10th Biosimilars & Follow-On Biologics Congregation 2017
Offering our customers the knowledge and connections for a profitable business
Speakers
  • MOURAD REZK

    MOURAD REZK Biogen

  • MATTHEW TURNER

    MATTHEW TURNER Merck KgA

  • NIRAJ CHHAYA

    NIRAJ CHHAYA Boehringer Ingelheim

  • AMARDEEP UDESHI

    AMARDEEP UDESHI Cipla (India)

  • PETAR BAST

    PETAR BAST Allergan

  • OZDEMIR SENGOREN

    OZDEMIR SENGOREN UCB Pharma

  • OLEKSANDR KARPENKO

    OLEKSANDR KARPENKO Olexacon

  • DIVYA CHADHA MANEK

    DIVYA CHADHA MANEK National Institute for Health Research (The research arm of the NHS)

  • MAARTEN VAN BAELEN

    MAARTEN VAN BAELEN Medicines for Europe

  • STEPHEN MURBY

    STEPHEN MURBY Alliance for Safe Biologic Medicines, Alliance of Patients Organizations

  • CECIL NICK

    CECIL NICK Parexel

  • DUNCAN EMERTON

    DUNCAN EMERTON FirstWord

  • OMAR ALI

    OMAR ALI University of Portsmouth & Former Adviser to NICE

  • STEINAR MADSEN

    STEINAR MADSEN Norwegian Medicines Agency

  • LOUIS BOON

    LOUIS BOON Bioceros

  • SANDY EISEN

    SANDY EISEN Frontline Pharma Consulting

  • LOUISE ANGELL

    LOUISE ANGELL Covance

  • DAVID DAILY

    DAVID DAILY DALI Medical Devices

  • CHRISTOPHER STOTHERS

    CHRISTOPHER STOTHERS Arnold & Porter Kaye Scholer

  • FEDERICO POLLANO

    FEDERICO POLLANO Polpharma Biologics

  • ASH RAMZAN

    ASH RAMZAN Woodley BioReg

  • JOANNA BROUGHER

    JOANNA BROUGHER BioPharma Law Group

  • DOMINIC ADAIR

    DOMINIC ADAIR Bristows

  • NEIL GRUBERT

    NEIL GRUBERT

  • HILARY JONES

    HILARY JONES Bristows

  • JACKIE MULRYNE

    JACKIE MULRYNE Arnold & Porter Kaye Scholer

9th – 10th May 2017, Pestana Chelsea Bridge Hotel, London UK

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

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CONFERENCE INTRODUCTION:-

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. The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020.

This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. This 10th Biosimilars and Follow-on Biologics Congregation 2016 will look at the multiple facets of Biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of Biosimilar product development to successfully deliver safe, Biosimilar products to the market place. By attending this conference, you will gain a comprehensive outlook on the key issues surrounding Biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in furthering Biosimilars development.

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 10th Biosimilars and Follow-on Biologics Congregation 2017.

 

KEY THEMES:-

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

 

WHO SHOULD ATTEND:-

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

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

 

WHY SHOULD YOU ATTEND:-

Get more from the event, 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
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis, FirstWord

MARKET OVERVIEW & ANALYSIS

 09:40 – Payer perspective on biológics and Biosimilars

  • NHS payer landscapes post Brexit
  • Payers perspectives on Biosimilars and levers for integration into formularies
  • Payers perspectives on Parent Innovators - when are payers willing to pay for premium price brands despite Biosimilars?
  • Differential Access & Reimbursmemet levers for primary care and hospital settings

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

 10:20 – Navigating the mAb biosimilar regulatory maze

  • Introduction to Mabs
  • What differences might be acceptable
  • Aligning of CQAs
  • The importance of comparative biological testing
  • The role of clinical data in supporting biosimilarity and its limitations

CECIL NICK, Vice President (Technical), Parexel 

 

11:00 – Morning Coffee/Tea & Discussion


CHALLENGES & OPPORTUNITIES

11:20 – Keynote Panel Discussion: BREXIT – What impact has it had on the biosimilars industry?

  • Global development of biosimilars – vision or reality?
  • What will happen to the market size of biosimilars in the emerging market?
  • Current - What are the myths and realities about biosimilars in EU & USA?
  • How are Big Pharma and Biologics Majors reacting to BREXIT?
  • Pros and cons of serving multiple growing markets

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

Panellists:

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

SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting  

DOMINIC ADAIR, Partner, Bristows

CHRISTOPHER STOTHERS, Partner, Arnold & Porter Kaye Scholer

 

SAFETY AND RISK MANAGEMENT PLANNING

 

12:00 – Planning for Success: A CMC Strategy for Biosimilars

  • Importance of CMC
  • What is required for successful Biosimilar development
  • Building a CMC Biosimilar strategy
  • How to de-risk a Biosimilar drug development program

LOUISE ANGELL, Lead Scientist, BioCMC, BioPharmaceutical CMC Solutions – Large Molecules, Covance

 
12:20 Networking luncheon

 

BUSINESS MODELS

 

13:30 – Biosimilar safety strategy: Challenges and Opportunities
OLEKSANDR KARPENKO, Managing Director, Olexacon

 

14:00 – Partnering with biosimilar and generic companies for injection devices:

  • Device requirements, self-injection needs
  • Implications of FDA & EMA biosimilar guidances
  • "Me-too" or "device-better"?
  • Examples from DALI's SAN product line and E3D's Flexi-Q autoinjector product line

DAVID DAILY, CEO & Co-Founder, DALI Medical Devices

 

14:30 – Role of physicians and pharmacists towards strategic business plans

  • Can we rely on the regulator – what constitutes ‘trusted’
  • USA physicians support labels with data to learn about and evaluate biosimilars
  • European doctors have insufficient knowledge of biosimilars – they’ve got company
  • Canadian physicians feel strongly about the need to retain sole prescription authority
  • 35% of Latin American physicians haven’t heard of or could not define biosimilars
  • USA hospital pharmacists are more likely to be “Very familiar…” with biosimilars than retail pharmacists (but that’s only 44% vs. 23%)
  • Lessons to be learnt from pharmacy level substitution in Australia.

STEPHEN MURBY, Alliance for Safe Biologic Medicines, International Advisory Board Member, International Alliance of Patients’ Organizations, Biosimilars Spokesperson    

 

15:00 – Afternoon Tea/Coffee


15:20 – From biosimilars to biogenerics

  • Attitudes and acceptance in clinical practice
  • Uptake in clinical practice
  • Nor-Switch study and other clinical trials
  • Switching and interchangeability

STEINAR MADSEN, Medical Director, Norwegian Medicines Agency

16:00 – Gainsharing and biosimilar medicines: the policy to increase medical use of biosimilars.

  • Gainsharing principles: how switching to biosimilars is in the benefits of all stakeholders
  • Gainsharing for the individual patient: improvement of care
  • Gainsharing for the healthcare professional: more patient treated, more treatment options
  • Gainsharing for the payers: still savings after splitting the gain

MAARTEN VAN BAELEN, Market Access Director, Medicines for Europe‎

16:40 - Panel Discussion: Market access in the EU market and the way forward

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

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

Panellists:
MAARTEN VAN BAELEN, Market Access Director, Medicines for Europe 

 CECIL NICK, Vice President (Technical), Parexel

STEINAR MADSEN, Medical Director, Norwegian Medicines Agency

NEIL GRUBERT, Independent Consultant

 

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


17:20 – 18:10 Networking Drinks Session

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

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

COMMERCIALISATION & MARKET ACCESS
 

09:40 – Biosimilars – 10 years’ experience – what have we learnt and what challenges are there going forward from a medical affairs perspective 

MATTHEW TURNER, Global Medical Director Biosimilars, Merck KgA

 

10:20 – Commercial Excellence in Pharma:  Beyond SFE

  • Global trends that form pharma landscape & their implications
  • Creating next-generation pharma
  • New capabilities and core processes to support the new pharma commercial model

OZDEMIR SENGOREN, Area Head - Turkey, Middle East & Africa, UCB Pharma

11:00 – Morning Coffee/Tea & Discussion

11:20 – Customized development and production of biosimilars

  • Time to market
  • High yield expression systems
  • Modular flexible production set up
  • One stop shop for biosimilars

FEDERICO POLLANO, Director Contract Manufacturing and Business Development, Polpharma Biologics

 

12:00 – Value-Added Medicine - The opportunities and challenges - Similarities to Biosimilars
PETAR BAST, VP Business Intelligence, Allergan

 

12:30 Networking luncheon

 

13:30 – The Access potential of biosimilars – Will we fully realize it?
AMARDEEP UDESHI, Head - Commercial Strategy, Cipla (India) 

 

14:00 – Innovators & Biosimilars: Challenges of Operating in an “Anti-Patent” Climate

  • Overview of recent cases affecting the biotechnology industry
  • Impact on biosimilar development
  • Strategies for obtaining adequate patent protection

 JOANNA BROUGHER, Owner & Principal, BioPharma Law Group

 
 14:30 – Boosting expression of biosimilar antibodies to reduce cost of goods   

  • Upstream process modulation
  • Improving expression levels
  • Critical Quality Attributes
  • Custom biosimilar bio-assay design

LOUIS BOON, CSO, Bioceros

15:00 – Afternoon Tea/Coffee

15:20 – The mystery of the NOCEBO effect  for Biosimilars and its relation to adherence
MOURAD REZK, Global Head Medical Affairs (Biosimilars), Biogen Idec

 

15:50 Harnessing the power of a national network to deliver clinical evidence for biosimilars:

  •  Is the NHS ready for the biosimilar clinical trial boom? 
  • Insight into the current clinical research landscape in the UK
  • Collaboration - the key to efficient and effective trial delivery
  •  Networking locally to deliver globally 

DIVYA CHADHA MANEK, Head of Business Development, National Institute for Health Research (The research arm of the NHS)

 
REGULATION OVERVIEW & UPDATE

16:20 Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow

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

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

Panellists:  

MOURAD REZK, Global Head Medical Affairs (Biosimilars), Biogen

ASH RAMZAN, Principal Consultant, Woodley BioReg

HILARY JONES, Senior Associate, Bristows

JACKIE MULRYNE, Counsel, Arnold & Porter Kaye Scholer

 

17:00 Chairperson’s closing remarks and end of conference
DUNCAN EMERTON, Senior Director, Syndicated Insights & Analysis, FirstWord 

 

17:10 – End of the 10th Biosimilars Congregation 2017

MOURAD REZK

Global Head Medical Affairs (Biosimilars)

Biogen

Dr Mourad Rezk joined Biogen in January 2015. He is a medical doctor who trained as a diabetologist. He brings more than 20 years of experience in the pharmaceutical industry, holding a number of leadership roles in medical affairs, R&D and
marketing.

Before joining Biogen, Dr Rezk was with Amgen for nearly eight years as an international medical lead for nephrology innovator biologics and the company’s EU biosimilars taskforce. While there, he established an internal biosimilars medical platform and led the development and execution of a significant number of multinational studies, key publications and poster presentations. He has also spoken at a number of key international biosimilars congresses.

Prior to that, Dr Rezk spent four years in Athens with Novo Nordisk Africa & Gulf as the region’s medical affairs director, establishing diabetes and hematology clinical and medical educational infrastructures that supported the launch of the company’s second‐generation insulin analogues and hemophilia treatments. He also previously spent nearly 11 years with J&J Middle East where he was marketing & sales lead for the biotech business unit, after which he moved to head the medical affairs team.

MATTHEW TURNER

Global Medical Director Biosimilars

Merck KgA

A scientist by training in the UK, Matthew has spent 21 years thus far with a career working in pharma industry from basic biotech research, to clinical development and medical affairs.  Matthew has been working in the biosimilar area for the last 10 years in medical affairs in global positions, notably as head of Europe medical affairs and global head of medical affairs at Sandoz. Matthew is working now within the Merck KgA group in medical affairs working on biosimilars.

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.

AMARDEEP UDESHI

Head - Commercial Strategy

Cipla (India)

PETAR BAST

VP Business Intelligence

Allergan

Petar has worked in the pharma industry for more than 20 years, most recently as VP Corporate Business Insights at Allergan. He is currently involved in a Swiss start-up focusing on Women’s Health, and just finalised a M.Sc. pharm. med. (specialised in Value-Added medicine); academic record also includes an MBA, B.Com. in Org.Dev. and M.Sc. pham.eng.

Previously worked for Amgen, and held several commercial roles here, including project manager of the biosimilars task-force.

Will be presenting on the synergies between Value-Added medicines and Biosimilars

OZDEMIR SENGOREN

Area Head - Turkey, Middle East & Africa

UCB Pharma

Ozdemir Sengoren was appointed as Area Head of UCB Turkey, Middle East & Africa in February 2014.

Prior to this, Ozdemir gained 17 years of experience in biopharmaceuticals working at; Abbott, Wyeth and more recently as Managing Director at Merck Serono. Ozdemir has a bachelor's degree in medicine from Marmara University İstanbul.

UCB is a patient-centric global biopharmaceutical leader, transforming the lives of people with severe diseases, operating in more than 40 countries with 8.700 employees. UCB is a specialist company in neurology & immunology.

Contact details:

Mobile:   +90 532 201 39 02
E-mail:   ozdemir.sengoren@ucb.com
Web-site:   www.ucb.com.tr

OLEKSANDR KARPENKO

Managing Director

Olexacon

DIVYA CHADHA MANEK

Head of Business Development

National Institute for Health Research (The research arm of the NHS)

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

Funded by government through the Department of Health, the National Institute for Health Research (NIHR) Clinical Research Network is the clinical research delivery arm of the National Health Service in England. We turn the pledges in the government’s Strategy for UK Life Sciences into reality, by creating a better environment for conducting large scale commercial contract clinical research, so that life sciences companies can place clinical studies in the UK with confidence.

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. With a degree in Clinical Psychology and a Masters in Clinical Research, Divya has worked with the Clinical Research Network for the past nine years. Divya’s fi rst role with the CRN was delivering commercial contract clinical research within a National Health Service hospital. Prior to her current role, Divya worked as the Industry Manager within the Mental Health team, performance managing and maintaining oversight of the national mental health portfolio of studies. Thus, Divya has experience of clinical research from a site level and from a national perspective in the UK. Divya is also currently studying for a PhD in Dementia Care from the University of Birmingham.

Divya Chadha Manek

Head of Business Development and Marketing (commercial)
E: divya.chadhamanek@nihr.ac.uk
T: 020 3328 6700
M: 07886854261

Delivering research to make patients, and the NHS, better

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”. 

STEPHEN MURBY

International Advisory Board Member, Biosimilars Spokesperson

Alliance for Safe Biologic Medicines, Alliance of Patients Organizations

Amongst other things, Stephen is: a member of the International Advisory Board of the Alliance for Safe Biologic Medicines (ASBM), headquartered in Virginia, USA; a Special Board Representative of the Consumer Health Forum of Australia (CHF) Board (having previous roles as Director, Treasurer andChair); and a biosimilars spokesperson for the International Alliance of Patients’ Organizations (IAPO), headquartered in London; In 2014, Stephen was made an Honorary Life Member of CHF. He is also a Life Fellow of the Royal Society of Arts (RSA), headquartered in London and a Life Member of the Graduate Union of The University of Melbourne.

Stephen has a special interest in biosimilars from the patient perspective and has been working with ASBM, CHF, IAPO and others over the past six years in developing and disseminating biosimilars information and educational resources to patient, prescriber and dispenser organisations around the world. In February, this year he travelled to Australia on behalf of ASBM to facilitate severaltop-level meetings with peak professional organisations and government bodies on the outcomes of the ASBM Australian Prescribers Survey. Stephen has also spoken at peak body meetings on biosimilars in The Philippines, Hong Kong, Switzerland, USA and the United Kingdom.

CECIL NICK

Vice President (Technical)

Parexel

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

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

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

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

DUNCAN EMERTON

Senior Director, Syndicated Insights & Analysis

FirstWord

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

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

OMAR ALI

Visiting Lecturer

University of Portsmouth & Former Adviser to NICE

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”.

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.

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. In addition, he held position as CSO for MacroZyme BV, 4AZA Bioscience NV, FF Pharma and VP Preclinical for PanGenetics BV and Tanox. Dr. Boon is author of over 240 papers in international scientific journals in the field of medical biotechnology.

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 innovative new molecular antibody entities, which now within the Polpharma Biologics group can be extended to GMP production and clinical testing

SANDY EISEN

Chief Medical Officer

Frontline Pharma Consulting

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

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

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

Contact details:

Sandy.eisen@btinternet.com

 

+44 7921 495663 (mobile)

+44 0208 3648426 (office)

LOUISE ANGELL

Lead Scientist, BioCMC, BioPharmaceutical CMC Solutions - Large Molecules

Covance

DAVID DAILY

CEO & Co-Founder

DALI Medical Devices

CHRISTOPHER STOTHERS

Partner

Arnold & Porter Kaye Scholer

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.

FEDERICO POLLANO

Director Contract Manufacturing and Business Development

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

ASH RAMZAN

Principal Consultant

Woodley BioReg

Dr. Ramzan has over 25 years of international experience to over 40 World territories within the pharmaceutical and biopharmaceutical industry. He has held a number of senior positions in product and clinical development, manufacturing to cGMP, Analytical Development, Quality Control and Assurance, and Regulatory Affairs. Dr. Ramzan has experience in the successful Technology Transfer of the manufacture of a complex biologics including biosimilars and their associated methods. His expertise also includes the management and implementation of Regulatory Conformance programmes (“Registration Drift”) for both Pharmaceuticals and Biopharmaceuticals (biologics and vaccines).  Dr. Ramzan is a University of Liverpool graduate and holds a PhD in Protein Biochemistry.

JOANNA BROUGHER

Owner & Principal

BioPharma Law Group

Joanna is a patent attorney who focuses her practice on all aspects of services related to patents in the life sciences. Joanna has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act. Joanna is also an Adjunct Lecturer at the Harvard T.H. Chan School of Public Health and the Editor-in-Chief of the Journal of Commercial Biotechnology.  She regularly speaks or lectures on intellectual property-related topics and is a frequent author of articles related to patent law and healthcare.  In 2013, Joanna published a book called Intellectual Property and Health Technologies: Balancing Innovation and the Public's Health which examines the relationship between patents and public health in the context of medical technologies. Joanna received her J.D. degree from Boston College Law School, and is admitted to the Massachusetts and New York State Bars as well as the USPTO.

DOMINIC ADAIR

Partner

Bristows

NEIL GRUBERT

Independent Consultant

Neil Grubert is a pharmaceutical market access specialist with 27 years of experience tracking the global prescription drug and self-medication markets. He has written more than 150 reports on all aspects of pricing, reimbursement and market access in 20 mature and emerging markets, including work on generics, biosimilars and life cycle management. Before becoming an independent consultant, Neil spearheaded the development of Decision Resources Group’s international market access business, most recently as Vice President of Global Market Access Insights.

HILARY JONES

Senior Associate

Bristows

Hilary is a senior associate in the IP Regulatory team and specialises in all aspects of EU and UK law in the bio-pharmaceutical and medical devices sectors.  Hilary was previously part of the in-house legal team at Pfizer for twelve years and has also worked at Gilead Sciences. As a senior corporate counsel she supported the UK, EU and global business units, gaining excellent knowledge of the pharmaceutical industry enabling her to bring a strong business approach to her legal advice.  Her experience ranges from the early stages of a product’s development to post marketing activities and long established brands. Hilary regularly speaks at public conferences on topics such as paediatric research, HTA and market access, and orphan designation for medicines. Prior to working within the pharmaceutical industry Hilary spent two years in the legal team at the Consumers’ Association (and Which?) specialising in consumer law, general commercial matters and public affairs activities.

Credentials    

     LLB Law, University of Southampton
     LPC, Nottingham Law School
     Qualified 2001

JACKIE MULRYNE

Counsel

Arnold & Porter Kaye Scholer

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,

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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.

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Biosimilar News

Technology Networks

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

Going To Meet

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.

Farmavita

BioChem Adda

BioChem Adda aims to provide the most reliable information portal related to Biotech Jobs, Biotech Internships in the USA, Biotech Internships in India, Biotech Companies Database, Careers, Education, Fellowships, News, Articles, and Events from the field of Biological and Chemical Sciences!

LIMSfinder

Welcome to LIMSfinder, the most comprehensive online, interactive magazine devoted to Laboratory Information Management Systems (LIMS) and other Laboratory Informatics Solutions. LIMSfinder is simply the best resource for Information Technology in the Laboratory.

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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 £1150 - (Limited seats left) - 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

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Address: 354 Queenstown Rd, London SW8 4AE, United Kingdom
Phone:+44 20 7062 8000

Testimonials from our past Biosimilars Congregations

 

 

Well discussed topics with a distinguished and prolific panel of experts in their respective fields in Biosimilars - Ankit Kapoor, 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 - Juan Vergez, 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 - Debolina Partap, AVP & Head Lega, Wockhardt

Excellent workshop. It did meet our expectation in term of complete representation of the biosimilar development - Sonika Shah, 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 - Vandana Jolad Shivangi, 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 - Asima shifali singh, 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 - Babita kirodian, 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 - Annesha bhattacharaya, MANAGER - BD & PROGRAM MANAGEMENT, LUPIN

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

The conference is good to know about the regulatory scenario - Shailesh Sonar, 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 - Alex Kudrin, 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 - Richard Dennet, 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 - Anna Harrington-Morozova, Scientific & Regulatory Director, Regem Consulting Ltd

All in all, Biosimilars Congregation 2012 was a very worthwhile and informative conference - C. Patrick McAtee, 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 - Bent Ulrich Frandsen, 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 - Richard Dennett, Director, Voisin Consulting Life Sciences

Biosimilar Congregation was a really good conference, well organized and of good quality - Dr. Karl Michaelis, 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 - Paul Greenland, 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 - Sirjiwan Singh, Managing Director - UK, Wockhardt

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