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The SMi Group are thrilled to present the 9th annual conference on Biosimilars & Biobetters, taking place on 26th & 27th September in Central London, UK.

Following the success of our previous events in both UK and USA, Biosimilars and Biobetters UK 2018 will deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.

After over a decade, the biosimilars industry is finally reaching a stage where key stakeholders understand and accept biosimilars. This is reflected in more tolerant legislation and an increased uptake of biosimilars across the globe.

We are now entering a very exciting time, for over the next few years several originator patents are expiring, and we will see a new wave of biosimilars enter the market. Will the originator dominate or will the biosimilar be a successful contender and spark a competitive environment? Have we done enough to convince the payer, prescriber and patient to switch?

JOB TITLES & DEPARTMENTS

Chief Executives, Vice Presidents, Executive Directors, Directors, Heads, Managers and Specialists from the following, but not limited to, sectors should attend:

  • Biosimilars / Biologics
  • Biopharmaceuticals
  • Research and Development
  • Legal Affairs
  • Intellectual Property
  • Regulatory Compliance
  • Quality affairs and control
  • Pharmacovigilance, Drug Safety and Risk Management
  • Business Development
  • Commercialisation
  • Marketing and sales

 

PREVIOUS ATTENDEES INCLUDE:

Alliance For Safe Biologic Medicines; Barclays; Bioceros; Biocon; Bionovis; Boehringer Ingelheim International; Boehringer Ingelheim Pharma GmbH & Co. KG; Bristows LLC; Celltrion; Celltrion Inc.; Challand Biosimilar Consulting; CinnaGen Inc; CIRION; EXANE BNP Paribas; Faculty of medicine of Mauritania; Farmacia; GaBI Journal ; Gan & Lee Pharmaceuticals; Gan & Lee Pharmaceuticals USA Co.; Gedeon Richter Ltd; Gedeon Richter Plc.; Generics Bulletin; GfK HealthCare; HealthTrust Europe LLP; Independant Consultant; Iqvia; Lupin (Europe) Ltd; medac GmbH; Mishcon de Reya LLP; Norwegian Medicines Agency; Prolong Pharmaceuticals; SAI MedPartners; Samsung Bioepis; Sun Pharmaceutical Industries; Teva Pharma BV; University Of Central Lancashire; University Of Portsmouth; Utrecht University

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars
View Bio

9:10 OPENING ADDRESS: After more than a decade of Biosimilars in Europe – how will the markets change over the next couple of years?

Michael Muenzberg

Michael Muenzberg, Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen
View Bio

• Historical Background about Biosimilars from 2006 until now
• Claims and Assumptions during the first years
• Differences in the acceptance of Biosimilars between US and Europe – how come?
• Biosimilars of Avastin®, Herceptin® and Humira® will enter the European markets in 2018/2019 – what can we expect?

9:50 KEYNOTE ADDRESS: Sustainability, affordability and expanded patient access: The keys to ensuring biosimilar success in europe

Erin Federman

Erin Federman, Head of Biologics, Europe, Mylan
View Bio

• Success for biosimilars involves delivering a positive impact today, but also continuously over time
• Policy changes and widespread adoption will be critical to expand access and get these products in the hands of patients
• Biosimilars must be viewed through a lens that goes beyond price, and includes overall affordability and sustained value

10:30 Morning Coffee

11:40 Session Reserved for Sandoz

Christian Naumann

Christian Naumann, Head Global Marketing Biopharmaceuticals, Sandoz International GmBH

Presentation Details to be confirmed

12:20 Networking Lunch

13:30 CASE STUDY: Biosimilar Development in a Mid-Size Pharma Environment – the Pegfilgrastim Case at Cinfa Biotech

Ruediger Jankowsky

Ruediger Jankowsky, Managing Director, Cinfa Biotech
View Bio

• Case study example of pegfilgrastim biosimilar clinical trial design
• Understanding how we can build a bridge between the originator and biosimilar product using a specific, consistent and tailor-made approach
• The importance of study population, study design, endpoints and statistics
• Collaborating with regulatory affairs and making clinical studies as sensitive to differences as possible

14:10 CASE STUDY: Challenges in Coming to Market with an Etanercept Biosimilar

Richard  Peck

Richard Peck , Vice President Regulatory Affairs, Lupin (Europe) Ltd
View Bio

• Changes in the competitive environment
• Biosimilar market trends
• Uptake of biosimilars in different European countries
• Regulatory requirements in different countries impact biosimilar uptake
• Go-to-market considerations

14:50 Afternoon Tea

15:20 Payer perspectives on value drivers for biosimilars

Omar Ali

Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth
View Bio

• Healthcare Fiscal overview and medicines funding landscape for Biosimilars
• 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

16:00 When perceptions matter... addressing the NOCEBO effect

Mourad  Farouk Rezk

Mourad Farouk Rezk, Global Head Medical Affairs Biosimilars, Biogen
View Bio

• Expanded use of generics and now the increasing use of Biosimilars have brought the NOCEBO effect  to the attention of clinicians.
• NOCEBO describes  the correlation between negative expectations or negative communications with negative subjective treatment outcomes
• NOCEBO  can cause the induction or the worsening of symptoms by sham or active therapies and may account for some adverse events (AEs) reported by patients following treatment , additionally it can have an effect on the adherence on Biosimilars
• Proper fact-based explanations by health care professionals coupled with strategies to reassure and engage patients upon initiating or switching to a biosimilar are key in ensuring better treatment outcomes and sustainability on Biosimilars

16:40 Do we really need clinical trials for a biosimilar?

Uwe Gudat

Uwe Gudat, Head of Safety Biosimilars, Fresenius Kabi

• What is the medico-scientific question?
• Revisiting David Sackett (EBM)
• Different stakeholders hold different perspectives
• Is there an ethical dilemma?
• Disagreeing agreeably

17:20 Chairman’s Closing Remarks and Close of Day One

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars
View Bio

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars
View Bio

9:10 Towards sustainability and harmonisation of biosimilars through WHO international standards

Meenu Wadhwa

Meenu Wadhwa, Head, Cytokines & Growth Factors, Biotherapeutics Group, , National Institute for Biological Standards and Control

• The concept of international standardisation
• Setting new standards: WHO international standards for monoclonal antibodies 
• Future plans for WHO standards for biosimilars and immunogenicity testing

9:50 US-FDA Interchangeability Guidance - what is needed to obtain the Interchangeable status for the Biosimilar product

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars
View Bio

• Learn the latest FDA regulatory changes towards interchangeability of biosimilars
• Evaluation of biosimilars in the race to obtaining this status
• First in line: recommendations on how to achieve interchangeability
• Discuss what will need to be done after accomplishing this to increase biosimilar uptake in patients, physicians and prescribers’ groups

10:30 Morning Coffee

11:00 Increasing market opportunities in China

• Review the latest regulatory updates in China
• Hear how these changes increase market opportunities for companies across the globe to sell in China
• Determine how to optimise Chinas growing ability to pay

Daotian Fu

Daotian Fu, General Manager, Livzon Mabpharm
View Bio

11:40 Biosimilar Orphan Drugs

Rodeina Challand

Rodeina Challand, General Manager, Challand Biosimilar Consulting
View Bio

• The value of Orphan drugs
• Why we need biosimilar orphan drugs
• How do we show similarity?
• What will the regulators expect?

12:20 Networking Lunch

13:30 Lessons from the front line; launching biosimilars in Europe

Richard Trollope

Richard Trollope, Head of Biosimilars, Mundipharma International

  • Biosimilar uptake in the EU
  • The heterogeneity of European health economies
  • Experience from 3x mAb biosimilar launches in EU
  • Essentials of procurement
  • Long term sustainability of the European biosimilar market
  • 14:10 The importance of analytical and pharmacological data for the biosimilar development

    Niklas Czeloth

    Niklas Czeloth, Head of Biosciences Biosimilars, Boehringer Ingelheim GmbH
    View Bio

    • Timing of method availability during the biosimilar development program
    • Tiering of quality attributes and the respective needs for analytics
    • Requirements for analytical and pharmacological methodologies to comply with regulatory expectations
    • The importance of structure function relationship knowledge

    14:50 Afternoon Tea

    15:20 Designing and Conducting Clinical Trials for Biosimilars

    Ekkehard Brockstedt

    Ekkehard Brockstedt, Team Leader Outsourced Trials, Boehringer Ingelheim
    View Bio

    • Clinical trial development for Biosimilars: present and future
    • Clinical operational challenges
    • Best operational procedures to minimize cost and maximize result

    16:00 Optimising Biosimilar Uptake

    Aurelio Arias

    Aurelio Arias, Senior Thought Leadership Consultant, Iqvia
    View Bio

    • With several biosimilars in the market, what lessons can we learn on subsequent launches?
    • Which countries provide a good environment for a biosimilar launch?
    • What levers does a manufacturer have to promote successful uptake?
    • What should be considered in creating an ideal commercial model?

    16:40 Experiences of delivering biosimilar medicine studies in a national health service

    Divya Chadha Manek

    Divya Chadha Manek, Head of Business Development Commercial, National Institute for Health Research
    View Bio

    • Case study examples of initiating biosimilar medicine trials in the NHS
    • Implementing solutions to unique challenges
    • Adopting the network approach to site selection
    • Increasing clinical confidence through education

    17:20 Chairman’s Closing Remarks and Close of Day Two

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars
    View Bio

    +

    FEATURED SPEAKERS

    Aurelio Arias

    Aurelio Arias

    Senior Thought Leadership Consultant, Iqvia
    Daotian Fu

    Daotian Fu

    General Manager, Livzon Mabpharm
    Divya Chadha Manek

    Divya Chadha Manek

    Head of Business Development Commercial, National Institute for Health Research
    Erin Federman

    Erin Federman

    Head of Biologics, Europe, Mylan
    Michael Muenzberg

    Michael Muenzberg

    Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen
    Michel  Mikhail

    Michel Mikhail

    International Expert in Regulatory Affairs, Global Expert in Biosimilars
    Mourad  Farouk Rezk

    Mourad Farouk Rezk

    Global Head Medical Affairs Biosimilars, Biogen
    Omar Ali

    Omar Ali

    Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth
    Richard  Peck

    Richard Peck

    Vice President Regulatory Affairs, Lupin (Europe) Ltd
    Ruediger Jankowsky

    Ruediger Jankowsky

    Managing Director, Cinfa Biotech

    Aurelio Arias

    Senior Thought Leadership Consultant, Iqvia
    Aurelio Arias

    Aurelio is a Senior Consultant in the Thought Leadership team at IQVIA, a market leader in healthcare data, real world evidence, clinical trials and consulting.

    Aurelio generates thought leadership insights with a view to spark high-level discourse on current and future pharma trends. He presents at numerous conferences worldwide and advises executives on global pharma strategy. His primary focus lies within the off-patent markets.

    Prior to IQVIA, Aurelio has advised blue chip companies in both Life Sciences and Financial Services while working for LEK and Accenture. He has worked in R&D for Pfizer and GlaxoSmithKline while completing a Chemistry degree at Imperial College London.

    Christian Naumann

    Head Global Marketing Biopharmaceuticals, Sandoz International GmBH
    Christian Naumann

    Daotian Fu

    General Manager, Livzon Mabpharm
    Daotian Fu

    Daotian Fu is Vice President & Managing Director of Livzon Pharmaceutical Group. He is also General Manager of Livzon MabPharm, Inc., a clinical stage biologics development company. Daotian received his BS from Shandong University in China, and his Ph.D. from Iowa State University. He also received post-doctoral training at University of Georgia in collaboration with Harvard Medical School. Prior to joining Livzon in May 2012, Daotian was Vice President at Genzyme, where he was responsible for the quality control and analytical development of all biologics at Genzyme. Daotian is the recipient of the China National “1000 Talent” program

    Divya Chadha Manek

    Head of Business Development Commercial, National Institute for Health Research
    Divya Chadha Manek

    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.

    Ekkehard Brockstedt

    Team Leader Outsourced Trials, Boehringer Ingelheim
    Ekkehard Brockstedt

    Ekkehard Brockstedt is a clinical research professional with more than 18 years of experience in drug development from phase II-IV with a focus on biologics. He has led the conduct of global clinical trial programmes in multiple therapeutic areas such as immunology/inflammatory diseases (Rheumatoid Arthritis, Crohn’s disease, Ulcerative Colitis, Psoriasis) and cardio-metabolic diseases (Stroke, DVT).
    Prior to joining Boehringer Ingelheim he has held various project leader positions in clinical research and R&D project management at PRA Health Sciences Inc., Sankyo Pharma GmbH as well as Schering AG.
    Ekkehard holds an MSc in chemistry from the Freie Universität, Berlin, a PhD in biochemistry from the Technische Universität, Berlin (Max-Delbrück-Centrum für Molekulare Medizin Berlin) and an MBA from the University of Edinburgh.

    Erin Federman

    Head of Biologics, Europe, Mylan
    Erin Federman

    Erin Federman is Head of Biologics, Europe for Mylan and the Chair of the Market Access Committee for Medicines for Europe. Erin is a senior-level, award-winning strategic marketer and problem solver with over 20 years sales and marketing experience across multiple industries and geographies. She has led strategic marketing initiatives for a broad range of biotech, pharmaceutical and technology products, from early development through launch and LOE with a particular focus on launch excellence, patient advocacy and market access. Specifically, she has led the launch preparation and roll-out of nine new medical devices (global) and three pharmaceutical assets (two global, one EU). Erin has worked for such leading healthcare focused organizations as Boehringer Ingelheim, Pfizer, Smiths Medical and Fujifilm SonoSite. She has lived and worked in the U.S., Italy, the United Kingdom and Germany. Erin is originally from Cincinnati, Ohio and is based in Frankfurt, Germany.

    Meenu Wadhwa

    Head, Cytokines & Growth Factors, Biotherapeutics Group, , National Institute for Biological Standards and Control
    Meenu Wadhwa

    Michael Muenzberg

    Member of the Comparative Outcomes Group , Former Medical Director Biosimilars EU, Amgen
    Michael Muenzberg

    Dr. Mike Muenzberg received his M.D. degree from the Medical University of Vienna. He did his clinical training in Austria, Canada, South Africa and Sweden and is licensed in Nuclear Medicine. He is working since 20 years in Pharma Industry with Biotech Compounds, since 14 years as Global Medical Executive Biosimilars for SANDOZ, Merck Serono and Amgen.
    Mike Muenzberg is currently working as an independent Consultant for Biosimilars and Biotech related topics and is member of the Comparative Outcomes Group.

    Michel Mikhail

    International Expert in Regulatory Affairs, Global Expert in Biosimilars
    Michel  Mikhail

    Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Monoclonal antibodies Medicines. He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organizations. Dr. Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP).

    Mourad Farouk Rezk

    Global Head Medical Affairs Biosimilars, Biogen
    Mourad  Farouk Rezk

    MOURAD FAROUK REZK, MD MSc MBA
    Senior Director, Global Head of Medical and Scientific Affairs, Biosimilars

    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.

    Niklas Czeloth

    Head of Biosciences Biosimilars, Boehringer Ingelheim GmbH
    Niklas Czeloth

    Niklas Czeloth has studied Biochemistry in Hannover (Germany) and specialized in Immunology during his PhD and Post-Doc time. He started his industrial career at Biotest AG as a Manager Toxicology and became Associate Director Pharmacology in the Non-clinical department at Biotest. After 5 years developing monoclonal antibodies at Biotest he joined Boehringer Ingelheim (Germany) as a Project Manager DMPK and became responsible for the PK and Immunogenicity activities for Biosimilars in the Biosciences group. Since June 2014, Niklas is heading the Biosciences group and is leading DMPK, Pharmacology and Toxicology activities for the biosimilar portfolio at Boehringer Ingelheim.

    Omar Ali

    Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth
    Omar Ali

    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”.

    Richard Peck

    Vice President Regulatory Affairs, Lupin (Europe) Ltd
    Richard  Peck

    Richard Peck studied medicine in the USA and obtained a Doctor of Philosophy from the University of Tennessee. Following a Post-Doc at the Biozentrum of the University of Basel (medical virology, molecular biology), he was employed by F. Hoffmann La Roche, Basel as International Regulatory Affairs Manager (Global Regulatory Leader). He holds a Master of Science in Regulatory Affairs at the University of Wales in Cardiff. He was appointed as Head of Regulatory Affairs at CSL-Behring and became Director of Regulatory Affairs at Finox. He is now Vice President Regulatory Affairs at Lupin Ltd in Zug, Switzerland, a company specialising in the development of biosimilar medicines.

    Richard Trollope

    Head of Biosimilars, Mundipharma International
    Richard Trollope

    Rodeina Challand

    General Manager, Challand Biosimilar Consulting
    Rodeina Challand

    Science and Law Graduate with 30 years of experience in healthcare, cancer research, pharmaceutical industry and CRO, across a wide range of roles including developing and implementing clinical development strategies for biosimilars and complex generics. Experience in all aspects of biosimilar development including study design and regulatory agency discussions (EMA, FDA, MENA, GCC, Australia, India, Japan and S. Korea). In the last few years have worked with the developing regions and conducted several meetings with MENA and GCC Regulatory Agencies to educate and better understand their expectations licensing biosimilars; also supporting them in implementing clinical trial regulations and educating potential investigators in the region. Worked on over 15 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, Heparins, Insulins and monoclonal antibodies in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV).

    Ruediger Jankowsky

    Managing Director, Cinfa Biotech
    Ruediger Jankowsky

    Ruediger Jankowsky, PhD, Managing Director of Cinfa Biotech (Pamplona, Spain/ Munich, Germany)

    Ruediger Jankowsky is responsible for the operational leadership of Cinfa Biotech, the biosimilars company of Cinfa Group, a pharmaceutical leader in Spain. He joined Cinfa Biotech in 2014 and has since then created corporate structures for the development, manufacturing and commercialisation of Cinfa Biotech’s products, and positioned the company in the market for high-quality biosimilars. Ruediger has nearly 20 years of experience in the pharmaceutical industry where he held various international executive positions in global and mid-size pharmaceutical compan

    Uwe Gudat

    Head of Clinical Safety & Pharmacovigilance, Fresenius-Kabi
    Uwe Gudat

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Global Development of Biosimilars: A Refresher
    Workshop

    Global Development of Biosimilars: A Refresher

    Copthorne Tara Hotel
    25th September 2018
    London, United Kingdom

    Value Based Agreements with Biosimilars: Architecture of Value Based Agreements
    Workshop

    Value Based Agreements with Biosimilars: Architecture of Value Based Agreements

    Copthorne Tara Hotel
    25th September 2018
    London, United Kingdom

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

    Biosimilars & Biobetters Speaker Interview MICHEL MIKHAIL

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    Biosimilars & Biobetters 2018 PAST ATTENDEES

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    Biosimilars & Biobetters 2018 PROGRAMME UPDATED

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    Speaker interview with Niklas Czeloth, Boehringer Ingelheim

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    Speaker interview with Erin Federman

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    Chairman's Invite Letter to Biosimilars & Biobetters Conference 2018

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    2017 Speaker Presentation Teva Pharmaceuticals Europe

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    2017 Speaker Presentation Gedeon Richter

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    Biosimilars & Biobetters 2018 BROCHURE

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    Biosimilars & Biobetters 2018 WORKSHOPS

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    Biosimilars & Biobetters 2018 SPEAKERS

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    Sponsors and Exhibitors


    Impact Medical Education

    Sponsors and Exhibitors
    http://www.impactmedicaleducation.com

    Impact helps build global biosimilar brands. Our programs accelerate biosimilar uptake and provide you with meaningful differentiation in an increasingly competitive market. We understand the challenges facing new biosimilars and can advise you on how to maximize clinician engagement and long-term adoption of your brand.

    Media Partners


    GaBI

    Official Media Partner
    http://www.gabionline.net

    Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines. Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net. GaBI’s mission – Building trust in cost-effective treatments


    Biosimilar Development

    Official Media Partner
    http://www.biosimilardevelopment.com/

    Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property. Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.


    The Medicine Maker

    Official Media Partner
    http://www.themedicinemaker.com

    The Medicine Maker


    World Pharma News

    Official Media Partner
    http://www.worldpharmanews.com/



    Farmavita

    Official Media Partner
    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    pharmanews hq

    Official Media Partner
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    Samedan

    Official Media Partner
    http://www.samedanltd.com/magazine/13.

    International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.

    Media Partners


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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