Invitation Only) 3:00 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. ‐ 6:00 p.m. Biotechnology Advisory Board Meeting (Invitation Only) 6:30 p.m. ‐ 9:30 p.m. PDA Awards Dinner (Invitation Only) Monday, March 16, 2015 7:00 a.m. ‐ 5:30 p.m. Registration Open 7:00 a.m. ‐ 7:50 a.m. PDA Orientation Breakfast (Invitation Only) 7:00 a.m. ‐ 8:00 a.m. PCMO Steering Committee Meeting (Invitation Only) 7:30 a.m. ‐ 5:30 p.m. Speaker Ready Room Open 7:30 a.m. ‐ 8:30 a.m. Continental Breakfast 8:00 a.m. ‐ 8:15 a.m. Welcome, Opening Remarks & PDA Award Announcements 8:15 am. ‐ 10:00 a.m. P1 ‐ Changing Manufacturing – Fulfilling Future Treatment Options and Financial Necessities Moderator: Glenn Wright, Senior Director, Project Management Manufacturing Science and Technology, Eli Lilly & Company and Chair, Program Planning Committee Session Description: The manufacturing environment continues to evolve. The arrival of personalized medicine and the overall business environment are two factors that are altering the landscape. This session will take a closer look at how an approved personalized medicine product is changing the traditional concepts of manufacturing and the challenges that presents. The session will also take a look at how the business environment around manufacturing is changing and the impact this will have on the industry going forward. 8:15 a.m. – 8:45 a.m. Spread the Magic Chad Juros, Marketing Associate, Azzur Group LLC 8:45 a.m. 9:15 a.m. Scale‐up and Manufacturing Personalized Medicine Jeff Boyd, Head of Technical Operations & Gene Therapies Unit, Novartis 9:15 a.m. – 9:45 a.m. Operational Effectiveness Index ‐ A Balanced Approach to Operational Excellence for Pharmaceutical and Life Sciences Companies Adwait Bhagwat, Director ‐ Advisory, PricewaterhouseCoopers 9:45 a.m. ‐ 10:00 a.m. Questions and Answers/Discussion 9:45 a.m. ‐ 7:00 p.m. Exhibit Hall Open 10:00 a.m. ‐ 10:45 a.m. 2015 PDA Aging Facilities Program Planning Committee Meeting (Invitation Only) 10:00 a.m. ‐ 10:45 a.m. Refreshment Break and Poster Presentations in Exhibit Hall 2
Poster Presentations
The following posters will be presented during today’s refreshment breaks and the networking reception Defining the Current Quality Culture and Providing a Roadmap for Change
Mark Balboni, President, Mark Balboni LLC Process Validation for Lyophilized Drug Products: Developing a Program for Continued Process Verification Karen Bossert, Vice President, Lyophilization Technology, Inc. A Strategy for the Discovery of Novel Viral Contaminants in Biomanufacturing‐A Case Study Colette Cote, PhD, Principal Scientist, BioReliance by SAFC Key Elements to Successful Discrepancy Management Program Michele Creech, Quality Manager, Grifols Therapeutics, Inc. Selecting and Verifying Integral Packaging Systems for Injectable Drug Products Kristine Davidson, Technical Account Specialist, West Pharmaceutical Services Applications of Advanced Handheld 1064 nm Raman Spectrometers Claire Dentinger, Senior Applications Scientist, Rigaku Raman Technologies Optimization of the Bake‐on Siliconization Process of Cartridges by High‐Speed‐Recording and 3D‐Laser Scanning Microscopy Stefanie Funke, Department of Pharmacy/Pharmaceutical Technology and Biopharmaceutics, LMU Munich (Ludwig‐Maximilians‐
Universität) Aseptic Processing Hot Topics (non‐ sterile results) from the View of a Senior QA Microbiologist, and Practical Experiences in Usage of Sterile Risk Assessment Tools Guenther Gapp, PhD, Consultant, Gapp Quality GmbH Human Factors Summative Study for Disposable Pen Platform Development Charo Garrido, Clinical Development Manager, BD Development & Standardization of Continued Process Verification (CPV) Reporting Process Alekhya Gummaregula, MS, Senior Engineer, Merck How to Move Beyond Risk Assessment to a Robust Risk Management Program Lisa Hawkins, BA, BA, Principal Consultant, Commissioning Agents, Inc Development of an Endotoxin Method for a Biologic Drug Product using EndoLISA® Technology Devon Kleindienst, MS, Research Scientist, Bristol‐Myers Squibb Company Virus Removal Paper Filter Made of 100% Naturally Derived Nanofibers Albert Mihranyan, Associate Professor, Uppsala University Designing Aseptic Filling for Post Installation Operational Cost Reduction, Maximize Quality and to "Go Green" Jim Nadlonek, B.S., Pharmaceutical Operations Specialist, Bausch & Stroebel Machine Company (Pending Confirmation) Justification of Applying Acceptable Residual Limit (ARL) Based on Toxicological Data and Visual Inspection Mariann Neverovitch, MS, Research Scientist, Bristol Myers Squibb Bringing the Cleanroom Online after a Worst Case Event James Polarine, MS, Technical Service Manager, Steris Corporation In‐line Automated Visual Particle Inspection of "Blow Fill Seal" Containers for Incetable Drug Products Heino Prinz, PhD, Director Inspection Devices, Rommelag Endotoxin Testing – A Gamble on the Test System? Johannes Reich, MSc, Student, University of Regensburg Quantitative Analysis of Moisture in Intact Lyophilized Protein Samples by NIRS Suzanne Schreyer, Senior Scientist, Thermo Fisher Scientific Compairing Sterilization Methods Mason Schwartz, Sterilization Manager, Co‐inventor of the REVOX Sterilization Method, REVOX Sterilization Solutions Quality Metrics for Contract Clinical Supply Operations Amit Sitapara B.S., Quality Engineer, Lyophilization Technology Inc. Effects of Pressure Sensor Calibration Offset on Filter Integrity Test Values Magnus Stering, Product Manager, Sartorius Stedim 3
Development and Benefits of a UPLC‐RP Method for the Determination of Extra‐ Cellular Synthetic Insulin‐like Growth Factor 1 Protein (ECS‐IGF1) and its Related Compounds Nicolas Thurin, PhD, New Product Introduction & Development Team Leader, Catalent Pharma Solutions 10:45 a.m. ‐ 12:15 p.m. P2 – The Importance of Science & Technology to Building a Quality Culture Moderator: Steven Lynn, Vice President, Global Quality Compliance, Mylan Session Description: Science and Quality are at the foundation of everything we do in the Pharmaceutical Industry. In this session various aspects of Science and Technology, from the downside of cost an organization produces from poor quality to how management styles have a powerful effect on an organization to the critical link of manufacturing science and finally how all of these areas help to enable and ensure a robust quality culture is built and sustained. 10:45 a.m. ‐ 11:10 a.m. The Cost to Manufacturing for Poor Quality Fran Zipp, President, Lachman Consultant Services 11:10 a.m. ‐ 11:35 a.m. Process Capability Assessments as a way to improve Productivity and Compliance Jeff Levy, PhD, Vice President, Technical Services, Manufacturing Science, Eli Lilly & Company 11:35 a.m. ‐ 12:00 p.m. An Investigation into Management Styles that are the Most Likely to Impact Employee Behavior? Ira Mann, Senior Director of Quality, Validation & Regulatory Affairs Executive Search and Professional Development, FPC of Atlanta 12:00 p.m. ‐ 12:15 p.m. Questions and Answers/Discussion 12:15 p.m. ‐ 1:45 p.m. Networking Luncheon in Exhibit Hall 12:15 p.m. ‐ 1:45 p.m. Portfolio Steering Committee (Invitation Only) 12:15 p.m. ‐ 1:45 p.m. PDA Chapter Council Meeting (Invitation Only) 1:45 p.m. ‐ 2:45 p.m. 2016 PDA Annual Meeting Program Planning Committee (Invitation Only) 1:45 p.m. ‐ 3:15 p.m. Concurrent Sessions Improving Manufacturing Performance Changing Regulatory Landscape Biotechnology Advances & Expectations A1 – Reducing Manufacturing Variability B1 ‐ Threats to Global Supply Chain
C1 – Advances in Manufacturing Moderator: Ghada Haddad, Director, Moderator: John Geigert, PhD, RAC Moderator: Morten Munk, Senior Engineering, Sterile & Validation CoE, Merck President, BioPharmaceutical Quality Technology Partner, NNE Pharmaplan & Company Solutions Session Description: Variability in Session Description: Threats can come from Session Description: The manufacturing is a common problem in all almost anywhere in our global drug supply biopharmaceutical industry is facing a industries. The sources of variability include chains, impacting both chemical drugs and commercial environment that constantly people (e.g. human Error, interpretation of biologics. Herceptin and Remicade were requires higher productivity, higher quality information, natural human variability, etc.), stolen from a shipping truck in Italy and and lower costs. This has increased the machine (e.g. equipment degradation, reintroduced into hospitals around Europe. focus on evaluation of new production software not up to date, etc.), and methods Avastin was smuggled into the USA from technologies, including Single Use Systems (e.g. insufficient documentation, data Turkey and turned out to not even contain (SUS) and Continuous Processing. analytics, queue time management, etc.). any active ingredient. Adderol, Alli, Viagra, The presenters in is session will provide the Understanding and reducing this variability and many other drugs, all have been audience updated knowledge on the is a critical part of the continual impacted by counterfeits. The U.S. FDA innovation within emerging technologies improvement journey to improve quality, Office of Criminal Investigations (OCI) has and sophisticated approaches to 4
yields, equipment availability and cycle times leading to lower cost. The use of Manufacturing Control Strategies has been increasing as a way to identify the sources of manufacturing variability and the manufacturing controls needed to address this variability. Being able to develop a control strategy requires a deep understanding of the processes being used and their variability. The use of statistical process control (SPC) and statistical methods for understanding the level of variation is a significant part of any continuous improvement journey. Design of Experiments and the use of statistical methods to quantify variation are key principles of the more contemporary Six Sigma Quality and Lean Six Sigma (LSS) philosophies. Six Sigma Quality and LSS philosophies promote reduction in long‐
term variation. Traditional quality control suffers in that it is reactive to problems with an overemphasis on inspection and sorting. Continuous improvement philosophies are proactive with a focus on prevention and early detection of problems. Continuous improvement philosophies are data‐driven with the use of defendable statistical methods for diagnosing problems. This session will address the use of manufacturing control strategies and statistics in reducing manufacturing variability and will illustrate the challenges and opportunities in developing such strategies while emphasizing the benefits. pictures on their website of the 10 most wanted fugitives involved in counterfeit medicines. Regulatory authorities are taking action to try to control the problem. European Union (EU) issued in 2013 a directive spelling out steps that must be taken to prevent falsified medicinal products from entry into the supply chain. FDA is implementing the Drug Supply Chain Security Act (DSCSA) of 2013. This session will provide an update on the successes and ongoing challenges to this serious threat to the safety of our patients, and will focus on what the pharmaceutical companies must do to stay in compliance with the regulatory changes. 1:45 p.m. ‐ 2:15 p.m. Developing Manufacturing Control Strategies Gerald Leister, Advisor, Technical Services/Manufacturing Science, Eli Lilly & Company 2:15 p.m. ‐ 2:45 p.m. The Role of Statistics in Identifing Areas for Improvement Abe Germansderfer, Global Statistics Lead, MS&T, Novartis 2:45 p.m. ‐ 3:15 p.m. Questions and Answers/Discussion 1:45 p.m. ‐ 2:15 p.m. Implementation of Track and Trace Thomas Pizzuto, Vice President, Johnson and Johnson 3:15 p.m. ‐ 4:00 p.m. Refreshment Break in Exhibit Hall 4:00 p.m. ‐ 5:30 p.m. 2:15 p.m. ‐ 2:45 p.m.
Update on Counterfeiting Issues and Trends Michael Dalton, Advisor, Global Product Protection, Eli Lilly & Company 2:45 p.m. ‐ 3:15 p.m.
Questions and Answers/Discussion FDA Representative, Office of Criminal Investigation, FDA (invited) 5
streamlining the biopharmaceutical product supply. The first presenter is Bob Repetto who was the lead author on the recently published PDA Technical report on SUS, which offers a practical best practice approach to effective and quality oriented implementation of SUS. Additionally to presenting the key concepts from the PDA Technical Report, the presentation will offer insight to the latest developments and the future perspectives within this fast developing area. The second presenter is John Bonham‐
Carter, who was the editor of “Continuous Bioprocessing, Current Practice and Future Potential”. Continuous Processing has proven its worth in several related industries, while the acceptance and the implementation rate has, until now, been hesitant in the generally conservative biopharmaceutical field. Potential reasons will be discussed, including the technical complexity and concerns around the regulatory aspects, which for example could be as simple as how to define a batch. However, Continuous Processing has over the last years transformed to be one of the hot subjects in the industry, supported by an increasing number of companies’ reporting a successful implementation of this emerging technology. Take the opportunity to meet one of the front runners within the area, and listen to hands‐on experience as well as an inspiring view on the future development of Continuous Processing. 1:45 p.m. ‐ 2:15 p.m. Single Use Systems ‐ Current and Future Applications Robert Repetto, Senior Director, External Affairs, Pfizer, Inc. 2:15 p.m. ‐ 2:45 p.m.
Continuous Bioprocessing – Trends and Challenges John Bonham‐Carter, Director, Repligen Corporation 2:45 p.m. ‐ 3:15 p.m.
Questions and Answers/Discussion Concurrent Interest Group Sessions IG1‐ Filtration IG2‐ Biotechnology IG3‐ Combination Products IG4‐ Vaccines IG5‐ Pre‐Filled Syringe IG6‐ Process Validation Leader: Russell Madsen, President, The Williamsburg Group, LLC Interest Group Description: The Filtration IG meeting will up‐date on the Pre‐Use Post‐
Sterilization Integrity Testing (PUPSIT) issue, including change suggestions to Annex I. Other current topics of general interest to the IG participants will be discussed. The meeting is designed to encourage participation from the attendees and to ensure their filtration issues are thoroughly explored. Leader: Vince Anicetti, Senior Vice President, Quality, Coherus Biosciences
Interest Group Description: The Biotechnology interest group will review to conclusions and key points from the new PDA Technical Report “ Bioburden and Biofilm Management in Pharmaceutical Drug Substance Manufacturing" The presentations will review the current best practices in detection and remediation of biofilms in biologic drug substance manufacturing as well as case studies in detection and remediation of biofilm problems in biotech manufacturing plants. The session will also present authorship group consensus in process limits for bioburden during Biotech Drug Substance Manufacturing steps. Bioburden and Biofilm Management in Pharmaceutical Drug Substance Manufacturing Marc Mittelman, PhD, Co‐leader PDA Technical Report & Senior Managing Scientist, Exponent Leader: Lee Leichter, President, P/L Biomedical
Interest Group Description: Almost two years to the day after publication of the Final Combination Product GMP Rule on January 22, 2013, FDA has published a Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products. In the preamble to the Final Rule, FDA promised to publish a guidance to address issues that were raised in comments to the proposed rule, but not fully addressed. This guidance purports to address those remaining issues. Comments to the Guidance were requested by FDA to be submitted within 60 days. To respond, PDA organized a working group/task force to organize comments, suggestion and positions for approval and submission by PDA. Due to the timing, the interest group session will review and discuss the guidance and the PDA comments. Please plan to attend the meeting for a stimulating and informative discussion. Leader: John Finkbohner, PhD, Senior Regional Policy Director ‐ US, AstraZeneca
Interest Group Description: The Vaccines IG will be a review of hot topics in vaccines and will be followed by open discussion and a brainstorming session to identify new group goals to pursue in 2015. Leader: Olivia Henderson, Principal Scientist, Biogen Idec Interest Group Description: The Pre‐filled Syringe interest group will discuss topics such as:  Prefilled syringes Technical Report; what is it, and what does it do for me?  BPOG Extractables Protocol; will this affect my extractable studies?  Changes to USP <1207>; will this dictate changes to our current methods? Hear from industry experts and participate in the knowledge exchange. This session is open to anyone interested in this topic. Leader(s): Scott Bozzone, Senior Manager, Quality Systems & Technical Services Validation, Pfizer, Inc. and Vijay Chiruvolu, PhD, Senior Director, Kite Pharma Interest Group Description: Join us for an exciting session as we hear what’s new in process validation. Vijay Chiruvolu, will lead a discussion on One Patient = One ‘Batch’ ‐ Cell Therapy Products & Process Validation. The application of a process lifecycle during design, qualification, and use of continued process verification to unique individualized cell therapies will be discussed. Scott Bozzone, will update on pending approvals of international guidelines (to drafts from 2014) – EU Annex 15, WHO Appendix 7 and China FDA Annex 1, on Qualification and 6
IG7‐ Facilities & Engineering 5:30 p.m. ‐ 7:00 p.m. Networking Reception in Exhibit Hall 7:00 p.m. ‐ 9:30 p.m. Chair’s Reception (Invitation Only) Validation. Any recent approvals in 2015 will be described briefly. Michael Blackton , Co‐chair of the Annex 1 team on Oral Solid Dosage Forms and Semisolids to TR‐60 (Process Validation: a Lifecycle Approach) will present on activities of the team. Michael Blackton, AVP Validation Technical Services, Eli Lilly & Company (confirmed) Open discussion‐ bring your questions to get feedback from others present. Leader: Christopher Smalley, PhD, Director, BioSterile Validation, Merck & Company, Inc
Interest Group Description: The subject of Aging Facilities has become a topic of interest to regulators, and for a variety of reasons. Aging and unreliable facilities have been identified as a contributing cause of drug shortages. Aging facilities can contribute to higher manufacturing costs, and quality issues. But the answer is not always to raze an aging facility and start anew. There is a phrase, ‘Old but Gold’ that applies to facilities that have been properly maintained to provide on‐going assurance of high quality production at a reasonable cost – in fact a cost that is not driven up by large capital expenditures. We will be using this Interest Group session to discuss how a maintenance program can make a facility ‘Old but Gold,’ and even achieve higher reliability and quality through the use of not only preventive maintenance, but predictive maintenance. Come share your ideas, and together we can devise great solutions! Tuesday, March 17, 2015 7:15 a.m. ‐ 5:30 p.m. Registration Open 7:15 a.m. ‐ 8:30 a.m. Continental Breakfast 7:15 a.m. ‐ 8:15 a.m. Concurrent Breakfast Sessions 7:15 a.m. ‐ 8:15 a.m. Breakfast I: Portfolio Management Moderator: Glenn Wright, Senior Director, Project Management Manufacturing Science and Technology, Eli Lilly & Company Session Description: Regulatory reporting of post approval changes for manufacturing processes continue to increase throughout the world. Understanding the complexity a single or multiple changes can bring in regards to project delivery timing, supply chain constraints, as well as project value is critical to the manufacturing operation. This session will take a closer look at this complexity and the importance of portfolio management in understanding these connections. 7:15 a.m. ‐ 7:45 a.m. The Impact of Change and Post Approval Regulatory Reporting Requirements on 7:15 a.m. ‐ 8:15 a.m. Breakfast II: Quality Metrics Moderator: Susan Schniepp, Consultant, Regulatory Compliance Associates 7:15 a.m. ‐ 8:15 a.m. Breakfast III: Supply Chain Moderator: Steven Lynn, Vice President, Global Quality Compliance, Mylan Session Description: PDA has been working with FDA on the effort to establish quality metrics for the pharmaceutical industry and held their second Pharmaceutical Quality Metrics Conference in December 2014 with the theme Exploring Quality Culture and Quality Systems Maturity. This session will update attendees regarding the current thinking and direction for implementing meaningful quality metrics for the pharmaceutical industry. Session Description: The session will discuss the FDA’s Secure Supply Chain Pilot Program that was announced in August of 2013. The Pilot initially had 13 companies admitted which enables these companies to expedite the importation of active pharmaceutical ingredients and finished drug products into the US. 7:15 a.m. ‐ 7:45 a.m.
Update on Quality Metrics Steven Mendivil, Excutive Director, 7:15 a.m. ‐ 7:45 a.m.
Perspectives on FDA’s Secure Supply Chain Pilot 7
Manufacturing Operations – Managing the International Quality External Affairs,
Christelle Laot, PhD, Technical Fellow ‐
Portfolio of Change Amgen, Inc. Cold Chain Management, Life Sciences & Kim Clingerman‐Rice, Consultant – Global Specialty Services (LS3), FedEx Express Supply Chain, Insulins, Eli Lilly & Company 7:45 a.m. ‐ 8:15 a.m. 7:45 a.m. ‐ 8:15 a.m. Questions and Answers/ Discussion Questions and Answers/ Discussion 7:45 a.m. ‐ 8:15 a.m. Questions and Answers/ Discussion 8:30 a.m. ‐ 10:00 a.m. P3 – Flexible Manufacturing – Current Solutions and Future Visions Moderator: Maik Jornitz, President, G‐Con Manufacturing Session Description: Flexible manufacturing has become a pressing topic to be able to respond to varying capacity demands, fast deployment needs, multi‐product processing and reduction of cost burdens, to name a few. In this session, two cases, one for orals solid doses and the other for biologics, will be presented, which will show current activities in flexible manufacturing, the possibilities and the future vision. Both will describe manufacturing flexibilities in regard to facility, as well as process technology options. The cases can serve as examples for other flexible manufacturing initiatives or support activities already implemented. Furthermore, the options presented are applicable for green field facilities and process, but may also be option for process optimization, aging facility improvements and/or refurbishment possibility 8:30 a.m. ‐ 9:00 a.m. Advanced Development & Manufacturing Technologies and Concepts Michael O’Brien, Vice President Technology & Innovation, Worldwide R&D – PTx Pharmaceituic Sciences, Pfizer Inc. 9:00 a.m. ‐ 9:30 a.m. Securing Quality and Performance across an Extended Network Infrastructure Duncan Low, PhD, Scientific Executive Director, Amgen, Inc. 9:30 a.m. ‐ 10:00 a.m. Questions and Answers/ Discussion 8:30 a.m. ‐ 9:30 a.m. 2016 PDA Annual Meeting Exhibit Space Draw 9:45 a.m. ‐ 4:00 p.m. Exhibit Hall Open 10:00 a.m. ‐ 10:45 a.m. Refreshment Break and Poster presentations in Exhibit Hall Poster Presentations
The following posters will be presented during today’s refreshment breaks Quantification and Analysis of Vitamins, Amino Acids, and Metals in Upstream Biologics Drug Substance Raw Materials
Colleen Alexander, PhD, Scientist I, Bristol‐Myers Squibb Company Sterility Assurance Risk Management ‐ Aseptic Manipulations Frederic Ayers, BA, Associate Consultant Scientist – Technical Services / Manufacturing Science: Sterility Assurance, Eli Lilly & Company Comparison of Emerging Analytical Techniques for Particle Speciation in Sub‐micron Range and Application to Primary Packaging of Biologics Theresa Bankston, PhD, BS, MBA, MEM, Manager, BioAnalytical & Pharmaceutical Development, BD Preventing Virus Contamination of Bioreactors with a Virus Barrier Filter Christina Carbrello, Senior Scientist, EMD Milipore Understanding the Performance of a Lyophilizer Through Shelf Temperature Mapping Studies: Improving Technology Transfer Results Timothy Dutill, Research Scientist, Lyophilization Technology When Speed Matters: Facilitating Faster Technology Transfer by Engraining Quality into a Project Lifecycle Aaron Goerke, Senior Group Leader, Genentech Serialization Track‐and‐Trace ‐ Best Practices for the Packaging of Parenteral Products Jeffrey Henderson, Key Account Manager, Vetter Pharma International GmbH 8
Particle Reduction During Component / Closure Processing
Thomas Jochimsen, Project Manager, ATEC Sterile Technology Adsorption of Water using Packed‐Bed Column of Molecular Sieves for Pharmaceutical Preparation of Drug Product Formulation Chandrashekhar Kadam, PhD, Senior Principal Scientist (Director), Dr. Reddys Laboratories Ltd Cold Chain International Regulation in HMC Tarek Khary, Pharmacist, Hamad Medical Corperation High Barrier Multilayer Blow‐fill‐seal Containers: A Comparison of 4 different Analytical Methods for Oxygen Permeation Tim Kram, General Manager, Rommelag Investigation of Rouge on Cleaning and Efficacy of P. aeruginosa Biofilm on 316L Stainless Steel Surfaces Paul Lopolito, BA, Technical Services Manager, STERIS Corporation Validating an Automated Compendial Rapid Method for Water Testing Paul Lukes, GlaxoSmithKline Human Genome Sciences Gamma Irradiated Tubing Oxidation Impact on Monoclonal Antibody Cassandra Mifkovich, Associate Director, Engineering, Merck & Company, Inc. Nancy Schaffner, Principle Process Scientist, MSD Ireland Characterization of Buffer Solutions to Support GMP Manufacturing in the Biologics Pilot Plant Marta Muzylowski, Scientist, Merck & Company, Inc. Kelly Meighan, Scientist, Merck & Company, Inc. Large‐Scale Study on Glass Contamination: First Step in Continuous Improvement Plan Michele Poncini, Chemical Laboratory Manager ‐ Pharma BU, Bormioli Rocco The Life Cycle Approach to Cleaning Validation Elizabeth Rivera, MS CHE, Technical Service Specialist, STERIS Quality Involvement in Development Monica Rose, Dev QA, Manager, Novartis Vaccines Optimizing Bioburden Testing of Mammalian Cell Cultures Samples through the Use of Differential Lysis, Membrane Filtration and Analysis by a Rapid Micro Methods Andrew Sage MS, PhD, Principal Scientist, Rapid Micro Biosystems Sterility Testing ‐ The Detection of Stressed Microorganisms in Seven Days Sommer Vogel, Research Associate, Rapid Micro Biosystems Filtration as a Means to Remove Glass Particles From Liquid Medications Elinor Zarour‐ Shalev B.Sc, Mechanical Engineer, West Pharmaceutical Services Glass Strengthening: Producing Stronger, More Durable Glass by Ion Exchange Jianxiu Zhao, R&D Staff Scientist, BioAnalytical & Pharmaceutical Development, BD 10:45 a.m. ‐ 12:15 p.m. Concurrent Sessions Improving Manufacturing Performance Changing Regulatory Landscape Biotechnology Advances & Expectations A2 – Methods for Improving our B2 – Drug Shortages C2 – Cell Therapies – New Processes / New Manufacturing Performance Moderator: Susan Schniepp, Consultant, Challenges Moderator: William Miele, PhD, Regulatory Compliance Associates Moderator: Michael DeFelippis, PhD, Director/Team Leader, Microbiology and Senior Research Fellow, Eli Lilly & Company Aseptic Support, Pfizer, Inc. Session Description: Recently there has Session Description: This session will Session Description: Cell therapy involves been an emphasis and now a concerted provide the necessary background on how the administration of living cells for the focus on the use of metrics as key FDASIA became law, how it impacts the specific purpose of treating diseases. With performance indicators not only by industry and where FDA is at in successful regulatory approvals for some industry but also stimulated by regulatory implementing its many requirements in products already achieved, rapid growth in interest. Already the application of metrics particular those related to Drug Shortages. this area continues as evidenced by an has had broad impact on how we as an Once the stage is set the attendees will be increasing number of clinical trials industry do our business and how we will updated on the current status of how PDA is evaluating cell therapies for a variety of 9
control our processes into the future. Presentations in this session explore the broad range of these applications describing metrics and continuous improvement of processes in the future, use and improvement of legacy processes through metrics, and the intertwined and embedded issue of human error. Whether it is in the form of quality metrics, manufacturing performance metrics or the assessment and reduction of human error, performance gains can “pay off” only if there application is integrated throughout the continuum of our processes. Hear industry leaders relate their vision and actions to meeting the challenges through case studies and current programs. addressing drug shortages through the related PDA Drug Shortages Task Force and Strategic Plan. The information will provide the status and details of the PDA Technical Report on Risk Management for the Prevention of Drug Shortages. 10:45 a.m. ‐ 11:15 a.m. Analytics of the Future Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc. 10:45 a.m. ‐ 11:15 a.m. FDASIA Update John Finkbohner, PhD, Senior Regional Policy Director ‐ US, AstraZeneca unmet medical needs. Although cell therapy products hold great promise, many challenges to their successful development, commercialization and registration remain. One of the greatest challenges lies in developing reliable and robust manufacturing processes for producing safe, efficacious and reproducible products that are also economically viable. Depending on the product format, scale‐out or scale‐up process strategies need to be devised. Other manufacturing considerations include: preservation to minimize cell losses and prevent potential changes in function and/or clinical outcome, maintenance of cells during processing, handling and distribution, and characterization and testing requirements. This session focuses on the manufacturing challenges associated with developing and commercializing cell therapies and how these complexities may be managed to achieve their pharmaceutical promise. 10:45 a.m. ‐ 11:15 a.m.
Adapting Manufacturing to Meet the Needs for Cell Therapies Knut Niss, PhD, Senior Technical Project Leader, Novartis Pharmaceuticals Corporation 11:15 a.m. ‐ 11:45 a.m.
Case Study on Overcoming Manufacturing Challenges for a Cell Therapy Product Ali Siahpush, PhD, President and Founder, Pharmefex Consulting 11:15 a.m. ‐ 11:45 a.m. 11:15 a.m. ‐ 11:45 a.m.
Metrics: Transforming Data from Technical Report Output Information into Actionable Process Emma Ramnarine, Senior Director, Head Knowledge Global Biologics QC Network, Genentech, Sarah Horton, Six Sigma Leader, Pfizer, Inc. Inc. 11:45 a.m. ‐ 12:15 p.m. 11:45 a.m. ‐ 12:15 p.m.
11:45 a.m. ‐ 12:15 p.m.
Panel Discussion: Questions and Answers/Discussion Questions and Answers/Discussion Kerry Ingalls, Vice President, Regional Manufacturing, Amgen Europe 12:15 p.m. ‐ 1:45 p.m. Networking Luncheon in Exhibit Hall 12:15 p.m. ‐ 1:30 p.m. Interest Group Leaders Meeting (Invitation Only) 12:15 p.m. ‐ 1:30 p.m. PDA Publishing Committee (Invitation Only) 12:15 p.m. ‐ 1:45 p.m. Marketing Advisory Board (Invitation Only) 12:15 p.m. ‐ 1:45 p.m. Education Advisory Board (Invitation Only) 1:45 p.m. ‐ 3:15 p.m. Concurrent Sessions Improving Manufacturing Performance Changing Regulatory Landscape Biotechnology Advances & Expectations 10
A3 ‐ The Value of Knowledge Transfer and Process Validation Moderator: Vijay Chiruvolu, PhD, Senior Director, Kite Pharma Session Description: Process Validation has evolved significantly since the publication of the 2011 FDA Process Validation Guidance and the 2014 EMA guideline. Process Validation is no longer a 3‐batch exercise but a demonstration of process performance throughout the lifecycle of the product. The lifecycle approach allows for a comprehensive use of prior knowledge and science‐ and risk‐
based QbD approach to the demonstration process understanding and therefore the process performance. This session will highlight the importance of knowledge transfer generated from Process Design and prior knowledge in a lifecycle approach to Process Validation. B3 – Biologic Combination Products
Moderator: Michael DeFelippis, PhD, Senior Research Fellow, Eli Lilly & Company C3 ‐ Virus Contamination
Moderator: Mary Cromwell, Head, Global MSAT and Global Packaging Development, Genentech, Inc Session Description: Advances in biotechnology Session Description: Adventitious virus have accelerated growth in the number of contamination during production of biological products being pursued as biotherapeutics may impose a serious therapeutic agents for various diseases. Since health risk to patients receiving the dose administration by injection remains a therapeutics. One source of potential primary mode of delivery manufacturers are contamination is through some raw utilizing combination product approaches materials that are used in the cell culture incorporating injector‐based technologies as a process. Open processing may increase means to improve the patient experience. Pen, the risk of contamination through jet, and related injectors provide enhanced environmental sources. Manufacturers safety, improved dosing accuracy, and use risk mitigation strategies to reduce increased patient compliance, particularly in the potential for contamination of their self‐administration situations. Recent guidance cell banks, processes, and published by the FDA on the Technical facilities. Health authorities require Considerations for Pen, Jet, and Related manufacturers to develop purification Injectors Intended for Use with Drugs and processes that are demonstrated to have Biological Products (June 2013) describes the robust and sufficient removal or types of information expected to be included in inactivation of viruses to ensure the safe a marketing application. Nevertheless, the use in patients. There are several actual process of developing and registering a challenges in conducting the studies to biologic in combination with an injector evaluate the ability of process to remove platform can be extremely challenging. This or inactivate viruses, most notably the session will focus on the science and regulatory testing methods used for measuring the considerations associated with combination levels of the viruses. This session will product development programs and provide highlight risk mitigation strategies and practical insight needed to successfully navigate emerging methods for detecting and the submission and approval process removing viruses. 1:45 p.m. ‐ 2:15 p.m. 1:45 p.m. ‐ 2:15 p.m.
10:45 a.m. ‐ 11:15 a.m.
Applying Knowledge Transfer – Case Case Study on Combination Products Emerging Methods for Virus Detection Study Manfred Maeder, PhD, Head GCA Devices & and Removal Walter Manger, Associate Director, Merck Combination Products, Novartis Pharma AG Kathryn King, PhD, Biologist, CDER, FDA Sharp & Dohme Corporation 2:15 p.m. ‐ 2:45 p.m. 2:15 p.m. ‐ 2:45 p.m. 11:15 a.m. ‐ 11:45 a.m.
Process Validation and its Value – Case Case Study on the Successes and Challenges of CHO Endogenous Retroviral like Particle Study Registering a Biologic Pre‐filled Syringe and Removal by Protein A Chromatography John Clarke, Director of Process Pen Injector Combination Products Min Zhang, Associate Scientist, Process Validation, CMC Biologics John Towns, PhD, Senior Advisor Regulatory Virology, Genentech, Inc. Devices, Eli Lilly & Company 2:45 p.m. ‐ 3:15 p.m. 2:45 p.m. ‐ 3:15 p.m.
2:45 p.m. ‐ 3:15 p.m.
Questions and Answers/Discussion Questions and Answers/Discussion Questions and Answers/Discussion 3:15 p.m. ‐ 4:00 p.m. Refreshment Break in Exhibit Hall 4:00 p.m. ‐ 5:30 p.m. Concurrent Interest Group Sessions IG8 ‐ Sterile Processing/Parenteral Drug Leader: William Miele, PhD, Director/Team Leader, Microbiology and Aseptic Manufacturing Support, Pfizer, Inc. Interest Group Description: The manufacture of sterile products continues to receive a great deal of attention during regulatory inspections. This Interest Group session will review some of the most important points to consider in preparing for regulatory inspections, and provide an overview of a general inspection plan. Input from the attendees is encouraged and welcomed. 11
IG9 ‐ Management of Outsourced Operations IG10 ‐ Supply Chain Management IG11 ‐ Microbiology/Environmental Monitoring IG12 ‐ Visual Inspection of Parenterals IG13 ‐ Packaging Science Leader: Susan Schniepp, Consultant, Regulatory Compliance Associates and Karen Ginsbury, CEO, PCI Interest Group Description: Continuing from previous meetings of this growing Interest Group and in the light of FDAs draft guidance on Quality Agreements, this group will discuss current issues in communication and cooperation related to outsourced operations. A facilitated discussion led by the group co‐chairs and other experts both Contract Givers and Contract Acceptors will look at managing risk assessments, regulatory inspections and batch release in the light of recent regulatory guidances on these issues. Leader(s): Lucy Cabral, Quality Director, Genentech, Inc. and Amy Mutere, Global Inspection Management EU Region, Genentech, Inc. Interest Group Description: Supply Chain Interest Group will discuss the implementation of Annex 16 Supply Chain requirements and implementation of Elemental Impurities as part of ICHQ3D requirements. We welcome you attendance and input. Leader: Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting Interest Group Description: The Microbiology/Environmental Monitoring group will be having a presentation by Dr. Stephan Kraus of Astra Zeneca regarding the setting of bioburden limits for upstream monitoring. Following the presentation there will be a group discussion regarding issues/concerns with how these limits are set. Presenter: Stephan Krause, PhD, Director QA Technical Support, AstraZeneca Leader: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC Interest Group Description: The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products. A review of recent FDA 483 observations, warning letters and recalls will be presented. We will also discuss the new USP Chapter <790> Visible Particulates in Injectables and the associated Information Chapter <1790> Visual Inspection of Injectables, published in January 2015. We will plan time to discuss topics of interest and recent experiences of those in attendance. Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, inspection of protein‐based biopharmaceuticals, inspection of other difficult products or packages and country specific inspection requirements. Leader: Edward Smith, PhD, Principal Consultant, Packaging Science Resources
Interest Group Description: The following topics will be discussed during this interest group session:  The proposed changes in EP 3.2.1, their impact on glass quality, and comparison with current USP chapters on glass will be discussed.  A PDA Task Force has been working on a report on the nonconformities in rubber and seal components. The purpose of the task force is to develop a Technical Report including a Lexicon of defects for elastomeric closures and seal used with vials, cartridges and syringes that will visually illustrate nonconformities, their definition, location and classification. The report and lexicon will be similar to the current TR #43 for glass nonconformities.  A new glass formulation characterized as alkali aluminosilicate has been developed and discussed by Corning in a recent PDA Journal paper (Sept‐Oct 2014). A comparison of this glass with existing Type I borosilicate glasses for parenteral applications will be reviewed. Comparison of Proposed Changes in EP Chapter 3.2.1, Glass Containers for Pharmaceutical Use, with USP <660> & <1660> Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies Overview and Status of the PDA Task Force on Rubber and Seal Component Nonconformities Andrea M. Straka, Senior Technical Account Specialist, West Pharmaceutical Services 12
Comparison of Corning's Alkali Aluminosilicate Glass with Conventional Alkali Borosilicate Type I Glasses for Parenteral Applications Edward J. Smith, PhD, Principal Consultant, Packaging Science Resources 6:00 p.m. ‐ 9:00 p.m. Bowling With the Stars (Optional Event) Bowling is the perfect atmosphere to network alongside conference attendees. You will be placed in teams of 4 people. The evening includes food, prizes awards, music & fun! Additional information of pricing can be found in the networking section of the program brochure. Wednesday, March 18, 2015 7:00 a.m. ‐ 12:00 p.m. Registration Open 7:00 a.m. ‐ 11:00 a.m. Speaker Ready Room 7:15 a.m. ‐ 8:30 a.m. Continental Breakfast 7:15 a.m. ‐ 8:15 a.m. Concurrent Breakfast Sessions 7:15 a.m. ‐ 8:15 a.m. 7:15 a.m. ‐ 8:15 a.m. Breakfast IV: Enhanced Decision Making Breakfast V: Sterile Product Using ICH Q9
Manufacturing Moderator: Ursula Busse, PhD, Head GxP Moderator: Michael Sadowski, Director, Regulations Coordination, Novartis Sterile Manufacture Support, Baxter Healthcare Corporation Session Description: Decisions to either Session Description: The PDA Points to accept, mitigate, or eliminate a risks have Consider for Aseptic Processing was initially always been central to the risk published in 2003 and a Task Force of management process. Many of the ICH Q9 industry experts has been commissioned to tools for quality risk management use revise this document with focus on both objective information and subjective evolving contemporary practice. Recently a judgments as inputs into risk PIC/S Working Group was convened to decisions. Uncertainties of human consider updates to EU Annex 1 which judgments often—but not necessarily—
covers the Manfucture of Sterile Medicinal complicate risk decisions and decision Producsts. It is expected that the new making. The methods of decision analysis PIC/S document will include an expanded are complementary to those of quality risk scope and significant revision. A member management; and decision tools offer of the Task Force will summarize the critical ways to confront and control for uncertain content of the PtC Document and provide human judgments in risk decisions. This an update on the Annex 1 revision. session provides examples of expert judgments in quality risk management and how decision analysis provides a path to better risk decisions. 7:15 a.m. ‐ 7:45 a.m. 7:15 a.m. ‐ 7:45 a.m.
H. Gregg Claycamp, Research Biologist, Revision of the 2003 PDA Points to CVM, FDA Consider for Aseptic Processing and the Revision of the EU GMP Annex 1 7:45 a.m. ‐ 8:15 a.m. Gabriele Gori, Global Head GMP Questions and Answers/ Discussion Compliance & Auditing, Novartis 7:45 a.m. ‐ 8:15 a.m. Questions and Answers/ Discussion 13
7:15 a.m. ‐ 8:15 a.m. Breakfast VI: Aging Facilities ‐ Task Force Update Moderator: Glenn Wright, Senior Director, Project Management Manufacturing Science and Technology, Eli Lilly & Company Session Description: Aging facilities, in conjunction with drug shortage, have become a rising concern. PDA has responded to that concern and initiated the aging facility task force. In this session an up‐
date on the activities and progress of the aginign facility will be given. 7:15 a.m. ‐ 7:45 a.m. Update from the Task Force Maik Jornitz, President, G‐Con Manufacturing 7:45 a.m. ‐ 8:15 a.m. Questions and Answers/ Discussion 8:30 a.m. ‐ 10:00 a.m. P4 – Biosimilars on the Doorstep – Challenges and Opportunities Moderator: Ursula Busse, PhD, Head GxP Regulations Coordination, Novartis Session Description: Biosimilars are expected to increase patient access to affordable, high‐quality biologics, while reducing the financial burden on healthcare. In the European Union, Canada, Australia and several other countries, regulations have permitted market access to biosimilars for almost a decade. The US passed the Biologics Price Competition and Innovation Act (BPCIA) in 2010, and is finalizing guidances on biosimilars registration requirements and naming convention. Meanwhile, FDA received its first two biosimilars applications with an expected approval in early 2015. Biosimilars are however not “normal” generics. Their development is almost as long and complex as those of originator biologics. Each biosimilar requires a unique, scientifically tailored development program focused on comprehensive analytic characterization and clinical assessment. This session will cover regulatory and industry perspectives of biosimilars, addressing differences and similarities in worldwide biosimilars regulations, development strategies, manufacturing quality aspects, and hurdles to market. Case studies will illustrate the unique challenges and opportunities this new class of therapeutics encounters as it starts to gain acceptance in the global marketplace. 8:30 a.m. ‐ 9:00 a.m. Biosimilar Arriving in the US: Perceptions vs Reality Mark McCamish, MD, PhD, Global Head, Biopharmaceutical Development, Sandoz International GmbH 9:00 a.m. ‐ 9:30 a.m. Creating a Sustainable Global Biosimilars Market Sumant Ramachandra, MD, PhD, Senior Vice President R&D, Medical and Regulatory Affairs, Chief Scientific Officer, Hospira 9:30 p.m. ‐ 10:00 a.m. Questions and Answers/ Discussion 10:00 a.m. ‐ 10:30 a.m. Refreshment Break 10:30 a.m. ‐ 12:00 p.m. P5 ‐ Continuous Improvements of Facilities and Inspection Trends Moderator: Maik Jornitz, President, G‐Con Manufacturing Session Description: Inspection trends show that aging or failing facilities and processes happen and may cause major drug shortage problems. To rectify such manufacturing problems continuous improvement activities are necessary. If these activities were not utilized frequently, radical modernization may be needed. The session discusses current inspection trends and improvement processes. 10:30 a.m. ‐ 11:00 a.m. Aging Facilities – Upgrading your Manufacturing Facilities George Wiker, Vice President, US‐Life Sciences and Chemicals Market Segment Lead, M+W Group 11:00 a.m. ‐ 11:30 a.m. Inspection Trends CAPT Sharon Thoma, PharmD, National Expert, Pharmaceutical Inspections, ORA, FDA 11:30 a.m. ‐ 12:00 p.m. Questions and Answers/ Discussion 12:00 p.m. – 12:15 p.m. Closing Remarks and Adjournment Maik Jornitz, President, G‐Con Manufacturing and Co‐Chair, 2016 PDA Annual Meeting Program Planning Committee 14