Building Toward a Modern Pharmaceutical Manufacturing Sector: Encouraging Development and Adoption of Emerging Technology

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1 Building Toward a Modern Pharmaceutical Manufacturing Sector: Encouraging Development and Adoption of Emerging Technology Sau (Larry) Lee, Ph.D. Associate Director for Science Office of Pharmaceutical Quality FDA Center for Drug Evaluation and Research IFPAC Annual Meeting Jan Jan. 27, 2016 Arlington, VA (Washington DC), U.S.A 1

2 Presentation Outline Current State of Pharmaceutical Quality Emerging Technologies Advanced Manufacturing Regulatory Science 2

3 Class 1 Drug Product Recalls Class I - denoting a situation in which there is a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death U.S. Food and Drug Administration, "Drug Recalls," [Online]. Available: 3

4 Drug Shortage State of Pharmaceutical Quality? U.S. Drug Shortages All Dosage Forms Shortages Sterile Injectable Shortges Shortages

5 Drug Shortage State of Pharmaceutical Quality? Reasons for Shortage 2011 Component Problems 4% 0% 19% Delays/ Capacity Issues Discontinuation Increased Demand 47% 12% Loss of Manufacturing Site 10% 2% 6% Other/Unknown Quality Issue Raw Materials (API) 5

6 Globalization Due to economic factors, supply chains for many APIs and final drug products span several countries and are potentially susceptible to multiple supply vulnerabilities. Under current manufacturing practices, intermediates may not be immediately processed. Globalization trend may be reflected in the product recall data. 26% of drug recalls reported to the FDA were international in nature impacting more than one country during 2014 compared to just 4% in the beginning of Stericycle ExpertSolutions, "Stericycle Quarterly Recall Index Q4 2014,"

7 Emerging Technology Development and adoption of emerging manufacturing technology is one mechanism for addressing current manufacturing challenges Support more robust, flexible, and agile manufacturing processes Fewer interruptions in production Fewer product failures (before or after distribution) Greater assurance that the drug products manufactured will provide the expected clinical performance Ability to tailor production to different patient populations Ability to quickly adjust production in face of emergencies or changing market demand Continuous manufacturing, 3-D printing, single-use technologies, etc. 7

8 FDA encourages innovation by facilitating the development and implementation of technological advancements in the pharmaceutical manufacturing 8

9 Timeline of Key Initiatives to Support Modernization of Pharmaceutical Development and Manufacturing 2002: Pharmaceutical cgmps for the 21st Century: 2006: ICH Q9 Guidance 2009: ICH Q8 Guidance 2015: Emerging Technology Team 2004: PAT Guidance 2008: ICH Q10 Guidance 2012: ICH Q11 Guidance 9

10 FDA 21 st -Century Initiative (2004) Objectives (partial list): Encourage the early adoption of new technological advances Encourage implementation of risk-based approaches Promote modern quality management techniques across industry Goals (partial list): Facilitate industry-wide implementation of quality systems approaches Outreach and collaboration with industry Introduce new manufacturing science into regulatory paradigm Harmonize concepts internationally 10

11 PAT Guidance (2004) The goal of Process analytical technology (PAT) is to enhance understanding and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design A desired objective of the PAT framework is to facilitate the design and development of well understood processes that will consistently ensure a predefined quality at the end of the manufacturing process 11

12 H. Wu et al., Eur. Pharm. Rev. 20: (2015) 12

13 Quality by Design A systematic scientific and risk-based approach to pharmaceutical development Implement effective quality control strategies to achieve a predefined objective, based on product and process understanding ICH Q8/Q9/Q10/Q11 High-level guidelines with respect to the scope and definition of QbD and other key concepts as it applies to the pharmaceutical industry Fundamental to the development of emerging technologies 13

14 L.X.Yu et al., AAPS. 16: (2015) 14

15 CDER s Office of Pharmaceutical Quality OPQ Objectives: Provide seamless integration of review, inspection, surveillance, and research across the product lifecycle Assure that all human drugs meet scientifically sound quality standards to safeguard clinical performance Enhance science- and risk-based regulatory approaches Transform product quality oversight from a qualitative to a quantitative, expertise-based assessment Encourage development and adoption of emerging pharmaceutical technology L.X.Yu et al., AAPS. 16: (2015) 15

16 Emerging Technology Team (ETT) Vision Encourage and support the adoption of emerging technology to modernize pharmaceutical development and manufacturing where the FDA has limited review or inspection experience A small cross functional team with representation from all relevant CDER and ORA review and inspection programs Chair: Sau (Larry) Lee, Associate Director of Science, OPQ PM: Cheryl Kaiser (OPQ/OPRO) Members: Thomas O Connor(OPQ/IO-SRS), Celia Cruz (OPQ/OTR), Mohan Sapru & Ray Frankewich (OPQ/ONDP), Geoffrey Wu (OPQ/OLDP), Kurt Brorson (OPQ/OBP), Grace McNally, Sharmista Chatterjee & Bryan Riley (OPQ/OPF), Rebeca Rodriguez & Susanne Richardson (ORA) Other subject matter experts as needed 16

17 ETT Objectives Serve as a centralized location for external inquiries on novel technologies Provide a forum for firms to engage in early dialog with FDA to support innovation Ensure consistency, continuity, and predictability in review and inspection ETT member(s) will be part of the OPQ quality assessment team for applications containing an emerging technology Help establish review and inspection standards and policy, as needed Identify and evaluate roadblocks relating to existing guidance, policy, or practice Long-term goals: Engage international regulatory agencies to share learnings and approaches Modernizing pharmaceutical development and manufacturing Contact us: CDER-ETT@fda.hhs.gov 17

18 ETT-Industry Interactions More than 10 ETT meetings since the launch of ETT program in early Continuous manufacturing Drug substance Drug product Small molecules and biotechnology products 3-D Printing Novel aseptic filling system New container and closure system for injectable products 18

19 Draft ETT Guidance Provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology to FDA. Applicable to companies that intend to include the technology as part of an investigational new drug application (IND) or original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance. 19

20 Continuous Manufacturing FDA has identified CM as an emerging technology (1) Batch (2) Hybrid (3) End-to-End 20

21 Potential Benefit vs. Challenges Potential Benefits Flexibility Efficiency Cost Quality Challenges Relatively new manufacturing approach in comparison with other chemical process industries Current inventory of available batch manufacturing facilities can be an economic barrier Knowledge of process dynamics is a critical component of process development and implementation for CM Adoption and advancement of system engineering tools may be needed to maximize potential benefits 21

22 Lee et al., J. Pharm. Innov. 10: (2015) 22

23 3D Printing Technology * From: 23

24 3D Printing Technology 3-D printing employs an additive manufacturing process whereby products are built on a layer-by layer basis, through a series of crosssectional slices * Benefits: Easy to design drug release profile Minimize waste Small equipment/footprint Accurate amount/personalized medicine Challenges: Advancing knowledge on material properties (drug product and binder solution) and process parameters product quality including mechanical strength Understanding the effect of geometry on drug performance given the potential for unique shapes and dosage forms Safety and security concerns regarding the potential for using the technology to counterfeit substandard medical products Future regulatory challenges for potential de-localized manufacturing * Berman, Barry. "3-D printing: The new industrial revolution." Business horizons 55.2 (2012):

25 U.S. Approves First 3D Printed Pill TIME, Aug. 4, U.S. Approves First 3D Printed Pill The pill is better for children and elderly users who find it difficult to swallow large tablets BBC NEWS, Aug. 4, First 3Dprinted pill approved by US authorities. The Washington Post, Sept. 22, For the first time ever, the FDA has approved a 3D-printed prescription pill for consumer use... 25

26 From DCAT Value Chain Insights (VCI) By Patricia Van Arnum posted Sep 18, :37 PM Vertex Pharmaceuticals, a Boston, Massachusetts-based pharmaceutical company, has developed several manufacturing processes to produce commercial quantities of co-formulated lumacaftor/ivacaftor, including a process utilizing continuous manufacturing technology as well as a traditional batch manufacturing process. Ivacaftor is the API in Vertex s Kalydeco, a drug to treat cystic fibrosis (CF). It was approved in 2012 in the United States and European Union as a treatment for patients with CF six years of age and older who have the G551D mutation in their CFTR gene. In November 2014, Vertex submitted a new drug application to the US Food and Drug Administration (FDA) and a marketing authorization to the European Medicines Agency for lumacaftor in combination with ivacaftor in patients with CF twelve years of age and older who are homozygous for the F508del mutation in their CFTR gene. In July 2015, Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) was approved by the FDA for this indication, and a decision by the EMA is expected later this year. accessed January 16,

27 Advancing Regulatory Science Current regulatory science activities for CM: 1. Process simulation and modeling tools are in development 2. Investigations into material properties and equipment configurations; linking design space to final product quality 3. Establishment of knowledge base to assess advanced process control & monitoring approaches (active controls, multivariate statistical process control, etc.) 4. Concept development for utilizing process and materials data (raw and in-process) that support real-time release testing 5. Continuous flow reactors Biomedical Advanced Research and Development Authority (BARDA)-FDA CM Innovations Initiative Building OPQ Laboratory capability and planning a Center of Excellence for advanced manufacturing Review and inspection training 27

28 Bookings Meeting October 19, 2015 Identify the major scientific/technological, operational, and regulatory barriers to the adoption of continuous manufacturing in the pharmaceutical industry Discuss regulatory policies and strategies that could help to address those barriers Explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing 28

29 Future of Pharmaceutical Quality Building robust, flexible, and agile pharmaceutical manufacturing processes! 29

30 IFPAC-2016 Quality by Design Real-Time Release Continuous Manufacturing Risk Management Lifecycle Management, Post-Approval Manufacturing Emerging Technology & Integrated Control Strategy Smart Manufacturing Analytical Methods Enabling Technologies Bioprocessing More (e.g., Advanced Separations, Sample Handling, NeSSI, chemometrics, Big Data and improvements in process analysis) 30

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