Quality by Design Concept

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1 3rd Jerusalem Conference on Quality and Pharma Sciences 6-7 June, 2012 QbD in Clinical Research - Where Can QbD Impact Clinical Research Practices? Dr. Yafit Stark Vice President, TEVA Pharmaceutical Industries, Ltd. R&D Quality by Design Concept New concept for drug development and approvable process Creates a road map for designing new compounds Quality is easily transferable throughout development Allows more flexibility in development and regulatory approach Understanding and optimizing: How designing and manufacturing of a product may affect the product s quality, its clinical safety and effectiveness How the product s safety and effectiveness will affect its design and quality Moving towards a more scientific, risk-based, holistic and proacative approach 2 1

2 Why Do We Need Quality by Design? 3 Why Do Projects Fail? Success and failure are defined according to 3 main dimensions: On time or ahead of time Quality meets expectations, fulfils purpose Cost on or under budget 4 2

3 Can Failure Be Prevented? Prevention is dependent on the extent to which we can anticipate and manage risk 5 Failure Prevention by Implementation of QbD The goal of Quality by Design is to build quality in prospectively, rather than test it in retrospectively This means identifying in advance where the risks to quality lie and planning to avoid or mitigate them 6 3

4 What is QbD? Ph 1 Ph II Ph III -NDA- Commercial Manufacture Target Product Profile Product Design Product Enhancement Material Science & API Development Product Development Process Design Process Development & Tech Transfer A Work Plan Quality Risk Management People, Equipment and Facilities Knowledge management Process Analytical Technology In Vitro In Vivo Correlation Process Performance Continuous Process Verification Continual Improvement 7 FDA View: How Can We Make It Differently? Janet Woodcock, 2004: FDA concluded Basic research isn t enough; we have to look at the critical path that the product must follow before it is introduced to market The science required to evaluate new product safety and efficacy. The outgrowth of that effort was the critical path concept: We are accelerating the pace of introducing the new science and technology More from empirically derived trial and error methods to rigorous mechanistically based and statistically run processes 8 4

5 The QbD Process Streamline the clinical development of innovative drugs Better understanding the product early on will lead to better science Improve product reliability and reproducibility Making available new products, including targeted therapies Maximizing efficacy while minimizing safety hurdles to patients Increase productivity of drug development 9 FDA Viewpoints: QbD Establishing a clear linkage between safety and efficacy of the drug product in the patients Quality of the product is linked back to the process of its preparation QbD requires: Clinical understanding: link between the product and its safety and efficacy in humans Process understanding: link between the drug product and process attributes 10 5

6 Click EMA to edit Roadmap Master title Outlines style Drug Regulation/Vision Vision for future EU regulatory environment Regulators and Industry start working together earlier on in policy for new drug development process Speed up availability of certain drugs Addressing public health needs Improving access to medicines Optimizing the safe use of medicines 11 Possible QbD Clinical Approach Determine: Target indication Route of administration Target patient population What s ahead: Advancing reliable new methodologies to harness the potential of the clinical product development 12 6

7 Clinical Deliverables Definition and design of clinical criteria that will evaluate potential and biological relevance of the product early on in development Explore alternatives to large clinical studies (insilico patients) Design and implement innovative clinical design protocols during clinical development Quality should be built in by design Information from clinical development as the basis for quality risk management 13 Click Transition to edit Master Toward title A style Mechanistic Based Approach Trial and Error Empirical Testing Patient Exposure Based Assessment of Efficacy & Adverse Events Mechanistic Based Approach Predictive Evaluation Based On a New Molecular Knowledge About the Mechanisms of Disease and Products 14 7

8 A Click New to Product edit Master Development title style Toolkit is Urgently Needed New predictive tools: Improve predictability and efficiency along the critical path Early identification of product candidate with greatest efficacy against molecular and biological processes Early evaluation of product safety New evaluative tools: Improve the performance of clinical trials and treatment choices 15 Innovative Drug Development to Ensure Efficacy & Success Better Evaluative & Predictive Tools Advancing Use of Biomarkers & Next Generation Technologies Disease Safety Efficacy Streamlining Clinical Trial Process Innovative Clinical Development Plan Adaptive & Exploratory Design Ensure Efficacy & Success Early Stage Decision Making Developing Drugs Faster Smaller Patient Population Lower Costs More Certainty 16 8

9 A New Era of Drug Development Decreasing productivity Increasing cost per successful trial Slow incremental change in processes Paradigm shift underway towards: Learn/Confirm Structure Innovative Trial Design/Adaptive Clinical Trials 17 Click Employing to edit Master Novel title Paradigms style in Clinical Development Discovery Preclinical Phase I Phase II Phase III Phase IV LCM Discovery Pre clinical Exploratory Registrational Commercialization Biomedical Sciences Early Development Bimarkers Strategy 18 9

10 Moving Forward Moving forward for the patient s benefit requires: Methods based on understanding, knowledge and good science Selection/application of the right tool for the right purpose Studies based on and developed with QbD principles 19 Regulatory Basis and Context for Quality Risk Management (QRM) Main focus to date has been on CMC Gradual shift to apply concept to clinical drug development, focusing on highly regulated areas: GCP Clinical trials Pharmacovigilance ICH Q8 (Pharmaceutical ), Q9 (QRM) final in 2005, Q10 (Quality Systems) final 2008 FDA Quality by Design: Pharmaceutical Quality for the 21 st Century A Risk-Based Approach Scientific, risk-based, holistic and proactive approach to pharmaceutical development Deliberate design effort from product conception through commercialization Full understanding of how product attributes and process relate to product performance Concern about practical implementation of Q9-10 into GCP 20 10

11 Click Expectations to edit Master of title Regulatory style Authorities for QRM FDA: Can t inspect in quality retrospectively need to build in prospectively Expect shift from data-heavy NDA/BLA submissions to knowledge-rich, i.e. with insights gained from QRM approaches Involve regulators proactively in agreeing quality definitions for programs EU: Identify risks prospectively Comprehensive/holistic approach: Organizational level Project level In clinical program, apply concept at early program design stage, before individual trials are running 21 How can QbD Help in Mitigating the Clinical Drug Risk of Development Quality by Design adds value anywhere where time, cost or quality matters: Designing optimal infrastructure Optimizing processes and systems De-risking clinical programs and individual studies Fit-for-purpose training and communication Enhancing GCP compliance and reducing audit/inspection findings Meeting health authority expectations Reducing costly errors Getting it right first time minimizing need for laborious fixes 22 11

12 Project Risk Management Plan Ideally, should be included in project management plan Can be simple, informal, e.g. Risk sources reviewed Risks identified Mitigation plans Formal risk management plan should contain plans and procedures for: Sources of risk and risk identification Risk analysis (impact, probability, detectability) Risk response planning Risk monitoring and control 23 Conclusions Innovations in study designs are critical for success of clinical development: Simulations Adaptive Designs Bayesian Networks New initiatives to translate animal data into early human testing are underway (IVIVC) More management maturity (on the Quality Ladder) Expanded application of QbD in pharmaceutical industry Build in quality in advance instead of fixing things afterwards Evan a simple risk management plan is better than nothing Start as far upstream as possible and think holistically Update the project RMP periodically, e.g. at milestones/phase transitions Use project RMP in communications with management Use project RMP in de-brief at project end Structured RMP for all projects allows systemic findings across organization Establish a culture of proactive risk management and what if thinking 24 12

13 Conclusions (contd.) Quality by Design in Clinical Development Do we wish to have a new concept? Foster clinical development Maximize success in clinical development Ensure safety and effectiveness making successful drugs available for unmet needs QbD is a strategic/systemic approach in improving product development to maximize the success of getting new products to the market: faster safer smarter 25 and for less!!! 13

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