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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA/FDA Joint Regulatory Conference

Putting Patients First: Ensuring Innovation, Quality, Compliance, and Supply in an Evolving Environment
Sep 24 - Sep 26, 2018 |
Sep 26, 2018 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
Exhibition: September 24-25
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Speaker Biographies

The PDA/FDA Joint Regulatory Conference is now in its 27th year. This important conference provides a forum for discussions centered on the requirements that assure the availability and delivery of high-quality medical products, and offers an opportunity to hear about the latest issues in the regulatory, quality, supply, and compliance areas for medical products in an ever-evolving landscape. Attendees will hear straight from regulators and industry leaders about how to meet the challenges of developing, manufacturing, and assuring availability and safe supply of necessary medicines to serve the patient.

In keeping with the focus on putting patients first, this Conference will explore topics that ensure innovation, quality, compliance, and a continued supply of important drugs, biologics, and combination products. The past year, 2017, presented the medical products industry with many challenges in assuring a continued supply of necessary medical products. These challenges included major natural disasters and disruptions that affected manufacturing and supply chains. Combined efforts of industry and regulators were necessary to assure uninterrupted supplies of safe and high-quality products in the face of such challenges. 

It light of the fact that it is nearly 10 years since the heparin incidents, the Conference will address issues affecting the supply chain and the evolving regulatory landscape. Solutions that have been successful in keeping the supply chain secure, assuring quality of medicinal products, and achieving compliance with regulatory and quality expectations as they continue to evolve, will also be explored. 

The Conference program will include discussions on combination products, aging facilities, quality risk management, post-approval changes and life-cycle management, process validation, and challenges of regulatory application submissions. Attendees will also learn about hot topics, such as aseptic processing, managing enforcement actions (e.g., consent decrees), inspection updates, quality systems, and quality trending, among others.

Sessions will include many case studies and practical solutions to current supply challenges, such as shortage prevention and disaster recovery, management of contract manufacturers, supplier oversight, supply chain challenges for innovative products (e.g., cell and gene therapy), and supply chain safety. The traditional and ever-popular presentations of each of the FDA’s medical product areas to discuss program specific initiatives and compliance updates will also be included. There will also be speakers from other regulatory agencies and global industry leaders who will explore the issues facing companies that operate globally.

Monday, September 24

7:00 a.m. – 7:00 p.m.
Registration Open

7:00 a.m. – 8:00 a.m.
PDA Orientation Breakfast (Invitation Only)
Supported in part by Amgen Inc.                                                                                         

7:00 a.m. – 8:30 a.m.
Continental Breakfast

8:15 a.m. – 10:00 a.m.
P1: Taking Stock of the Drug Supply Chain
Moderator: Richard L. Friedman, MS, Deputy Director, OMQ, CDER, FDA

This year’s conference occurs 10 years after the heparin supply chain crisis. Since that time, industry has enhanced supply chain management while also adjusting to further evolutions in the global market. In addition to industry’s progression, the passage of the landmark FDASIA legislation in 2012, and subsequent amendments to the Act, provided the FDA with modern authorities that help the Agency to better regulate quality and safety of drugs in the global supply chain.

This opening plenary session will focus on current priorities of regulators and industry in the area of drug product supply, with a focus on effective risk management of today’s complex global supply chains to assure reliable manufacturing, quality, and availability of medicines. Each of these are integral to “Putting Patients First.” The value of synergistic partnerships between industry and regulators to ensure strong public health standards for safety and effectiveness, while also accelerating access to groundbreaking medical products will also be discussed.

8:15 a.m. – 8:30 a.m.
Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Richard Johnson, President & CEO, PDA
Rebecca Devine, PhD, Regulatory Consultant and Chair, PDA Board of Directors
Richard L. Friedman, MS, Deputy Director, OMQ, CDER, FDA

8:30 a.m. – 9:00 a.m.
FDA Update on Supply Chain Risks and Opportunities
Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, FDA

9:00 a.m. – 9:30 a.m.
Our Commitment to Patients: Ensuring Supply for Every Patient, Every Time
Esteban Santos, MS, Executive Vice President, Operations, Amgen, Inc.

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

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area
Supported in part by Sparta Systems, Inc.

10:45 a.m.-12:15 p.m.
P2: The Evolving Regulatory Landscape
Moderator: Rebecca Devine, PhD, Regulatory Consultant

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

10:45 a.m. – 11:15 a.m.
Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, FDA

11:15 a.m. – 11:45 a.m.
John Lynch, MSc, MPSI, Director of Compliance, Health Products Regulatory Authority

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 Area Closed) – A listing of local restaurants is available at the PDA Registration Desk. Boxed lunches will also be available for purchase.

12:30 p.m. – 1:30 p.m.
Concurrent Interest Group Sessions

IG1: Pharmacopoeial

Global Needs, Global Patients
We live in a world where supply chains are complex, and patients are global. We need to continue to evolve and be creative regarding the compendial standards and work towards innovative solutions for the future.

IG2: Regulatory Affairs

Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?
Supply shortages of medically necessary products still pose a significant challenge to public health. FDA announced in July 2018 the creation of a new drug shortages task force to strike at underlying structural issues that cause persistent shortages of critical medicines.

In June 2018, The Economist Intelligence Unit (EIU) published a PDA-funded research report on "Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?". The report explores whether the varying regulatory requirements for pharmaceutical products across the world are associated with medicine and vaccine shortages.

In this session, key messages from the findings of the literature review and insights from the expert interviews will be presented. The presentation will be followed by an interactive panel discussion.

IG3: Supply Chain

Current Topics in Supply Chain Management: Supplier Quality Management of Materials, Hot Topics, and Evolving Regulations in China

Putting patients first: how safe and secure are the raw materials, excipients and components since the Heparin event? What progress has the industry made in 10 years to prevent adulteration of ingredients? Focus will be made on hot topics in supply chain and focus on the emerging China regulations.

Drug counterfeits in emerging markets are still on the rise. Are drug makers using innovative ideas to prevent/combat counterfeits for all patients around the world? Are counterfeits preventing patients from getting needed drugs in some parts of the world, e.g., Africa?

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

LIFECYCLE MANAGEMENT AND INNOVATION

A1: Combination Products
Moderator: Lucy Cabral, Senior Director, Global External Quality, Roche Genentech

Do you have a strong understanding of combination products requirements? Do your processes and systems meet the regulatory agency expectations? What do we need to put in place for smart devices? In this session, presentations will address both standards and connectivity with existing devices.

1:45 p.m. – 2:15 p.m.
Considerations in Development of Delivery Devices and Connected Solutions
Anthony L. Schaff, Sr., PE, Senior Engineering Advisor, Eli Lilly and Company

2:15 p.m. – 2:45 p.m.
Current Regulatory Standards Related to Connected Systems
CAPT Scott A. Colburn, MS, Director, CDRH Standards Program, CDRH, FDA

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

QUALITY AND COMPLIANCE

B1: Aseptic Processing/Annex 1
Moderator: Carol L. Rehkopf, Chief, Review Management Business Operations Staff, CBER, FDA

The global healthcare system relies on numerous critical injection products to cure and mitigate disease and illness. Most of these injections are made by aseptic processing, rather than terminal sterilization. Substandard manufacturing conditions at an aseptic processing facility can pose a risk to patients both due to contamination hazards and supply shortfalls. This session will address the technological and risk management framework that ensures robustness in an aseptic processing operation. It will also explore current regulatory expectations and include an update on the Annex 1 revision.

1:45 p.m. – 2:15 p.m.
Sterile Manufacturing: An MHRA Inspector’s Perspective, Including an Annex 1 Update
Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA)

2:15 p.m. – 2:45 p.m.
FDA Regulatory Perspective on Aseptic Processing: Ensuring Quality of Sterile Drug Products
Virginia Carroll, PhD, Microbiologist, CDER, FDA

2:45 p.m. – 3:15 p.m.
Panel Discussion with Presenters and Additional Participant
Hal Baseman, Chief Operating Officer, ValSource, LLC

SUPPLY CHAIN

C1: Effective Supplier Quality Audit Programs
Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

The quality of a company’s drug products is directly connected to the strength and quality of its suppliers and partners. Therefore, the effectiveness of a supplier quality audit program is critical to a firm’s success. The speakers at this session will explore practices used to identify partners and suppliers that share the same quality standards. The speakers will also discuss how to integrate risk-based approaches into effective audit programs, and they will share best practices for sustaining an effective supply chain oversight program.

1:45 p.m. – 2:15 p.m.
Industry Perspective on Effective Supplier Quality Audit Programs
James M. Fries, MBA, CEO, Rx-360

2:15 p.m. – 2:45 p.m.
Regulatory Perspective on Effective Supplier Quality Audit Programs
Ranjani Prabhakara, PhD, Team Leader, CDER, FDA

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

3:15 p.m. – 4:00 p.m.
Refreshment Break in Exhibit Area
Supported in part by Corning

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

LIFECYCLE MANAGEMENT AND INNOVATION

A2: Aging Facilities and Quality Risk Management
Moderator: Paul Perdue, Jr., Branch Chief, Pharmaceutical Quality Program Operations Branch, ORA, FDA

Manufacturing capability and quality problems are a major factor in shortages of drugs. While this problem can be greatly solved by upgrades in a company’s manufacturing facilities, needed upgrades are often slowed by a company’s lack of understanding of current technologies or insufficient commitment to invest in more reliable manufacturing equipment. This session will discuss real-world industry case studies of manufacturing upgrades and the economic benefits of these upgrades. The session will also discuss the amenability of regulators to higher capability manufacturing operations through adoption of modern technology and opportunities for regulatory flexibility.

4:00 p.m. – 4:30 p.m.
Peter E. Gallagher, MBA, Vice President, Strategic Affairs, Teligent, Inc.

4:30 p.m. – 5:00 p.m.
Remediation of Aging Facilities and Equipment
Ronald A. Berk, Chief Technology Officer, Hyde Engineering + Consulting

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participants
Ileana Barreto-Pettit, RN, MPH, Captain, U.S. Public Health Service, Drug National Expert, ORA, FDA
Anthony F. Lorenzo, Lead Consumer Safety Officer, CBER, FDA
John Lynch, MSc, MPSI, Director of Compliance, Health Products Regulatory Authority

QUALITY AND COMPLIANCE

B2: A Successful Journey under Consent Decree
Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

This session will explain how consent decrees are negotiated and the possible elements of a consent decree. A company will describe its journey after entering into a consent decree and its acquisition and remediation of the facility. The road to remediation has required systematic improvements in quality culture and quality systems. Insight into the ongoing efforts and success factors driving this metamorphosis will be explained by senior leadership.

4:00 p.m. – 4:15 p.m.
Anatomy of a Consent Decree
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

4:15 p.m. – 5:00 p.m.
Lessons Learned While Successfully Navigating a Consent Decree
Brandon Varnau, Head of Quality Operations Biologics Platform, Global Quality, Sanofi

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

SUPPLY CHAIN

C2: CMO Oversight: Challenges and Opportunities
Moderator: Tim G. Kilroy, PhD, Director, Global Quality Audits, Bristol-Myers Squibb

This session will explore CMO relationships and delve into the challenges and best practices of performing quality oversight of externally sourced contract manufacturers and partners. Themes will include risk-based approaches to quality oversight, partnering with the business to build strategic partnerships, and due diligence processes in qualifying CMOs. Speakers will present both industry and regulatory perspectives using case studies.

4:00 p.m. – 4:20 p.m.
Regulatory Perspective on CMO Oversight
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA

4:20 p.m. – 4:40 p.m.
An Industry Perspective on End-to-End CMO Oversight
Mary Collins, PhD, Executive Director, Quality, External Manufacturing, Bristol-Myers Squibb

4:40 p.m. – 5:00 p.m.
Collaborative Manufacturing Partnerships: The CMO Perspective
Natasha Rivas, Director, Quality Assurance and Quality Control, Vetter Development Services USA, Inc.

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

5:45 p.m. – 6:45 p.m.
Concurrent Interest Group Sessions

IG4: Environmental Monitoring/Microbiology & Quality Risk Management

In December 2017 the consultation period for revised Annex 1 draft was initiated for public comment. This document carries new requirements for aseptic processing and increases requirements for application of Quality Risk Management to sterile and aseptic processing. Many companies in the healthcare and pharmaceutical industry have collaborated to provide a single set of responses/comments to the Annex 1 revision committee. This collaboration was one of the most involved undertaking in the history of our industry. This session will share how this interactive process had evolved and what will be the next steps for various companies in this joint process and how to effectively apply Quality Risk Management to meet the requirements of the draft Annex.

IG5: Facilities and Engineering

The Facilities and Engineering Interest Group can cover many specific technical interests within the industry as they relate to Manufacturing Facilities and Engineering capabilities. There has been a tremendous amount of discussion around Aging Facilities the past couple of years, so for this meeting, we will continue a look at innovative solutions.

Our group is also working on two technical Points-to-Consider (PtC) documents related to Isolator Technology and VHP impact to process.  We will provide a look into the main concepts that are covered within and discuss some of the “hottest areas” of consideration.

IG6: Management of Outsourced Operations

RiskBased Oversight on Outsourced Operations

IG7: Packaging Science & Visual Inspection

This session will provide a brief update on general regulatory and pharmacopeial activities related to visual inspection and the packaging of sterile injectable products. It will provide a focus on the topic of the recently published proposed changes to Annex 1 and evolving technologies to assure container integrity. Brief presentations will be given followed by a moderated discussion of the use of these technologies and challenges and opportunities with their implementation.

IG8: Quality Systems

FDA Metrics Guidance Documents

6:45 p.m. – 10:00 p.m.
Networking Reception

Tuesday, September 25

7:00 a.m. – 7:00 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

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

Breakfast 1: Microbiology Issues
Moderator: Clarice Haigh Hutchens, PhD,
Director, Global Chemistry Manufacturing Control Advisory Office, Worldwide Safety and Regulatory, Pfizer Biotech

In this session, presenters will discuss common issues regarding microbiological data integrity and investigations of sterility failures.

7:15 a.m. – 7:35 a.m.
Meaningful Investigations of Sterility Failures from the Perspective of a USFDA Microbiologist
Jennifer M. Gogley,
Microbiologist, ORA, FDA

7:35 a.m. – 7:55 a.m.
Microbial Data Integrity
Paul Stinavage, PhD,
Senior Manager, Pfizer Inc.

7:55 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 2: Container Closure Integrity Testing
Moderator: Mai X. Huynh, MS,
Supervisory Team Leader, Antimicrobial Team, CVM, FDA

The assurance of product quality depends on the ability of the product to maintain integrity throughout the stresses anticipated during storage, distribution, and use. Therefore, satisfactory package integrity is a critical parameter for all parenteral products. Choosing the appropriate integrity test method for your container closure can be a challenge. This session will provide some key points to consider when selecting traditional versus more recent or advanced leak test methods, including discussion on feedback received since the revision of USP <1207>, Package Integrity Evaluation – Sterile Products.

7:15 a.m. – 7:30 a.m.
Container Closure Integrity Testing <USP 1207>
Donald C. Singer,
USP General Chapters - Microbiology Expert Committee

7:30 a.m. – 7:55 a.m.
FDA Perspectives on Container Closure Integrity
Christine Harman, PhD,
Chemist, Division of Manufacturing and Product Quality, CBER, FDA
Jason A. Rossi, MS, Review Chemist, Division of Manufacturing Technologies, CVM, FDA
Marla Stevens-Riley, PhD, Master Microbiology Reviewer and Quality Assessment Lead (acting), Division of Microbiology Assessment, OPF, CDER, FDA

7:55 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 3: Breakfast with the FDA
Moderator: Douglas A. Campbell,
Senior Consultant, InterPro QRA

Set your alarm to attend this eye-opening breakfast session that will allow for your direct input and provide you with insights regarding inspections trends and center initiatives, including serialization. This session gives you the chance for a Q&A with FDA investigators and Center representatives during your attendance at this premier pharmaceutical manufacturing event.

7:15 a.m. – 8:15 a.m.
Panel Discussion
James L. Dunnie,
Consumer Safety Officer, ORA, FDA (Invited)
Carl Fischer, PhD, Senior Advisor, Office of Compliance, CDRH, FDA
Marea K. Harmon, Compliance Officer, Division of Compliance and Surveillance, CVM, FDA
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA
Connie T. Jung, RPh, PhD, Senior Advisor for Policy, CDER, FDA
Simone E. Pitts, National Expert, Drugs, ORA, FDA

Breakfast 4: 503B Compounding
Moderator: Susan Schniepp,
Fellow, Regulatory Compliance Associates Inc.

Come and hear the latest information and developments regarding 503B Pharmacy Compounders (Outsourcing Facilities). PDA’s compounding pharmacy expert, Chris Smalley, and one of FDA’s experts in this area, Ian Deveau, will discuss the regulations affecting 503B facilities. Their presentations will be followed by an audience participation question and answer session.

7:15 a.m. – 7:35 a.m.
Two Big "Whys" of Compounding Pharmacy
Christopher J. Smalley, PhD,
Compounding Pharmacist Advisor, ValSource, LLC

7:35 a.m. – 7:55 a.m.
Insanitary Conditions and CGMP Requirements for Outsourcing Facilities
Ian F. Deveau, PhD,
Supervisory Consumer Safety Officer, CDER, FDA

7:55 a.m. –8:15 a.m.
Questions and Answers/Discussion

8:30 a.m. – 10:00 a.m.
P3: Compliance Updates
Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

This session is one of the highlights of the Conference, featuring Compliance Directors from the FDA Centers and Office of Regulatory Affairs. It will focus on problem areas that FDA has found during inspections, significant regulatory actions initiated, and FDA’s current enforcement strategy for a wide array of regulated products. FDA’s top leaders in Compliance and Enforcement will describe their programs and initiatives related to inspection and compliance activities. This is the best possible opportunity for you to understand FDA’s thinking and expectations for GXP compliance of the industry. Most importantly, there will be ample time for the audience to ask probing questions of FDA’s top leadership. This very popular session is one you cannot afford to miss.

8:30 a.m. – 10:00 a.m.
Panel Discussion
Donald D. Ashley, JD, Director, Office of Compliance, CDER, FDA
Carl Fischer, PhD, Senior Advisor, Office of Compliance, CDRH, FDA
Martine Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, CVM, FDA
Melissa J. Mendoza, Deputy Director, Director, Office of Compliance and Biologics Quality, CBER, FDA
Armando P. Zamora, Deputy Director, Office of Enforcement and Import Operations, ORA, FDA

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

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

LIFECYCLE MANAGEMENT AND INNOVATION

A3: Product Lifecycle Management and Q12
Moderator: Commander Tara Gooen Bizjak, MS,
Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA

A single post-approval change can take three to five years to implement across all regions, resulting in additional costs and potential supply disruption. Does Q12, with established conditions, post-approval change management protocols (PACMPs), and product lifecycle management plans, lay out a path forward to further incentivize manufacturers to make improvements, increase process robustness, and facilitate change implementation? What are practical quality considerations for implementing these approaches in a pharmaceutical quality system? The speakers at this session will focus on case studies relevant to brand small molecule and biologic products. The speakers will also provide an update on PDA's efforts on the Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) with respect to Q12; including an update on an associated PDA technical report on product lifecycle and post-approval change management for biologics and pharmaceutical drug products. The session will close with a panel discussion and include a regulatory perspective.

10:45 a.m. – 11:00 a.m.
Introduction to Q12 and Established Conditions
Ashley B. Boam, MSBE,
Director, OPPQ, CDER, FDA

11:00 a.m. – 11:20 a.m.
ECs, PACMPs, PQS, and MAbs…BFFs
Shannon F. Holmes, PhD, RAC,
Director, Product Development Quality, Biogen Inc.

11:20 a.m. – 11:40 a.m.
ICH Q12 – Global Change Management Made Easier? A Small Molecule Case Study
Kara Follmann, PhD,
Senior Director, Pfizer Essential Health Global Regulatory Affairs, Brands CMC, Pfizer Inc.

11:40 a.m. – 12:00 p.m.
Update on PDA's PAC iAM Activities with Respect to ICH Q12
Karolyn Gale,
Senior Manager, Regulatory Affairs, Emergent BioSolutions

12:00 p.m. – 12:15 p.m.
Panel Discussion with Presenters and Additional Participant
Chikako Torigoe,
Biologist, CBER, FDA

QUALITY AND COMPLIANCE

B3: Inspections and Compliance Update
Moderator: David L. Chesney,
Principal and General Manager, DL Chesney Consulting, LLC

It's back by popular demand! This session will include short presentations from CDER and CBER Compliance Managers that are designed to provide more than just the usual "Top 10" 483 observations and a summary of the latest warning letters. These presentations will be followed by a panel discussion with panelists from each of the Agency's Centers and will be an opportunity for participants to gather specific insight.

10:45 a.m. – 11:05 a.m.
CDER Compliance Update
Francis Godwin, MBA,
Office Director (Acting), Office of Manufacturing Quality, CDER, FDA

11:05 a.m. – 11:25 a.m.
CBER Compliance Update
Maria C. H. Anderson, MS,
Chief, Biological Drug and Device Compliance Branch, CBER, FDA (Invited)

11:25 a.m. – 11:45 a.m.
ORA Inspection and Enforcement Update
Nicholas A. Violand,
Consumer Safety Officer, ORA, FDA

11:45 a.m. – 12:15 p.m.
Panel Discussion with Presenters and Additional Participants
Ileana Barreto-Pettit, RN, MPH,
Captain, U.S. Public Health Service, Drug National Expert, ORA, FDA
Marea K. Harmon, Compliance Officer, Division of Compliance and Surveillance, CVM, FDA

SUPPLY CHAIN

C3: Shortage Prevention and Availability: Disaster Recovery Case Studies
Moderator: Renée Kyro, MBA,
Director Share Services, Quality Assurance, Abbvie Inc.

2017 was an unprecedented year of natural disasters, with earthquakes in Mexico; wild fires in California; record flooding from monsoons and torrential rainfall across the globe; and hurricanes in Texas, Florida, and Puerto Rico. These events presented significant challenges for our industry to provide assurance of supply to our patients and the handling of drug shortages. Hear from industry leaders and regulators on lessons learned and case studies from some of these catastrophic events.

10:45 a.m. – 11:15 a.m.
The María Experience: Challenges and Opportunities
Saritza E. Ríos-Solá,
Director, Quality Assurance, AbbVie Ltd.

11:15 a.m. – 11:45 a.m.
Emergency Preparedness and Lessons Learned from Hurricane Maria
Christopher M. Jones, MBA,
Vice President, Operations Strategy and External Contract Manufacturing, Baxter Healthcare Corporation

11:45 a.m. – 12:15 p.m.
Panel Discussion with Presenters and Additional Participant
CAPT Valerie E. Jensen, RPh,
Associate Director of the Drug Shortage Staff, CDER, FDA

12:15 p.m. – 1:45 p.m.
Lunch on your own (Exhibit Area Closed) – A listing of local restaurants is available at the PDA Registration Desk. Boxed lunches will also be available for purchase.

12:30 p.m. – 1:30 p.m.
Concurrent Interest Group Sessions

IG9: GMP Links to Pharmacovigilance

Patients are the ultimate recipients of our products. Monitoring distributed products requires surveillance and data analysis capabilities linked to an understanding of the product’s quality attributes. In this session, we will explore how one can utilize pharmacovigilance systems to monitor post-approval manufacturing process changes and support comparability assessments.

IG10: Inspection Trends

The session will be a discussion of Data Integrity issues presented by Ron Tetzlaff followed by a Q&A with the audience over questions they may have and experiences. Additional details will be provided after additional conversations with Ron.

IG11: Vaccines

The session will present the activities considered for the next twelve months, the Industry expectations that have driven the proposed agenda and engage the participants to actively contribute with the upcoming activities in the Vaccines Interest Group (VIG). The session is intended to spark discussions about putting patients first when current or innovative vaccines are launched into the market in a compliant and reliable manner. A rapid talk about a vaccines case study will be presented.

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

LIFECYCLE MANAGEMENT AND INNOVATION

A4: Process Validation Implementation: Taking Stock, Where are We?
Moderator: Mai X. Huynh, MS,
Supervisory Team Leader, Antimicrobial Team, CVM, FDA

Where are we with the process validation since the publication of the 2011 FDA Guidance for Industry, "Process Validation – General Principles and Practices?" This session offers an opportunity for industry and FDA to share their experiences regarding how the principles and approaches described in the current guidance apply to the manufacturing process, including process design, process qualification, and continued process verification. The session will share lessons learned from both the industry and FDA perspectives.

1:45 p.m. – 2:15 p.m.
Learning to Love the Validation Lifecycle: Reflections and Musings
Kenneth D. Hinds, PhD,
Scientific Director, Janssen R&D, LLC

2:15 p.m. – 2:45 p.m.
Process Validation: Important Indicator of Process Understanding
José E. Meléndez,
FDA Drug National Expert, ORA, FDA

2:45 p.m. – 3:15 p.m.
Panel Discussion with Presenters and Additional Participants
Alexey Khrenov, PhD,
Senior Staff Fellow, CBER, FDA
Michael J. Popek, Team Leader, Division of Manufacturing Technologies, CVM, FDA
Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA

QUALITY AND COMPLIANCE

B4: Trending for Quality
Moderator: Myriam M. Sosa, MS,
President, TGG, LLC

Trending of quality data can be used to control processes to maintain their validated state and to monitor process performance for early detection of excursions from the validated state. Data for trending includes process parameters, materials, performance and quality indicators, and complaint data. Methods include Shewhart control charts and more advanced trending tools like CUSUM charts and changepoint analysis. Methods are available for both attribute (pass/fail) data and measurable characteristics. The basic process of setting up a trending program, from deciding what to trend, how to trend it and actions to take will be covered.

1:45 p.m. – 2:20 p.m.
Trending Data to Drive Product Quality Improvements
Commander Tara Gooen Bizjak, MS,
Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA

2:20 p.m. – 2:55 p.m.
Statistical Methods for Trending Quality Data
Wayne A. Taylor, PhD,
Chairman, Taylor Enterprises, Inc.

2:55 p.m. – 3:15 p.m.
Questions and Answers/Discussion

SUPPLY CHAIN

C4: Supply Chain Issues and Innovative Products for Cell and Gene Therapy
Moderator: John D. Ayres, MD, JD,
Pharma Safety Solutions, LLC

Innovation in cell- and gene-based therapeutics continues to advance rapidly. It is critical that supply chain and product integrity systems evolve to meet the unique demand these products present. Supply chain security is critical to avoid environmental excursions, trauma, or diversion. For cell therapies, although both allogeneic and autologous cell sources are utilized therapeutically, autologous cells present significant chain-of-custody challenges that must be demonstrated as fail-safe to ensure that the donor-recipient match (needle-to-needle) is maintained. Likewise, gene therapy presents its own unique issues related to viral and non-viral vectors and associated challenges. This session will explore these issues and considerations around integrating cGMP and quality systems for cell and gene therapy products, and recent FDA guidance for these therapies.

1:45 p.m. – 2:15 p.m.
CBER's Expectations for GMPs for Autologous Cell Therapies
Donald B. Ertel,
Regulatory Officer, CBER, FDA

2:15 p.m. – 2:45 p.m.
Supply Chain Challenges for Autologous Cell Therapies
John S. Lunger, MBA,
Vice President, Manufacturing and Supply Chain, Adaptimmune Therapeutics

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

3:15 p.m. – 4:00 p.m.
Refreshment Break in Exhibit Area

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

LIFECYCLE MANAGEMENT AND INNOVATION

A5: Hot Topics in Submissions
Moderators: Reyes Candau-Chacon, PhD,
Biologist, CDER, FDA and Laurie P. Norwood, Deputy Director, Division of Manufacturing Product Quality, OCBQ, CBER, FDA

How are industry and FDA adapting to meeting the shorter review timeframes for applications required for breakthrough products regulated by CBER and CDER? Are there new challenges in the review and inspection process of biosimilar applications? What are the FDA expectations for new transition biological products? In this session, FDA and industry experts will present case studies that will address manufacturing and product quality challenges encountered with new types of biologicals products and new manufacturing platforms.

4:00 p.m. – 4:30 p.m.
Current Challenges in Quality Microbiology and Sterility Assurance of Biotech Products
Bo Chi,
Microbiologist, CDER, FDA

4:30 p.m. – 5:00 p.m.
Case Studies from Recent BLAs: Manufacturing and Product Quality Content
Joan C. Kwong, MS,
Senior Manager, Global Regulatory Affairs, Pfizer Inc.

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participant
Anthony F. Lorenzo,
Lead Consumer Safety Officer, CBER, FDA

QUALITY AND COMPLIANCE

B5: Quality Systems
Moderator: Enrique Diloné, PhD, RAC,
Senior Vice President, Technical Operations, Amicus Therapeutics, Inc.

In this session, speakers will discuss quality issues facing biotech companies. Biotech companies in clinical development may not have a fully established quality management system (QMS). Their quality functions may be challenged to meet increasing compliance requirements while enabling business objectives in highly dynamic environments. As biotech companies mature from clinical development into global commercial operations, the QMS and quality culture must evolve to meet the changing needs of the business. Case studies will be presented in a separate session demonstrating how the evolution of the QMS enabled increased oversight of their outsourced biologics manufacturing and the maturation of quality culture required to ensure product safety and quality.

4:00 p.m. – 4:30 p.m.
Evolving the Quality Culture as the Company Matures Its Quality System
Jan Paul Zonnenberg,
Partner, PriceWaterhouseCoopers, LLC

4:30 p.m. – 5:00 p.m.
Evolution of the Quality System
Laura A. Singer,
Vice President, Global Quality Assurance, Amicus Therapeutics

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participant
Grace E. McNally,
Supervisory Health Scientist, CDER, FDA

SUPPLY CHAIN

C5: Ingredient Supplier Oversight
Moderator: Lucy Cabral,
Senior Director, Global External Quality, Roche Genentech

How robust is your company's process for qualification, management, and risk reduction of your suppliers of API and excipients? Does your process prevent quality failures and ensure uninterrupted supply to the patients your company serves? In this session, participants will hear from Dr. Marla Phillips as she presents practical paradigm-shifting supply chain practices you can implement today from the Xavier University Good Supply Practices (GSPs) Initiative led by FDA officials and industry professionals across the pharma and device industries. Dr. Ralph Quadflieg will follow with a risk-based approach to manage API, excipients, container closures, and addresses best practices managing a large portfolio of materials and suppliers.

4:00 p.m. – 4:30 p.m.
Good Supply Practices: Practical Solutions You Can Implement Today
Marla A. Phillips, PhD,
Director, Xavier Health, Xavier University

4:30 p.m. – 5:00 p.m.
Risk-Based Approach to Manage Quality Supply of API, Excipients, and Container Closures
Ralph Quadflieg, PhD,
Regional Head Global Supplier Quality Management, Roche

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

5:45 p.m. – 6:45 p.m.
Concurrent Interest Group Sessions

IG12: Cell and Gene Therapy

In this session we will discuss what the PDA is doing in support of Cell and Gene Therapy. In addition, we will discuss the recently published Technical Report that focuses on the development of control strategies for cell therapy.

IG13: Data Integrity

How to implement an effective data integrity program across the lifecycle to ensure quality and compliance. How do you expand data integrity into clinical trials and hospital settings to support the product lifecycle? What are the differences from a GMP environment and challenges that need to be considered. How do you ensure Data Governance and Data Integrity across multiple data systems and functional areas? Are there tools such as big data and AI that can be utilized under the data integrity framework. Explore tools and how they can be utilized.

IG14: Quality Systems

The Quality System Interest Group will be discussing development of the role of Quality leaders and how the Quality System can be leveraged for this. Quality leaders have stated cGMP compliance responsibilities within the regulations, we intend to take the discussion beyond this aspect of the role.

IG15: Technology Transfer

Ensuring a Quality TT
The IG is working on a Technology Transfer (TT) R&R and Documentation matrix to support TT best practices definition, sharing and implementation among the pharma industry. The TT matrix will provide the minimum requirements in terms of documentation and readiness as well as guidance for Departments involvement and inter-connections during a TT lifecycle.

It will support industry in putting in place appropriate high standards in a practice, the Technology Transfer, which is becoming common practice in pharma.

As a final output the TT matrix will support increase in success rate, quality level and process robustness during TT.

Additionally, a Survey is being developed and will be available for presentation at the Session. 

Wednesday, September 26

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

7:00 a.m. – 8:30 a.m.
Continental Breakfast

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

Breakfast 5: Green Chemistry and Product Sustainability
Moderator: Clarice Haigh Hutchens, PhD,
Director, Global Chemistry Manufacturing Control Advisory Office, Worldwide Safety and Regulatory, Pfizer Biotech

This session will focus on three dimensions of Sustainability relevant to Pharma— (1) EHS Site Facilities' focus on energy, waste, and water; (2) researchers' focus on green chemistry and sustainable processes; and (3) product sustainability and branding perspective with approaches to telling the "story."

7:15 a.m. – 7:30 a.m.
Green Chemistry in Research and Facilities
Brad Stanard, MPH, PhD,
Associate Director, Occupational and Quality Toxicology, AstraZeneca

7:30 a.m. – 7:45 a.m.
Product Sustainability and Branding
Tom Polton, MS,
Senior Director, Environmental Sustainability, Pfizer Inc.

7:45 a.m. – 8:15 a.m.
Panel Discussion with Presenters and Additional Participan
Thomas F. O'Connor, PhD,
Chemist, CDER, FDA

Breakfast 6: Evolving Large Volume Parenteral Manufacturing
Moderator: Jacqueline Kunzler, MBA, PhD,
Senior Vice President, Chief Quality Officer, Baxter

This session will review the history of large volume parenteral (LVP) manufacturing and contemplate where the future should lead. What is the Agency's perspective on areas that need additional focus in LVP manufacturing? How can industry drive meaningful change in a commoditized market?

7:15 a.m. – 7:45 a.m.
Visual Inspection Advancements in Flexible Packaging
Merle Goddard, MS,
Senior Director, Global Quality, Baxter

7:45 a.m. – 8:15 a.m.
Panel Discussion with Presenter and Additional Participants
Karen E. D'Orazio,
Compliance Officer, CDER, FDA
Reynold Tan, PhD, Quality Assessment Lead, CDER, FDA

Breakfast 7: Restricted Access Barrier Systems and Isolators: Current Perspectives
Moderator: David J. Jaworski, MBA,
Senior Policy Advisor, CDER, FDA

This session is focused on the significant sterility assurance benefits of using restricted access barrier and isolator systems to manufacture sterile biologic and drug products. These systems, when used and maintained properly, are exceptional; however, as the speakers will discuss, there are a number of critical variables that must be carefully controlled to assure quality.

7:15 a.m. – 7:45 a.m.
QA and Operations Perspectives on Upgrading to Isolator Filling
Anne Huffman,
Vice President Quality Assurance - Plant Operations, Fresenius Kabi USA, LLC
Anthony Pavell, Plant Manager - PU GI, Fresenius Kabi USA, LLC

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

Breakfast 8: Water Systems
Moderator: Shane Killian, MS,
Senior Director, Licensing & Acquisition Head, Johnson & Johnson

Maintaining a qualified pharmaceutical water system requires key design elements and a reliable maintenance plan, especially if you are dealing with an aging facility. This session will bring us "back to basics" with water system types, design elements, maintenance, and monitoring.

7:15 a.m. – 7:45 a.m.
Control of Pharmaceutical Water Systems: A Regulatory Perspective
Stephen E. Langille, PhD,
Acting Division Director, Division of Microbiology Assessment, Office of Process and Facilities, CDER, FDA

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

Breakfast 9: Training Effectiveness
Moderators: Douglas A. Campbell,
Senior Consultant, Interpro QRA and Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

There is a common effort throughout the industry to better manage the training program. There is also a general understanding of the cycle of training/re-training as a component of many corrective actions. This session is designed to provide insight related to the evaluation of the effectiveness of training. These types of evaluations can provide value added, not only to the training program and the qualifications of the employees, but also to the organization through the direct benefits of a reduction in deviations, OOS, etc. Participants in this session will take away a simple concept that could provide a modern outlook and improvement to the training program.

7:15 a.m. – 7:45 a.m.
Achieving Success through an Effective Training Program
Kristy A. Zielny,
Director, Regional Quality & Compliance North America, Sun Pharmaceutical Industries, Inc.

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

8:30 a.m. – 10:00 a.m.
P4: Center Updates
Moderator: Laurie P. Norwood, Deputy Director, Division of Manufacturing Product Quality, OCBQ, CBER, FDA

How is FDA adapting to the evolving environment of regulating new innovative drugs and devices and ensuring product quality, compliance, and product to the patients? Hear from FDA senior management officials from various FDA Centers and learn about their new initiatives, challenges, and plans as the Agency moves forward to maintain a constant supply of approved products and to bring new and novel products to the market. A panel discussion will follow, along with time for questions from the audience.

Panel Discussion
CAPT Sean Boyd, MPH, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA
Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
Steven Solomon, DVM, MPH Director, Center for Veterinary Medicine, FDA
Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs, CDER, FDA

10:30 a.m. – 12:15 p.m.
P5: Quality Culture: What’s Holding Us Back?
Moderator: Valerie Whelan, Vice President, Corporate Quality, Amgen Inc.

“A nation’s culture resides in the hearts and in the souls of its people” Mahatma Ghandi, the same is true for Quality culture. Over the last number of years, we have attempted to evolve the maturity of our industry in terms of our understanding of a culture of Quality and in considering how to ‘measure/evaluate’ this, our success to date has been limited. In this session, we will hear how others, outside our industry, have achieved success in similar areas. Where we are in our journey will be explored and an in-depth examination of where the future opportunities and risks lie will be undertaken. The speakers will consider what is preventing us from truly tackling the cultural challenges and realizing the full value that a culture of Quality can bring from both the business and patient perspectives.

10:30 a.m. – 11:00 a.m.
Lead Proudly to Failure, or Ask Why
Paul Sean Hill, Former NASA Flight Director

11:00 a.m. – 11:30 a.m.
Quality Culture: What’s Holding Us Back?
Scott C. Nickerson, Head of Quality, Moderna Therapeutics

11:30 a.m. – 12:00 p.m.
Panel Discussion with Presenters and Additional Participants
Ashley B. Boam, MSBE, Director, OPPQ, CDER, FDA

12:00 p.m. – 12:15 p.m.
Closing Remarks and Introduction of 2019 PDA/FDA Joint Regulatory Conference Co-Chairs

Conference Registration | September 24-26, 2018

Member

By July 30, 2018
$2,395

After July 30, 2018
$2,995

Non-member

By July 30, 2018
$2,674

After July 30, 2018
$3,274


Young Professional Member

Member*

By July 30, 2018
$1,198

After July 30, 2018
$1,498


Government/Health Authority† 

Member*

By July 30, 2018
$700

After July 30, 2018
$700

Non-member*

By July 30, 2018
$700

After July 30, 2018
$700


Academic

Member

By July 30, 2018
$700

After July 30, 2018
$700

Non-member*

By July 30, 2018
$800

After July 30, 2018
$800


Student

Member

By July 30, 2018
$280

After July 30, 2018
$280

Non-member*

By July 30, 2018
$310

After July 30, 2018
$310


One Day Only Fee

Monday, September 24 | Tuesday, September 25

PDA Member
$1,398

Nonmember
$1,510

All prices in US dollars.

If you are a Government/Health Authority Member Type, you must use the Government/Health Authority Registration Form. The cost of food functions is $350.

* 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 Conference.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference and receive the 4th registration free. Other discounts cannot be applied. Complimentary Conference registration does not qualify for discount offered for Workshop.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by July 26, 2018 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). If your written request in received on or before July 26, 2018,you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

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

RECORDING: Tape Recordings are prohibited at all PDA Conferences.

Renaissance Washington, DC Downtown Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000



Rate:
Single: $317.00, plus applicable taxes.

Cut Off Date: Friday, August 10 (Availability may be limited. Requests will be processed on a first-come, first-served basis). Attendees staying within the PDA block will receive the conference rate.

Hotel Accommodations

To make reservations at the Renaissance Washington, DC Downtown Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2018 PDA/FDA Joint Regulatory Conference to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.

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. All cancellations must be received by 11:59 p.m., 3 days before arrival to avoid a penalty of one night's room and tax.

Amenities

The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron, and an ironing board.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

Ground Transportation
Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

Metro
Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train
Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com.

Driving
Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking
$35 / Daily Self-Parking
$45 / Daily Valet Parking

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA/FDA Joint Regulatory Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This Conference will bring together industry experts from, quality, compliance, operations, supply chain, engineering, project management, manufacturing, regulatory affairs, and science professionals.

At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

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

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

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https://store.pda.org/Meetings/Login.aspx?ID=3903

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