Global Event Calendar and Registration

2016 PDA Annual Meeting

Achieving Manufacturing Excellence: Current Trends and Future Technologies in Bioprocessing
Mar 13 - Mar 16, 2016 |
Mar 16, 2016 |
JW Marriott San Antonio Hill Country | San Antonio, TX
  • Conference
  • Western Hemisphere Events
March 14-15
March 16-17
March 17-18
Add event to: ICal Outlook Google Calendar

Call for Posters

Call for Posters Download

Submit an abstract for a one-day poster presentation at the 2016 PDA Annual Meeting by OCTOBER 15. Abstracts related to novel manufacturing and analytical technology are preferable, but those addressing improving manufacturing performance, changing regulatory landscape technology as well as advances and expectations are also welcome.

The Opening Plenary session at the 2015 PDA Annual Meeting looked closely at how approved personalized medicine products are changing the traditional concepts of manufacturing. The session also focused on how the business environment around manufacturing is changing and the impact it has on the industry going forward.

Biotechnology and bioprocessing continue to advance as novel therapies emerge for the treatment of a variety of diseases. In response to new molecular modalities and novel molecular entities, development and manufacturing approaches are evolving to meet the challenges associated with reliably and efficiently producing and supplying these products to enable patient access globally. The 2016 PDA Annual Meeting is the most significant conference to attend to gain the newest and most comprehensive information about innovative biopharmaceutical approaches and the bioprocessing technologies and manufacturing sciences being applied for development and commercialization.

The three main tracks of the meeting, “Advances in Bioprocess Development," “Innovation in Manufacturing Sciences,” and “Lifecycle Management and Continuous Improvement” will address many of the current challenges facing industry. Plenary sessions are focused on novel biopharmaceutical therapies, rapid product development approaches and manufacturing considerations. The program, which also includes breakfast and interest group sessions, is designed to offer science, innovation and technology information in a format that allows participants to gain a broad perspective on key topics as well as the opportunity to select the areas that are of most importance to them.

We will hear from experts involved in discovering novel therapies, rapid product development, bioprocess advances, manufacturing sciences, control strategies, regulatory submission and lifecycle management planning along with many other important topics. The 2016 PDA Annual Meeting is the most inclusive event, which provides insight into current and future trends in bioprocessing and manufacturing, providing participants the information they will need to prepare for the next wave of biopharmaceutical innovation. The PDA Annual Meeting also offers abundant networking opportunities for peer to peer discussion during the breaks and social events.

Please be sure and mark your calendar now so you don’t miss this exceptional information and networking opportunity.

Learning Objectives

  • Gather current trends in upstream and downstream process development and assess utility of future technology applications in pharmaceutical and biopharmaceutical processing
  • Discover manufacturing needs required to process and supply novel cell therapies and personalized medicines
  • Examine approaches to mitigate supply chain risks for biopharmaceuticals and cell therapies and define effective strategies for implementation.
  • Explore practical solutions for using analytical control systems, product and process monitoring information to successfully drive continuous improvement over the product lifecycle.
  • Understand the current issues with microbiological and adventious agent control strategies and identify strategies to mitigate risks.
  • Gain best practices for successful technology transfers and application of data to support process validation.
  • Uncover approaches to increase global access to medicines and describe industry response strategies to worldwide health crises, like Ebola.

Who Should Attend

Job Function:

  • Executive and Mid-Level Management
  • Project Management
  • Technical Services
  • Supply Chain
  • Manufacturing Application
  • Risk Management

Departments:

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

Contact

Registration inquiries

Wanda Neal,CMP
Sr. VP Programs and Registration Services
(301) 656-5900 ext. 111
Email: neal@pda.org

(301) 656-5900 ext. 115
Email: day@pda.org

Exhibition inquiries

 

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

Sunday, March 13, 2016

7:00 a.m. – 12:00 p.m.
8th Annual PDA Golf Tournament
(TPC San Antonio Golf Course)

8:00 a.m. – 10:00 a.m.
10th Annual Walk/Run Event (Optional Event)
On your mark, Get set, Go...to the PDA 10th Annual Walk / Run Event. Set off on your choice of a 5k run or 3k walk through the outdoors of San Antonio.  Start your week with a fresh breeze and light workout with colleagues, family, and friends.  There will be prizes for the 1st, 2nd and 3rd place winners of the walk and run and a good time for all.

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, March 14, 2016

7:30 a.m. - 5:30 p.m.
Registration Open

7:30 a.m. - 5:30 p.m.
Speaker Ready Room Open

7:30 a.m. - 8:30 a.m.
Continental Breakfast

8:00 a.m. - 8:30 a.m.
Welcome and Opening Remarks
Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc. and Chair, PDA Board of Directors
Richard Johnson, President & CEO, PDA
Maik Jornitz, President, G-Con Manufacturing, Inc. and Co-Chair, 2016 PDA Annual Meeting Program Planning Committee

8:30 am. - 10:00 a.m.
P1 - Opening Plenary Session: Putting the Patient First
Moderator: Maik Jornitz, President, G-Con Manufacturing, Inc.

Session Description: Patients are our foremost focus of our daily work, of our quality principles and our joined activities. It is of importance to hear and learn from patients and it is of importance to see progress in other innovative treatment options. This session focuses on the patients and new treatment options, which save lives.

8:30 a.m. - 9:00 a.m.
Patient Perspective
Dave deBronkart, Co-Founder & Co-Chair, Society of Participatory Medicine

9:00 a.m. - 9:30 a.m.
Accelerating Innovation to the Patient
Marina Kozak, PhD, Science Policy Analyst¸ Friends of Cancer Research

9:30 a.m. - 10:00 a.m.
Questions and Answers/Discussion

9:45 a.m. - 5:30 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.
P2 - Manufacturing and Supply Considerations to Enable Novel Therapies
Moderator: Ghada Haddad, Director, Engineering, Sterile & Validation, Merck & Company, Inc.

Session Description: Novel therapies are in fact novel because they are unique and innovative.  Once they become ‘mainstream,’ as with monoclonal antibodies targeting TNF (tumor necrosis factor-alpha) many of the issues associated with their manufacture and distribution needed to be substantially resolved.  But while they are novel, the batch sizes are small, the distribution pathways are individualized and a myriad of other issues pose challenges to their development and introduction.

Many times these circumstances are so unique that the ICH S6 guidance is sometimes known as the ‘case-by-case’ approach.  What might have worked for one novel therapeutic might not be able to be leveraged and optimized for the next.  However there are approaches to addressing the highly complex manufacturing processes, difficulty in not only developing an appropriate analytical method but in achieving accuracy with the method,  the sensitivity to light, heat, shaking and other phenomenon encountered during preparation and distribution, among others which all can be tackled in a scientific and robust manner.
Our first presentation will be made by the founder and CEO of Tara Immuno-Oncology Therapeutics, LLC, who leads his organization in developing and bringing to market novel targeting Chimeric Antigen Receptor (CAR-T) constructs for both hematological and solid tumors.

Our second presentation will address the complexities associated with collecting, modifying and returning to the same patient autologous cell therapies, knowing that timing is crucial to both the product and the patient.  How can we adapt the concepts of assay and batch release, sterility testing and the other classic GMP systems to novel therapies?

10:45 a.m. - 11:15 a.m.
The Importance of Manufacturing Novel Therapies
John Francis Crowley, Chairman & CEO, Amicus Therapeutics (Invited)

11:15 a.m. - 11:45 a.m.
Developing a Supply Chain for Autologous Cell Therapy Products
Michele Myers, PhD, Director CMC, Advanced Therapy Delivery, Biopharm R&D, GlaxoSmithKline

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

12:15 p.m. - 1:45 p.m.
Networking Luncheon in Exhibit Hall

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

Advances in Bioprocess Development
Innovation in Manufacturing Sciences
Lifecycle Management and Continuous Improvement

A1 - Achieving High Quality and Productivity in Cell Culture Processes

B1 - Ensuring Supply by Using Multiproduct Facilities and Reducing Supply Chain Risk

C1 - Integrating  New Technologies and Products;  Processes and Tools for Managing Decisions and Execution

Moderator: Michael DeFelippis, PhD, Senior Research Fellow, Eli Lilly & Company

Moderator: Vijay Chiruvolu, PhD, Senior Director, Kite Pharma

Moderator: Jean Stanton, Director, Regulatory Compliance, Johnson & Johnson

Session Description:  With the explosive growth in biopharmaceutical candidates entering various stages of clinical development and being commercialized along with significant advances in cell therapies, industry is continually exploring novel approaches for reducing time to market, maintaining cost effectiveness, and providing robust manufacturing capability in an ever increasing competitive landscape.  These realities have driven significant investments in process development to meet demand for greater output from cell cultures while simultaneously reducing variability to ensure the highest possible product quality.  For example, advances in mammalian cell culture processes for biopharmaceuticals over the last 20 years have resulted in tremendous increases in product concentration with titers now routinely reaching 5 g/L. Cell culture medium optimization is considered a recent key factor in realizing these improvements.  In parallel with these productivity achievements, came understanding of the critical importance of raw materials utilized in cell culture.  Raw material selection and control is paramount to maintaining the health of cells and reducing variability ensuring ultimate product quality.  These same raw material considerations apply to cell therapies as well.  While productivity and quality are desired, the high cell densities achieved in biopharmaceutical manufacturing can place increased burden on other operations such as cell retention particularly in perfusion processes and novel alternatives to filter systems are being evaluated.  This session focuses on current strategies and new technologies for cell culture processes with emphasis on approaches for optimizing product output and ensuring quality.

Session Description: Preventing and mitigating drug shortages is a top priority for FDA and therefore the industry. Drug supply disruptions can occur due to factors that are under the control of the manufacturers or reasons unforeseen. The likelihood of drug shortages for biologics may be high since they are produced in living cells, require complex manufacturing processes and rigorous regulatory compliance, and are sensitive to storage and shipping conditions. Driven by cost pressures, the biopharmaceutical manufacturing paradigm is shifting from large, single-product facilities to smaller-scale, flexible, multiproduct facilities that are cheaper to build. These facilities enable flexible, multiproduct production using single-use technologies, continuous processing and modular designs. Similarly, autologous cell therapy products are made in multi-patient facilities that utilize single-use technologies and rely on manual aseptic operations. In addition, the challenges faced by supply chain are enormous due the need for traceability and a shorter product shelf life. This session focuses on use of risk management and innovations in technology to reduce supply disruptions and shortages.

Session Description: Innovation for the purpose of improved productivity is a primary driver for many current biopharmaceutical trends. The top trends related to innovation center around, downstream process improvement, single use implementation, analytical methods, cost reductions, and product platforms.
A timely, cost-effective method to evaluate new technologies is critical to an organization’s return on investment for such a process. A number of Biopharmaceutical organizations have developed some type of process with which to analyze the technical and operational need for an appraisal, tools to assist with data collection the decision making process, and a way to implement the new technology.

This presentation will highlight a decision matrix tool for the appraisal of a new technology as well as a governance model for the evaluation, the selection and the implementation of new technologies. A case study will be used demonstrate this decision making process for the selection of both a new chromatography technology and a new single use filtration technology.

1:45 p.m. - 2:05 p.m.
Managing Raw Material Risks for Biopharmaceuticals and Cell Therapies
Karen Walker, Head Cell and Gene Therapy Quality,  Novartis

1:45 p.m. - 2:15 p.m.
Multi-Product & Multi-Purpose Patient Facilities
Harry Lam, PhD, Senior Vice President, Manufacturing, PCT-Caladrius (Invited)

1:45 p.m. - 2:15 p.m.
A Case Study for Evaluating New Technologies
Younok Dumortier Shin, Director Engineering, Janssen Pharmaceuticals

2:05 p.m. - 2:25 p.m.
Increases in Productivity by Progressive Cell Culture Medium Optimization
Tongtong Wang, PhD, Senior Director, Bioprocess R&D and Operation, Eli Lilly & Company

2:15 p.m. - 2:45 p.m.
Supply Chain for Personalized Medicines – Facing the Challenges
George O'Sullivan, Senior Director, Supply Chain, Kite Pharma

2:15 p.m. - 2:45 p.m.
Application of QRM in Cell Therapy Manufacturing (Needle to Needle) Bernadette Keane, Vice President, QA/QC, blue bird bio

2:25 p.m. - 2:45 p.m.
Advances in Primary Recovery and Cell Retention
Louis Masi, Executive Vice President, FloDesign Sonics, Inc.

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

 

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

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

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

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

IG1 -  Vaccines

Leader: John Finkbohner, PhD, Senior Regional Policy Director - US,  AstraZeneca

Interest Group Description: The Vaccines Interest Group (VIG) focuses on issues that affect the biological, biotechnology, and vaccine industry. The Interest Group has previously discussed regulatory issues, new technologies, and emerging industry trends. Recent issues include vaccine availability and supplies, homeland security, and inspection trends. The group also issues a newsletter (VIG)

IG2 - Biotechnology Leader: Vince Anicetti, Senior Vice President, Quality, Coherus Biosciences  

Interest Group Description:  This Interest Group provides a forum for technological, regulatory and educational discussions with the challenges facing the biotechnology sector of the industry, including use of recombinant organisms, novel biochemical, technological and regulatory approaches in bringing biotechnology based products to the public.

The Biotechnology Interest Group meets the mission of PDA of advancing understanding of existing and cutting edge biotechnology internationally by promoting scientifically sound, practical technical information and education for industry and regulatory agencies.

IG3 - Combination Products Leader: Lee Leichter, President, P/L Biomedical Interest Group Description: The newly re-formed Combination Products IG provides a forum for discussion of topical issues concerning technical, regulatory (submissions) and compliance matters related to combination product types with emphasis on drug delivery devices and functional pharmaceutical packaging.
IG4 -  Facilities & Engineering Leader: Shelley Preslar, Vice President, Southeast Operations, 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 Conference, as well as a discussion forum on the PDA website.

The format of this IG’s 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. 

IG5 - Management of Outsourced Operations Leader: Susan Schniepp, Consultant, Regulatory Compliance Associates

Interest Group Description: The Management on 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 of the Interest Group:

  • 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 TRI courses on outsourcing

IG6 -  Microbiology/Environmental Monitoring

Moldenhauer, Vice President, Excellent Pharma Consulting

implementation of USP <1116> and environmental monitoring.  Panelists will be giving a brief set of comments followed by group discussion.
Panel members for the discussion include:
Jim Akers, PhD, President, Akers Kennedy & Associates
Claudio Denoya, Senior Applications Scientist, Particle Measuring Systems
Karen Ginsbury, President & CEO, PCI
David Hussong, PhD, Senior Consultant for Regulatory Microbiology, Concordia ValSource
Dona Reber, Global Quality Operations, Pfizer, Inc.
Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource

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

Tuesday, March 15, 2016

7:15 a.m. - 5:30 p.m.
Registration Open

7:15 a.m. - 8:30 a.m.
Continental Breakfast

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

7:15 a.m. - 8:15 a.m.
Breakfast I:  The Flexible and Agile Facility of the Future
Moderator: Maik Jornitz, President, G-Con Manufacturing, Inc.

7:15 a.m. - 8:15 a.m.
Breakfast II:  QRM in Engineering Design
Moderator: Susan Schniepp, Consultant, Regulatory Compliance Associates, Inc.

7:15 a.m. - 8:15 a.m.
Breakfast III:  QbD-Enabled Control Strategies/ Process Validation of Biosimilar Processes
Moderator: Steven Lynn, Global Head Group Compliance and Audit, Novartis

7:15 a.m. - 8:15 a.m.
Breakfast IV:  Serialization
Moderator: Veronique Davoust, PharmD, Manager, Global Quality Strategy, Pfizer, Inc.

Session Description: A major financial burdens is capital expenses, invested into rigid production facilities, which are often only designed to facilitate one product, are very inflexible in regard to scaling-up and -down, are unable to be divested if the drug target fails or the product patent expires. The predicament of investment versus financial risk mitigation was a major problem for start-up companies, but nowadays affect as much large biopharma. Furthermore, the product portfolio of the industry is changing from large volume multi-patient treatments to low volume individual patient treatment. Production site design flexibility is becoming a key element, so much that plug and play options are required. This session will review current and up-coming facility models, which create flexibility, reduced time-to-run and investment. Session Description: Aging products and offer a unique challenge when companies chose to upgrade their facilities and processes to meet today's standards. This could compromise a company's ability to provide necessary medicine to patients.  This session will focus on applying QMR and modern engineering concepts to older products to bring them up to today's standards. Session Description: The emergence of Biosimilar products in the industry has raised a number of questions about how these products are validated and determined to be equivalent to the original product. This session will try and answer how QbD control strategies are employed when validating manufacturing processes for Biosimilar products. The expert speakers will provide information based on their experience with Biosimilar products and the challenges of providing relevant validation information demonstrating the suitability of Biosimilars for the pharmaceutical industry. Session Description: This session aims to aid in clarifying expectations for serialization and its practical implementation from an industry perspective. After a brief overview of the international global environment, a featured speaker will inform about the U.S. DSCSA requirements, and focus on the implementation efforts to date, lessons learned and next steps.

7:15 a.m. - 7:45 a.m.
Morten Munk, Senior Technology Partner, NNE Pharmaplan

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

7:15 a.m. - 7:45 a.m.
Jason Martin, Director, External Supply Quality Operations, Americas, Novartis-Sandoz, Inc.

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

7:15 a.m. - 7:45 a.m.
Industry Presenter to be Invited

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

7:15 a.m. - 7:45 a.m.
Peggy Staver, Director, Product Integrity, Pfizer

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion


8:30 a.m. - 10:00 a.m.
P3 - Improving Efficiency and Reducing Manufacturing Cost
Moderator:  Glenn Wright, Senior Director, Project Management, Technical Services/Manufacturing Science, Eli Lilly & Company

Session Description: What was once a futuristic vision is become reality as manufactures work to develop and implement manufacturing process that incorporate continuous manufacturing to provide greater production efficiency as well as single use systems to maximize product flexibility and reduce the overall manufacturing footprint.  Join us as we take a deeper look at both of these approaches and how they are being applied to meet the needs of our industry and the patients we serve.

8:30 a.m. - 9:00 a.m.
Single Use Systems: Manufacturing of the Future
Kimball Hall, Vice President, Manufacting, Amgen, Inc.

9:00 a.m. - 9:30 a.m.
Continuous Manufacturing
Konstantin Konstantinov, Vice President, Technology Development, Genzyme

9:30 a.m. - 10:00 a.m.
Questions and Answers/ Discussion

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

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

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

Advances in Bioprocess Development
Innovation in Manufacturing Sciences
Lifecycle Management and Continuous Improvement

A2 - Challenges and advances within Downstream Technologies

B2 - Adapting Manufacturing Facilities - Case Studies

C2 - Driving Continuous Process Improvement Through Effective Lifecycle Management

Moderator: Morten Munk, Senior Technology Partner, NNE Pharmaplan

Moderator:  Ghada Haddad, Director, Engineering, Sterile & Validation, Merck & Company, Inc.

Moderator:  Susan Schniepp, Consultant, Regulatory Compliance Associates, Inc.

Session Description: For a long period, the biopharmaceutical industry focus has been on optimizing and improving the upstream process steps, which to a large extent has been accomplished. This has led to an increased attention on the downstream process area, to ensure this part of the process do not become a bottleneck for an increased productivity and cost-effectiveness in biopharmaceutical manufacturing.

Disruptive innovation is required to meet the demand for cost-effective and especially flexible purification solutions, which meets the same level of improvements as seen in for example the cell culture area.

This session will address some of the challenges, this historically conservative industry are facing, and give insight to the opportunities for innovation within existing technologies as well as discuss the possibilities for introduction new technologies in the downstream area.

Even continuous manufacturing cannot be described as novel concept in industrial manufacturing; its use is still quite scarce in the downstream area. However, over the last few years the interest has increased dramatically and an increasing number of suppliers are now offering technical attractive solutions which also meet the needed quality and regulatory requirements. This development might have been supported by the positive experience of the advantages of the implementation of Single Use Technologies (SUT) in several are areas of downstream processing. One example of an area within SUT that has developed over the last years is pre-packed chromatographic columns. But in order for this area to develop even further, the impact on the total production costs has to be addressed. The combination of pre-packed columns and continuous chromatography might be the solution that can get those two technologies more widely accepted and implemented in the industry.

Session Description: Do you have an aging facility?  Sometimes it can seem that our facilities are out-of-date by the time the first product is manufactured.  In this session, two case studies will be shared to address the challenges with aging facilities.  The first case study will discuss a facility that is a dependable and reliable quality manufacturing site, but has fallen behind the technology curve.  As part of continuous improvement, the process of determining which technologies are appropriate for incorporation into the facility will be evaluated. The second case study will discuss an organization with compliance risks associated with an aging facility, with an added concern about the potential for drug shortages and customer service.  The case study will evaluate how to maintain quality production while mitigating the compliance risks.

Session Description: Implementing new procedures and processes at a manufacturing facility takes time and resources. This session will present practical solutions for using analytical control systems and product and process monitoring information that will help successfully drive continuous improvement at your facility. The case studies are real life examples from leading pharmaceutical companies that will educate the participants on how continuous improvement can be achieved and successfully implemented.

10:45 a.m. - 11:15 a.m.
Host Cell Proteins
Gunter Jagschies, PhD, Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences

10:45 a.m. - 11:15 a.m.
Case Study – A Single Use System as an Enabler for Converting a Dedicated, Cytotoxic, Parenteral IMP Facility to Multi-Purpose IMP Manufacturing
Tsutomu Ota, Manager, Global IMP GMP Assurance, Takeda Pharmaceutical Company Ltd.

10:45 a.m. - 11:15 a.m.
Lifecycle Management of Analytical Control System - A Practical Application Case Study
Paul Motchnik, Associate Director, Analytical Control System Lifecycle Management, Genentech, Inc.

11:15 a.m. - 11:45 a.m.
Downstream Process Monitoring and PAT for Implementation of Continuous Bioprocessing
Veena Warikoo, Director, Purification Development,Genzyme - A Sanofi Company

11:15 a.m. - 11:45 a.m.
Implementing Changes to a Facility While it Continues to Operate
George Wiker, Executive Director, AES Clean Technology, Inc.

11:15 a.m. - 11:45 a.m.
Case Study - Leveraging Product and Process Monitoring to Drive Continual Improvement
Dan Blackwood, Associate Research Fellow Pfizer, Inc.

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

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

 

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

Advances in Bioprocess Development
Innovation in Manufacturing Sciences
Lifecycle Management and Continuous Improvement

A3 - Advances in Analytical Technologies for Microbial Control 

B3 - Review of Single-Use Processing Equipment Experiences and Needs

C3 - From Development to Commercialization – Technical Transfer Strategies and the Use of Development Data in Validation Plans

Moderator:Emabelle Ramnarine, Senior Director, Head Global Biologics Quality  Control, Genentech, Inc.

Moderator: Maik Jornitz, President, G-Con Manufacturing, Inc.

Moderator:  Glenn Wright, Senior Director, Project Management, Technical Services/Manufacturing Science, Eli Lilly & Company

Session Description: There are continued advances in microbial and adventitious agents control strategies and detection technologies across the industry for biologics manufacturing. This session will share advances and practical application considerations on two hot analytical technology topics for biopharmaceuticals – PCR-based testing of microbial contaminants and endotoxin masking/demasking phenomenon in different biological product matrices.

Session Description: Single-use process technologies are not new any longer, but well established within the industry. The session will reflect back on the experiences with single-use technologies, the benefits and obstacles, how are these technologies implemented and used. It will also review technology improvement needs, for example robust integrity test strategies for some of the bags and bioreactors utilized.

Session Description: This session will discuss Tech Transfer Strategies developed as products move from development to commercial manufacturing as well as the use of development data in validation plans and through the process lifecycle.

1:45 p.m. - 2:15 p.m.
Masking and Demasking of Endotoxins in Common Biological Product Matrices
Johannes Reich, PhD Student, University of Regensburg/Hyglos GmbH

1:45 p.m. - 2:15 p.m.
Single Use Technology  - Experience from Large Scale Commercial SUS Facilities
Chris Chen, PhD, Senior Vice President & Chief Technology Officer, WuXi AppTec

1:45 p.m. - 2:15 p.m.
Commercial Tech Transfer Strategies for New Products
David Allen, PhD, Senior Director, Parenteral TS/MS,  Eli Lilly & Company

2:15 p.m. - 2:45 p.m.
Advances in Adventitious Agents Control Strategies
Sven Deutschmann, Director, Microbiology & Cell Biology, Global MMTech Head PCR & Nucleic Acid Technologies, Roche Diagnostics GmbH

2:15 p.m. - 2:45 p.m.  
Integrity Testing of Single Use Bags and Bioreactors
Marc Hogreve, Senior Scientist for Integrity Testing Solutions, Sartorius Stedim Biotech GmbH

2:15 p.m. - 2:45 p.m.
Continuous Use of Development Data in Validation Plans and the Process Lifecycle Scott Bozzone, Senior Manager, Quality Systems & Compliance Validation, Pfizer, Inc.

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

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

 

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

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

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

IG7 - Pharmacopeial

Leader : Janeen Skutnik-Wilkinson, Partner, NSF-DBA

Interest Group Description: This session will focus on the emerging changes to pharmacopoeias around good pharmacopoeial practices and the increased focused on monographs for biologics and biotech products.  This session will provide members an opportunity to discuss the impact of these changes and discuss opportunities for PDA engagement.

IG8 - Process Validation Leaders: Scott Bozzone, Senior Manager, Quality Systems & Compliance Validation, Pfizer, Inc. and Vijay Chiruvolu, PhD, Senior Director, Kite Pharma

Interest Group Description:  This interest group will focus on opportunities and challenges in the process validation area. We will share and discuss the “lessons learned” from implementing the lifecycle process validation approach, including any regulatory responses or inspection experiences.

In addition, there will be a presentation on process validation approaches for Biosimilars and Cell/Gene therapy products. Finally, there will be time for open discussion to share and benchmark on best industry practices.

IG9 - Quality Risk Management

Leaders: Jeff Hartman, Senior Consultant, Concordia ValSourceand Emabelle Ramnarine, Senior Director, Head Global Biologics Quality Control, Genentech, Inc.

Interest Group Description:  All attendees are welcomed to participate in this session.  A lot of suggestions were received on great discussion topics.  We’ll conclude the session with a brief overview of one of the most suggested hot topics and provide participants an opportunity to share their thoughts.

Kelly Waldron, Manager, Global Quality Risk Management, Genzyme (Invited)

IG10 - Sterile Processing Leader: Edward Tidswell, PhD, Senior Director, Sterility Assurance, Baxter Healthcare Corporation

Interest Group Description: The manufacture of sterile products requires robust process and environmental controls (including layers of redundancy) to assure suitable assurance of sterility.  This interest group session will review those past, current, future (known and likely) guidance and regulations to achieve and sustain the sterility assurance of drug and device products.

IG11 -  Supply Chain Management Leader: Lucy Cabral, Quality Director, Genentech, Inc.

Interest Group Description: The Supply Chain Management Interest Group offers its members the opportunity to influence the suppliers of the pharmaceutical and biotech industry to develop requirements that meet the needs of the industry in the areas of material quality, continuous improvement efforts, supply chain security, and supplier/customer business partnerships.  The Interest Group will use existing information gathered from PDA members, suppliers, other industry groups, and drug manufacturers to document and develop best practices approach for suppliers to meet customer requirements globally.

IG12 -  Visual Inspection of Parenterals

Leader: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

Interest Group Description: The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products.  A review of recent FDA 483 observations, warning letters and recalls will be presented.  We will also discuss the new USP Chapter <790> Visible Particulates in Injectables and the associated Information Chapter <1790> Visual Inspection of Injectables.  We will plan time to discuss topics of interest and recent experiences of those in attendance.  Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, inspection of protein-based biopharmaceuticals, inspection of other difficult products or packages and country specific inspection requirements.

Wednesday, March 16, 2016

7:15 a.m. - 12:00 p.m.
Registration Open

7:15 a.m. - 8:30 a.m.
Continental Breakfast

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

7:15 a.m. - 8:15 a.m.
Breakfast V:  Data Integrity
Moderator:  Susan Schniepp, Consultant, Regulatory Compliance Associates, Inc.

 

7:15 a.m. - 8:15 a.m.
Breakfast VI: Manufacturing Initiative
Moderator: William Miele, PhD, Director/Team Leader, Microbiology & Aseptic Support, Pfizer, Inc
7:15 a.m. - 8:15 a.m.
Breakfast VII: Defining the Product Specification
Moderator
:  Michael DeFelippis, PhD, Senior Research Fellow, Eli Lilly & Company
7:15 a.m. - 8:15 a.m.
Breakfast VIII: Post-Approval Life-Cycle Management Plans/Change Management
Moderator: Kerry Ingalls,  Vice President, Regional Manufacturing, Amgen Ireland

 

Session Description: Data integrity has become a major concern for the industry and regulators.
This session will focus on some recent data integrity issues and explain the reason they are a problem, what you can do to remediate them and how to prevent them from recurring. In addition, the leader of the PDA task force on data integrity will give an update on how PDA is addressing this issue on behalf of our members.
Session Description: The PDA Manufacturing Initiative (officially titled the ”PDA Manufacturing Science Program (MSPsm)”) is now underway. As we think of pharmaceutical manufacturing’s future what will it require, what areas do we as an industry need to be focusing on in regards to our manufacturing operations (the technology, the process, the people). This session will discuss the new initiative and how PDA, through its use, is assuring a clear focus on manufacturing’s future and its success. Session Description: The strategy for defining specifications for biopharmaceutical drug substances and drug products follows an iterative process. Early versions of the specifications typically include wider acceptance criteria for most tests because material used in Phase 1 and 2 clinical trials is often derived from immature processes, there is limited manufacturing experience, very few batches are produced and the final analytical testing strategy is likely not defined. Regulatory authorities are aware of these considerations and generally allow greater flexibility in the initial stages of clinical investigation, but also expect that sponsors will evolve the specifications to incorporate tighter acceptance criteria during Phase 3 and certainly by the time the product is submitted for licensure. ICH Q6B states that the specifications should be linked to preclinical and clinical studies, the manufacturing process, analytical procedures and account for drug substance and drug product stability. However, regulators often base allowable acceptance criteria primarily on material that was used in pivotal clinical studies. Because these batches are not representative of long term process variability, it may be difficult to achieve adequate manufacturing capability for all specification tests. This session will explore the process for defining biopharmaceutical product specifications and discuss approaches for meeting regulator expectations while simultaneously ensuring robust manufacturing capability. Session Description: Products that have been released on the market change over time and must be monitored as it transitions through stages. A change control system should be put in place to complete the variation process and ensure that products are compliant with regulatory guidelines. This session will address related compliance challenges and strategies from a regulatory perspective.

7:15 a.m. - 7:45 a.m.
Andrew Harrison, Vice President and General Counsel, Regulatory Compliance Associates, Inc.

7:45 a.m. - 8:00 a.m.
Anil Sawant, PhD, Vice President, Quality Management Systems,  Merck & Company

8:00 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

7:15 a.m. - 7:45 a.m.
Glenn Wright, Senior Director, Project Management, Technical Services/Manufacturing Science, Eli Lilly & Company

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

 

7:15 a.m. - 7:45 a.m.
Ciaran Brady, PhD,  Director, Biotech Technical Services/Manufacturing Sciences, Eli Lilly SA, Dunderrow, Kinsale, Co Cork, Ireland

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

 

7:15 a.m. - 7:45 a.m.
FDA Presenter Invited

7:45 a.m. - 8:15 a.m.
Questions and Answers/ Discussion

 


8:30 a.m. - 10:00 a.m.
P4 - Rapid Product Development
Moderator:  Emabelle Ramnarine, Senior Director, Head Global Biologics Quality  Control, Genentech, Inc.

Session Description: One of the most challenging tasks pharmaceutical professionals face is developing products that receive regulatory approval and reach the market in an expedited amount of time. With the ultimate goal of providing safe and effective solutions for patients, companies must always be mindful that a project can become disasterous if it is managed incorrectly. Presenters in this session will discuss aspects of rapid product development from CMC and regulatory point of views.

8:30 a.m. - 9:00 a.m.
CMC Considerations when a Drug Development Project is Assigned Breakthrough Therapy Status
Earl Dye, Director, Technical Regulatory Policy, Genentech, Inc.

9:00 a.m. - 9:30 a.m.
Case Study - Breakthrough Designation
FDA Presenter Invited

9:30 p.m. - 10:00 a.m.
Questions and Answers/ Discussion

10:00 a.m. - 10:30 a.m.
Refreshment Break

10:30 a.m. - 12:00 p.m.
P5 - Ensuring Supply of Medicines and Expanding Access
Moderator:  Michael DeFelippis, PhD, Senior Research Fellow, Eli Lilly & Company

Session Description: Ensuring an uninterrupted supply of medicine is a primary focus of the pharmaceutical industry.  Mitigating risk of drug shortages requires investment in manufacturing facilities and other continuous improvement initiatives throughout the product lifecycle.  However, ensuring that patients throughout the world have access to high quality and affordable pharmaceutical products, particularly in developing countries and emerging markets, has many challenges and requires additional manufacturing and logistical considerations.  Healthcare crises, such as the recent Ebola epidemic, represent another challenge to traditional development and manufacturing models and alternative strategies are required to enable expedited availability of novel therapies to the marketplace when they are critically needed.  These issues will be addressed in this plenary session with presentations focused on rapid commercialization of Ebola vaccines and strategies for expanding access in emerging markets.

10:30 a.m. - 11:00 a.m.
Development, Manufacturing and Supply of Ebola Vaccines
Jeffrey Blue, Director of Vaccine Drug Product Development, Merck & Company, Inc.

11:00 a.m. - 11:30 a.m.
Expanding Access in Emerging Markets
Jayanth Sridhar, PhD, Global Head of Biologicals Manufacturing, Cipla Limited

11:30 a.m. - 12:00 p.m.
Questions and Answers/ Discussion

12:00 p.m. – 12:15 p.m.
Closing Remarks and Adjournment
Michael DeFelippis, PhD, Senior Research Fellow, Eli Lilly & Company and Co-Chair, 2016 PDA Annual Meeting Program Planning Committee

Conference and Workshop Registration

Before January 11, 2016 January 11-February 11, 2016 After February 11, 2016
Member $2,545 $2,795 $3,045
Nonmember $2,804 $3,054 $3,304

Conference Registration

Before January 11, 2016 January 11-February 11, 2016 After February 11, 2016
Member $1,895 $2,095 $2,295
Nonmember $2,154 $2,354 $2,554
Government/Health Authority Member $700 $700 $700
Government/Health Authority Nonmember* $800 $800 $800
Academic Member $700 $700 $700
Academic Nonmember* $800 $800 $800
Student Member $280 $280 $280
Student Nonmember* $310 $310 $310

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 workshop and course.

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 cancellation notice is not received by January 13, 2016 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 Conference/Events: If your written request in received on or before January 13, 2016, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site 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 cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

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

RECORDING/PHOTO RELEASE: 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.

Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA’s recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

JW Marriott San Antonio Hill Country Resort & Spa
23808 Resort Parkway
San Antonio, TX USA 78261
Tel: +1 210-276-2500
Reservations: +1 866-882-4420

Rate: Single/Double: $269, plus 16.75% state and local taxes.

Website: www.jwsanantonio.com

Cut Off Date: Friday, February 12, 2016 (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 JW Marriott San Antonio Hill Country Resort & Spa. The rate is $269 for single or double occupancy, plus 16.75% state and local taxes. Reservations must be secured by Friday, February 12, 2016. 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 JW Marriott at +1 866-882-4420. Please make sure to tell the reservationist that you are with the PDA group attending the 2016 PDA Annual Conference 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.

Amenities

Located just 20 minutes from downtown San Antonio and the airport, the JW Marriott Resort is situated in Texas Hill Country in Cibolo Canyons, where crystal clear streams and towering oak and cedar trees meet the majesty of the hills. The elements of authentic roots, hacienda style, beautiful views and healing waters serve as the inspiration in bringing this magnificent resort to life. The Hill Country resort features 265,000-square-feet of meeting space, two TPC golf courses and a sophisticated spa.

Travel

Area Airports
San Antonio International Airport (SAT) is located 14 miles south of the JW Marriott Resort.

Ground Transportation
Taxi service to the JW Marriott is approximately $45 one way, not including tip.

Shuttle service is available through Go Shuttle at a rate of $35 each way (per person). Reservations are required and can be made online via www.goairportshuttle.com/reservations.

Driving
From North HWY 281, take a right at the light onto TPC Parkway. The JW Marriott Resort will be located on your left on Resort Parkway.

Hotel Parking
Self-Parking at the JW Marriott Resort is Complimentary. Valet parking is $29 overnight or $15 daily for up to 9 hours.

Sponsorship and Exhibit Opportunities are Available!

The 2016 PDA Annual Meeting will provide your company with the premier opportunity to gain access to and network with hundreds of key decision makers from the biopharmaceutical science and manufacturing industry. Become a sponsor of and/or exhibit at the 2016 PDA Annual Meeting to connect with industry thought leaders, strengthen your brand image, showcase your technology, launch new products, and show your company’s strong commitment to the industry.

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

David Hall, Vice President, Sales
Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=2756
Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Direction