Develop biosimilars that exhibit comparability in every required category and avoid ever having a biosimilar application rejected. With so much at stake, are you 100% confident of demonstrating comparability every time?
In fact the FDA still wants to take a cautious case by case approach. Complex biosimilar comparability studies are inherently risky and the consequences of a rejected submission are dramatic. This means that an open dialogue with FDA & other developers is essential.
To know exactly how other drug developers are tackling challenges such as structural comparability, immunogenicity and interchangeability
What the FDA is currently thinking and how this would apply to their development programs
In response to this demand for insight and support we’ve assembled the FDA alongside the industry’s best at Demonstrate Biosimilarity Washington DC (13-14th February).
13th February, 2013
8.00 Registration
8.55 Chair’s Opening Remarks
Optimizing Quality Assessments: Biochemical and Physiochemical Properties
9.00 Regulatory Expectations Regarding Aggregates and Comparability
• A guide from the FDA regarding quantitation and characterization of protein aggregates to ensure quality and safety, consistency of manufacture and comparability when the manufacturing process is being changed
• Overcoming challenges associated with characterization of the aggregates’ full size range to maximize safety information
Ewa Marszal, Chemist, Laboratory of Plasma Derivatives, Division of Haematology, CBER, FDA
9.30 An Industry Perspective: Optimizing Approaches to Protein Characterization in the Development of Biosimilars
• Practical guidance for optimizing analytical characterization of commercial products
• Understanding the innovation required in both technical development and clinical development
• Devising a systematic engineering approach to match biosimilar to reference product
Roxana Butoi, Manager, Biosimilars, GSK
10.00 Solution Spotlight: Analytical methods for monitoring biosimilar glycosylation
Scott Barksdale, Director, Business Development, Procognia
10.15 Speed Networking & Morning Refreshments
11.45 CASE STUDY: Implementing Advanced Analytical Methods and Regulatory Approved Comparability Strategies
• Numerous case studies demonstrating when test methods are changed during the product life cycle and a non-inferior, equivalent, or superior replacement study model has been selected based on the intended use of the new test method
• How to set risk-based acceptance criteria from product specifications and existing manufacturing process knowledge
Stephan Krause, PDA Task Force Leader for Analytical Methods, and Principal Scientist, Analytical Biochemistry, MedImmune
12.15 Application of Hydrogen/Deuterium Exchange with Mass Spec Detection (H/DX-MS) to Assess Comparability
• Applications of instrumental hardware and computer software to enable H/DX-MS to be employed in a practical and routine way to assess biosimilarity
• Optimizing comparability studies to monitor the higherorder structure and associated dynamics of biosimilar drugs
Steven Berkowitz, Principal Investigator, Analytical Development, Biogen Idec
12.45 Effective use of Bioassays to Streamline Biosimilar Development
• Applications of bioassays to determine product potency, aid biological characterization, and test comparability
• Bioassays as a bioanalytical tool in support of pre clinical and clinical studies throughout the span of biosimilar development
• Developing an assay strategy and clear understanding of regulatory expectations, development and implementation of validated biological assays to ensure approval
Patrick Liu, Senior Director and Global Head of Bioassays, Teva Pharmaceuticals
1:15 Lunch & Networking
2.15 CASE STUDY: Correcting Biases in Light Obscuration and Light Scattering Measurements of Protein Particles
• A demonstration of the applications of optical models for measuring of protein particles
• Several case studies involving protein aggregates, examining size errors and the practicality of corrections for biosimilar development
Dean Ripple, Leader, Bioprocess Measurements Group, National Institute of Standards and Technology
Demonstrating Biosimilarity: Biochemical and Physiochemical Properties
Roxana Butoi, Manager, Biosimilars, GSK
Stephan Krause, PDA Task Force Leader for Analytical Methods, and Principal Scientist, Analytical Biochemistry, MedImmune
Steven Berkowitz, Principal Investigator, Analytical Development, Biogen Idec
Patrick Liu, Senior Director and Global Head of Bioassays, Teva Pharmaceuticals
3.15 Afternoon Refreshments & Networking
Achieving Interchangeability with a Biosimilar Product
3.45 Application of Biophysical Techniques in Comparability Exercises: Quantitative Assessment of Spectral Similarity
• Effective use of biophysical tools, including circular dichroism spectroscopy to provide qualitative assessment of the similarity in higher order structure for biological molecules
• Using statistical analysis to provide a more quantitative evaluation of spectral similarity
Qin Zou, Senior Principal Scientist, BioProcess Analytics, Pfizer
4.15 The Momenta Approach to Developing Biosimilars and Potentially Interchangeable Biologics
• Establishing biosimilarity and potential interchangeability by focussing on “comparison” between RPP and biosimilar
• An overview of Momenta’s key takeaways from the recently issued FDA draft guidance
Jim Roach, SVP, Development and Chief Medical Officer, Momenta Pharmaceuticals
4.45 Comparability and Biosimilarity – Two Sides of the Same (or a Different) Coin?
• Compare and contrast the comparability and biosimilarity paradigms, with consideration for the impact of Quality by Design on these product development strategies
• The challenges and future directions of product characterization for biosimilars
Brent Kendrick, Director of Analytical Sciences, Amgen
5.15 Chair’s Closing Remark
Day Two
14th February, 2013
8.15 Registration
9.10 Chair’s opening remarks
9.15 Analysis of the Biosimilar Development Pipeline
• Gain a better understanding of how the biosimilar market will develop and evolve in light of the biosimilarity guidelines
• Understand when products will begin entering the U.S. and European markets
• What different development approaches are companies taking?
• What will be the involvement of companies in the US/EU
vs. those in developing countries?
Ronald Rader, President, Biotechnology Information Institute
9.45 Minimizing the Impact of Immunogenicity Understanding the Role of Protein Aggregates in Unwanted Immunogenicity
• How subvisible protein aggregates may interact with the immune system, their potential impact on product safety and efficacy
• An FDA perspective on the current regulatory considerations pertaining to the control of these particulates
Jack Ragheb, Chief Medical Research Officer, CDER, FDA
10.15 Morning Refreshments & Networking
Navigating the Regulatory and Legal Environment for Biosimilars
11.00 Comparison of the EMEA and USA Regulation for Biosimilar Development
• A review of the current state of initiatives for biosimilars in both EMEA and USA
• Perspective on how regulatory uncertainty could be reduced in the implementation of quality by design arguments
• A comprehensive comparison of the EMEA Vs USA landscape an the intricacies of harmonization
Ajaz Hussain, Chief Scientific Officer, Workhardt
11.30 An Industry Perspective: USA Current and Future Regulatory Setting for Biosimilars
• Understanding the need to maximize productivity of FDA biosimilars development meetings
• Identifying and justifying differences between structural and functional characterization
• Negotiating regulatory landscape for clinical development and determining the required magnitude of the program
• Pursuing interchangeability for your biosimilar product without FDA guidance
John Pakulski, Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz
12.00 Biosimilar Regulation Roundtable Session
• An opportunity for delegates to discuss with the regulators and regulatory experts the recent FDA biosimilar guidelines
• Collaboratively discuss the impact of the regulation and strategies to comply with it
12.45 Lunch & Networking
2.00 A Practical Guide and Overview of Current Strategies of Biocomparability and Biosimilarity
• Industry perspective on the current guidance from EMEA and FDA for biocomparability
• Current strategies to assess the the extent of physiochemical, pre-clinical and clinical characterization based on the stage of development
• Emerging guidance on biosimilarity and the implications on the pre-clinical and clinical development programs for biosimilars
• Use of biomarkers in the biocomparability exercise: Are we there yet?
Shefali Kakar, Senior Fellow, Clinical Pharmacology, Oncology Business Unit, Novartis
2.30 Understand the Nuances and Implications of the FDA Guidelines on Biosimilars
• A detailed examination of the content of the recently released FDA guidelines and how to best understand the requirements for quantity of data, sources of material and types of studies permitted
• What kind of potential exists for increased efficiency, collaboration and cost-effectiveness in the U.S?
• The repercussions of important FDA decisions that have been made regarding user fees to be paid by companies in order to submit an application for a biosimilar
Helen Hartman, Regulatory Affairs Strategist, Pfizer
3.00 Afternoon Refreshments & Networking
Optimizing Approaches for Biosimilar Production and Manufacture
3.30 CASE STUDY: Evaluation of Comparability due to Changes in Scale-up, Process, Manufacturing Site, and Formulation
• A case study of a preliminary comparability study used to evaluate the changes due to scale-up, manufacturing site, process and formulation of batches used in phases I/II and III
• A detailed overview of the extended characterization results from this study
• Preliminary assessment of comparability studies to establish the type of analytical testing required to correlate manufacturing changes to the product characteristics in the final comparability testing
Soundara Soundararajan, Principal Scientist, Bioprocess Development, Merck
4.00 Biosimilars: The Age of Post-Patent Medicine
• How will the thorny issues of safety, efficacy and cost (and in that order) impact the role of biosimilars in 21st century healthcare
• A detailed look at the challenges associated with demonstrating biosimilarity to the relevant regulatory bodies
Peter Pitts, President, Center for Medicine in the Public Interest
4.30 Chair’s Closing Remarks
Workshops
Pre Conference Workshops: 12th February 2013
Workshop A) 08.00 – 11.00: Measurement, Characterization and Impactof Impurities for Biosimilars
Biotechnology and biosimilar products have substantial differences fromchemical entities in their starting materials, manufacturing processes, productcharacteristics, stability profiles, and interactions with containers and closures.Each of these can impact the nature of the impurities present in the finalproduct.
This workshop will provide an overview of these differences with links tothe current regulatory expectations and notes on current ‘best practices’for impurities assessment during development.
- Impurities in Biotechnology/Biosimilar Products – What Makes themCritical?
– What are the specific guidance requirements for biosimilar productimpurities?
– What elements impact meaningful, reliable specifications for processand product impurities?
– How are the risks of impurities managed during development?
- Example of Critical Process-Related Impurities: Host Cell Proteins
– What are the key requirements for measuring host cell proteins fromvarious expression systems?
– How should host cell protein assays be selected, optimized, and validated?
- Example of Critical Product-Related Impurities: Particulates
– What types of particulates are of concern?
– How do we measure particulates?
- Example of Critical Container/Closure Related Impurities: Extractables/Leachables
– How do we identify the extractables and leachables?
– How can extractables or leachables affect the product?
You will leave this workshop with a detailed understanding of the impact of key impurities in biosimilar development, through case study examples ofeach, to review the current and emerging issues for biotechnology productsassociated with each.
Led By: Nadine Ritter, Senior CMC Consultant, Biologics Consulting Group
Workshop B) 12.00 – 15.00: Strategies for an Abbreviated Clinical Programfor Biosimilar mAbs
This workshop is designed to give you a practical guide to develop theoptimum clinical strategy for developing a biosimilar to minimize the size ofthe clinical program require to demonstrate biosimilarityIn this workshop you will:
- Understand how to design an abbreviated clinical program for biosimilardrugs
- Learn to optimize phase I by developing a streamlined FIM PK study usingreference product and PK equivalence as endpoints
- Discuss best practices for phase III dose and time response design
- Develop solutions to challenges associated with safety, immunogenicity, interchangeability and extrapolation across multiple indications
You will leave this workshop with a step by step guide to taking a biosimilarthrough clinical development that will minimize the amount of clinical workrequired without compromising the quality or quantity of clinical evidence.
Led by: Partha Roy, Principle Consultant, PAREXEL Consulting
Please note that workshop B runs at the same time as workshop C – so you cannot attend both.
Workshop C) 12.00 – 15.00: Biosimilars: Is the Risk worth the Reward?
This workshop will demonstrate how you can capitalize on the recentregulatory developments, and offer all of the information you need tomove quickly and decisively to turn the streamlined biosimilars processinto a lucrative commercial opportunity.In this workshop you will:
- Gain an understanding of the potential of the biosimilar market andassess the potential entry routes available for your business
- Get an overview via numerous case studies of the latest progress inthe biosimilar field and discover how you can capitalize on the latestdevelopments
- Understand the complex issue of biosimilar ROI and discusspractical strategies to maximize your return
- Hear both provider and payer perspectives to gain a betterunderstanding of how you can cater to both of their needs
You will leave this workshop with all the information you need todevelop an effective commercially viable biosimilar development strategy.
Led by: James Harris, Chief Executive Officer, Healthcare Economics LLC
Please note that workshop B runs at the same time as workshop C – so you cannot attend both.
Workshop D) 15.30 – 18.30: Gain a Biosimilar Market Overview:Present and Future Challenges
Biosimilars present a new set of challenges for regulatory authoritieswhen compared with conventional generics. After many years in theslow lane, changes are driving new momentum in the market forbiosimilarsIn this workshop you will:
- Analyze with industry leaders the present and future actions of themain players in biosimilar market in different regions of the world tohelp identify best practises from varying geo-specific approaches
- Get an understanding of the patents used for the first generation ofapproved biopharmaceuticals and discover how to capitalize onpatents about to expire to open up new opportunities in the biosimilarmarket
- Understand the critical issues for healthcare professionals surroundingthe use of biosimilars to make informed treatment decisions
You will leave this workshop with a greater understanding of thebiosimilar market place and an actionable biosimilar strategyincorporating the best practises discussed during this case study anddiscussion lead workshop.
Led by: Leandro Mieravilla, Global Market Manager mAbs, Cassara Biotech
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