Biosimilars global congress 2014 europe copy 3 (6)

To Book Call: +44 (0) 207 193 3485 / Email: info@paradigmglobalevents.com / www.paradigmglobalevents.com
Associate Sponsor
Organised by
The two - day Congress will provide and interactive discussion and networking
format led by key industry expert speakers with intimate knowledge in the
industry. Gain practical strategies and best practices on challenges,
innovations, technologies and concepts surrounding biosimilars.
Day one topics will focus on:
 Global Regulatory Perspective on Biosimilars
 Update on FDA Development for Biosimilars
 The Concept of Biosimilarity
 Challenges and obstacles in conducting clinical trials for biosimilars
 An Innovator Perspective on Developing a Global Biosimilars Strategy
 CMC requirement for Biosimilar Product Development /
Manufacturing
 Patients perspective on Biosimilars
 Preperaing for U.S. Market entry – strategy considerations in view of
BPCIA and AIA
 The challenges of Developing Biobetters, They has Better be Better!
Day two topics will focus on:
 Biosimilars: Hurdles to Patient’s access
 Using Innovative Analytical Technologies to Address Curent
challenges in Establishing Similarity for Biosimilar Products
 Complexity of Biologics Manufacturing: Manufacturing Changes in
the Biosimilars Era
 Mass Spectrometry for Characterization and Comparability Analysis
for Biosimilars
 Pharmacovigilance and Traceability
 Biosimilars Infliximab – Experiences and Expectations
 Interchangeability – Guidelines
 Biosimilars: Driving on Global Commercial Potential through the
Emerging Markets
 Substitution and Interchangeability
 Regulatory strategies for biosimilars in emerging markets
 Richard DiCicco, Co- Founder, Harvest Moon
Pharmaceuticals, USA
 Dr. Steinar Madsen, Medical Director, Norwegian Medicines
Agency, Norway
 Dr. William Strohl, VP and Head, Biotechnology Center of
Excellence, Janssen R&D, Pharmaceutical companies of
Johnson & Johnson
 Silmara Cristiane Silveira Andreoli, Specialist in Regulation
and Health Surveillance, Coordination of Biological Products,
hemotherapic GESEF / GGMED / ANVISA
 Dr. Michel Mikhail, Executive Vice President Global Regulatory
Government Relations, Fresenius Kabi, Germany
 Cyprus Karkaria, President, Biotech
Lupin Pharmaceuticals, India
 Martin Bluggel, Chief Executive Officer, Protagen Protein
Services GmbH
 Michael A. Swit, Special Counsel, FDA Law Practice, Duane
Morris LLP, USA
 Renita S. Rathinam, Partner, Patent Litigation Practice,
Sughrue Mion , PLLC, USA
 Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency
for Health and Food Safety, AGES
 Sarfaraz K. Niazi, Ph.D. – Founder, Chairman and CEO,
Therapeutic Proteins International
 Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global
medical Affairs, Biologics Strategic Development, Abbvie
 Stephen Murby, Board Director, Consumer Health Forum of
Australia
 Fredrik Sundberg, Global Director Strategic Customer
Relations, GE Healthcare Life Sciences
 Dr. Mourad Farouk, International Medical Director, Amgen
Supported by
Pre – Conference Workshop - Wednesday 17th September 2014
1st Part - Biosimilar monoclonal antibodies: From theory in
guidelines to reality after approval
Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency for
Health and Food Safety, AGES
Pre – Conference Workshop - Wednesday 17th September 2014
2nd Part - Clinical Development of Biosimilars
Cecil Nick, Vice President, (Technical)
Biotechnology, PARAXEL International
17th – 19th September 2014 | Hilton Kensington, London, UK
Featuring Key Industry Experts
Latest Development Revolutionizing the World of Biosimilars Register Now!
Silver Sponsor Promotional Sponsor

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Dear Colleague,
Paradigm Global Events are once again proud to present the annual
Biosimilars Global Congress 2014 Europe.
The global biosimilars market have generated $1.2 billion in 2013. It
is anticipated to rise to $ 24 billion by 2019 – which is not bad for a
novice industry that’s at present only compose of only a small
number of drugs. Another analysis estimates that the global
Biosimilars market will grow at a Compound Annual Growth rate of
27.58% over the period of 2013-2018. A huge contributing factor
for this high level of growth is that a large number of original
reference medicines losing their data exclusivity. Another reason is,
the costs acquired in the discovery and manufacturing of biosimilar
products are plummeting due to increase in outsourcing to
emerging markets.
In this two day conference, we will look at the complexities involve
in manufacturing Biosimilars products. We will also examine the
relevant regulatory criteria that applies for approving Biosimilars
medicine. Naming issues, safety issues and interchangeability
studies involve will also be discussed.
Following the approval of the first Monoclonal Antibody biosimilars,
we will share latest information about the uptake of biosimilars
Infliximab to the market. We would also analyse the challenges and
obstacles in view of bringing more efficient and more affordable
antibody based drugs to the market.
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 maximize opportunities.
Why you should attend this conference
• Gain a better understanding of the global regulations and
guidelines for Biosimilars including variations and new
developments
• Explore clinical and preclinical challenges in the development of
biosimilars  
• Identify challenges encountered with specific product
manufacturing
• Examine the issues of conducting trials, assessing immunogenicity
and pharmacovigilance
• Explore CMC requirements in order to produce high quality
similar biologic product
• Focus on issues in developing biosimilars mAbs
• Learn how the BRIC market is dealing with Biosimilars
• Network with experts and leaders of the industry
I look forward to meeting you at the conference.
Kind Regards,
Jocelyn Raguindin
Conference Director
jraguindin@paradigmglobalevents.com
Who should attend?
Chief Executives, Executive Directors, Vice Presidents, Heads and Team
Leaders and 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
Biosimilars Global Congress 2014 Europe
Conference Introduction
17th – 19th September 2014 | London, UK
By Attending you will be exposed to:
 New Technologies, Innovations and Concept
 New Product and Trends
 Addressing the common issues and Solutions to overcome
 Networking with Service Providers
 Establish, network and source opportunities with major
suppliers
 Gain new ideas that offers real value to your business
 Listen to key industry expert speakers who are in the
know and discuss major issues with a broad range of other
senior level business executive leaders and establish
rapport.
Register now for a group Discount.
To register contact: Kimberly Tecson
Tel No: +44 (0) 207 193 3485
Email Address: Kimberly@paradigmglobalevents.com

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Pre – Conference Workshops & Testimonials
Wednesday - 17th September 2014 | London, UK
Wednesday - 17th September 2014
Morning - 1st - Part Pre- Conference Workshops
Registration & Coffee: - 08:00 – 09:00
09:00 – 13:00 - Biosimilar monoclonal antibodies: From theory
in guidelines to reality after approval
• Update on regulatory guidelines and scientific advice
• Challenges during approval and post-marketing
• Update on global regulatory approaches
13:00 – 14:00 – Networking – Lunch Break
Wednesday - 17th September 2014
Afternoon – 2nd - Part Pre- Conference Workshops
14:00 – 17:30 – Clinical Development of Biosimilars
This Workshop will highlight and discuss the must know critical
issues in the clinical development of biosimilars; how to navigate
potential hurdles and how to build an efficient and effective
program leading to ultimate success.
• Deciding when ready to move to clinical trials
• Challenges of Phase 1 programs (healthys vs. patients;
combination with phase 3; study designs; pitfalls)
• Therapeutic equivalence trials (overcoming challenges;
choice of trial population; sample size; justifying margin;
selecting endpoints; safety considerations)
• Extrapolation across indications
• Immunogenicity testing
• Substitutability vs. interchangeability
• Interacting with the regulators
• Educating the market
“Conference had topics stimulating the interest
of everyone from the biosimilars novices to the
experts – overall great conference!”
Priyanku Basu, Senior Analyst, BCG
“I was impressed with the organization of this event. I attend many conferences
per year and find the organizers on site to be detached and not focus on good
service to the delegates. This team was even providing weather forecast
warning to ensure everyone was aware and made appropriate plans.” “Well
done!” Adriana E. Manzi, PhD, Managing Director, Atheln, Inc.
“The consistently high quality of international faculty was most impressive. It
was also obvious that they were carefully chosen not only for their particular
expertise but also for their ability to communicate the subject matter to
clinical and non-clinical participants alike. As market access consultant for
pharma clients of various sizes, I now feel much better prepared to explain
the nuances & dynamics involved in bringing their products to market. In
addition, I am in a much better position to intelligently advice my clients &
help them set realistic expectations.” Thomas Martin, Associate Vice
President, VCGA - Quintiles
“Paradigm organizes a packed high quality
agenda with high quality industry and EMA
assessor speakers”
Richard DiCicco, chairman, Harvest Moon
Pharmaceuticals USA
“Very well moderated and conducted – a very
good Conference”
Amatul Mateen, QA Auditor / Scientist,
TEVA Pharmaceutical
Workshop Leader:
Dr. Andrea Laslop, Head of Scientific Office
Austrian Agency for Health and Food Safety,
AGES, Austria
Workshop Leader:
Cecil Nick, Vice President, (Technical)
Biotechnology,
PARAXEL International
“It was a pleasure to attend – Very Helpful!”
Jan L. Hillson, MD, Senior Director Clinical
Research Development, Momenta Pharma
“Rich informative received, update to level on worldwide overview of
Biosimilars – very good focused and well delivered Conference.”
“Excellent programme, chair, keynote, panel and in particular Q & A
sessions allowing audience to obtain answers to specific questions – very
good!” Senior Regulatory Affairs, Baxter BioScience
“What others said about our previous Biosimilars Event”

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Your Key Industry Expert Speakers
Richard Di Cicco, Co-Founder, Harvest Moon Pharmaceuticals USA (Conference Chair)
Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of products developed since 1984.
Harvest Moon Pharma develops, manufactures, markets and exports worldwide, complex generic drug products and biosimilars. Small
molecule generics include a complete line of transplantation products; complex hospital injectables such as enoxaparin, octreotide LAR
and generic depots; transdermal patches; complex oral solids such as dronedarone; and, oral controlled release products such as -
methylphenidate and nifedipine. Biosimilar products include adalimumab, rituximab, trastuzumab, infliximab, bevacizumab and
etanercept entering phase III clinical trials and comply with the WHO revised biosimilar guidelines, all to be launched no later than 2015.
Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks
often and is widely published in generics and biosimilars.
Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency Norway
Dr. Steinar Madsen, is medical director at the Norwegian Medicines Agency.
He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology. He has been working with
generic substitution since it was introduced in Norway in 2001. He is member of a working group at the Agency that is looking into
several aspects on the regulation of generic substitution in Norway, including biosimilar drugs, with the aim of a better legal framework.
Dr. Madsen is also engaged in the Agencys drug information service, with a special interest in the safe use of drugs.
Dr. William Strohl, VP and Head Biotechnology Center of Excellence Janssen R & D
Pharmaceutical companies of Johnson & Johnson
Dr. William R. Strohl received his Ph.D. in Microbiology from Louisiana State University, and worked as a guest researcher at the GBF in
Braunschweig, Germany. From 1980 to 1997, he rose from Assistant to Full Professor in the Department of Microbiology and the
Program of Biochemistry at The Ohio State University, Columbus, OH. There he pursued the molecular biology and biochemistry of
polyketide biosynthesis pathways, particularly doxorubicin, in actinomycetes, and the physiology of E. coli in computer-controlled high
cell density fermentations. As part of the latter endeavor, Dr. Strohl designed, implemented, and equipped a P2 fermentation facility at
The Ohio State University (in 1994). Dr. Strohl moved to Merck in 1997 to head up Natural Products Microbiology, which he did for 4
years before being asked to start a new department in the field of recombinant monoclonal antibodies. From 2001 to 2008, Dr. Strohl
was a leader in Merck’s efforts to develop therapeutic monoclonal antibodies, as well as in-licensing of therapeutic targets and
technologies associated with monoclonal antibodies. As part of this effort, Dr. Strohl was the scientific leader in the acquisition and
integration of Abmaxis and GlycoFi into the Merck Biologics organization. In April, 2008, Dr. Strohl was named leader of Antibody Drug
Discovery at Centocor (J&J). Concomitant with the evolution of Biologics at Johnson & Johnson to serve additional therapeutic areas
beyond Immunology and Oncology, in 2009 Dr. Strohl was named as VP and Head, Biologics Research, the biologics discovery
department within the Biotechnology Center of Excellence. In 2013, Dr. Strohl was named as VP and Head, Biotechnology COE, Janssen
R&D. Dr. Strohl has over 120 publications and 11 issued patents, has edited two books, and has recently written a book entitled
“Therapeutic Antibody Engineering: Current and Future Advances Driving the Strongest Growth Area in the Pharma Industry”, which
was published in October, 2012.
Prof. Andrea Laslop, MD Head of Scientific Office, AGES MEA
Dr. Andrea Laslop joined AGES, the Austrian Agency for Health and Food Safety, on January 1st, 2006. She is heading there the Scientific
Office, which constitutes the link to the European Medicines Agency (EMA) with a focus on the different types of centralised European
procedures during drug development, marketing authorisation applications and life-cycle management.
Prior to this Andrea Laslop worked as an associate professor of pharmacology and toxicology at the Medical University of Innsbruck,
Austria. Already during her engagement at the university she was appointed as member to several working groups of the EMA, e.g. the
Efficacy Working Party in 1998, the Paediatric Expert Group and the Scientific Advice Working Party in 2003, in the latter serving on an
ongoing basis. In June 2007, she also became alternate member of the Committee for Human Medicinal Products of the EMA, where she
is representing Austria now as the full member since January 2009. Andrea Laslop studied medicine at Innsbruck University where she
earned her MD and later on specialized as a pharmacologist. Her professional career included several sojourns for joint research projects
at the NIMH in Bethesda, the Albert Einstein College of Medicine in New York and the Clinical Research Institute of Montreal. Since
November 2007 Andrea Laslop served as the president of the Austrian Pharmacological Society and from November 2011 as vice
president.
Cecil Nick, Vice President, Biotechnology, PAREXEL International
Cecil provides expert consulting services to clients globally particularly on the clinical and regulatory development of biotech and
biological products. Cecil has been involved in the development and regulatory approval of a number of innovative and biosimilar
medicinal products in Europe and is a well-known industry speaker, particularly on subjects such as comparability and biosimilarity.
Cecil has extensive experience in the development and EU registration of biotechnology and blood products, devices, new chemical
entities, CMC, orphan drugs, health economics and scientific advice. He has extensive therapeutic area experience including diabetes,
hematology, oncology, lupus, epilepsy, growth, wound healing, gynecology, HIV, anti-inflammatory agents and vaccines.
Cecil has worked with PAREXEL for 8 years, prior to which he worked in Regulatory Affairs at Novo Nordisk for 13 years. Among various
industry affiliations, he is a Fellow of The Organization for Professionals in Regulatory Affairs. Cecil holds a B.Sc. with Honors in
biochemistry from the University of Cape Town in South Africa.

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Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global medical Affairs, Biologics Strategic Development, Abbvie
Jaap Venema is Senior Director Biotherapeutics, Global Medical Affairs at AbbVie, serving as the global head as well as the US lead. He
holds a Master’s degree in Chemistry from the Free University (Amsterdam, the Netherlands); a Ph.D. in Biochemistry and Molecular
Biology from Leiden University (the Netherlands); and he is a certified Project Management Professional (PMP). He has over 13 years of
pharmaceutical industry experience ranging from early discovery, clinical development, project management, business development to
medical affairs.
While at Solvay Pharmaceuticals in the Netherlands, he served as the Global Head of Exploratory Biology before he transferred to the
Business Unit Vaccines, where he was Global Project Director for marketed as well as early phase vaccines, including the 2009 H1N1
pandemic influenza vaccine. After the acquisition by Abbott Laboratories, he spent several years as Project Director in different
therapeutic areas, including Early Immunology and Pain, with accountability for the clinical and product development of several early
phase compounds, including monoclonal antibodies. In his current role, he oversees the global medical and scientific biotherapeutics
strategy, focusing on the Immunology therapeutic area.
Mr Cyrus Karkaria, President, Biotech,  Lupin Pharm aceuticals
Cyrus Karkaria is currently President of the Biotechnology division of Lupin Pharma is based in Pune. Prior to that he was Vice
President at Celldex Therapeutics and CuraGen Corporation in New Haven, Connecticut, USA heading Operations and Biopharmaceutical
Process Sciences. He has also held positions at Biogen Idec and Scios. He has been part of teams that have developed multi billion $
blockbusters in the field of neurology, immunology and oncology such as Avonex, Amevive and Tysabri (Biogen Idec) from the bench to
manufacturing scale (2000L to 15,000L). As part of the commercialization process he has also faced Regulatory bodies from the US FDA,
EMEA, Australian TGA etc., through pre-IND to BLA filings. He holds a Ph.D in Biochemistry from the University of Maryland and was a
post doctoral researcher at the Harvard Medical School.
Fredrik Sundberg, Global Director, GE Healthcare
As Global Director of Strategic Market Development and Customer Relations, Fredrik is responsible for working with the global
pharmaceutical industry and major academic power centers to improve current workflows with innovative protein analysis solutions
and value-added services. He has over the past years been supporting the industry to expand the application of label-free interaction
analysis throughout drug discovery, development and manufacturing processes. Additionally, he also advises on R&D projects, Vaccine
Growth Initiatives and Business Development activities. Fredrik is author of several publications in the field of Drug Discovery Strategies,
Biosimilars and Vaccines. A recognized industry leader, he is also member of an EMEA Pharmaceutical Industry Expert Panel. On a
regular basis, Fredrik lectures and discusses regulatory issues with government authorities, such as US FDA.
Stephen Murby, Board Director, Consumer Health Forum Australia
Born in Melbourne, Australia, Stephen has lived on the far north-west coast of Scotland since 2012. He is a Board director of Consumers
Health Forum of Australia (CHF), a member of the International Advisory Board of the Alliance for Safe Biologic Medicines (USA) and a
Life Fellow of the Royal Society of Arts (UK). In 2006 Stephen moved into in the community sector as CEO of Cystic Fibrosis Victoria
(Australia). During his six year tenure at CFV he was also Chair of the Chronic Illness Alliance, Chair of CHF and a Board member of the
Australian Council for Healthcare Standards.
Formerly, Stephen was Vice President of Swinburne University of Technology, where he worked for nine years. Before joining Swinburne
he spent five years in Hong Kong and was the Foundation Head of Continuing and Community Education at the now Open University of
Hong Kong. Stephen has spent over 30 years in “Greenfield” public and community sector innovation around the world. He has travelled
widely in Europe, Asia and North America. He has diverse community interests, working with a number of community organisations,
groups and councils. He has been a board member of the Sir Edward Dunlop Medical Research Foundation, Chairman of More Than
Opera and a Director of the RSA in Australia & New Zealand.
Renita Rathinam, Partner, Litigation Practice, Sughrue Mion, PLLC, USA
Renita Rathinam is a partner at Sughrue Mion, PLLC. She has served as litigation counsel in matters involving the pharmaceutical and
mechanical arts, and has significant experience in all pre-trial, trial, and post-trial aspects of patent litigation. She also engages in
pharmaceutical/biotechnology patent infringement and validity opinion practice, as well as freedom-to-operate, due diligence and
product clearance work, and licensing and contract matters, including joint ventures. Central to Ms. Rathinam’s practice is Hatch-
Waxman Act analysis and as such she has represented a number of pharmaceutical companies in ANDA/NDA related actions and in
preparation of Paragraph IV Notifications under section 505(j). Her practice likewise includes analysis of the Biologics Price Competition
and Innovation Act (BPCIA) and developments concerning implementation of the U.S. abbreviated approval pathway. Ms. Rathinam
speaks on licensing, litigation, pre-litigation strategies, including U.S. post-grant proceedings and developments in U.S. patent law
pertinent to both small molecule pharmaceuticals and biologics. Ms. Rathinam holds a B.S. in Biology from Emory University, a M.S. in
Biochemistry and Molecular Biology from Georgetown University and received her law degree from the University of North Carolina –
Chapel Hill.

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Michael A. Swit, Special Councel, FDA Law Practice, Duane Morris LLP
Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP as a Special
Counsel in its San Diego office in March 2012, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA
regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory
and other strategies, compliance and enforcement initiatives for drug, biologic, device, IVD, and other life sciences companies, as well as
those in the food, cosmetic, and dietary supplement industries. Mr. Swit’s multi-faceted experience includes serving as general counsel of
Par Pharmaceutical, a major publicly-traded generic drug manufacturer, where he spearheaded Par’s successful response to multiple
federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years
as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information. His prior law firm service
included being a vital part of the FDA practices at two major international law firms and a national firm with a prominent food & drug
practice.Mr. Swit has taught and written on an array of subjects relating to FDA law, regulation and related commercial activities. A
former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at conferences sponsored by
such organizations as RAPS, FDLI, ACRP, and DIA.A magna cum laude graduate of Bowdoin College, with high honors in history, Mr.
Swit earned his law degree from Emory University School of Law.
Martin Blüggel, Chief Executive Officer, Protagen Protein Services GmbH
Martin Blüggel is an expert for peptide and protein analysis, mass spectrometry and bioinf ormatics for protein analysis and proteomics.
He is author of more than 35 scientific publications and has presented state of the art analytical methods to the Biotechnology Working
Party (BWP, EMA) and Paul Ehrlich Institute (PEI). He became member of the extended Board of the EAPB (European Association of
Pharma Biotechnology) in 2009. He holds a diploma in Chemistry for his research in protein chemistry combined with mass
spectrometric methods for protein structure analysis.
As a co-founder of Protagen in 1997 Martin Blüggel set up the business in Protagen´s Protein Services Unit serving over 100 international
clients as CRO to support the development of protein therapeutics from early phases of discovery, production to GMP release testing. He
has supervised biosimilar comparability studies and protein characterization for a range of 15 top originator molecules for leading
Biosimilar developers worldwide and is an expert in CMC part of Biosimilars including latest regulatory aspects. Martin Blüggel holds the
position of Chief Operating Officer of Protagen since 2002; Executive Vice President Protein Services since 2009 and CEO since 2013.
Dr. Michel Mikhail, Executive Vice President Global Regulatory Government Relations, Fresenius Kabi
Germany & Member, Executive Committee and Board, European Generic Medicines Association
(EGA). Belgium
Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and
International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generics industry.
Dr. Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert.
Dr. Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry
associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research
and Manufacturers of America (PhRMA Europe), on the Regulatory and Scientific Affairs Group of the European Generic medicines
Association (EGA), as well as on different associations and organisations. Dr Mikhail is a Board Member of The European Generic
Medicines Association (EGA) as well as member of the Executive Committee of the EGA. He is member of the British Institute of
Regulatory Affairs (BIRA), the European Society of Regulatory Affairs (ESRA), both now known as The Organisation for Professionals in
Regulatory Affairs (TOPRA). Dr Mikhail is member of the Expert Committee for Toxicology of the United States Pharmacopea (USP).
Currently Dr. Mikhail is Executive Vice President Global Regulatory – Governmental Relations at Fresenius Kabi, a Multinational
Pharmaceutical company.
Dr. Mourad Farouk, International Medical Director, Amgen Europe, Switzerland
Dr. Mourad Farouk is the Nephrology and Biosimilars Medical lead for Amgen Europe and Middle East.
He was trained as a diabetologist in the national diabetes institute of Cairo/Egypt where he received his masters in internal medicine
after which he developed his career in the pharmaceutical industry with different multinational pharmaceuticals (including Janssen Cilag,
Novo-Nordisk and Amgen) where he had assumed a variety of regional and international leading roles in research and development and
medical affairs along the course of the last 20 years
Dr Farouk is a member of the European society of nephrology, dialysis and transplant as well as selected diabetes societies worldwide
and he has co-authored a range of publications in nephrology and biotechnology.
Silmara Cristiane Silveira Andreoli, Specialist in Regulation and Health Surveillance,
Coordination of Biological Products, hemotherapic
GESEF / GGMED / ANVISA
Silmara Cristiane da Silveira Andreoli is a specialist in health surveillance and regulation from the Brazilian Health Authority (Anvisa).
She is an industrial pharmacist and she has a master degree in genetics and biotechnology. She’s been working at the Coordination of
Biological Products from Anvisa since 2005, dealing with the licensing and post licensing changes of biological products. She frequently
represents Anvisa at WHO meetings and other conferences regarding biological products.

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08:00 – 08:50 – Registration - Networking Coffee
08:50 – 09:00 – Chairperson’s Welcome and Opening Remarks
Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals
09:00 – 09:40 – Global Regulatory Perspective on Biosimilars
 Most recent regulatory requirement for Biosimilars
 EU vs the US: what are the key differences?
 What other countries do you need to be aware of?
 Clinical and non – clinical studies for biosimilars
 Demonstration of efficacy and safety
Dr. Andrea Laslop, Head of Scientific Office, Austrian
Agency for Health and Food Safety, AGES, Austria
09:40 – 10:20 – Update on FDA Development for Biosimilars
 Interchangeability – Guidance (if issued by then: if not, what it
might say)
 Naming issues – Where is the WHO going and will FDA follow on
the INN – the GPhA Petition
 State legislative activities to restrict substitution of interchangeable
biosimilar
 REMS and their impact on restricting access to branded products
needed for Biosimilars comparability studies
Michael A. Swit, Special Counsel, FDA Law Practice
Duane Morris LLP, USA
10:20 – 10:50 – Networking – Morning Refreshment (Exhibitors
Lounge)
10:20 – 10:50 – Panel Discussion: Global regulations and current
developments
 Are we near to international harmonized development?
 Moving towards global Biosimilars guidelines
 Update focus on the emerging markets
Moderator - Dr. Andrea Laslop - Austrian Agency for
Health and Food Safety, AGES
 Renita Rathinam - Sughrue Mion, PLLC
 Michael A. Swit - FDA Law Practice Duane Morris LLP
 Dr. Michel Mikhail - Fresenius Kabi,
11:30 – 12:10 – The Concept of Biosimilarity
 What is meant by “biosimilarity”
 How similar is biosimilar
 Can clinical data substitute for chemical differences
 How important is secondary biological activity?
 Extrapolation across indications
 Substitutability vs. interchangeability
Cecil Nick, Vice President, (Technical) Biotechnology,
PARAXEL International
12:10 – 12:50 – Challenges and obstacles in conducting clinical
trials for Biosimilars
 Key considerations in planning clinical trials for biosimilars
 Patient recruitment and education
 Operational procedure to minimize cost and optimize delivery
12:50 – 13:50 – Networking Lunch Break
13:50 – 14:30 – An Innovator Perspective on Developing a Global
Biosimilars Strategy
 For biologics – including biosimilars – design and manufacturing
matters because product quality and supply are affected by how
medicine is made
 Science – based, tailored EU Regulatory pathway has successfully
brought biosimilars to market; other regulatory bodies across the
globe have followed suit
 The development and availability of EMA approved biosimilars may
increase competition in the market, leading to reduced prices and
wider access to medicines
 As highly complex medicines, biologics and biosimilars require
robust and active identification and traceability to ensure any
adverse effects are quickly detected, reported and attributed to the
correct product and manufacturer
 As biosimilar mAbs become available, greater focus will be given
to the terms of use and building trust and understanding with
healthcare practitioners and patients.
 Amgen is uniquely equipped to leverage our leading position in
biotechnology to produce and reliably supply biosimilars globally
Dr. Mourad Farouk, International Medical Director, Amgen
Europe, Switzerland
14:30 – 15:10 – CMC requirements for Biosimilar Product
Development / Manufacturing
 How to achieve comparability to the reference product?
 Analytical testing to demonstrate similarity between biosimilars
and reference product
 Reference product selection and cell line development
Martin Bluggel, Chief Executive Officer, Protagen Protein
Services GmbH
15:10 – 15:40 – Networking Morning Refreshment -Exhibitors
15:40 – 16:20 - Patients perspective on Biosimilars
 Scientific and Clinical Considerations for Biologics and Biosimilars
 Challenges on patient education
 Harmonization to ensure patient safety
Stephen Murby, Board Director, Consumer Health Forum
of Australia
16:20 – 17:00 – Preparing for U.S. Market entry – strategy
considerations in view of BPCIA and AIA
 Brief review of BPCIA patent information exchange and litigation
framework – updates on applicable U.S. case law
 Brief review of key modifications under the America Invents Act
 Practical steps and immediate considerations for prosecution,
collaboration/partnering and litigation strategies
Renita Rathinam, Partner, Litigation Practice, Sughrue
Mion, PLLC, USA
17:00 – 17:40 – The challenges of Developing Biobetters, They
has Better be Better!
 Biobetters, which are designed in discovery, need to differentiate in
the clinic, typically using the same or similar mechanism-of-action
 Biobetter 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 exeisting therapeutics
Dr. William R. Strohl, VP and Head, Biotechnology Center of
Excellence, Janssen R & D, Pharmaceutical companies of
Johnson & Johnson
18:20 – 18:30 – Chairperson’s closing remarks
Congress Day 1
Thursday – 18th September 2014 | London, UK
Reserved – To be Confirmed Shortly…

8
08:00 – 08:50 – Registration - Networking Coffee
08:50 – 09:00 – Chairperson’s Welcome and Opening Remarks
Richard DiCicco, Co-Founder, Harvest Moon Pharmaceuticals
09:00 – 09:40 – Biosimilars: Hurdles to Patient’s access
 Development of Biosimilars – Case Study
 INN
 Switching, Interchangeability and Substitution
Dr. Michel Mikhail, Chief Regulatory Officer, Executive VP,
Global Regulatory Affairs, Fresenius Kabi, Germany, EGA
Belgium
09:40 – 10:20 – Using Innovative Analytical Technologies to
Address Current challenges in Establishing Similarity for
Biosimilar Products
 Market and regulatory update
 Product characterization and process consideration
 Advances in label-free technologies and current industry trends
 Strategies to accelerate process development and quality control
 Industry case-study for EPO, G-CSF and Monoclonal Antibodies
Fredrik Sundberg, Global Director of Strategic Customer
Relations, GE Healthcare
10:20 – 10:50 – Networking afternoon refreshment break
(Exhibitors Area)
10:50 – 11:30 – Awaiting for full Presentation
Sarfaraz K. Niazi, Ph.D. – Founder, Chairman and CEO,
Therapeutic Proteins International
11:30 – 12:10 – Complexity of Biologics Manufacturing:
Manufacturing Changes in the Biosimilars Era
 Good manufacturing process
 Focus on patient safety
 Achieving a quality and reliable supply
Jaap Venema, Therapeutic Area Lead Biotherapeutics,
Global medical Affairs, Biologics Strategic Development,
Abbvie
12:10 – 12:50 – Mass Spectrometry for Characterization and
Comparability Analysis for Biosimilars
 Why mass spectrometry (MS) is growing in importance as
comparator
 Using MS in comparing Biosimilars to originator: What are the
benefits?
 Biosimilars - to- innovator comparisons
 Batch – to – batch comparisons
 Protein characterization
12:50 – 13:50 – Networking Lunch Break
13:50– 14:30 – Pharmacovigilance and Traceability
 Pre and post – authorization comparative testing
 Regulators tests – To ensure the manufacturing process are the
same for biosimilarity and immunogenicity
 Risk management
To be Confirmed Shortly – Awaiting for Speakers
Details
14: 30 – 15:10 – Biosimilar Infliximab- Experiences and
Expectations
 Experiences with Biosimilar Infliximab in Norway
 Physicians attitude and public debate
 Switching study
 Prices and reimbursement of Infliximab
Dr. Steinar Madsen, Medical Director, Department of Drug
Information, Norwegian Medicines Agency
15:10 – 15:40 – Afternoon refreshment break - Networking -
Exhibitors Lounge
15:40 – 16:20 – Biosimilars: Driving on Global Commercial
Potential through the Emerging Markets
 Understand how developing healthcare policy in the emerging
markets plays to the biosimilars opportunity
 Identify key emerging markets particularly conducive to the
biosimilars opportunity
 Determine non- pricing options for achieving competitive
advantage relative to other biosimilars Market
Richard DiCicco, Co- Founder, Harvest Moon
Pharmaceuticals, USA
16:20 – 17:00 – Regulatory strategies for biosimilars in
emerging markets
 Regulatory framework of biosimilars
 Interchangeability studies
 Clinical and non-clinical comparability studies
 Are we moving towards harmonization?
Silmara Cristiane Silveira Andreoli, Specialist in
Regulation and Health Surveillance, Coordination of
Biological Products, hemotherapic, GESEF / GGMED /
ANVISA
17:00 – 17:40 – Panel Discussion – How the Emerging market
countries is dealing with the Biosimilars Market
 Anticipate the growing demand for low-cost countries in
developing Biosimilars
 Recognise how the BRIC market will be a competitive presence in
Biosimilars
 Understanding how the BRIC and Asian government are assisting
local companies to develop biosimilars
 Silmara Cristiane Silveira Andreoli, Specialist in
Regulation and Health Surveillance, Coordination of
Biological Products, hemotherapic, GESEF / GGMED /
ANVISA
 Cyrus Karkaria, President, Biotech, Lupin Pharma, India
17:40 – 17:50 – Chairs Closing Remark – End of Conference
Richard DiCicco, Co- Founder, Harvest Moon Pharmaceuticals,
USA
Congress Day 2
Friday – 19th September 2014 | London, UK
Sponsor Spotlight Presentation
Take this unique opportunity to be a part of the conference
theme, network, share ideas and provide an overview of
your services to the audience. For more information contact:
r.magali@paradigmglobalevents.com

9
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