Day 1
Thursday, 5 December 2019
  • 0830 - 1015
    Opening Plenary - Innovation and Quality during Lifecycle Management
    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
    Deputy Director, Office of Testing and Research
    Director, CDER
    Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector)
    CEO and President
    Presentation Information
    [Evolution of Pharmaceutical Manufacturing: Science and Technology Throughout the Product Lifecycle]
    Speaker: Janet Woodcock
    || [Healthcare of the Future: Creating an Enabling Environment for Pharmaceutical Innovation]
    Speaker: David Churchward
    || [Welcome and Opening Remarks]
    Speaker: 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, Enterprise Regulatory Compliance
    Johnson & Johnson
    Director Quality Systems
    Johnson & Johnson
    Global Director, Consumer Product Quality Assurance
    Eli Lilly
    Global Director, Quality Systems
    Presentation Information
    [Learnings from CDRHs Case for Quality Voluntary Improvement Program]
    Speaker: Laura Corrado
    || [ISPE's Advancing Pharmaceutical Quality Framework]
    Speaker: Kira Ford
    || [Cultural Excellence ISPE/PDA Collaboration]
    Speaker: Tami Frederick
  • 1100 - 1230
    Regulation of Innovation in Biotechnology
    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
    Cellular Therapy Branch
    Division of Cell and Gene Therapies
    Vice President, Regulatory CMC
    Kite Pharma, Inc.
    Presentation Information
    [Regulatory Considerations for Advanced Therapeutic Biologics]
    Speaker: Melanie Eacho
    || [Yescarta’s Journey and Beyond]
    Speaker: Dr. Mehrshid Alai-Safar
    Yescarta was approved in the U.S. in October 2017 and in the EU in August 2018 for adult patients with certain types of relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy. In this presentation development and registration of Yescarta will be described. Emphasis will be made on the unique aspects of genetically modified autologous cell therapy development and life cycle management.
  • 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.

    Panel Discussion

    Betsy Fritschel, Director, Johnson & Johnson Enterprise Regulatory Compliance
    Steven A. Greer, External Engagement Leader, Corporate Quality Assurance, Proctor & Gamble

    Thomas Friedli, PhD, Director, Institute of Technology Management, University of St. Gallen
    Cindy Buhse, PhD, Director, Office of Quality Surveillance, FDA
    Alex Viehmann, Operations Research Analyst, Office of Pharmaceutical Quality, CDER, FDA
    Kira L. Ford, Global Director, Consumer Product Quality Assurance, Eli Lilly and Company
    Tami J. Frederick, Global Director, Corporate Quality Systems, Perrigo Company
    Laura Corrado, Director, Quality System Improvements & Integrations, Johnson & Johnson
    Session Leaders
    Director, Enterprise Regulatory Compliance
    Johnson & Johnson
    Director, Institue of Technology Management
    University of St. Gallen (Switzerland)
    Director, Enterprise Regulatory Compliance
    Johnson & Johnson
    Presentation Information
    [The Next Generation of Quality Management Insights from the Year 3 St. FDA Quality Metrics Research ]
    Speaker: Thomas Friedli
    || [FDA Quality Metrics Site Visit Program: Industry Perspectives & Learnngs]
    Speaker: Betsy Fritschel
    || [Learnings form FDA’s Quality Metrics 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.

    Panel Discussion

    Tara Gooen Bizjak, CDR, Senior Science Policy Advisor, OPQ, FDA
    Gabriella Dahlgren, Manager, Analytical Sciences & Technology, Advanced Analytics & Design to Value, Janssen Supply Group LLC
    Sau (Larry) Lee, PhD, Director & Emerging Technology Team Chair, Office of Testing and Research, CDER, FDA
    Session Leaders
    Senior Director, Small Molecule Design and Development
    Eli Lilly & Co
    Manager, Strategy Deployment and Excellence, PQM
    Janssen Supply Group LLC
    Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality
    Presentation Information
    [Advanced Process Control and Real Time Release to Reach Continious Process Validation - An Industry Perspective ]
    Speaker: Gabriella Dahlgren
    || [Process Validation Opportunities - A Regulatory Perspective]
    Speaker: Tara Gooen Bizjak, CDR
  • 1530 - 1700
    APQ Guiding Principles for Quality Maturity in Sponsor and CMO Relationships
    This session will provide insight into real-world challenges and opportunities faced by sponsors and CMOs relating to ensuring appropriate quality oversight exists, open lines of communication are maintained, and quality data is shared and assessed to effectively rate quality system performance. Three speakers will share their unique perspectives from the sponsor and CMO points of view. This session will include ample opportunity to engage with the speakers who, during their individual presentations, will provide you answers to questions such as:
    - What is oversight and does oversight go both ways between sponsors and CMOs?
    - What are the challenges faced by the CMO when working with numerous (sometimes competing) sponsors? What are the challenges from the sponsor perspective?
    - How can we optimize communication to ensure Sponsor and CMO expectations are clear?
    - How does a CMO manage the different data needs from their customers? Should a CMO customize data needs for each customer?
    - What are best practices for leveraging data generated across the sponsor and CMO engagement?
    - What are the key performance indicators used in assessing risk from both the sponsors and CMO perspectives?
    Session Leaders
    Placeholder Person Graphic
    Senior Manager Compliance
    Placeholder Person Graphic
    Senior Manager Compliance
    Director, External Supply Quality
    Placeholder Person Graphic
    Head of Quality Standardization and Harmonization Within the Human Pharma Supply
    Dir Quality Systems
    DPT Laboratories Ltd
    Site Quality Head
    Hitachi Chemical Advanced Therapeutics Solutions
    Presentation Information
    [Risk Based Quality Oversight]
    Speaker: Patrick R Gondek
    || [Quality Information Sharing between Sponsor - CMO]
    Speaker: Rafael Beerbohm
    || [Perspective From the CMO on the Management and Reporting of Quality Data]
    Speaker: Belinda Green
    || [A CMO Perspective: Data Management]
    Speaker: Scott Bobbitt
  • 1530 - 1700
    Drug Shortage Prevention
    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.

    Panel Discussion

    Jeannie David, Senior Program Management Officer, CDER Drug Shortages Staff, Office of the Center Director, FDA
    Mahesh R. Ramanadham, Pharm.D./M.B.A., R.P., Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities, FDA/CDER/OPQ
    David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA
    Session Leaders
    President, Executive Director - CMC Regulatory
    PharmTree Consultants
    Placeholder Person Graphic
    Industry Representative, Invited
    Placeholder Person Graphic
    Senior Program Management
    Director, Regulatory Affairs
    Merck & Co., Inc.
    Presentation Information
    [A Regulatory Perspective on Drug Shortages]
    Speaker: Jeannie David
    || [Drug Shortage Initiative Team]
    Speaker: Diane Hustead
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.

    Panel Discussion

    Jennifer Lauria Clark, CPIP, Executive Director, Strategic Development Commissioning Agents, Inc.
    Lou Kennedy, CEO and Owner, Nephron Pharmaceuticals
    Jim Breen, Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals
    Tara Gooen Bizjak, CDR, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, CDER, FDA
    Richard (Rik) Lostritto, PhD, Associate Director for Science, Office of Policy for Pharmaceutical Quality, CDER, FDA
    Session Leaders
    Executive Director, Strategic Development
    CEO and Owner
    Nephron Pharmaceuticals
    Executive Director, Strategic Development
    Placeholder Person Graphic
    Division Director OMD QA
    Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality
    Vice President, Lead Biologics Expansion
    Janssen Pharmaceuticals
    Presentation Information
    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
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    Director & Emerging Technology Team Chair, Office of Testing & Research
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    Senior Scientist for Emerging Technologies & Medical Countermeasures
    Presentation Information
    [CDER Approach to Pharmaceutical Innovation]
    Speaker: Sau (Larry) Lee, PhD
    || [Innovative Technology Development and Regulatory Challenge]
    Speaker: Christine Moore
    || [Advanced Manufacturing of Complex Biologics: A CBER Perspective]
    Speaker: Manuel Osorio
    FDA regulates pharmaceutical products to ensure a continuous supply of high-quality products in the United States. In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics. To help achieve this vision, the Center for Biologics Evaluation and Research (CBER) encourages the development and adoption of advanced technologies to modernize biopharmaceutical manufacturing of complex biologics. In this presentation, new CBER initiatives to promote the development of advanced manufacturing technologies will be discussed.
  • 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
    Executive Director and Team Leader, CMC Advisory Office
    Pfizer Inc
    Senior Director, Regulatory Affairs-CMC
    AstraZeneca Pharmaceuticals
    Placeholder Person Graphic
    Director, Product Quality
    Amgen Inc (NMOS)
    Deputy Director, Office of Biotechnology Products
    Presentation Information
    [Impurities Specification in Synthetic Drug Substances and Drug Products]
    Speaker: Greg Rullo
    || [IQ Consortium Biologics Phase-Appropriate Specifications Working Group]
    Speaker: Barbara Rellahan, PhD
    || [Patient Centric Quality Standards for Biological Products]
    Speaker: Jeffrey Baker, PhD
  • 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

    Panel Discussion

    Mahesh Ramanadham, LCDR, Acting Senior Scientific and Policy Advisor for the Office of Process and Facility, OPQ, FDA
    Ingrid Markovic, PhD, Senior Director, U.S. Technical Regulatory Policy, Genentech
    David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA
    Session Leaders
    Director Regulatory Affairs - CMC
    Amgen Inc.
    Senior Director, US Pharma Technical Regulatory
    Genentech Inc
    Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities
    Presentation Information
    [Accelerating Development of Innovative Therapies: A CMC Perspective]
    Speaker: Ingrid Markovic
  • 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
    Senior Program Manager, Office of Combination Products
    Head of Medical Affairs
    Abbott Molecular, Inc
    Sr. Director, Global Value Chain Quality Design
    Johnson & Johnson
    Presentation Information
    [FDA Update on Combination Products Postmarketing Safety]
    Speaker: Melissa Burns
    || [Post-Market Safety Reporting (PMSR): Are You Ready?]
    Speaker: Khaudeja Bano
    This presentation will focus on:
    -Outlining practical steps that need to be taken by organizations to be ready for implementation by July 2020.
    -Adopting a risk-based approach to PMSR to add efficiencies to the process.
    -Key operational challenges and industry best practices to address them.
    || [Combination Products Evolving Global Regulations]
    Speaker: Susan Neadle
  • 1515 - 1645
    Global Reliance & Harmonization
    In our regulatory world of 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 Unit Manager, Inspectorate Strategy and Innovation, MHRA
    FDA Representative, Invited

    Session Leaders
    Senior Director, External Affairs, Quality Intelligence and Inspection
    Novo Nordisk A/S
    Executive Vice President & Chief Science Officer
    United States Pharmacopeia
    Senior Principal Technical Advisor
    Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector)
    Director, Office of Pharmaceutical Quality Operations
    Presentation Information
    [Pharmacopeial Collaboration and Harmonization from the USP Perspective]
    Speaker: Jaap Venema
    The mission of the United States Pharmacopeia (USP) is to improve global health through public standards and related programs that help ensure the quality, safety and benefit of medicines, supplements and foods. Pharmacopoeial standards are important tools for promoting quality of medicines globally. USP works in close partnership with global stakeholders, including many national and regional pharmacopeias, to promote access to quality medicines worldwide. This presentation will provide a USP perspective on successes, challenges and future opportunities in an evolving global landscape.
    || [Closing Remarks]
    Speaker: George Millili, PhD
    || [The Impact of the US-EU MRA on Pharmaceutical Inspection]
    Speaker: Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA