CMO QUALITY OVERSIGHT & RISK MANAGEMENT SUMMIT 4 TH EXECUTIVE SUMMARY

Transcription

1 EXECUTIVE SUMMARY 4 TH CMO Strategic Insights on Drug Development Outsourcing to a Contract Manufacturing Organization in an Evolving Regulatory Landscape QUALITY OVERSIGHT & RISK MANAGEMENT SUMMIT

2 CONTENTS INTRODUCTION 3 SESSION SUMMARIES 4 EXL PHARMA S 5TH CMO QUALITY OVERSIGHT AND 9 RISK MANAGEMENT SUMMIT DETAILS

3 INTRODUCTION WHAT YOU MISSED AT EXL PHARMA S 4TH CMO QUALITY OVERSIGHT AND RISK MANAGEMENT SUMMIT With a focus on maintaining quality and compliance with CMOs in a Changing Regulatory Environment, the 4th CMO Quality Oversight and Risk Management Summit took place on April 23-24, 2014 in Boston, MA and provided new regulatory updates, information on aligning quality systems, tips on tried and true CMO selection, risk assessments, a variety of illustrative case studies and much more. With the global CMO market expected to generate revenues of $60 billion by 2018, it s critical to implement comprehensive strategies for robust quality oversight of external manufacturers to ensure GMP compliance and avoid the lofty costs of potential product recalls, consent decrees and adverse events. To that end, ExL Pharma s 4th CMO Quality Oversight and Risk Management Summit provided an opportunity to gain best practice strategies to effectively oversee and manage quality of contract managers in an evolving regulatory landscape and provided critical updates on new FDA guidance for quality agreements as well as practice knowledge to revise quality agreements to reflect new guidance and prepare for reporting and inspections. Attendees took away the latest information on auditing procedures, risk assessment and management, quality system alignment and inspection readiness as well as frameworks to implement continuous improvement to improve quality, reduce costs and increase profitability. 3

4 SESSION SUMMARIES Update Quality Agreements to Align with Revised FDA Guidance, led by Priya Jambhekar of PBS Regulatory Consulting Group, focused on the content and purpose of quality agreements and a focus on ensuring that internal procedures are in place with external suppliers. All quality agreements should include a purpose/ scope, terms, dispute resolution, responsibilities, and change control and revisions. She also presented a variety of case studies related to quality agreements and encouraged session attendees to build flexibility into quality agreements to achieve the same flexibility externally. Dan Trimberger of Momenta Pharmaceuticals provided details on how to Align Quality Systems with External Manufacturers to Ensure High Quality. This involves developing a quality standard for policies, guidelines and SOPs (and working with CMO partners to communicate standards early in the process, sharing standards with CMOs (recognizing that all systems are different and that flexibility is important) and recognizing that deviations are one of the most important things to maintain oversight of when working with CMO. He recommended focusing efforts on deviations being documented and appropriate corrective and preventive actions. When it comes to harmonized systems, it s important to develop a list of acceptable/unacceptable documents that require approval and to develop a scorecard. 27 Overall Assessment of CMO Area CMO MNTA Comments Deviations 2 4 Change Controls 2 2 v No issues Timeliness of Reviews 4 4 Momenta Confidential Information v Deviations XXX and YYY should have been reported to MNTA at time of occurrence not provided with Batch release documentation v Reviews not occurring in a timely manner Batch Release 1 1 v Outstanding area Quality Relationship 3 3 v No issues; performs as expected. Overall 3 4 v Works needs to be done Denise McDade of Capricor Therapeutics presented Updates to Contract Manufacturing Arrangements for Drugs: Quality Agreements and ICH Q3D Guidelines for Elemental Impurities. McDade discussed the company s product candidates and pipeline as well as the latest information on the FDA s revised standards for quality agreements to ensure GMP compliance. She focused on ensuring that quality agreements remain independent of other commercial and business agreements and noted that everyone is liable do the right thing. 4

5 SESSION SUMMARIES Todd Mabe of Roche presented the case study, Implement Contract Quality Requirements to Drive Continuous Improvement. Mabe s discussion illustrated his company s rollout documenting tool that was used to assess the quality systems of contract facilities as well as further discussion of how Roche established risk ranking and profiling of CMOs to mitigate risk. In this process, Roche learned that a collaborative approach to PQS assessment and implementation at CMOs was needed. The case study on contact quality requirements also provided examples of risks that the company identified and options for risk mitigation. Pharmaceutical Quality System Document Structure Roche/Genentech Quality Policy Quality Requirements Global Standards and Processes Network SOPs (as applicable) Contract Manufacturing Organiza.on Contract Quality Requirements and Template Confidential - Internal Use Only - Version 2.0 Joint Management Team CQR Gap Assessment (QRM) Document & Track (Risk Log) Remedia.on, Mi.ga.on or Acceptance 7 Prasad Gogineni of Actavis presented Are You Ready for a Pre-approval Inspection? Comprehensive Strategies to Prepare for and Manage an FDA Inspection. While audits make most people uncomfortable, knowing the type of audit can help with preparations. Six factors are examined in FDA pre-approval inspection audits: 1) Quality system; 2) Facilities and equipment; 3) Materials system; 4) Production system; 5) Packaging and labeling system; and 6) Laboratory control system. Objectives for these audits should include readiness (the facility is ready for commercial manufacturing), conformance (information submitted is consistent with information contained in the application s CMC section) and data integrity (data authenticates that submitted in the CMC section). It is important to identify audit support teams in both organizations and define roles and responsibilities while preparing documentation. Audit closure should include a precise understanding of all findings. Michael Gross of Biogen Idec led Risk Assessment and Management of Vendors: A Risk-based Approach to Sustainable Compliance. The process includes gathering data, determining risk, developing a plan and assessing changes. In terms of risk in the pharma world, companies should first define what they are trying to protect from harm and then simply figure out all of the hazards that may cause that harm. For a risk assessment, a comprehensive database is needed for all materials and services used in Phase I and II and beyond programs and products. Segregating the data and defining risk come next. Then, based on the assigned risk, a plan of action can be formed. He reminded that products are only as good as their suppliers and patients are depending on the best products possible. 5

6 SESSION SUMMARIES Madeline Fisher of Astra Zeneca shared a case study entitled, Supplier Quality Relationship Management Process Implementation to Drive Continuous Improvement. According to Fisher, a supplier qualification program should include auditing, supplier change notifications and supplier status maintenance. Integration of supplier quality and risk management can ensure reduced business risk. Since suppliers play a critical role in fulfilling an organization s mission, developing world-class supplier relationship management processes is essential to managing business risk, scaling future operations and driving continuous improvement. Formal processes identify and mitigate potential relationship risks, enable key performance metrics tracking and encourage strategic collaboration across companies. Tools Processes Principles 12 Supply Risk Management Continuity Planning Supplier Compliance Vision For SRM Program Supplier Relationship Management Supply Continuity Plan Responsible Procurement Compliance Forms Financial Assessment SRM Systems Performance Management Performance Tracking Supplier Review Stakeholder Needs Supplier Scorecard Supplier Review Materials Service Level Agreement Continuous Improvement Supplier Improvement Supplier Collaboration Supplier Strategy Supplier Action Plan Supplier OE Project Collaboration Tools Lee Fox of Bristol-Myers Squibb presented Effective Strategies for Process Validation Oversight, with a focus on clinical versus commercial production and creating a master plan. General principles and practices for the industry include: Stage 1: Process Design, which involves building and capturing process knowledge and understanding; Stage 2: Process Qualification, designing a facility and qualification of utilities and equipment as well as process performance qualification, protocol, execution and reporting; and Stage 3: Continued Process Verification. A process validation master plan outlines the strategy to validate the process, defining the process characterization and validation activities required for validation of the manufacturing process. It should include a proactive approach, a formal GMP document, roles/responsibilities/timeframes, and an overarching source document. 6

7 SESSION SUMMARIES Jonathan Patroni of Shire Pharmaceuticals directed the session, Establishing a Meaningful Supplier Qualification/Partnership Program, with a focus on standard programs and opportunities. Shire s strategy was to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs, creating a standard qualification program (with due diligence, audits, contracts and more) and a standard partnership program, including key performance indicators and product quality reviews. They instituted a monthly supplier quality index for each supplier within the supply chain, reviewing the index and reacting as needed; this also includes independent qualitative quality record checks. Further, writing an SOP or procedure isn t an oversight activity partnership is doing something to ensure compliance with written instructions, standards and specifications. Key takeaways are that quality oversight of suppliers is changing and should now focus more on establishing effective partnerships than oversight, and companies must become more engaged with supplier and develop joint robust supplier management programs. Preparing for a Successful CMO Audit, including pre-audit inspections (PAI), certification and more, was discussed by Jim Damon of Supply Chain Diligence and Solutions and Prasad Gogineni of Actavis. The FDA s objective for PAI is readiness for commercial manufacturing, conformance to application and data integrity. Inspection techniques determine if quality systems have sufficient control as well as if formulation, manufacturing and analytical methods are consistent with pivotal batches and they also ensure data integrity. Due diligence is critical for any pre-audit inspection, and steps to success include: identify supply chain; get the experts; form the team; pre-pai inspections; and results and corrective actions. Further, inspection basics include: have company protocols/policies, understand expectations and daily internal communications. His top piece of advice: Manage the inspection and be prepared! 7

8 SESSION SUMMARIES James Nelson of Arena Pharmaceuticals delivered a presentation on Small Molecules Perspective: Best Practice Models for Seamless Technology Transfer. He recommended having one global change control system, standardized change forms and supporting templates, and local versus global management. A good model for technology transfer involves a defined control strategy, lifecycle management, continuous improvements, manufacturing development and process risk management to support ongoing improvements. The sponsor is responsible for clearly communicating its quality expectations to the CMO. Regardless, the most important key to efficient technology transfer is minimizing risk. Identifying Leading Indicators during CMO Selection to Reduce the Risk of CMO Quality Failures, from Amnon Eylath of Genzyme, centered on quality risk management as a valuable component of an effective quality system. Key areas for a pharma quality systems are process performance and product quality monitoring; corrective action and preventive action (CAPA); change management system; and management review of process performance and product quality. It s critical to assess the CMO s competency across the expanded pharmaceutical quality system. Finally, thoroughly researching FDA and EMA warning letters, technical capabilities, regulatory history, financial stability and client references are all important when establishing potential quality risks. 8

9 EXL PHARMA S 5TH CMO DETAILS QUALITY OVERSIGHT & RISK MANAGEMENT The utilization of contract manufacturing organizations (CMOs) in the life science industry has become increasingly popular over the past decade, and experts project that the CMO market value will exceed $60 billion by As the trend continues to rise across the pharmaceutical, biotech and medical device industries, effective quality oversight and risk management is a critical component while launching and sustaining a successful sponsor-cmo partnership. The 5th CMO Quality Oversight & Risk Management Summit, taking place on April 23-24, 2015 in Boston, MA is the premier outsourcing meeting of its kind, featuring 16+ sessions led by industry leaders This conference is the ideal forum to learn best practices for quality oversight and risk management, benchmark directly from your peers, and connect with industry leaders from top pharma, biotech and medical device companies and CMOs. FEATURED PROGRAM SESSIONS: Weaknesses Associated with Service Systems and Products of a CMO by Implementing Quality by Design (QbD) Practices Ben Locwin, Head of T&D, Global Head of Center of Excellence, LONZA Process Performance Qualification, PAI Readiness, PAI Execution and Post Approval Lee Fox, Biologics External Manufacturing Quality Manager, BRISTOL-MYERS SQUIBB Incorporate CMO Oversight into Your Organization s Governance Structure Nelson M Lugo, Senior Director, Contract Manufacturing and San Diego Site Lead, ASTRAZENECA Cultivate Smart Guidelines for Collaborating with External Vendors in Emerging Markets Dan Trimberger, Director, Quality Assurance, MOMENTA PHARMACEUTICALS Identify Best Practices for Selection and Oversight of CMOs Brian Clark, Executive Director, Quality, IMMUNOGEN Streamline Procedures for Monitoring Process Performance and Product Quality Denise McDade, Vice President, Quality, CAPRICOR Best Practices for Working Together with a Sponsor to Achieve Seamless Execution of Product Development Timothy Scott, President, PHARMATEK Learn CMO and License Holder Integration and Atypical Visible Particle Reduction Jonathan Patroni, Vice President, US Quality Assurance, SHIRE & Will Tilton, Vice President, US Supply Chain, SHIRE Identify the Right Suppliers for Emerging, Niche or Start-Up Companies Amnon Eylath, Senior Director, Quality Assurance, GENZYME For more information visit

10 HERE ARE JUST SOME OF THE MANY INDUSTRY PROFESSIONALS THAT HAVE BENEFITED FROM ATTENDING OUR PREVIOUS CMO QUALITY OVERSIGHT & RISK MANAGEMENT CONFERENCES: Company Abbott Abbott Acella Pharmaceuticals Actavis Affymax Alkermes Alkermes Alkermes Alkermes Amarin Pharma Inc. Amphenol Alden Products Amylin Pharmaceuticals,Inc ARIAD Pharmaceuticals, Inc. Astellas AstraZeneca PLC Auxilium Pharmaceuticals, Inc. Baxter Baxter Bioscience/Baxter Healthcare Corp Baxter Bioscience Baxter Healthcare Baxter Healthcare Baxter Healthcare Baxter Healthcare BioMarin Biotest Pharmaceuticals BMS Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Boehringer Ingelheim Roxane Inc. Boehringer Ingelheim Roxane Inc. Bristol Myers Squibb Bristol Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Calcott Consulting Catalent Catalent Catalent Celgene Title Director, Quality Assurance Senior Program Manager Director Quality Sr Manager Associate Director of API Manufacturing and Process Development Quality Specialist Senior Manager, API Development Senior QA Associate QA Associate Quality Director Global Director of Quality Assurance Senior Director, Contract Manufacturing Director, Quality Quality Assurance Manager Associate Director, QA Sourcing QA Manager Senior manager, Global Compliance VP, Quality Manager One Quality Director, Manufacturing Sr. Scientist Senior Quality Manager Director Business Quality Sr. Director GMP Compliance Sr Manager, External QA TPM Quality Manager Senior Manager Third Party Quality Management Executive Director, Commercial Quality Sr. Mgr. Quality Compliance and Regulatory CMC Coach-QA Supplier Quality Specialist QA Supplier Quality Manager, Quality Operation QA Director Outsourcing Project Manager Quality Assurance Manager, GMP Associate Director In Procurement Global Services Director EMO Management President VP Quality, QMS & Compliance VP Quality, Development & Clinical Services VP Quality Operations Vice President Quality Assurance Company Title Celldex Thereapeutics, Inc. QA Supervisor Chartwell Pharmaceuticals Corporate Development Compliance Insight, Inc. Vice President Covidien Senior Director, Global Quality Covidien Principal Quality Engineer Cubist Pharmaceuticals Sr Mgr GMP QA Deloitte Consulting LLP Manager Deloitte Consulting LLP Manager, Life Sciences Depomed, Inc. Quality Assurance Associate Dyax Corp. QA Manager - Quality Systems Dynavax Associate Director, QA Dynavax CMC Dynavax Sr. Manager, Quality Assurance Eisai Inc Principal Manager, Quality Assurance Elan Pharmaceuticals Former Senior Director, Legal Eli Lilly & Co. Head of Quality Lilly Vteam Eli Lilly & Co. Development Sourcing Endo Pharmaceuticals Mgr. Quality Systems & Compliance Endocyte cgmp Compliance Manager Endocyte Quality Associate IV EpiCept Senior Vice President Evonik Corporation QA Team Leader Evonik Degussa Corporation Senior QA Analyst Evonik Degussa Corporation Manager Evonik Degussa Corporation Manager, Clinical Supplies Management Ferring Pharmaceuticals Vice President Logistics Forest Laboratories Global Head, External QA & QP Forest laboratories, Inc. Head, External QA Forest Pharma Director, QA External Mfg FreightWatch International Chief Executive Officer FreightWatch International Business Development Coordinator FreightWatch International Technical Sales Manager Fresenius Medical Care Sr. Product Director QA Fresenius Medical Care Supplier Quality Engineer, Pharma Fresenius Medical Care QS/Director, Pharma Fresenius Medical Care Manager, QS Risk Management Fresenius Medical Care QS Technician Fujifilm Diosynth Quality Manager Biotechnologies Genentech Sr. Technical Manager Genentech A.I. Head, Development Outsourcing PTMD Genentech Head of Biologics, Drug Substance CMO's Genentech Technical Manager Genzyme QA Manager Genzyme Director Clinical Manufacturing Genzyme Quality Assurance Associate Director Genzyme Sr. Compliance Specialist

11 Company Genzyme Genzyme Genzyme Genzyme Title Sr Compliance Specialist Quality Assurance Associate Director Quality Senior Manager Senior Quality Assurance Officer Gilead Sciences, Inc. Sr Mgr, Chemical Development Strategic Outsourcing GlaxoSmithKline Procurement Director GlaxoSmithKline Director, External QA GlaxoSmithKline Regional Extenal Supply Quality Lead GlaxoSmithKline Director, Operations Guthy-Renker QA Manager Harris Pharmaceuticals, Inc. VP & COO Harris Pharmaceuticals, Inc. Regulatory Affairs Hospira, Inc. Quality Manager, Third Party Manufacturing Hospira, Inc. VP, Commercial Quality Hospira, Inc. Manager, Customer Quality Hospira, Inc. Associate, One 2 One Quality Hospira, Inc. VP, Business development Hospira, Inc. Alliance Manager Idenix Pharmaceuticals, Inc. Quality Assurance Manager Ikaria Senior Vice President, Global Manufacturing & Operations ImmunoGen, Inc. Director of Contract Manufacturing ImmunoGen, Inc. Director of Clinical Supply Impax Laboratories, Inc. Director Business Alliance Quality Infinity Pharmaceuticals, Inc. Senior Quality Assurance Specialist Intermune Quality Assurance Manager JM Bonelle Consulting Owner Johnson & Johnson Head, Strategic Sourcing Johnson & Jonhson Director, External Supply Integration Quality PDMS & ECL Johnson & Jonhson Senior Director, Chem Pharm Development Quality Assurance Kadmon Pharmaceuticals, LLC QA Manager Kadmon Pharmaceuticals, LLC Project Manager Kythera Biopharmaceuticals Sr. Director QA Lantheus Medical Imaging Associate Director, QA Lantheus Medical Imaging Associate Director, APO and Parenteral DP Mfg Lantheus Medical Imaging Associate Director - Contract Manufacturing Lundbeck US Sr. Manager, QA Mallinckrodt Pharmaceuticals QA Manager Global External Supply Meda Pharmaceuticals Senior Director Quality Assurance MEDA Pharmaceuticals QA Specialist Medicis Director, Quality Assurance Medicis Senior Specialist QA Medicis Quality Data Analyst MedImmune Compliance MedImmune, LLC Director, Supplier Quality Management Merck & Co., Inc. Vice President Quality Operations, Na, Puerto Rico and Consumer Merck & Co., Inc. Director, Quality Operations Biologics External Merck Serono Director, GCP Quality Assurance Merck, Sharp & Dohme Quality Associate Millennium Senior Associate Auditor Millennium: The Takeda Oncology Company Molecular insight Novartis Pharma AG Noven Pharmaceuticals Noven Pharmaceuticals, Inc. Olympus Biotech Onyx Pharmaceuticals Inc. Onyx Pharmaceuticals Inc. Company Title Millennium Senior Scientist 1 Millennium Senior Operations Associate Millennium Assoc Director, Investigational QA Senior Director, Global Regulatory Affairs - CMC Associate Director QA Global External Supply QA Head Director, Manufacturing Quality Assurance ESQ Lead Project Manager Sr. Manager QA Product Disposition Manager, External Manufacturing and Supply Chain Onyx Pharmaceuticals Inc. Sr. Manager QA Product Disposition Otsuka Director of Supply Chain Pfizer Vice President, Contract Operations Quality Assurance Pfizer Senior Director, Biotherapeutics & Vaccines Outsourcing Pfizer Inc Manager, QA Vendor Management Pharmalucence, Inc. QA Specialist II Prometheus Laboratories Senior Manager, Quality Systems Quintiles Snr Director Reata Pharmaceuticals V.P., Quality Operations Regeneron Associate Director Procurement Regeneron Manager Sourcing Roche Chemical Development Manager Sarepta Therapeutics QA Manager Seaside Therapeutics Director, Regulatory and Quality Affairs Seattle Genetics Senior Quality Assurance Manager Seattle Genetics CMC Project Manager Shire Senior QA Specialist QA External Operations Shire Senior Project Manager Shire QA Specialist II Shire QA Director Siegfried Business Development Manager Tesaro VP, R&D Tesaro Manager, Quality Assurance Tesaro Inc. Senior Manager of QA TEVA Pharmaceuticals USA Senior Director Quality Assurance Teva Pharmaceuticals, Inc. Auditor I TraceLink Inc. Solutions Sales Manager UCB cgmp Manager VersaPharm Inc Director of Quality Watson Executive Director of Corporate Quality Assurance Watson Pharmaceuticals, Inc Associate Director, Pharmaceutical Technology West Pharmaceutical Services Vice President, Quality Wilson Quality & Compliance Vice President, Corporate Quality Assurance Consulting