Skip To The Main Content
2019 PDA Annual Meeting

2019 PDA Annual Meeting

Mar 11 - Mar 13, 2019
San Diego, CA

Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products

  • Conference
  • The Americas
Program Highlights

The 2019 PDA Annual Meeting is the premier venue for learning, benchmarking, and exploring the latest thinking with respect to innovation and continuous improvement in bio/pharmaceuticals. Investigate unique challenges, analyze current capabilities, and envision the possibilities of bio/pharmaceutical manufacturing!

Overview

PDA’s flagship Annual Meeting provides a venue for obtaining the latest and most comprehensive information on a broad range of topics related to processing, manufacturing, supply chain and quality control.  Moreover, the meeting provides a venue for learning, benchmarking and sharing of learnings with respect to innovation and continuous improvement, ultimately providing quality medicines for patients.

The theme of the 2019 meeting is Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products.  In selecting this theme, the planning committee’s goal is to design a comprehensive event that encompasses the wide-ranging interests of all PDA members. Whether you are focused on improving existing processes or delving into entirely new technologies and therapies, we will cover relevant information important to both small molecule pharmaceutical and biopharmaceutical industries will be covered. 

Plenary sessions will inspire all of us to engage each other as we focus on the importance of what we do every day to improve the quality of life for millions of people.  It is a daunting and empowering task we are faced with and these sessions will focus on key aspects of our work including innovative manufacturing strategies, supply chain complexity, disruptive technologies and rapid drug development.

Rounding out the program are Interest Group sessions, which offer participants a chance to engage in interactive discussions on a variety of important topics and specific disciplines. The exhibition hall provides opportunities for one-on-one interactions with service providers and vendors who will showcase the latest services and technologies. Authors of numerous poster presentations will also be present to discuss their latest research and data. This year, students and young professionals will have the opportunity to present a poster or from the podium. Social events and breaks are scheduled throughout the meeting to allow time for further networking and peer-to-peer discussions.

This meeting is a ‘must attend’ knowledge sharing event for everyone and especially for those who have recently joined the industry, it is an ideal opportunity to accelerate your impact and position in your company as well as in the pharmaceutical society. Register by February 1, 2019 to take advantage of early bird savings.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Sunday, March 10

    1:00 p.m. – 7:00 p.m.
    Exhibitor Set Up

    4:00 p.m. – 7:00 p.m.
    Registration Open

    6:30 p.m. – 9:30 p.m.
    PDA Awards Dinner (Invitation Only)

  • Monday, March 11

    6:00 a.m. – 7:30 a.m.
    5k Run/3k Walk A Run/Walk to support Global Genes, a non-profit organization advocating for the needs of the rare disease community

    9:00 a.m. – 4:00 p.m.
    Exhibitor Set Up

    9:00 a.m. – 5:00 p.m.
    Registration Open

    11:30 a.m. – 12:30 p.m.
    PDA Orientation Lunch (Invitation Only)

    1:00 p.m. – 1:30 p.m.
    Welcome and Opening Remarks from the Chair of the PDA Board of Directors, PDA’s President, and the Meeting Program Planning Committee Co-Chairs
    Rebecca Devine, Biopharmaceutical Consultant
    Richard Johnson, President and CEO, PDA
    Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.
    Melissa S. Seymour, MBA, Vice President, Global QC Operations, Biogen, Inc.

    1:30 p.m. – 3:00 p.m.
    P1: From Bench to Bedside
    Moderator: Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

    Translational medicine is often described as the process of transferring a therapy “from bench to bedside” and the journey spans years to decades, even under the most expeditious conditions. Success depends not only on biological efficacy, but also on the collaboration of a diverse workforce crossing many disciplines to move the therapeutic through the “valley of death” between basic research and commercial production. Translational oncology has grown rapidly over the past 15 years, in part due to advances in both research and diagnostic tools. These advances have enhanced our understanding of human biology and improved countless human lives. In this session we explore the accelerated development and commercialization of a cancer immunotherapy and hear directly from a patient treated with that immunotherapy.

    1:30 p.m. – 2:00 p.m.
    Moving Heaven and Earth: The Manufacturing Commercialization of a Cancer Treatment…And What Came After
    Michael P. Thien, Sc.D., Senior Vice President of Operations, Manufacturing Systems Design & Commercialization, Merck & Co., Inc.

    2:00 p.m. – 2:30 p.m.
    Recurrent Stage 4 Head and Neck Cancer, a Patient’s Journey and Hope for the Future
    Chester Kitchen, Director, Corporate Development, Merck & Co., Inc.

    2:30 p.m. – 3:00 p.m.
    Questions and Answers/Discussion

    3:00 p.m. – 3:30 p.m.
    Refreshment Break

    3:30 p.m. – 5:00 p.m.
    P2: Accelerating Pharmaceutical Innovation
    Moderator: Michael R. De Felippis, PhD, Distinguished Research Fellow, Bioproduct Research and Development, Eli Lilly and Company

    The arrival of personalized therapies, issues with product availability and affordability and evolving regulatory expectations are highlighting that conventional approaches to biopharmaceutical manufacturing are no longer adequate to meet current and future manufacturing demands. A reluctance to change further diminishes agility and impedes the ability to accelerate pharmaceutical innovation. Even though there are compelling reasons to move beyond business as usual, the pharmaceutical industry still lags other manufacturing sectors in adopting technologies such as robotics and automation, integrated process monitoring and control, and predictive modeling. This session explores needed transformation in sterile biopharmaceutical manufacturing. Case studies and specific examples will provide insights into the opportunities, challenges and potential solutions for facilitating necessary improvements now and into the future.

    3:30 p.m. – 4:00 p.m.
    Opportunities and Challenges in Implementing Next-Generation Technologies for Drug Product Manufacturing
    Nitin Rathore, PhD, Director of Core Technologies, Amgen Inc.

    4:00 p.m. – 4:30 p.m.
    Sterile Biopharmaceutical Manufacturing Today and Tomorrow – A Call to Action
    Hal Baseman, Chief Operating Officer, ValSource, LLC

    4:30 p.m. – 5:00 p.m.
    Questions and Answers/Discussion

    5:00 p.m. – 6:30 p.m.
    Grand Opening Celebration in Exhibit Hall

  • Tuesday, March 12

    7:30 a.m. – 5:30 p.m.
    Registration Open

    7:30 a.m. – 8:30 a.m.
    Continental Breakfast

    8:30 a.m. – 10:00 a.m.
    P3: Overcoming Regulatory Hurdles to Manufacturing Innovation
    Moderator: Ursula Busse, PhD, MBA, Head Quality Intelligence, External Relations, Novartis

    Today’s innovative therapies require a complete revision of the traditional manufacturing environment. Manufacturing of the future must become efficient, flexible and agile to adapt to rapidly changing demands and to meet evolving patient needs. Meanwhile, improvements need not compromise the quality and availability of therapies. This implies the use of innovative manufacturing and supply approaches and cutting-edge technologies. And it requires overcoming challenges and barriers to their implementation.

    This session will focus on challenges encountered when introducing improvements in the manufacturing space during a product’s lifecycle. Participants will learn how companies manage to introduce continual improvements and manufacturing innovation despite the current global regulatory complexity for post-approval changes (PAC). Solutions using risk- and science-based approaches to PAC, leveraging effective quality systems, and using additional means such as safety surveillance to minimize residual risks will be presented. A panel discussion will explore how we can use current tools in addition to ICH Q12 to further reduce the regulatory reporting burden and encourage faster adoption of novel, state of the art technologies in manufacturing.

    8:30 a.m. – 8:50 a.m.
    Managing Continual Improvement/Manufacturing Innovation during a Product’s Lifecycle
    Juan Torres, PhD, Senior Vice President, Global Quality, Biogen

    8:50 a.m. – 9:10 a.m.
    Using Risk-Based Approaches to Reduce the PAC Regulatory Burden
    Anders Vinther, PhD, Vice President, Quality & Engagement, Intarcia Therapeutics, Inc.

    9:10 a.m. – 9:30 a.m.
    Maximizing the Utility of Safety Surveillance for Post-Approval Manufacturing Changes
    John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    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

    10:45 a.m. – 12:15 p.m.
    Concurrent Sessions 

    INNOVATIVE MANUFACTURING STRATEGIES

    A1: Biomanufacturing of Tomorrow
    Moderator: Aaron R. Goerke, PhD, Director, Head of MSAT, Singapore Technical Operations, F. Hoffmann-La Roche

    New visions are on the horizon for the future of biologics manufacturing, and the field is on the cusp of great change.  Shouldn’t we therefore refer to these visions as Biomanufacturing of Tomorrow?  The possibility of end-to-end continuous bioprocess facilities is coming to realization with recent advancements. Yet significant effort may be required to realise implementation for clinical and commercial manufacturing in terms of sophisticated analytics for monitoring and control, novel methodologies or technologies to bridge differences from traditional platform, change management mindset and establishing the business case. This session looks to discuss progress and strategies where technologies and continuous platforms will better serve our needs and in conjuncture with progress in data analytics with PAT enables predictive process control and ultimately attains real-time release.

    10:45 a.m. – 11:15 a.m.
    Future of Sterile Drug Product Manufacturing: An Approach and Ideas to Increase Agility Compliance and Efficiency
    Sven Hauptmann, PhD, 
    Executive Vice President, Drug Product Manufacturing, 
    F. Hoffmann-La Roche

    11:15 a.m. – 11:45 a.m.
    Large Scale Production of MAbs and MAb-Like Products using Continuous and Integrated Processing
    Jon Coffman, PhD, Global Head, Innovation, Boehringer Ingelheim

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    DISRUPTIVE TECHNOLOGIES

    B1: Connected Health and Drug Delivery
    Moderator: Austin Caudle, Associate Director, Business Development, IQVIA

    Pharmaceutical companies are embracing connected drug delivery technologies to help differentiate their products and provide a balance between fostering innovation and cost containment. With drugs alone becoming less important, delivery technologies could be the key to market positioning and help propel companies to profitable growth and positive patient experiences. In the past, deployment of connected drug delivery devices has been hampered by high product cost, limited reimbursement, and lack of technology awareness with patients. This is changing however as manufacturers of connected drug delivery devices focus on collaboration with software companies and utilization of cloud-based data systems. This session focuses on how digital health and connected devices are pushing the healthcare industry in a fundamentally new direction.

    10:45 a.m. – 11:15 a.m.
    Digital Health Transformation and the Role of Drug Delivery
    Divakar Ramakrishnan,
    Chief Digital Officer and Vice President, Delivery, Device, and Connected Solutions, Eli Lilly and Company

    11:15 a.m. – 11:45 a.m.
    Industry Presenter Invited

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    IG1: QUALITY RISK MANAGEMENT AND CELL & GENE THERAPY INTEREST GROUPS

    QRM Leaders: Magaly Aham, Senior Director, Quality Compliance, Takeda, and Amanda Bishop McFarland, Consultant, ValSource, LLC,

    CGT Leaders: Michael Blackton, MBA, Vice President, Quality, Adaptimmune LLC, and Vijay Chiruvolu, PhD, Vice President, Process Development, Kite Pharma, a Gilead Sciences company

    The Quality Risk Management Interest Group and Cell and Gene Therapy Interest Group will join together in this session to explore the ways that QRM can help enable CTG firms to overcome regulatory and manufacturing challenges with strategic risk-based decision making. Cell and Gene Therapy products are experiencing a unique set of challenges with respect to navigating regulatory guidance and the personalized medicine supply chain.  One of the ways to overcome these challenges is using strategic risk management practices and embedding a culture of risk-based decision making into the firm’s culture.

    Speaker:
    Effective Application of Risk Management in the Cell and Gene Therapy Supply Chain

    Polly M. Hanff, Global Regulatory Affairs & Quality Director, Saint-Gobain Life Sciences

    IG2: TECHNOLOGY TRANSFER INTEREST GROUP

    Leader: Melissa S. Seymour, MBA, Vice President, Global QC Operations, Biogen, Inc.

    Technology transfer continues to be a major area of interest within the pharmaceutical industry.  Recent advancements in knowledge and risk management play a significant role in how the industry is adapting technology transfer.  The TT IG has submitted a proposal for a Technical Report focused on tools for technology transfer as well as an industry survey.  This session will begin with a review of the tools and strategies being developed as part of the TR, followed by a summary of the survey results which will focus on the use and methodology for technology transfer including emerging technologies, knowledge and risk management, regulatory implications, documentation and business strategies. The session will end with an innovative manufacturing case study utilizing some of the tools discussed with a goal of making this interactive.

    Speakers:

    Tech Transfer Essentials: Benchmarking, Tools, Tips and Supplemental TR Guidance
    Beth J. Haas,
    Principal Consultant, CAI
    John D. Wass, Global Business Lead, Process and Manufacturing Technology,CAI

    12:15 p.m. – 1:45 p.m.
    Networking Luncheon and Tech Talks in Exhibit Hall

    1:45 p.m. – 3:15 p.m.
    Concurrent Sessions

    INNOVATIVE MANUFACTURING STRATEGIES

    A2: Turning Data into Operational Solutions
    Moderator: Karen Walker, Vice President, Global Quality, Seattle Genetics

    In this era of Big Data, Data Lakes and the Internet of Things, this session will explore what is being done to capture knowledge and drive adaptability into the manufacturing, quality and supply chain processes.

    1:45 p.m. – 2:15 p.m.
    Industry 4.0: From Long Term Vision to Concrete Practical Steps
    Arne Zilian, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    2:15 p.m. – 2:45 p.m.
    Sadik Kassim, Chief Scientific Officer, Mustang Bio

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    DISRUPTIVE TECHNOLOGIES

    B2: Cell and Gene Therapy
    Moderator: Kelly Waldron, PhD, Senior Consultant,ValSource LLC

    The advent of gene editing in the 1980s foretold next-generation lifesaving and life sustaining medicinal applications. As industry sought to develop and commercialize this technology into safe and effective treatments, challenges began to surface. PDA meetings and conferences have provided a forum for industry to discuss these issues and, more importantly, share potential solutions. This session is focused on solutions, rather than challenges, and will explore two potential approaches to common goals in the production of cell and gene therapies: non-target viral clearance, and best practices in biopreservation.

    1:45 p.m. – 2:15 p.m.
    A Stage Appropriate Viral Clearance Strategy for Sf9/Baculovirus Based Manufacturing of rAAV
    Andrew M. Wood, MS, Senior Engineer,Voyager Therapeutics

    2:15 p.m. – 2:45 p.m.
    Phase-Appropriate Application of Biopreservation: Best Practices to Support Regenerative Medicine Advanced Therapy Commercialization
    Brian J. Hawkins, PhD, Scientific Applications Director,BioLife Solutions, Inc.

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    IG3: FACILITIES AND ENGINEERING INTEREST GROUP

    Leader: Shelley Preslar, General Manager, Azzur Group South East

    In today’s marketplace, we are constantly running into manufacturing and supply challenges.  In this session, we’d like to hear about some innovative solutions being put in place within the industry to address some of these issues. There are multiple opportunities to learn from – Focus will be on “hot topics” which may include:

    1. Aseptic fill in a non-classified environment
    2. Integrated manufacturing – real time data management
    3. Facilities & Equipment risk management – so what??  Does it add value?
    4. Manufacturing quality/supply chain issues

    IG4: VACCINES INTEREST GROUP

    Leader: Sabrina A. Restrepo, PhD, Director, Sterile & Validation Center of Excellence, Merck & Co., Inc.

    The session will present to the participants the status of the ongoing activities within the Vaccines Interest Group which are mainly focused around the development of technical report(s) or key deliverables regarding vaccines lifecycle management, vaccines specifications and new technologies. Participants will have the opportunity to listen case study or studies that frame the relevance of these topics and share their perspective as well. 

    Speaker:
    Philip R. Kuhl, PhD, 
    Director, Engineering, Merck & Co., Inc. 

    3:15 p.m. – 4:00 p.m.
    Refreshment Break, Passport Raffle and Poster Presentations in Exhibit Hall

    4:00 p.m. – 5:30 p.m.
    Concurrent Sessions

    INNOVATIVE MANUFACTURING STRATEGIES

    A3: Manufacturing Lessons Learned: Great Risks and Innovative Solutions
    Moderator: Shelley Preslar, General Manager, Azzur Group South East

    Our industry continues to face increased challenges with solving unique patient needs and being able to deliver needed medicines to the patient population. With the growing complexity of human disease and manufacturing supply chains, there is a constant need to deliver innovative solutions. Success requires continually evolving thought processes to look at problems from a new perspective. In this session we explore how one company developed a truly unique approach to an existing patient issue by implementing groundbreaking technology with a unique process. Additionally, we will hear about a disruptive approach designed to eliminate drug shortages.

    4:00 p.m. – 4:30 p.m.
    The Power of Vascular Innovation
    Heather L. Prichard, PhD, Senior Vice President, Process Development, Humacyte

    4:30 p.m. – 5:00 p.m.
    A New Approach to Ensuring Uninterrupted Patient Supply
    Greg Larsen, Business Partner, Civica Rx

    5:00 p.m. -5:30 p.m.
    Questions and Answers/Discussion

    RAPID DRUG DEVELOPMENT

    B3: Accelerated Development for Unmet Medical Needs
    Moderator: Diane M. Paskiet, Director of Scientific Affairs,West Pharmaceutical Services, Inc.

    There are certain aspects of typical drug development programs which may not be practical for accelerating approval of medicines intended for serious or life-threatening conditions. Novel drug products and treatments for severe conditions will have unique considerations for enabling rapid drug development. Regulatory flexibility is essential for patient access to these life-saving medicines, while preserving appropriate standards for safety and effectiveness. There are four principle FDA programs to address expedited approval pathways for unmet medical needs. This session will provide a background from FDA on expedited programs for serious conditions. Since 2008 more than 320 drug products have been developed and approved based on breakthrough therapy designations and/or expedited pathways. In addition, a case study will be given based on pharma experience with expedited pathway designation and approval.

    4:00 p.m. – 4:30 p.m.
    Living in Uncertain Times: Challenges with Accelerated Development and Deployment of Pharmaceutical Countermeasures for Unanticipated and Unmet Medical Needs
    Douglas Kiehl, Research Advisor, Eli Lilly and Company

    4:30 p.m. – 5:00 p.m.
    Candis Morrison, PhD, Senior Clinical Analyst, CDER, FDA

    5:00 p.m. -5:30 p.m.
    Questions and Answers/Discussion

    IG5: BIOPHARMACEUTICAL MANUFACTURING INTEREST GROUP

    Leader: Peter Makowenskyj, Director of Sales Engineering, G-Con Manufacturing, Inc.

    Major advancements in manufacturing continue to occur in the biopharmaceutical sector but our field also faces many challenges. We will look at two distinct areas where challenges and growth continue to exist, continuous manufacturing for Mabs and Cell and Gene Therapy. First, we plan to hear from a representative of the BPOG Continuous Manufacturing Road Map team and the work they have done over the past two years putting this together along with their findings. Next, we plan to have a panel discussion from industry experts in the field of cell and gene therapy reviewing the evolution in this space as well as how we plan to address challenges moving forward.

    IG6: FILTRATION INTEREST GROUP

    Leader: Maik W. Jornitz, CEO, G-Con Manufacturing and
    Russell Madsen, President, The Williamsburg Group, LLC

    The main topic of discussion will be PDA’s PUPSIT initiative, including the status of blocking studies and the ability of the post-filtration integrity test to detect a flawed or non-integral filter. Attendees will be updated on the current status of the PUPSIT initiative and its potential impact on regulators’ requirements for preforming PUPSIT.

    5:00 p.m. – 6:30 p.m.
    Nautical Nights Celebration: Admission is included with a Full Conference registration. Guests are welcome to attend at $70 per person!

  • Wednesday, March 13

    7:30 a.m. – 3:15 p.m.
    Registration Open

    7:30 a.m. – 8:30 a.m.
    Continental Breakfast

    8:30 a.m. – 10:00 a.m.   
    P4: Bridging Current Technology with the Future of Medicine
    Moderator: Morten Munk, Global Technology Partner,NNE

    The pharma industry is moving beyond the traditional “one drug, one protein, one disease” paradigm to pipelines with multiple sophisticated new drug modalities, covering a wide array pharmaceutical product ranging from simple proteins to cell-based therapy. This transition will for require deployment of a range of new technologies, but the future manufacturing challenges can also benefit from an increased use of tools, that are currently established or in the process of being developed. To a large extent those tools are based on a better utilization of available data to develop an increased amount of product and process knowledge, as both data and established knowledge often are not explored sufficiently, as it is not structured and accessible enough.

    The two presentations in this session, will discuss how an improved Control Strategy can be deployed by using tools from the Pharma 4.0 world, which include increased use of statistical methods, data analysis, real time monitoring and not at least Artificial Intelligence to help exploring, interpreting and presenting all the obtainable data.

    8:30 a.m. – 9:00 a.m.
    Artificial Intelligence use in the Pharmaceutical Industry - Quality Performance in a Pharma 4.0 World
    Claus Abildgren, Director of Sales, North America, Bigfinite Inc.

    9:00 a.m. – 9:30 a.m.
    Databased Road Map to Continuous Control Strategy and Real-Time Release
    Per Vase, PhD, Managing Partner, Applied Manufacturing Science,NNE

    9:30 p.m. – 10:00 a.m.
    Questions & Answers/Discussion

    9:45 a.m. – 1:45 p.m.
    Exhibit Hall Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break, Passport Raffle, and Poster Presentations in Exhibit Hall

    10:45 a.m. – 12:15 p.m.
    Concurrent Sessions 

    RAPID DRUG DEVELOPMENT

    A4: Novel Modalities Driving Changes in Traditional Manufacturing Approaches
    Moderator: Tia L. Bush, Vice President, Rhode Island Site Operations, Amgen Inc.

    Increasingly diverse product pipelines and technological advances are driving innovation in the biomanufacturing space. Historically, marketed biologics were comprised primarily of recombinant proteins and monoclonal antibodies.  Today, human biology is driving multiple modalities including Car T cells, RNAi, and bi-specific T-cell engagers in drug discovery and development.  This session will focus on how companies are designing their manufacturing footprint to accommodate these novel modalities by building new manufacturing capabilities while increasing speed and flexibility in their supply chain.

    10:45 a.m. – 11:15 a.m.
    Art Hewig, Executive Director, Process Development, Amgen Inc.

    11:15 a.m. – 11:45 a.m.
    Jose Vidal, PhD, Senior Vice President, Quality Assurance and Process Sciences, Atara

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    HANDLING COMPLEXITY IN THE PRODUCT VALUE CHAIN

    B4: Supply Chain Complexity
    Moderator: Magaly Aham, Senior Director, Quality Compliance,Takeda

    Supply chain complexity is a system with a broad range of variations. A typical example would be a globally operating corporation with multiple production sites, all of which are in contact with numerous distribution centers worldwide, supplying thousands of end points. But there are other issues that pose further threat to the supply chain and consequently patients such as counterfeiting, natural disasters, cargo theft and diversion among others. Health Authorities and Companies need to be prepared to rapidly respond to potential health crisis in order to minimize risks to patients. Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in environment and market demand. This session will discuss some of these challenges and available routes and suggestions to deal with these worst-case scenarios.

    10:45 a.m. – 11:15 a.m.
    Managing Risks to your Supply Chain and Increasing Patient Safety
    Leo Vaytsman, Regional Manager, Global Product Protection, Takeda 

    11:15 a.m. – 11:45 a.m.
    Product and Process Authentication
    John P. Jasper, PhD, 
    Chief Scientific Officer, Molecular Isotope Technologies LLC/ Nature's Fingerprint Authentication

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    IG7: ENVIRONMENTAL MONITORING/MICROBIOLOGY INTEREST GROUP

    Leaders: Julie Barlasov-Brown, Associate Director, Sterile and Microbiology QA, Merck & Co. Inc. and
    Marc Glogovsky, MS, S.M.,
    Senior Consultant, Microbiology, ValSource, LLC

    Majority of testing in the microbiology laboratory are being performed manually and many companies still use paper-based systems to collect the data. Some use a combination of paper and digital records. Having well validated and properly functioning electronic systems will create strong data integrity and less regulatory issues. This session will touch base on regulatory expectations, industry direction and will provide a case study on going paperless in microbiology laboratory testing (from EM to sterility). After the presentation there will be extensive Q&A and round table discussion on the subject.

    Speaker:
    Staci Williams,
    Microbiologist, Adaptimmune LLC

    YOUNG PROFESSIONALS/WORKFORCE OF THE FUTURE

    Moderators: Jason Kerr, Quality Assurance Specialist,Amgen Inc. and
    Kristin Valente, Director, Vaccine Process Development & Commercialization, Downstream, Merck & Co. Inc.

    Every day, approximately 10,000 baby boomers (individuals born between 1946 and 1964) reach retirement age. As these critical scientists and leaders exit the workforce, training the workforce of the future represents a significant challenge that is crucial to the success of pharmaceutical organizations. This session begins with knowledge transfer tools and capabilities for a products entire life cycle and highlights its importance. Additionally, this session highlights case studies from two young professionals: The first example explores potential career options facing young professionals early in their careers and the second presents a case study in the development of innovative antisense oligonucleotide therapies by a scientist early in her career. The collection of knowledge management, career development and scientific achievement, presented here, will explore the factors necessary for young professional development and workforce evolution.

    10:45 a.m. – 11:15 a.m.
    Capture and Reuse of Critical Knowledge during Technology Transfer
    Paige E. Kane, PhD, Director, Knowledge Management, Merck & Co., Inc.
    Martin J. Lipa, Executive Director, Knowledge Management, Merck & Co., Inc.

    11:15 a.m. – 11:30 a.m.
    Industry Presenter Invited

    11:30 a.m. – 11:45 a.m.
    Antisense Oligonucleotide Therapies: Molecule Requirements from a Packaging Perspective
    Amy A. Kim, Analyst-Specialist, West Pharmaceutical Services, Inc.

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:45 p.m.
    Networking Luncheon and Tech Talks in Exhibit Hall

    1:45 p.m. – 3:15 p.m. 
    P5: When Disaster Strikes: Business Continuity for Continuous Supply
    Moderator: Melissa S. Seymour, MBA, Vice President, Global QC Operations, Biogen, Inc.

    1:45 p.m. – 2:05 p.m.
    How Crisis Management & Business Continuity Plans Sustained Product Supply to Patients during Hurricane María
    Yaritza M. Rodriguez, Risk Management Manager, Amgen Manufacturing Limited

    2:05 p.m. – 2:25 p.m.
    Innovative Vaccine Delivery Methods
    Linda Pulli, Chief of Staff, Global Supply Chain,Merck & Co. Inc.

    2:25 p.m. – 2:45 p.m.
    Cyber Threats and Readiness Activities
    Steve Thompson, Sr. Manager Professional Services, ValGenesis

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:15 p.m.
    Closing Remarks & Adjournment from Co-Chairs of the 2020 PDA Annual Meeting Program Planning Committee


Networking Opportunities

Monday, March 11

PDA Charity Walk/Run benefiting Global Genes®
6:00 a.m. - 7:30 a.m.
Put on your walking or running shoes in the morning before the 2019 PDA Annual Meeting gets started to support Global Genes®! Meet behind the hotel for a beautiful scenic 5k run/3k walk along San Diego’s Embarcadero seaside walkway in support of this worthy cause. Sign me up!

Exhibit Hall Grand Opening Reception
5:00 p.m. - 6:30 p.m.
Join us for the Grand Opening Celebration in the Exhibit Hall. Use this as an opportunity to make connections with colleagues, peers, and suppliers and wind down from a busy first day!

Tuesday, March 12

Nautical Nights Reception
6:30 p.m. – 9:30 p.m.
Anchors aweigh! Meet out on the Marina Terrace for a beautiful view of the Harbor and celebrate with your fellow conference-goers at the outdoor Nautical Nights Reception! Enjoy food, drink, and snap pictures in the photo booth while listening to a live band.

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this event, attendees will be able to:

    • Define  manufacturing and quality requirements for immunotherapies, gene and cell therapy products
    • Navigate the complexities of supply chain and serialization requirements
    • Apply continuous manufacturing applications and flexible facility designs of the future
    • Identify new trends and potential disruptive developments in the health care sector
    • Understand rapid drug development pathways
    • Define and understand risks and mitigation of those risks
    • Interpret the latest regulations and requirement of Data Integrity
    • Establish relevant control strategies through streamlining of parameter classification
  • Who Should Attend

    Who Should Attend

    Job Functions
    Scientist | Executive and Mid-Level Management | Project Management | Technical Services | Supply Chain | Manufacturing Application | Risk Management

    Departments
    Manufacturing | Product Development | Quality | Research & Development | Regulatory Affairs | Engineering | Laboratory Science | Information Technology | Validation | Training

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ACPE # 0116-0000-19-001-L04-P | 1.35 CEUs

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Marriott Marquis San Diego

333 W Harbor Drive
San Diego, CA
Phone: +1(619)-234-1500

Make a Reservation
Marriott Marquis San Diego
  • Accommodations

    The PDA room block is now closed. However, reservations can still be made on a space-and-rate available basis. Please contact the Marriott Marquis San Diego directly at +1 (888)-236-2427.

    Guestroom rates are subject to State and Local taxes, 10.5% occupancy tax, 2% San Diego Tourism Marketing District tax and $0.77 Commerce Fee per room per night. Tax rates are subject to change without notice. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival to avoid cancellation fees.

  • Amenities

    Immerse yourself in the charm of San Diego by staying at Marriott Marquis San Diego. Situated on the waterfront with a 466-slip marina, our four-star hotel is within walking distance to the best of downtown. Ideal for both business travelers and vacationers, the hotel is steps from the San Diego Convention Center and within walking distance to City Walk, the Gaslamp Quarter, Seaport Village, and Petco Park. After exploring the area, relax in our spacious accommodations, all offering either scenic city or waterfront views. Take a dip in one of our two freeform swimming pools, indulge in an onsite spa treatment, or keep your workout routine in our fitness center. Enjoy award-winning cuisine at Marina Kitchen Restaurant & Bar, or sample inventive Asian-fusion at Roy's.

    Read more about the amenities offered at the Marriott Marquis San Diego.

How to Get Here

By Air

San Diego International Airport (SAN) is located 3.3 miles (about 15 minutes) northeast from the Hotel. Taxis are on standby at the San Diego International Airport (SAN), offering service to and from the Marriott Marquis San Diego for an approximate fare of $18 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 15 minutes.

By Car

Directions from San Diego International Airport
Turn left on Harbor Drive. Follow Harbor Drive along waterfront. Hotel will be on right (about 2 miles).

Parking at the Hotel
Self-parking at the Marriott Marquis San Diego is $10 hourly, $35 daily. Valet parking is $50 daily.

Other Options

Bus Station
San Diego Greyhound Transit Station
0.9 miles SE from Hotel

Subway Station
San Diego Metropolitan Transit System
0.1 miles N from Hotel

Train Station
San Diego Amtrak
0.7 miles NW from Hotel

Directions

Registration Fees

Early Registration
Registration Type Price by February 1
Conference Conference + Workshop
Member $1,995 $2,940
Non-member $2,274 $3,219
Young Professional Member $998 $2,093
Gov’t/Health Auth. Member $700 $1,795
Gov’t/Health Auth. Non-member* $800 $1,895
Academic Member $700 $1,795
Academic Non-member* $800 $1,895
Student Member $280 $1,375
Student Non-member* $310 $1,405
Regular Registration
Registration Type Price after February 1
Conference Conference + Workshop
Member $2,595 $3,640
Non-member $2,874 $3,919
Young Professional Member $1,298 $2,393
Gov’t/Health Auth. Member $700 $1,795
Gov’t/Health Auth. Non-member* $800 $1,895
Academic Member $700 $1,795
Academic Non-member* $800 $1,895
Student Member $280 $1,375
Student Non-member* $310 $1,405
One Day Only Registration
Tuesday/Wednesday Only
Member $1,498
Non-member $1,637







* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Feb 11, 2019, no fee will be charged. After Feb 11, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Feb 11, 2019, a full refund will be given minus a $200 fee. After Feb 11, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially