The 2021 Cell & Gene Meeting on the Mediterranean was delivered in a virtual format over the course of four days. The agenda included a mix of on-demand content that was released each morning in addition to two live-streaming panels each day.
LIVE STREAMING SESSIONS WITH Q&A
OUTLOOK FOR THE EUROPEAN ATMP SECTOR IN 2021
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
Chair:
Christopher Vann, SVP and Chief Operating Officer, Autlolus
Speakers:
Doug Danison, SVP, Head of Europe, bluebird bio
Robin Kenselaar, SVP and General Manager, EMEA, Orchard Therapeutics
Emanuele Ostuni, Ph.D., Head of Cell and Gene Therapy, ORE, Novartis Oncology
Dick Sundh, VP, Head of Australia, Canada and Europe (ACE), Kite, a Gilead Company
CMC: ARE WE MOVING IN THE RIGHT DIRECTION?
3pm – 4pm CET (Europe) / 9am – 10am ET (USA)
The year 2017 was the annus mirabilis for cell and gene therapy approvals, with three BLAs approved in the U.S. quickly followed by licensure in the rest of the world. Since then, approval rates have barely hit one per year and multiple applications have been delayed, suspended, and rejected. CMC issues underpinned a majority of these disappointing events, which leads us to the question “are we moving in the right direction?” This diverse panel will address criticality in a candid and forthright manner, bringing insight from every angle.
Chair:
Anthony Davies, Ph.D., Founder and CEO, Dark Horse Consulting
Speakers:
Neil Almstead, Ph.D., Chief Technical Operations Officer, PTC Therapeutics
Nirupama (Rupa) Pike, Ph.D., Director, Enterprise Science and Innovation Partnerships, Global Corporate Accounts, Thermo Fisher Scientific
Martha Rook, Ph.D., SVP, Head of CMC and Analytics, Sigilon Therapeutics
Stephen Ward, Ph.D., Chief Manufacturing Officer, Cell and Gene Therapy Catapult
DURING BREAKS IN LIVE PROGRAMMING
Participate in 1×1 Partnering, Visit Virtual Exhibit Booths, View On-Demand Content
ON-DEMAND CONTENT
Available Beginning Tuesday, April 6, 2021
90+ COMPANY PRESENTATIONS
View the Full List
SHAPING THE EUROPEAN ATMP SECTOR: THE INDUSTRIAL POLICY PERSPECTIVE
As a physician and 14-year Member of Parliament, Dr. Bușoi’s influential Committee legislates on several of the most important policy areas of the European Union. His committee will shape the larger pharma sector and ATMP policies for years to come, especially with a view to industrial policy and innovative technologies. Join us for a featured presentation by Dr. Bușoi followed by moderated Q&A.
Chair:
Paige Bischoff, SVP of Global Public Affairs, Alliance for Regenerative Medicine (ARM)
Speakers:
Cristian-Silviu Bușoi, Ph.D., Member of the European Parliament, Chair of the Committee on Industry, Research and Energy
CELL AND GENE THERAPIES FOR OPHTHALMOLOGIC DISEASES
This panel of distinguished leaders will discuss aspects of the eye and ocular disease that make it an attractive target for cell and gene therapy, as well as potential future developments that may occur in the space. The session will cover the developmental, regulatory, and clinical challenges in this sector, and aspects of commercialization of cell- and gene-based therapies in ocular disease.
Chair:
Richard Beckman, M.D., Chief Medical Officer, ReNeuron
Speakers:
Stéphane Boissel, CEO, SparingVision
Bernard Gilly, Ph.D., CEO and Co-Founder, GenSight Biologics
Jane Lebkowski, Ph.D., President, Regenerative Patch Technologies
Federico Mingozzi, Ph.D., Chief Scientific Officer, Spark Therapeutics
INNOVATION SHORTENING THE PATH TO COMMERCIALIZATION IN ADVANCED THERAPIES
Sponsored by Precision ADVANCE
Chair:
Clare Sarvary Fourrier, SVP, Clinical Operations, Europe, Precision for Medicine
Speakers:
Alex Grosvenor, SVP, PRECISIONadvisors, Precision Value and Health
David Lennon, Ph.D., President, Novartis Gene Therapies
Anshul Mangal, President, Project Farma and Precision ADVANCE
Parag Meswani, Pharm.D., Chief Commercial Officer, Sio Gene Therapies
Pascal Touchon, President and CEO, Atara Biotherapeutics
LIVE STREAMING SESSIONS WITH Q&A
REGULATORY PATHWAYS TO COMMERCIALIZATION: WHERE DO WE STAND ON THIS JOURNEY?
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
This session brings together leading regulators from around the world to discuss the ability of regulatory frameworks to deliver advanced therapies to patients globally. It will consider whether existing tools, such as facilitated regulatory pathways, are living up to their aspirations and are capable of meeting the demands of stakeholders to address unmet medical need in this rapidly evolving sector. In particular, considerations around the development of advanced therapies for slow progressing, chronic conditions and orphan conditions, including the optimization of traditional and novel endpoints and the role of early diagnosis, will also be discussed.
Chair:
John Way, Ph.D., VP, International Regulatory Sciences, Biogen
Speakers:
Ana Hidalgo-Simon, M.D., Ph.D., Head of Advanced Therapies, European Medicines Agency (EMA)
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)
Yoshiaki Maruyama, Ph.D., Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA)
Christian Schneider, M.D., Interim Chief Scientific Officer, Medicines and Healthcare Products Regulatory Agency (MHRA)
TRENDS AND CHALLENGES IN GENE THERAPY IN EUROPE
3pm – 4pm CET (Europe) / 9am – 10am ET (USA)
Sponsored by Pfizer
Chair:
Bob Smith, SVP, Global Gene Therapy Business, Pfizer Inc.
Speakers:
Jean-Philippe Combal, Pharm.D., Ph.D., Co-Founder and CEO, Vivet Therapeutics
Amy DuRoss, Co-Founder and CEO, Vineti
Michael Linden, Ph.D., Founder and Chief Scientific Officer, Handl Therapeutics
Durhane Wong-Rieger, Ph.D., Chair, Rare Diseases International
DURING BREAKS IN LIVE PROGRAMMING
Participate in 1×1 Partnering, Visit Virtual Exhibit Booths, View On-Demand Content
ON-DEMAND CONTENT
Available Beginning Wednesday, April 7, 2021
KEYNOTE SPEAKER: THE EMA’S PLAN FOR THE CONTINUING ACCELERATION OF THE ATMP SECTOR
Chair:
Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)
Speakers:
Emer Cooke, Executive Director, European Medicines Agency (EMA)
ATMPs TREATING THE CENTRAL NERVOUS SYSTEM
Chair:
Jon Garen, Chief Business Officer, uniQure
Speakers:
Bettina Cockroft, M.D., SVP and Chief Medical Officer, Sangamo Therapeutics
Chris Mason, M.D., Ph.D., Chief Scientific Officer, AVROBIO
Rachel McMinn, Ph.D., CEO, Neurogene
Jeffrey Sevigny, M.D., Chief Medical Officer, Prevail Therapeutics
LARGE CAP CELL AND GENE THERAPY STRATEGIES
A new wave of large cap players has emerged these past three years. These players have thought through a deliberate strategy of organic growth coupled with M&A. During this panel, attendees will hear from cell and gene experts sharing their experiences, having been actively observing and participating in a spectrum of change as new cutting-edge innovations in cell and gene therapy progress toward reality for patients.
Chair:
Usman “Oz” Azam, M.D., President and CEO, Tmunity Therapeutics
Speakers:
Katherine High, M.D., President of Therapeutics, AskBio
Bastiano Sanna, Ph.D., EVP, Chief of Cell and Genetic Therapies and VCGT Site Head, Vertex Pharmaceuticals
Jacob Sten Petersen, DMSc., Corporate VP and Head of Stem Cell R&D, Novo Nordisk
Krishnan Viswanadhan, Pharm.D., SVP, Global Cell Therapy Franchise Lead, Bristol-Myers Squibb
LIVE STREAMING SESSIONS WITH Q&A
THE STATE OF INVESTMENT IN CELL AND GENE THERAPY
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
This session will be an examination of the current status of public and private finance for ATMPs and will cover subjects such as a temperature check of the public markets, and the requirements for follow-on funding. Panelists will also discuss the relative merits of public vs. private markets for large follow-on rounds, the competitiveness of funding for spinouts and start-ups, as well as predictions for the next twelve months.
Chair:
Matthew Durdy, Chief Executive, Cell and Gene Therapy Catapult
Speakers:
Rachel Mears, Partner, Jeito Capital
Alice Renard, Pharm.D., Partner, Syncona Investment Management
Brian Silver, Chief Financial Officer and Head of Corporate Development, Freeline
NEXT GENERATION APPROACHES USING IPSCs
3:00pm – 4:00pm CET (Europe) / 9am – 10am ET (USA)
Chair:
Gregory Block, Ph.D., SVP, Corporate Development, Notch Therapeutics
Speakers:
Kevin Alessandri, Ph.D., CEO and Chief Technology Officer, TreeFrog Therapeutics
Jo Brewer, Ph.D., SVP, Allogeneic Research, Adaptimmune
Emile Nuwaysir, Ph.D., President and CEO, BlueRock Therapeutics
Alberto Santagostino, SVP, Head of Cell and Gene Technologies, Lonza Pharma & Biotech
DURING BREAKS IN LIVE PROGRAMMING
Participate in 1×1 Partnering, Visit Virtual Exhibit Booths, View On-Demand Content
ON-DEMAND CONTENT
Available Beginning Thursday, April 8, 2021
OPPORTUNITIES EMERGING IN A POST-PANDEMIC WORLD
Listen in on this assembly of experts from the EU, UK, and U.S. as they discuss the acceleration and opportunity that is arising from the tragedy and burden brought about by COVID-19. Attendees will hear about emerging best practices, and what to watch for and intentionally drive in your own organization to ensure your programs accelerate as swiftly and as safely as possible in this altered state of normal.
Chair:
Michelle Berg, President, GMP Nucleic Acids, Aldevron
Speakers:
Nicole Faust, Ph.D., CEO, CEVEC Pharmaceuticals
James Miskin, Ph.D., Chief Technical Officer, Oxford Biomedica
Vasu Rangadass, Ph.D., President and CEO, L7 Informatics
Joe Tarnowski, Ph.D., SVP, Cell and Gene Therapy Platform, GSK
ALTERNATIVE CELL SOLUTIONS FOR ONCOLOGY
This panel session brings together four highly experienced biotechnology industry leaders who will discuss a spectrum of cell therapy approaches from NK Cells to CAR-macrophages, autologous and allogeneic. Attendees will hear about each speaker’s respective technologies, what these CEOs have learned from past successes and failures in the field, and where they see their alternative approaches fitting into the cell therapy armamentarium.
Chair:
Martin Lachs, Ph.D., VP, Global Project Management, ICON plc
Speakers:
Julian Adams, Ph.D., CEO, Gamida Cell
Steven Kelly, President and CEO, Carisma Therapeutics
Arthur Lahr, CEO, Kiadis Pharma
Filippo Petti, CEO and Chief Financial Officer, Celyad Oncology
OPEN DAY
Participate in 1×1 Partnering, Visit Virtual Exhibit Booths, View On-Demand Content
LIVE STREAMING SESSIONS WITH Q&A
OUTLOOK FOR THE EUROPEAN ATMP SECTOR IN 2021
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
Chair:
Christopher Vann, SVP and Chief Operating Officer, Autlolus
Speakers:
Doug Danison, SVP, Head of Europe, bluebird bio
Robin Kenselaar, SVP and General Manager, EMEA, Orchard Therapeutics
Emanuele Ostuni, Ph.D., Head of Cell and Gene Therapy, ORE, Novartis Oncology
Dick Sundh, VP, Head of Australia, Canada and Europe (ACE), Kite, a Gilead Company
CMC: ARE WE MOVING IN THE RIGHT DIRECTION?
3pm – 4pm CET (Europe) / 9am – 10am ET (USA)
The year 2017 was the annus mirabilis for cell and gene therapy approvals, with three BLAs approved in the U.S. quickly followed by licensure in the rest of the world. Since then, approval rates have barely hit one per year and multiple applications have been delayed, suspended, and rejected. CMC issues underpinned a majority of these disappointing events, which leads us to the question “are we moving in the right direction?” This diverse panel will address criticality in a candid and forthright manner, bringing insight from every angle.
Chair:
Anthony Davies, Ph.D., Founder and CEO, Dark Horse Consulting
Speakers:
Neil Almstead, Ph.D., Chief Technical Operations Officer, PTC Therapeutics
Nirupama (Rupa) Pike, Ph.D., Director, Enterprise Science and Innovation Partnerships, Global Corporate Accounts, Thermo Fisher Scientific
Martha Rook, Ph.D., SVP, Head of CMC and Analytics, Sigilon Therapeutics
Stephen Ward, Ph.D., Chief Manufacturing Officer, Cell and Gene Therapy Catapult
LIVE STREAMING SESSIONS WITH Q&A
REGULATORY PATHWAYS TO COMMERCIALIZATION: WHERE DO WE STAND ON THIS JOURNEY?
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
This session brings together leading regulators from around the world to discuss the ability of regulatory frameworks to deliver advanced therapies to patients globally. It will consider whether existing tools, such as facilitated regulatory pathways, are living up to their aspirations and are capable of meeting the demands of stakeholders to address unmet medical need in this rapidly evolving sector. In particular, considerations around the development of advanced therapies for slow progressing, chronic conditions and orphan conditions, including the optimization of traditional and novel endpoints and the role of early diagnosis, will also be discussed.
Chair:
John Way, Ph.D., VP, International Regulatory Sciences, Biogen
Speakers:
Ana Hidalgo-Simon, M.D., Ph.D., Head of Advanced Therapies, European Medicines Agency (EMA)
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)
Yoshiaki Maruyama, Ph.D., Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA)
Christian Schneider, M.D., Interim Chief Scientific Officer, Medicines and Healthcare Products Regulatory Agency (MHRA)
TRENDS AND CHALLENGES IN GENE THERAPY IN EUROPE
3pm – 4pm CET (Europe) / 9am – 10am ET (USA)
Sponsored by Pfizer
Chair:
Bob Smith, SVP, Global Gene Therapy Business, Pfizer Inc.
Speakers:
Jean-Philippe Combal, Pharm.D., Ph.D., Co-Founder and CEO, Vivet Therapeutics
Amy DuRoss, Co-Founder and CEO, Vineti
Michael Linden, Ph.D., Founder and Chief Scientific Officer, Handl Therapeutics
Durhane Wong-Rieger, Ph.D., Chair, Rare Diseases International
LIVE STREAMING SESSIONS WITH Q&A
THE STATE OF INVESTMENT IN CELL AND GENE THERAPY
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
This session will be an examination of the current status of public and private finance for ATMPs and will cover subjects such as a temperature check of the public markets, and the requirements for follow-on funding. Panelists will also discuss the relative merits of public vs. private markets for large follow-on rounds, the competitiveness of funding for spinouts and start-ups, as well as predictions for the next twelve months.
Chair:
Matthew Durdy, Chief Executive, Cell and Gene Therapy Catapult
Speakers:
Rachel Mears, Partner, Jeito Capital
Alice Renard, Pharm.D., Partner, Syncona Investment Management
Brian Silver, Chief Financial Officer and Head of Corporate Development, Freeline
NEXT GENERATION APPROACHES USING IPSCs
3:00pm – 4:00pm CET (Europe) / 9am – 10am ET (USA)
Chair:
Gregory Block, Ph.D., SVP, Corporate Development, Notch Therapeutics
Speakers:
Kevin Alessandri, Ph.D., CEO and Chief Technology Officer, TreeFrog Therapeutics
Jo Brewer, Ph.D., SVP, Allogeneic Research, Adaptimmune
Emile Nuwaysir, Ph.D., President and CEO, BlueRock Therapeutics
Alberto Santagostino, SVP, Head of Cell and Gene Technologies, Lonza Pharma & Biotech
ON-DEMAND CONTENT
Available Beginning Tuesday, April 6, 2021
90+ COMPANY PRESENTATIONS
View the Full List
SHAPING THE EUROPEAN ATMP SECTOR: THE INDUSTRIAL POLICY PERSPECTIVE
As a physician and 14-year Member of Parliament, Dr. Bușoi’s influential Committee legislates on several of the most important policy areas of the European Union. His committee will shape the larger pharma sector and ATMP policies for years to come, especially with a view to industrial policy and innovative technologies. Join us for a featured presentation by Dr. Bușoi followed by moderated Q&A.
Chair:
Paige Bischoff, SVP of Global Public Affairs, Alliance for Regenerative Medicine (ARM)
Speakers:
Cristian-Silviu Bușoi, Ph.D., Member of the European Parliament, Chair of the Committee on Industry, Research and Energy
CELL AND GENE THERAPIES FOR OPHTHALMOLOGIC DISEASES
This panel of distinguished leaders will discuss aspects of the eye and ocular disease that make it an attractive target for cell and gene therapy, as well as potential future developments that may occur in the space. The session will cover the developmental, regulatory, and clinical challenges in this sector, and aspects of commercialization of cell- and gene-based therapies in ocular disease.
Chair:
Richard Beckman, M.D., Chief Medical Officer, ReNeuron
Speakers:
Stéphane Boissel, CEO, SparingVision
Bernard Gilly, Ph.D., CEO and Co-Founder, GenSight Biologics
Jane Lebkowski, Ph.D., President, Regenerative Patch Technologies
Federico Mingozzi, Ph.D., Chief Scientific Officer, Spark Therapeutics
INNOVATION SHORTENING THE PATH TO COMMERCIALIZATION IN ADVANCED THERAPIES
Sponsored by Precision ADVANCE
Chair:
Clare Sarvary Fourrier, SVP, Clinical Operations, Europe, Precision for Medicine
Speakers:
Alex Grosvenor, SVP, PRECISIONadvisors, Precision Value and Health
David Lennon, Ph.D., President, Novartis Gene Therapies
Anshul Mangal, President, Project Farma and Precision ADVANCE
Parag Meswani, Pharm.D., Chief Commercial Officer, Sio Gene Therapies
Pascal Touchon, President and CEO, Atara Biotherapeutics
ON-DEMAND CONTENT
Available Beginning Wednesday, April 7, 2021
KEYNOTE SPEAKER: THE EMA’S PLAN FOR THE CONTINUING ACCELERATION OF THE ATMP SECTOR
Chair:
Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)
Speakers:
Emer Cooke, Executive Director, European Medicines Agency (EMA)
ATMPs TREATING THE CENTRAL NERVOUS SYSTEM
Chair:
Jon Garen, Chief Business Officer, uniQure
Speakers:
Bettina Cockroft, M.D., SVP and Chief Medical Officer, Sangamo Therapeutics
Chris Mason, M.D., Ph.D., Chief Scientific Officer, AVROBIO
Rachel McMinn, Ph.D., CEO, Neurogene
Jeffrey Sevigny, M.D., Chief Medical Officer, Prevail Therapeutics
LARGE CAP CELL AND GENE THERAPY STRATEGIES
A new wave of large cap players has emerged these past three years. These players have thought through a deliberate strategy of organic growth coupled with M&A. During this panel, attendees will hear from cell and gene experts sharing their experiences, having been actively observing and participating in a spectrum of change as new cutting-edge innovations in cell and gene therapy progress toward reality for patients.
Chair:
Usman “Oz” Azam, M.D., President and CEO, Tmunity Therapeutics
Speakers:
Katherine High, M.D., President of Therapeutics, AskBio
Bastiano Sanna, Ph.D., EVP, Chief of Cell and Genetic Therapies and VCGT Site Head, Vertex Pharmaceuticals
Jacob Sten Petersen, DMSc., Corporate VP and Head of Stem Cell R&D, Novo Nordisk
Krishnan Viswanadhan, Pharm.D., SVP, Global Cell Therapy Franchise Lead, Bristol-Myers Squibb
ON-DEMAND CONTENT
Available Beginning Thursday, April 8, 2021
OPPORTUNITIES EMERGING IN A POST-PANDEMIC WORLD
Listen in on this assembly of experts from the EU, UK, and U.S. as they discuss the acceleration and opportunity that is arising from the tragedy and burden brought about by COVID-19. Attendees will hear about emerging best practices, and what to watch for and intentionally drive in your own organization to ensure your programs accelerate as swiftly and as safely as possible in this altered state of normal.
Chair:
Michelle Berg, President, GMP Nucleic Acids, Aldevron
Speakers:
Nicole Faust, Ph.D., CEO, CEVEC Pharmaceuticals
James Miskin, Ph.D., Chief Technical Officer, Oxford Biomedica
Vasu Rangadass, Ph.D., President and CEO, L7 Informatics
Joe Tarnowski, Ph.D., SVP, Cell and Gene Therapy Platform, GSK
ALTERNATIVE CELL SOLUTIONS FOR ONCOLOGY
This panel session brings together four highly experienced biotechnology industry leaders who will discuss a spectrum of cell therapy approaches from NK Cells to CAR-macrophages, autologous and allogeneic. Attendees will hear about each speaker’s respective technologies, what these CEOs have learned from past successes and failures in the field, and where they see their alternative approaches fitting into the cell therapy armamentarium.
Chair:
Martin Lachs, Ph.D., VP, Global Project Management, ICON plc
Speakers:
Julian Adams, Ph.D., CEO, Gamida Cell
Steven Kelly, President and CEO, Carisma Therapeutics
Arthur Lahr, CEO, Kiadis Pharma
Filippo Petti, CEO and Chief Financial Officer, Celyad Oncology
The Cell & Gene Meeting on the Mediterranean is the leading conference bringing together the ATMP community from Europe and beyond. Covering a wide range of commercialization topics from market access and regulatory issues to manufacturing and financing the sector, this program features expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and 80+ dedicated presentations by leading publicly traded and privately held companies in the space. Join ARM for Europe’s premier conference for advanced therapies.
April 19-21, 2022
Barcelona, Spain
