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2019 PDA Annual Meeting

Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products
Mar 11 - Mar 13, 2019 |
Mar 13, 2019 |
Marriott Marquis San Diego | San Diego, CA
  • Conference
  • Western Hemisphere Events
Exhibition: March 11-13
Post-Workshop: March 13-14
Courses: March 15
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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.

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

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

Contacts

Jason Brown
Assistant Director, Programs
(301) 656-5900 ext. 131
Email: brown@pda.org

Registration & Customer Care
(301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition inquiries
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: hall@pda.org

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

7:00 a.m. – 4:00 p.m.
Exhibitor Set Up

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

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

This session will provide a high-level overview of the major regulatory initiatives at the FDA and in the EU. FDA will provide updates on topics such as program alignment, organizational changes, key inspectional priorities, and response to supply chain disruptions. The session will also cover EU hot topics, including changes in the EU with the impact of BREXIT, the EMA headquarters move, and other global issues affecting the pharmaceutical supply chain and drug availability. The presenters will also discuss harmonization topics, including Mutual Recognition Agreements (MRA) and PIC/S collaboration.

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

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

6:00 p.m. – 7:30 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
Industry Presenter Invited

8:50 a.m. – 9:10 a.m.
Using Risk-Based Approaches to Reduce the PAC Regulatory Burden
Industry Presenter Invited

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.
Stacey Ma, PhD, Global Head, Innovation, Technology & MSAT, Genentech, Inc.

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 and Technology, 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

10:45 a.m. – 11:15 a.m.
Industry Presenter Invited

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, Amanda Bishop McFarland, MS, Consultant, ValSource, LLC, and Emma Ramnarine, Senior Director, Global Biologics, Genentech/Roche

CGT Leaders: Michael N. Blackton, MBA, Vice President, Quality, Adaptimmune LLC, and Vijay Chiruvolu, PhD, Vice President of Process Development, Kite Pharma

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:
Polly Hanff, Global Regulatory Affairs & Quality Director, Saint-Gobain

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:

Beth J. Haas, Senior Project Manager/Consultant, Commissioning Agents International, Inc.

John D. Wass, Business Area Lead, New Technologies and Technology Transfers, Commissioning Agents International, Inc.

12:15 p.m. – 1:45 p.m.
Networking Luncheon 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 Presenter Invited

2:15 p.m. – 2:45 p.m.
Industry Presenter Invited

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 M. Preslar, MBA, 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

Leaders: Jane Halpern, PhD, Regulatory Lead, National Institutes of Health (NIH) and
Sabrina A. Restrepo, PhD, Director, Sterile & Validation Center of Excellence

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. 

Update of the VIG opportunities in the PDA Biopharmaceuticals week will be presented.

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

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

INNOVATIVE MANUFACTURING STRATEGIES

A3: Manufacturing Lesson’s Learned: Great Risks and Innovative Solutions
Moderator: Shelley M. Preslar, MBA, 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
Martin G. VanTrieste, President & CEO, Civica

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.

4:00 p.m. – 4:30 p.m.
Regulatory Presenter Invited

4:30 p.m. – 5:00 p.m.
Industry Presenter Invited

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

IG5: BIOPHARMACEUTICAL MANUFACTURING INTEREST GROUP

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

6:30 p.m. – 9:30 p.m.
Reception

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
Gilad Langer, PhD, Vice President of Business Development,Bigfinite
Chris Watts, PhD, Principal, VolPal

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 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.
Industry Presenter Invited

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

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.
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

IG7: ENVIRONMENTAL MONITORING/MICROBIOLOGY INTEREST GROUP

Leaders: Julie Barlasov-Brown, Associate Director, Sterile and Microbiology Quality Assurance, Merck & Co. Inc. and Marc Glogovsky, 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.

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.

This session will begin with a presentation that explores challenges and opportunities regarding the capture of tacit knowledge (knowledge in the heads of people) and explicit (documented) knowledge during Technology and Knowledge Transfer activities and position that knowledge for reuse through the product lifecycle. The presenters will explore Pharmaceutical KM research on the topic of Technology Transfer and a pilot case study. The second presentation will address how pharmaceutical landscape has seen an unprecedented number of biologic therapies gain expedited FDA approval in the past decade.  Among those most promising are antisense oligonucleotides (ASOs), medium MW, synthesized nucleic acids that function by modulating protein/gene expression or splicing.  The talk considers how by understanding and anticipating the needs of these complex molecules from a packaging perspective, drug and containment/delivery system compatibility issues can be circumvented. 

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.
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 Passport Raffle 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 Rodriguez Falero, Risk Management Manger,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

Conference and Workshop Registration | March 11-14

Member

By February 1, 2019
$2,940

After February 1, 2019
$3,640

Non-member

By February 1, 2019
$3,219

After February 1, 2019
$3,919


Conference Registration | March 11-13

Member

By February 1, 2019
$1,995

After February 1, 2019
$2,595

Non-member

By February 1, 2019
$2,274

After February 1, 2019
$2,874


Government/Health Authority

Member

By February 1, 2019
$700

After February 1, 2019
$700

Non-member*

By February 1, 2019
$800

After February 1, 2019
$800


Academic

Member

By February 1, 2019
$700

After February 1, 2019
$700

Non-member*

By February 1, 2019
$800

After February 1, 2019
$800


Student

Member

By February 1, 2019
$280

After February 1, 2019
$280

Non-member*

By February 1, 2019
$310

After February 1, 2019
$310


Young Professional Member

Member

By February 1, 2019
$998

After February 1, 2019
$1,298


One Day Only Registration - Available for Tuesday, March 12 and Wednesday, March 13

Member

$1,498

Non-member

$1,637

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 registration@pda.org 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 10, 2019 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 10, 2019, 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 info@pda.org 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: Tape recordings are prohibited at all PDA Conferences.

Marriott Marquis San Diego Marriott Marquis
333 West Harbor Drive
San Diego, CA USA 92101
Tel: +1(619)-234-1500

 

 Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

Rate: Single/Double: $289/per night*

*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.

Cut Off Date: Monday, February 11, 2019

The PDA block of rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

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.

Airport

San Diego International Airport (SAN) is located 3.3 miles (about 15 minutes) northeast from the Hotel.

Ground Transportation

Taxis

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.

Directions

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

Hotel Parking

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

Exhibit and Sponsorship Opportunities Available

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 decision-makers, 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 at +1 (301) 656-5900 ext. 160; cell +1 (240) 688-4405; hall@pda.org or Alison Caballero at +1 (301) 656-5900 ext. 135; caballero@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4253

Directions