biosimilars global congress 2014 europe copy 3 (6)

To Book Call: +44 (0) 207 193 3485 / Email: [email protected] / 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

mailto:[email protected]

http://www.paradigmglobalevents.com/

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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 [email protected]

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: [email protected]






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Biosimilars Global Congress 2014 Europe 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:



“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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Biosimilars Global Congress 2014 Europe 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 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


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


Biosimilars Global Congress 2014 Europe Congress Day 1

Thursday – 18th September 2014 | London, UK

Reserved – To be Confirmed Shortly…



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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 – 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


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


Biosimilars Global Congress 2014 Europe 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:

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Biosimilars Global Congress 2014 Europe

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Health & Medicine