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CONFERENCE

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12th Biosimilars Americas

Evaluating safety assessments and manufacturing strategies in an uncertain regulatory environment

15th - 17th April 2013, The Seaport Hotel, Boston, USA

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Background Info
Workshop
Day 1
Day 2
Partners
Past Papers
Venue Info

Gold Sponsors

Associate Sponsors

Exhibitor

Media Partners

Background Info

Key Speakers
• Jerry Stewart, Regulatory Policy Head, Emerging Markets, Pfizer
• John Pakulski , Head Biopharmaceutical Regulatory Affairs, Sandoz
• Rebecca Sendak, Vice President - Head of analytical development and validation, Genzyme
• Haiyan Jiang, Senior Director, Preclinical and Clinical Research (Hemophilia), Biogen-Idec
• Joerg Bluemel, Director, R&D, Medimmune
• William Strohl, Vice President, Biologics Research, Janssen R&D (Johnson & Johnson)
• Fredrik Sundberg, Director, Global strategic market development, GE Healthcare
• John Doyle, Senior Vice President and Managing Director, Quintiles
• Shefali Kakar, Director - Clinical Pharmacology, Novartis
• Carolyn Huntenburg, Vice President, Regulatory Affairs, Momenta
• James Harris, CEO, Healthcare Economics LLC
• Peter Pitts, President, Center for Medicine in the Public Interest (CMPI)
• Partha Roy, Principal Consultant, Parexel
• Paul Calvo, Director, Sterne Kessler Goldstein & Fox (SKGF)
• Victor Vinci, Vice President, Chief Scientific Officer, Cook Pharma
• Dr. Deven V Parmar, Chief Scientific Officer, Karmic Lifesciences Inc
• Fiona Greer, Global Director, BioPharma Services Development, SGS M-Scan
• Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International

The global pharmaceutical biological drug market is one of the fastest growing sectors generating revenue of $114.8bn in 2010, which corresponds to over 15% of the total pharmaceutical market. There is a large and potentially lucrative demand for lower cost biological drugs worldwide.

In 2011, the global biosimilars market was worth a little over $1,300m. Biosimilars account for just 1.1% of the global biologics market at present.
The national biosimilars markets expected to experience the fastest growth throughout the period 2012-2022 are developed markets such as the US and Japan.

‘Biosimilar’ or ‘Follow-on Biologic’ are terms given to manufactured biological molecules, however due to the complexity of biologics, the product made can only be similar not identical to its reference molecule.
Due to the complexity of such products, there are many issues revolving around it such as immunogenicity, developmental, FDA guidelines patents and many more. It is more critical than ever to make sure your company’s plan to tackle these issues set by industry leaders.

Following the huge success of our events in Boston and London, the 12th Biosimilars conference will face important questions associated with cost-effective methods of developing biosimilars, key regulatory issues, safety assessments both clinical & non-clinical methods and the future of biosimilars.

Key USPs- Why should delegates attend?
• Explore the future and opportunities of biosimilars
• Discuss clinical development strategies of biosimilars
• Examine commercialisation of biosimilars
• Learn cost-effective methods of manufacturing high-quality biosimilars
• Evaluate challenges in developing biosimilars/ follow-on biologics
• Understand the key regulatory, scientific issues and latest developments of biosimilars
• Discover the process development of biosimilars including technical consideration.
• Discuss immunogenicity
• Gain insight into the role the US, European and Asia markets will have in developing biosimilars
• Network and discuss ideas with industrial experts and market leaders.

Who Should Attend?

VPs, Directors, Heads, Managers of:
• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Legal Affairs
• Intellectual Property
• Health Economics
• Pricing and Reimbursement
• Biopharmaceuticals/ Biotherapeutics
• Clinical Immunology
• Principal Scientist
• Chief Scientific Officer
• Process Control and Analytical Technologies
• Analytical Characterisation
• Regulatory Compliance
• Pharmacovigilance
• Drug Safety & Risk Management
• Quality Affairs/ Quality Control
• New Product Development
• Process Science
• Portfolio Management
• Research & Development
• Business Development
• Business Operations
• Scientific Affairs
• Commercial Affairs
• Marketing

Venue:

The Seaport Hotel,
One Seaport Lane,
Boston, MA 02210, USA
Front Desk Phone: 001 617.385.4000
Front Desk Fax: 001 617.385.4001
http://www.seaportboston.com/

Workshop

Pre-Conference Workshop, Monday 15th April, 2013

Launching a Biosimilar in an Innovator v Generic World

Led by: Kristie C. Kuhl, JD, Senior Vice President, Makovsky

This interactive workshop will discuss the unique aspects of launching successfully a biosimilar in the United States. Topics discussed include;
• Filing a BLA or sBLA – When to determine the path to approval
• Government Affairs – Likely allies and foes of biosimilars, what regulations to expect
• Revenue Discussion – What will reimbursement look like? How will the major biologics be impacted and when?

Day 1

Day One, Tuesday 16th April, 2013

08:30 Registration and refreshments

09:20 Opening address from the Chair

Fiona Greer
Global Director, BioPharma Services Development
SGS M-Scan

09:30 Developments in the regulation of biosimilars in the US
• Current regulatory environment
• FDA guidelines
• Regulatory challenges

John Pakulski
Head Biopharmaceutical Regulatory Affairs
Sandoz

10:10 Biosimilars in the age of post-patent medicine
• How will the thorny issues of safety, efficacy and cost impact the role of biosimilars in 21st century healthcare
• A detailed look at the challenges associated with demonstrating biosimilarity to the relevant regulatory bodies
• The potential dangers to innovation and intellectual property protection
• The role of biobetters
• The many issues faced by regulatory bodies

Peter Pitts
President
CMPI

10:50 Morning refreshments

11:10 Addressing current analytical challenges and improving productivity with innovative assay technologies
• Characterization of biosimilars and process considerations
• Latest advances in label-free technologies and market update
• Monitoring patient immunogenicity in real-time to support development
• Analytical platform approach to process development and manufacturing QC

Fredrik Sundberg
Global Strategic Market Development Director
GE Healthcare

11:50 Global regulatory environment, with emphasis on emerging markets and harmonization efforts by industry

Jerry Stewart
Regulatory Policy Head, Emerging Markets
Pfizer

12:30 Networking lunch

13.30 Addressing questions of biosimilar characterization
What? - Development requires comprehensive physicochemical structural characterization of the (glyco)protein to demonstrate Biosimilarity with the originator
When? - Initially, batches of the target molecule must be studied to ascertain the exact structure, post-translational modifications and variability of quality attributes
Why? - Subsequently, comparative data for the biosimilar, side-by-side with the originator, is required by various regulatory guidelines
How? - Strategies for primary and higher order structure determination will be discussed, particularly for antibodies, where their size and complexity requires LC/MS/MS approaches

Fiona Greer
Global Director, BioPharma Services Development
SGS M-Scan

14:10 Non-clinical safety assessments of biosimilar products

Joerg Bluemel
Director R&D
Medimmune

14:50 Challenges in developing biosimilars
• Complex protein structures
• Characterization
• Analytical and bioanalytic assay development programs

Rebecca Sendak
Vice president- Head of analytical development and validation
Genzyme

15:30 Afternoon Refreshments

15:50 New patent reform litigation options for biosimilars
• The America Invents Act (AIA) has introduced the most significant changes to patent law in over fifty years
• The new inter partes proceedings instituted by AIA are dealt with at the US Patent and Trademark Office, rather than in district courts
• The new proceedings have the potential to provide earlier resolution for originator and biosimilar conflicts
• The new proceedings also provide an avenue to bring about settlements that could avoid more costly litigation altogether

Paul Calvo
Director
Sterne, Kessler, Goldstein & Fox

16:30 Biosimilars: real challenges for a seamless global clinical development
• Selection of Reference Comparator
• Country Selection and Patient Recruitment
• Choice of Clinical Endpoints and Sample Size
• Immunogenicity Assessment
• Extrapolation across indications/population

Partha Roy
Principal Consultant
Parexel

17:10 Opportunities and challenges for biosimilars in the global market
• Assessing the potential for biosimilars
• Latest progress in the development

Dr. Deven V Parmar
Chief Scientific Officer
Karmic Lifesciences Inc

17:50 Closing remarks from the Chair

18:00 Networking Drinks

Day 2

Day Two, Wednesday 17th April, 2013

09:00 Registration and refreshments

09:30 Opening address from the Chair

John Pakulski
Head Biopharmaceutical Regulatory Affairs
Sandoz

09:40 Developing biosimilars and potentially interchangeable biologics: the Momenta approach
• Provide an Industry perspective on the current guidance from the FDA for biosimilars;
• Provide an outline of Momenta’s approach to the development of biosimilars and potentially interchangeable biologics as compared with the traditional pathway of new drugs and
• Discuss the challenges and outlook for biosimilar development

Carolyn C. Huntenburg
Vice President, Regulatory Affairs
Momenta

10:20 Next generation of long-acting FVIII replacement therapy for severe hemophilia A

Haiyan Jiang
Senior Director, Preclinical and Clinical Research (Hemophilia)
Biogen Idec

11:00 Morning refreshments

11:20 The challenge of making biobetters, they had better be better!
• Biobetters, which are designed in discovery, need to differentiate in the clinic, typically using the same mechanism-of-action
• Biobetters may be better based on efficacy, safety, delivery, dosing frequency, and other such factors
• Biobetter development strategies need to include early indicators of differentiation from existing therapeutics

William R Strohl
Vice President, Biologics Research
Janssen R&D (Johnson & Johnson)

12:00 Biosimilars: Is the risk worth the reward?
• Assessing the promise and potential of biosimilars
• Latest progress in biosimilars development
• Provider perspectives and acceptance of biosimilars
• Payer perspectives and formulary acceptance
• Biosimilar ROI considerations

James Harris
CEO
Healthcare Economics LLC

12:40 Networking Lunch

13:40 Panel Discussion: Patient uncertainty and misconception of biosimilars

Panelists: William R Strohl, Vice President, Biologics Research, Janssen R&D (Johnson & Johnson)

14:20 Value proposition and evidence optimization strategy of biosimilar commercialization

John Doyle
Senior Vice President and Managing Director
Quintiles

15:00 Afternoon refreshments

15:20 Addressing the challenges in conducting Biosimilar clinical trials
• What are the key study design considerations that drive recruitment?
• Does investigator/ patient education make a difference?
• Country selection: East vs. West?
• What are the key operational considerations for optimum cost and time to deliver?

Rodeina Challand
Executive Director, Biosimilars Development, Scientific Affairs
PRA International

16:00 Clinical pharmacology of biosimilars
• PK/PD considerations of biosimilars
• Assessment of immunogenicity of biosimilars
• Interchangeability – the science in the politics

Shefali Kakar
Director - Clinical Pharmacology
Novartis

16:40 CMO perspectives on collaborating with a biosimilar development and manufacturing strategy
• Challenges of doing very rapid development at the bench and large-scale to match innovator specs at Ph I
• Integrating client and CMO quality expectations to reflect flexibility early in development with an view to commercial needs
• Fill finish challenges in support of biosimilar clinical studies

Victor Vinci
Chief Scientific Officer - Vice President
Cook Pharmica

17:20 Chair’s closing remarks

17:30 End of Conference

Partners

Gold Sponsors:

SGS Life Science Services
SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Delivering solutions for pharmaceutical, biologics, and medical-device manufacturers, SGS provides clinical trial management (Phase I to IV) and services encompassing bioanalytical testing, data management, biostatistics, and regulatory consultancy. SGS also offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, cell bank and virus seeds characterization, and protein analysis. Operating 28 facilities in 15 countries, SGS Life Science Services represents the broadest global network of contract analytical laboratories. For further information, please visit www.sgs.com/lifescience

Associate Sponsors:

Shimadzu
For further information, please visit www.shimadzu.com/an

PRA International
As a leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. Our successful history of helping to bring new drugs to market demonstrates our successful approach to clinical research.
PRA supports our global reach through flexible and reliable service delivery. Thanks to our advanced technological tools and finely tuned systems, we achieve seamless delivery and operational transparency throughout our organization. PRA's dynamic services and forward-thinking approach are making a difference to healthcare patients worldwide. For further information, please visit www.prainternational.com

Exhibitors:

EMD Millipore
EMD Millipore is the Life Science division of Merck KGaA of Germany, supporting research, development and production of biotech and pharmaceutical drug therapies. We support our customers with solutions for insightful cellular analysis, multianalyte network elucidation and functional genomics. Our live cell, whole-cell and cell-based activity assays, reporter systems, biosensors and cell culture platforms advance direct and indirect detection of cellular processes and facilitate live cell imaging. These technologies, including our groundbreaking SmartFlare™ probes for live cell RNA detection, help validate targets, identify cellular pathways and determine mechanism of action for lead optimization environments. For further information, please visit www.emdmillipore.com

World Courier, Inc
For over 40 years World Courier has been the acknowledged leader in next flight out premium courier service. Our global network is comprised of over 150 company owned, GxP compliant offices in 52 countries. Specializing in the transportation of pharmaceutical shipments, we pride ourselves in providing temperature controlled logistics solutions to ensure patient safety and global supply chain compliance. Each of our 2,500 global employees are committed to meet and exceed our customers' expectations by delivering their pharmaceutical products in the fastest and most efficient manner available. For further information, please visit www.worldcourier.com

Media Partners:

PharmiWeb.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
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 main 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
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

InPharm
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.InPharm.com

Sponsorship and exhibition opportunities

This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by:
• Hosting a networking drinks reception
• Taking an exhibition space at the conference
• Advertising in the delegate documentation pack
• Providing branded bags, pens, gifts, etc.

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 12th Biosimilars Americas Conference, please contact us.
Damian Gorman, +44 (0) 20 7549 9934
damian.gorman@visiongainglobal.com

Past Papers

Speaker presentations are free to paying delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

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Venue Info