Conference Agenda

15th Biosimilars Global Congress 2023 Europe

Day 2: Tuesday 26th September 2023

Rodeina Challand, VP Scientific Affairs, BioFactura, Inc.

Current Regulatory Landscape

  • Critical aspects of the global Biosimilar market such as vendor landscape, competitive strategies,
    market drivers and challenges
  • Changing market dynamics within the Biosimilars market
  • The (relatively) welcoming EU environment vs. the US quagmire
  • The patent dance – or the last waltz for US biosimilars?

Moderator:

Rodeina Challand, VP Scientific Affairs, BioFactura, Inc.

Panelist:

Cecil Nick, Vice President (Technical), PAREXEL
Xavier Fraise, Principal, F.-X. Frapaise Pharma Consulting, Former VP. Clin Dev. Merck
Rajpreet Grewal, Senior Medical Scientific Liaison, Fresenius-Kabi 

  • What EMA and FDA require
  • To what extent can analytical and invitro data provide assurance of therapeutic similarity
  • The value of clinical pharmacology data in confirming biosimilarity
  • Value of therapeutic equivalence trials and thoughts on how these can be streamlined

Cecil Nick, Vice President (Technical), PAREXEL

Access, Collaborations and Commercial Strategies

  • A fundamental and thorough belief in science
  • An efficient procurement system
  • An involvement of all relevant stakeholders
  • Available and reliable information to patients
  • Application of the lessons learned

Peter Jørgensen, CEO, The Danish Generic and Biosimilar Medicines Association

  • Significantly invest in the training of medical professionals, including nurses
  • Develop patient information/assistance programs
  • Partner with patients organizations and regulators
  • Economically incentivize patients to accept a biosimilars prescription
  • Consider patients as partners, and no longer as “subjects”

Xavier Fraise, Principal, F.-X. Frapaise Pharma Consulting, Former VP. Clin Dev. Merck

TBC

Zafer Toksöz, President & Founder, Arven Pharmaceuticals

  • There are still access inequalities in Europe to tackle
  • No or late treatment will result in a high medical burden for patients and a high economic burden for
    healthcare systems
  • Knowledge gaps around the concept of biosimilarity lead to misperceptions and misjudgment
  • Despite low Rx volumes in some European countries and the COVID pandemic biosimilars induce huge
    savings for healthcare systems
  • Informed shared decision making is critical to address patients’ needs and to avoid nocebo effect and
    non-adherence

Burkhard Pieper, Global Scientific Officer, Biogen Biosimilars Unit (BBU)

  • Overview of Tendering for Biosimilars in Europe
  • Key capabilities for Tendering success
  • The Biosimilar Tender Opportunity Calendar

Nico Bacharidis, Member of the Board of Directors, Cube RM

  • High yield cell line engineering
  • Stable quality attribute
  • DNA to Pilot scale in 4 months.
  • Optimization of platform for IP protection.

H. Fai Poon, President, QuaCell Biotechnology, Co., Ltd.

  • This talk aims to give an overview of key concepts of biosimilars including extrapolation, switching
    and regulatory requirements
  • It also discusses the phase 1, and randomised phase 3 neoadjuvant studies that led to the regulatory
    approvals.
  • They raise the intriguing question of whether we still require large studies for approval.

Justin Stebbing, Visiting Professor, Cancer Medicine & Oncology, Imperial College London

  • Strategies for overcoming barriers to biosimilar adoption
  • How can biosimilar developers, patients, healthcare proffesionals and payers conspire
    to establish a sustainable biosimilar market
  • Importance of Physician and Patients input in shaping international standards for
    biosimilars
  • Policies in place to encourage physicians / pharmacist collaboration
  • Commercial potential and best ways on how to gauge such an opportunity in biosimilar

Moderator:

Rodeina Challand, VP Scientific Affairs, BioFactura, Inc.

Panelist:
Jo Pisani, Board Member, Non-executive Director, The RSA Group

Rajpreet Grewal, Senior Medical Scientific Liaison, Fresenius-Kabi

Sponsors & Exhibitors
Confirmed Speakers

Who Attends

The 14th Biosimilars Global Congress 2022 Europe, will provides a unique platform for the convergence of stakeholders in the biosimilars industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organizations, biosimilar developers as well as regional and local manufacturers. Our event delegates include Chief Executives, Executive Directors, Vice Presidents, Heads, Team Leaders & Managers from a range of organisations including..

AbbVie Canada – Abbvie – Abzena – AGES MEA – Alliance for Safe Biologics – Amgen Inc – Applied Photophysics Ltd – Arecor – Avalere Health – AstraZeneca – Barclays – Bates White – Baxalta Inc – Baxalta US Inc – Baxter Healthcare – Benchworks Inc – Biocad Brazil – Biocad Russia – Bioeq – BioFactura Inc – Biogen Idec – Biogen International GmbH – Biogen – Biologics Consulting Group Inc – BIOMEDICA – BioPharm Insight – Biopharmaspec Inc – BioVirtus – BioWorld Today – Bird and Bird – Boehringer Ingelheim – Bristol Myers Squibb – Caprion – Cardinal Health – Charles River Laboratories – Chatfield Pharmaceuticals Ltd – CIMA Industries SA – Cipla Ltd – Clearside Biomedical – Clinigen CTS – CMC Biologics A/S – COFEPRIS – Consumer Health Forum of Australia – Cook Pharmica LLC – Deutsche Bank – Dr. Reddy’s Laboratories – Drinker Biddle & Reath – Durbin Global – Dyadic International (USA) Inc – EMD Millipore – EMD Serono – ENCB-IPN – Epirus Biopharmaceuticals – Eurofins Lancaster Laboratories – FirstWord – Fresenius Kabi – Fujifilm Diosynth Biotech – Fujifilm Kyowa Kirin Biologics Co. Ltd – GE Healthcare Life Sciences – Genentech – Geolab Pharmaceutical Industry – Glyconex – Granzer Regulatory Consulting & Services – Grupo Farmaceutico Somar – GSK – Hanwha Biologics – Hanwha Chemicals – Harvest Moon Pharmaceuticals – Hospira Inc – IMS Health – Innovent Biologics Inc – Intra – Cellular Therapies Inc – inVentiv Health Clinical – Janssen Inc – JHL Biotech Inc Taiwan – KLJ Associates – Lake Partners – Libbs Farmaceutica – Lifescience Dynamics – Lonza Biologics PLC – Lupin Pharmaceuticals India – mAbXience – Medimmune – Merck & Co – Merck Biosimilars – Merck Millipore – Merck Serono – Merck Sharp & Dome Ltd – Merck – Merckle GmbH – Milliman – MITSUBISHI GAS CHEMICAL COMPANY INC – Momenta Pharmaceuticals Inc – Multipharma – Mylan – Myoderm – Napp Pharmaceuticals – Nippon Kayaku Co Ltd – NIPTE – Norwegian Medicines Agency – Novo Nordisk – Omnicare Pharma GmbH – Orygen Biotechnologica – PARAXEL International – Patheon – PCI Pharma Services – Pfizer Inc – Plexus Ventures Limited – PPD – PRA Health Sciences – PRA International – Probiomed S.A de C.V – Protagen Protein Services GmbH – Qually Corporacion S.A de C.V – Queens University – Ratiopharm – Roche Farmaceutica – Sanape LLC – S &Oz Inc. (a Novartis Company) – Sciex Separations – SciMentum – SGS Group Ltd (USA) – SGS Life Sciences Services – SGS M-Scan Ltd – Shanghai CP Guojian Pharmaceutical Co Ltd – Spectrum Paharmaceuticals – SPL – Stefantech Systems Inc – Sterne Kessler Goldstein & Fox P.L.L.C – Sughrue Mion PLLC USA – Sun Pharmaceuticals Industry Ltd – Taylor Wessing LLP – Teva Pharmaceuticals – Texcell – Therapeutic Proteins International LLC – Toxikon Europe – Transformity – University Alkharh EDU – Virdispharma – Voisin Consulting Life Sciences – West Pharmaceutical Services Inc – Woodley Bio Reg Ltd – Wyatt Health Management – YAKUMED – Ypsomed AG – ZOTEK King Lai Co. Ltd (KunShan)