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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Annual Meeting

Manufacturing Innovation: The Next Wave of Sterile and Biopharmaceutical Science, Technologies and Processing


Apr 03 - Apr 05, 2017 | Anaheim, CA
Anaheim Marriott
 
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Program Highlights

2017 PDA Annual Meeting Keynote Presenter

Suleika Jaouad is the critically acclaimed New York Times “Well” author of the column “Life, Interrupted,” which chronicles her journey as a young woman living with cancer. An award-winning video series accompanies the column, which earned Suleika the 2013 News & Documentary EMMY award.

Suleika graduated with highest honors from Princeton University in 2010. Shortly after graduation, at age 22, Suleika was diagnosed with myelodysplastic syndrome and acute myeloid leukemia. After almost three years of chemotherapy and a bone marrow transplant, she is finally cancer-free and continuing to make the most of a life, interrupted.

Suleika is a young adult healthy living advocate, motivational speaker and cancer warrior, who speaks and writes about topics including patient advocacy, nutrition, sexuality and relationships. A strong and powerful voice for the young adult generation, Suleika has been featured in The New York Times, Glamour Magazine, Women’s Health, NBC’s Weekend TODAY Show, NPR’s Talk of the Nation and All Things Considered, Everyday Health among other numerous media outlets.

Overview

PDA’s flagship Annual Meeting provides a venue for obtaining the latest and most comprehensive information on a broad range of topics related to processing, manufacturing and quality control. More importantly, the Annual Meeting is the ideal forum for sharing best practices and learning how industry is applying novel approaches for development and commercialization of pharmaceutical and biopharmaceutical products. The trend continues with the 2017 PDA Annual Meeting taking place April 3-5 in Anaheim, CA.

The theme of the 2017 Meeting is Manufacturing Innovation: The Next Wave of Sterile & Biopharmaceutical Science, Technologies & Processing. In selecting this theme, the goal was to design an inclusive event that encompasses the wide ranging interests of all PDA members. Relevant information important to both small molecule pharmaceutical and biopharmaceutical industries will be covered. Taking full advantage of the Meeting being held in the United States, which is known as being a “hot bed” of innovation, novel approaches and future strategies for bringing products to the market will figure prominently on the program.

Plenary sessions focus on advanced therapeutic strategies, including the emerging fields of immunotherapy, gene and cell-based therapies. Emphasis is placed on science and technologies needed to bring these innovative products to the patient. Additional plenary sessions further explore current and future trends in process development and manufacturing, including topics on next generation processing and facilities, application of big data for process design and optimization and accelerating the industry response to healthcare needs. Concurrent sessions were designed to support the Conference theme and allow Meeting participants to take a deeper look at the technology, science and processing approaches that are shaping our industry now and in the future. These focus areas form the basis of tracks that include topics related to advances in analytical sciences and quality control strategies, developments in patient-centered precision medicine and next generation manufacturing.

Rounding out the program are Breakfast Sessions and Interest Group meetings offering the opportunity for  Meeting participants to engage in interactive discussions on a wide range of important topics and specific disciplines. The Exhibition Hall will offer opportunities for one-on-one interactions with service providers and vendors showcasing 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.

Don’t miss out on this important learning opportunity. Make plans now to attend the 2017 PDA Annual Meeting.

Learning Objectives

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

  • Determine manufacturing and quality requirements for immunotherapies, gene and cell therapy products
  • Describe continuous manufacturing applications and flexible facility designs of the future
  • Demonstrate how big data can be applied to design and optimize manufacturing processes
  • Define strategies to accelerate new products to the market
  • 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
  • Explain delivery system design and manufacturing logistics for patient-centered therapies and precision medicine
  • Summarize best practices for identifying and introducing new technologies

Who Should Attend

Job Function:
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

Contact

Jason Brown
Senior Manager, Programs & Registration Services
Tel: (301) 656-5900 ext. 131
Email: brown@pda.org
Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries

David Hall
Vice President, Sales 
Tel: +1 (240) 688-4405
Email: hall@pda.org

Course Inquiries

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

Agenda

As of March 30, 2017

Sunday, April 2, 2017

6:30 a.m. - 9:30 a.m.

11th Annual Walk/Run Event - Benefiting Global Genes
Sponsored in part by the following PDA Chapters: Capital Area, Delaware Valley, Metro, Midwest, Missouri Valley, New England,  and Southern California
Registration Opens at 6:30 a.m.
Race starts at 7:15 a.m.

Set off on your choice of a 5k run or a 3k walk and get in a light workout while taking in the local sites. The $45 registration fee includes a t-shirt, race bib, light refreshments and fun with colleagues, family and friends.

Global Genes is one of the leading rare disease patient advocacy organizations in the world. The non-profit organization promotes the needs of the rare disease community under a unifying symbol of hope – the Blue Denim Genes Ribbon. What began as a grassroots movement in 2009, with just a few rare disease parent advocates and foundations, has since grown to over 500 global organizations.

12:00 p.m. - 1:00 p.m.
Advisory Board Mix & Mingle (Invitation Only)
1:00 p.m. – 4:00 p.m.
Science Advisory Board (SAB) Meeting (Invitation Only)
1:00 p.m. – 4:00 p.m.
Biopharmaceutical Advisory Board (BioAB) Meeting (Invitation Only)
1:00 p.m. – 5:00 p.m.
Regulatory Affairs/Quality Advisory Board (RAQAB) Meeting (Invitation Only)
1:00 p.m. – 4:00 p.m.
Science Advisory Board (SAB) Meeting (Invitation Only)
3:00 p.m. - 6:00 p.m.
Registration Open
3:00 p.m. - 6:00 p.m.
Speaker Ready Room Open
4:00 p.m. - 5:00 p.m.
2017 Annual Meeting Program Planning Committee Meeting (Invitation only)
4:00 p.m. - 5:30 p.m.
Meet & Greet Reception
4:00 p.m. - 7:00 p.m.
Registration Open
6:30 p.m. - 9:30 p.m.
PDA Awards Dinner (Invitation Only)

Monday, April 3, 2017

7:00 a.m. - 8:00 a.m.
Continental Breakfast
7:00 a.m. - 8:00 a.m.
Orientation Breakfast - Sponsored by Amgen, Inc.
7:00 a.m. - 5:30 p.m.
Registration Open
7:00 a.m. - 5:30 p.m.
Speaker Ready Room Open
8:00 a.m. - 8:45 a.m.
Welcome & Opening Remarks
Hal Baseman, Chief Operations Officer, ValSource, LLC
Richard Johnson, President & CEO, PDA
Michael DeFelippis, PhD, Senior Research Fellow, Bioproduct Research & Development, Eli Lilly and Company, and Co-Chair, 2017 PDA Annual Meeting Program Planning Committee and
Morten Munk, Global Technology Partner, NNE, Co-Chairs, 2017 PDA Annual Meeting Program Planning Committee
8:45 am. - 10:15 a.m. | Platinum Ballroom 5/6
P1 - Opening Plenary Session: Focus on the Patient
Moderator: Michael DeFelippis, PhD, Senior Research Fellow, Bioproduct Research & Development, Eli Lilly and Company

Session Description: The Opening Plenary session will provide an intriguing example of how scientific discovery in new frontiers of medicine is leading to novel, potentially life-saving treatment options. Emphasis will be placed on industry’s role in helping to bring future pharmaceutical innovations to the patients we serve. As a reminder of the importance of our work, we will hear directly from a patient who has benefitted from advancements in medicine.

8:45 a.m. - 9:15 a.m.
Genome Engineering for Therapeutic Applications
Bruce Conklin, MD, Senior Investigator, Gladstone Institute of Cardiovascular Disease, Professor, Department of Medicine, University of California, San Francisco
9:15 a.m. - 9:45 a.m.
Making the Most of a Life, Interrupted
Suleika Jaouad, Well Columnist, New York Times, Health Advocate and Cancer Survivor
9:45 a.m. - 10:15 a.m.
Questions & Answers/Discussion
10:00 a.m. - 7:00 p.m.
Exhibit Hall Open
10:15 a.m. - 11:00 a.m.
Refreshment Break and Poster Presentations in Exhibit Hall
The following posters will be presented during refreshment breaks on Monday, April 3, 2017.

Process Validation/Lifecycle Approach: Assessment Methodologies for Stage 2 & 3
Naheed  Sayeed-Desta, Manager, Technical Operations Process Validation, Apotex Inc.

Gaining Value through External Collaborations towards Standardization of Single-Use Systems Aspects
Jeffrey Carter, PhD, Strategic Projects Leader, GE Healthcare Pt Ltd.

Automated Inspection of Parenteral Drug Products –Evaluation of Product Quality Impact of Small-Molecule Products and Biologics
Sean Tomlinson, PhD, Senior Process Engineer, Pfizer Inc.

Total Organic Carbon (TOC) Method Development for Low Solubility Compounds in Cleaning Validation
Jenny Watson,Global Pharmaceutical Applications Manager, GE Analytical Instruments

Container Closure Integrity Testing (CCIT): New USP for Pre-filled Syringes
Nicolas Thurin, PhD, Analytical R&D Manager, Catalent Pharma Solutions

Practical Applications and Benefits of Sterile Product Compliance Risk Assessments and case studies This poster is related to "Microbial Control Program/ Control Strategy Design"
Guenther Gapp, PhD, Microbiologist, Gapp Quality GmbH

Development of Predictive Risk Elements within an Internal Product Quality Risk Model for cGMP Manufacturing and Testing              
Michael  LaBruto, Director, Quality Process Improvement, GSK

Mixing/Blending Processes in Single Use Systems
Abhijit Banerjee, PhD, Director of Technical Services, Advent

Development and Validation of an Aerosol Method to Validate the Integrity of Single Use Systems
Kathleen Souza,
R&D Manager, Microbiology, EMD Millipore Corporation

Product Commercialization is more than just Building a Facility; It's About Building Organizational Ability
Roger Filannino, Validation Engineer, Project Manager & Client Manager, CAI

Bioanalytical Assessment of Compatibility of Model Biologics with Commercial and Developmental Elastomeric Packaging Materials
Lloyd Waxman, PhD, Senior Chemist, West Pharmaceutical Services

Total Quality Allows for Continuous Production Process Improvement
Paul Bilotti, North America Sales Manager, Wilco-USA

Challenges of Implementing Sterile Single Use Systems for Non-Aqueous Parenteral Formulations
David Royle, Associate Principal Scientist, Pharmaceutics Project Expert, AstraZeneca

Case Study: Data on Liquid Shipping in Single-use Bags Supporting Biotech Process Qualification
Elisabeth Vachette, Senior Global Product Manager, Sartorius Stedim FMT SAS

Case Study: Reducing the  Number of Validation Deviations during Project Implementation
Walid El Azab, Manager, Technical Services, STERIS Corporation

Process Analytical Technology (PAT) in Continuous Bioprocessing
Edita Botonjic-Sehic, PhD, Senior Principal R&D Scientist, Pall Life Sciences

Biofilm Remediation Strategies for the Pharmaceutical Industry
Paul Lopolito, Senior Manager, Technical Services, STERIS Corporation

The Effect of a Plunger Surface Roughening Treatment on CCI: Evaluation of Inherent Package Integrity by Helium Leak Detection in the Vacuum Mode
Brandon Zurawlow, Associate Director, CCIT, Whitehouse Laboratories

11:00 a.m. - 12:00 p.m.
Exhibits Committee Meeting (Invitation Only)
11:00 a.m. - 12:30 p.m.
P2 - Advanced Therapies/Cell and Gene Therapies: Quality Aspects
Moderator: Melissa Seymour, Vice President, Corporate Quality, Biogen

Session Description: Scientific progress over the last several years has led to novel methods for the transfer of genetic material into patients’ cells for therapeutic purposes. Many quality challenges exist in this space including insertional mutagenesis, induced cellular changes and vector DNA mobilization. This session will address quality aspects in the production of gene transfer vectors and genetically modified somatic cells, including appropriate characterization and validation requirements.

11:00 a.m. - 11:30 a.m.
CTL019: Journey to Industrialization
Karen Walker, Global Head of Technical Development & Manufacturing, Cell and Gene Therapies Unit, Novartis Pharma Corp
11:30 a.m. - 12:00 p.m.
Overcoming Quality Challenges in Cell Therapy
Bethany Dudek, Senior Director, Site Head Quality, Kite Pharma
12:00 p.m. - 12:30 p.m.
Questions & Answers/Discussion
12:30 p.m. - 1:45 p.m.
Publishing Meeting (Invitation Only)
12:30 p.m. - 2:00 p.m.
Networking Luncheon in Exhibit Hall
12:30 p.m. - 2:00 p.m.
Chapter Council Meeting (Invitation Only)
12:30 p.m. - 2:00 p.m.
Education Advisory Board (Invitation Only)
2:00 p.m. - 3:30 p.m.
Concurrent Sessions

Technology Track: Advances in Analytical Sciences & Quality Control Strategies

A1 - Analytical Sciences & Process Monitoring
Moderator: Aaron Goerke, PhD, Associate Director/Head of Downstream Global Manufacturing Science & Technology, Genentech, A Member of the Roche Group

Session Description: The manufacture of pharmaceutical products is a complex process. These processes and products are susceptible to contamination by adventitious agents such as bacteria, fungi and viruses. Adventitious agent contaminations can have a significant impact on manufacturing operations, product quality and patient safety. This qualifies for the increased attention by both industry and health authorities. Perspectives, forwardlooking practice and new technologies surrounding adventitious agent control and detection will emerge from this session.


2:00 p.m. - 2:30 p.m.
Microbiological Control and Adventitious Agents
Patricia Hughes, PhD, Team Leader, Biotech Manufacturing, FDA


2:30 p.m. - 3:00 p.m
Virus Control, Safety, and New Technologies for Virus Detection
Arifa Khan, PhD, Senior Investigator, CBER,FDA


3:00 p.m. - 3:30 p.m.
Questions & Answers/Discussion

Science Track: Developments in Patient-Centered Precision Medicine

B1 - Delivery System Design
Moderator: Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck & Company/Merck, Sharp & Dohme

Session Description: Delivery Systems for Bio/Pharmaceuticals, which includes combination products, has expanded when measured by many parameters, including the number of drugs involved, the therapeutic areas treated and the size of the patient population targeted. But the goal remains the same: ensuring that the patient gets the right drug at the right dose at the right time. No longer restricted to administration by healthcare professionals, delivery systems need to be robust to accommodate patients’ lifestyles, and be as user friendly as a smartphone. Do we understand how the patient is using the delivery system? Are they intimidated or empowered? How can we make sure that the drug, when in the patient's control, is protected from light or stored at the appropriate temperature? The presentations will discuss some of the challenges of designing drug delivery systems in this rapidly changing environment.


2:00 p.m. - 2:30 p.m.
Navigating Risk Management and Design Control Challenges for Combination
Products:  A Deeper-Dive Look
into Complex Drug/Device Combination Products and Co-Packaged Kits
Tracy TreDenick, Head of Regulatory & Quality Assurance, Founding Partner, BioTechLogic


2:30 p.m. - 3:00 p.m
System Integration of Drugs, Pre-filled Syringes and Delivery Devices
Galen Shi, PhD, Engineering Advisor, Eli Lilly & Company


3:00 p.m. - 3:30 p.m.
Questions & Answers/Discussion

Processing Track: Next Generation Manufacturing

C1 - Future Facility Design
Moderator: Morten Munk, Global Technology Partner, NNE

Session Description: There is a growing trend in the pharma industry toward ‘personalization’ of healthcare. More and more specialized products used by a small group of patients are being developed, and the regulatory authorities support this trend by offering accelerated approval processes for these types of products. Additionally, with an increased focus on reducing manufacturing costs and with less predictability of the future demands for different products, there is a need for more flexible and agile facilities. This session highlights some of the toolsthat need to be activated to accommodate this trend for a new type of facilities and manufacturing strategies. The focus of the second presentation is to address the concern from the industry regarding how the authorities view introductions of new technologies in general plus a specific focus on continuous manufacturing.


2:00 p.m. - 2:30 p.m.
Flexible Manufacturing Strategies: Applying QRM to Implement Straight Thru Processing
Lisa Sykes, Director, Vaccine Operations,Merck & Company/Merck, Sharp & Dohme


2:30 p.m. - 3:00 p.m
Small Molecule/Continuous Biomanufacturing
Rapti Madurawe, PhD, Division Director (Acting), Process Assessment I, CDER, FDA

3:00 p.m. - 3:30 p.m.
Questions & Answers/Discussion

3:30 p.m. - 4:15 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall
4:15 p.m. - 5:30 p.m.
Concurrent Interest Group Sessions
IG1 - Advanced Virus Detection

Leader: Dominick Vacante, PhD, Scientific Director, Janssen Pharmaceutical R&D

Interest Group Description: Advanced nucleic acid based technologies are emerging, cutting-edge techniques with various potential applications for biologicals, such as detection of unknown adventitious viruses in novel cell substrates and product and raw material characterization. Additionally these new methods have the potential to complement some current assays. This interest group (IG) is comprised of experts representing industry, academia, government agencies and regulators who discuss the current thinking and planned efforts regarding application of new technologies for virus detection in biologicals.
IG2 - Facilities & Engineering

Leader: Shelley Preslar, General Manager, Azzur Group

Interest Group Description: The Facilities and Engineering Interest Group provides a forum for the discussion of topics and interests related to the design, construction, operation and maintenance of the production and research facilities used for GMP and GLP purposes. Discussions are held in conjunction with two of the PDA meetings: the Annual Meeting and the PDA/FDA Joint Regulatory Conference, as well as a discussion forum on the PDA website.
The format of the Facilities and Engineering Interest Group meetings are an open forum for discussion, where attendees select the topic for discussion and the leader moderates the discussion of peers seeking to reach a better understanding of regulatory expectations and opportunities to share and learn best practices. Where appropriate, the Facilities and Engineering Interest Group will compile these understandings and best practices into technical reports with the contributions and review of interested members.

IG3 - Filtration

Leader: Maik Jornitz, CEO, G-Con Manufacturing, Inc.

Interest Group Description: On April 11, 2016, EMA issued the document "Guideline on the sterilization of the medicinal product, active substance, excipient and primary container" for comment.  The document contains a section on sterilizing filtration requirements that is of interest to the members of the Filtration IG.

Under "Sterile filtration" the document states, "The integrity of the sterilized filter should be verified before use but after its sterilization unless specifically justified and validated, and should be confirmed immediately after use. Nominal pore sizes of 0.22 μm or less are acceptable without further justification, in accordance with Ph. Eur." Note that the document suggests that mandatory post-sterilization integrity testing of the filter is not necessary if validated and justified.  Interesting and not entirely clear is the statement about the acceptability without justification of filters having nominal pore sizes of 0.22 μm or less.  Also, the previously stated pre-filtration bioburden limit of NMT 10 CFU per100 mL has been softened. The comment period on the document closed October 13, 2016.

IG4 - Management of Outsourced Operations

Leader: Sharon Ayd, PhD, Chief Scientific Officer & Senior Vice President, Pharmaceuticals, Regulatory Compliance Associates, Inc.

Interest Group Description: The Management of Outsourced Operations Interest Group provides a forum for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities. The meeting is open discussion format with a moderator.  The group discussion at PDA annual meeting will focus on the issue of “Customer Concerns Related to Their Relationship with Their Outsourced Service Provider”. Some matters we will be discussing:

  • “If I am only a small volume client of a large CMO, what leverage do I have to negotiate a favorable quality agreement”
  • “I am a virtual pharma company that relies exclusively on CMOs. In the US there is insufficient manufacturing capacity for a specific pharma product in my portfolio but there is a CMO in Asia that can manufacture the product.
    • Can anyone comment on the state of the CMO industry in the US in terms of expected future expansion?
    • Can anyone comment on the use of a CMO in Asia / outside the USA”

If you have other related issues or questions you would like to raise you can add new and different ideas to this session.

IG5 - Microbiology/
Environmental Monitoring

Leader: Julie Barlasov, Associate Director, Sterile & Microbiology Quality Assurance & Quality Risk Management COE, Merck & Company/Merck, Sharp & Dohme

Interest Group Description: The Microbiology/Environmental Monitoring Interest Group addresses topics in pharmaceutical microbiology, rapid microbiology, environmental monitoring and compendial issues. The group typically has a guest speaker followed by a group discussion. If warranted, task forces are established to respond to issues relevant to microbiologists.

Speaker

Jette Christensen, Scientific Director, Compliance, Novo Nordisk A/S

IG6 - Packaging Science

Leader: Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies

Interest Group Description: The session will provide updates on current activities in the area of parenteral packaging, including Technical Reports, Tasks Forces and regulatory Issues. An area of focus will be change control for packaging system components. Perspectives will be presented by Susan Dounce of Datwyler Pharma and Jennifer Johns of Pfizer. The meeting will provide an open forum for further discussion on this issue and additional topics of interest.

Speakers

Susan Dounce, PhD, Senior Manager, Business Development & Innovation, Injection Systems Datwyler  Sealing Solutions
Jennifer Johns, Director, Packaging & Device Services, Pfizer, Inc.

5:30 p.m. - 7:00 p.m.
Networking Reception in Exhibit Hall - Sponsored in Part by the PDA Southern California Chapter

Tuesday, April 4, 2017

7:00 a.m. - 8:30 a.m.
Continental Breakfast
7:00 a.m. - 5:15 p.m.
Registration Open
7:00 a.m. - 5:15 p.m.
Speaker Ready Room Open
7:15 a.m. - 8:15 a.m.
Concurrent Breakfast Sessions
Breakfast I: Overcoming the Barriers to Technology Implementation & Change Management
Moderator: Tia Bush, Vice President, Quality, Amgen, Inc.

Session Description: Developing a new therapy requires significant investment and is often marked by lengthy development to commercialization timelines and a high risk of failure.  Innovation in the pharmaceutical industry has a dramatic impact on the health and wellness of millions of people and the ability of the company to maintain the solid business results that are expected by shareholders. For many pharmaceutical companies, innovation is the core element of their vision and mission to serve patient needs. Partnering with regulators can ensure that innovative and safe medicines are available to those that need it most.
The regulators’ primary role is to ensure patient safety; however, it is clear that they are playing an active role in promoting innovation. The regulatory framework is rigid in order to maintain high standards, but regulators are open to discussion with the industry. This session will focus on the collaborative initiatives that are underway as well as the opportunities that still exist to overcome the barriers of introducing new technology both internal to the company and external with the regulators.


Rapti Madurawe, PhD, Division Director (Acting), Process Assessment I, CDER, FDA
Michael Abernathy, Executive Director, Regulatory Affairs, Amgen, Inc.

Breakfast II: Knowledge Management – Q12 Update
Moderator: Melissa Seymour, Vice President, Corporate Quality, Biogen

Session Description: Knowledge Management is becoming increasingly important to the industry with respect to facilitating product development, continuous improvement across the product lifecycle and post-marketing process control. It is clear, also, that the current regulatory processes are less than optimal for encouraging product and process improvements. The Q12 initiative is driving more intense dialogue on what the most effective KM and regulatory reporting processes could achieve.
Knowledge Management and how that information flows both internally and externally to regulators could be a turning point in how Post Approval Changes are managed. This session will focus on integrated use of knowledge gained during the product lifecycle, including transparency with regulators, to establish and maintain a state of control that could facilitate opportunities for reduced reporting of Post Approval Changes.


7:15 a.m. - 7:40 a.m.
Post Approval Change and Knowledge Management – Where are We? Results from the PAC iAM Task Force Survey
Emma Ramnarine, Head, Global Biologics Quality Control, Genentech, A member of the Roche Group

7:40 a.m. - 8:05 a.m.
The Future State  - Knowledge Management and Sharing to Reduce Regulatory Burden
Ursula Busse, PhD, Quality Intelligence & External Relations, Novartis

8:05 a.m. - 8:15 a.m.
Questions & Answers/Discussion

Breakfast III: Business Management of QRM
Moderator: Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck & Company/Merck, Sharp & Dohme

Session Description: ICH Q9 (Quality Risk Management), defines harm as damage to health, including the damage that can occur from loss of product quality or availability. At many firms, the principles outlined in ICH Q9 are leveraged in a very detailed, complex manner, to assess the intricate failure modes or hazards associated with specific process steps or equipment within the manufacturing process. While this may be beneficial in understanding and controlling granular risks associated with a specific process step, it does not always lend itself to a strategic landscape. A holistic review of systems, processes and company strategies is necessary to identify the strategic risks that could potentially have more impact on the overall compliance status, product availability to patients and strategic direction of the firm. This presentation will discuss the connection of risk management (including Quality Risk Management) to business strategy and what tools and methodologies could be used to identify this level of risk. Follow the methodology used in the lifecycle of a risk; how it is communicated and escalated to senior leadership; and how the risk control recommendations are incorporated into business processes, portfolio management and in decision-making principles. The outcome of this process should be a decision focused on ensuring a compliance-driven, sustainable business that consistently delivers quality product to patients.


Integration of Risk Management into Product Strategy and Portfolio
Lori Richter, Site Risk Manager, Genentech, Inc., A member of the Roche Group

8:30 a.m. - 9:30 a.m.
2018 Annual Meeting Exhibit Space Drawing (Invitation Only)
8:30 a.m. - 10:00 a.m.
P3 - Next Generation Manufacturing and Facilities
Moderator: Maik Jornitz, CEO, G-Con Manufacturing, Inc.

Session Description: Capital expenses, invested into rigid production facilities, which are often only designed to facilitate one product, are a high risk. These are highly inflexible, difficult to scale and unable to be divested if the drug target fails. In addition, process intensification due to higher expression rates and continuous processing efforts require rapidly deployable facilities with a smaller footprint. Production site design and process equipment flexibility is becoming a key element. The session will address modular facilities, production process platforms and single-use equipment, which can be established fast track and with high degree of flexibility.

8:30 a.m. - 9:00 a.m.
Next Generation Biomanufacturing
Mike Vandiver,  Vice President, Manufacturing & Plant Design, Just Biotherapeutics
9:00 a.m. - 9:30 a.m.
Trends in Creating Flexible Clinical and Launch Facilities for Parenteral Products
Barry Starkman,  Principal Consultant, Parenteral Manufacturing, DPS Engineering
9:30 a.m. - 10:00 a.m.
Questions & Answers/Discussion
9:45 a.m. - 4:00 p.m.
Exhibit Hall Open
10:00 a.m. - 10:45 a.m.
Refreshment Break & Poster Presentations in Exhibit Hall
The following posters will be presented during refreshment breaks on Tuesday, April 4, 2017.

Downstream Processing of a Large Live Virus: Challenges in Development and Scale Up for a Sterile Purification Process
Wanli (Justin) Ma, Senior Scientist, Vaccines Process Development,  Merck Research Laboratories

A Harmonized Approach to Data Integrity
Kimberley Buytaert-Hoefen, PhD, Senior Consultant, Parexel

Performance Analysis – Inspiring Innovation for Reliable Supply
Pia Krieger, Performance Analysis Workstream Lead, Roche GmbH

Analytical Approach for Implementation of Visual Inspection
Mariann Neverovitch, Research Scientist, Bristol-Myers Squibb

Operational Excellence: Lean Six Sigma Applied to Analytical Method Transfers
Charlotte Brice, Account Director, Catalent Pharma Solutions

Cleaning Validation Concerns for Continuous Manufacturing Processes
Elizabeth Rivera, Technical Services Manager, Steris Corporation

A Software System for Next Generation Sequencing Based Detection of Adventitious Agent Contamination
Asa Oudes, PhD, Scientific Account Manager, Genedata Inc.

Can Single Use Components be Considered Commodities?
Christopher  Smalley, PhD, Director, Engineering BioSterile Validation,   Lyophilization Technology, Inc.

Process Analytical Technology (PAT) in Continuous Bioprocessing
Edita Botonjic-Sehic, PhD, Senior Principal R&D Scientist, Pall Life Sciences

Beyond The Count: A Three-Pronged Approach To USP <788> Utilizing Particle Counting, Automated Raman Spectroscopy and Automated SEM-EDS for Source Determination
Emily Landsperger, Scientist II, Gateway Analytical

The Future of Outsourcing: How to Ensure a Successful Contract Partner Relationship
Brittany Cloud, Group Leader, Quality Compliance, Eurofins Lancaster Laboratories, Inc.

Mold Control and Detection In Biological Drug Substance Manufacturing Facilities: An Industry Perspective
Stephanie Ramsey, Manager II, Global QC Microbiology, Shire

Combination Products - Lessons Learned and Case Studies
Steve Coulter, PhD, General Manager, RCA West, Regulatory Compliance Associates, Inc.

Usability Formative Study for Risk Mitigation in the Early Development Phase of a full Passive, Integrated Safety System for Prefilled Syringes
Alessandro Artioli, PhD, Core Team Leader,  Nuova Ompi S.r.l.

Raw Material Management and Product Design Strategy for Enhanced Quality, Assurance of Supply, Validation & Change Control of Single-Use Systems
Paul Preibe, Director, Product Management, Sartorius Stedim

Application of Online Process Analytical Technology (PAT) to Evaluate Lyophilized Parenteral Formulations for Process Understanding and Product Quality
Charudharshini Srinivasan, PhD¸ Staff Fellow, CDER, FDA

Safe, Reliable Bulk Drug Substance Transfers via Frozen Storage and Logistics in Single-Use Containers
Michael Marciniak, Senior Product Manager, Freeze-Thaw Technologies, Sartorius Stedim NA, Inc.

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

Technology Track: Advances in Analytical Sciences & Quality Control Strategies

A2 - Real Time Release Testing
Moderator: Tia Bush, Vice President, Quality, Amgen, Inc.

Session Description: Real time release testing (RTRT) and continuous manufacturing are hot topics with industry and regulators alike. ICH defines RTRT as "the ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls."  Many companies and academic research centers are making investments in the implementation of continuous manufacturing processes and RTRT. The benefit of increased knowledge of the product and the manufacturing process is a fundamental concept of quality by design (QbD) and the harmonized ICH quality guidelines. Experts believe that RTRT approaches have both economic and quality benefits from manufacturing efficiency to an increased assurance of product quality.  However, progress has been slow due to the technical challenges that exist. This session will explore RTRT approaches, benefits and challenges in a manufacturing environment.


10:45 a.m. - 11:15 a.m.
Real-Time Release Testing: A Case Study on an existing Commercial Product
Juan Torres, PhD, Senior Vice President, Global Quality, Biogen Idec


11:15 a.m. - 11:45 a.m.
Predictive Process Analytical Technologies as Enabler of More Efficient Operations Towards Real-time Release
Cenk Undey, PhD, Executive Director of Process Development, Amgen, Inc.


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

Science Track: Developments in Patient-Centered Precision Medicine

B2 - Immunotherapies
Moderator: Tor Gråberg, Head of External Advocacy Operations, Quality, AstraZeneca


Session Description: 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.


10:45 a.m. - 11:15 a.m.
Advances in the Assessment and Control of the Effector Functions of Therapeutic Antibodies
Xu-Rong Jiang, MD, Quality &Technical Director, AstraZeneca


11:15 a.m. - 11:45 a.m.
Immunotherapies for the Future
Mark Dudley, PhD, Senior Vice President, Bioprocessing, Adaptimmune, Ltd.


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

Processing Track: Next Generation Manufacturing

C2 - Manufacturing & Logistics for Personalized Medicine
Moderator: Maik Jornitz, CEO, G-Con Manufacturing, Inc.


Session Description: Gene and cell therapies are rapidly rising therapies with unique processing and logistics needs. These therapies can be patient based, utilize a high standard of aseptic processing due to the lack of a terminal sterilization possibility, require rapid release possibilities to ship the injectable to the patient,respectively, and have a need for robust and secure needle-to-needle logistics. These are just a few facets of the differences in personalized medicine processing compared to traditional therapies. The session will discuss key needs and trends within the personalized medicine area and will introduce processing and manufacturing possibilities.


10:45 a.m. - 11:15 a.m.
Facilities for Personalized Medicine: Today and Tomorrow - When Redoing the Batch is Not an Option
Henriette Schubert, Global Technology Partner, Facility & Lab, NNE
Mikkel Mohr Madsen, Engineer, Active Products & Utility, NNE


11:15 a.m. - 11:45 a.m.
Manufacturing and Process Systems for Cell Therapies
Vijay Chiruvolu, PhD, Vice President, Process Sciences & Engineering, Kite Pharma


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

12:15 p.m. - 1:30 p.m.
Interest Group Leaders Meeting (Invitation Only)
12:15 p.m. - 1:30 p.m.
Portfolio Steering Committee Meeting (Invitation Only)
12:15 p.m. - 1:45 p.m.
Networking Luncheon & Passport Raffle in Exhibit Hall
1:00 p.m. - 2:00 p.m.
Audit Committee Meeting (Invitation Only)
1:45 p.m. - 3:15 p.m.
Concurrent Sessions

Technology Track: Advances in Analytical Sciences & Quality Control Strategies

A3 - Control Strategies Based on Product Characterization
Moderator:Marcia Baroni, Director, QC Microbiology & EM/Sterility Assurance, Eli Lilly and Company


Session Description: In the past five years, with broader implementation of ICH Q8, 9 and 10, we have seen a drastic increase in the use of design space, risk management and control strategies in pharmaceutical manufacturing. More robust control strategies can lead to much more capable and in control processes and more effective and efficient manufacturing. Initial applications started with the control of more traditional physical, chemical and microbiological parameters, but have progressively evolved, becoming increasingly complex and process/product specific and are now taking advantage of product characterization to further refine control strategies and mechanisms.
This session will explore examples of successful applications, the implementation process and its benefits.


1:45 p.m. - 2:15 p.m.
Using QRM to Determine Critical Process Parameters and the Process Control Strategy
Kelly Waldron, Senior Consultant, ValSource, LLC


2:15 p.m. - 2:45 p.m.
Characterization and Control of Cell and Gene Therapies
Margit Jeschke, PhD, Global Head, Analytical Development, Cell and Gene Therapy, Novartis AG


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

Science Track: Developments in Patient-Centered Precision Medicine

B3 - Genomic Profiling
Moderator: Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck & Company /Merck, Sharp & Dohme


Session Description: As research on genomic profiling progresses, knowledge is gained on why some individuals are susceptible to certain diseases while others are not and why people have different reactions to the same drug. It can also be used as an innovative approach to diagnose, treat or even prevent diseases. This session will address some current uses and future opportunities to use genomic profiling as a tool to improve healthcare.


1:45 p.m. - 2:15 p.m.
Enabling Precision Medicine:  The Applications of Genomics in Clinical Drug Development
Angela Qu, MD/PhD, Scientific Director, Genomic Medicine, PAREXEL International


2:15 p.m. - 2:45 p.m. 
Metabolic Profiling
Sandra Merkel DeJames, PhD, Director, Commercial Strategy & Execution, Precision Medicine, Metabolon


2:45 p.m. - 3:15 p.m.
Tia Bush, Vice President, Quality, Amgen, Inc. (Confirmed)
Tor Graberg, Head of External Advocacy Operations, Quality, AstraZeneca

Processing Track: Next Generation Manufacturing

C3 - Selecting and Introducing New Technologies
Moderator: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates, Inc.


Session Description: The pharmaceutical industry is always looking for new and innovative technologies that will help ensure potential lifesaving medicines are available to patients in a timely manner. This session will discuss the efforts of Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT) project launched in the UK. This project’s mission is to enable digital design of the manufacturing process for innovative medicines. In addition, this session will discuss recent advances in the use of 3-D printing and how it can be used to advance the pharmaceutical industry.


1:45 p.m. - 2:15 p.m.
ADDoPT: Consortium to Enable Digital Design of Drug Manufacturing
David Royle, Associate Principal Scientist, Pharmaceutics Project Expert, AstraZeneca


2:15 p.m. - 2:45 p.m.
Emerging Technologies
Laurie Graham, Biologist (Team Leader), CDER, FDA


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

Panelists:
Tia Bush, Vice President, Quality, Amgen, Inc.

Tor Graberg, Head of External Advocacy Operations, Quality, AstraZeneca

3:15 p.m. - 4:00 p.m.
Refreshment Break, Poster Presentations and Passport Raffle in Exhibit Hall
4:00 p.m. - 5:15 p.m.
Concurrent Interest Group Sessions
IG7 - Process Validation
Leaders: Scott Bozzone, PhD, Principal, Pharm Lifecycle Validation & Vijay Chiruvolu, PhD, Vice President, Process Sciences & Engineering, Kite Pharma

Interest Group Description: We will have a brief presentation by Vijay Chiruvolu, Ph.D. of Kite Pharma, on “The Challenges of Establishing a Control Strategy for Autologous Cell Therapy Product”. Establishing a robust control strategy is essential and fundamental to successful process validation.  Cell therapy manufacturing process present unique challenges. This presentation will highlight some of the known unknowns of building a control strategy for manufacture of autologous cell therapy products.

Also, we will discuss what's new in process validation such as the PDA TR on Oral Solids/Semisolids, new FDA warning letters, inspection observations, and regulations. Challenges that face these new technologies (e.g. continuous manufacturing) may be discussed in an open forum. Please bring your questions and share your thoughts.
IG8 - Quality Risk Management
Leader: Magaly Aham, Vice President of Compliance & US Operations, PharmaBioServ, Inc.
Amanda McFarland, Consultant Concordia ValSource, LLC. Emma Ramnarine, Head, Global Biologics Quality Control, Genentech, Inc., A member of the Roche Group

Interest Group Description: We are very excited to be meeting again at the 2017 Annual PDA meeting.  We welcome all current members and potential new members to join us in the QRM Interest Group (IG) session. The mission of our QRM IG is to learn, promote, share best practices within our interest group community that can help us incorporate and advance QRM practices in our respective organizations and QRM implementation journeys.  The Pharma industry is facing a significant increase of QRM-related tasks at any stage of a product/process lifecycle, driven by regulatory pressure, business-related reasons and the agility required by both. Most companies have tackled these challenges so far without an integrated approach. Overall that makes knowledge management and integrated QRM activities very difficult in terms of consistency and efficiency. In this session, we will query and drive a discussion with the QRM-IG audience on the requirements and expectations that need to be realized in QRM activities to support an agile life cycle management and continual improvement of products and processes. We will capture the audience experiences with different approaches and facilitate a discussion on best practices that could be adopted.

IG9 - Sterile Processing

Leader: Vanessa Vasadi-Figueroa, Partner/Microbiologist, Quality Executive Partners, Inc.

Interest Group Description: Complex and changing regulations, supply chains, markets, technology and product portfolios and new dimensions to familiar and continued challenges in the manufacture, control and assurance of sterile products.  This session will offer participants the opportunity to develop their know-how in applied solutions through real-life examples, case-studies and shared best practices.

IG10 - Technology Transfer

Leader: Melissa Seymour, Vice President, Corporate Quality, Biogen

Interest Group Description: The Technology Transfer IG was launched in 2016 and has as its main objective to capture the opportunity given by benchmarking industry experience in Technology Transfer in order to provide useful information through Technical Reports, articles, position papers, training sections, deliverable templates and lectures.  
As part of this meeting we will provide an overview of the IG including, history, current goals and opportunities, as well as the strategic plan for the coming years.  Additionally, the IG has developed a TT Matrix which provides a framework on the knowledge transfer needs and required activities based on current regulatory guidance for commercial to commercial Technology Transfer.  This matrix is broken into the five main stages or technical transfer associated with the organizational functions typically involved in a technical transfer.  Additionally the team has started a library of industry Guidances, References, Articles, Books, and Position Papers.  We will take the opportunity of the IG meeting to: Review the proposed matrix of activities/deliverables, Expand the benchmarking on the time/resources required for TT activities, and Continue Development of the TT library. This IG will be an active discussion between presenters and the audiences with a key goal of benchmarking.

Speaker

John Wass, Consultant, Commissioning Agents, Inc.

IG11 - Visual Inspection of Parenterals / Lyophilization

Leaders: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
Edward Trappler, President, Lyophilization Technology, Inc

Interest Group Descriptions: With the publication of USP <790>, which became official on August 1, 2014 and USP <1790> which will become official on August 1, 2017, there has been significant discussions within the industry on considerations for application of these chapters to difficult to inspect products.  This includes issues of sampling, testing and interpretation of the results.  This joint interest group session will focus on considerations in utilizing the information embodied within these chapters for lyophilized products.

The session will begin with review of the information provided within chapters <790> and <1790>, and current industry trends in their application.  As lyophilized preparations are one of those products that are difficult to inspect, and for which <1790> provides supporting information, the joint session will focus on visual inspection of lyophilized products.

The focus of this joint interest group session will be on these USP chapters, however, discussions on current topics brought to the session by participants on visual inspection and lyophilization are also welcome.  Topics discussed in past sessions have included technical and operational aspects, quality and regulatory expectations, as well as the latest trends throughout our industry, both domestic and international.

This open forum is structured so that topics of current interest are identified at the onset of the meeting for open discussions among participants.  The informal forum provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices.  Bring your experience and questions in applying the information within USP <790> and <1790>, along you’re your current topics of interest for discussion with your peers at this upcoming session.

IG12 - Pre-filled Syringes

Leader: Olivia Henderson, PhD, Principal Engineer, Amgen, Inc.

Interest Group Descriptions: The Prefilled Syringe Interest Group provides a forum for discussions of actual topics related to prefillable injection system components such as cartridges or syringes and combinations thereof with injection and safety devices. Members come together to exchange in an open discussion latest information about technological improvements in the universe of prefillable syringes and injection devices, covering production, filling, handling and regulatory aspects. The format of the Interest Group meetings includes formal presentations of experts from industry and government as well as open discussion forums and preparation of upcoming conferences to related topics.

Speaker:
Polymer Syringes: Market Trends and Growth Drivers
Patrick Gallagher, Business Development Manager, Syringes, Schott North America, Inc.

5:30 p.m. - 7:30 p.m.
Red Carpet Reception

Wednesday, April 5, 2017

7:00 a.m. - 8:30 a.m.
Continental Breakfast
7:00 a.m. - 12:00 p.m.
Registration Open
7:15 a.m. - 8:15 a.m.
Concurrent Breakfast Sessions
Breakfast IV: Data Integrity
Moderator: Ursula Busse, PhD, Quality Intelligence & External Relations, Novartis
Session Description: This session will include updates from the Data Integrity (DI) Working Group and the latest developments and trends in the world of DI.
Anil Sawant, PhD, Vice President, Global Quality Management Systems & External Affairs,  Merck & Company/Merck, Sharp & Dohme
Breakfast V: Applying Phase-Appropriate GMPs in Personalized Medicines - Development and Manufacturing
Moderator: Veronique Davoust, PharmD, Senior Manager, Global Quality Intelligence, Pfizer, Inc.
Session Description: A few of the core challenges with GMPs lie within the structure of an organization’s research and development. Advances in personalized medicine may require the application of a different approach to manufacturing. This session will address challenges and potential solutions to meet GMP standards.
John Geigert, PhD, President, BioPharmaceutical Quality Solutions
Breakfast VI: PDA Manufacturing Initiative
Moderator: Maik Jornitz, CEO, G-Con Manufacturing, Inc.
Session Description:  Manufacturing sites and processes are changing rapidly to more flexible, smaller systems to be implemented in new sites. Older or aging sites need to be modernized and optimized to still fulfill manufacturing and regulatory requirements. These are just two aspects of the need for a PDA Manufacturing Initiate to support the industry and be an interface between endusers and regulatory authorities. The session will give an update on the Manufacturing Initiative and invites discussions and input to further this project.
Hal Baseman, Chief Operations Officer, ValSource, LLC.
8:30 a.m. - 10:00 a.m.
P4 - Application of Big Data for Manufacturing Process Design and Optimization
Moderator: Aaron Goerke, PhD, Associate Director/Head of Downstream Global Manufacturing Science & Technology, Genentech, A Member of the Roche Group

Session Description: ‘Big data’ is a topic with a lot of potential. The potential is not merely the collection of data but includes the analysis combined with the knowledge to answer complex questions. This creates new possibilities for the pharmaceutical industry to drive operational and business performance to higher levels. Industry success stories will be presented with concepts being discussed that will provide unique opportunities for your organization. New strategies, processes, mindsets and skills are key takeaways. The important question is:  Can you afford not to adapt to the big data era?

8:30 a.m. - 9:00 a.m.
Big Data to Optimize Manufacturing
Michele D’Alessandro, Vice President & Chief Information Officer, Merck & Company/Merck, Sharp & Dohme
9:00 a.m. - 9:30 a.m.
Practical ‘Big Data’ Insights for R&D and Commercial Manufacturing Organizations
Adam Fermier, PhD, Scientific Director, PDMS, Janssen Pharmaceuticals R&D
9:30 p.m. - 10:00 a.m.
Questions & Answers/Discussion
10:00 a.m. - 10:30 a.m.
Refreshment Break
10:30 a.m. - 12:00 p.m.

P5 - Industry Response to Emerging Healthcare Needs for Uninterrupted Medicine Product Supply
Moderator:  Morten Munk,
Global Technology Partner, NNE

Session Description: New threats to our global health seem to surface more and more frequently. Diseases like Ebola and the Zika virus, which were unknown or only a local problem just few years ago, have begun to spread rapidly, causing a global threat. The pharmaceutical industry is a key player in resolving these crises and faces a major challenge to move potentially lifesaving products  more rapidly through the development pipeline, test them in clinical studies and deliver them to the market ready to be distributed to patients. An important tool to prioritize this effort is the generation and sharing of valid knowledge globally.

10:30 a.m. - 11:00 a.m.
Trends in the Global Burden of Disease: Results from the GBD 2015 Study and Forecasts to 2040
Christopher Murray, MD, Professor, Global Health, University of Washington,  and Director, Institute for Health Metrics & Evaluation
11:00 a.m. - 11:30 a.m.
Challenges after The Finish Line – How Can We keep a Product in Supply after Its Initial Approval?
Anders Vinther, PhD, Chief Quality Officer, Sanofi Pasteur
11:30 a.m. - 12:00 p.m.
Questions & Answers/Discussion
12:00 p.m.
Closing Remarks & Adjournment
Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck & Company /Merck, Sharp & Dohme and Morten Munk, Global Technology Partner, NNE, Co-Chairs, 2018 PDA  Annual Meeting Program Planning Committee

Speakers

  • Ursula Busse

    Novartis
  • Vijay Chiruvolu, PhD

    Kite Pharma
  • Bruce Conklin

    Bruce Conklin, MD

    University of California, San Francisco
  • Michele DAlessandro

    Michele D’Alessandro

    Merck
  • Susan Dounce

    Susan M. Dounce, Ph.D

    Datwyler
  • Mark Dudley

    Mark Dudley, PhD

    Adaptimmune Therapeutics
  • John Geigert, PhD

    Biopharmaceutical Quality Solutions
  • Patricia F. Hughes, PhD

    Food and Drug Administration
  • Suleika Jaouad

    Suleikha Jaouad

    New York Times
  • Rong Jiang-Xu

    Xu-Rong Jiang, PhD

    AstraZeneca
  • Khan Arifa

    Arifa S. Khan, PhD

    Food & Drug Administration
  • Mikkel Madsen

    Mikkel Mohr Madsen

    NNE
  • Christopher Murray

    Christopher J L Murray, MD

    Institute for Health Metrics and Evaluation
  • Angela Qu

    Angela Qu, MD, PhD

    PAREXEL International
  • Emma Ramnarine

    Emma Ramnarine

    Genentech/Roche
  • Lori Richter

    Lori Richter

    ValSource
  • David Royle

    David Royle

    AstraZeneca
  • Anil Sawant

    Anil Sawant, PhD

    Merck & Company, Inc.
  • Henriette Schubert

    Henriette Schubert

    NNE
  • Barry Starkman

    Barry Starkman

    DPS Engineering
  • Lisa Sykes

    Lisa Sykes, MBA

    Merck & Company, Inc.
  • Juan Torres

    Juan L. Torres, PhD

    Biogen
  • Tracy TreDenick

    Tracy L. TreDenick

    BioTechLogic, Inc.
  • Mike Vandiver

    Michael W. Vandiver

    Just Biotherapeutics, Inc.
  • Anders Vinther

    Anders Vinther, PhD

    Sanofi Pasteur
  • Kelly Waldron

    Kelly Waldron

    Sanofi
  • Karen Walker

    Karen Walker

    Novartis
  • John Wass

    John Wass

    Commissioning Agents, Inc.
  • Keith Wonnacott

    Keith M. Wonnacott, PhD

    Novartis Pharmaceuticals
  • Glenn Wright

    Eli Lilly & Company

Registration Fees

Conference and Workshop Registration | April 3-6, 2017

Member

Before January 20, 2017
$2,545

January 20 - February 17, 2017
$2,995

After February 17, 2017
$3,245

Nonmember

Before January 20, 2017
$2,804

January 20 - February 17, 2017
$3,254

After February 17, 2017
$3,504

Conference Registration | April 3-5, 2017

Member

Before January 20, 2017
$1,895

January 20 - February 17, 2017
$2,295

After February 17, 2017
$2,495

Nonmember

Before January 20, 2017
$2,154

January 20 - February 17, 2017
$2,554

After February 17, 2017
$2,754

Government/Health Authority/Academic

Member

Before January 20, 2017
$700

January 20 - February 17, 2017
$700

After February 17, 2017
$700

* Nonmember

Before January 20, 2017
$800

January 20 - February 17, 2017
$800

After February 17, 2017
$800

Student

Member

Before January 20, 2017
$280

January 20 - February 17, 2017
$280

After February 17, 2017
$280

* Nonmember

Before January 20, 2017
$310

January 20 - February 17, 2017
$310

After February 17, 2017
$310

Workshop Registration | April 5-6, 2017

Member | Nonmember

$800

All prices in US dollars.

* For this member type, online registration is not available must be faxed in.
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 event.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference and receive the 5th 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 February 2, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. 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 Workshop/Events: If your written request in received on or before February 2, 2017, 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 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 onsite. 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. Recordings are prohibited at all PDA conferences.

 

Venue

Anaheim Marriott Anaheim Marriott
700 West Convention Way
Anaheim, CA USA 92802
Tel: +1 714-750-8000
Reservations: +1-877-622-3056

  Make Your Reservation Online

 

Rate: Single/Double: $229.00, plus 15% state and local taxes, and a 2% Anaheim Tourism Improvement District Assessment and Tourism Taxes.

Website: www.marriott.com/Anaheim

Cut Off Date: Thursday, March 16, 2017 (A 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.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Anaheim Marriott. The rate is $229 for single or double occupancy, plus 15% state and local taxes and a 2% Anaheim Tourism Improvement District Assessment and Tourism Taxes.  Reservations must be secured by Thursday, March 2, 2017. 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 call the Anaheim Marriott at +1-877-622-3056. Please make sure to tell the reservationist that you are with the PDA group attending the 2017 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.

Amenities

The Anaheim Marriott is conveniently located near Downtown Disney, Honda Center and Angel Stadium of Anaheim.  You can take a 15 minute walk to the Anaheim GardenWalk featuring outdoor dining, shopping and entertainment.

The guest rooms and suites feature contemporary decor and upscale amenities including plush bedding. After a day of sightseeing or meetings, enjoy a workout in our state-of-the-art fitness center, soak up sun at the pool, enjoy a snack on the dining deck or cozy up near a fire pit.  Enjoy an unforgettable Southern California stay at the Anaheim Marriott!

Travel

Area Airports

John Wayne Airport - Orange County (SNA) is located 14 miles Southeast of the Anaheim Marriott.
Long Beach Airport (LGB) is located 19 miles West of the Anaheim Marriott.
Los Angeles International Airport (LAX) is located 35 miles Northwest of the Anaheim Marriott.

Ground Transportation

John Wayne Airport - Orange County (SNA):

  • Taxi service to the Anaheim Marriott is approximately $45 one way, not including tip.
  • Alternate transportation: Super Shuttle; fee: $11 USD each way (per person); reservation required.

Long Beach Airport (LGB)

  • Taxi service to the Anaheim Marriott is approximately $70 one way, not including tip.
  • Alternate transportation: Super Shuttle; fee: $35 each way (per person); reservation required.

Los Angeles International Airport (LAX)

  • Taxi service to the Anaheim Marriott is approximately $120 one way, not including tip.
  • Alternate transportation: Super Shuttle; fee: $17 each way (per person); reservation required.

Super Shuttle Reservations can be made online via www.supershuttle.com.

Driving

From Katella Avenue/Disney Way/Civic Center/Disneyland. Merge onto South Anaheim Way. Proceed to East Katella Avenue and turn left. Turn left again onto South Harbor Boulevard. Take the first right onto West Convention Way. Make a U-turn and the hotel will be on the right.

Hotel Parking

Onsite Parking at the Anaheim Marriott is $25 daily. Valet parking is $30 daily.

Directions

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, 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.

Contact

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

David Hall
+1 (240) 688-4405
hall@pda.org

Alison Caballero
+1 (301) 656-5900 ext. 135
caballero@pda.org

Networking Opportunities

PDA 11th Annual Walk/Run - Sunday, April 2

7:15 a.m
Sponsored in part by the following PDA Chapters: Capital Area, Delaware Valley, Metro, Midwest, Missouri Valley, New England, Southern California

Global Genes is one of the leading rare disease patient advocacy organizations in the world. The non-profit organization promotes the needs of the rare disease community under a unifying symbol of hope – the Blue Denim Genes Ribbon. Support this organization by registering to participate in the 11th Annual Walk/Run event on Sunday, April 2nd. There will be both a 5k race and a 3k walk. Tickets can be purchased for $45 at the registration counter on-site or by calling (301) 656-5900 ext. 115.

 

 

Networking Reception in the Exhibit Hall – Monday, April 3

5:30 p.m.-7:00pm
Sponsored in Part by the PDA Southern California Chapter

Join fellow attendees and exhibitors in the Marquis Ballroom for this opening night networking event which will feature wine, beer and tasty treats found in the local Southern California area. This reception is included in the cost of the full conference registration and open to all exhibitors at no additional cost.

 

 

Red Carpet Networking Reception - Tuesday, April 4

5:30 p.m.-7:30 p.m.
After a full day of attending session and meetings, be a star for the evening at our Red Carpet Reception. Strut your best outfit or go casual and be ready to dance!

This reception is included in the cost of the full conference registration and additional tickets for guests can be purchased for $70 at the registration counter or by calling (301) 656-5900 ext. 115.

 

Course Series

Want to know more about cleanroom management, container closure, quality culture, and other hot topics?

Immediately following the 2017 PDA Annual Meeting, PDA Education has you covered with five courses designed to meet your needs. All courses will be held April 6 - 7, 2017 at the Anaheim Marriott.

Available Courses

Workshop

Hear from industry experts on the latest developments in bringing cell and gene therapies to market and ultimately to the patient. The 2017 PDA Cell and Gene Therapy Workshop will provide you with best practices and insights into how the industry is applying new approaches for the development and commercialization of novel therapies.

Development control strategies, managing a complex supply chain and leveraging automation for increased capacity as they relate to gene and cellular therapies will be covered. Current and future trends in process development and manufacturing will also be explored.