Home
overview

SMI are proud to present the inaugural Biosimilars and Biobetters USA conference due to take place Monday 7th – Tuesday 8th April 2014 at the magnificent Renaissance Woodbridge Hotel, Iselin, NJ. Following on from the phenomenal success of a portfolio of international pharmaceutical events, including our flagship annual European Biosmilars and Biobetters conference, we bring you this exciting, timely and important conference.


As the expiration of patent protection for several top-selling biologicals over the next decade draws closer, this is predicted to open up an estimated US$24 billion in EU sales and US$30 billion in US sales of biosimilars. With the potentially rapid growth of this market, biosimilar manufacturers are set to make a ‘beeline’ towards this lucrative opportunity.


Despite having to overcome a number of commercial, regulatory, financial and business challenges, the anticipated establishment of robust FDA regulatory guidelines, coupled with the economic need for cheaper biological drugs is expected to add momentum to the growth of the USA biosimilars industry.
 

This superb networking event will invite in-depth discussion of key industry issues and drivers central to biosimilars including cost effective development and process methods, implementation of clinical trials, evaluating safety and quality, as well as regulatory and legal preparedness.


Through a series of exciting panel discussions, presentations and workshops, delivered by true industry experts and players, the Biosimilars and Biobetters USA conference will offer strategies and solutions for developing cost effective biosimilars. Do not miss this opportunity to network, establish new connections, exchange ideas and gain knowledge as we explore the future opportunities of biosimilars and biobetters in 2014! 
 

• Gain up to date insight into the regulatory landscape and how it is effecting the industry
• Evaluate commercialization and development strategies to gain a competitive advantage
• Calculate possible revenue stream from biosimilar production
• Discover what lessons have been learned so fart and what the future holds
• Boost your industry knowledge and relationships by networking and learning from key industry and academic leaders 


 

Senior Vice Presidents, Vice Presidents, Directors, Heads of Department with responsibility in the following departments:-

Intellectual Property
Legislation and Policy Advisers
Analysts
Business Development
Biostatistician
Licensing
Manufacturing
Bioequivalence
Drug and Safety Assessment
Market Strategy
Regulatory/Legal Affairs
Biomedical Product Development
Health Economics
Scientific Affairs
Research and Development

Ablynx; Ark Patent Intelligence; Arterium Corporation; Bayer AG; Bioscience Valuation; Bird & Bird LLP; BTG; Catenion; Eisai; Ellery Pharma Consulting ; F. Hoffmann La-Roche AG; Galderma International; GenericsWeb; GlaxoSmithKline plc; IDEA Pharma UK; Janssen Strategic Marketing; John Ansell Consultancy; Kilburn & Strode; Kromite; Laboratorios Servier; London School Of Economics; LSE Health and Social Care; Merck Serono International S.A.; MorphoSys AG; Norgine Ltd; NovaSecta Ltd; Pharmawise; Roche Chemische Unternehmungen AG; Stewart-Long Solutions Ltd.; Sunstein Kann Murphy & Timbers LLP; Swa Consulting; Turnstone Business Solutions Ltd.; United Drug plc; University Of Glasgow; University of Strathclyde; Xenoplat Consulting;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard DiCicco

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

9:10 Biosimilars and specialty products: current status and future

Douglas  Long

Douglas Long, Vice President Industry Relations , IMS Health

• Understanding how the global pharmaceutical market is becoming more specialized and precise
• Identifying what the experience on follow on biologics, generics and biosimilars has been so far
• Assessing what role follow on biologics, generic biologics and biosimilars play in the future

9:50 Ensuring that interchangeability does not thwart US innovation – legislation at both federal and state level and FDA’s expectations

John Pakulski

John Pakulski , Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz Pharmaceuticals

• Assessing the risk of interchangeability to biologic innovation
• Understanding the basis for interchangeability at state and federal level
• Analyzing the variations in state-level legislation governing biosimilar substitution
• Reaching a consensus on interchangeability - how and when should this be permitted
• Determining whether physicians should be notified when pharmacies substitute biosimilar for brands
• Preparing for future FDA guidance regarding safety and quality considerations for interchangeable products
 

10:30 Morning Coffee

10:50 Biosimilars - the state of the union

Peter Pitts

Peter Pitts, President, former FDA Associate commissioner, Center for Medicine in the Public Interest

• Reviewing current regulatory concerns
• An update on biobetters and biosimilars
• Discussing the EU experience
• Analysing cost versus quality

11:30 Ready, set, go! …… but watch out for IP hurdles along the way in an age of post-patent medicine!

Dominic Adair

Dominic Adair, Associate, Bristows

• Reviewing the impact of patent laws on biosimilar production
• Identifying and overcoming the potential patent pitfalls biosimilar applicants may encounter pertaining to:
o  development o  marketing
o  approval 
• Evaluating how to challenge patents and potential patent extensions from innovator companies

12:10 Networking Lunch

13:30 Considering the impact of biosimilars on competition

Joseph Fuhr

Joseph Fuhr, Professor of Economics , Widener University

• Examining the balance between innovation and competition
• Analysing the potential entry into the USA market
• Reviewing the European Experience of biosimilar production
o           barriers to entry
o           market opportunities 
o           competitive response
o           differences in the biosimilars versus biobetter  route
 

14:10 Insights into the structure function relationship of monoclonal antibodies (mAbs) with respect to their evaluation of biosimilarity

Magdalena Leszczyniecka

Magdalena Leszczyniecka, Founder and CEO, STCBiologics Inc

• Ensuring quality CMC is in place before embarking on mAb production to achieve successful biosimilarity
• Considerations for building a pipeline of mab biosimilars
• Understanding why US mAbs will be an important target for the development of biosimilar therapeutic products

 
 

14:50 Physician's perspective on biosimilars: the importance of pharmacovigilance

Eric  Hargan

Eric Hargan , Shareholder, Healthcare, Greenberg Traurig, LLP

• Understanding why patient safety is paramount.
• Realizing that information is power: the more doctor's have, the better it is for patients
• Examining why manufacturers must be transparent for physician's to have confidence in the product

15:30 Afternoon Tea

15:50 Evaluating the potential revenue streams achievable from biosimilar production

Richard DiCicco

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

• Biosimilar investing: what to expect for a return on investment (ROI)
• Presenting a  biosimilar sales forecast from a manufacturing view
• Profit margins in biosimilar production 
• Evaluating biosimilar unit floor prices in a hyper-competitive market

16:30 What is the state of play! Highlighting what lessons have been learned to date and where the industry is heading

• Discussing industry insights and what work you should be planning to do
• What opportunities are awaiting the market
• Deciding which models to use for successful biosimilar launch
• What benchmarks can be learned from biosimilar development in Europe

Richard DiCicco

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

Rodeina Challand

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

17:10 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard DiCicco

Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

9:10 What is in a name! Reviewing the ongoing debate in the biosimilars naming process to ensure appropriate pharmacovigilance!

Rodeina Challand

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

• Presenting an update on the FDA ‘s naming preference -  determining their stand on distinctive International Nonproprietary Names (INNs) for biosimilars 
• Assesing the options for long-term biosimilar naming:
o     Common non-proprietary name
o     Shared  root or prefix
o     Distinct non-proprietary name
• Recognizing the need for clear naming principles to avoid patients receiving the incorrect product and reduce confusion among healthcare providers
 

 

9:50 Exploring the European (EU) biosimilars landscape to determine what lessons and ‘take homes’ the US market can employ

Liz Fuller

Liz Fuller, Partner, Bird & Bird

• Analyzing current regulatory requirements  for biosimilar approval in Europe and the future path of this legislation
• Reviewing the variations between the EU and US law and regulations 
• Implementing strategies for harmonizing US and EU developments to avoid program duplications

10:30 Morning Coffee

10:50 Essential Infrastructure for successful mAb biosimilar development

ShinJae  Chang

ShinJae Chang, Vice President of R&D, Celltrion

• Introduction of biosimilars and how to secure the comparability to reference products
• Highlighting key global opportunities of mAb biosimilars
• Understanding the key infrastructure for successful biosimilar development
• Approval of world’s first mAb biosimilar from both developed and emerging countries
• Utilizing bridging studies to enable the application of already generated data

11:30 Biosimilars vs. biobetters! Determining the implications for product developers in the pharmaceutical industry

Paul Ashton

Paul Ashton, President & CEO, pSivida

• Biobetters claim that they are a better product, but what evidence is there to prove this?
• Discussing the regulatory status pertaining to production of biobetters
• Analyzing which features can be improved by utilizing biobetters
• Evaluating whether biobetters are better than biosimilars based on efficacy, safety and delivery 
 

12:10 Networking Lunch

13:30 Can biobetters or biosuperiors meet the challenges of best in class molecules and cheaper biosimilars

Rakesh Dixit

Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, Medimmune Inc

• Reviewing the challenges and opportunities in developing relatively cost effective biosimilars
• Innovations in improving the existing biologics therapies in diseases with unmet medical needs
• Making biobetters or biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - case studies of biosuperior vs. biosimilars
• Identifying which products have significant potential for ‘biosuperior’ development
• Developing biosuperior protein therapeutics that address sub-optimal, in-market characteristics of currently licensed biologics
• Examining current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins 

14:10 Identifying how to create a truly marketable product! Assessing commercialization considerations for

Branimir Cvetkovic

Branimir Cvetkovic, Global Strategy Lead - Biosimilars , Novartis Pharmaceuticals Corp

• Understanding the role of partnerships in the development and delivery of commercially successful biosimilars to secure specific capabilities
• What are the various partnership models to consider in co-commercializing 
• Providing relevant preclinical and clinical data for marketing authorization
• Honing marketing tactics to achieve accelerated biosimilars sales
• Ensuring sufficient manufacturing capability and human capital to produce and commercialize biosimilars 
 
 

14:50 Biosimilars – The formula for success

Nader  Halim

Nader Halim, Director, US Policy, Pfizer

•   Clinical and reglatory considerations
•   Manufacturing considerations
•   Commercial considerations

15:30 Afternoon Tea

15:50 Creating effective strategies to control the manufacturing process and address the unique challenges facing biosimilar producers

Steve Flatman

Steve Flatman, Head of Biosimilars Research and Development, Lonza Biologics Plc

• Overcome challenges in developing biosimilars through formulated testing strategies:
o      analytical and bioanalytical method development capabilities
o      defined characterization programs
• Implementing procedures to prepare your manufacturing lifecycle for each step of product development 
• Applying the fundamentals of process analytical technology (PAT) 
• Discovering how a small difference in the  manufacturing process may create a different product 
• Understanding the importance of supply-chain expertise procurement and quality assurance to speed up development 
 

16:30 Post-Approval Monitoring of Biosimilars: Is the United States ready for multisource biologics?

Thomas Felix

Thomas Felix, Director, R&D Policy Global Regulatory Affairs and Safety, Amgen

•      The FDA has clearly communicated the importance of post-approval monitoring for biosimilars
•      Can pharmacovigilance be ensured for patients receiving multisource biologics in all settings? 
•      Do current electronic health record systems allow for  pharmaco-epidemiological studies to understand differences that may exist between biosimilars?
•      What short and long-term solutions should be considered to better track outcomes related to multisource biologics
 

17:10 The optimal manufacturing strategy! - exploring what is shaping the strategic biosimilar manufacturing plan of today's leading companies

• Discovering how to build or procure this manufacturing base in a cost effective way
• Evaluating where should this manufacturing base be located and why
• Analysing how competition from new players is changing the landscape

Kristopher  Howard

Kristopher Howard, Managing Director, Operational Excellence Leader, NRL Enterprise Solutions

Niranjan M.  Kumar

Niranjan M. Kumar, President, ABS Inc. USA

Abraham Shamir

Abraham Shamir, Retired Executive Director, Emerging markets, Vaccines and Biologics, Merck & Co., Inc.

Don  Stewart

Don Stewart , CEO, PlantForm Corp

17:50 Chairman’s Closing Remarks and Close of Day Two

+

FEATURED SPEAKERS

Douglas  Long

Douglas Long

Vice President Industry Relations , IMS Health
John Pakulski

John Pakulski

Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz Pharmaceuticals
Peter Pitts

Peter Pitts

President, former FDA Associate commissioner, Center for Medicine in the Public Interest
Richard DiCicco

Richard DiCicco

Chairman, Harvest Moon Pharmaceuticals

Abraham Shamir

Retired Executive Director, Emerging markets, Vaccines and Biologics, Merck & Co., Inc.
Abraham Shamir

Asa Cox

Founder & President, Generic Pharma 2.0
Asa Cox

Branimir Cvetkovic

Global Strategy Lead - Biosimilars , Novartis Pharmaceuticals Corp
Branimir Cvetkovic

Dominic Adair

Associate, Bristows
Dominic Adair

Don Stewart

CEO, PlantForm Corp
Don  Stewart

Douglas Long

Vice President Industry Relations , IMS Health
Douglas  Long

Eric Hargan

Shareholder, Healthcare, Greenberg Traurig, LLP
Eric  Hargan

John Pakulski

Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz Pharmaceuticals
John Pakulski

Joseph Fuhr

Professor of Economics , Widener University
Joseph Fuhr

Kristie C Kuhl

Senior Vice President, Makovsky & Co Inc
Kristie C Kuhl

Kristopher Howard

Managing Director, Operational Excellence Leader, NRL Enterprise Solutions
Kristopher  Howard

Liz Fuller

Partner, Bird & Bird
Liz Fuller

Magdalena Leszczyniecka

Founder and CEO, STCBiologics Inc
Magdalena Leszczyniecka

Nader Halim

Director, US Policy, Pfizer
Nader  Halim

Niranjan M. Kumar

President, ABS Inc. USA
Niranjan M.  Kumar

Paul Ashton

President & CEO, pSivida
Paul Ashton

Peter Pitts

President, former FDA Associate commissioner, Center for Medicine in the Public Interest
Peter Pitts

Rakesh Dixit

Vice President, R&D, Global Head, Biologics Safety Assessment, Medimmune Inc
Rakesh Dixit

Richard DiCicco

Chairman, Harvest Moon Pharmaceuticals
Richard DiCicco

Rodeina Challand

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

ShinJae Chang

Vice President of R&D, Celltrion
ShinJae  Chang

Steve Flatman

Head of Biosimilars Research and Development, Lonza Biologics Plc
Steve Flatman

Thomas Felix

Director, R&D Policy Global Regulatory Affairs and Safety, Amgen
Thomas Felix

Workshops

Differentiation Strategies for the Generics Industry
Workshop

Differentiation Strategies for the Generics Industry

Renaissance Woodbridge Hotel
9th April 2014
Iselin, USA

Launching a Biosimilar in an Innovator v. Generic World
Workshop

Launching a Biosimilar in an Innovator v. Generic World

Renaissance Woodbridge Hotel
9th April 2014
Iselin, USA

Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

HOTEL BOOKING FORM

Title

SubTitle
speaker image

Content


Title


Description

Download


WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




Forgotten Password

Please enter the email address you registered with. We will email you a new password.