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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.

  • 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

    • Partner, Head of Operations
    • Executive Insight, 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).

  • 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.

  • 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.

  • Michela  Gabaldo, PharmD, MSc

    Michela Gabaldo, PharmD, MSc

    • Evotec, 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.

  • Oswald  Bentinck

    Oswald Bentinck

    • Vice President, Global Head of Value & Access
    • Rocket Pharmaceuticals, Inc., United States

  • 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.

  • Philippe  Coune

    Philippe Coune

    • Director
    • Executive Insight, Switzerland

  • Emil Andrei  Cochino, MD, MHS

    Emil Andrei Cochino, MD, MHS

    • Scientific Officer, Risk Management Specialist, Office of vaccines and therapies
    • European Medicines Agency, Netherlands

    Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance.

  • Julio  Delgado

    Julio Delgado

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

  • Sandra  Petraglia, MD, PhD

    Sandra Petraglia, MD, PhD

    • Head of Pre Authorisation Department
    • AIFA - Agenzia Italiana Del Farmaco, Italy

    Sandra Petraglia has been working at the AIFA since 2004. Currently Head of Pre Authorisation Department, with close involvement in the national implementation activities and requirements for the Clinical Trials Regulation since 2015, being also the Italian representative at the CTFG and at the EMA and EU Commission groups on implementation of Regulation 536/2014 EU. Medical Doctor by education, Dermatologist and PhD in Dermatological Immunology, her previous activities at the AIFA have been as Clinical assessor, MRP/DCP Coordinator and Italian CMDh member from 2005 to 2016. Previously, she has being working in the fields of Information and Advertising on Medicines and of Dermatological Oncology and Immunological therapy.

  • Sophie  Schmitz

    Sophie Schmitz

    • Managing Partner
    • P4A Partners for Access, Netherlands

    Sophie is Managing Partner at Partners4Access (P4A), a global consultancy 100% focused on orphan drug access. P4A support the biotechnology and pharmaceutical industry along their launch journey to help secure successful price, reimbursement and access for orphan drugs. The company has solid partnerships with clients supporting their strategy and operations to effectively ensure launch success. Sophie has worked in a range of disease therapy areas and has industry experience in both medical device and pharmaceutical industries, as such she has developed a solid appreciation of strategic challenges and opportunities facing companies.

  • Anne  Kerber

    Anne Kerber

    • SVP Head of Cell Therapy Development
    • Bristol Myers Squibb , Germany

    Anne Kerber serves as senior vice president, head of Cell Therapy Development at Bristol Myers Squibb and leads all clinical trial and development activities of BMS’ cell therapy portfolio. Anne is an experienced leader and drug developer, with particular expertise in cell therapies. Prior to BMS, she worked at Kite, a Gilead Company, as vice president, Clinical Development. Before that, she held several leadership roles at Affimed. Anne received her M.D. from Philipps University in Marburg, Germany and completed her clinical training in Internal Medicine at Johann Wolfgang Goethe University Hospital in Frankfurt. She also holds a degree in Pharmaceutical Medicine from the University of Basel, Switzerland.

  • Antonella  Cardone

    Antonella Cardone

    • Director
    • Cancer Patients Europe, Belgium

    Antonella Cardone is currently collaborating with Cancer Patients Europe, which is a pan-European and all-cancer types patient organization. She is the Patient Advocacy Expert and Advisor to the Board of Pancreatic Cancer Europe (PCE). She has been Vice-Chair of PCE.

  • Nicolas  Koebel

    Nicolas Koebel

    • Chief Executive Officer of EpilepsyGTx Limited
    • EpilepsyGTx Limited, United Kingdom

    Nicolas Koebel is the CEO of EpilepsyGTx, a Biotech developing cutting-edge gene therapies targeting epilepsy, since September 2022.In his career spanning 20 years, he has specialized in gene and cell therapies.At GSK(2005-2015), he was responsible for the commercialization strategies of gene therapies targeting rare diseases, including STRIMVELIS, the first autologous ex vivo gene therapy approved by the EMA.As founder and first employee of Orchard Therapeutics (2016-2022), he set up the development function of the company and was involved in the company fundraising including IPO in 2018. He pioneered the commercialization of LIBMELDY in Europe, leading the qualification of treatment sites and reimbursement negotiations in several markets.

  • Marcus  Guardian

    Marcus Guardian

    • COO EUnetHTA 21, General Manager - Heads of HTA Agencies Group
    • EUnetHTA, Netherlands

    Based on the educational background in international law and diplomatic studies, Marcus has forged a career in network development, strategic guidance, and policy management. In 2016, he accepted the Chief Operating Officer position at EUnetHTA Joint Action 3 and now continues with EUnetHTA 21 Consortium. He also leads work of the Heads of HTA Agencies Group and supports the Chairs in processes of the strategic decision making, preparing European HTA landscape for the EU HTA Regulation. Moreover, in 2018 Marcus launched the International Horizon Scanning Initiative, building a global database of pharmaceutical products in development combined with novel data-modelling tools that support member state healthcare product negotiation potential.

  • François  Houyez

    François Houyez

    • Treatment Information and Access Director, Health Policy Advisor
    • European Organisation for Rare Diseases (EURORDIS), France

    François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

  • Maria João  Garcia, PharmD

    Maria João Garcia, PharmD

    • Global Access Evidence Lead
    • F. Hoffmann-La Roche, Ltd., Switzerland

    Maria João Garcia is a PharmD with 8+ years of experience in the pharmaceutical industry across different departments (drug development, regulatory affairs and access) in oncology and neuroscience. In her role as Global Access Evidence Lead, Maria was the project manager of the last two Roche pilot EUnetHTA REAs and is currently leading Roche's internal communication, awareness and education on the evolving EU HTA framework. She is passionate about EU HTA and enthusiastic about the potential benefits it will bring to all relevant stakeholders across the EU. She is also leading HTA evidence generation and synthesis activities in Duchenne Muscular Dystrophy (gene therapy) and Alzheimer's Disease.

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