The Parenteral Drug Association presents the 2017 PDA · PDF file · 2017-02-03The...

The Parenteral Drug Association presents the...

2017 PDA Annual MeetingInnovation in Manufacturing Science and TechnologyApril 3-5, 2017 | Anaheim, CaliforniaAnaheim MarriottExhibition: April 3-4#PDAAnnual

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

2017 PDA Cell and Gene Therapy Workshop: April 5-6 2017 PDA Annual Meeting Course Series: April 6-7

pda.org/2017Annual

SCIENCE TECHNOLOGYAND PROCESSING

ADVANCES IN ANALYTICAL SCIENCE QUALITY CONTROL STRATEGIES

CONTINUOUS MANUFACTURING

MANUFACTURING PROCESS DESIGN AND OPTIMIZATION

ADVANCED CELL/GENE THERAPIES

ACCELERATING PRODUCT

DEVELOPMENT

PATIENTS

GMP

QRM

DATA INTEGRITYROBOTICS

IMMUNOTHERAPIES OF THE FUTURE

NEXT GENERATION MANUFACTURING

BIG

DATA

EMER

GING

HE

ALTH

CO

NCER

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PATIENT-CENTERED DEVELOPMENT OF MEDICINE

FLEXIBLE PROCESSES

DRUG SHORTAGEGENOMIC

PROFILING

This preliminary agenda is current as of December 12, 2016

RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS

Register by February 17 and save up

to $200

http://www.pda.org/2017Annual

Connecting People, Science and Regulation®

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PROGRAM PLANNING COMMITTEE

A MESSAGE FROM THE PROGRAM CO-CHAIRS

Program Co-Chairs:

Michael R. De Felippis, PhDEli Lilly & Company

Morten MunkNNE Pharmaplan

Marcia Baroni Eli Lilly & Company

Tia Bush Amgen, Inc.

Véronique Davoust, PharmD Pfizer, Inc.

Madlene Dole Novartis

Aaron Goerke, PhD Genentech, A Member of the Roche Group

Tor Gråberg AstraZeneca

Laurie Graham FDA

Ghada Haddad Merck & Company, Inc.

Maik W. Jornitz G-Con Manufacturing, Inc.

Susan Schniepp Regulatory Compliance Associates Inc.

Melissa Seymour Biogen

Jason E. Brown PDA Planning Committee Liasion

Rich Levy, PhD PDA

Jahanvi (Janie) Miller, MBA PDA

Molly O’Neill Moir, CMP PDA

Dear Friends, Colleagues and Peers:

As the Co-Chairs of the Program Planning Committee, we invite you to attend the 2017 PDA Annual Meeting taking place at the Anaheim Marriott in Anaheim, CA, April 3-5.

There is no question that these are exciting times to be working in the pharmaceutical and biopharmaceutical industries. Scientific research continues to unravel mechanistic details of human

disease and identify novel approaches for treatment not even dreamed of a few years ago.

Likewise, technological advances are literally changing how pharmaceutical products are being developed, manufactured and delivered to patients across the globe.

However, in the information-rich society in which we currently live, it is often difficult to keep up with the rapid pace of new scientific developments and technological advances. How does one know what is truly important? What approaches are being adopted by industry peers, and how is new technology being applied? Equally important, what are the perspectives of regulatory authorities? Sifting through this wealth of information can be both challenging and time consuming.

Fortunately, there is a convenient way to gain firsthand knowledge on a variety of subjects – by attending the 2017 PDA Annual Meeting. The theme of this year’s conference – Manufacturing Innovation: The Next Wave of Sterile and Biopharmaceutical Science, Technologies & Processing – emphasizes a forward-looking view into the future of bio/pharmaceutical science and technology.

The 2017 PDA Annual Meeting Program Planning Committee has worked diligently over the past several months to develop a comprehensive and informative program directly aligned with the conference theme. A wide variety of topics of critical interest to everyone working in the field will be covered. Plenary sessions will focus on cell and gene technologies for personalized medicine, the patient perspective, next generation manufacturing and facilities, application of "big data" for manufacturing process design and optimization, and accelerating product development.

Conference participants can also select from three concurrent session tracks focused on analytical sciences and quality control strategies, developments in patient-centered precision medicine and next-generation manufacturing. These interactive sessions will cover microbiological control and adventitious agents, delivery system design, future facility design, real time release, immunotherapies, manufacturing logistics for personalized medicine, control strategies, genomic profiling and implementing new technology.

The Conference program further includes breakfast sessions and Interest Group meetings, offering the opportunity to select areas and obtain information that is most relevant to personal interests. Poster presenters will be on hand to discuss their latest research. Vendor representatives will also be available in the Exhibit Hall, showcasing their latest technologies.

Last but not least, there will be ample opportunities for peer-to-peer discussions and networking during the breaks and social events.

As you can see, there is something for everyone! This is definitely an event not to be missed. On behalf of the 2017 PDA Annual Meeting Program Planning Committee, the presenters, exhibitors and the PDA team, we look forward to seeing you in Anaheim!

Michael R. De Felippis, PhDEli Lilly & Company

Morten MunkNNE Pharmaplan

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2017 PDA Annual MeetingApril 3-5, 2017 | Anaheim Marriott | Anaheim, CA

Exhibition: April 3-4 | Post-Workshop: April 5-6 | Courses: April 6-7

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GENERAL INFORMATION, REGISTRATION

For specific information on the 2017 PDA Cell and Gene Therapy Workshop, turn to page 17.

FOUR WAYS TO REGISTER

1. Click pda.org/2017Annual2. Fax +1 (301) 986-10933. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 600 Bethesda, MD 20814 U.S.A.4. Phone (301) 656-5900 ext. 115

VENUEAnaheim Marriott 700 West Convention Way Anaheim, CA U.S.A. 92802 Phone: +1 (877) 622-3056Website: www.anaheimmarriott.com

Rate: Single/Double: $229.00, plus 15% state and local taxes, and a 2% Anaheim Tourism Improvement District Assessment and Tourism Tax. Cut-Off Date: Thursday, March 2, 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.

CONTINUING EDUCATION CREDITSPDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits.

To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically track their CPE credits.

The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

2017 PDA Annual Meeting ACPE # 0116-0000-16-027-L04-P | 1.45 CEUsType of Activity: Knowledge

LEARNING OBJECTIVESAt 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 ATTENDJob 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

CONFERENCE REGISTRATION HOURSSunday, April 2: 3:00 p.m. – 6:00 p.m.Monday, April 3: 7:00 a.m. – 5:15 p.m.Tuesday, April 4: 7:00 a.m. – 5:15 p.m.Wednesday, April 5: 7:00 a.m. – 12:00 p.m.

WORKSHOP REGISTRATION HOURSWednesday, April 5: 7:00 a.m. – 5:00 p.m.Thursday, April 6: 7:30 a.m. – 5:15 p.m.

COURSE REGISTRATION HOURSThursday, April 6: 7:30 a.m. – 4:00 p.m.Friday, April 7: 7:30 a.m. – 4:00 p.m.

DRESS/ATTIREBusiness casual attire is recommended for the 2017 PDA Annual Meeting. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

SPECIAL REQUIREMENTSIf you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can

be directed to [email protected].

CONTACT INFORMATIONConference InquiriesJason E. Brown Senior Manager, Programs & Registration Services Tel: +1 (301) 656-5900 ext. 131 Email: [email protected]

Registration Customer CareTel: +1 (301) 656-5900 ext. 115 Email: [email protected]

Exhibition/Sponsorship InquiriesDavid Hall Vice President, Sales Tel: +1 (301) 760-7373 Email: [email protected]

Education Course Series InquiriesStephanie Ko Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 Email: [email protected]


mailto:[email protected]





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SUNDAY, APRIL 2 – MONDAY, APRIL 3, 2017 AGENDASUNDAY, APRIL 2, 2017

7:00 a.m. – 10:00 a.m. 11th Annual Walk/Run Event

3:00 p.m. – 6:00 p.m. Registration Open

3:00 p.m. – 6:00 p.m. Speaker Ready Room 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. – 5:15 p.m. Registration Open

7:00 a.m. – 5:15 p.m. Speaker Ready Room Open

8:00 a.m. – 8:30 a.m. Welcome & Opening Remarks Martin VanTrieste, Former Senior Vice President, Quality, Amgen, Inc. Richard M. Johnson, President & CEO, PDA Michael R. De Felippis, PhD, Senior Research Fellow, Bioproduct Research & Development, Eli Lilly & Company, and Co-Chair, 2017 PDA Annual Meeting Program Planning Committee

8:30 am. – 10:00 a.m. P1: Opening Plenary Session: Focus on the PatientModerator: Michael R. De Felippis, PhD, Senior Research Fellow, Bioproduct Research & Development, Eli Lilly & 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.

8:30 a.m. – 9:00 a.m.Genome Engineering for Therapeutic Applications Bruce Conklin, MD, Senior Investigator, Gladstone Institute of Cardiovascular Disease, and Professor, Department of Medicine, University of California, San Francisco

9:00 a.m. – 9:30 a.m.Making the Most of a Life, InterruptedSuleika Jaouad, Well Columnist, New York Times, Health Advocate and Cancer Survivor

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

9:45 a.m. – 6:45 p.m. Exhibit Hall Open

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

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MONDAY, APRIL 3, 2017 AGENDA (CONTINUED)

10:45 a.m. – 12:15 p.m. P2: Advanced Therapies/Cell and Gene Therapies: Quality AspectsModerator: 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.

10:45 a.m. – 11:15 a.m.Quality Gene Therapies Karen Walker, Global Head of Technical Development & Manufacturing, Cell & Gene Therapies Unit, Novartis Pharma Corp.

11:15 a.m. – 11:45 a.m. Advanced Therapies Bethany Dudek, Senior Director, Site Head Quality, Kite Pharma

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

12:15 p.m. – 1:45 p.m. Lunch on your own. Exhibit Hall Closed – A listing of local restaurants is available at the PDA Registration Desk.

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

TECHNOLOGY TRACK Advances in Analytical Sciences and Quality Control Strategies

SCIENCE TRACK Developments in Patient-Centered

Precision Medicine

PROCESSING TRACK Next Generation Manufacturing

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

B1: Delivery System Design Moderator: Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck & Company, Inc.

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

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 has resulted in increased attention by both industry and health authorities. Perspectives, forward-looking practices and new technologies surrounding adventitious agent control and detection will emerge from this session.

Session Description: Delivery systems for bio/pharmaceuticals, which includes combination products, have 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 in 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?

Session Description: There is a growing trend in the pharma industry toward the "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 tools that need to be activated to accommodate this trend for a new type of facilities and manufacturing strategies.


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Precision Medicine


A1: Analytical Sciences and Process Monitoring (continued)

B1: Delivery System Design (continued) C1: Future Facility Design (continued)

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.

The focus of the second presentation will be concerns from the industry regarding how the authorities view introductions of new technologies in general as well as a specific focus on continuous manufacturing.

1:45 p.m. – 2:15 p.m. Microbiological Control and Adventitious Agents Patricia Hughes Troost, Team Leader, Biotech Manufacturing, FDA

2:15 p.m. – 2:45 p.mVirus Control, Safety and New Technologies for Virus Detection Arifa Khan, PhD, Senior Investigator, CBER, FDA (Invited)

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

1:45 p.m. – 2:15 p.m. Drug Delivery Device Platform for a Diverse Drug Pipeline that is Operations Ready Stephen Fournier, Director, Business Development, NNE Pharmaplan US, Inc.

2:15 p.m. – 2:45 p.mNavigating Risk Management and Design Control Challenges for Combination Products: A Deeper-Dive Look into Complex Drug/Device Combination Products and Co-Packaged KitsTracy TreDenick, Head of Regulatory & Quality Assurance, Founding Partner, BioTechLogic


1:45 p.m. – 2:15 p.m. Flexible Manufacturing Strategies: Applying QRM to Implement Straight through ProcessingLisa Sykes, Director, Vaccine Operations, Merck & Company, Inc.

2:15 p.m. – 2:45 p.mSmall Molecule/Continuous BiomanufacturingSau Lee, PhD, Deputy Director (Acting), Emerging Technology Team Chair, OPQ, FDA


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

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4:00 p.m. – 5:15 p.m. Concurrent Interest Group Sessions

IG1: Advanced Virus Detection

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

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 is comprised of experts representing industry, academia, government agencies and regulators who will discuss the current thinking and planned efforts regarding application of new technologies for novel 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 PDA ConnectSM.

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: Russell Madsen, President, The Williamsburg Group LLC

Interest Group Description: The Filtration Interest Group provides a forum for discussion of topics and issues related to filtration in pharmaceutical and biopharmaceutical applications, including sterilizing filtration of liquids and gases, depth filtration of process streams and process systems, and viral removal and purification.

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 will provide a platform for sharing information among PDA members on management, oversight and regulatory responsibilities of outsourced activities and serve as the liaison between RAQAB and follow up of the PCMO Task Force.

Scope:

• To monitor regulatory developments, guidances and standpoints regarding management of outsourced activities

• To support the preparation of position papers, Points to Consider documents or a Technical Report on outsourcing as well as submission of articles to the PDA Letter, which may evolve from IG Meetings

• To proactively identify ways of ensuring a global approach for integration of ICH Q10 using ICH Q9 and principles of quality risk management in managing outsourced activities

• To provide input to scheduling and content of PDA Conferences and PDA Education courses on outsourcing


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MONDAY, APRIL 3 – TUESDAY, APRIL 4, 2017 AGENDA

IG5: Microbiology/Environmental Monitoring

Leader: Julie Barlasov, Associate Director, Sterile & Microbiology Quality Assurance & Quality Risk Management COE, Merck & Company, Inc.

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.

IG6: Packaging Science

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

Interest Group Description: The Packaging Science Interest Group allows for the exchange of knowledge and ideas about pharmaceutical packaging. Members come together to develop presentations for PDA programs, organize special meetings on current topics, review USP and FDA proposals and regulations, work on task forces on focused topics and educate each other. Meetings are held in conjunction with PDA meetings.

5:15 p.m. – 6:45 p.m. Networking Reception in Exhibit Hall

TUESDAY, APRIL 4, 2017



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 and Change ManagementModerator: Tia Bush, Vice President, Quality, Amgen, Inc.

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

BREAKFAST III: Business Management of QRMModerator: Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck & Company, 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

Session Description: Knowledge management (KM) 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

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,

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TUESDAY, APRIL 4, 2017 AGENDA (CONTINUED)

BREAKFAST I: Overcoming the Barriers to Technology Implementation and Change Management (continued)

BREAKFAST II: Knowledge Management – Q12 Update (continued)

BREAKFAST III: Business Management of QRM (continued)

of their vision and mission to serve patient needs. Partnering with regulators can ensure that innovative and safe medicines are available to those who need them 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 internally to the company and externally with the regulators.

regulatory reporting processes could achieve. KM 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.

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. Learn 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.

Sau Lee, PhD, Deputy Director (Acting), Emerging Technology Team Chair,OPQ, FDA

7:15 a.m. – 7:40 a.m.Post-Approval Change and Knowledge Management – Where are We? Results from the PAC iAM Task Force SurveyEmma 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 BurdenUrsula Busse, PhD, Quality Intelligence & External Relations, Novartis


Integration of Risk Management into Product Strategy and PortfolioLori Richter, Site Risk Manager, Genentech, A Member of the Roche Group


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8:30 a.m. – 10:00 a.m.P3: Next Generation Manufacturing and FacilitiesModerator: Maik W. Jornitz, President, G-Con Manufacturing, Inc.

Session Description: When capital expenses are invested into rigid production facilities designed to facilitate only one product, it creates risk. These facilities 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 are becoming key elements in next-generation facilities. The session will address modular facilities, production process platforms and single-use equipment, which can be fast tracked with a 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 ProductsBarry Starkman, Principal Consultant, Parenteral Manufacturing, DPS Engineering


9:45 a.m. – 4:00 p.m. Exhibit Hall Open

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

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



Precision Medicine


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

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

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

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 in treatment 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 and provide examples of successful research.

Session Description: Gene and cell therapies are rapidly rising therapies with unique processing and logistics needs. These therapies can be patient based and utilize a high standard of aseptic processing due to the lack of a terminal sterilization possibility. In addition, options for rapid release are required in order to ship the injectables to the patient. There is also 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



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Precision Medicine


A2: Real-Time Release Testing(continued)

B2: Immunotherapies (continued) C2: Manufacturing & Logistics for Personalized Medicine (continued)

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.

medicine area and will introduce new processing and manufacturing possibilities to accommodate those needs.

10:45 a.m. – 11:15 a.m.Real-Time Release Testing: A Case Study on an Existing Commercial ProductJuan Torres, 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 toward Real-time ReleaseCenk Undey, PhD, Executive Director of Process Development, Amgen, Inc.


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

11:15 a.m. – 11:45 a.m.Immunotherapies for the FutureGwendolyn Binder-Scholl, PhD, Chief Technology Officer, Adaptimmune, Ltd.


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

11:15 a.m. – 11:45 a.m.Manufacturing and Process Systems for Cell TherapiesVijay Chiruvolu, PhD, Senior Director, Kite Pharma


12:15 p.m. – 1:45 p.m. Networking Luncheon and Passport Raffle in Exhibit Hall


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



Precision Medicine


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

B3: Genomic Profiling Moderator: Madlene Dole, Data Integrity Program Lead & Head of Strategic Planning & Operations Group QA, Novartis

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

Session Description: In the past five years, with broader implementation of ICH Q8, 9 and 10, we have seen a dramatic 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.

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.

Session Description: The pharmaceutical industry is always looking for new and innovative technologies that will help ensure potentially life-saving 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.Using QRM to Determine Critical Process Parameters and the Process Control StrategyKelly Waldron, Manager, Global Quality Risk Management & Design Control, Sanofi

2:15 p.m. – 2:45 p.m. Characterization and Control of Cell and Gene TherapiesKeith Wonnacott, Director, Regulatory Affairs for Cell and Gene Therapy, Novartis

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

1:45 p.m. – 2:15 p.m.Metabolic ProfilingJohn Ryals, PhD, President & Chief Executive Officer, Metabolon (Invited)

2:15 p.m. – 2:45 p.m. Applications and Treatments Industry Presenter Invited


1:45 p.m. – 2:15 p.m.ADDoPT: Consortium to Enable Digital Design of Drug ManufacturingDavid Royle, Associate Principal Scientist, Product Development, AstraZeneca

2:15 p.m. – 2:45 p.m.3-D Printing in the Advancement of MedicineRegulatory Representative Invited


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



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4:00 p.m. – 5:15 p.m. Concurrent Interest Group Sessions

IG7: Blow-Fill-Seal

Leader: Chuck Reed, Principal, Reeds & Rushes, LLC

Interest Group Description: The Blow-Fill-Seal (BFS) Interest Group will address anddiscuss issues related to the polymer as primary packaging material for parenterals (but applying polymers in the formulation of parenteral products). The group will also manage and produce guidelines of how LEAN can be implemented within the BFS manufacturing, scientific studies that produce risks and opportunities of polymer technology and, from a scientific perspective, challenge the BFS technology regarding what is needed further to achieve certifying the technology as advance aseptic technology or manufacturing.

IG8: Process Validation

Leaders: Scott Bozzone, PhD, Principal, Pharm Lifecycle Validation and Vijay Chiruvolu, PhD, Senior Director, Kite Pharma

Interest Group Description: This Process Validation Interest Group session will focus on understanding the process validation lifecycle for new technologies such as continuous manufacturing processes, biologics, gene and cell therapies or other new innovations. The challenges that face the process validation of new technologies will be discussed in an open forum.

We are also pursuing combining aspects of two other Interest Groups in this session: Applied Statistics and Quality Risk Management as these topics are related to an innovative process validation.

Please plan to attend this Interest Group session as your input and questions will make for a valuable and interesting meeting.

IG9: Quality Risk Management

Leader: Jeffrey Hartman, Senior Consultant, Validation & Quality Risk Management, Concordia ValSource, LLC

Interest Group Description: The Quality Risk Management (QRM) Interest Group hosts a PDA ConnectSM group where you can post questions, seek answers, generate discussions and, in general, interact with peers. The mission of our QRM Interest Group is to learn, promote and share best practices within our Interest Group community that can help us incorporate and advance quality risk management practices in our respective organizations. Your postings and discussions on PDA ConnectSM will serve a critical function in not only building and advancing communications within this Interest Group, but also helping with our own QRM implementation journeys.

IG10: Sterile Processing

Leader: Edward Tidswell, PhD, Executive Director, Microbiology Quality Assurance, Merck & Company, Inc.

Interest Group Description: The Sterile Processing Interest Group discusses such topics as 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.


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IG11: Technology Transfer

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

Interest Group Description: This Interest Group's main objective is to capture our experience in technology transfer projects, with potential opportunities for sharing information, including Technical Reports, articles, position papers, training sections and lectures.

The Group will discuss the technology transfer projects topics, from manufacturing process to analytical transfer, equipment user requirements definition to process validation, contract manufacturing organization selection to business discontinuity, appropriateness of the documentation to a “lessons learned” approach and statistical data analysis.

Pharmaceutical technology transfer projects consist of planned and controlled actions that are based on well-defined acceptance criteria to convey a pharma technology with all its attributes from a sending unit to a receiving unit and involve a complex group of internal and external stakeholders. Risks are hidden everywhere; it’s mandatory to have a robust and efficient methodology to identify, mitigate and control them.

For that reason, the Technology Transfer Interest Group is designed to help all of us find best practices; monitor worldwide trends; and analyze clusters of peculiarities based on companies, countries, dosage forms and drug entities.

IG12: Visual Inspection of Parenterals/Lyophilization

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

Interest Group Description: 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 have 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 qualify as 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 with your current topics of interest for discussion with your peers.

IG 13: Pre-filled Syringes

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

Interest Group Description: The Pre-filled Syringe Interest Group provides a forum for discussions of actual topics related to pre-fillable 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 the latest information about technological improvements in the universe of pre-fillable syringes and injection devices, covering production, filling, handling and regulatory aspects. The format of the Interest Group meetings includes formal presentations by experts from industry and government and open discussion forums and preparation of upcoming conferences on related topics.

6:00 p.m. – 9:00 p.m.Gala Event

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WEDNESDAY, APRIL 5, 2017 AGENDAWEDNESDAY, APRIL 5, 2017



7:15 a.m. – 8:15 a.m. Concurrent Breakfast Sessions

BREAKFAST IV: Data Integrity Moderator: Madlene Dole, Data Integrity Program Lead and Head of Strategic Planning & Operations Group QA, Novartis

BREAKFAST V: Applying Phase-Appropriate GMPs in Personalized Medicines – Development and Manufacturing Moderator: Véronique Davoust, PharmD, Manager, Global Quality Strategy, Pfizer, Inc.

BREAKFAST VI: PDA Manufacturing InitiativeModerator: Maik W. Jornitz, President, G-Con Manufacturing, Inc.

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.

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.

Session Description: Manufacturing sites and processes are changing rapidly to more flexible, smaller systems that are 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 Initiative to support the industry and be an interface between end users and regulatory authorities. This session will give an update on the Manufacturing Initiative. Participants are invited to provide their ideas for advancing this initiative.

Anil D. Sawant, PhD, Vice President, Global Quality Management Systems & External Affairs, Merck & Company, Inc.

John Geigert, President, BioPharmaceutical Quality Solutions

Glenn Wright, Senior Director, Project Management, Eli Lilly & Company

"The PDA Annual Meeting is clearly one of the best meetings to attend if you want up-to-date information on what is new in pharmaceutical and biopharmaceutical technology, regulation and best practices."

Christopher Smalley, Merck & Company, Inc.


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WEDNESDAY, APRIL 5, 2017 AGENDA (CONTINUED)

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 great deal of potential. The potential is not merely the collection of data, but also 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 and concepts 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 ManufacturingMichele D’Alessandro, Vice President & Chief Information Officer, Merck & Company, Inc.

9:00 a.m. – 9:30 a.m. Practical Big Data Insights for R&D and Commercial Manufacturing OrganizationsAdam Fermier, PhD, Scientific Director, PDMS, Janssen Pharmaceuticals R&D

9:30 a.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 Pharmaplan

Session Description: New threats to our global health seem to surface more and more frequently. Diseases such as Ebola and the Zika virus, which were unknown or only local problems just a few years ago, have begun to spread rapidly, causing global threats. The pharmaceutical industry is a key player in resolving these crises. However, the industry 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.Continuous Improvement in Healthcare Needs 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


12:00 p.m. Closing Remarks & Adjournment Morten Munk, Global Technology Partner, NNE Pharmaplan, and Co-Chair, 2017 PDA Annual Meeting Program Planning Committee

2017 PDA Cell and Gene Therapy WorkshopApril 5-6, 2017 | Anaheim Marriott | Anaheim, CA

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2017 PDA CELL AND GENE THERAPY WORKSHOPPROGRAM PLANNING COMMITTEE

Michael Blackton Adaptimmune, Ltd.

Vijay Chiruvolu, PhD Kite Pharma

Karen Walker Novartis Pharma Corp.

Josh Eaton PDA

Jason E. Brown PDA Planning Committee Liasion

WHO SHOULD ATTENDJob 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

WORKSHOP REGISTRATION HOURSWednesday, April 5: 7:00 a.m. – 5:00 p.m. Thursday, April 6: 7:30 a.m. – 5:15 p.m.

For specific information on the 2017 PDA Annual Meeting, turn to page 3.

GENERAL INFORMATION

http://www.pda.org/2017CGT


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WEDNESDAY, APRIL 5, 2017 AGENDA7:00 a.m. – 5:00 p.m. Registration Open

1:00 p.m. – 1:15 p.m. Welcome and Opening Remarks Michael Blackton, Vice President, Quality, CMC, Adaptimmune, Ltd.

1:15 p.m. – 2:45 p.m. P1: Opening Plenary Session - The Promise of Cell Therapy Moderator: Michael Blackton, Vice President, Quality, CMC, Adaptimmune, Ltd.

1:15 p.m. – 1:45 p.m.TCR as a Novel Cancer TherapyGwendolyn Binder-Scholl, PhD, Chief Technology Officer, Adaptimmune, Ltd.

1:45 p.m. – 2:15 p.m.Innovative Usage of Cell TherapyIndustry Presenter Invited


2:45 p.m. – 3:30 p.m. Refreshment Break in Exhibit Area

3:30 p.m. – 5:00 p.m. P2: Material Challenges for Cellular and Gene Therapy Products Moderator: Karen Walker, Global Head of Technical Development & Manufacturing, Cell & Gene Therapies Unit, Novartis Pharma Corp.

3:30 p.m. – 4:00 p.m.Viral Vector DevelopmentsJohannes Van der Loo, PhD, Director, Clinical Vector Core, Children’s Hospital of Philadelphia (CHOP) (Invited)

4:00 p.m. – 4:30 p.m. Raw Material SafetyIndustry Representative Invited


5:00 p.m. – 6:15 p.m. Networking Reception in Exhibit Area

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THURSDAY, APRIL 6, 2017 AGENDA7:30 a.m. – 5:15 p.m. Registration Open


8:30 a.m. – 10:00 a.m. P3: Managing the Product Lifecycle – Process Change, Comparability and Process Validation Considerations Moderator: Vijay Chiruvolu, PhD, Senior Director, Kite Pharma

8:30 a.m. – 9:00 a.m.Balancing Regulatory Requirements with Process Optimization for Commercial Feasibility in Advanced Stage T Cell Therapy ProductsPhillip Bassett, Head of Process Development, Adaptimmune, Ltd.

9:00 a.m. – 9:30 a.m.Cell & Gene Therapy/Product Lifecycle Margit Jeschke, Global Head, Analytical Development, Cell and Gene Therapy, Novartis AG (Invited)


9:45 a.m. – 5:30 p.m. Exhibit Area Open

10:00 a.m. – 10:45 a.m. Refreshment Break in Exhibit Area

10:45 a.m. – 12:15 p.m. P4: Managing the Supply Chain – Vein-to-Vein and across the GlobeModerator: Karen Walker, Global Head of Technical Development & Manufacturing, Cell & Gene Therapies Unit, Novartis Pharma Corp.

10:45 a.m. – 11:15 a.m.Chain of IdentityJian Irish, PhD, Senior Vice President, Supply Chain, Kite Pharma

11:15 a.m. – 11:45 a.m. Managing Global Supply Chain Kimberly Lounds-Foster, Celegene (Invited)


12:15 p.m. – 1:30 p.m. Lunch


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THURSDAY, APRIL 6, 2017 AGENDA (CONTINUED)

1:30 p.m. – 3:00 p.m. P5: Manufacturing Systems Moderator: Michael Blackton, Vice President, Quality, CMC, Adaptimmune, Ltd.

1:30 p.m. – 2:00 p.m.Enabling Development & Production of Future Medicines Dolores Baksh, Innovation Leader, Cell Therapy Technologies, GE Healthcare

2:00 p.m. – 2:30 p.m. Achieving Cost Effective Cell Therapies with Automation Brian Hanrahan, Manager, Cell Therapy, Invetech


3:00 p.m. – 3:45 p.m. Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m. P6: The Future Path of Cell and Gene TherapyModerator: Vijay Chiruvolu, PhD, Senior Director, Kite Pharma

3:45 p.m. – 4:15 p.m.Highly Characterized Processes to Produce Novel Cell Therapies for the ClinicClaudia Mitchell, PhD, CEO, Universal Cells

4:15 p.m. – 4:45 p.m. The Future of Gene TherapyJ. Fraser Wright, PhD, Co-Founder & Chief Technology Officer, Spark (Invited)


5:15 p.m. Closing Remarks and Adjournment Vijay Chiruvolu, PhD, Senior Director, Kite Pharma

2017 PDA Annual Meeting Course SeriesApril 6-7, 2017 | Anaheim Marriott | Anaheim, CA

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pda.org/2017AnnualCourses 21

2017 PDA ANNUAL MEETING COURSE SERIES

Following the 2017 PDA Annual Meeting, April 6-7, 2017, PDA Education will offer five courses designed to advance your knowledge.

CONTINUING EDUCATION

Continuing Education for Pharmacists

PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy

Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit.

ALERT: ACPE and the National Association of Boards of Pharmacy developed the CPE Monitor that allows pharmacists to electronically track their CPE credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE accredited activity. Always submit CPE activity claims as soon as possible and by the deadline specified on the CPE credit request form.

Continuing Education for Engineers

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of CPC activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

Contact Stephanie Ko via email at [email protected] to learn more.

CLASS SCHEDULEAll lecture courses begin at 8:30 a.m. and end at 4:00 p.m. Please arrive at your course location approximately 30 minutes before the start of the course to register and receive your name badge. Please be sure to bring your confirmation letter as proof of registration during check in. PDA will not allow persons to attend a course without payment or guarantee of payment. Continental breakfast will be served before class beginning at 7:30 a.m. Lunch will be provided from 12:00 p.m. – 1:00 p.m. Snacks will be provided during the morning break from 10:00 a.m. – 10:15 a.m. and the afternoon break from 2:30 p.m. – 2:45 p.m.

Students who pre-register will now be given access to electronic course notes, which may be printed once approximately 1-2 weeks in advance for use during the course. Hard copies of course notes will no longer be provided to pre-registered students and only a limited number of hard copies will be available for onsite and transferring registrants on a first-come, first-served basis.

http://www.pda.org/2017AnnualCourses


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2017 PDA ANNUAL MEETING COURSE SERIES (CONTINUED)

Cleanroom Management

Location: Anaheim Marriott | Anaheim, CA Date: April 6-7, 2017Duration: 2 daysTime: 8:30 a.m. – 4:00 p.m.

CPE: PDA #361 | ACPE #0116-0000-16-028-L04-P | 1.2 CEUs Type of Activity: Application

This course provides practical and theoretical information on contamination control and cleanroom management. Extensive guidance will be presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain the cleanliness levels required.

WHO SHOULD ATTENDThis course is designed for management and technicians and will benefit experienced cleanroom personnel as well as newcomers. Emphasis is placed on new developments and methods for operating every level of cleanroom or clean zone.

LEARNING OBJECTIVESUpon completion of this course, you will be able to:

• Assess a cleanroom training program• Manage the daily requirements of the cleanroom• Evaluate cleanroom supplies and garments• Assess the efficiency and frequency for aseptic and non-aseptic

cleaning methods

FACULTY Anne Marie Dixon-Heathman, Managing Partner, Cleanroom Management Associates, Inc.

Quality Metrics and Quality Culture


CPE: PDA #223 | ACPE #0116-0000-16-022-L04-P | 1.2 CEUs Type of Activity: Knowledge

The day on quality metrics will help the participants select the appropriate quality metrics, determine how best to collect the data and how to use the data to improve the quality system. The kinds of processes to be discussed include the production process, supporting processes such as change control, training and validation, supplier processes and materials management. The day on quality culture will discuss the possible components of quality culture and how to measure, change and improve culture.

WHO SHOULD ATTEND• Senior management responsible for the quality system (QS) and

its continuous improvement• Production management responsible for the quality of core

process and production• QA management responsible for assisting senior management in

its responsibilities for the QS and for collecting and analyzing the quality metrics and presenting them in usable form


• Identify what quality metrics or performance indicators your operation needs

• Collect and analyze the appropriate quality metrics data in the most cost effective way and use the data to drive continuous improvement of the quality system

• Describe the desired culture for your company• Identify and prioritize cultural gaps, and develop a strategic plan

for changing your company culture• Utilize tools for measuring the current culture and for progress

in changing it

FACULTY David Talmage, Director, Education, PDA

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2017 PDA ANNUAL MEETING COURSE SERIES (CONTINUED)

Quality Strategy for Biopharmaceuticals


CPE: PDA #448 | ACPE #0116-0000-16-029-L04-P | 1.2 CEUs Type of Activity: Knowledge

This course will provide insights and practical guidance for those responsible for determining and assuring the required quality for biopharmaceuticals for human use. Using a quality risk-based approach, an effective quality strategy will be explained addressing challenges from Phase 1 clinical studies through commercialization and for recombinant proteins, monoclonal antibodies, genetically engineered viruses and human cells. The course emphasis will include FDA, EMA and ICH guidance.

WHO SHOULD ATTENDThis two-day course is designed for management and professional staff involved in or interested in evaluating or developing an effective quality strategy for biopharmaceuticals (recombinant DNA-derived proteins, monoclonal antibodies, gene therapy and cellular therapy medicinal products), including senior management, directors and managers/supervisors, QA/QC, regulatory affairs, manufacturing, process development and analytical development personnel.


• Explain the importance and underlying principles for an effective quality strategy for the various types of biopharmaceuticals – recombinant proteins, monoclonal antibodies, gene therapy and cellular therapy medicines – through clinical development into the marketplace

• Describe the importance and underlying quality principles for biopharmaceuticals leads regulatory agencies (FDA, EMA) to have different regulatory quality requirements for these products compared to pharmaceuticals of chemical origin

FACULTY John Geigert, President, BioPharmaceutical Quality Solutions

NEW COURSE Container Closure Systems and Integrity Testing



This course introduces a practical and meaningful methodology to construct a package integrity profile using a risk-based approach and appropriate container closure integrity testing methods.

WHO SHOULD ATTENDParenteral drug packaging engineers and formulation scientists, laboratory scientific staff and managers, parenteral manufacturing staff, sterility quality assurance, regulatory affair scientists, CMC project management and pharmaceutical packaging component manufacturing staff.


• Define current regulatory requirements for container closure integrity verification throughout product lifecycle

• Develop meaningful design requirements for maximum allowed leakage limit for various product-package types

• Describe working principles of various container closure integrity (CCI) testing techniques, with focus on deterministic methods, such as vacuum decay, electrical conductivity and capacitance (HVLD), laser-based gas headspace analysis and mass extraction leak test

• Identify advantages and limitations of each CCI technical technique• Select and apply appropriate CCI testing methods for specific

product-package systems• Define CCI testing method development and validation approach• Formulate a comprehensive CCI testing plan throughout the

product lifecycle in support of package integrity verification profile• Apply risk-based approaches to develop a CCI control strategy

in which various CCI testing methods are used to inform, verify and demonstrate package integrity

FACULTY Lei Li, PhD, Associate Engineer Advisor, Delivery and Device R&D, Eli Lilly & Company


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• Introduce cost of quality in facilities & engineering (F&E) to demonstrate long term value of resource investments

• Classify cost of quality categories for association to F&E work at scrap, appraisal and prevention costs

• Illustrate a cost of quality analysis to teach important attributes of a successful capital project proposal

• Examine current ways issues are identified in equipment/ facilities/utilities and evaluate their effectiveness

• Collaborate and assemble an improved way to track and trend issues to feed cost of quality analyses

• Construct vision and mission statements that can be shared among F&E professionals

• Identify knowledge gaps within F&E teams and outside of F&E groups

• Develop a keyword-based knowledge transfer solution that fills gaps within and outside of F&E groups

FACULTY Chris M. Hanff, CMQ/OE, Senior Consultant and Project Lead, CONCORDIA ValSource, LLC

Knowledge Management Applied in Facilities & Engineering to Improve Manufacturing Reliability



This course will engage participants in a common goal of effecting positive change and improving equipment, facility and utility reliability through facilities and engineering. Participants will learn to identify and anticipate equipment problems and then apply techniques to ensure resources are provided to those equipment issues. Topics and perspectives will be presented to provoke thought and elicit potential actions that participants can take back to their organizations, such as analyzing and presenting the cost of quality and comparing the impact of fixing the problems now, fixing them later or fixing when it’s too late. Through the lens of facilities and engineering work, this course will traverse the FDA process validation lifecycle with a punch list of many topics, some of which are aging facilities, knowledge management and meaningful metrics.

WHO SHOULD ATTENDProfessionals in the pharmaceutical industry who have the following roles and/or responsibilities will benefit from this course:

Engineering | Facilities | Maintenance | Project Management (i.e. new build/expansion) | Finance/Accounting | Learning & Development | Process Excellence | Manufacturing | Quality

PREREQUISITESParticipants are expected to have experience working in or working closely with facilities & engineering teams. Participants should have some of the following:

• Working knowledge of equipment maintenance; equipment selection, including documents URS, design qualification and commissioning

• Experience with capital project requests• Familiarity with personnel qualification and training practices• Familiarity with departmental metrics and the data

sources involved

Subject to Change | pda.org/calendar CURRENT AS OF 12/5/16

PDA North America Calendar of Events

PDA holds nearly two dozen global conferences and workshops annually. Start planning ahead for next year – see recently released dates and locations for 2017 PDA Signature Conferences below.

Explore the complete lineup of PDA Conferences and Workshops at pda.org/calendar.

DAT E E V E N T LO C AT I O N

FEBRUARY 21-22 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference Bethesda, MD

APRIL 3-5 2017 PDA Annual Meeting Anaheim, CA

APRIL 5-6 2017 PDA Cell and Gene Therapy Workshop Anaheim, CA

MAY 8-9 2017 PDA Extractables & Leachables Workshop Washington, DC

MAY 10 2017 PDA Pre-filled Syringes Interest Group Meeting Bethesda, MD

MAY 10-11 2017 PDA Annex 1 Workshop Washington, DC

MAY 11 2017 PDA Combination Products Interest Group Meeting Bethesda, MD

JUNE 19-20 2017 PDA Quality Risk Management for Manufacturing Systems Conference Chicago, IL

JUNE 26-27 2017 PDA Biosimilars Conference Bethesda, MD

SEPTEMBER 11-13 2017 PDA/FDA Joint Regulatory Conference Washington, DC

SEPTEMBER 13-14 PAC iAM Workshop Washington, DC

OCTOBER 16-18 12th Annual PDA Global Conference on Pharmaceutical Microbiology Bethesda, MD

OCTOBER 18-19 2017 PDA Endotoxins Workshop Bethesda, MD

OCTOBER 23-24 2017 PDA Visual Inspection Forum Bethesda, MD

DECEMBER 5-6 2017 PDA Cell and Gene Therapy Conference San Diego, CA

2017

http://www.pda.org/calendar

http://www.pda.org/calendar

1 Contact Information PDA Membership Number Prefix First Name Last Name Job Title Company Business AddressCity State/Province ZIP+4/Postal CodeCountry EmailBusiness Phone Fax Substituting for(Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

2 Premier Package | CONFERENCE & WORKSHOP Registration | April 3-6 Please check appropriate fee (US$).

Save up to $750! Member Non-member

Before January 20, 2017 $ 2,545 $ 2,804

January 20 – February 17, 2017 $ 2,995 $ 3,254

After February 17, 2017 $ 3,245 $ 3,504

3 CONFERENCE Registration | April 3-5 Please check appropriate fee (US$).

Before Jan. 20, 2017

Jan. 20 – Feb. 17, 2017

After Feb. 17, 2017

PDA Member $ 1,895 $ 2,295 $ 2,495

Non-member $ 2,154 $ 2,554 $ 2,754

Government/Health Authority Member $ 700 $ 700 $ 700Non-member* $ 800 $ 800 $ 800

Academic Member $ 700 $ 700 $ 700Non-member* $ 800 $ 800 $ 800

Student Member $ 280 $ 280 $ 280Non-member* $ 310 $ 310 $ 310

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

7 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number, expiration date and billing address. Please bill my: American Express MasterCard VISATotal amount $ Campaign Code

Credit Card Guarantee Only

Account Number Exp. DateName (exactly as it appears on card) SignatureBilling Address (must match credit card statement)City State Zip Country Wire Transfer Payments: If you require wire transfer, please contact [email protected].

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 onsite at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a subsitute 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 Conference/Workshop: If your written request is 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. Refunds for courses: If your written request is received by March 7, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds will be approved. CANCELATION: PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. PLEASE NOTE THAT 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 BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

PDA USE ONLY Date: Check: Amount: Account:

PDA Federal Tax I.D. #52-1906152

Group Registration: 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. All forms MUST be faxed in together.

040317D

2017 PDA Annual Meeting (April 3-5) and 2017 PDA Cell and Gene Therapy Workshop (April 5-6)April 3-5, 2017 | Anaheim, CAAnaheim MarriottExhibition: April 3-4 | 2017 PDA Cell and Gene Therapy Workshop: April 5-6 | Courses: April 6-7

Four easy ways to register –Click: pda.org/2017AnnualFax: +1 (301) 986-1093 (U.S.A.)Mail: PDA Global Headquarters

4350 East West Highway, Suite 600Bethesda, MD 20814 U.S.A.

Call: +1 (301) 656-5900 ext. 115

4 WORKSHOP Registration | April 5-6 Please check appropriate fee (US$).

2017 PDA Cell and Gene Therapy Workshop $ 800

5 COURSE Registration | April 6-7#223 Quality Metrics and Quality Culture (April 6-7)#361 Cleanroom Management (April 6-7)#448 Quality Strategy for Biopharmaceuticals (April 6-7)#513 Knowledge Management Applied in Facilities & Engineering to Improve Manufacturing Reliability (April 6-7)#109 Container Closure Systems and Integrity Testing (April 6-7)

Course #223 Course #361 Course #448 Course #513 Course #109

By Feb. 20, 2017Standard Member $ 1,709 $ 1,709 $ 1,709 $ 1,709 $ 1,709Non-member $ 2,051 $ 2,051 $ 2,051 $ 2,051 $ 2,051

Government/Health Authority/Academic Member $ 1,139 $ 1,139 $ 1,139 $ 1,139 $ 1,139Non-member* $ 1,139 $ 1,139 $ 1,139 $ 1,139 $ 1,139

After Feb. 20, 2017Standard Member $ 1,899 $ 1,899 $ 1,899 $ 1,899 $ 1,899Non-member $ 2,279 $ 2,279 $ 2,279 $ 2,279 $ 2,279

Government/Health Authority/Academic Member $ 1,139 $ 1,139 $ 1,139 $ 1,139 $ 1,139Non-member* $ 1,139 $ 1,139 $ 1,139 $ 1,139 $ 1,139

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

Special Dietary Requirements (Please be specific):

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

Check here to become a member and receive the member price for this event. (add $259 to your total before Dec.31/ add $279 to your total after Jan.1)

https://www.pda.org/2017Annual

2017 PDA Annual Meeting Networking EventsApril 2-4, 2017 | Anaheim, CAAnaheim MarriottExhibition: April 3-4 | 2017 PDA Cell and Gene Therapy Workshop: April 5-6 | Courses: April 6-7

Four easy ways to register –Click: pda.org/2017AnnualFax: +1 (301) 986-1093 (U.S.A.)Mail: PDA Global Headquarters

4350 East West Highway, Suite 600Bethesda, MD 20814 U.S.A.

Call: +1 (301) 656-5900 ext. 115

1 Contact Information PDA Membership Number

Prefix First Name Last Name

Job Title Company

Business Address

City State/Province ZIP+4/Postal Code

Country Email

Business Phone Fax

Substituting for(Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

2 NETWORKING Registration Please check appropriate fee (US$).

Sunday, April 2, 2017 | 7:00 a.m. – 10:00 a.m. | 11th Annual Walk/Run Event Walk/Run for a cause with PDA, colleagues, family and friends.

# of tickets:

_________

$ 45 per registered attendee or guest. All net proceeds will go to charity.

Tuesday, April 4, 2017 | 6:00 p.m. – 9:00 p.m. | Gala Event Admission is included with a full Conference registration. Guests are welcome to attend at $70 per person!

# of tickets:

_________ $ 70 per person.

Total Due $

3 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number, expiration date and billing address. Please bill my: American Express MasterCard VISA

Total amount $

Account Number Exp. Date

Name (exactly as it appears on card) Signature

Billing Address (must match credit card statement)

City State Zip

Country Wire Transfer Payments: If you require wire transfer, please contact [email protected].

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 onsite at the prevailing rate. If you are non-member substituting for a member, you will be required to pay the difference in the non-member fee. If you are pre-registering as a subsitute 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 Conference/Workshop: If your written request is 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. Refunds for courses: If your written request is received by March 7, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds will be approved. CANCELATION: PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. PLEASE NOTE THAT 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 BADGES AND MATERIALS. RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

PDA USE ONLY Date: Check: Amount: Account:

PDA Federal Tax I.D. #52-1906152

040317D

Check here to become a member and receive the member price for this event. (add $259 to your total before Dec.31/add $279 to your total after Jan.1)

https://www.pda.org/2017Annual

The Parenteral Drug Association presents the...

2017 PDA Annual MeetingInnovation in Manufacturing Science and TechnologyApril 3-5, 2017 | Anaheim, CaliforniaAnaheim Marriott

EXHIBITION AND SPONSORSHIP OPPORTUNITIES | APRIL 3-4The 2017 PDA Annual Meeting will provide your company with a premier opportunity to gain access to and network with hundreds of key decision makers from the biopharmaceutical science and manufacturing industry. Align your company with leading industry experts and world-class content by exhibiting at and/or sponsoring the industry’s leading conference and exhibition. Extended, dedicated Exhibit Hall hours will allow ample time for information exchange with attendees from companies such as Genentech, Eli Lilly, Pfizer, Amgen, GlaxoSmithKline, AstraZeneca, Janssen, Novartis, Merck and others. In addition, many high-profile, cost-effective sponsorship options are available to help raise your company profile, build brand awareness and differentiate your company from your competitors.

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

David Hall, Vice President, SalesDirect: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | Email: [email protected]

pda.org/2017Annual #PDAAnnual

PDA GLOBAL HEADQUARTERS4350 East West HighwaySuite 600Bethesda, MD 20814 USAPhone: +1 (301) 656-5900Fax: +1 (301) 986-0296

Register by February 17 and save up

to $200


The Parenteral Drug Association presents the 2017 PDA · PDF file · 2017-02-03The...

Documents

Transcript of The Parenteral Drug Association presents the 2017 PDA · PDF file · 2017-02-03The...