12th Biosimilars Congregation 2018
Offering our customers the knowledge and connections for a profitable business
Speakers
  • NIRAJ CHHAYA

    NIRAJ CHHAYA Boehringer Ingelheim

  • THOMAS SACHNIK

    THOMAS SACHNIK Teva Pharmaceuticals

  • SUE NAEYAERT

    SUE NAEYAERT Fresenius Kabi SwissBioSim

  • CHRISTIAN AGBOTON

    CHRISTIAN AGBOTON Takeda

  • ANNA AILLERIE

    ANNA AILLERIE Lupin

  • LIZ POLLITT

    LIZ POLLITT BPCRCS

  • FREDRIK SUNDBERG

    FREDRIK SUNDBERG GE Healthcare

  • BER OOMEN

    BER OOMEN European Medicines Agency

  • MAARTEN VAN BAELEN

    MAARTEN VAN BAELEN Medicines for Europe

  • LOUIS BOON

    LOUIS BOON Bioceros

  • PETER JORGENSEN

    PETER JORGENSEN Danish Generic and Biosimilar Medicines Industry Association (IGL)

  • ANDREAS HERRMANN

    ANDREAS HERRMANN Baliopharm

  • VLADIMIR ZAH

    VLADIMIR ZAH ZRx Outcomes Research (Canada)

  • ROBERT A. JOHNSTONE

    ROBERT A. JOHNSTONE International Alliance of Patients Organisations

  • STEINAR MADSEN

    STEINAR MADSEN Norwegian Medicines Agency

  • OMAR ALI

    OMAR ALI NICE

  • FEDERICO POLLANO

    FEDERICO POLLANO Polpharma Biologics

  • ALEX KUDRIN

    ALEX KUDRIN

  • DIVYA CHADHA MANEK

    DIVYA CHADHA MANEK NHS - NIHR Clinical Research Network

  • PAUL CALVO

    PAUL CALVO Sterne, Kessler, Goldstein & Fox (USA)

  • AIDAN FRY

    AIDAN FRY Generics Bulletin

  • SANDY EISEN

    SANDY EISEN Frontline Pharma Consulting

  • ANNA FORSYTHE

    ANNA FORSYTHE Purple Squirrel Economics (USA)

  • MARIE MANLEY

    MARIE MANLEY Bristows

  • JACQUELINE MULRYNE

    JACQUELINE MULRYNE Arnold & Porter

27th & 28th February 2018, Holiday Inn, Kensington High Street, London, UK

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

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CONFERENCE INTRODUCTION:-

The biosimilar impact is coming - The coming wave of biosimilars, which are essentially generic versions of expensive biologic drugs, are about to take a chunk of sales away from big pharmaceutical companies. The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. To date, EMA has approved 38 biosimilars. Three biosimilar approvals have been withdrawn, this leaves a total of 35 biosimilars approved for use in Europe.


The Biosimilars market is going to heat up considerably over 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 the growing number of diagnosed chronic diseases, it will be essential to harness the potential of Biosimilars to deliver savings, so that greater numbers of patients can be treated with these medicines.

Our 12th Biosimilars Congregation 2018 will provide insight into the current state of play in the EU and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. Beyond a comprehensive outlook of key European market access policies,  our speakers will outline the key recent developments in regulatory science and regulatory policy in the EU and other international jurisdictions. Special emphasis will be placed on strengthening the link between regulators and medical communities as an essential basis for greater understanding and acceptance of biosimilar medicines. 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 furthering Biosimilars development.

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 12th Biosimilars and Congregation 2018.



KEY THEMES:-

  • Strategies for market access and expansion by identifying key changes and future projections in biosimilars
  • Brexit and Biosimilars
  • Current market trends and future challenges for Biosimilar success
  • A Clinician ́s Guide to Biosimilars in Oncology: understanding the Science of Extrapolation and Interchangeability
  • Current challenges and opportunities - strategies to develop Biosimilars
  • Payer perspective on biológics and Biosimilars
  • Biosimilar Interchangeability: The newest regulation
  • Biosimilar, biobetter and next generation therapeutic antibodies
  • Guidance on interchangeability laws, patient litigation and IP rules
  • CMC, Preclinical and clinical considerations for Biosimilars and Follow-on Biologics
  • Impact of Technology
  • Know the challenges of Biosimilar manufacturing
  • Gain in-depth knowledge on role of technology transfer - How does this effect market access?
  • Biosimilars development and impact on clinical practice
  • Hear case studies on biosimilars drug development from pre-clinical to clinical and the various testing required such as immunogenicity and bio-similarity tests
  • Production of biosimilar MAbs
  • Research-based industry Biosimilar strategies
  • Considerations for the analytical similarity assessments when designing a Biosimilar development program
  • Determining the right investments & potential returns from Biosimilars
  • Latest developments in regulation to increase speed of entry and compliance
  • Future of next generation biosimilars
  • 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, 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 network with your conference colleagues.

09:30 – Chairperson opening remarks

LOUIS BOON, CSO, Bioceros


MARKET OVERVIEW & ANALYSIS

09.40 – The biosimilar business case

  • The profitability of the biosimilar business and its sustainability 
remains a major question mark for the corporate decision 
makers in pharma
  • The past has shown a variety of partnerships in the field driven 
by a high degree of uncertainty of the business model of biosimilars – While investments are high and returns uncertain, risk is shared by partnerships and collaborations along the entire value chain of biosimilars
  • Comparing the biosimilar waves, how will the business case change and how did and will the competitive landscape evolve?

THOMAS SACHNIK, Senior Manager Strategic Associate to the President & CEO Generics Europe, Teva Pharmaceuticals

PAYER’S PERSPECTIVE


10:20 – Integration, Assimialtion, Value based offerings and Future landscapes
OMAR ALI, Visiting Lecturer, University of Portsmouth & Former Adviser, NICE

11:00 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES


11:20 – Keynote Panel Discussion: Challenges & Opportunities - Consequences of Brexit on Biosimilars

  • Biosimilar Interchangeability
  • Preparing for the Implications of “Brexit” in the Pharmaceutical Industry
  • A difficult road ahead for a “Pure-Play” Biosimilar maker
  • How to strengthen biosimilar medicine developers in Europe
  • Biosimilars and Biobetters - Manufacturing and Bio-analytics
  • Future of next generation biosimilars
  • The key roles & responsibilities of pharmacists in biosimilars development
  • Biosimilars Policy “By Year End”

Moderator:
LOUIS BOON, CSO, Bioceros


Panellists:
OMAR ALI, Visiting Lecturer, University of Portsmouth & Former Adviser, NICE
DIVYA CHADHA MANEK, Head of BD (Commercial), NHS - NIHR Clinical Research Network

SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting

AIDAN FRY, Editor, Generics Bulletin

12:00 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com

12:20 – Current challenges and opportunities - strategies to develop Biosimilars

  • The usual suspects - a unique UK challenge
  • A UK strategy to drive delivery of biosimilar clinical trials - the Network approach
  • Facilitating success - case study examples of working with the biosimilars industry
  • Changing attitudes, appetite and acceptance in the NHS

DIVYA CHADHA MANEK, Head of BD (Commercial), NHS - NIHR Clinical Research Network

12:40 – Networking luncheon


SAFETY AND RISK MANAGEMENT PLANNING


13:50 – Biosimilars – savings and sustainability.

•    To switch or not to switch – to be or not to be?
•    The winner takes all – the problem of the second entrant
•    Are we throwing money out of the window?
STEINAR MADSEN, Medical Director, Norwegian Medicines Agency

COMMERCIALISATION & MARKET ACCESS


14:30 Panel Discussion: The commercial landscape and market access for Biosimilars: Planning in an uncertain environment

  • Comparison of US/EU biosimilar guidelines
  • Sustainability defined by the Stakeholders securing the future of healthcare
  • Challenges and obstacles faced by manufacturers in developing biosimilars
  • Bringing the next generation of Biosimilars to the market
  • Biobetters: Market access opportunity?
  • Evidence generation will be the key to future success

Moderator:
LOUIS BOON, CSO, Bioceros

Panellists:
STEINAR MADSEN, Medical Director, Norwegian Medicines Agency
SUE NAEYAERT, Global Head Pricing, Market Access, Government Affairs and Policy Biosimilars, Fresenius Kabi SwissBioSim
ANNA AILLERIE, Director, Commercial Biosimilars EMEA, Lupin

FREDRIK SUNDBERG, Director Strategic Customer Relations, GE Healthcare

ANNA FORSYTHE, Managing Partner, Purple Squirrel Economics (USA)


15:10 – Afternoon Tea/Coffee


15:30 – Biosimilars – Of all experience – What have we learnt? What are the challenges ahead?

  • Biosimilars market access and penetration in the current era – Considerations for providers, payers, prescribers and patients
  • Exploring government pricing and reimbursement policy challenges associated with biosimilars
  • Commercial potential and suceceful ways on how to gauge such an opportunity in biosimilar
  • The pricing and reimbursement of biosimilars in EU, US and Asia?
  • Why biosimilars are different to generics from a market access and impact perspective

MAARTEN VAN BAELEN, Market Access Director, Medicines for Europe

16:10 – Topic TBC
ROBERT A. JOHNSTONE, Board Member, International Alliance of Patients Organisations

16:40 – Switch management in Bio-Similar: Education of Nurses and collaboration in interdisciplinary context

  • Introduction in Nurses Guideline on Switch Managament
  • Patient safety in health means a collaborative and interdisciplenary approach
  • Continuing Professional Development for nurses on biosimilar medication: a shared responsebility

BER OOMEN, Expert Member Health Care Professionals, European Medicines Agency

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


17:20 18:20 Networking Drinks Session

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

09:30 – Chairperson opening remarks
LOUIS BOON, CSO, Bioceros


COMMERCIALISATION & MARKET ACCESS

09:40 – Topic TBC

SUE NAEYAERT, Global Head Pricing, Market Access, Government Affairs and Policy Biosimilars,
Fresenius Kabi SwissBioSim


MANUFACTURING


10:10 – Know the challenges of Biosimilar, Biobetters manufacturing

  • Best Practices for a competitive Market
  • Antibody and Biosimilar Manufacturing
  • Opportunities for Additional Industry Insight
  • Improving the Functional Characterization of Biosimilars
  • Biosimilar Milestone

LOUIS BOON, CSO, Bioceros

10:40 – Morning Coffee/Tea & Discussion

BUSINESS MODELS

11:00 – Differentiation as success factor for biosimilars

  • Different approaches to avoid the main stream
  • Reduce competition
  • How to differentiate

ANDREAS HERRMANN, CEO, Baliopharm


11:30 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com

11:50 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com


12:10 – The Danish way to a high uptake – a blueprint?

  • The role of science
  • The role of the Health Authorities
  • The role of payers, tenders and pricing
  • The role of stakeholder participation
  • The role of information to patients

PETER JORGENSEN, CEO, Danish Generic and Biosimilar Medicines Industry Association (IGL)

12:40 – Networking luncheon


13:40 – Case Study - Lean and cost efficient mAB production set up

  • Set up state of the art biopharmaceutical development and production in Europe
  • Cell culture and bacterial platform for internal and external customers
  • Modular/Flexible/Lean
  • Covering of the whole value chain from the cell line development up to large scale production
  • Costs of goods estimation from the very beginning

FEDERICO POLLANO, Director Contract Manufacturing and BD, Polpharma Biologics

14:10 Market access strategies for Biosimilars – Different strategies need to be deployed in different parts of the world
VLADIMIR ZAH, CEO, ZRx Outcomes Research (Canada)


CLINICAL

14:40 – Clinical considerations and challenges in pharmacovigilance for biosimilars

  • Pharmacovigilance: During clinical development and post-marketing phases
  • Key topics: Immunogenicity, Interchangeability, Risk management
  • Real world evidence

NIRAJ CHHAYA, Senior Risk Management Physician of Biosimilar Compounds, Boehringer Ingelheim

15:10 - Biosimilars: anatomy of a quiet clinical revolution

  • Impact of biosimilars in clinical setting: what is the evidence so far?
  • Interchangeability among biosimilars: Is it the future?
  • Biosimilars or new MoA: what’s best?

CHRISTIAN AGBOTON, Sr Global Brand Medical Director - Global Medical Affairs, Takeda

15:40 – Afternoon Tea/Coffee


16:00 Biosimilar development: analytical and clinical challenges. Pitfalls and lessons learned

  • Limitations of analytical and clinical tools: what is the path forward?
  • Oncology Mab biosimilar advances and difference in dynamics
  • Future trends and forecast of biosimilar market.

ALEX KUDRIN, Independent Consultant and clinical expert

REGULATION OVERVIEW & UPDATE


16:30 Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow

  • Highlighting the Differences between EU and USA in Terms of regulatory Requirements
  • Intellectual property and regulatory interplay in biosimilars
  • How regulators, payers and policy makers take initiatives to make healthcare more sustainable
  • Policy practices to maximise social benefit from Biosimilars
  • Regulatory changes necessary to maximize biosimilars potential
  • The way forward

Moderator:
LOUIS BOON, CSO, Bioceros

Panellists:
MARIE MANLEY, Partner, Head of the Regulatory Practice, Bristows
JACQUELINE MULRYNE, Counsel, Arnold & Porter

LIZ POLLITT, Head of CMC Regulatory Affairs Biosimilars, Merck Group
PAUL CALVO, Director, Sterne, Kessler, Goldstein & Fox (USA)


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


17:15 – End of the 12th Biosimilars Congregation 2018

NIRAJ CHHAYA

Senior Risk Management Physician of Biosimilar Compounds

Boehringer Ingelheim

Dr. Niraj Chhaya is a Risk Management expert for biosimilar portfolio within Global Pharmacovigilance at Boehringer Ingelheim based out of its corporate office in Ingelheim, Germany. After completing post‐graduation in Internal medicine, he started his career by joining Tertiary Care hospital in Mumbai, India. Apart from clinical practice, he was involved with clinical research as an investigator covering various therapeutic areas. After a decade of work in hospital setting, Dr. Chhaya joined pharmaceutical industry in 2006. He has more than 7 years of experience in the field of biosimilars through his involvement in clinical development, medical monitoring and pharmacovigilance at Dr. Reddy's Laboratories and Boehringer Ingelheim.

THOMAS SACHNIK

Senior Manager Strategic Associate to the President & CEO Generics Europe

Teva Pharmaceuticals

SUE NAEYAERT

Global Head Pricing, Market Access, Government Affairs and Policy Biosimilars

Fresenius Kabi SwissBioSim

CHRISTIAN AGBOTON

Sr Global Brand Medical Director - Global Medical Affairs

Takeda

ANNA AILLERIE

Director, Commercial Biosimilars EMEA

Lupin

LIZ POLLITT

Independent consultant - Biologicals CMC Regulatory Affairs

BPCRCS

Jackie Mulryne advises clients in the life sciences, medical devices, cosmetics and foods sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law, and has experience with a range of regulatory issues that arise throughout the product life cycle, including borderline classification, classification of new active substances, clinical research, authorisation, advertising and labelling, and pricing and reimbursement. She has assisted a number of life science and medical device companies with challenges to the decisions of regulatory authorities, and in developing and implementing cross-border regulatory action and compliance programmes.

FREDRIK SUNDBERG

Director Strategic Customer Relations

GE Healthcare

BER OOMEN

Expert Member Health Care Professionals

European Medicines Agency

After having his diploma on the job trained general nurse in 1980 he specialized in mental health nursing for long term high care clinical setting. Currently he is unit leader of a ward for  patients with severe mental conditions, Nijmegen Netherlands and responsible for overall patient and staff management.
In 2003 he joined the Dutch association for psychiatric nursing as secretary and was co-founder of the European Association for Psychiatric Nurses in Europe. He fulfilled the role as secretary general in the organisation until 2009. In 2005 he took part in the first network meeting of the European Specialist Nurses Organisations accepted in 2008 the position of secretary. He reform the network into an European association based in Brussels and current executive secretary of the ESNO.
In his position he is responsible for the overall management of the association, being proactive in expanding the network, advocating the role and position of the specialist nurse in the perused of recognition under the EU directive of professional qualification. He is active in a variety of health programs: Expert group health workforce of DG Sante, member of the European Policy Platform, Expert EMA health professional working party, participate in focus group in OECD on Skills mismatches, active on the bio-similar issue under DG Growth and EMA and antimicrobic resistance in EPHA and EMA. In ESNO he is project leader of the Switch Management Guideline for nurses.
In addition he is also a strong promoter of Continuing Professional Development and life Long Learning during nursing lifespan career, has a personal passion for creative thinking, generate opportunities, interconnect chances for others and loves outdoors activities in nature.

MAARTEN VAN BAELEN

Market Access Director

Medicines for Europe

The goal of « Medicines for Europe » (formerly EGA) is to improve health by ensuring better access to treatment for patients in Europe and beyond. As Market Access Director, the objective of Maarten’s team is to shape in the EU a dynamic and sustainable market situation that enables fast and fair pricing and reimbursement for generic, biosimilar and value-added medicines.

Maarten joined « Medicines for Europe » in 2011 as Medical Affairs Manager with responsibilities in the areas of fighting Falsified Medicines and Pharmacovigilance. In his life before the association, he worked in the pharmaceutical industry providing pharmacovigilance consultancy and in the medical device industry liaising with Key Opinion Leaders. He combined these roles while working weekends in a community pharmacy.

Maarten is a pharmacist by education and holds an MBA from “Solvay Brussels School of Economics and Management” and “École des Ponts Paris Business School”. 

Rue d'Arlon 50 - 1000 Brussels - Belgium
email: maarten@medicinesforeurope.com
T: +32 (0)2 736 84 11    +32 (0)2 239 20 10 (Direct)
+32 478 771 883 (Mobile)
www.medicinesforeurope.com

LOUIS BOON

CSO

Bioceros

Dr. Boon received his Ph.D. in Biochemistry at the University of Amsterdam. In 2003, he was one of the founders of Bioceros BV were he currently hold a position of CSO.
Bioceros generates production cell lines for the industry and used its proprietary CHOBC® platform to generate a portfolio of cell lines producing biosimilar monoclonal antibodies. Since the acquisition of Bioceros by EPIRUS in 2015, he extended this expertise and developed a complete process toolbox to fit biosimilar CQAs. After the acquisition of Epirus NL by the Polpharma Biologics group in June 2016, he has continued to work on biosimilar development and developed the SPOT™ technology to improve cell line productivity. Next to biosimilars, Dr. Boon is also responsible for the discovery and development of innovative new molecular antibody entities, which now within the Polpharma Biologics group can be extended to GMP production and clinical testing.  In addition, before he founded Bioceros, he held positions as CSO for MacroZyme BV, 4AZA Bioscience NV, FF Pharma and VP Preclinical for PanGenetics BV and Tanox. Dr. Boon is author of over 260 papers in international scientific journals in the field of medical biotechnology.

PETER JORGENSEN

CEO

Danish Generic and Biosimilar Medicines Industry Association (IGL)

•   Master in Political Science from the University of Copenhagen, 1977
•   40 years of professional experience, including:
•   Head of section in the Ministry of Social Affairs
•   Head of section in the Ministry of Labour
•   Labour Counsellor at the Danish UN-mission in Geneva
•   Health Counsellor at the Danish EU-representation in Brussels
•   Spokesman in the European Commission in Brussels for the Danish Commissioner for Environment and Climate Change
•   Advisor in the Cabinet of the Danish Minister for Health
•   Head of International Affairs in the Association of Danish Pharmacies (pharmacy owners)
•   Since 2013:
•   CEO in The Danish Generic and Biosimilar Medicines Association
•   Member of the Board of Medicines for Europe

ANDREAS HERRMANN

CEO

Baliopharm

VLADIMIR ZAH

CEO

ZRx Outcomes Research (Canada)

Dr. Zah brings more than 20 years of Health Economics, technology and business experience.  Since 2000, in various roles as Health Economist, Project Manager and Chief Investigator, Vlad has implemented more than 180 health economic models and assessments in the phase 2-4 setting across various disease areas for top 20 global pharmaceutical and medical device companies.

His PhD research on early vs. late HIV detection in the UK contributed to revisions in HIV early detection policies made by the UK Parliament in 2011.

He co-founded the Serbian ISPOR Chapter in 2007 and served as president until 2012. Vlad was ISPOR Central East Europe Executive Committee Chair 2015-17, and is Health Policy Council member and Meeting Travel Grants Committee chair.

ROBERT A. JOHNSTONE

Board Member

International Alliance of Patients Organisations

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.

OMAR ALI

Visiting Lecturer, University of Portsmouth & Former Adviser

NICE

FEDERICO POLLANO

Director Contract Manufacturing and BD

Polpharma Biologics

Federico Pollano is the Business Development and Contract Manufacturing Director at Polpharma Biologics, located in Gdańsk. He has 28 years of experience in pharmaceuticals and biopharmaceuticals mainly in senior and executive positions, which includes:
2008-2015 Richter-Helm-Biotec Managing Director
2005-2007 Helm AG - Executive Manager Generics
2001-2005 BioGenerix AG ratiopharm Business development - Member of the Management Board
1991-2001 GlaxoWellcome - Clinical research, pharmacoeconomics, business development
1989-1991 Zambon , Clinical research
Federico Pollano received his education at University of Bielefeld, specializing in Biology, as well as at Stockholm School of Economics

ALEX KUDRIN

Independent Consultant and clinical expert

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 till March 2016 he held position of a Vice-President and Head of Global Development at Celltrion Inc in Korea leading development efforts for Remsima/Inflectra and approvals in the US, EU, Canada, Australia and other territories. He has also led development of biosimilar rituximab and trastuzumab candidates. Currently he is biopharmaceutical consultant based in the UK. 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 70 publications including 5 books on immunopharmacology, immunopathology and immunology of cancer.

DIVYA CHADHA MANEK

Head of BD (Commercial)

NHS - NIHR Clinical Research Network

The Clinical Research Network
www.supportmystudy.nihr.ac.uk

Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Divya’s role is to maintain strategic relationships with Global and UK life sciences companies. Divya facilitates key discussions between life sciences industry and the Clinical Research Network. Divya provides advice and works collaboratively with companies on how they are able to tap into the Clinical Research Network services to ensure clinical studies are set up quickly and effi ciently so that they recruit to time and target. Divya also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organisation is evolving to service life sciences industry requirements.

Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Divya’s role is to maintain strategic relationships with Global and UK life sciences companies. Divya facilitates key
discussions between life sciences industry and the Clinical Research Network. Divya provides advice and works collaboratively with companies on how they are able to tap into the Clinical Research Network services to ensure clinical studies are set up quickly and effi ciently so that they recruit to time and target. Divya also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organisation is evolving to service life sciences industry requirements.

Delivering research to make patients, and the NHS, better

E: divya.chadhamanek@nihr.ac.uk
T: 020 3328 6700
M: 07886854261

PAUL CALVO

Director

Sterne, Kessler, Goldstein & Fox (USA)

AIDAN FRY

Editor

Generics Bulletin

SANDY EISEN

Chief Medical Officer

Frontline Pharma Consulting

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 Chief Medical Officer, 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)

ANNA FORSYTHE

Managing Partner

Purple Squirrel Economics (USA)

MARIE MANLEY

Partner, Head of the Regulatory Practice

Bristows

Maria Isabel is a Partner and head of the IP Regulatory Department at Bristows LLP. She specialises in European and UK regulatory and competition law in the bio-pharmaceutical and medical devices sectors.
She advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a pharmaceutical or a biotechnology business. In particular, Marie represents leading bio-pharma companies in litigation before the English and EU courts.  Recently, Marie successfully represented both Laboratoires CTRS before the General Court in relation to the Commission’s refusal to grant a marketing authorisation for an orphan medicinal product (Case T-301/12); and Seattle Genetics Inc. in an SPC case before the Court of Justice (C-471/12); as well as Shire Pharmaceuticals which secured a Paediatric extension. Marie also regularly co-ordinates EU and overseas litigation. Marie is also representing Les Laboratoires Servier against a decision of the EU Commission for breach of competition rules, as well as representing them in a damage action before the English Courts.
Marie also represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission).  For example, Marie successfully represented Clinuvel Pharmaceuticals before the EMA in relation to their application for SCENESSE®, a breakthrough drug.
Marie is Chairperson of the Legal Affairs Community for DIA. Marie is considered as a leading practitioner for regulatory law and is described by clients as a “regulatory superstar”. She is recommended in Legal 500, Chambers and Partners; also London Top 100 & London Top 50 Women and EU Law & Super Lawyers UK (2013).

JACQUELINE MULRYNE

Counsel

Arnold & Porter

Jackie Mulryne advises clients in the life sciences, medical devices, cosmetics and foods sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law, and has experience with a range of regulatory issues that arise throughout the product life cycle, including borderline classification, classification of new active substances, clinical research, authorisation, advertising and labelling, and pricing and reimbursement. She has assisted a number of life science and medical device companies with challenges to the decisions of regulatory authorities, and in developing and implementing cross-border regulatory action and compliance programmes.

ORGANISED BY

Virtue Insight

Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.

Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.

SUPPORTED BY

Pharma Phorum

Pharmaphorum is the primary facilitator of thought leadership and innovation within pharma. We support the next generation of pharmaceutical industry leaders through producing, curating and publishing media that will help pharma embrace the challenges of being a healthcare solutions provider in the 21st century.

Our services include:

  • Publication of interesting new written, audio and video content addressing critical pharma issues from around the world.
  • Showcasing key service providers who can work with pharma executives to forge the business models of the future.
  • Curation of global news, industry events and job opportunities within pharma.
  • Production of written, audio and video content for publication on pharmaphorum or client channels.
  • Advice and support on the use of social media within pharma to effectively connect companies, improve PR and share innovation.

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Conference Locate

Clocate.com is a leading international directory for worldwide conferences and exhibitions. Clocate.com is equipped with a unique and comprehensive search that helps you find easily any event in any category or location.  Each event includes detailed information, like, description, dates, location, map, prices, link to the official event's  website and more...

If you search for a conference or exhibition in areas such as Industry and manufacturing, Health and medicine, Technology and IT, Business and finance, sciences, education, services (banking, insurance, tourism, Hospitality and more), government, environment, life style and arts, you'll find it in Clocate.com

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Partnering with Virtue Insight means more than making the right contacts. It means being an insider. It means being connected to the right people with the right level of influence, and it means you are allied with a globally respected organization and leaders in the industry.?


Sponsorship, exhibiting and advertising packages are designed to provide a solid platform to help you stand out and make an impact. Our programs allow you to achieve your marketing goals and deliver a maximum return on your investment. We have developed convenient and customizable packages to help your organization meet its objectives and reach your target market.


Why Sponsor / Exhibit:

PROFIT: To Maximize
MARKET SHARE: Defending and Increasing Market Share
COMPETITION: To attach and defend against competition


Benefits:

  • Generating sales leads
  • Build brand image
  • Maintaining customer relations
  • Consolidating business relationships
  • Accessing new and emerging markets
  • Obtaining technical knowledge
  • Leverages the events extensive marketing campaign to add value to your organisations marketing strategy and budget leading up to the event
  • Live product demonstration to test market responses
  • Facilitating quick market penetration
  • Reach important targeted commercial prospects face to face in a social, relaxed environment. The ideal platform to build strong business friendships Strengthen your market position


Our conferences offer not only a unique combination of benefits (as listed above) to enable the sponsor/exhibitor to communicate the message but also a major opportunity that other forms of selling or media cannot provide.


Contact Us Today

UK
Email - sponsor.uk@virtueinsight.com
Tel: +44-2036120886


INDIA
Email - sponsor@virtueinsight.com
Tel: +91 44 64536444


Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.


What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


What are the benefits of attending?

  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
  • Enjoy our informal networking at drinks and lunch
  • Meet the leading solution providers in the market to forge partnerships and discover solutions
  • Receive electronic versions of the conference documentation for use of reference post-event.
  • Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
  • Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
  • Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
  • Delegates also benefit from discounted rates onfuture event attendance


For more information or to register at the event please contact us TODAY:


Contact Us Today

UK
Email - delegate.uk@virtueinsight.com
Tel: +44-2036120886


INDIA
Email - delegate@virtueinsight.com
Tel: +91 44 64536444

Introductory Offer (3 delegate places for the price of 2):- A huge saving of £750 - (Limited seats left) - You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

Super Early Discount (Valid From 03rd October 2017 - 17th December 2017):- Conference Delegate Pass (£750 + VAT per delegate) – You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

Standard Registration :-
Conference Delegate Pass (£1150 + VAT per delegate) – You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com


Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL: +44 2036120886. Email – sponsor.uk@virtueinsight.com

Holiday Inn, Kensington High Street

Address:
Wrights Lane, Kensington, London W8 5SP, United Kingdom
Phone:
+44 20 7368 4023

Testimonials from our past Biosimilars Congregations

 

 

Well discussed topics with a distinguished and prolific panel of experts in their respective fields in Biosimilars - Senior Business Analyst, Jakob & Partners

The only way to stay up to speed in this fast evolving market is to touch base with your peers. The biosimilars congregation is the right place to do it - Global Brand Manager & Global Biosimilars Business Intelligence, Merck Serono

I think the event was great and really threw insight on positioning biosimilars vis a vis other drugs on the regulatory side in India and World and what are challenges faced by industry as well as government and also regulators It was a great learning - AVP & Head Lega, Wockhardt

Excellent workshop. It did meet our expectation in term of complete representation of the biosimilar development - Senior Manager, Regulatory Affairs Sanofi

It was a splendid show yesterday, and esp with you and Sid managing the whole show so smoothly, was very well seen. Virtue Insight Staff were very helpful all throughout - Director, VIaTAL Pharma Consulting

All the topics picked up very good and were pretty informative. The panel discussions brought very nice views and insights on agenda points - BUSINESS DEVELOPMENT & PM, LUPIN BIOTECH

New topic to organize by virtue insight appreciate your choice of current hot topics participated as a deligate with inquisitiveness to learn more biosimilars mission accomplished - HEAD PV, BMS INDIA

Well done, most of the speakers selected for the conference were excellent and there was informative as well as participative discussion - MANAGER - BD & PROGRAM MANAGEMENT, LUPIN

A good interactive & learning session delivered by expert panels - BUSINESS ANALYST, JAKOB & PARTNERS INDIA PVT LTD

The conference is good to know about the regulatory scenario - Senior Research Scientist, Quantimmune Solutions

Good Discussion about commercial Challenges and lessons with 1st class biosimilar products and challenges/ development, regulatory and commercial with biosimilars MABs - Medical Assessor in Licensing of Biological Products, MHRA

Keeping in mind actuality of the biotech drug discovery and development, the Biosimilars Congregation 2012 defined  topics can be for congratulations only. Key items as pharma and generics industries approach relative to emerging and developing biosimilar market, clinical trials changes in clinical practice and evolution in understanding of the biology of the disease, challenges in clinical study design for biosimilar development arising from endpoint variability, identifying issues and solutions surrounding biosimilars etc., that have been discussed at the conference, gave the course for  predicting future trends inside the pharmaceutical industry worldwide. Choice of the lecturers as well as panelists  with so divergent, but so complementary  professional background, gave the Meeting special seriousness.Owing to this heterogeneity, the success of the after - lecture discussion as well as the panel ones, was even more productive and promotional  for next similar meetings. Moderators were professional and  prepared for all  the Keynote Addresses. They successfully  managed to bridge the gaps arisen from divergent attitudes occurred during the discussions. It contributed to the air of specificity and  uniqueness of that very Meeting. Summaries done from this Meeting shall remembered and incorporated in my professional work. I do hope that I could be able to participate your next Meeting /2013./ - Violeta Stanimirovic, Expert of medicines and medical devices agency, Serbia - Alims & expert of Montenegrian National Drug Agency - CALIMS Excellent cross section of up to date & future directions of Biosimilars - Director, Voisin Consuting Lifesciences

The programme and the format were very good and the atmosphere provided great encouragement for the networking.  It was timely organised allowing the participants to exchange opinions on very recent regulatory changes in the US and the EU - Scientific & Regulatory Director, Regem Consulting Ltd

All in all, Biosimilars Congregation 2012 was a very worthwhile and informative conference - Global Marketing Manager-Biotechnology, SACHEM

The Biosimilars Congregation proved to be an insightful range of presentations which covered the most important aspects of the biosimilars field. I’d recommend it to all stakeholders, manufacturers and regulators alike, who wants to network and gain more up-to-date knowledge in this exciting business area of biologics - Director, Corporate Business Development, CMC Biologics A/S

The presentations were informative and the panel discussions engaging,  covering key and important topics of debate.  The food and wine reception were excellent and allowed for relaxed networking opportunities - Director, Voisin Consulting Life Sciences

Biosimilar Congregation was a really good conference, well organized and of good quality - Senior Director Biopharmaceuticals and Scientific Advisory, Nuvisan GmbH

Biosimilars Congregation 2012 organised by Virtue Insight was a professionally managed event that was able to pull together a broad and relevant agenda presented by a well informed and insightful faculty. It was also very timely with the recent release of the US Biosimilar guidance which added a lot of new information that has not been previously discussed. I would certainly be interested in attending future events organized by Virtue Insight - Biosimilars and Proprietary Marketing Director, EMEA, Hospira, UK

The Biosimilars Congregation  has been a very informative gathering especially with respect to the future landscape and opportunities in Biosimilars - Managing Director - UK, Wockhardt

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