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Effective Late Stage Pathways for Biosimilar Products
1.
© 2017 PAREXEL
INTERNATIONAL CORP. EFFECTIVE LATE STAGE PATHWAYS FOR BIOSIMILAR PRODUCTS Dr. JingPing Yeo Corporate Vice President, Clinical Research Services, PAREXEL International February 17th, 2017 PAREXEL India Symposium 2017
2.
© 2017 PAREXEL
INTERNATIONAL CORP. / 2 AGENDA EFFECTIVE LATE STAGE PATHWAYS FOR BIOSIMILAR PRODUCTS • Enhancing operational efficiencies of Late Phase Biosimilar trials • Optimizing patient recruitment and retention strategies • Investigator interest • Acquiring the reference product and changes in the reference product • Leveraging data driven monitoring for data surveillance in Biosimilar studies
3.
© 2017 PAREXEL
INTERNATIONAL CORP. / 3 SEAMLESS OPERATIONAL INTEGRATION Strategic Development Clinical Trials Marketing Approval Consulting Development Plan Commercialization Plan Early Phase Phase I Global Clinical Research Services Phase III Consulting Regulatory Filings Create aggressive defensible development plans and gain Agency buy-in Maximize ROI through a compelling value proposition • Overcome local regulatory and operational hurdles • Optimise patient access – “global reach” • Optimize operational efficiencies and risk management via integrated technologies • Direct experience in the preparation and submission of Biosimilar CTDs that resulted in approval • Negotiation of Phase IV commitments (risk management) • Implement risk sharing program that drives speed & efficiency • Implement dedicated leadership & expertise model
4.
© 2017 PAREXEL
INTERNATIONAL CORP. / 4 BIOSIMILAR COMPOUND GLOBALIZATION ROADMAP Phase III in US, Europe & Asia (>500 subjects) • Therapeutic equivalence (safety and immunogenicity) • 2 arms • Investigational product – xx subjects • Reference product (EU sourced) – xx subjects Global market access • Leverage the Phase I and Phase III study to apply Asia & EU MAA • Leverage EU MAA to apply for most emerging market MAA without or limited additional studies (local patients required in India, Russia, Mexico, Japan, Korea) Phase I & Phase Ib PK in a particular country • PK Equivalence in specific patient population • 2 arms • Investigational product – xx subjects • Reference product (EU sourced) – xx subjects
5.
© 2017 PAREXEL
INTERNATIONAL CORP. / 5 ACCELERATING THE PHASE III STUDY • Conservative Plan (Long overall timeline, Low risk if true no similarity) • Aggressive Plan (Short overall timeline, High risk if true no similarity) • Relative aggressive and Control the risk • Aggressive Plan and minimized the overall sample size Phase Ia Phase Ib PK Phase III Phase Ia Phase Ib PK Phase III Phase Ia Phase Ib PK Phase III Phase Ia Phase Ib PK/ Phase III
6.
© 2017 PAREXEL
INTERNATIONAL CORP. / 6 OPERATIONAL CONSIDERATIONS Understanding the regulatory environment • Early engagement of regulators (open to negotiation) • Manage the specific requirements of IRB/EC – Work closely with sites, lab to collect required documentation • Identify phase III sites in parallel with preclinical/Phase I work – RA and IRB/IEC submissions made in parallel – Consider early Phase III submissions • Appropriate patient population and sample size – Required designs not set in stone; early health authority input is critical – Limited relevance of original innovator’s basis of approval – Safety as a factor for sample size Knowing the “right” sites and engaging the investigators
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INTERNATIONAL CORP. / 7 OPERATIONAL CONSIDERATIONS (2) Ensuring quality data and compliance • Contingency plan in monitoring plan for missing data • Clear guidelines on SD requirement, CRF completion and protocol deviation management • Leverage data driven monitoring technology & data surveillance tools • Comprehensive/continuous training, tools and lessons learned to sites Identifying the right clinical endpoints • Include biomarkers or other surrogates predictive of clinical efficacy Selecting the reference products • Obtain from a combination of sources • May need to demonstrate in-vitro comparability to multiple sources
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INTERNATIONAL CORP. / 8 KEY SUCCESS FACTORS IN PATIENT ENROLMENT Proactive engagement with sites Accelerate site start-up and site activation • Weekly Prescreening log • Offer site support – e.g., via SMOs • Study level documentation in English, localized in each country Investigator relationship and retention is key • Bi-weekly enrollment status letter to all PIs, and Weekly booster call by CRA • Engage the sites at identification and qualification phase • Emphasize the study benefits including the extension study Patient and health care provider confidence • Perception that biosimilars have less rigid pre and post market data requirements • As a new category of drug products, need to educate on safety and efficacy Make effective use of Asian countries Leverage on established footprint and infrastructure
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INTERNATIONAL CORP. / 9 IDEAL SITE CRITERIA Key Factors • Does the site have this patient population? • Is the site correctly aligned to the protocol criteria? • Investigators with affiliation to country therapeutic groups/disease networks • The number of studies that PI conduct in parallel? The “Right” Sites • Sites that routinely treat specific indication patients with biologic agents • Sites that PAREXEL has a working relationship with, or has pre-identified, including good-performing sites from the previous biosimilar studies • Investigators with affiliation with strong network of indication working groups • Centers that have an adequate facility to conduct clinical trials for patients (e.g. chest x-ray, ESR measurement etc.) PATIENT EXPERIENECE & TECHNOLOGY PATIENTS MAKE INFO MORE TRANSPARENT, ACCESSIBLE, PATIENT FRIENDLY • Improve participation & experience • Reduce patient burden • Innovate data capture Difficult to: • Identify sites • Engage in a meaningful conversation
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INTERNATIONAL CORP. / 10 PATIENT ENROLLMENT/RETENTION STRATEGY Newsletters Referrals Patient Materials / Others Resource / Compensation Booster Actions • Give a heads-up in advance to investigators to assign sufficient Sub-Is/ SCs • Increased investigator fee for high enrollers considering the workload of site staff • Assign more CRA hours for high recruiting sites to provide more site support. • Compensations to patients for transportation fee • Recommend ‘Meetings within hospital’ to create awareness amongst colleagues on regular basis. • Laminated charts for trial design and trial flow chart for easy reference • Dear Doctor letter to other doctors within the country explaining Study • Prepare and distribute newsletters on a regular basis with up to date study updates • Highlight enrollment • Newsletters to address enrollment issues and major changes/ updates to the study procedures • Targets - high enrollers – Appreciation and Recognition!! • Patient retention status update • Close contact with the sites weekly during start-up to keep continued site engagement • PL/COL/sponsor visits sites, discuss with PI to motivate • Interim SC or local investigator meeting (experience sharing from high recruiters or good performance sites) • To share with PI the publication policy during SIV, if applicable • Patients facing tools: poster, study brochure, etc. • Identify Back-up sites at the beginning and get those initiated if applicable • Patient retention materials; appointment reminder card, etc.
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INTERNATIONAL CORP. / 11 LEVERAGING DATA DRIVEN MONITORING (Off site & centralized monitoring)
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INTERNATIONAL CORP. / 12 Improved data quality and patient safety RISK-BASED OPERATIONAL STRATEGY Design • Protocol Optimization (Design) • Data Driven Site Placement • Data Driven Patient Recruitment Risk Avoidance Execution • Mitigation & Contingency Planning • Adaptive Monitoring & Data Surveillance • Ongoing Risk Measurement Risk Monitoring Delivery Outcomes • Risk at Acceptable Levels • Mitigation & Triggered Contingency Deployment • Data Driven Operational Interventions Risk Mitigation DATA-DRIVEN OPERATIONAL STRATEGY CONTINUOUS FOCUS ON RISK MANAGEMENT Risk Assessment Assessment • Identification of Risk • Analysis of Risk • Evaluation of Risk DataSurveillanceTeam Project Lead Global Clinical Operations Lead Data Management Lead Medical Monitor(s) Biostatistics Lead Primary Statistical Programmer
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INTERNATIONAL CORP. / 13 RISK CATEGORIES Data Quality Data timeliness Milestone delay Protocol Adherence Site Management Quality Site Visit compliance Subject Safety DDM APPLICATION RISK CATEGORIES
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INTERNATIONAL CORP. / 14 EXAMPLES OF RISKS IDENTIFIED – FROM DDM High risk sites 0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 Total Data Quality 0.58 Data Timeliness 0.54 Protocol Adherence 0.07 Site visit compliance 0.81 Subject safety 0.24 Site management Quality 0.98 Delay milestone 3.07 Risk Categories Riskscore
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INTERNATIONAL CORP. / 15 DATA SURVEILLANCE – COUPLING WITH TECHNOLOGY • Standard library includes +60 visualizations focused on safety parameters across 17 SDTM domains • Visualizations align with the Data Surveillance Plan • Output can be accessed by sponsor on continuous basis
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INTERNATIONAL CORP. / 16 RISKS IDENTIFIED – FROM DATA SURVEILLANCE Inclusion/Exclusion Criteria Not Met - overall trends INC 4. ECOG performance status of 0-1 at Screening. INC 6. At least one measurable lesion according to RECIST v1.1. EXC18. Any of the following events within 6 months prior to Screening EXC 20. Serologically confirmed active or chronic disease Action: re-train investigator (as anticancer agents are prohibited within the study treatment). Only anticancer agents should be reported with correspondent indication. Supportive treatment agents should not be reported as “anticancer” Con Meds Distribution by Country
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INTERNATIONAL CORP. / 17 GAME CHANGER • Race to launch biosimilar products will intensify • Careful strategic planning and understanding of operational challenges are critical • Innovative trial designs needed – to reach biosimilar endpoints sooner • Leverage on innovative platforms (Data Driven Monitoring) to optimise study execution and deliver results of high scientific and statistical integrity
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INTERNATIONAL CORP. / 18© 2016 PAREXEL INTERNATIONAL CORP. / THANK YOU CONFIDENTIAL18© 2017 PAREXEL INTERNATIONAL CORP. / THANK YOU CONFIDENTIAL18
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