Posts Tagged ‘Biogen Idec’

Cambridge Healthtech Institute’s Sixth Annual

Integrated R&D Informatics & Knowledge Management

Supporting Collaboration, Externalization, Globalization & Translational Research

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA

Reporter: Aviva Lev-Ari, PhD, RN

For the past five years, Integrated R&D Informatics & Knowledge Management has brought together senior executives and leaders in R&D informatics from pharma, large biotech and their partners to discuss the latest ways to manage the integration of data from disparate sources to create valuable knowledge for their organizations. This year’s conference will focus on addressing how informatics teams are enabling and supporting internal collaboration along with externalization of data, helping deal with pre-competitive activities, as well as continuing to support translational research, all directed at the overall goal of improving productivity and efficiency in a cost-effective manner.


Day 1 | Day 2 | Day 3 | Download Brochure

Monday, February 10

10:30 am Conference Program Registration



11:50 Chairperson’s Opening Remarks

Martin Leach, Vice President, Research & Development IT, Biogen Idec

12:00 pm Roche’s Translational and Clinical Research Center (TCRC): How Our Big Data and Externalization Strategy Impacts Drug Discovery

Juergen Hammer, Ph.D., MBA, Pharma Research and Early Development Informatics (pREDi), pREDi Center Head; Global Head, Disease & Translational Informatics, Roche Translational Clinical Research Center

Pharmaceutical companies increasingly embed their research and early development organizations into vibrant academic hubs to enhance innovation and asset finding. Roche has recently opened “TCRC, Inc.”, soon to be located in New York City. The presentation will focus on our Big Data and Externalization approaches to support the TCRC, and will exemplify how we impact drug development decisions using informatics.

12:30 The Lilly Open Innovation Drug Discovery Program (OIDD)

Daniel H. Robertson, Ph.D., Senior Director, LRL IT Research, Eli Lilly and Company

Through OIDD, Lilly has established a network of top global research talent at academic and biotech institutions to provide them access to proprietary, in vitro phenotypic, and target-based assays (PD2 and TargetD2). In addition to supplying data that may lead to potential collaborations, Lilly has recently been partnering to deploy additional design tools for OIDD investigators to assist in designing compounds submitted to the assays through this collaboration.

1:00 Session Break

Sponsored by

1:15 Luncheon Presentation I: Building and Linking Disease and Drug Target Profiles Using Semantic Search Technologiesnt

Maria Shkrob, Ph.D.,Senior Bioinformatics Scientist, Elsevier

Researchers face a growing challenge in managing vast quantities of unstructured data to find relevant information that can guide their research. A new semantic search engine that incorporates text-mining capability along with customizable dictionaries and taxonomies rapidly finds facts and provides summary tables from multiple sources, including scientific abstracts and full-texts, grant applications, and in-house documents. This ability to accurately retrieve and summarize information significantly increases researcher productivity compared to traditional keyword search.

1:45 Luncheon Presentation II (Sponsorship Opportunity Available) 

2:15 Session Break

2:30 Chairperson’s Remarks

Martin Leach, Vice President, Research & Development IT, Biogen Idec

2:35 Building an Informatics Ecosystem for Externalized R&D

Sándor Szalma, Ph.D., Head, External Innovation, R&D IT, Janssen Research & Development, LLC

Pharma companies have historically been involved in many partnerships fueling their discovery engines, supported with non-optimal IT systems. With recent wide-spread adaptation of hosted solutions and cloud computing, there is an opportunity now to implement informatics solutions such that collaborative exploration of the data generated in partnerships becomes possible. We also discuss the opportunities to build parts of the ecosystem in a pre-competitive manner and our experience in deploying open source tools.

3:05 Cloud Solutions Spanning Applications across R&D, Development, G&A, and Compliance Functions

John Reynders, CIO, Moderna Therapeutics; former Vice President, Research & Development Information, AstraZeneca

This presentation will overview Moderna’s aggressive push into cloud solutions spanning applications across R&D, development, G&A, and compliance functions. Moderna’s cloud-based informatics workflows for the design, development, screening, and delivery of messenger RNA therapeutics will be shared along with associated challenges of Big Data, cloud security, collaboration, and cross-cloud integration.

3:35 PANEL DISCUSSION: Approaches and Lessons Learned to Build a Comprehensive R&D Search Capability

Martin Leach, Vice President, Research & Development IT, Biogen Idec

The accessibility of information within any R&D organization is key to the successful collaboration and development of a research pipeline. The holy grail for most research organizations is the one-stop search (aka. Google-like search for R&D). In this panel we will discuss the approaches a number of research organizations have taken, successes, failures and lessons learned.


John Koch, Director, Scientific Information Architecture & Search, Merck

Hongmei Huang, Ph.D., Director, NIBR IT, Novartis

Sponsored by
Thomson Reuters

4:05 Efficient Data Mining for Precision Medicine
Sirimon O’Charoen, Ph.D., Manager, Translational Medicine, Life Sciences Professional Services, Thomson Reuters

4:35 Refreshment Break and Transition to Plenary Keynote


5:00 Plenary Keynote Session (Click Here For More Details)


6:15 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:45 Close of Day

Tuesday, February 11

7:00 am Registration and Morning Coffee


8:00 Plenary Keynote Session (Click Here For More Details) 


Sponsored by
Slone Partners

9:15 Refreshment Break in the Exhibit Hall with Poster Viewing



10:25 Chairperson’s Remarks

Arturo J. Morales, Ph.D., Global Lead, Biology Platform Informatics, Novartis Institutes for Biomedical Research

10:30 Registration Systems: Applications or Data Stores?

Arturo J. Morales, Ph.D., Global Lead, Biology Platform Informatics, Novartis Institutes for Biomedical Research

Registration systems are not applications that usually stand on their own. Their value comes from the enablement of downstream data analysis and sample tracking through proper management of concept and sample metadata. As such, most registration systems offer little intrinsic value to those that use it directly and user compliance can be a challenge. Thus, it is important to adapt to workflows, as opposed to making users adapt to them.

11:00 Development of a LIMS Platform to Manage Biological Therapeutics

David M. Sedlock, Ph.D., Senior Director, Research & Development Systems, Takeda Cambridge US

The management of biological samples for testing as biotherapeutic agents requires a unique type of LIMS to handle both workflows and sample registration. We are currently engaged in a couple of projects at Takeda to create a working solution for both research and preclinical development samples to be managed across multiple R&D sites. The project status and business impact will be reviewed.

11:30 An Enhanced Electronic Laboratory Notebook to Support Biologics Research and Development

Beth Basham, Ph.D., Director, Account Management, Biologics Discovery & IT Site Lead, Merck

Merck is evolving our electronic lab notebook from a straightforward paper notebook replacement to a platform that structures data and results, provides basic LIMS-like capabilities and enables powerful search and analytics. We will share our experiences in providing a solution to support some of the stages of biologics research and development.

12:00 pm Biological Registration Systems at UCB and How They Integrate into the Discovery Workflow

David Lee, Ph.D., Principal Scientist, Informatics, UCB

The benefits of informatics-driven data management systems are well known in the small molecule therapeutics arena. Extending these systems to supporting biotherapeutics presents a number of challenges. We present a novel data management system, BioQuest, integrating bespoke and best in class software systems designed to capture and integrate NBE data at UCB. We will focus on registration systems, in particular on the antibody and non-antibody protein registration system based on the Genedata Biologics platform.

12:30 Session Break

Sponsored by

12:40 Luncheon Presentation I

Speaker to be Announced

1:10 Luncheon Presentation II (Sponsorship Opportunity Available)

1:40 Refreshment Break in the Exhibit Hall with Poster Viewing



2:15 Chairperson’s Remarks

Barry Bunin, Ph.D., CEO, Collaborative Drug Discovery (CDD, Inc.)

Sponsored by

2:20 Modern Drug Research Informatics Applications to CNS, Infectious, Neglected, Rare, and Commercial Diseases

Barry Bunin, Ph.D., CEO, Collaborative Drug Discovery (CDD, Inc.)

There are currently hundreds of commodity technologies for handling scientific information – each with its own scope and limitations. The application of collaborative technologies to interrogate potency, selectively, and therapeutic windows of small molecule structure activity relationship (SAR) data will be presented in 5 case studies. Given external (public and collaborative) data grows faster than internal data, novel collaborative technologies to gracefully manage combined external and private data provide an ever-increasing competitive advantage.

2:50 tranSMART: Use Cases from Deployments Highlighting Emerging Models for Pre-Competitive Collaboration and Open Source Sustainability

Dan Housman, CTO, Translational Research, Recombinant By Deloitte

The tranSMART open source translational research knowledge management software continues to make forward progress since the initial release in 2012. Specific use cases from a variety of projects incorporating tranSMART will be walked through to highlight emerging pre-competitive collaboration models including opportunities, new capabilities, and unresolved challenges. The current state of open project sustainability and approaches taken by Recombinant and other groups to ensure the software increases in value for adopters will be explored.

3:20 The Innovative Medicines Initiative: Collaborating around Knowledge Management

Anthony Rowe, Ph.D., Principal Scientist, External Innovation, Johnson & Johnson

The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Federation of Pharmaceutical Industry and Associates (EFPIA) and the European Union. It is dedicated to overcoming key bottlenecks in pharmaceutical research by enabling pre-competitive collaboration between industry and academic scientists. In this talk we will review the Knowledge Management activities undertaken by the IMI and how they are delivering new services and capabilities that can enhance pharmaceutical R&D.


Sponsored by

3:50 Bringing Scientific Data to Life: Agile Data Access and Analysis from Discovery to Development

Jonathan Feldmann, Vice President, Scientific Informatics, Certara

4:20 Valentine’s Day Celebration in the Exhibit Hall with Poster Viewing

5:20 Breakout Discussions in the Exhibit Hall

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

Collaboration, Externalization and Privacy

Micahel H. Elliott, CEO, Atrium Research & Consulting

  • At what extent is data exchange required in the era of R&D virtualization?
  • How do we balance ollaboration with security risk?
  • What tools are required to enable virtualization?  Will these be vendor supplied or custom?

Biological Registration Systems

Arturo J. Morales, Ph.D., Global Lead, Biology Platform Informatics, Novartis Institutes for Biomedical Research

  • How do we implement systems that users want to use?
  • What are some good practices?
  • Where are data standards making a difference?

Data Integration Today

Ajay Shah, Ph.D., Director, Research Informatics, City of Hope National Medical Center

  • Building extensible software platform for integrating basic, clinical and translational research data – technology, data and cultural challenges
  • Integrating deeper analysis and natural language processing tools to leverage the platform for translational research
  • Case studies from participants and discussion

Translational Informatics

Shoibal Datta, Director, Data Sciences, Biogen Idec

  • What does the perfect translational informatics platform look like and how do we get there?
  • Where does translation stop?
  • What does the Affordable Care Act mean to the future of Real World Evidence

6:30 Close of Day


Wednesday, February 12

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


8:00 Plenary Keynote Session (Click Here For More Details) 


9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall



10:35 Chairperson’s Remarks

Larry Hunter, Ph.D., Director, Center for Computational Pharmacology & Computational Bioscience Program, Professor, Pharmacology, University of Colorado

10:40 Knowledge-Based Analysis at Genomic Scale

Larry Hunter, Ph.D., Director, Center for Computational Pharmacology & Computational Bioscience Program, Professor, Pharmacology, University of Colorado

High-throughput instruments and the explosion of new results in the scientific literature is both a blessing and a curse to the bench researcher. Effective design and implementation of computational tools that genuinely facilitate the generation of novel and significant scientific insights remains poorly understood. This talk presents efforts that combine natural language processing for information extraction, graphical network models for semantic data integration, and some novel user interface approaches into a system that has facilitated several significant discoveries.

11:00 Combining Visual Analytics and Parallel Computing for Data-Driven Analysis Pipeline Selection and Optimization to Support the Big Data to Knowledge Transformation

Richard Scheuermann, Director, Informatics, J. Craig Venter Institute

This presentation describes our efforts at the J. Craig Venter Institute (JCVI) in collaboration with the Texas Advanced Computing Center (TACC) in the development of a high performance cyber-infrastructure that combines visual analytics and parallel computing for data-driven selection and optimization of analytical pipelines based on objective performance metrics. We demonstrate the application of these principles and infrastructure for the analysis of genome-wide gene expression and high-throughput, high dimensional flow cytometry data in clinical and translational research settings.

11:20 Real World Evidence for Pharma: Improving Traditional Research by Enhancing Real World Data Environment

Arpit Davé, Director, IT, Bristol-Myers Squibb

Life sciences organizations have started to change the way they discover, develop, and commercialize medicines to address patient, regulators and payer needs at every stage of the product lifecycle. Real world data (longitudinal and integrated patient information) is the key to answering complex questions in R&D and product commercialization. In order to access patient data across boundaries, companies and regulators are experimenting with various data and analytics collaboration models. This talk presents key lessons learned.

11:40 Spotfire Templates for Analysis & Visualization of Project Data

Sandhya Sreepathy, PMP, Head of Operations, Global Discovery Chemistry, Novartis

There has been a significant increase in the usage of Spotfire by project teams in Emeryville for visualization and analysis of data. To help streamline development activity and support the needs of project teams with data analysis and visualization, NIBR-IT in collaboration with computational chemistry group in Emeryville developed project based Spotfire templates. Templates were built leveraging existing technologies for retrieval/import of data and incorporated common elements of analysis and visualization(scaffold assignment, ligand, lipophilic efficiency, activity ratios, r-group decomposition etc). Predefined visualizations and filters helped accelerate project team decision making.

12:10 pm Session Break

12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing



1:40 Chairperson’s Remarks

Michael H. Elliott, CEO, Atrium Research & Consulting LLC

1:45 Harnessing Big Data to Accelerate Drug Development

Vinod Kumar, Ph.D., Senior Investigator, Computational Biology, GlaxoSmithKline Pharmaceuticals

With the rapid development of high-throughput technologies and ever-increasing accumulation of whole genome-level datasets, an increasing number of diseases and drugs can be comprehensively characterized by the changes they induce in gene expression, protein, metabolites and phenotypes. Integrating and querying such large volumes of data, often spanning domains and residing in diverse sources, constitutes a significant obstacle. This talk presents two distinct approaches that utilize these data types to systematically evaluate and suggest new disease indications for new and existing drugs.

2:15 Drug Process Design Improvement based on Data Management and Analysis

Valérie Vermylen, Knowledge Management, Director, GPS, UCB

Most of the scientific process data generated are not free to access, even if managed in databases. At UCB, data was recently made available including its context. It allows process developers to draw easily designed space and define critical parameters. To support investigation studies as impact analysis, manufacturing dashboards and trends are automatically published. An example of correlation between process data and patients’ clinical responses will be presented as an illustration of advanced data analysis.

2:45 The Library of Integrated Network-based Cellular Signatures (LINCS) Information FramEwork (LIFE)

Stephan C. Schürer, Ph.D., Associate Professor, Pharmacology, Center for Computational Science at Miller School of Medicine, University of Miami

The NIH-funded LINCS consortium is producing an extensive dataset of cellular response signatures to a variety of small molecule and genetic perturbations. We have been developing the LINCS Information FramEwork (LIFE) – a specialized knowledge-driven search system for LINCS data.

Sponsored by

3:15 An Enhanced Molecular Design Platform That Fosters Ideation, Knowledge Transfer, and Collaboration

John Conway, Enterprise Informatics, Schrödinger, Inc.

Drug discovery is the ultimate team sport. Schrödinger is developing a collaborative and knowledge engineered platform—LiveDesign—to help scientists not only capture their ideas and best practices, but to exploit and share these with select team members. Above and beyond the aggregation of 2D data, this platform will allow users to bring together 3D data with its associated annotations. LiveDesign will ultimately lead to better patient outcomes, promoting better scientific communication by exposing data, ideas, and colleague feedback during the design and redesign phases of molecular discovery.

3:45 Refreshment Break



4:00 Chairperson’s Remarks

Shoibal Datta, Ph.D., Director, Data Sciences, Biogen Idec

4:05 Designing and Building a Data Sciences Capability to Support R&D and Corporate Big Data Needs

Shoibal Datta, Ph.D., Director, Data Sciences, Biogen Idec

To achieve Biogen Idec’s strategic goals, we have built a cross-disciplinary team to focus on key areas of interest and the required capabilities. To provide a reusable set of IT services we have broken down our platform to focus on the Ingestion, Digestion, Extraction and Analysis of data. In this presentation, we will outline how we brought focus and prioritization to our data sciences needs, our data sciences architecture, lessons learned and our future direction.

4:35 Translational Informatics: Decomposing to Singularity

John Shon, M.D., Head, Translational Informatics IT, Johnson & Johnson

There has been an explosion of data across discovery, development, and beyond and all informatics groups are struggling with major challenges in computation, storage and analysis. In a large pharmaceutical environment, the value propositions of informatics lie primarily in three dimensions which I describe. In the larger hyperdynamic environments of research technologies, information technologies, and modern science, interdisciplinary and collaborative approaches become imperative to execute translational strategies effectively.

5:05 Integrating Translational Research Tools

Erik Bierwagen, Ph.D., Principal Programmer Analyst, Department of Bioinformatics, Genentech, Inc.

This talk will cover our efforts at creating an integrated informatics system for animal studies from birth to death and beyond. Our efforts span many different disciplines and groups, but share the common effort of integrating data seamlessly.

5:35 Close of Conference Program



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Reporter: Aviva Lev-Ari, PhD, RN

Demonstrate Biosimilarity with 100% confidence. Everytime

While offering greater flexibility, new FDA biosimilar guidelines lack specificity, nothing in the development can be taken for granted.

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? 

Demonstrate Biosimilarity is your opportunity to get first hand case studies from the leading biosimilar and generic drug developers as well as the FDA on the best approaches to…

  1. Interpret regulatory ambiguity and determine how much similarity must be demonstrated to gain approval and achieve interchangeability
  2. Ensure stability and analytical comparability as well as comparability in safety and PK/PD by optimizing your quality assessment strategy
  3. Reduce the impact of immunogenicity in your biosimilar drug and discover how to translate this regulatory expectation into a clinical trial concept
  4. Optimize your approaches to protein characterization with practical guidance from industry leading analytical scientists and service providers

Demonstrate Biosimilarity will tackle burning issues surrounding naming and pricing policiesoriginators defence strategiesmanufacturing challenges andhow to identify the best target for biosimilar development. Achieve technical insights and obtain cutting edge intelligence from 16 pharma case studies showcasing biosimilar best practise.

Attend and gain first hand testimony from the FDA, that combined with this depth of insight will give you the information you need to move quickly and decisively to get your biosimilar approved.

What you will learn? 

Attend Demonstrate Biosimilarity to:

  • Learn how to effectively monitor the higher-order structure and associated structural dynamics of your biosimilar drug molecules by optimizing your approach to comparability studies with practical guidance from Biogen Idec
  •  Expand your knowledge of how protein aggregates interact with the immune system and how this understanding can be used to reduce immunogenicitywith the Chief Medical Research Officer at the FDA
  •  More effectively determine the extent of physiochemical, pre-clinical and clinical characterization required to demonstrate biosimilarity and gain approval with case studies from Novartis and Sandoz
  • Enhance harmonization of your biosimilar data with a comprehensive comparison of the EMEA Vs USA regulatory landscape with Sandoz, Pfizerand Wokhardt
  • Get insight from MedImmune to achieve comparability when test methods are changed during the product life cycle and a non-inferior, equivalent, or superior replacement study model has been selected
  • Understand fully the applications of bioassays to determine product potency, aid biological characterization, test comparability, and determine stability with expert advice and clinical data from Teva Pharmaceuticals
  • Get a first hand guide from the FDA regarding quantitation and characterization of protein aggregates in biosimilars to ensure quality and safety of products,consistency of manufacture between lots and comparability when the manufacturing process has been changed

Does the FDA biosimilar guidance go far enough? Not if you want to operate with 100% confidence.

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.

Our recent industry survey highlighted two key desires for drug developers:


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).


Learn from the testimony of 18 industry speakers including Sandoz, Teva, Wokhardt, GSK, Pfizer, MedImmune, Biogen Idec, Amgen, Novartis, Merck and senior FDA representatives dedicated to answering these questions.  This will ensure that you can effectively achieve comparability , demonstrate biosimilarity and avoid costly failed submissions. View the agenda now.

Overcome challenges such as:


  • How do I assess the level of biological purity needed to match my innovator product and avoid making several submission to regulators?
  • Is it truly possible to achieve interchangeability and how can I convince patients and physicians of the equivalence of my biosimilar and ensure market access?
  • What are the best practises to decrease immunogenicity risk to increase my chances of achieving comparability?
  • Where can I obtain a suitable reference product to allow me to begin characterization?
  • What is the FDA’s current thinking on the criteria for analytical, stability, safety and PK/PD comparability?

Download the brochure now to view the full agenda, workshops & speaker line up.


This meeting will provide you with unrivalled access to 15 case study lead presentations from pioneering biosimilar and generic drug developers sharing their innovative new approaches.

Learn how your peers are decreasing the clinical work required, minimising the impact of immunogenicity, achieving interchangeability and how they define targets for biosimilar development.

If that isn’t enough, the FDA will be giving keynote presentations on the regulatory expectations regarding aggregates and comparability as well as minimizing the impact of immunogenicity by understanding the role of protein aggregates in unwanted immunogenicity.




Day One

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 KrausePDA 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



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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