Day 1
Thursday, 5 December 2019
  • 0830 - 1015
    Opening Plenary Session
    The global pharmaceutical industry continues to evolve and modernize. Medical product manufacturers continue to develop safe and therapeutic medications using novel technologies to treat patients. Close interactions between global regulators and industry is essential to ensure these life-saving products remain reliable and available throughout the product lifecycle. For continued success, innovation and regulatory harmonization is key to upholding the gold standards tenets of pharmaceutical quality worldwide. This opening plenary session provides for the latest thinking from industry and senior regulatory leaders who will set the tone for this premier "global pharmaceutical regulatory summit" regarding the manufacturing of reliable medicines to patients.
    Session Leaders
    Placeholder Person Graphic
    Deputy Director, Office of Testing and Research
    OPQ/CDER, FDA
    Speakers
    Director, CDER
    FDA/CDER/OCD
    President & CEO
    Lachman Consultant Services, Inc
    Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector)
    MHRA
    CEO and President
    ISPE
    Presentation Information
    [Welcome and Opening Remarks]
    Speaker: Fran Zipp and John Bournas
  • 1100 - 1230
    APQ Quality Maturity Frameworks
    Quality Maturity is foundational to achieving Janet Woodcock’s Vision for Pharmaceutical Quality for the 21st Century: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive oversight.”

    This session will include the latest tools and resources that are under development by the ISPE Advancing Pharmaceutical Quality (APQ) Core Team, industry learnings from the CDRH Case for Quality CMMI Business Maturity Pilot, and the current status of the ISPE/PDA collaboration to develop tools and resources for assessing and improving Quality Culture. Participants will be able to ask questions and provide input to each workstream.
    Session Leaders
    Director
    J&J Corporate
    Speakers
    Placeholder Person Graphic
    Industry Representative, Invited
    Placeholder Person Graphic
    Director Quality Systems
    Johnson & Johnson
    External Engagement Leader, Corporate Quality Assurance
    Procter & Gamble
    Director, Global Quality - Consumer Product Quality Assurance
    Eli Lilly
    Global Director, Quality Systems
    Perrigo
    Presentation Information
    [Industry Learnings from CDRH’s Case for Quality Program]
    Speaker: Laura Corrado
    || [Question and Answer/Discussion Moderator]
    Speaker: Steven A. Greer
    || [ISPE Quality Maturity Framework Overview]
    Speaker: Kira Ford
    || [Culture Underpins Quality – ISPE PDA Quality Culture Collaboration]
    Speaker: Tami Frederick
  • 1100 - 1230
    Biotech
    Advance Therapy Medicinal Products such as CAR-T cells, Tissues, and gene therapies are exciting additions to the traditional pharmaceutical options.  However, their complexity can require innovative regulatory thinking with regard to quality assurance, cGMPs, and process validation.  This session will provide real life experience from CBER and the industry regarding the challenges and opportunities for meeting the regulatory requirements for these innovative products.
    Session Leaders
    VP, Biotechnology
    Lachman Consultant Services
    Speakers
    Placeholder Person Graphic
    US FDA, Invited
    Placeholder Person Graphic
    VP Regulatory CMC
    Kite Pharma, Inc.
    Presentation Information
    [TBD]
    Speaker: Industry Representative
  • 1330 - 1500
    APQ Quality Maturity and Metrics, Academic Research and Learnings
    This session will provide information regarding FDA-sponsored programs currently in progress with a look ahead at work yet to be completed. Topics include the results related to St. Gallens’ Year 3 research program related to Quality Metrics sponsored by the FDA as well as potential future studies. Additionally, FDA leadership has been invited to discuss how a Quality Maturity element may be applied to the New Inspection Protocol Project (NIPP) utilized in select inspections. Participants will be engaged in an interactive Q&A session related to each topic.
    Session Leaders
    Director
    J&J Corporate
    Speakers
    Director, Institue of Technology Management
    University of St. Gallen (Switzerland)
    External Engagement Leader, Corporate Quality Assurance
    Procter & Gamble
    Director
    DPA/OTR/FDA
    Presentation Information
    [St. Gallen Year 3 Research Results and Potential Future Research with Questions]
    Speaker: Thomas Friedli
    The presentation will highlight some selected outcomes of the year 3 quality metrics research of the University of St.Gallen based on a collaborative grant from the FDA.
    || [Question and Answer/Discussion Moderator]
    Speaker: Steven A. Greer
    || [Learnings form FDA’s Quality Metrics Feedback and Site Visit Programs and the Integration of Quality Indicators in NIPP]
    Speaker: Lucinda (Cindy) Buhse
  • 1330 - 1500
    Continuous Manufacturing
    The FDA issued their draft guidance for continuous manufacturing in February of this year. The document, Quality Considerations for Continuous Manufacturing (CM), covered seven areas associated with pharmaceutical development, but focused most heavily on the concepts of Control Strategy and Process Validation. Within the Process Validation section, Continuous Process Verification (CPV) is listed as a stage of process validation. Very little detail is provided on what CPV should look like for CM processes.
    The purpose of this session is to describe from both a regulatory and industry perspective what CPV should be, and to engage the audience in a Q&A session based on these presentations. The presentations on CPV will touch upon the following items at a minimum:

    1) How much data, and what types of data are needed for CPV? Is parametric data sufficient, or are quality-indicating PAT data needed?
    2) How should the larger data stream associated with CM and CPV change our current "lot based" approach to process validation? (for example, could one week of CPV data replace a "lot" of traditional batch data?)
    3) What in our current batch validation requirements would be valuable to replace from both a regulatory and industry perspective?

    The session output should help to define CPV expectations and inform ongoing Q13 discussions.
    Session Leaders
    Senior Director
    Eli Lilly & Co
    Speakers
    Placeholder Person Graphic
    US FDA, Invited
    Placeholder Person Graphic
    Industry Representative, Invited
    Presentation Information
    [TBD]
    Speaker: Industry Representatiave
  • 1530 - 1700
    APQ Quality Maturity and the Business Case for Quality
    This interactive session will provide participants with the opportunity to provide input to two ISPE APQ Programs currently under development. The first program explores the relationship between the sponsor and contract manufacturing operations (CMO) and determines how this relationship impacts quality oversight (CMOs). The second program explores how to develop and present the Business Case for Quality to build leadership support for a commitment to Quality Maturity. Key take-aways include:

    -Provide input to ISPE’s Case for Quality and CMO Quality assessment programs
    - Hear experts discuss important business programs for justifying and assessing complex industry challenges
    -Take back to your company the latest thinking relating to these challenges
    Session Leaders
    Director
    J&J Corporate
    Speakers
    Placeholder Person Graphic
    Industry Representative, Invited
    Director
    J&J Corporate
    Presentation Information
    [Summary and Next Steps]
    Speaker: Betsy Fritschel
  • 1530 - 1700
    Drug Shortages
    Drug Shortages continue to challenge US, Europe, all world areas, and global health care, limiting patient access to life-saving medicines. Pharma and Biopharmaceutical companies along with regulatory agencies and government bodies have been developing various strategies to minimize the potential for drug shortages and to rapidly mitigate shortages when they occur. This session will present industry insight regarding how to prevent drug shortages before they occur, even in the event of natural disasters, and also present governmental strategies to identify potential shortages and resolve existing or pending shortages in a timely manner.
    Session Leaders
    President, Executive Director - CMC Regulatory
    PharmTree Consultants
    Speakers
    Placeholder Person Graphic
    Industry Representative, Invited
    Placeholder Person Graphic
    Industry Representative, Invited
Day 2
Friday, 6 December 2019
  • 0700 - 0830
    Women in Pharma® Roundtable Breakfast Session: Balance for Better in Biopharmaceutical Manufacturing
    Join the conversation! This Women in Pharma® panel of biopharmaceutical leaders will share their insights on achieving and the value of gender balance in biopharmaceutical manufacturing. In addition, the event will include audience participation in breakout group discussions.

    We hope you can join us, and all are welcome to take a seat at the table! This session is included with full conference registration.
    Session Leaders
    Executive Director, Strategic Development
    CAI
    Speakers
    CEO and Owner
    Nephron Pharmaceuticals
    Placeholder Person Graphic
    US FDA, Invited
    Placeholder Person Graphic
    US FDA, Invited
    Executive Director, Strategic Development
    CAI
    Vice President, Lead Biologics Expansion
    Janssen Pharmaceuticals
    Presentation Information
    [TBD]
    Speaker: FDA Representative
  • 0845 - 1015
    Regulatory & Industry Innovations
    The pharmaceutical industry is striving to develop new technology to improve product quality by adopting novel manufacturing technology or new product design. In recent years, there have been successful cases of new technologies (e.g. continuous manufacturing, 3D-printing, novel control strategy based on predictive modeling, etc.) approved by global regulatory agencies. However, the pharmaceutical industry may still face technical and regulatory challenges regarding the development and implementation of a novel technology. The potential concerns may present due to the unfamiliarity of the novel technology for both industry and regulatory agency. In this session, FDA speakers from the CDER Office of Pharmaceutical Quality (OPQ) Emerging Technology Team (ETT) and CBER Advanced Technologies Teams (CATT) will be invited to share their experience in managing these programs and how they collaborated with prospective innovators. Industry speakers will also be invited to give presentations on some cutting-edge technology development and to share their experience in interacting with regulatory agencies during the development and regulatory submission and approval process.
    Session Leaders
    Director, Regulatory Affairs CMC Biologics
    Merck & Co Inc
    Speakers
    Director & Emerging Technology Team Chair, Office of Testing & Research
    OPQ/CDER/FDA
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    Senior Scientist for Emerging Technologies & Medical Countermeasures
    CBER CATT/FDA
    Presentation Information
    [Innovative Technology Development and Regulatory Challenge]
    Speaker: Christine Moore
  • 1045 - 1215
    Patient Centric Specifications
    The development of patient centric specifications (PCS) builds on existing industry guidance and utilizes the science and knowledge generated through the development and life-cycle of a pharmaceutical product. By taking this understanding and applying it to establish specifications that focus on the patient, rather than simply the batch data available at time of marketing application, significant benefits can be gained for both patient and industry.

    The benefits from adopting patient centric specifications will be discussed, with the hope that wider adoption of these principles could form the cornerstone to achieving global regulatory harmonization, reducing the complexity of managing a product through its life-cycle, reducing environmental impact from our pharmaceutical processes, improving supply chain robustness and potentially minimizing drug shortage and disruption of supply of medicines to patients.

    Establishing appropriate specifications for drug substance and drug product within our regulatory submissions is vital to industry to enable manufacturability, assure quality and maintain a robust supply chain. In this session, regulatory and industry experts will be invited to present on the approaches for establishing patient centric specifications for impurity in small molecules and large molecules and time for Q&A.
    Session Leaders
    Senior Director, Global CMC
    Pfizer Inc
    Speakers
    Placeholder Person Graphic
    US FDA, Invited
    Placeholder Person Graphic
    Senior Director, Regulatory Affairs-CMC
    AstraZeneca
    Placeholder Person Graphic
    Director, Product Quality
    Amgen Inc (NMOS)
  • 1045 - 1215
    Accelerated Development
    The pace of medicinal product development is accelerating, and more and more novel therapies are entering the clinic that have the potential to dramatically impact the lives of patients. Regulatory agencies around the world have responded by creating formal or informal regulatory pathways for expediting approval and patient access. However, since these regulatory designations are based on clinical efficacy signals, the Quality/CMC aspects of the product are often rate-limiting. In particular, uncertainty concerning the finalization of product control strategies, process characterization needs, dosage form optimization, comparability, and limited batch history and stability data have created perceived risk to firms pursuing accelerated submissions as well as post-approval lifecycle management. Often, the accelerated approvals for such products are contingent upon post-approval commitments including clinical studies, stability, re-evaluation of specifications, and managing global supply chains to assure medicinal product availability. Some regulatory agencies offer increased opportunities for interaction with applicants, but companies continue to pursue accelerated programs on a case by case basis, resulting in inefficiencies and perpetuating divergence in regulatory views.

    This session will:
    o Outline Regulatory CMC challenges through commercialization
    o Discuss risk-based approaches to address common CMC issues
    o Discuss Regulatory tools currently available to accelerate development
    o Discuss the advantages of different forms of interactions with regulatory agencies including direct sponsor engagement, industry-regulator workshops, and other opportunities
    Session Leaders
    Regulatory Affairs - CMC
    Amgen Inc.
    Speakers
    Placeholder Person Graphic
    US FDA, Invited
    Placeholder Person Graphic
    Industry Representative, Invited
    Presentation Information
    [TBD]
    Speaker: FDA Representative
    || [TBD]
    Speaker: Industry Representative
  • 1315 - 1445
    Combination Products
    Drug-device combination products continue to be a growing area for advancing medication delivery.  These products are governed by an evolving global regulatory landscape.  During this session we will review combination product development, risk management, and safety considerations.
    Session Leaders
    Senior Director, Global Product Vigilance & Post Market Reporting
    Johnson & Johnson
    Speakers
    Senior Medical Director, Medical and Clinical Affairs
    Abbott Diagnostics
    Placeholder Person Graphic
    US FDA, Invited
    Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
    Johnson & Johnson
    Presentation Information
    [Post-Market Safety Reporting: Are You Ready?]
    Speaker: Khaudeja Bano
    This presentation will focus on:

    -Outline practical steps that need to be taken by organizations to be ready for implementation by July 2020
    -Adopt a risk-based approach to PMSR to add efficiencies to the process
    -Key Operational challenges and industry best practices to address them
    -Outline practical steps that need to be taken by organizations to be ready for implementation by July 2020
    -Adopt a risk-based approach to PMSR to add efficiencies to the process
    -Key Operational challenges and industry best practices to address them
    || [Combination Product Risk Management and Evolving Global Regulations]
    Speaker: Susan Neadle
  • 1515 - 1645
    Global Reliance & Harmonization
    In our regulatory world in pharmaceutical manufacturing, we encounter 48 different pharmacopoeias and 20 different sets of GMP globally basically regulating the same work. Harmonization or reliance has long been the holy grail but progress has been at a glacial pace. In this session we will listen to an area where reliance has yielded results, and an area where progress has not been as rapid.

    Panel Discussion

    Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA
    Jaap Venema, PhD, EVP & CSO, United States Pharmacopeia (USP)
    David Churchward, Deputy Unite Manager, Inspectorate Strategy and Innovation, MHRA
    FDA Representative, Invited
    Session Leaders
    Senior Director
    Novo Nordisk
    Speakers
    Placeholder Person Graphic
    Executive Vice President & Chief Science Officer
    United States Pharmacopeia (USP)
    Placeholder Person Graphic
    US FDA, Invited
    Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector)
    MHRA
    Director, Office of Pharmaceutical Quality Operations
    FDA/ORA