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Innovative Therapies in Europe

DIA-EUCOPE Workshop: 5 Years of ATMPs on the Market - Lessons Learned


Speakers

  • Alexander  Natz, JD

    Alexander Natz, JD

    • Secretary General
    • European Confederation of Pharmaceutical Entrepreneurs, Belgium

    Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements & licensing of pharmaceuticals. He has also worked in the field of competition law with the EC & in the pharma industry. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.

  • Oswald  Bentinck

    Oswald Bentinck

    • Vice President - Head of Market Access EMEA
    • Novartis Gene Therapies, Switzerland

  • Michela  Gabaldo, PharmD, MSc

    Michela Gabaldo, PharmD, MSc

    • Head Alliance Management & Regulatory Affairs
    • Fondazione Telethon, Italy

    Dr Gabaldo has more than 20 years of experience in drug development spanning from chemicals up to ATMP. Currently Head of Alliance Management & Regulatory Affairs at Fondazione Telethon where she joined in 2011. Her team manages gene therapy projects at different stage of development ranging from early development up to clinical translation, registration and patient access developed both internally & in partnership with relevant pharmaceutical industries. Degree in Pharmacy and Master in Regulatory Affairs & Market Access. Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans. Currently member of the IRDIRC Therapies Scientific Committee.

  • Jens  Grueger, PhD

    Jens Grueger, PhD

    • Global Market Access Expert
    • Former President at ISPOR, Switzerland

    Jens Grueger is Vice President and Head of Global Pricing & Market Access at Hoffmann-La Roche in Basel, Switzerland. He previously held leadership positions in pricing, health economics and market access at Pfizer, Novartis and SmithKline Beecham. Jens holds a PhD in mathematical statistics from University of Dortmund, Germany. From 2004-2006, he was a Director of the International Society for Pharmacoeconomics and Outcomes Research.

  • Ania   Mitan

    Ania Mitan

    • SVP & Managing Director EMEAIS
    • DIA, Switzerland

    Ania Mitan serves as the Senior Vice President & Managing Director, DIA EMEA, India and Singapore. She is former Executive Director of the commercial organization at Celgene, where she built the oncology business in the EMEA region with healthcare partners to shape quality delivery systems and new commercialization models in personalized medicine, specifically with novel cell and gene therapies. She began her career at Eli Lilly and Company, serving as Head of Commercial Development for EU mid-size countries, Head of Primary Care Business Unit for the UK and Ireland, and Head of Marketing for the Critical Care Unit. Ania earned her MBA from Simmons College and MSc in Pharmacy from Silesian Medical Academy (Poland).

  • Aleksandar  Ruzicic

    Aleksandar Ruzicic

    • President, Swiss Healthcare Industry Club (cHIC), INSEAD Alumni
    • Association Switzerland & Vice President, INSEAD Healthcare Alumni Network, Switzerland

    After his MSc in Chemistry from the University of Zürich, Aleks started his consulting career at McKinsey & Company from 1994 to 2000. He graduated with an MBA from INSEAD in 1997. Since 2005, he is a member of the Swiss Committee and president of the Swiss Healthcare Club. He is also co-founder and vice-president of the INSEAD Healthcare Alumni Network. Since 2000, Aleks focused on the healthcare/life sciences sector at Elsevier MDL, Roland Berger Strategy Consultants and IMS Consulting Group. In October 2013, he joined Executive Insight as a Partner. Since April 2020, he is Marketing & Service Design Lead, and member of the Executive Insight Operating Committee (EOC).

  • Vanessa Elisabeth   Schaub

    Vanessa Elisabeth Schaub

    • Global Access Senior Health Systems Strategy Leader HTA & Reimbursement
    • F. Hoffmann-La Roche, Switzerland

    Vanessa Schaub is Global Access Strategy Leader for HTA & Reimbursement at Roche. In this role she is in charge of ensuring consistent approach to HTA systems, assessment methodologies, appropriate evidence application, value frameworks and innovative reimbursement schemes globally. Before taking over the global role she hold diverse access and commercial positions in the Roche German affiliate. Vanessa has experience in the departments of oncology, neurology and respiratory diseases.

  • Jacquelyn  Awigena-Cook, MSc

    Jacquelyn Awigena-Cook, MSc

    • Director, Global Regulatory Policy & Intelligence
    • Bristol Myers Squibb, United Kingdom

    As Associate Director of Regulatory Policy and Intelligence at BMS, Jacquelyn is responsible for evaluating trends in the regulatory environment and working with stakeholders to advocate for policies supporting development of innovative medicines. She has been managing projects, leading initiatives, and designing processes to assess the impact of regulatory change on strategy, operations, and compliance in the pharmaceutical industry for 13+ years. Her current focus is on regulatory policies impacting ATMPs and supporting project teams in the Hematology & Oncology disease areas. Jacquelyn holds a degree in Cell Biology & Biochemistry from Bucknell University and a MSc from the London School of Economics and Political Science.

  • Thomas  Bols, MA

    Thomas Bols, MA

    • Head of Government affairs and Patient Advocacy, EMEA & APAC
    • PTC Therapeutics, Inc., Switzerland

    Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

  • Philippe  Coune

    Philippe Coune

    • Director
    • Executive Insight, Switzerland

  • Julio  Delgado

    Julio Delgado

    • Hematologist & CAR-T Programme Lead
    • Hospital Clinic of Barcelona, Spain

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