Lifecycle Management – Future Vision/ICH Q12

Moheb M. Nasr

PQRI

October 5, 2015

Disclosures

•The speaker is solely responsible for the content of this presentation •The views presented here do not necessarily represent the views of GSK or ICH

Japan QbD Study Group 2 05-Jun-2015

Presentation Contents

• Background

• What is our vision?

• Can Q12 realize that vision?

• Conclusions

• Acknowledgments

ICH Quality Strategy Workshop (1) • June, 2014, Minneapolis, USA • Co-chaired by PhRMA and EU • Purpose: To reflect on progress made since 2003 and develop

a future vision and strategy • 35 participants representing (6 ICH parties, plus HC, Swiss

Medic, WHO, WSMI, IGPA, BIO, USP, EDQM, JP, Korea, Taiwan, others

• Assessment of ICH Quality Vision and Needs • Implementation of ICH Q8,Q9, Q10 and Q11 provides opportunities

for a more science and risk based approach to assessing changes across the lifecycle • Main emphasis of these guidelines was on development stage

• Opportunities and benefits have not been fully realized (or enabled), and the envisioned “operational flexibility” has not been achieved

• We now need to focus more on the Commercial Manufacturing phase of the lifecycle

ICH Quality Strategy Workshop (2)

• Agreed on Quality vision and needs • Developed 5 years workplan • Priorities Identified:

• Lifecycle Management (ICH Q12) • API Starting Materials (ICH Q11 IWG) • Quality Overall Summary • Enhanced Approaches for Development and

Utilization of Analytical Procedures (AQbD) • Continuous Manufacturing of Pharmaceuticals

ICH SC Meeting, Minneapolis, MN, June 5, 2014

• ICH SC Endorsed the establishment of ICH Q12 EWG • ICH Q12: “Technical and Regulatory

Considerations of Pharmaceutical Product Lifecycle Management”

• Rapporteur: PhRMA; Regulatory Chair: FDA • Step 1 Target : June 2016

What is our vision??

• Pharmaceutical products developed using modern science and risk-based management principles (QbD), leading to • High quality, uneventful tech transfer and successful commercialization

• Robust pharmaceutical quality systems at manufacturing sites meet/exceed cGMP requirements

• A true risk-based regulatory oversight to assure the availability of high quality medicines

• Manufacturing innovation and continual improvements enabled

• Pharmaceutical product lifecycle strategy becomes a key aspect of development and regulatory processes (not a reactive after thought) • Facilitate accelerated development (Break through therapy designation)

Can Q12 realize that vision?

• Encourage the implementation of ICH Q8-11 • Enabling continual improvement and innovation

• Clarify established conditions for manufacture and control based on risk, product type, development approaches, manufacturing experience, GMP status

• Provide harmonized tools to facilitate prospective changes over the product lifecycle, e.g. comparability protocols

• Establish ICH expectations of assessment and implementation of frequent manufacturing changes

• Promote development of proactive product lifecycle strategy

LCM/Q12 Desired State (Proposed)

Vision: “Assure Reliable Supply of Quality Product to the Patient” • Once fully implemented, Q12 can address public health concerns through

greater assurance of supply, by enabling “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight”

• In order to achieve this “desired state”, there needs to have a more flexible regulatory framework in place that utilizes science and risk based principles to manage post-approval changes

– This would enable Companies who have invested in the science (QbD) and process understanding) and have optimized their Quality Systems, to manage post-approval CMC changes across the product lifecycle in a more predictable and efficient manner

– It would also encourage Companies to pursue continual improvement and innovation

Issues Under Discussion

• Q12 Level of details • High level similar to Q8-11, descriptive, or in between? • Is there a need to describe best practices for change management and knowledge

management?

• Product development and lifecycle strategy : summary of product development, control strategy, proposed established conditions, product lifecycle management strategy and proposed regulatory filing of future changes • What is the value of developing additional section in Q12 and inclusion into regulatory

submissions? • Inclusion in CTD? Module 2 or Module 3? What about Japan Application Form (AF)? • Mandatory or optional?

• Established conditions • What are the regulatory expectations of non-established conditions?

• Legacy products, biotechnological and biological products • How to assure the utility and benefits of Q12?

Conclusions (1)

• Q12 is a priority for both industry and regulators

• It is a challenging topic: • Balance between industry and regulators expectations

and needs • Addressing a number of complex issues • Different regulatory procedures and experiences for

managing manufacturing changes in most regions • Assumption is that Q12 needs to fit within current

legal frameworks (with minimal change???) • Guideline should provide sufficient detail to enable

implementation without additional supporting information or activities

Conclusions (2) • Q12 provides a unique opportunity to:

• Deliver a paradigm shift in how we manage post-approval CMC changes across the product lifecycle

• Enhance transparency between industry and regulators – builds trust

• Q12 tools could facilitate accelerated development, such as Adaptive Pathways and Breakthrough Designation programs.

• Harmonize technical and regulatory aspects of manufacturing changes within and outside ICH

• In order to fully realize the potential of Q12 , I believe we need to be open minded and be prepared to challenge/overcome any perceived or real barriers in order to make this happen – may need a radical change in mindsets

• Today’s discussion will stimulate discussion and contribute to Q12 development

Acknowledgements – Q12 EWG

The Big Picture – Patient Focused

•Availability of high quality pharmaceuticals is needed to improve the quality of human life • ICH Q12 is beneficial to patients, regulators and manufacturers

–Manufacturers are responsible for quality of marketed drug products, and

–Appropriate regulatory oversight is needed

Questions?

Japan QbD Study Group 15 05-Jun-2015