Biosimilars and Follow-On Biologics 2013 Americas

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Background Info

Biosimilars and Follow -On Biologics 2013 Americas

Paradigm Global Events is proud to present Biosimilars and Follow-On Biologics Americas 2013.

Biosmilars drugs are, in essence, the biological equivalent of generics for the biopharmaceutical sector. The issues with generic drugs are well known as they have been on the market for a number of years. However, biosimilars are only recently coming on the market as patents for the original innovator drug expires.

There are a number of challenges with biosimilar drugs: commercial, regulatory, and technical. This conference examines all of them in turn and discusses for example: the current usage of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at some of the regulatory issues surrounding the new US law on biosimilars and what this means for the issue of data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the key concern. Biological drugs by definition are produced with recombinant therapeutic protein: so a biosimilar has to be as well. However, no two cell lines are exactly the same, so biosimilar producers have to prove that the overall effects are the same. This can be done in a number of ways, this conference examines the use of mass spectrometry and quality by design.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximise opportunities.

Biosimilar drugs are, in essence, the biological equivalent of generics for the biopharmaceutical sector. The issues with generic drugs are well known as they have been on the market for a number of years. However, biosimilars are only recently coming on the market as patents for the original innovator drug expires.

There are a number of challenges with biosimilar drugs: commercial, regulatory, and technical. This conference examines all of them in turn and discusses for example: the current usage of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at some of the regulatory issues surrounding the new US law on biosimilars and what this means for the issue of data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the key concern. Biological drugs by definition are produced with recombinant therapeutic protein: so a biosimilar has to be as well. However, no two cell lines are exactly the same, so biosimilar producers have to prove that the overall effects are the same. This can be done in a number of ways, this conference examines the use of mass spectrometry and quality by design.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximise opportunities.

Key Speakers

Biosimilars and Follow- On Biologics 2013 Americas

 

Workshop

Half a day form: 09:00 – 13:10 Pre – Conference Workshop: Wednesday 27th February 2013

Global Biosimilars Development – from lab to clinic

This workshop addresses and will examine a step by stepwise approach to globalize your biosimilars product:

Talking point of the workshop will include:

08:50 – Opening Remarks

09:00 – Regulatory landscape – what’s new

09:30 – Bioquivalence studies

10:10 – Bioanalytical

10:50 – Morning Refreshment Break

11:20 – Phase III design considerations

11:50 – Reference product

12:05 – Operational Challenges

12:35 – Safety data-preand post market

12:50 – Q & A

13:10 – Lunch

Led by: Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International[/tab]

Day 1

Day 1 – Thursday 28th February 2013

08:00 – 09:00Registration

09:00 – 09:10Chairperson’s Welcome and Opening Remarks – Rodeina Challand, PRA International

09:10-09:50Current Commercial Trends in Biosimilars: Seeing the Bigger Picture
• Assessing the Promise and Potential of Biosimilars
• Latest Progress in Biosimilars Development
• Provider Perspectives and Acceptance of Biosimilars
• Payer Perspectives and Formulary Acceptance
• Biosimilars ROI Considerations
James Harris, CEO, Healthcare, Economics LLC

09:5010:30 – US Biosimilars Law – Opportunities and Challenges
• An update on the Biologics Price Competition and Innovation Act (BPCIA)
• An update on FDA Implementation
• Policy Challenges to the Biosimilars Pathway: 2007 Revisited
• Legal Challenges to the Biosimilars Pathway: Abbott Laboratories’ Citizen Petition
• The Patent Exchange Process: What the law does and does not say.
Bruce A. Leicher, Senior Vice President and General Council, Momenta Pharmaceutica, Inc.

Q and A to include
F. Owen Fields, Ph.D. Vice President, Regulatory Strategy WRD, Pfizer

10:30-11:10 – A US Regulatory Update on the Biosimilars Industry
• How implementation is proceeding
• Global Landscape
• Understanding Regulatory Development Paradigm
• Biosimilar FDA Meeting Structures
• Understanding Key Regulatory Development Issues, such as
– Reference Product
– Clinical Development Considerations
– Extrapolation
– Interchangeability
– Naming
F.Owen Fields, Ph.D Vice President, Regulatory Strategy WRD, Pfizer

Q and A to include:
Bruce A. Leicher, Senior Vice President and General Council, Momenta Pharmaceutica, Inc.

11:10 – 11:40Morning Refreshments and Networking (Exhibitors Area)

11:40 – 12:20Understanding the Global Regulatory Landscape for Biosimilars
• EU vs the US: what are the key differences?
• Understanding the differences in sourcing from US and EU markets
• What other countries do you need to be aware of?
Dr. Melissa Tice, Executive Director, Biologics Regulatory, Merck & Co. Inc.

12:20 – 13:00PANEL DISCUSSION: Obstacles and hurdles for entering the biosimilars market
An interactive discussion on the barriers of entry for developing biosimilars; discussing topics such as:
• Cost of development
• Legal requirements
• Technology demands
James Harris, CEO, Healthcare , Economics LLC
Magdalena Leszcyniecka, CEO, STC Biologics

13:00 – 14:00 – Networking Lunch

14:0014:40ROUNDTABLES (1)
A choice of roundtables to join to discuss topics pertaining to the biosimilars industry. Choose from the following topics:
• Legal/regulatory requirements
• PAT and biosimilars
• Market access
• Proving bioequivalence
• Biosimilars and BRIC
• Innovations and biobetters

14:40 – 15:20Biosimilars and Biomarkers: Challenges and tribulations (Full Presentation to be announced shortly)
Claudio Carini, MD, PhD, FRCPath, GlobalClinical Immunology & Biomarkers Lead, Pfizer

15:20 – 15:50Networking Afternoon Refreshments (Exhibitors Area)

15:50 – 16:30Addressing the challenges of Biosimilars Clinical Trials
Dr. Nigel Rulewski, Vice President, Global Strategic, Drug Development, Quintiles

16:30 – 17:10A Clinical Perspective Development of Biosimilars (Case Studies)
Rodeina Challand, Executive Director, Biosimilars Development – Scientific Affairs, PRA International

17:1017:20 – Chairperson’s Closing Comment
Rodeina Challand, PRA International

17:30Networking Drinks Reception (Take your dicussions further and build new relationships in a relaxed and informal setting)

18:30 – End of Day 1

Day 2

Day 2 – Friday 1st March 2013

08:00 – 08:50Registration

09:00 – 09:10Chairman’s Welcome and Opening Remarks

09:10 – 09:50 – Comparability Exercise for Biosimilars
• Quality strategy in developing Biosimilars
• State- of – the art analysis
• Case studies for Biosimilarity
Martin Bluggel, Chief Business Officer,
Protagen Protein Services GmbH

09:50 – 10:30 – Recommendations and requirements for the design of bioanalytical testing used in comparability studies for Biosimilar drug Development
Jeff Thomas – Project Manager / Principal Investigator
Intertek Pharmaceutical Services

10:30 – 11:10The Biosimilars (and Biobetters) Pipeline – Implications for Product Developers
Ronald A. Rader, President & Publisher of BIOPHARMA:
Biopharmaceutical Products in the U.S. and European Markets, Biotechnology Information Institute

11:10 – 11:50 – Morning Refreshments and Networking (Exhibitors Area)

11:50 – 12:30Providing Bioequivalence for the regulators (Bioequivalence Services)
• Understanding what clinical data is needed for approval
• What other information can be used to prove Bioequivalence
• Bioequivalence of follow-on or biogeneric biological
Dr. Zahra Shakrohk, Chief Development Officer, STC Biologics

12:30 – 13:10Panel Discussion: Bioequivalance and current methods for proving it
Dr. Zahra Shakrokh, Chief Development Officer, STC Biologics

13:10 – 14:20 – Networking Lunch

14:20 – 15:00 – Panel Discussion : Understanding the Nuences and Implications of the FDA Guidelines on Biosimilars
John M. Pakulski R.Ph, Head of Biopharmaceutical Regulatory Affairs, Sandoz Inc.
Bruce A. Leicher, Senior Vice President and General Councel, Momenta Pharmaceutical Inc.

15:00 – 15:40 – Mass Spectrometry for Characterisation and Comparability of Biosimilars
– Introduction to Mass Spectrometry
• Developments in Mass spec for protein analysis
• Review of software available
• What questions can mass spec answer
– Mass Spectrometry for Biosimilars
• Review of regulations
• Using mass spec for characterization with examples
• Examples of use in comparability
• Other uses
Sian Estdale, PhD, Manager, Protein Chemistry, Biotechnology Division, Covance Laboratories

15:40 – 16:10 – Networking Afternoon Refreshments (Exhibitors Area)

16:10 – 16:50 – Immunogenicity and Biosimilars Protein Development
• Potential clinical consequences viz. immunogenicity
• Factors relating to immunogenicity
• Why testing for immunogenicity is important for biosimilars
Crystal Montoya, M.S. – Senior Project Analyst,
Intertek Pharmaceutical Services

16:50 – 17:30 – Protein aggregates and immunogenicity
• Protein aggregation and its implication for biosimliars development
• Inceasing safety awareness issues for protein aggregation
Curtis W. Meuse, Scientist National Institute of Standard and Technology, NIST

17:30 – 17:40 Chairman’s closing remarks

Sponsors


Gold Sponsors



Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries.

Through its discovery,nonclinical, clinical, CMC, and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

 

Silver Sponsors



Quintiles is the world’s leading biopharmaceutical service provider.

With a network of more than 27,000 professionals working in more than 80 countries, we have helped develop or commercialize all of the top 50 best selling drugs on the market. With extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.

We address the needs of the biopharmaceutical industry and broader healthcare industries,
including payers and providers. We use our expertise and insights to help customers optimize the value of their drug development, commercialization and health care delivery.

We can support our customers from initial human testing through patent expiration, from strategy through planning and execution. Through our extensive range of services, we solve our customers’ biggest challenges: decreasing costs, improving productivity, and saving time. The broad scope of our services helps our customers rapidly assess the viability of a growing number of potential new therapies, cost-effectively accelerate development of the most promising ones, successfully launch new products to market and evaluate their impact and appropriate use in patients.

All along, we work with an unwavering dedication to patients, safety and ethics.


Associate Sponsors

 

 

Intertek (ITRK.L) Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world.
From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers’ products and processes, supporting their success in the global marketplace. With a network of more than 1,000 laboratories and offices and over 33,000 people in more than 100 countries, Intertek helps its clients to meet end users’ expectations across increasingly diverse quality, health, environmental, safety and social accountability aspects in virtually any market around the world. Visit: www.intertek.com

 


Protagen Protein Services GmbH

Protagen Protein Services GmbH is an international leading specialist in the fields of Protein Characterization, Biopharmaceuticals and GMP-compliant protein analysis. 15 year’s experience in business and the comprehensive, GMP compliant spectrum of analytical methods ensure highest quality the customers in the pharmaceutical, biotech, and the entire life science industry.

Besides a large number of new biological entities (NBE) currently in development, Protagen has supported a vast number of customer projects to develop biosimilars for Etanercept, Rituximab, Infliximab, Trastuzumab, Erythropoietin, Adalimumab, Bevacizumab, Filgrastim, Insulin, Interferons and several other products. PPS data sets are accepted by EMA, FDA, and Korean-FDA for scientific advices, phases 1 to 3 or release testing.

Partners

Media Partners

PharmaVOICE magazine provides commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE’s more than 25,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers. For further information please visit: www.pharmavoice.com

Biocompare is the most comprehensive, in-depth, and objective website for life science product information. Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking through multiple print catalogs. Visit www.biocompare.com to find the products you need, stay informed of new technologies, read product reviews, watch product videos, and keep up-to-date on life science news. For further information please visit: www.biocompare.com

European Life Science is the premier journal devoted to presenting outstanding research and researchers within the life science fields. For further information please visit: www.life-science.se

SelectScience.net is the leading online product and application publication for laboratory scientists featuring the latest news, application articles, videos, product directory and product reviews. Membership is fast, free and provides access to all of the SelectScience services. SelectScience.tv is a unique video news channel for laboratory application and product information. For further information please visit: www.selectscience.net

InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision- makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: www.futurepharmaus.com

Why attend

Why you should attend this conference?

• Review important regulations and guidelines
• Identify challenges encountered with specific product manufacturing
• Assess the threat of intellectual property strategies
• Evaluate the limitations of current analytical methodsExplore clinical and preclinical challenges in the development of biosimilars
• Analyze pricing and reimbursement policies
• Understand how to better manage immunogenicity of biologics in clinical trials

 

Who should attend this conference?

VPs, Directors, Heads, Managers – working within:

• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Biopharmaceuticals/ Biotherapeutics
• Legal Affairs
• Intellectual property
• Pricing and Reimbursement
• Clinical Immunology
• Regulatory Compliance
• R & D
• Preclinical and Clinical Development
• New Product Development
• Quality Affairs/ Quality Control
• Principal Scientist
• Pharmacovigilance
• Chief Scientific Officer
• Drug Safety & Risk Management
• Health Economics
• Process Control and Analytical Technologies
• Business Development
• Commercial Affairs
• Marketing & sales
• Intellectual Property
• Legislation and Policy Advice
• Business Development
• Licensing
• Manufacturing
• APIs
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs