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Mar 2018
Mar 2018


Loews Sapphire Falls Resort 6601 Adventure Way Orlando , Florida 32819
Tel: (407) 503-5000
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2018 PDA Annual Meeting - Parenteral Drug Association






$2,545 - $3,524


Event Overview:

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!

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 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

Exhibitor Information:

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.

About PDA:

The Parenteral Drug Association (PDA) is the leading global facilitator of science, technology and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers education for the community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical / biopharmaceutical manufacturing science and regulation so members can better serve patients.


Mar 19   

7:00 a.m. - 8:00 a.m.

Sunrise Yoga: All proceeds go to a charity

7:00 a.m. - 4:00 p.m.

Exhibitor Set Up

9:00 a.m. – 10:00 a.m.

Orientation Breakfast (Invitation only)

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.

Quality Culture Metrics Task Force Meeting (Invitation only)

9:00 a.m. – 12:00 p.m.

Science Advisory Board (SAB) Meeting (Invitation only)

10:00 a.m. – 11:30 a.m.

PDA Chapter Council Meeting (Invitation only)

12:00 p.m. - 1:00 p.m.

Advisory Board Mix & Mingle Lunch (Invitation only)

9:00 a.m. - 5:00 p.m.

Speaker Ready Room Open

9:00 a.m. - 5:00 p.m.

Speaker Ready Room Open

12:00 p.m. - 1:00 p.m.

Refreshments Available

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 GMP Auditing, Merck & Company

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.

Company Dynamics
Steven Spear, PhD, Senior Lecturer, System Dynamics, Massachusetts Institute of Technology (MIT)

4:00 p.m. - 4:30 p.m.

Regulatory Perspective on New Technologies
Regulatory Representative (Invited)

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)

Mar 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
David Lebwohl, MD, Franchise Global Program Head, CAR-T Team, Novartis Pharmaceuticals Corporation

9:00 a.m. - 9:30 a.m.

Industry Perspective on Genomic Profiling
Industry Presenter (Invited)

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

Non-Destructive CCIT (Leak Detection) of Assembled Auto Injectors - Challenges and Successes
Paul Bilotti, North America Sales Manager, Wilco-USA

The Prats and Pitfalls of Assessing Cell Viability After Cryopreservation
Brian Hawkins, PhD, Senior Application Scientist, BioLife Solutions

Case Studies in Bacterial Spore and Fungal Spore Excursions in Cleanrooms and Oral Solid Dose Operations
Jim Polarine, Senior Technical Services Manager, STERIS Corporation

Current Regulatory Considerations for Continuous Manufacturing of Pharmaceuticals in Japan
Issei Takayama, Reviewer, Pharmaceuticals and Medical Devices Agency

Pediatric Formulation Development of Epinephrine Injection: A Child’s Play?
Nicolas Thurin, PhD, Manager, Analytical Product Development, Catalent Pharma Solutions

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

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

Determining Performance Improvements by Quality by Design Plungers for Syringes in Auto-Injector Systems
Page McAndrew, PhD, Director, Scientific Communications

Maximizing Sterility Assurance using Aseptic Component Wrapping Systems
Aaron Mertens, Technical Service Specialist, West Pharmaceutical Services

Evolution of Container Closure Integrity Testing: 5 Case Studies on Prefilled Syringes
Lisa Caralli, Senior Director of Pharmaceuticals, Catalent Pharma Solutions

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

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

Data Integrity Governance and Metrics to Mitigate Regulatory Risks Across Corporate Networks
Danilo Neri, Vice President, Operations, PQE

Incorporating Diverse Patient Needs and Preferences into a Medical Device Offering
Aditya Ravi, Product Manager, North America and Europe, BD Medical – Pharmaceutical Systems

Striving for Zero Visible Particles: Practical Implementation in Elastomeric Closure Manufacturing and Quality Control
Rahul Thakar, PhD, Technical Manager, Datwyler Pharma Packaging

Impact of Selected Elements on the Accelerated Stability of Human Lysozyme
Erica Tullo, PhD, Technology Manager, Extractables and Leachables, West Pharmaceutical Services

10:45 a.m. - 12:15 p.m.

Concurrent Sessions

Track: Innovative Manufacturing Strategies

A1: IT: So Much More than Technology
Moderator: Aaron 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./Merck Sharp & Dohme

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
Dennis Kim, Vice President, Operations, Global Manufacturing and Supply Chain, 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.

Interest Group

IG2: Filtration
Leader: Maik W. Jornitz, MS CEO, G-Con Manufacturing

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

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 (Invitation only)

Track: Innovative Manufacturing Strategies

A2: Control Strategies for Continuous Processing
Moderator: Melissa Seymour, 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 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
Ross Gold, P. Eng., Vice President, Engineering and Co-founder, Vanrx Pharmasystems Inc.
Terrence E. Hollis, Process Engineering Manager, Patheon

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 GMP Auditing, Merck & Company, Merck Sharpe & Dohme
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.


Scale Out vs Scale Up for Biologics Manufacturing

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: Michael De Felippis, PhD, Senior Research Fellow, Bioproduct Research & Development, Eli Lilly and Company

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 Gammel, 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
Leaders: Michael Blackton, MBA,Vice President, Global Quality, Adaptimmune, LLC and Vijay Chiruvolu, PhD, Vice President, Process Sciences & Engineering, Kite Pharma

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.

Interest Group

IG6: Facilities and Engineering
Leader: Shelley 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


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

Mar 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.  Hear stories from leaders in the personalized medicine space on how they are approaching the challenges of patient identity, supply chain security, cost, speed, importation, exportation, and other challenges unique to these programs.

10:45 a.m. -11:15 a.m.
Perspective on Patient-Centric Supply Chain Needs
J. Andrew Case, Director, Supply Chain Emerging Technology, 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. -12:15 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

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 GMP Auditing, Merck Sharpe & Dohme

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, Executive Director, Global GMP Auditing, Merck & Company/Merck Sharpe & Dohme

7:00 p.m. - 10:00 p.m.

Closing Reception: Havana Nights



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