8th Biosimilars Congregation 2016
Offering our customers the knowledge and connections for a profitable business
Speakers
  • Uwe Gudat

    Uwe Gudat Merck

  • Ahmed Radwan

    Ahmed Radwan PIONEERA HealthCare Group (Egypt)

  • Atakan Yesil

    Atakan Yesil Abbott (Turkey)

  • Caroline Boulliat

    Caroline Boulliat Pfizer-Hospira

  • Malcolm I Mitchell

    Malcolm I Mitchell Eli Lilly

  • Cecil Nick

    Cecil Nick PAREXEL

  • Ken Walsh

    Ken Walsh Evidera

  • Gurmeet Singh

    Gurmeet Singh West Pharmaceuticals

  • Richard Littlewood

    Richard Littlewood Appliedstrategic

  • Alex Kudrin

    Alex Kudrin Celltrion (Korea)

  • Steinar Madsen

    Steinar Madsen Norwegian Medicines Agency

  • Alan Sheppard

    Alan Sheppard IMS Health

  • Francis P. Crawley

    Francis P. Crawley Good Clinical Practice Alliance - Europe (GCPA) & Member, Ethics Working Group, European Academy of Paediatrics (EAP)

  • Karsten Roth

    Karsten Roth Cinfa Biotech

  • Duncan Emerton

    Duncan Emerton FirstWord

  • Samantha Little

    Samantha Little Covance Laboratories

  • Peter Wittner

    Peter Wittner Interpharm Consultancy (Former Managing Director Ranbaxy UK)

  • Sandy Eisen

    Sandy Eisen Frontline Pharma Consulting

  • Mikhail Samsonov

    Mikhail Samsonov R-PHARM

  • Christopher Holloway

    Christopher Holloway ERA Consulting

  • Dominic Adair

    Dominic Adair Bristows

  • Maarten Meulenbelt

    Maarten Meulenbelt Sidley Austin

  • Anna Harrington - Morozova

    Anna Harrington - Morozova Regem Consulting

08th & 09th March 2016, Pestana Chelsea Bridge Hotel, London, UK

“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

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CONFERENCE INTRODUCTION:-

Biosimilars market is going to heat up considerably in the next three years. Biosimilar versions of a number of major biologic drugs used in the treatment of cancers and rheumatic diseases are expected to complete their development and potentially come on to the market. In order to ensure the sustainability of public healthcare systems, in the context of ageing populations and growing incidence of chronic diseases, it will be essential to harness to potential of biosimilars to deliver savings, so that greater numbers of patients can be treated with these medicines. The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. 

This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.  Hence, this 8th Biosimilars Congregation 2016 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place. By attending this conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting Biosimilars development. 

It gives me immense pleasure in welcoming all of you to the Virtue Insight’s 8th Biosimilars Congregation 2016.


KEY THEMES DISCUSSED IN THIS CONFERENCE:-
  • Current market trends and future challenges for biosimilar success
  • Biosimilar development in emerging markets
  • Payer Perspectives on Biosimilars - Current & future landscape with key drivers for NHS payers
  • Redesigning the biosimilar business model: What is the optimum business model for biosimilars?
  • Commercial challenges and opportunities - strategies to develop Biosimilars
  • Leading Biosimilars companies share their views and strategies on successful market penetration and learn to implement best practices through recent successful strategies and business models – real time case studies
  • How do payers see biosimilars and where the market is going?
  • Developing successful business models and dealing with every ambiguity in biosimilar product development
  • Advances in biosimilar clinical development and resulting regulatory challenges and opportunities
  • Non-Clinical Studies in biosimilars development
  • Biosimilars development and impact on clinical practice
  • Capturing the mAb biosimilar opportunity
  • Research-based industry biosimilar strategies
  • Gain in-depth knowledge on role of technology transfer - How does this effect market access?
  • Considerations for the analytical similarity assessments when designing a biosimilar development program
  • Determining the right investments & potential returns from Biosimilars
  • Understanding the current regulatory approval standards for Biosimilars in Europe, US and ROI including for monoclonal antibodies
  • Be part of a major networking opportunity

 

WHO SHOULD ATTEND:-

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

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

 

WHY SHOULD YOU ATTEND?
 
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway.  Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues   

09:30 – Chairperson opening remarks
 
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis, FirstWord


MARKET OVERVIEW & ANALYSIS

09:40 – Market access in the EU market and the way forward

  • Biosimilars – Market strategies and techniques to overcome the hurdles
  • Considerations for successful market of biosimilars
  • Market access experiences with initial biosimilars
  • Payer perception of antibody biosimilars
  • Surveying the battlefield: how are the key players lining up?
  • The way forward

ALAN SHEPPARD, Principal, Global Generics, Thought Leadership, IMS Health


10:20 – Biosimilars: current challenges & future opportunities in the MENA emerging markets

  • Emerging Markets & Biosimilars
  • MENA, Overview ,Analysis & Key Trends in the Healthcare Environment
  • Regulatory Landscape
  • Opportunities and Challenges for Biosimilars in MENA
  • Players & Partnership
  • Successful Commercialisation
  • Conclusion

AHMED RADWAN, Chairman & CEO, PIONEERA HealthCare Group (Egypt)


11:00 – Morning Coffee/Tea & Discussion


CHALLENGES & OPPORTUNITIES


11:20 – Keynote Panel Discussion: Market Challenges and Opportunities

  • Market opportunities for biosimilars – How about biosimilars coming through the R&D pipeline?
  • How to overcome some of the common developmental stumbling blocks that are being faced within the biosimilar sector?
  • What characteristics of biosimilar partnerships are critical in developing commercially successful biosimilars?
  • What is expected from the pricing strategy for this biosimilar?
  • How can payers and industry work together to ensure that innovative and valuable treatments make it to the market?
  • How do payers see biosimilars and where the market is going?

Moderator:
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis,
FirstWord

  

Panellists:
KEN WALSH, Senior Principal, Global Payer Strategy Consulting,
Evidera

CAROLINE BOULLIAT, Global Team Lead, Biosimilars, Pfizer-Hospira
MALCOLM I MITCHELL, Senior Medical Fellow, Clinical Pharmacology,
Eli Lilly

ALEX KUDRIN, VP and Head of Global Development,
Celltrion (Korea)

 

12:00 – “Education a key component in securing stakeholder confidence and enabling market success”
UWE GUDAT, Head of Safety, Biosimilars,
Merck

 

12:40 Networking luncheon

 

BUSINESS MODELS


13:50 – Importance of device selection for your biosimilar combination product

  • Review of devices used with branded biologics
  • Case studies of currently marketed biosimilar device combination products
  • Lifecycle strategies for devices to enhance your brand
  • Key risk factors and how to mitigate them in your selection process
  • Successful planning for device implementation

GURMEET SINGH, Director, Business Development, West Pharmaceuticals

 14:20 – Navigating  the mAb biosimilar regulatory maze

  • Ensuring quality before embarking on clinical Development
  • Ranking the importance of critical quality attributes
  • Analysing the monoclonal antibody
  • Guidelines: How to get regulatory approval of your mAb
  • Developing Biosimilar Mabs for EU vs. US vs RoW
  • The challenge of indication extrapolation for mAb Biosimilars
  • Drivers and barriers for mAb uptake:aligning the players

CECIL NICK, Vice President, Biotechnology, PAREXEL
 

15:00 – Afternoon Tea/Coffee 


15:20 – Biosimilar infliximab – lessons for future biosimilar monoclonals
 STEINAR MADSEN, Medical Director, Norwegian Medicines Agency

 

16:00 – A biosimilar CMC strategy for IDENTIFYING critical quality attributes

  • The EMA and FDA are interested in the ‘totality of evidence’ where the molecule and its physicochemical and biological attributes are assessed from the perspective of clinical relevance to support a claim of biosimilarity.
  • Assays used in these assessments need to have the ability to identify where changes in the molecule are key to clinical efficacy.
  • No type of assessment alone is capable of verifying biosimilarity and as such orthogonal approaches are required combining physicochemical and functional analyses.
  • Results from this approach should be reflective of a molecules critical quality attributes and should hopefully minimize the extent of any clinical studies for verification of biosimilarity, safety and efficacy.
  • We are presenting a case study exemplifying how identification of critical  quality attributes (linking to the known mode of action) could have mitigated risk to a biosimilar development program at the CMC characterisation stage.

SAMANTHA LITTLE, Lead Scientist at Global CRO (GCP/GLP/GMP), Covance Laboratories

 

16:30 - Panel Discussion: Developing successful business models and dealing with every ambiguity in biosimilar product development

  • What is the optimum business model for biosimilars?
  • Which are the emerging markets that represent the greatest commercial opportunity for biosimilars and why?
  • What are the funding opportunities for biosimilars within the emerging markets?
  • Global commercialisation strategies: How to strategically build a global biosimilar portfolio
  • Project management strategies for long-term biosimilar development projects

Moderator:
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis, FirstWord
  

Panellists:   
UWE GUDAT, Head of Safety, Biosimilars, Merck
PETER WITTNER, Senior Consultant,
Interpharm Consultancy (Former Managing Director Ranbaxy UK)

SANDY EISEN, Chief Medical Officer,
Frontline
Pharma Consulting
MIKHAIL SAMSONOV, Chief Medical Officer,
R-PHARM

 

17:10 Chairperson’s closing remarks and end of conference


17:20 – 18:10 Networking Drinks Session

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues

09:30 – Chairperson opening remarks
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis,
FirstWord


COMMERCIALISATION & MARKET ACCESS


09:40 – Payer Perspectives on Biosimilars - Current & future landscape with key drivers for payers

  • NHS Fiscal Landscape & Funding streams for medicines
  • National Guidance on Biosimilars from NICE and key issues for translational to Regional Uptake
  • Models for aggressive reimbursement from NHS Commissioners, inter-relationship with NHS providers and Clinical engagement models
  • Phased Introduction of Biosimilars within RA, Dermatology & GI/IBD within current NHS Commissioning Models, PbR issues & innovation trade-offs
  • Payer's perspectives on applicability of evidence and licensing, EMEA & regulatory issues
  • Payer's perspectives on the concept of "biosuperiors" and perceptions on biosimilar marketed by 'Big Pharma'

KEN WALSH, Senior Principal, Global Payer Strategy Consulting, Evidera

 

10:20 – Biosimilar litigation is born

  • A look at the recent Herceptin cases from the UK
  • Comparing to the Neupogen litigation in the US
  • Reasons why the litigation started
  • Future predictions as to what’s next

DOMINIC ADAIR, Partner, Bristows

 

11:00 – Morning Coffee/Tea & Discussion

 
11:20 – 10 years experience in biosimilars: launch to the future. What matters most?

RICHARD LITTLEWOOD, CEO Founder,
appliedstrategic

   

12:00 Commercial update of the performance of the first Mab biosimilar in Europe.
CAROLINE BOULLIAT, 
Global Team Lead, Biosimilars,
Pfizer-Hospira
 

 

12:40 Networking luncheon

 

PRECLINICAL & CLINICAL DEVELOPMENT
 

13:50 – Clinical development strategies; a mid size pharma perspective

  • Recent regulatory guideline updates, impact for preclinical and clinical development programs
  • Clinical trial models to test for bioequivalence
  • Pk, PD and immunogenicity testing in clinical trials

KARSTEN ROTH, Director Clinical Operations, Cinfa Biotech
 

14:30 – What constitutes a successful biosimilarity package for a biosimilar monoclonal antibody 
CHRISTOPHER HOLLOWAY, Group Director of Regulatory Affairs,
ERA Consulting


15:10 – Afternoon Tea/Coffee

 

15:30 – Health policy environment in Turkey and impact on Biosimilar R&D and production 

  • Macro Political & Economic Environment
  • Health Policy Environment
  • Incentives for Biotech products’ R&D and Production
  • Pricing & Reimbursement of Biosimilars
  • Interchangibility / Substitution of Biosimilars in Pharmacy Level

ATAKAN YESIL, Market Development & Reimbursement Manager, Abbott (Turkey)

 
REGULATION OVERVIEW & UPDATE


16:10 Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow

  • The latest in regulatory thinking - Update and current trends for EU and US biosimilar approvals, new and future guidelines. What has changed? – Get yourself updated.
  • What is the best way for industry to present data to the regulatory authorities?
  • Regulatory changes necessary to maximize biosimilars potential
  • How similar is similar? What is likely not to be accepted by the regulator?
  • What types of additional risk minimisation measures may be necessary?
  • IP and regulatory rights

Moderator:
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis, FirstWord


Panellists:

FRANCIS P. CRAWLEY, Executive Director, Good Clinical Practice Alliance –Europe (GCPA) & Member, Ethics Working Group, European Academy of Paediatrics (EAP)
MAARTEN MEULENBELT, Partner, Sidley Austin
ANNA HARRINGTON-MOROZOVA, Scientific & Regulatory Director, Regem Consulting
CHRISTOPHER HOLLOWAY, Group Director of Regulatory Affairs, ERA Consulting
  

16:50 Chairperson’s closing remarks and end of conference
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis,
FirstWord

 
17:00 – End of the 8th Biosimilars Congregation 2016 

Uwe Gudat

Head of Safety, Biosimilars

Merck

Ahmed Radwan

Chairman & CEO

PIONEERA HealthCare Group (Egypt)

Ahmed is currently the CEO of PIONEERA HealthCare Group and Vice President of INTEC for consultation. He has over 25 years of experience within the healthcare industry, including ethical pharmaceuticals, OTC, generics, medical devices & management consultation. His working experience included French, German, Japanese, British and Swiss multinational healthcare & pharmaceutical companies.

Previous positions held include; Marketing Director of Novartis, Egypt, Regional Marketing Director GSK, Near East and Regional Marketing Director of the Middle East, Otsuka . He also assumed the position of Managing Director at two market leaders in Egypt in their specialized fields in the healthcare sector, IFT & AB Pharma. Radwan has also provided professional advice on management processes and new launches in the major MENA markets to several local & multinational companies.

On the academic side, Ahmed is an Adjunct Professor of Management at the American University in Cairo& he also lectures at the MBA programme of Edinburgh Business School; Herriot Watt University and the Chartered Institute of Marketing, CIM.

Atakan Yesil

Market Development & Reimbursement Manager,

Abbott (Turkey)

Atakan Yesil has a Master of Science degree in Industrial Engineering, he also is holding a postgraduate diploma from UCBL-France in Market Access. He’s been working for Pharma industry for 15 years, where he spent his last 6 years on the management of Market Access, Health Policy, International Reference & Strategic Pricing, Health Economics & Outcomes Research and Stakeholder Engagement topics in Sanofi, MSD & Abbott. He’s currently working for Abbott as Market Development & Reimbursement Manager since 2014 for Turkey & Middle East Region.

Caroline Boulliat

Global Team Lead, Biosimilars

Pfizer-Hospira

Caroline Boulliat is Global Team Leader – Biosimilars at Pfizer/Hospira and is based in the UK. She has been in the pharmaceutical industry for about 15 years, working in a variety of commercial and market access roles in  European markets mainly but also emerging markets.

Caroline joined Hospira in 2014 to launch the First Monoclonal Antibody Biosimilar approved in Europe.

Now, at Pfizer / Hospira she is responsible for the commercialization of the worldwide immunology biosimilar business.

Malcolm I Mitchell

Senior Medical Fellow, Clinical Pharmacology

Eli Lilly

Malcolm Mitchell is a graduate of Newcastle Medical School, following a decade in the NHS, he joined the pharmaceutical industry over 30 years ago, with positions in Pfizer, NAPP and Lilly.  He has been working in  clinical pharmacology at  Eli Lilly for the past 20 years. He has been involved  in ongoing drug development for many aspects of clinical pharmacology through the portfolio. This includes most of the studies performed from FIH through to BE for formulation change, working with both small molecule NCEs and biologicals. The extensive changes over the years in expectations of results from FIH studies has been a focus.

Cecil Nick

Vice President, Biotechnology

PAREXEL

Cecil Nick, Vice President (Technical), at PAREXEL Consulting has been working in regulatory affairs and clinical development for over 30 years; for over 25 years he has focused on biological medicines. Cecil Nick has particular expertise in monoclonals and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported  6 submissions in the EU and US. He has also participated extensively in Industry and International meetings on the subject. Additionally, Cecil Nick has extensive experience in orphan drugs and in numerous therapeutic areas including, but not limited to, oncology, inflammatory disease, diabetes, growth and hematology.

Since joining PAREXEL in February 2001 Cecil has applied his extensive scientific, drug development and regulatory experience in supporting clients  with clinical development plans and regulatory strategies for EU, US and global approval. In the last five years alone he has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft plans which are effective, highly efficient and achievable

Cecil has been working in Regulatory Affairs since 1979. From 1987 – 2000, prior to joining PAREXEL, Cecil served as Regulatory Manager at Novo Nordisk Ltd., working on the development and registration of biotechnological products and NCE’s. In addition he has knowledge of health economic assessments.

Cecil is a Fellow of TOPRA and has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University MSc in Pharmaceutical Sciences courses and Biotech Module leader for the TOPRA MSc course. He was on the editorial panel of SCRIP Clinical Research and has authored many articles on regulatory and clinical development issues.

Ken Walsh

Senior Principal, Global Payer Strategy Consulting

Evidera

Ken leads the London based Payer Strategy Consulting team as a Senior Principal

Ken brings 13 years of global market access and pricing experience spanning both industry and consulting roles based in the US, EU and Emerging Markets

Ken recently joined Evidera from GlaxoSmithKline where he was head of pricing across their portfolio in the Emerging Markets Asia Pacific (EMAP) division based at their HQ in Brentford

Prior to joining GSK, Ken was head of Global Pricing and Market Access for Sandoz’s Biosimilars and Oncology Injectibles Business Unit based at their HQ in Munich

Prior to moving into industry Ken spent 10 years in consulting based in the USA and Asia with companies including Bridgehead, Kantar Health, GfK Healthcare and Cambridge Pharma

Ken holds a MA in Economics from Heriot-Watt University and an MSc in Finance from the Cass Business school, London

Gurmeet Singh

Director, Business Development

West Pharmaceuticals

Richard Littlewood

CEO Founder

Appliedstrategic

Dr Richard Littlewood has worked for 15 years in healthcare and life sciences strategy. He is a UK registered physician with an MA from Trinity College, Cambridge and is a graduate of the Sloan Masters management program at London Business School. He worked at Bain & Company and Pfizer. He started the strategy firm, applied strategic in 2005 and continues to serve clients in life sciences.

Biosimilars are a key area of focus: he worked directly on the launch of the first complex biosimilars in Europe from 2007, advising on strategic, development and commercial matters. He continues to advise international companies on biosimilar strategy and is expert in emerging markets opportunities. This is matched with a range of other work in regulatory and marketing strategy, new business development and valuation advisory work.

Alex Kudrin

VP and Head of Global Development

Celltrion (Korea)

Dr Alex Kudrin has graduated Orenburg Medical Academy in Russia in 1997 and received PhD / MD in Respiratory Medicine and Immunology from Moscow Medical University (2001) and MBA from Westminster University in London (2011). He was employed at Acambis, GlaxoSmithKline, GlaxoSmithKline Biologicals and Takeda Global R&D at various senior positions in clinical development of novel anti-inflammatory agents and vaccines. Between 2007-2012, he was appointed as a Medical Assessor in Biological PLAT of Licensing Division at MHRA in London participating in clinical evaluation, scientific advice and approval of various biotechnology products, including monoclonal antibodies, vaccines, blood products, and advanced cell therapies. Since September 2013 he holds position of a Vice-President and Head of Global Development at Celltrion Inc in Korea. Dr Kudrin has specific interests in biosimilars, oncology, immunology, vaccines; clinical development, emerging markets in Asia, Latin America and Russia. He is an author of 60 publications including 5 books on immunopharmacology, immunopathology and immunology of cancer.

Steinar Madsen

Medical Director

Norwegian Medicines Agency

Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr. Madsen is also engaged in the drug information service, with a special interest in the safe and cost-effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.

Alan Sheppard

Principal, Global Generics, Thought Leadership

IMS Health

Alan has over 45 years extensive experience within the healthcare industry, including innovator R&D pharmaceuticals, OTC and generic companies and working with Government departments, law firms, venture capital companies and industry associations.

Heading up the global generics arm of IMS Health’s Thought Leadership Alan is responsible for developing services and insights for the industry and its associations on generic medicines and biosimilars through a combination of consulting, information and market analyses.

Previous positions held include Executive Vice-President, Europe Generics, for Dr Reddy’s Laboratories Ltd; Vice-President of Global Corporate Strategy for PLIVA (now Teva); European Marketing Director for Medeva (now UCB); General Manager, Rhône-Poulenc Rorer UK (now Sanofi); General Manager, Institute Mérieux UK; and management roles with Servier Laboratories, SmithKline & French and Upjohn.

Alan is also an expert witness on patent litigation issues and their commercial impact, working with leading international law firms.

Other roles have included Chairman of the Technical Advisory Group for the Access to Medicines Foundation; guest lecturer at the University of Wales working in the medicines faculty specialising in pharmaceutical marketing; a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board; a Fellow of the Chartered Institute of Management; Fellow of the International Doctors’ Association and Member of the Chartered Institute of Marketing.

Francis P. Crawley

Executive Director

Good Clinical Practice Alliance - Europe (GCPA) & Member, Ethics Working Group, European Academy of Paediatrics (EAP)

Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe in Brussels, Belgium. He is the co-founder and a Steering Committee member of the Strategic Initiative for Developing Capacity in Ethical Review. He is a philosopher specialised in ethical, legal, and regulatory issues in health research, teaching at several European, Asian, and Middle East universities. He is the past Secretary General, Ethics Officer, and Chairman of the Ethics Working Party at the European Forum for Good Clinical Practice. He has acted as an author or expert for the leading international and European research ethics and GCP guidelines, as well as for several guidelines in Asia, Africa, the Americas, and Europe.

He is currently Chairman of the Ethical Review Committee of the International Network for Cancer Treatment and Research (INCTR); a member of the INCTR Tissues Committee; and a member of the Ethics Committee of the European Organization for Research & Treatment of Cancer; Consultant to the Peking University Institutional Review Board; and a member of the Steering Committee of the Chinese Ethics Committee of Registering Clinical Trials (ChECRCT). He has been a member of the joint EMVI-AMVTN Ethical Review Committee; a Permanent Liaison Officer to the International Bioethics Committee of UNESCO; and a Contact Officer for CIOMS. In 2006 he was Visiting Expert in research ethics in the Health Manpower Development Programme, Ministry of Health, Singapore.

He the committee chairman of the WHO guidelines on ethics committees and data monitoring committees; and he was a member of the Scientific Advisory Committee for the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). He also served for four years on the UNAIDS Ethical Review Committee. He is a co-founder and past Steering Committee Member of the Global Forum for Bioethics in Research; a past member of the Committee of Interested Parties of the Centre for the Management of Intellectual Property in Health Research & Development; a past member of the European Science Foundation’s Education Working Group, and a past member of the WHO GCP Handbook drafting committee. In addition, he is a member of the Ethics Working Group, European Academy of Paediatrics (UEMS-EAP); and an investigator in several European Commission projects, including ‘The Development of European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations’, ‘Ethical Function in Hospital Ethics Committees’, & ‘Ethical Considerations in Clinical Trial Collaboration with Developing Countries’, ‘European Network for Expertise for Rare Paediatric Neurological Disorders (nEUroped)’ and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials (RESPECT). He is also Vice-Chairman of the Ethics Committee of the<

Karsten Roth

Director Clinical Operations

Cinfa Biotech

Karsten Roth is Director of Clinical Operations at Cinfa Biotech, leads all of Cinfa Biotech’s clinical development programs. He is responsible for the development and implementation of preclinical, clinical and post-approval activities.. He has more than 20 years of experience in the pharmaceutical industry having held various executive positions with a strong focus on clinical development across several therapeutic areas. He worked at big pharmaceutical companies in Europe like Astellas, Novartis Pharma and recently Sandoz Biopharmaceuticals in several global functions before taking up a new opportunity at Cinfa Biotech. In his current function, he is a member of the executive board and responsible for the clinical development and operational oversight of pre-clinical, clinical and post approval activities. In his role he is supervising the clinical operations teams including internal and external stakeholders. Within his function, he plays an active part in due diligence processes and long term strategic planning. In addition he is a member of international advocacy groups and presented at several scientific advice meetings at the EMA, FDA and PMDA.

Karsten holds a PhD in biochemistry, a postgraduate degree in pharmaceutical medicine and a Masters in project management from the George Washington University.

Duncan Emerton

Senior Director, Syndicated Insights & Analysis

FirstWord

Duncan has been working in the pharma industry for over 15 years, gaining experience across a broad range of disciplines including pre-clinical and clinical R&D, sales, marketing, medical affairs, competitive intelligence, management consulting, and business analysis. For nearly a decade, Duncan has followed the biosimilars market, and is recognised as one of the leading international voices on the subject. He is a regular presenter and Chair at biosimilar-focused conferences, has contributed several articles and book chapters on key issues in the biosimilars industry, and runs The Biosimilarz Blog (www.biosimilarz.com).

Next month Duncan will be attending the European Biosimilar Group’s 14th annual biosimilars conference where he will be presenting and facilitating an interactive panel discussion on how biosimilars have performed so far, and what the future holds. Duncan holds a BSc(Hons) in Medical Biochemistry from the University of Surrey, and a PhD in Microbiology from the University of Kent.

Samantha Little

Lead Scientist at Global CRO (GCP/GLP/GMP)

Covance Laboratories

Dr. Samantha Little is a Lead Scientist within the BioPharmaceutical CMC Solutions Division at Covance, a global drug development company, where she has worked since 2009. She has experience in CMC methodologies to support drug development of Biologics including ADCs and Biosimilars and has been a member of the Global Bioanalysis Consortium Harmonisation Team for Large Molecule Run Acceptance. Previous to Covance, Samantha worked as a Senior Scientist for a biodefense company and a post-doctoral fellow at the Hull York Medical School researching proteomics and angiogenesis. Samantha has a PhD in analytical chemistry.

Peter Wittner

Senior Consultant

Interpharm Consultancy (Former Managing Director Ranbaxy UK)

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial aspects of generics with nearly 40 years’ pharmaceutical experience. The major part of this has been spent the generic industry. He was Managing Director for the UK subsidiary of the Indian generic leader Ranbaxy, having joined them to set up the business before returning to consultancy work (http://www.interpharm-consultancy.co.uk/).

Before that, he had headed the European Sales & Marketing department of the UK generics companies Evans Medical and H.N. Norton, which later became part of IVAX and then Teva.

In the field of generics, Interpharm works with new market entrants on developing commercial strategies, compiling competitor intelligence and gaining EU-GMP approval and assists in business development for companies outside the EU that are trying to enter the market. Recently, he has increasingly become involved in the field of biosimilars.

On the other side of the equation, Interpharm has also worked with originator companies that are looking at ways of defending their major brands from generic incursion or are themselves considering entry in to the field of generics.

Peter is a regular speaker at generic and biosimilars conferences, and runs workshops on generic and Biosimilars topics for various organisations as well as conducting training seminars. He has written a number of reports on generics industry topics and a series of reports for Decision Resources and other publishers. Originally based in north London, Peter has now relocated to Israel.

Sandy Eisen

Chief Medical Office

Frontline Pharma Consulting

(Previously Chief Medical Officer, Teva Europe, 2006 – 2011)

Dr Eisen graduated from Cambridge University in 1980 and studied clinical medicine at St Bartholomew’s Hospital Medical School in London.  He has postgraduate medical qualifications in Surgery and in Pharmaceutical Medicine and now has over 25 years’ experience in pharmaceutical regulation and pharmaceutical medicine.  He has worked in several senior positions in both Government and the Pharmaceutical Industry, most recently having been Chief Medical Officer for Teva Pharmaceuticals Europe for 5 years.

In 2011 he set up his own Company, Frontline Pharma Consulting Ltd providing independent advice to pharmaceutical and financial companies on all aspects of research, pharmaceutical regulation and drug safety, and covering innovative products, biosimilars and generics in all therapeutic areas.  He also works on contract in interim senior management roles, including Medical Director, Clinical Research Director and as a Senior Safety Physician/QPPV.

Contact details:

Sandy.eisen@btinternet.com

+44 7921 495663 (mobile)
+44 0208 3648426 (office)

Mikhail Samsonov

Chief Medical Officer

R-PHARM

Dr. Mikhail Samsonov is currently Head of Development, Medical and Regulatory at  R-Pharm managing all activities across several therapeutic areas (cardiology, oncology, infectious disease and rheumatology)  in fast growing R&D company. He is a member of several Joint Steering Committees with Merck, Eli Lilly, UCB, Theravance, Quintiles etc dedicated to technology transfer, development and commercialisation of innovative medicines, biosimilars and generics.

Prior RPharm he was Chief Scientific Officer at Novartis Russia & CIS overseeing all R&D activities for Novartis in one of key complex emerging markets and  member of Board of Directors Association of Clinical Trials Organizations in Russia in 2009-2011.

Dr Samsonov was  Executive Director Regional Clinical Operations at Bristol-Myers Squibb Company overseeing EMEA and Asia Pacific regions including such emerging markets as China, India and Eastern Europe during last three years in BMS.  With over 14 years of experience at BMS in variety of roles in medical affairs and clinical operations, Dr Samsonov has dedicated much of his career to building capabilities in fast-growing clinical research markets , continuous productivity improvement in well established R&D markets and developing  10 new molecules in several areas ( antibiotics, autoimmune, CNS, CVS, oncology, virology). He was based at several BMS offices in the US, UK, Russia and Belgium.

Dr. Samsonov’s education includes MD from Moscow Medical University, National Cardiology Centre (Moscow) training  in Clinical Cardiology,  Ph.D. in Cardiology & Immunology from National Cardiology Centre, BA from Open University, London and several  business courses at INSEAD and OWEN business school.

He is an active speaker and panel expert at various international conferences at scientific conferences, DIA, BIO USA, industry and investor meetings  on development  strategies, operational models, vendor management  in established and  emerging markets.   

Christopher Holloway

Group Director of Regulatory Affairs

ERA Consulting

Dr. Chris Holloway has worked in regulatory affairs, specialising in biotech products and other biologics for nearly 30 years, since leaving academia, where he was Professor of Clinical Biochemistry at Hannover Medical School in Germany. Chris graduated in 1971 and obtained his Ph.D. in 1975, after which he held a Royal Society European Research Fellowship at the Max-Planck-Institute in Germany. He then moved into university, and was awarded the Venia Legendi in 1982.

Chris began consulting in the regulation of biologics in the 1980s. Subsequently, in 1987, he launched the regulatory consultancy that is now the ERA Consulting Group, providing advice on processes and products, as well as regulatory support to a large number of client companies. At the vanguard of this field, Chris has personally been involved in the development of over 400 different biological products, contributing particularly towards approaches to manufacturing and control as well as early non-clinical and clinical development. His team has compiled complete dossiers, and Chris authors expert reports for European and international submissions. He has personally had oversight in the approval of novel as well as biosimilar products in Europe and his team and, most recently, Chris played an instrumental role in the approval of the first stem cell product in Europe.

Of the many twists, turns and pitfalls of getting these complex products to market, Chris has interacted with EU member state agencies, the EMA and FDA. Coupled with a thorough knowledge of current regulatory guidelines and regulatory expectations in general, this has enabled clients of ERA to confidently navigate these challenges, thus expediting their application. Finally, Chris is a sought-after speaker for numerous courses and seminars each year and is always delighted to share his knowledge and experience on how to build a prudent strategy for development of complex biologics, in this case biosimilar products.

Dominic Adair

Partner

Bristows

Dominic is a partner in the patent litigation group at Bristows LLP. He specialises in life sciences cases, reflecting his scientific background in this area (BA Natural Sciences and PhD Zoology, University of Cambridge).

He has extensive experience of cross-border litigation in and beyond Europe. This has involved working closely with other lawyers, in-house and external, to ensure alignment with global strategic objectives concerning the defence and enforcement of several portfolios of patents.

In the pharmaceutical and biotechnology sector, Dominic has worked on all aspects of the drug life cycle, from freedom to operate analyses and early-stage risk assessment of generic competition to end-stage litigation, SPCs and anti-trust issues.

Dominic writes regularly on reported patent cases in the UK and at the EPO. He is a member of the European Patent Lawyers Association (EPLAW) and sits on the UK council of AIPPI. He is a regular conference speaker and presenter.

Maarten Meulenbelt

Partner

Sidley Austin

MAARTEN MEULENBELT is a partner in Sidley’s Brussels office and a member of the firm’s Global Life Sciences practice and Antitrust practice. Maarten focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe.

In addition to advising on EU life sciences matters, Maarten also handles competition litigation at the EU and national levels. He has extensive litigation experience before the EU Courts, national courts and competition authorities, the European Commission and national regulatory authorities in several EU Member States. Maarten has significant competition law experience in a variety of sectors.

Maarten writes and speaks widely on legal issues affecting the life sciences industry and is featured prominently in the life sciences and competition rankings of leading bar publications, such as Chambers, The Legal 500 EMEA and Who’s Who Legal. Clients in Chambers Europe 2014 describe him as a "sharp, hands-on lawyer who is clear regarding what can be done and realistic about chances and possibilities." Most recently Maarten has been recognized in the LMG Life Sciences for regulatory and non-IP litigation enforcement.

MEMBERSHIPS & ACTIVITIES

• Dutch Association of Pharmaceutical Law
• Dutch Association of Procurement Law
• Member of the Editorial Board of Scrip Regulatory Affairs

Anna Harrington - Morozova

Scientific & Regulatory Director

Regem Consulting

Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained in regulatory authority, academia, clinical and industry environment.

Anna’s senior positions in global pharmaceutical and health care industry in Russia and the UK included GSK, EISAI and Procter & Gamble, as well as global CROs and regulatory consultancy groups PAREXEL, ICON and PRA.

Anna currently acts as a Scientific and Regulatory Director at Regem Consulting Ltd. Regem Consulting Ltd is a regulatory and drug development consultancy with a focus on global regulatory and drug development strategies, advocacy and registrations in emerging markets.

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