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2018 PDA Annual Meeting

Agile Manufacturing Strategies: Driving Change to Meet Evolving Needs

Mar 19 - Mar 21, 2018 | Orlando, FL
Loews Sapphire Falls
Register Now

Program Highlights

PDA’s Annual Meeting is one of the “can’t miss” events for 2018, offering a multifaceted look into the future of pharmaceutical manufacturing! At this year's meeting, speakers will focus their presentations on the end-user’s/patient perspective, innovative manufacturing strategies, disruptive technologies, and product value chain logistics. The increased use of Big Data, Artificial Intelligence, and robotics in the industry will also be explored.

In response to attendee feedback, PDA is debuting a NEW meeting format at the 2018 PDA Annual Meeting. This format is designed to better meet the needs of our attendees.

Most notably:

  • The Conference will now begin with the Opening Plenary at 1:00 p.m. on Monday
  • The Grand Opening Celebration will kick off in the Exhibit Hall at 5:00 p.m. on Monday – take advantage of your first opportunity to see the latest products and services and meet with exhibitors!
  • There will be no Breakfast Sessions at this Conference
  • Interest Group sessions will be held at the same time as the breakout sessions, giving attendees more sessions from which to choose during the day and allowing for more free time in the eveningThe Gala will be the final event of the Conference, taking place on Wednesday at 7:00 p.m. – Be sure to stay and celebrate with us!

In the wake of the back-to-back hurricanes that devastated Puerto Rico and its pharmaceutical manufacturing plants in 2017, PDA will make a charitable donation to CASA, a 501 (c)(3) non-profit organization based in Orlando, Florida, that has been actively helping the hurricane survivors, sending more than 2.5 million pounds of supplies to the people of Puerto Rico. CASA is also actively assisting evacuees who have relocated to Florida by offering English classes and other trainings to help improve their opportunities for employment.

Donations can be taken onsite at the 2018 PDA Annual Meeting or by contacting the PDA Registration Department at +1 (301) 656-5900 ext. 115  or


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 and quality control. More importantly, the Annual Meeting is the ideal forum for sharing best practices and learnings on how the industry applies novel approaches for the development and commercialization of pharmaceutical and biopharmaceutical products. The trend continues with the 2018 PDA Annual Meeting.

The theme of the 2018 meeting is Agile Manufacturing Strategies: Driving Change to Meet Evolving Needs. 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. We will cover relevant information important to both small molecule pharmaceutical and biopharmaceutical industries.

Plenary sessions focus on patient perspective and future visions, genomic profiling and even a new topic – Disruptive Technologies. Additional plenary sessions further explore current and future trends in process development and manufacturing including next generation processing and facilities, the application of big data for process design and optimization, and accelerating the industry response to healthcare needs. Concurrent session tracks were selected to support the conference theme and offer participants a closer look at continuous processing, patient centricity, disruptive technologies and complexities in the product value chain. 

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. 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. Don’t waste time to organize your attendance at the 2018 PDA Annual Meeting.

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
  • Understand requirements for a patient centric supply strategy
  • Apply continuous manufacturing applications and flexible facility designs of the future
  • Identify new trends and potential disruptive development in the health care sector
  • Demonstrate the value of applying  Big data  when designing and optimizing manufacturing processes
  • Define strategies to accelerate new products introductions
  • Interpret the latest trends in microbiological and adventitious agent control strategies
  • Identify advanced analytical approaches that can be applied for quality control and real time release
  • Explore delivery system design and manufacturing logistics for patient-centered therapies and precision medicine
  • Harvest (or benefit or take advantage of) best practices for identifying and applying  new technologies

Who Should Attend

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

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


Jason E. Brown
Assistant Director, Programs
Tel: (301) 656-5900 ext. 131
Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115

Exhibition Inquiries

David Hall
Vice President, Sales 
Tel: +1 (240) 688-4405

Course Inquiries

Stephanie Ko
Senior Manager, Lecture Education 
Tel: +1 (301) 656-5900 ext. 151


As of March 12, 2018
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Sunday, March 18

1:00 p.m. - 5:00 p.m.
Biopharmaceutical Advisory Board (BioAB) Meeting (Invitation only)
1:00 p.m. - 7:00 p.m.
Exhibitor Set Up
4:00 p.m. - 7:00 p.m.
Registration Open
4:00 p.m. - 7:00 p.m.
Speaker Ready Room Open
6:30 p.m. - 9:30 p.m.
PDA Awards Dinner (Invitation Only)

Monday, March 19

9:00 a.m. – 10:00 a.m.
2018 PDA Annual Meeting Program Planning Committee Meeting (Invitation only)
9:00 a.m. – 12:00 p.m.
Science Advisory Board (SAB) Meeting (Invitation only)
9:00 a.m. - 4:00 p.m.
Exhibitor Set Up
9:00 a.m. - 5:00 p.m.
Registration Open
9:00 a.m. - 5:00 p.m.
Speaker Ready Room Open
10:00 a.m. – 11:30 a.m.
PDA Chapter Council Meeting (Invitation only)
11:30 a.m. – 12:45 p.m.
Orientation Lunch (Invitation only): Sponsored by Amgen
12:00 p.m. - 1:00 p.m.
Advisory Board Mix & Mingle 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, PhD, Biopharmaceutical Consultant
  • Richard Johnson, President and CEO, PDA
  • Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.
  • Morten Munk, Global Technology Partner, NNE
1:30 p.m. - 3:00 p.m.
P1: Patient Perspective - Future Visions
Moderator: Morten Munk, Global Technology Partner, NNE

Session Description: All delegates at this conference are in some way involved in the path of providing pharmaceuticals to patients. It is a privilege and offers a clear purpose to be part of a community that have the possibility to make an instrumental difference to the individual patient as well as to the society in general. This option to make a difference, comes with substantial responsibility to ensure that we do our outmost to meet the expectations of the patients and health care professionals, who rely on us in providing safe and effective pharmaceuticals. During a busy workday with numerous daily challenges, the outcome of our work might be a bit out of focus, and maybe not the first thing we think about when we start working in the morning.  This session offers to give a clear perspective of the individuals that ultimately are benefiting from our daily efforts.

1:30 p.m. - 2:00 p.m.
Clinician Perspective on Future Patient Therapies
Stephen Kingsmore, MD, President and CEO, Rady Children’s Institute for Genomic Medicine
2:00 p.m. - 2:30 p.m.
Patient Perspective
Lori Richter, Senior Consultant, ValSource LLC
3:00 p.m. - 3:30 p.m.
Refreshment Break
3:10 p.m. - 3:30 p.m.
Press Conference (Invitation only)
3:30 p.m. - 5:00 p.m.
P2: Disruptive Technology and the Future of Medicine
Moderator: Tia Bush, Vice President, Quality, Amgen, Inc.

Session Description: Today’s healthcare is not sustainable due to the rising costs of treatment, ageing populations, and healthcare worker shortages.  The future of medicine will be innovative, patient focused, and digital.  Our industry and the regulatory framework that governs our products and services must overcome technical and cultural challenges by embracing disruptive technologies that make healthcare more effective, by putting patients in the center of healthcare strategies, by digitizing information to grow our understanding of disease and treatment, and shifting the healthcare from a “break and fix” mentality to one of prevention.  This session will explore the trends in technology and how they will alter our current view of the healthcare system and the medicines we make to improve the lives of patients.  We will also explore how companies must build their culture of innovation in order to deliver on this promise.

3:30 p.m. - 4:00 p.m.
Discovering your Way to Greatness
Steven Spear, PhD, Senior Lecturer, System Dynamics, Massachusetts Institute of Technology (MIT)
4:00 p.m. - 4:30 p.m.
Emerging Technology: A Key Enabler to Meet the Needs of the Patient
Sharmista Chatterjee, PhD, Director, Division of Process Assessment II, CDER, FDA
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 (Grand Opening of Exhibit Hall)

Tuesday, March 20

7:30 a.m. - 5:30 p.m.
Registration Open
7:30 a.m. - 5:30 p.m.
Speaker Ready Room Open
7:30 a.m. - 8:30 a.m.
Continental Breakfast
8:30 a.m. - 10:00 a.m.
P3: Genomic Profiling
Moderator: Austin Caudle, MSc, Associate Director, Business Development, IQVIA

Session Description: Our understanding of genomics is dramatically changing healthcare, leading the way to personalized care. Advances in the field of DNA sequencing and the ability to collect and analyze large amounts of data quickly has played a critical role in the evaluation of research. Using genomic profiling it is possible to map an individual’s unique genomic profile, providing physicians with invaluable information to help determine the best treatment. It can be used to find out why certain people get diseases while others do not, or why people react differently to the same drug.  Likewise, this data can help biotech companies make informed decisions in their R&D investments. This session will explore the role of genomic profiling as a tool for identifying the potential risk of certain health conditions and application of treatment strategies/therapies that are tailored to the genetic profile of each patient.

8:30 a.m. - 9:00 a.m.
Learning from Kymriah, a CAR-T Therapy Which Targets B Cell Malignancies
Vadim V. Romanov, MD, MPhil, FFPM, Executive Medical Director, CAR-T, Novartis Pharmaceuticals Corporation
9:00 a.m. - 9:30 a.m.
Genomic Profiling from the Perspective of B2C
Victor Weigman, PhD, Director, Translational Genomics, IQVIA
9:30 a.m. - 10:00 a.m.
Questions and Answers/Discussion
8:30 a.m. - 10:00 a.m.
PDA Publications Meeting (Invitation only)
9:45 a.m. - 6:30 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 refreshment breaks on Tuesday and Wednesday

  1. Non-Destructive CCIT (Leak Detection) of Assembled Auto Injectors - Challenges and Successes
    Paul Bilotti, North America Sales Manager, Wilco-USA
  2. The Prats and Pitfalls of Assessing Cell Viability After Cryopreservation
    Brian Hawkins, PhD, Senior Application Scientist, BioLife Solutions
  3. Case Studies in Bacterial Spore and Fungal Spore Excursions in Cleanrooms and Oral Solid Dose Operations
    Jim Polarine, Senior Technical Services Manager, STERIS Corporation
  4. Current Regulatory Considerations for Continuous Manufacturing of Pharmaceuticals in Japan
    Issei Takayama, Reviewer, Pharmaceuticals and Medical Devices Agency
  5. Pediatric Formulation Development of Epinephrine Injection: A Child’s Play?
    Nicolas Thurin, PhD, Manager, Analytical Product Development, Catalent Pharma Solutions
  6. How to Safely Handle and Transport Bulk Drug Substances? Case Study: Extensive Qualification Test for Enhanced Confidence in Liquid BDS Handling Strategies
    Elisabeth Vachette, Senior Global Product Manager, Sartorius Stedim FMT SAS
  7. A Time-Saving Recombinant Factor C (rFC) Endotoxin Test Including a Novel Microplate Pre-Coated with Control Standard Endotoxin (CSE) Concentrations and Positive Product Controls
    Gregory Devulder, PhD, Endotoxin Program Director, Hyglos GmbH - a bioMérieux company
  8. Determining Performance Improvements by Quality by Design Plungers for Syringes in Auto-Injector Systems
    Page McAndrew, PhD, Director, Scientific Communications
  9. Maximizing Sterility Assurance using Aseptic Component Wrapping Systems
    Aaron Mertens, Technical Service Specialist, West Pharmaceutical Services
  10. Evolution of Container Closure Integrity Testing: 5 Case Studies on Prefilled Syringes
    Lisa Caralli, Senior Director of Pharmaceuticals, Catalent Pharma Solutions
  11. Process Validation Risk-Based Lifecycle Approach - Oral Solid and Semi-Solid Dosages
    (PDA Technical Report 60-2, Annex 1, March 2017)
    Igor Gorsky, Senior Consultant, ValSource, LLC
  12. Feasibility Evaluation of Blow Fill Seal Process and Compatibility with Aluminum Phosphate Adjuvanted Recombinant RSV F Vaccine
    Yen-Huei Lin, PhD, Senior Director, Formulation and Drug Product Development, Novavax
  13. Incorporating Diverse Patient Needs and Preferences into a Medical Device Offering
    Aditya Ravi, Product Manager, North America and Europe, BD Medical – Pharmaceutical Systems
  14. Striving for Zero Visible Particles: Practical Implementation in Elastomeric Closure Manufacturing and Quality Control
    Rahul Thakar, PhD, Technical Manager, Datwyler Pharma Packaging
  15. Impact of Selected Elements on the Accelerated Stability of Human Lysozyme
    Erica Tullo, PhD, Technology Manager, Extractables and Leachables, West Pharmaceutical Services
  16. mproving Product Quality During Technical Transfers
    Eric Good, PhD, Director, Compliance Services, ProPharma Group
  17. Developing a High-Throughput Formulation Development Platform for High-Concentration, Therapeutic Monoclonal Antibodies
    Jessica Ripley, MS, Scientist, Process and Formulation Development, Catalent Biologics
  18. A Continuous Improvement Metric for Pharmaceutical Manufacturing
    Ajay Babu Pazhayattil, Associate Director, Apotex, Inc.
  19. Understanding the Science Behind Liquid Leak and Microbial Ingress Mechanisms as the Foundation for Single Use Container Closure Integrity (SU-CCI)
    Marc Hogreve, Senior Engineer Integrity Testing Solutions, Sartorius Stedim Biotech GmbH
  20. A Proactive Approach to the Particulate Management Lifecycle in Parenteral Drug Products
    David Exline, President, Gateway Analytical
    Angela M. Flowers, Scientist II, Gateway Analytical
10:45 a.m. - 12:15 p.m.
Concurrent Sessions

Track: Innovative Manufacturing Strategies

A1: IT: So Much More than Technology
Moderator: Aaron R. Goerke, PhD,Director/Head of MSAT, Singapore Technical Operations, F. Hoffmann-La Roche Ltd.

Session Description: The IT revolution is evident all around us, but the emphasis has mostly been on the T, the technology.  It is time to recast our gaze to focus on the I, the information. Perhaps this information really means insight.  Has your company made this transition and began treating data as an asset and not a cost?  Are you getting insight out of information? Responses vary across Pharma manufacturing as do their ability to harness information in novel ways to produce insights of significant value.  This session will explore examples of where data is being put to new uses to solve difficult real-world problems. Different strategies, learning's and challenges encountered, some of which might not have been overcome, will be key takeaways.  There is a revolution underway in IT, but it is just as much in the information side of the acronym as in technology.

10:45 a.m. -11:15 a.m.
Insights on the Manufacturing Floor
Michele D’Alessandro, Vice President and Chief Information Officer, Manufacturing IT, Merck & Co., Inc.

11:15 a.m. -11:45 a.m.
Beyond the Product – Data, Insights, and Value
Thomas Seewoester, PhD, Executive Director and Plant Manager, Amgen Inc.

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

Track: Handling Complexity in the Product Value Chain

B1: In-House vs. CMO
Moderator: Marcia C. Baroni, Director, QC Microbiology & EM/Sterility Assurance, Eli Lilly and Company

Session Description: The face of pharmaceutical manufacturing has changed drastically in the past two decades. Not only from a technological and science standpoint, but also with regards to the regulatory and political environment. Shorter patent protection, lower price premiums and increasing barriers to reimbursability have created a market where faster development, smaller volumes and increasing levels of customization are not only more common, but also more desirable. Deciding when to invest in house and when to leverage a third party has become a critical business decision, as limited resources must be carefully divided amongst a wider range of needs. Third party companies are being actively leveraged cross all stages of the product lifecycle, from development to launch and through product end of life; from the labs to manufacturing. This session will explore a few of those scenarios, sharing experiences and points to consider when making these critical decisions.

10:45 a.m. -11:15 a.m.
Strategies and Complexities around Outsourcing of Labs
Jeffrey T. Gelwicks, PhD, Senior Director, Global Quality Labs, Eli Lilly and Company

11:15 a.m. -11:45 a.m.
Contract Manufacturing/Supply Chain
Jay Buchanan, Head of US Supply Chain and LATAM External Supply, Takeda Pharmaceuticals

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

Interest Group

IG1: Process Validation
Leader: Scott Bozzone, PhD, Principal, Pharm Lifecycle Validation, LLC

Session Description: This session will have short presentations on current issues in process validation (PV), followed with open discussion afterwards. A small panel of SMEs will be assembled to lead the open discussions.


Ajay Pazhayattil, PhD, Associate Director, Apotex, Inc. (Confirmed)

Michael Long, PhD, Senior Director, ValSource LLC

Interest Group

IG2: Filtration
Leader: Russell Madsen, President, The Williamsburg Group, LLC

Session Description: Annex I includes a controversial paragraph on the integrity test pre-use/post sterilization. This paragraph causes severe problems within the industry. Since the Annex I revision will be published, we require to review the paragraph posted in the revised Annex I and see what activities require to be taken.

We will also inform attendees on new initiatives regarding PUPSIT:

  • Statement by filter manufacturers
  • Blocking test proposal within PDA TRI
  • MOU with BPOG to work together on PUPSIT

Maik W. Jornitz, CEO, G-CON Manufacturing

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)
1:45 p.m. - 2:45 p.m.
Concurrent Sessions
1:45 p.m. - 3:15 p.m.
2019 Annual Meeting Exhibit Space Draw Meeting

Track: Innovative Manufacturing Strategies

A2: Control Strategies for Continuous Processing
Moderator: Melissa Seymour, MBA, Vice President, Corporate Quality, Biogen

Session Description: Continuous manufacturing offers compelling benefits with respect to costs, process flexibility and capacity.   In fact, the 21st Century Cures Act, enacted in December 2016, authorized grants to support studying Continuous Manufacturing of drugs and biological products. Control strategies for these processes must also continuously provided assurance of quality, mitigating any risk to product quality because of process variations over time.  This session will focus on science and risk based approaches to control strategies that can be implemented to monitor and ensure appropriate understanding of process dynamics and their relation to process conditions and raw material control.  Tools including model-based control, multivariate monitoring, automation and real-time release testing will be discussed as well as identification and rejections of non-conforming segments.

1:45 p.m. -2:15 p.m.
Continuous Manufacturing: Considerations on Controls of a Dynamic Process
Markus Krumme, PhD, Head, Continuous Manufacturing Unit, Novartis

2:15 p.m. -2:45 p.m.
Building Quality in Continuous API Manufacturing: Key Learnings
Erwin Irdam, Principal Engineer, Technical Development, Biogen

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

Track: Disruptive Technologies

B2: Aseptic Processing/Isolators
Moderator: Shelley M. Preslar, MBA, PMP, General Manager, Azzur Group

Session Description: The need for improved aseptic manufacturing capabilities has led to innovations in Isolator technology. To meet increasing product demand while ensuring patient safety and product quality requires new thinking in implementing aseptic processes and capabilities. To continue to be effective manufacturing it is necessary to look at systems that are reliable yet flexible.  This session will showcase two different strategies for implementation of strategies to improve aseptic processing capabilities. Speakers will share innovative ways to implement robotics and environmental considerations with regards to isolator technology.

1:45 p.m. -2:15 p.m.
Installation and Qualification of a Closed, Gloveless Isolator System for Aseptic Filling
Terrence E. Hollis, Process Engineering Manager, Patheon
Ross Gold, P. Eng., Vice President, Engineering and Co-founder, Vanrx Pharmasystems Inc.

2:15 p.m. -2:45 p.m.
Can RABS and Isolator Cleanroom Technology be Combined to Help Achieve the Highest Level of Quality and Flexibility in Aseptic Processing? A New Approach allows Companies to Take Advantage of Both Cleanroom Technologies
Ute Schleyer, PhD, Project Manager, Plant and Site Development, Vetter Pharma-Fertigung GmbH & Company KG

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

Interest Group

IG3: Quality Risk Management
Leaders: Amanda Bishop McFarland, MS, Consultant, ValSource, LLC and Emma Ramnarine, Head, Global Biologics Quality Control, Genentech, A Member of the Roche Group

Session Description: Surviving a QRM Program Audit: With new and evolving manufacturing strategies, QRM programs are also evolving to meet new demands and in some cases becoming more mature. With this change in the environment, Regulatory Authorities are also changing and requiring more from the industry with respect to their QRM programs. In this session we will discuss strategies in presenting a QRM program to Health Authorities, with presenters who will provide actual examples and case studies. Participants will also be working in teams to develop audit strategies and responses to practice scenarios. Examples will be presented that address both what the auditor is expecting as well as how the auditee should plan on responding. This will include both proper and improper use of QRM in audit responses. The session will end with lively dialogue involving both the participants and the presenters, as we work through the scenarios as a group.


Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.
Lori Richter, Senior Consultant, ValSource LLC

Interest Group

IG4: Biopharmaceutical Manufacturing
Leaders: Arleen C. Paulino, Vice President, Singapore Site Operations, Amgen Inc.  and
Peter Makowenskyj, Sales Engineer, G-CON Manufacturing, Inc.

Session Description: BioAB has recently changed the name and scope for the Biotechnology IG.  We renamed the IG to Biopharmaceutical Manufacturing as this focus better aligns with PDA’s overall mission to advance pharmaceutical manufacturing science and technology.  This session represents the inaugural meeting for the newly formatted Biopharmaceutical Manufacturing IG.

The session program includes:
  • Outline the objective and mission of the Biopharmaceutical Manufacturing IG
  • Solicit input from participants on future directions and focus areas for the IG

Following this introductory discussion, the session will focus on the latest developments in manufacturing science and technology for biopharmaceutical products including advanced cell and gene therapies.  The content will include both presentation and time for interactive dialogue addressing topics related to process optimization to streamline operations, improvements to increase efficiency and reduce costs, and approaches for achieving the highest level of biopharmaceutical product quality.


Weichang Zhou, PhD, Chief Technology Officer, Senior Vice President, Biologics Development and Manufacturing, WuXi Biologics
Peter Makowenskyj, Sales Engineer, G-CON Manufacturing, Inc.

3:15 p.m. - 4:00 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall
4:00 p.m. – 5:00 p.m.
Exhibits Committee Meeting (Invitation Only)
4:00 p.m. - 5:30 p.m.
Concurrent Sessions

Track: Innovative Manufacturing Strategies

A3: Agile Bioprocessing
Moderator: Morten Munk, Global Technology Partner, NNE

Session Description: High production costs, patient affordability and accessibility, and maintaining an uninterrupted supply of product are primary concerns of the biopharmaceutical industry. To address these issues, the term agile bioprocessing might best describe the next evolution needed for biopharmaceutical manufacturing. Indeed, industry efforts are now being directed towards reducing the long development cycle times, increasing production flexibility and eliminating processing complexities all with an aim towards addressing current challenges. This session explores innovative approaches being considered for future biopharmaceutical manufacturing operations, with an emphasis on latest developments in continuous bioprocessing.

4:00 p.m. - 4:30 p.m.
Continuous Processing Strategies - nextBioPharmDSP
Gorazd Hribar, PhD Project Manager Next BioPharm DSP and Research Scientist, Lek, A Sandoz Company

4:30 p.m. - 5:00 p.m.
Streamlining Biopharmaceutical Decision-Making: Designing for Manufacturability, Facility Fit and Cost-Effectiveness
Suzanne Farid, PhD, CEng, FIChemE, Professor and Co-Director, Future Targeted Healthcare Manufacturing Hub, Department of Biochemical Engineering, University College London

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

Track: Disruptive Technologies

B3: Trends in Digital Information and Automated Technology
Moderator: Tia Bush, Vice President, Quality, Amgen, Inc.

Session Description: The healthcare industry is experiencing unparalleled change.  Millions of data points are generated throughout the end-to-end supply chain that can be converted to knowledge and understanding that leads to meaningful and timely action to improve manufacturing processes and drive organizational efficiency. A comprehensive digital strategy and structured data analytics can explore techniques such as visualization, modeling, automation, machine learning, and artificial intelligence to dematerialize manufacturing processes and facilities and drive productivity through fewer errors, higher output, and improved quality, safety, and speed.  This session will explore case studies where companies have advanced their digital strategy to deliver meaningful value and advancements to the business.

4:00 p.m. - 4:30 p.m.
New Approaches to Harnessing Data at a Portfolio Level
Patrick Gammell, PhD, Director, Process Development, Amgen, Inc.


Greg Naugle, MS, Executive Director, Lead Drug Substance Technology and Engineering, Amgen, Inc.
Paul Stey, PhD, Biomedical Data Scientist, Brown University

4:30 p.m. - 5:00 p.m.
The Rise of Human Data Science in the Real World: Eight Environments for Innovation
Malcolm R. Postings, Vice President, Head of Innovation & Emerging Technologies, IQVIA

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

Interest Group

IG5: Cell and Gene Therapy
Leader: Michael Blackton, MBA, Vice President, Global Quality, Adaptimmune, LLC

Session Description: The session will introduce the first program for the Cell and Gene Therapy Interest Group. This session will:

  • Outline the objective and mission of the Cell and Gene Therapy Interest Group.
  • Introduce and solicit volunteers for a new Technical Report, Process Validation for Cell Therapy.
  • Provide a 30-minute presentation on risk assessment for aseptic processing for cell therapy.  This presentation will be a case study and set of recommendations for the establishment of an effective aseptic processing verification program for these innovative products.

Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC
Darius Pillsbury, Head of Quality Lifecycle Management, Adaptimmune LLC

Interest Group

IG6: Facilities and Engineering
Leader: Shelley M Preslar, MBA, PMP, General Manager, Azzur Group

Session Description: The Facilities and Engineering Interest Group can cover many specific technical interests within the industry as they relate to Manufacturing Facilities and Engineering capabilities.  There has been a tremendous amount of discussion around Aging Facilities the past couple of years, so for this meeting, the focus will shift to look at innovation.

During the B2 session, we heard about two different approaches to improving aseptic manufacturing capabilities.  In this IG session, we will continue to talk with those speakers to take a bit of a deeper dive into their presentations to learn more about their specific examples.


Guenther Gapp, PhD, Consultant, Gapp Quality GmbH
Terrence E. Hollis, Process Engineering Manager, Patheon


Ute Schleyer, PhD, Project Manager, Plant and Site Development, Vetter Pharma-Fertigung GmbH & Company KG

5:30 p.m. - 6:30 p.m.
Happy Hour in the Exhibit Hall

Wednesday, March 21

7:30 a.m. - 3:15 p.m.
Registration Open
7:30 a.m. - 8:30 a.m.
Continental Breakfast
7:30 a.m. - 1:45 p.m.
Speaker Ready Room Open
8:30 a.m. - 9:00 a.m.
2019 Annual Meeting Exhibit Space Draw Meeting
8:30 a.m. - 10:00 a.m.
P4: Increasing Capacity and Capability without Increasing Costs
Moderator: Maik W. Jornitz, MS, CEO, G-CON Manufacturing

Session Description: In the past capacity and capability increases meant lengthy, but especially cost intensive expansions of rigid production and process infrastructures. New technology platforms, like single-use processes create the ability to increase or utilize the current capacity in a more flexible, but also efficient way. The new process technologies furthermore enable new process models like continuous processing. The factors listed will change our current thinking of investments to be made, capacity flexing and capacity location, to name a few. Examples of such innovative production and processing platforms will be presented as well as the benefits of such.

8:30 a.m. - 9:00 a.m.
Transforming Operations with Next-Generation Biomanufacturing
Arleen C. Paulino, Vice President, Singapore Site Operations, Amgen, Inc.
9:00 a.m. - 9:30 a.m.
Improving Operational Performance Using a Resilience Engineering Approach: A Case Study
Amy D. Wilson, PhD, Director, Global Human Performance, Biogen
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 and Poster Presentations in Exhibit Hall
10:45 a.m. - 12:15 p.m.
Concurrent Sessions

Track: Innovative Manufacturing Strategies

A4: Implementing Manufacturing Innovation
Moderator: Ursula Busse, PhD, Head Quality Intelligence, External Engagement, Novartis

Session Description: Innovation in manufacturing should be at the heart of our efforts to ensure the sustained supply of better, safer medicines to patients. Yet our industry is very slow in adopting the wealth of new manufacturing technologies available. This session will discuss strategies for successful implementation of innovative technologies in pharmaceutical manufacturing, focusing on challenges, success factors and key learnings. Presentations will cover both the technical as well as the cultural and leadership aspects of implementation.

10:45 a.m. -11:15 a.m.
Next Generation Advancements – Treatment Modalities, Innovative Manufacturing and Novel Attribute Assessments
Michael Abernathy, Executive Director, Regulatory Affairs CMC, Amgen Inc.

11:15 a.m. -11:45 a.m.
The Human Side of Innovation
Pierre Boulas, PhD, Senior Director, Pharmaceutical Development, Biogen

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

Track: Handling Complexity in the Product Value Chain

B4: Addressing Unique Challenges of Patient Centric Supply Chain Needs
Moderator: Karen Walker, Vice President, Quality, Seattle Genetics

Session Description: With the recent approval(s) of (a) CAR-T therapies in the US, and the explosion in the research into these types of therapies, there are over 300 trials listed on, and over 40 active. CAR-T is not the only Patient Centric therapy being developed, and with this increase in active clinical studies, there is increased attention on managing the supply chain for these types of products. During this session, we will hear how the shift to a more patient-focused supply chain has impacted manufacturing models, price, cost, and complexity. We will also explore some proven solutions to the challenges posed.

10:45 a.m. -11:15 a.m.
Perspective on Patient-Centric Supply Chain Needs
Kirstin Powel, Global Quality Head, CGTDM, Novartis Pharmaceuticals Corporation

11:15 a.m. -11:45 a.m.
Intelligent Biomanufacturing and the Impact on Facility Design on the Factory of the Future
Jeffery Odum,
Global Technology Partner, NNE

11:45 a.m. - 12:00 p.m.
Successful Commercialization of CAR T-Cell therapies: COG Versus Reimbursement Perspectives
Suzanne Farid, PhD, CEng, FIChemE, Professor and Co-Director, Future Targeted Healthcare Manufacturing Hub, Department of Biochemical Engineering, University College London

12:00 p.m. -12:15 p.m.
Questions and Answers/Discussion

Interest Group

IG7: Visual Inspection of Parenterals
Leader: John G. Shabushnig, PhD, Principal Consultant, Professional title, Insight Pharma Consulting, LLC and Richard (Rick) Watson, Director, Sterile & Validation, COE, Merck & Co., Inc.

Session Description: This Interest Group session will focus on the inspection of injectable products, specifically those considered “difficult to inspect” such as lyophilized powders, suspensions and protein solutions, as well as those in amber glass or plastic containers.  A review of the recently published PDA Technical Report on this subject will be included in the agenda.  A brief presentation reviewing relevant recalls, warning letters and 483 observations will be given followed by a moderated discussion on inspection topics of interest to those in attendance. Past discussions have included current experience with USP <790> and <1790>, selection and training of inspectors who perform manual inspection, industry benchmarks for inspection practices and inspection results.

Interest Group

IG8: Combination Products
Leader: Lee Leichter, President, P/L Biomedical

Session Description: This session will include a discussion of the concepts, expertise, expectations, and requirements for a pharmaceutical company to develop, manufacture, and market a combination product. Topics will include areas, such as:

  • Design Controls
  • Mechanical/Electronic Engineering
  • Risk Management
  • Human Factors Engineering
  • Device Software Engineering, validation and controls
  • Mobile Medical Applications
  • Medical Device Reports (MDRs)
  • Device Purchasing Controls
  • Change Management for devices
  • Functional Stability
  • Drug Compatibility

This session will help attendees gain an appreciation for the challenges of successfully developing, manufacturing, and marketing a combination product within the pharmaceutical company environment.

12:15 p.m. - 1:30 p.m.
Interest Group Leaders Meeting (Invitation only)
12:15 p.m. - 1:45 p.m.
Networking Luncheon and Passport Raffle in Exhibit Hall
1:30 p.m. - 1:45 p.m.
Pharmaceutical Manufacturing Forum (PMF) (Invitation only)
1:45 p.m. - 3:15 p.m.
P5: Personalized Medicine
Moderator: Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

Session Description: Until now, most medical treatments have been designed for the “average patient.” Because of this “one-size-fits-all” approach, treatments can be very successful for some patients but not for others. Precision Medicine, on the other hand, is an innovative approach that considers individual differences in people’s genes, environments, and lifestyles. It gives medical professionals the resources they need to target the specific treatments of the illnesses we encounter, further develops our scientific and medical research, and keeps our families healthier. Advances in Precision Medicine have already led to powerful new discoveries and several new treatments that are tailored to specific characteristics, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor. This is helping transform the way we can treat diseases such as cancer: Patients with breast, lung, and colorectal cancers, as well as melanomas and leukemias, for instance, routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

In the last few years, we have seen a rapid development of new methods using immunotherapies in treating different types of cancer. By combining immunotherapy with other types of treatment, an increase of the effectiveness may be accomplished. Newer types of immune treatments are now being developed, and they will affect how we treat cancer in the future. This session will explore more about the status of where pharma development is today as well as example of a successful research.

1:45 p.m. - 2:15 p.m.
Personalized Cancer Vaccines
Rainer Mueller, PhD, Global Technical Head, Personalized Cancer Vaccine Project, Roche Diagnostics GmbH
2:15 p.m. - 2:45 p.m.
Cancer Immunotherapy and Update on Brain Tumor Trials
Matthias Gromeier, MD, Professor, Department of Neurosurgery, Duke University Medical School
3:15 p.m.
Closing Remarks & Adjournment from Co-Chairs of the 2019 PDA Annual Meeting Program Planning Committee
Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.
Melissa Seymour, MBA, Vice President, Corporate Quality, Biogen
7:00 p.m. - 10:00 p.m.
Closing Reception: A Night in Havana
Your full conference badge is required to access this reception.


  • Michael Abernathy

    Michael Abernathy

    Amgen Inc.
  • Pierre Boulas

    Pierre Boulas, PhD

  • Jay Buchanan

    Jay Buchanan

    Takeda Pharmaceuticals
  • Sharmista Chatterjee

    Sharmista Chatterjee

  • Michele DAlessandro

    Michele D’Alessandro

    Merck & Co./Merck Sharp & Dohme
  • Suzanne Farid

    Suzanne Farid, PhD, CEng, FIChemE

    University College London
  • Patrick Gammel

    Patrick Gammel, PhD

    Amgen Inc.
  • Guenther Gapp

    Guenther Gapp, PhD

    Gapp Quality GmbH
  • Jeffrey Gelwicks

    Jeffrey Gelwicks, PhD

    Eli Lilly and company
  • Ross Gold

    Ross Gold, P.Eng

    Vanrx Pharmasystems Inc.
  • Matthias Gromeier

    Matthias Gromeier, MD

    Duke University Medical School
  • Ghada Haddad

    Merck & Co., Inc.
  • Terrence Hollis

    Terrence E. Hollis

  • Gorazd Hribar

    Gorazd Hribar, PhD

    Lek, A Sandoz Company
  • Erwin Irdam

    Erwin Irdam

  • Maik Jornitz

    Maik Jornitz

    G-Con Manufacturing LLC
  • Stephen Kingsmore

    Steven Kingsmore, MD

    Rady Children’s Institute for Genomic Medicine
  • Markus Krumme

    Markus Krumme

  • Mike Long

    Michael Long, PhD

    ValSource LLC
  • Peter Makowenskyj

    Peter Makowenskyj

    G-CON Manufacturing
  • Rainer Mueller

    Rainer Mueller, PhD

    Roche Diagnostics GmbH
  • Susan Neadle

    Susan Neadle

    Janssen Pharmaceuticals
  • Jeffrey Odum

    Jeffrey Odum

  • Arleen Paulino

    Arleen C. Paulino

    Amgen Inc.
  • Ajay Pazhayattil

    Ajay Pazhayattil

    Apotex Inc.
  • Darius Pillsbury

    Darius Pillsbury

    Adaptimmune LLC
  • Malcolm Postings

    Malcolm R. Postings

  • Kirstin Powel

    Kirstin Powel

    Novartis Cell and Gene Therapy
  • Lori Richter

    Lori Richter

    ValSource LLC
  • Vadim Romanov

    Vadim V. Romanov, MD, MPhil, FFPM

    Novartis Pharmaceutical Corporation
  • Ute Schleyer

    Ute Schleyer, PhD

    Vetter Pharma-Fertigung GmbH & Company KG
  • Thomas Seewoester

    Thomas Seewoester, PhD

    Amgen Inc.
  • Steven Spear

    Steven Spear, PhD

    Massachusetts Institute of Technology (MIT)
  • Stabler Hardiman

    Marsha Steed (Hardiman)

  • Paul Stey

    Paul Stey, PhD

    Brown University
  • Viky Verna

    Viky Verna, MS, RAC

    Confinis AG
  • Victor Weigman

    Victor Weigman, PhD

    Q2 Solutions, a Quintiles Quest Joint Venture
  • Amy Wilson

    Amy D. Wilson, PhD

  • Weichang Zhou

    Weichang Zhou, PhD

    WuXi Biologics

Registration Fees

Conference and Workshop Registration* | March 19-22


By January 8, 2018

After January 8, 2018


By January 8, 2018

After January 8, 2018

* Complimentary Conference registration does not qualify for discount offered for Workshop.

Conference Registration | March 19-21


By January 8, 2018

After January 8, 2018


By January 8, 2018

After January 8, 2018

Government/Health Authority/Academic


By January 8, 2018

After January 8, 2018

* Nonmember

By January 8, 2018

After January 8, 2018



By January 8, 2018

After January 8, 2018

* Nonmember

By January 8, 2018

After January 8, 2018

Young Professional Member **


By January 8, 2018

After January 8, 2018

One Day Only Fee




All prices in US dollars.

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

** You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

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

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by January 18, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before January 18, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.


Loews Sapphire FallsLoews Sapphire Falls 
6601 Adventure Way 
Orlando, FL USA 32819
Tel: +1 (407)-503-5000

Reservation Group Call-In Center
Toll Free: +1 (866)-360-7395
Local: +1 (407)-503-9276

Rate: Single/Double: $252.00 - Guestroom rates are subject to State and Local taxes, 6% per room night occupied.

Cut Off Date: The cut off date has now passed. Please contact the hotel directly to secure a room based on availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Loews Sapphire Falls. The rate is $252 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, February 16, 2018. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

To make reservations, individuals may click on the reservation link above or call the Loews Sapphire Falls at +1 (866)-360-7395. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA Annual Meeting to receive the PDA group rate.

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 72 hours prior to check-in to avoid cancellation fees.


Loews Sapphire Falls is conveniently located near Universal Orlando™. The venue features a beautifully landscaped, resort-style pool with a water slide surrounded by cascading waterfalls, this hotel truly captivates at every turn. From the ruins of the stone turret in the lobby, to the inviting island charm of the 1,000 guest rooms and suites, guests will be surrounded by a vivid, textured haven that is inspired by landmarks of the islands. The venue also offers a complimentary water taxi to the Universal CityWalk™area, allowing guest to enjoy a variety of great restaurants and attractions.

Additional information on service and amenities offered at Loews Sapphire Falls.


Orlando International Airport- (MCO) is located 18 miles (about 20-25 minutes) northeast from Loews Sapphire Falls.

Ground Transportation

Preferred Vendor

Destination MCO has been selected as the preferred vendor for airport transportation for Loews Hotels at Universal Orlando™. Exclusive chauffeured services begin at $115 (tax and gratuity included) for a sedan and can be charged to your geust room. Reservations are required. Visit or call the concierge at +1 (407)-503-5200.

Shared-Ride and Direct Service Airport Shuttles

Mears Transportation offers a shared-ride airport shuttle from Orlando International Airport to Loews Sapphire Falls. Tickets are available at the Mears Transportation counters located inside the baggage claim area on level two, as well as on level one
where the shuttle departs for Loews Sapphire Falls Resort every 30 – 40 minutes. Reservations are not required. Pricing is shown below.

  • One-way fare: $21 adult or $16 child (ages 3-9)
  • Round-trip fare: $33 adult or $25 child (ages 3-9)

Mears Transportation also offers a direct service airport shuttle from Loews Sapphire Falls to Orlando International Airport. Travel time is approximately one hour. Reservations are required. Visit or call the concierge at 407.503.5200 at least 24 hours prior to departure.


Taxis are on standby at Orlando International Airport, offering service to and from Loews Sapphire Falls for an approximate fare of $55 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 30 minutes.


From Orlando International Airport
Take the north exit onto the Martin B. Andersen Beachline Expressway (State Road 528) West approximately 11 miles to Interstate 4 (I-4) East. Continue on I-4 East to exit 75A (Universal) and turn left onto Universal Boulevard. Continue on Universal Boulevard to Hollywood Way and turn left. Continue on Hollywood Way and turn left onto Adventure Way. Loews Sapphire Falls is on the left at 6601 Adventure Way.
Note: FL-528 is a toll road with one toll of $2.25 between Orlando International Airport and Loews Sapphire Falls.

From Florida's Turnpike
Take exit 259 (Orlando) onto I-4 West. Travel on I-4 West to exit 74B (Universal) and continue on Adventure Way. Loews Sapphire Falls Resort is the first entrance on the right at 6601 Adventure Way.

From Eastbound Interstate 4
Take exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Continue on Hollywood Way and turn left onto Adventure Way. Loews Sapphire Falls Resort is on the left at 6601 Adventure Way.

From Westbound Interstate 4
Take exit 74B (Universal) and continue on Adventure Way. Loews Sapphire Falls Resort is the first entrance on the right at 6601 Adventure Way.

From Southbound Interstate 95
Take exit 205 (State Road 528). Travel on FL-528 to I-4 East. Travel on I-4 East to exit 75A and continue to Universal Boulevard. Turn left onto Universal Boulevard and travel approximately one-half mile to Hollywood Way. Turn left onto Hollywood Way. Continue on Hollywood Way and turn left onto Adventure Way. Loews Sapphire Falls Resort is on the left at 6601 Adventure Way.

From Northbound Interstate 95
Take exit 260B (I-4 West). Travel on I-4 West to exit 74B (Universal) and continue on
Adventure Way. Loews Sapphire Falls Resort is the first entrance on the right at 6601
Adventure Way

Hotel Parking

Self-parking at the Loews Sapphire Falls is $22 overnight or $24 daily. Valet parking is $29 overnight or $34 daily.

Exhibit and Sponsor

Network, Collect Intelligence and Forge Key Relationships

The Annual Meeting is one of PDA’s Signature Events, and one of our most popular meetings as well, typically attracting more than 600 Conference attendees. With multiple networking breaks, luncheon, and reception, exhibitors have ample time to connect with your desired audience of industry leaders, strengthen business relationships, and create new sales leads.

The comprehensive 10’ x 10’ booth package includes one full conference registration and two exhibit only badges, company listing on the Conference website and in the on site exhibit guide, six foot skirted table, chair, trash can, ID sign, on site personal assistance, list of pre-registered attendees distributed at the meeting, and exclusive access to hundreds of highly qualified biopharmaceutical manufacturing, operations, supply chain, engineering, project management, quality, regulatory affairs and laboratory science professionals.

Increase Brand Recognition

Become a sponsor at the conference to strengthen your brand image, increase your visibility, drive traffic to your booth, and align your company with industry leading minds and world class content. High profile sponsorships are available for lanyards, notepads, mobile app, audience response systems, tote bags, hotel keycards, mobile device charging stations, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall

+1 (301) 656-5900 ext. 160
Cell +1 (240) 688-4405

Alison Caballero

+1 (301) 656-5900 ext. 135

Networking Opportunities


Closing Reception: A Night in Havana!

Wednesday, March 21 | 7:00 p.m.

Grab your sundresses and sandals, guayabera shirt and fedora, and celebrate the end of the PDA Annual Meeting - Cuban Style! Join your fellow attendees for a Night in Havana, a Cuban-themed closing reception. Enjoy a night under the stars with live entertainment, specialty cocktails, and Cuban-inspired bites.


Course Series

Want to know more about cleanroom management, container closure, combination products, and other hot topics?

Immediately following the 2018 PDA Annual Meeting, PDA Education has you covered with six courses designed to meet your needs. All courses will be held March 22 - 23, 2018 at the Loews Sapphire Falls Resort.

Available Courses

2018 PDA Manufacturing Intelligence Workshop

Digital Strategies to Drive Manufacturing and Supply Chain Reliability

This inclusive event is designed to enable participants to discuss the needs and challenges of managing manufacturing-related data. Acquiring an understanding of the development and implementation of big data strategies will also be a key take away! Find out how the holistic use of data and corresponding insights gained can be an effective way to meet many of the challenges surrounding global manufacturing in a regulated bio/pharmaceutical industry.