View the Program Agenda!
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.
We hope our virtual attendees appreciated having breaks in the streaming content in order to take 1×1 partnering meetings, grab a real life snack, visit the program’s virtual exhibit booths, or simply check their emails.
Agenda Sponsors
LIVE STREAMING SESSIONS WITH Q&A
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
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.
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.
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.
INNOVATION SHORTENING THE PATH TO COMMERCIALIZATION IN ADVANCED THERAPIES
Sponsored by Precision ADVANCE
LIVE STREAMING SESSIONS WITH Q&A
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.
3pm – 4pm CET (Europe) / 9am – 10am ET (USA)
Sponsored by Pfizer
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
ATMPs TREATING THE CENTRAL NERVOUS SYSTEM
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.
LIVE STREAMING SESSIONS WITH Q&A
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.
3:00pm – 4:00pm CET (Europe) / 9am – 10am ET (USA)
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.
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.
OPEN DAY
Participate in 1×1 Partnering, Visit Virtual Exhibit Booths, View On-Demand Content
LIVE STREAMING SESSIONS WITH Q&A
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
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.
LIVE STREAMING SESSIONS WITH Q&A
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.
3pm – 4pm CET (Europe) / 9am – 10am ET (USA)
Sponsored by Pfizer
LIVE STREAMING SESSIONS WITH Q&A
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.
3:00pm – 4:00pm CET (Europe) / 9am – 10am ET (USA)
ON-DEMAND CONTENT
Available Beginning Tuesday, April 6, 2021
80+ 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.
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.
INNOVATION SHORTENING THE PATH TO COMMERCIALIZATION IN ADVANCED THERAPIES
Sponsored by Precision ADVANCE
ON-DEMAND CONTENT
Available Beginning Wednesday, April 7, 2021
KEYNOTE SPEAKER: THE EMA’S PLAN FOR THE CONTINUING ACCELERATION OF THE ATMP SECTOR
ATMPS TREATING THE CENTRAL NERVOUS SYSTEM
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.
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.
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.
