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

  • MICHAEL MUENZBERG

    MICHAEL MUENZBERG Comparative Outcomes Group, Amgen

  • CHRISTIAN AGBOTON

    CHRISTIAN AGBOTON Takeda

  • KAUSTUBH BERDE

    KAUSTUBH BERDE Wockhardt

  • CORNELIA ULM

    CORNELIA ULM Biotec Regulatory Consulting GmbH (former Fresenius Kabi SwissBioSim GmbH)

  • HANMANT BARKATE

    HANMANT BARKATE Glenmark

  • LIZ POLLITT

    LIZ POLLITT BPCRCS

  • FREDRIK SUNDBERG

    FREDRIK SUNDBERG GE Healthcare

  • BER OOMEN

    BER OOMEN ESNO, European Specialist Nurses Organisations

  • 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)

  • PEARL FONG

    PEARL FONG Mycenax Biotech

  • ANDREAS HERRMANN

    ANDREAS HERRMANN ValeriusBio

  • VLADIMIR ZAH

    VLADIMIR ZAH ZRx Outcomes Research (Canada)

  • ROBERT A. JOHNSTONE

    ROBERT A. JOHNSTONE

  • STEINAR MADSEN

    STEINAR MADSEN Norwegian Medicines Agency

  • OMAR ALI

    OMAR ALI NICE

  • ALEX KUDRIN

    ALEX KUDRIN

  • DIVYA CHADHA MANEK

    DIVYA CHADHA MANEK NHS - NIHR Clinical Research Network

  • CHIRAG SHAH

    CHIRAG SHAH Cliantha

  • PAUL CALVO

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

  • AIDAN FRY

    AIDAN FRY Generics Bulletin

  • SANDY EISEN

    SANDY EISEN Frontline Pharma Consulting

  • ADRIAN RABE

    ADRIAN RABE Purple Squirrel Economics

  • CHRISTOPHER STOTHERS

    CHRISTOPHER STOTHERS 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 Three biosimilar approvals have been withdrawn, this leaves a total of 35 biosimilars approved for use in Europe.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.

09:20 – Chairperson opening remarks

LOUIS BOON, CSO, Bioceros


MARKET OVERVIEW & ANALYSIS

09.30 – 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


10:00 – Integration, Assimialtion, Value based offerings and Future landscapes

  • NHS Fiscal overview and why medicines funding landscape
  • New NHS CQUINs on Biosimilars and how payers are implementing this
  • How Payers are aligning biosimilars with innovative parent brands to streamline patient care settings
  • Physician loyalty [brand v biosimilar and biosimilar v biosimilar] and how this affects formulary uptake
  • What value offerings from biosimilars resonate with payers and formulary decison makers
  • Drivers for outcomes based, innovative contracting for new medicines
  • Bridging the 'uncertainty gap' between payers & pharma - the shifting paradigm

OMAR ALI, Visiting Lecturer, University of Portsmouth & Former Adviser, NICE

10:40 – Cost vs Quality: What’s the best strategies for Emerging Markets

  • Exploring biosimilar opportunities in Emerging Markets
  • Exploring market entry strategies in addressing differences in biosimilar regulation
  • Understanding the changing market dynamic and landscape in emerging markets

KAUSTUBH BERDE, Vice President - International Business : Emerging Markets, Wockhardt

11:10 – Morning Coffee/Tea & Discussion


CHALLENGES & OPPORTUNITIES


11:30 – 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

12:10 –
Clinical strategies for development of Biosimilars

  • In the development of Biosimilars, clinical strategies should aim to resolve uncertainties that may remain post preclinical development regarding the similarity of proposed biosimilar with the reference product.
  • Pharmacokinetic and pharmacodynamics studies create a sound scientific platform to design early phase as well as late phase clinical trials for biosimilars  .
  • Phase 3 clinical trials should demonstrate that difference in efficacy or safety between proposed biosimilar and reference product is less than of pre-specified margin of clinical equivalence .
  • Biosimilar guidelines issued  by various regulatory authorities or WHO do not provide standard equivalence margins for most biologicals used to detect clinically meaningful differences in the targeted diseases.
  • The equivalence margins should be considered on a case-by-case basis, and regulators may recommend a different margin than that proposed by sponsors.

HANMANT BARKATE, Vice President & Head Medical Services, Glenmark

12:40 – Networking luncheon


13:30 – 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

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
FREDRIK SUNDBERG, Director Strategic Customer Relations, GE Healthcare
ADRIAN RABE, Manager, Market Access Communications, Purple Squirrel Economics

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 – Patient experience & Expectations
ROBERT A. JOHNSTONE, Patient Representative & Inclusion Advocate

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, Executive Secretary, ESNO, European Specialist Nurses Organisations

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.

09:20 – Chairperson opening remarks
LOUIS BOON, CSO, Bioceros


09:30 –
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

MANUFACTURING


10:00 – 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

10:20 - Manufacturing Biosimilars: The current challenges and opportunities by using new technology

  • The current biosimilar developing challenges.
  • The technologies to facilitate the development
  • The potential benefit and challenge

PEARL FONG, Associate Vice President, Mycenax Biotech

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, ValeriusBio


11:30 – Regulatory considerations in Clinical Study Design of Biosimilars
CHIRAG SHAH, Director – Late Phase,
Cliantha


1
1:50 – After more than a decade - how will the future of Biosimilars look like? Biosimilar or maybe more like Biogeneric
MICHAEL MUENZBERG, Comparative Outcomes Group (Former EU Medical Director, Biosimilars, Amgen)

CLINICAL


12:20 – 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

12:50 – 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

LOUIS BOON, CSO, Bioceros

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)


14:50 – 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)

15:30 – Afternoon Tea/Coffee


15:50 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


16:20 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:
CORNELIA ULM, Independent Consultant, Biotec Regulatory Consulting GmbH (former Fresenius Kabi SwissBioSim GmbH)
CHRISTOPHER STOTHERS, Partner, Arnold & Porter

LIZ POLLITT, Director, BPCRCS
PAUL CALVO, Director, Sterne, Kessler, Goldstein & Fox (USA)


17:00 – 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

Besides supporting the President & CEO Generics Europe, Thomas is leading the European Generics long term strategy for Teva Pharmaceuticals. Being the European commercial contact for the global biosimilar team, he gained knowledge of the biosimilar market in Europe. Previously, Thomas was launching an innovative monoclonal Antibody against severe asthma as an European Brand Manager at Teva, where he started his career in the ‘Future European Leadership Programme’. He has a protein manufacturing and engineering background gained at his Master thesis project at Harvard Medical School and his Master degree in Pharmaceutical Bioprocess Engineering at TU Munich.

MICHAEL MUENZBERG

Former EU Medical Director, Biosimilars

Comparative Outcomes Group, Amgen

Dr. Mike Muenzberg is Medical Director Biosimilars EU at Amgen Europe. He was born in Austria and educated in Austria, Canada and Sweden. Dr. Muenzberg is licensed as Doctor of Nuclear Medicine and has more than 15 years’ experience in Pharmaceutical Industry, working as local as well as global Medical Manager/Director for Serono, Novartis, Amgen, Roche, Sandoz International Biopharmaceuticals and Merck Serono Biosimilars.

Since 2017 Dr. Muenzberg holds his position as Medical Director Biosimilars EU at Amgen Europe, responsible for the launch of pipeline Biosimilars in Oncology and Inflammatory Diseases.

Dr. Muenzberg is member of the Comparative Outcomes Group based in Bristol.

CHRISTIAN AGBOTON

Sr Global Brand Medical Director - Global Medical Affairs

Takeda

Christian Agboton graduated from the Free university of Brussels school of medicine in 1993. He is a member of the UK Faculty of pharmaceutical medicine and worked mainly in clinical research and medical affairs.

Christian got his experience of biologics by working on certolizumab pegol, efalizumab and more recently on the launch of the first biosimilar monoclonal antibody (CT-P13 infliximab) approved in Europe. During his 20 years in the industry, Christian observed the revolution that biologics brought to the treatment of chronic immune-mediated inflammatory diseases.

The impact of biosimilars cannot be fully appreciated yet, but their role in the management of chronic diseases is already visible - as they quietly reshape areas of therapeutic research, clinical development and clinical practice.

KAUSTUBH BERDE

Vice President - International Business : Emerging Markets

Wockhardt

CORNELIA ULM

Independent Consultant

Biotec Regulatory Consulting GmbH (former Fresenius Kabi SwissBioSim GmbH)

Cornelia works as Independent Consultant for Biotherapeutic and Biosimilar Products. She has more than 20 years experience in the biopharmaceutical industry and served as Head of Regulatory Affairs Biosimilars for Fresenius Kabi SwissBioSim GmbH (former Merck Serono) CH, Mylan GmbH CH, Apotex Inc, CA,  and Biopartners GmbH, CH.

Cornelia develops global regulatory strategies as well as leads in-depth discussions on CMC, nonclinical and clinical aspects in meetings with Regulators such as FDA, EMA, PEI, MEB, SwissMedic and ANVISA. She authors and reviews regulatory documents on CMC, nonclinical and clinical for IND, IMPD, CTA and CTD submissions. Cornelia holds a degree in pharmacy from the J.W. Goethe University of Frankfurt Germany.

HANMANT BARKATE

Vice President & Head Medical Services

Glenmark

  • A Medical professional with specialization in  M.D. Clinical Pharmacology
  • Certified in Diabetes management by IDF (International Diabetes Federation)
  • 20 years of experience: 1 year in Medical college & hospital as faculty  plus 19 years in Pharma/Biopharma in diversified functions like Medical affairs, Clinical development, Drug regulatory affairs and pharmacovigilance in a leadership role
  • Currently, working as Vice President & Head – Medical Services (India & MEA) for Glenmark Pharmaceuticals ltd. Mumbai  since September, 2017 with responsibility of medical affairs, late phase clinical studies and pharmacovigilance for India & MEA
  • Earlier worked with Wockhardt and Intas Pharmaceuticals Ltd and Alembic Ltd in Leadership role
  • Demonstrated expertise in diversified functions like clinical research, regulatory medical affairs and pharmacovigilance functions
  • Hands on experience of clinical development (Phase I to Phase III)  of Biosimilars, NCEs, NDDS, Generics
  • Conducted Early & Late phase clinical trials for number of molecules from diverse therapeutics segments like cardiovascular, diabetology, pain management, urology, oncology, neurology, rheumatology, ophthalmology etc
  • Lead role in successful clinical development & commercialization of  12 biosimilars in India; two biosimilars for the first time in World
  • Planned and Successfuly conducted Phase III studies for two vaccines.
  • Worked as Medical Lead for protocol development for biosimilars  as per advice of  International regulatory agencies (EMA & US FDA)
  • Authored no. of regulatory dossiers for NDAs (new drug applications), CTAs (clinical trial applications) & MA (marketing authorization) for biosimilars, NCE & NDDS products.
  • Introduced number of new molecules (generics) for first time in India from different therapeutic segments
  • 25 publications of  mainly of original research work, in national and international journals of repute
  • Invited speaker for conferences/ workshops on topics of clinical research, regulatory affairs, pharmacovigilance and biosimilars in National & International conferences

LIZ POLLITT

Director

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

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 GE Healthcare 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.

BER OOMEN

Executive Secretary

ESNO, European Specialist Nurses Organisations

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

PEARL FONG

Associate Vice President

Mycenax Biotech

Pearl has worked over 15 years in the biotechnology industries to serve both operating and consulting roles for more than 30 biomedical projects.

As Director of Project development, Pearl has handy experiences in the whole life cycle of biologics development from CMC manufacturing to regulatory consulting.

She has brought biosimilar products from CMC to clinical phase in Taiwan, Japan, Australia, and U.K.

ANDREAS HERRMANN

CEO

ValeriusBio

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

Patient Representative & Inclusion Advocate

Chair: Access Matters, Midstream, UK
Board Member; European Forum for Good Clinical Practice (EFGCP),
Healthcare Quality Improvement Partnership (HQIP), International Foundation
for Integrated Care (IFIC)

Having had Rheumatoid Arthritis for more than 60 years from the age of three, I
have a wealth of experience as a user of health services.
Since 1990 I have voluntarily represented people with disabilities & chronic
conditions locally, nationally & internationally

“The people have the right & duty to participate individually & collectively in the
planning & implementation of their healthcare”
Alma Ata Declaration – Principle IV, 1978 World Health Organisation

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

https://www.linkedin.com/in/alipha

 

Qualified with a hospital pharmacy background, Omar has been working as the Formulary Advisor for Surrey & Sussex Healthcare NHS Trust for over 15 years, sitting on the regional Joint Drugs & Therapeutics Committee as well as the CCG/Commissioning Prescribing Clinical Network.

Omar has been a visiting Lecturer at UCLH Pharmacy Programme and was both Lecturer & Examiner on the Independent Prescribing V300 Course at the University of Surrey and has over 30 publications to date. He has been appointed as Visiting Lecturer on Value Based Pricing & Innovative Contracting at the University of Portsmouth, is an Editorial Content Adviser to Guidelines, and has recently been invited to the position of Associate Editor to the Canadian Journal of Population
Therapeutics & Clinical Pharmacology.

Omar has served a position on the External Reference Group on Cost Impact Modelling for NICE for 6 years and was subsequently appointed Panel Member for the newly formed Adoption & Impact Program Reference for NICE. He advises foreign investors (US Embassy) on ‘Value Based Assessments (hosted by the UK Department of Trade & Industry) and recently delivered a Healthcare NHS Reform program to over 40 Healthcare Insurance Provider delegates visiting from the US.

Last year he was invited to address the Italian Healthcare Senate [Senato della Repubblica] on Pharmaco-economic Evaluation & Sustainability Models of Healthcare and featured at the Westminster Health Forum Keynote Seminars [chaired by Lord Howe, All Party Parliamentary Group on Pharmacy] on the Future for Pharmacy Commissioning, Organisation & Delivery. At this current time he has embarked on a PhD with his doctorate thesis entitled “Value Based Pricing & Outcomes Based, Innovative Contracting of New Medicines”.

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

CHIRAG SHAH

Director - Late Phase

Cliantha

Dr.Chirag Shah has rich experience of more than 19 years in multidisciplinary area of Global Product Development in Pharmaceutical, Biotech companies and in Clinical Research Organisation (CRO) and strong leadership abilities to his role as a Director – Late Phase Trials.

His expertise includes in Set up of new department, Global Project Management (Discovery & Clinical-Phase I-IV), Preclinical drug development, Regulatory affairs, Medical Services, Pharmalicensing, Financial Management, System development, Business Development, Due Diligence for Acquisition and Marketing. Currently, he is managing Business Strategy and Business development functions to provide the Organic and Inorganic growth of the company.

During his career span overseen the development of more than 10 Biosimilars from lab to market. Apart from that have several publications in peer reviewed journals, delivered lectures in Professional associations, Academia and Community

Prior to joining Cliantha, he has worked with leading Indian companies such as Cipla, Intas, Alembic, Nicholas Piramal and SIRO Clinpharm.

Dr.Chirag Shah is Ph.D in Clinical Pharmacology from Saurashtra University, Rajkot, India. He is also specialized in the Pharmaceutical Management (PGDPM) from IES’s Management College and Research Centre, Mumbai with special focus on Marketing, Operation and Finance.

He is an associate member of American College of Clinical Pharmacology (ACCP), American Society of Clinical Oncology (ASCO), Life member of Indian Pharmacological Society (IPS),Indian Society of Clinical Research(ISCR) and Drug Information Association (DIA).

PAUL CALVO

Director

Sterne, Kessler, Goldstein & Fox (USA)

Dr. Calvo, a director in the Biotechnology/Chemical Group at the Washington, DC-based law firm Sterne, Kessler, Goldstein and Fox, represents a diverse group of U.S. and international companies innovating in the biotechnology and pharmaceuticals industries.  He provides counsel with regard to global patent portfolio strategy, licensing, patent validity, infringement, and design around strategies.  Dr. Calvo also has extensive expertise in prosecuting and investigating patents related to bioproduction methods and therapeutic formulations. Prior to joining Sterne Kessler, Dr. Calvo gained extensive technical expertise in the areas of vaccines, therapeutic antibodies, cellular immunology, and biotherapeutics during his graduate studies and post-doctoral fellowships at The University of Pennsylvania and National Institutes of Health.

AIDAN FRY

Editor

Generics Bulletin

Aidan Fry has been the editor of Generics bulletin, the business newsletter for the generic, biosimilar and value-added medicines industries, since August 2008. He had previously been the deputy editor of Generics bulletin since the newsletter’s inception in 2003, having also spent five years working on its sister publication, OTC bulletin, which also now forms part of the Informa group. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.

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)

ADRIAN RABE

Manager, Market Access Communications

Purple Squirrel Economics

Dr Adrian Rabe is a physician with more than 10 years experience in General Internal Medicine, Clinical Epidemiology, Data Science, Health Economics and Market Access. He has worked to strengthen health technology assessment systems and public health policy in developing countries and in the UK. Dr Rabe was trained at the University of the Philippines, the London School of Economics and Political Science, and the London School of Hygiene and Tropical Medicine. He currently works with Purple Squirrel Economics assisting organisations in bringing their health innovations into the market through independent evidence collation and generation.

CHRISTOPHER STOTHERS

Partner

Arnold & Porter

Assisting companies from all fields of technology, from pharmaceutical and medical devices to software and telecommunications, Christopher is an experienced litigator on strategic, cross-border patent disputes (including opposition work before the European Patent Office). He also litigates and arbitrates other types of intellectual property (trade mark, copyright, and designs), antitrust (including follow-on damages claims), pharmaceutical regulation, European Union law and commercial disputes. He is a creative and efficient problem-solver who thinks laterally across the breadth of his practice. He has taken cases before the First Tier Tribunal, the Upper Tribunal, the Patents County Court, the High Court, the Court of Appeal, the House of Lords, the Supreme Court, the European Patent Office, and the European Court of Justice.

Christopher is a Visiting Professor in Intellectual Property and Competition Law at University College London, and his 2007 practitioner textbook, "Parallel Trade in Europe: Intellectual Property, Competition and Regulatory Law," has been cited by the UK Supreme Court. He is committed to pro bono matters, including cases on recognition of change of gender for social security and tax purposes. Christopher is also chair of the firm's Diversity Committee for the London office.

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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.

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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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