Agenda

View Last Year's Agenda!

The 2022 Cell & Gene Meeting on the Med was delivered in a hybrid format with live programming available over the course of two days at the Hotel Arts Barcelona. Virtual registrants had access to all content via livestream during the program dates. Additionally, all content was made available on-demand within 24 hours of the live program time for all registrants to view.

Agenda Sponsor:

Last Year's Agenda

  • Full Agenda
  • Day 1 - April 20
  • Day 2 - April 21
  • Day 3 - April 22

ON-DEMAND VIRTUAL CONTENT

Available Beginning Wednesday, April 20, 2022

PRE-RECORDED VIRTUAL COMPANY PRESENTATIONS

Pre-recorded virtual company presentations will be available on-demand within the platform for all delegates to view starting April 20, 2022.

 

Accelerated BiosciencesAmicus Therapeutics | Arbor Biotechnologies | Aruvant Sciences | AVROBIOBioCentriqCabaletta Bio | Caribou BiosciencesCellusionCharles River Laboratories | GenprexKrystal Biotech | Prescient TherapeuticsRejuvenate Bio | SantenStandards Coordinating BodyUltragenyx

IN-PERSON PROGRAM AND LIVESTREAM

8:00am – 9:00am | REGISTRATION

Sponsored by BioLife Solutions, Catalent, VectorBuilder and World Courier

9:00am | GENERAL SESSION AND PARTNERING OPENS

WELCOME REMARKS
{Gaudi 3}

9:00am – 9:30am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

Cell and Gene Therapies for EU Patients:

Stella Kyriakides, European Commissioner for Health and Food Safety

PLENARY SESSION: HOW CAN WE SUCCESSFULLY COMMERCIALIZE ATMPS IN EUROPE?
{Gaudi 3}

9:30am – 10:30am
Launching new advanced therapies in Europe requires working across national boundaries with a diverse set of HTAs and payers. Several promising products have been withdrawn at the EU level. Hear from trailblazing cell and gene therapy developers about their launch experiences and their commercial strategies for success.

Chair:

Sven Kili, M.D., CEO, Antion Biosciences

Speakers:

Robin Kenselaar, Senior Vice President and General Manager, EMEA, Orchard Therapeutics

Klaus Langhoff-Roos, Corporate Vice President, Cell Therapy Commercial Unit, Novo Nordisk
Sissel Rodahl, Senior Vice President Commercial Operations, GenSight Biologics
Dick Sundh, Head of Australia, Canada, and Europe, Kite Pharma

10:30am – 11:00am | MORNING BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

11:00am – 12:30pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{Gaudi 3}

11:00am – 11:15amCynata Therapeutics
11:15am – 11:30amBone Therapeutics
11:30am – 11:45amSernova
11:45am – 12:00pmBlueRock Therapeutics
12:00pm – 12:15pmAdaptimmune
12:15pm – 12:30pmOxford Biomedica

COMPANY PRESENTATIONS

{Gaudi 2}

11:00am – 11:15am SparingVision
11:15am – 11:30am Genethon
11:30am – 11:45am Ncardia
11:45am – 12:00pm VectorY
12:00pm – 12:15pm CTI Clinical Trial & Consulting
12:15pm – 12:30pm AskBio

12:30pm – 1:45pm | LUNCH

Sponsored by Andelyn Biosciences

1:45pm – 3:15pm | CONCURRENT TRACKS

PAYING FOR THE COMING WAVE OF ATMPS {Gaudi 3}

1:45pm – 2:45pm With the European Medicines Agency set to approve between 10-20 new ATMPs every year starting in 2025, how are payers preparing and what does this mean for patients? This panel will discuss establishing earlier dialogues among developers, payers, and HTA authorities, as well as addressing cross-border barriers that can delay patient access. Panelists will also discuss the balance between evaluating the long-term safety and efficacy of ATMPs and the value these transformative therapies can deliver to patients.

Chair:

Francis Pang, Vice President and Head, Global Market Access, Orchard Therapeutics

Speakers:

Yann Le Cam, CEO, EURORDIS-Rare Diseases Europe

Ulf Maywald, Pharm.D., Head, Drug and Digital Health Apps, Supply and Reimbursement, AOK PLUS, Germany

Valérie Paris, President, Economic and Public Health Committee (CEESP), Haute Autorité de Santé, France

COMPANY PRESENTATIONS

{Gaudi 2}

1:45pm – 2:00pm Coave Therapeutics
2:00pm – 2:15pm Forge Biologics
2:15pm – 2:30pm TreeFrog Therapeutics
2:30pm – 2:45pm Aspect Biosystems

TACKLING THE GLOBAL VIRAL VECTOR SHORTAGE – A CGT ECONOMIC DEVELOPMENT CASE STUDY
{Gaudi 3}

2:45pm – 3:15pm
Gene therapy development requires targeted manufacturing capabilities. Selecting the appropriate CDMO is a critical step. Viralgen and the Basque Country government created a unique ecosystem that addresses higher customer expectations and growing regulatory requirements.

Chair:

Nicole Faust, Ph.D., CEO, CEVEC Pharmaceuticals

Speakers:

Javier García, General Partner, Columbus Venture Partners; CEO, Viralgen Vector Core

Gotzone Sagardui, Minister of Health, Basque Government

COMPANY PRESENTATIONS

{Gaudi 2}

2:45pm – 3:00pmVivet Therapeutics
3:00pm – 3:15pmLogicBio

3:15pm – 3:45pm | AFTERNOON BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

3:45pm – 5:30pm | CONCURRENT TRACKS

INVESTMENT TRENDS IN EUROPE’S CELL AND GENE THERAPY SECTOR

{Gaudi 3}

3:45pm – 4:45pm
What is the state of investment in cell and gene therapy in Europe and the outlook for the rest of 2022 and beyond? This panel will discuss the availability and deployment of capital, from the perspective of venture capital, mergers and acquisitions, and contract manufacturing.

Chair:

Matthew Durdy, CEO, Cell and Gene Therapy Catapult

Speakers:

Dmitry Kuzmin, Ph.D., Managing Partner, 4BIO Capital

Alberto Santagostino, Senior Vice President, Head of Cell and Gene Technologies, Lonza Pharma & Biotech

Isabelle Scarabin, Director, Business Development and Licensing Officer, Bayer AG

Alan Selby, Managing Director, Torreya

COMPANY PRESENTATIONS

{Gaudi 2}

3:45pm – 4:00pmVERIGRAFT
4:00pm – 4:15pmThe Technology Partnership
4:15pm – 4:30pmCryoport Systems
4:30pm – 4:45pmCatamaran Bio

THE NEXT NORMAL: PREDICTIONS FOR THE FUTURE OF ADVANCED MEDICINES WORKSHOP

Sponsored by Precision ADVANCE
{Gaudi 3}

4:45pm – 5:30pm
This panel discussion will focus on the sector’s continued success and challenges that may lie ahead in research and development, manufacturing, regulatory, pricing, and reimbursement. We will also hear from experts about new emerging technologies like gene editing, non-viral delivery methods, and allogeneic cell therapies. This panel will feature insights from industry leaders on the future of advanced medicines including:

– Innovation in research and development

– Implementing next-generation technologies

– Manufacturing and talent bottlenecks

– The evolution of reimbursement payment models

Chair:

Anshul Mangal, President, Project Farma and Precision ADVANCE

Speakers:

Robert Ang, President and CEO, Vor Biopharma

Deb Phippard, Ph.D., Chief Scientific Officer, Precision for Medicine

Brent Rice, Senior Vice President and Chief Commercial Officer, Autolus Therapeutics

Johanna Rossell, Chief Commercial Officer, Enzyvant Therapeutics

TRANSLATING FROM LAB TO GMP PRODUCTION NEEDS FOR SMALL-BATCH MANUFACTURING OF NOVEL THERAPIES WORKSHOP

Sponsored by SmartLabs
{Gaudi 2}

4:45pm – 5:30pm
This session discusses the challenges of translating novel cell and gene therapies from lab research into process development and then to clinical-stage cGMP. Solving for these manufacturing needs requires significant upfront planning and capital, and can be challenging to understand what the best option is for your unique problem. Join this session to hear experts discuss:

– Do you outsource to a CMO / CDMO?

– Do you build or lease your own facility?

– Do you access a hybrid approach to cGMP?

– How do you prioritize quality, speed, IP protection, and other important considerations?

– How does your team evaluate each of these models?

Chair:

Brian Taylor, Executive Vice President, BioPharma Solutions, SmartLabs

Speakers:

Scott Cross, Senior Principal, Dark Horse Consulting Group

Tania Pereira Chilima, Ph.D., Chief Technology Officer, Univercells Technologies

Stephen Ward, Ph.D., Chief Manufacturing Officer, Cell and Gene Therapy Catapult

5:30pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 9:00pm | NETWORKING BASH

Sponsored by Dark Horse Consulting

8:00am – 9:00am | REGISTRATION

Sponsored by BioLife Solutions, Catalent, VectorBuilder and World Courier

9:00am | GENERAL SESSION AND PARTNERING OPENS

WELCOME REMARKS

{Gaudi 3}

9:00am – 9:15am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

9:15am – 10:45am | CONCURRENT TRACKS

GLOBAL ATMP COMPETITIVENESS: SPOTLIGHT ON THE EUROPEAN UNION
{Gaudi 3}

9:15am – 10:15am
The forecast for the global ATMP sector is positive, with record financings, growth in developer and clinical trial numbers, and regulators poised to approve a growing number of cell and gene therapies. In this session, panelists will discuss the EU’s outlook amid growing global competition. Where does the EU stand in the race to the top? Join policymakers as they discuss key regulatory and legislative policies under consideration, including the implementation of the EU’s Pharmaceutical Strategy, which refers to ATMPs as “milestones of major progress” but also stresses affordability.

Chair:

Paige Bischoff, Senior Vice President, Global Public Affairs, Alliance for Regenerative Medicine (ARM)

Speakers:

Christian Desaintes, Ph.D., Policy Officer, Health Innovations and Ecosystems, European Commission DG RTD

Ana Hidalgo-Simon, M.D., Ph.D., Head of Advanced Therapies, European Medicines Agency (EMA)

Andrzej Ryś, M.D., Director, Health Systems, Medical Products and Innovation, DG SANTE, European Commission

Susana Solís Pérez, Member of the European Parliament (MEP)

COMPANY PRESENTATIONS

{Gaudi 2}

9:15am – 9:30amAnocca
9:30am – 9:45amLuminary Therapeutics
9:45am – 10:00amPDC*line Pharma
10:00am – 10:15amFraunhofer IZI

NAVIGATING GENE THERAPY COMMERCIALIZATION AND REIMBURSEMENT HURDLES IN EUROPE

{Gaudi 3}

10:15am – 10:45am

Chair:

Bob Smith, Senior Vice President, Global Gene Therapy Business, Pfizer

Speaker:

Mike Fraser, General Manager, Europe, Middle East, and Africa, Novartis Gene Therapies

COMPANY PRESENTATIONS

{Gaudi 2}

10:15am – 10:30amAvectas
10:30am – 10:45amExothera

10:45am – 11:15am | MORNING BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

11:15am – 12:15pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{Gaudi 3}

11:15am – 11:30amSangamo Therapeutics
11:30am – 11:45amAutolus
11:45am – 12:00pmAstellas Pharma
12:00pm – 12:15pmGenSight Biologics

COMPANY PRESENTATIONS

{Gaudi 2}

11:15am – 11:30amEG 427
11:30am – 11:45amMarken
11:45am – 12:00pmQuell Therapeutics
12:00pm – 12:15pmEnzyvant Therapeutics

12:15pm – 1:30pm | LUNCH

Sponsored by Jellagen

1:30pm – 3:00pm | CONCURRENT TRACKS

WHAT DOES IT TAKE TO SUCCESSFULLY BUILD AN ADVANCED THERAPY COMPANY IN EUROPE?
{Gaudi 3}

1:30pm – 2:30pm
Seasoned advanced therapy leaders will discuss the unique challenges to building a successful company in Europe. Topics include how to secure financing, building a successful pipeline and business strategy, finding and hiring the best talent, when to make capital investments (e.g. manufacturing facilities), and interacting with the regulators. The panelists will share their experiences including lessons learned and obstacles they’ve overcome.

Chair:

Alexander Vos, CEO, VectorY Therapeutics

Speakers:

Julia Berretta, Ph.D., CEO, Genespire

Stéphane Boissel, President and CEO, SparingVision
Miguel Forte, M.D., Ph.D., CEO, Bone Therapeutics
Kasper Møller, Ph.D., Chief Technical Officer, AGC Biologics
Christopher Vann, Senior Vice President and Chief Operating Officer, Autolus Therapeutics

COMPANY PRESENTATIONS

{Gaudi 2}

1:30pm – 1:45pmCEVEC
1:45pm – 2:00pmSynthego
2:00pm – 2:15pmMammoth Biosciences
2:15pm – 2:30pmCellaïon

COMPANY PRESENTATIONS

{Gaudi 3}

2:30pm – 2:45pmMatricelf
2:45pm – 3:00pmVor Biopharma

COMPANY PRESENTATIONS

{Gaudi 2}

2:30pm – 2:45pmL7 Informatics
2:45pm – 3:00pmMission Bio

3:00pm – 3:30pm | AFTERNOON BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

3:30pm – 5:00pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{Gaudi 3}

3:30pm – 3:45pmAGTC
3:45pm – 4:00pmMiromatrix
4:00pm – 4:15pmSensorion

COMPANY PRESENTATIONS
{Gaudi 2}

3:30pm – 3:45pmWuXi Advanced Therapies
3:45pm – 4:00pmAndelyn Biosciences
4:00pm – 4:15pmKytopen

THE POWER OF PROCESS KNOWLEDGE: BUILDING WORKFLOWS TO ACHIEVE PREDICTABLE MANUFACTURING OUTCOMES WORKSHOP

Sponsored by Sartorius
{Gaudi 3}

4:15pm – 5:00pm

The recent success of cell-based therapies is generating momentum to overcome bottlenecks in bringing these innovative therapies to market faster. Traditional approaches often rely on manual operations that lead to insufficient process and cell characterization and ultimately extend development time. Further, disjointed workflows across upstream, downstream, and data analysis processes impede the generation of critical insights for future scale-up. Building process knowledge is foundational to developing streamlined workflows throughout R&D, process development, and manufacturing to deliver on the promise of cell-based therapies. Join this session to hear from experts on:

– Building a framework early in development to achieve clinical goals

– The importance of gaining process knowledge to reduce product variability

– Designing scalable workflows that maintain cell product quality

Chair:

Andres Castillo, Cell and Gene Process Manager, Sartorius

Speakers:

Jessica Carmen, Ph.D., Business Development Advisor, Oxford Biomedica

Jason C. Foster, CEO and Executive Director, Ori Biotech

François Gianelli, Pharm.D., Senior Director, CMC and Quality, Voisin Consulting Life Sciences

Andy Holt, Chief Commercial Officer, Ncardia

David Smith, President and Chief Commercial Officer, Akron Biotech

CURRENT CHALLENGES, OPPORTUNITIES AND TRENDS IN GENE EDITING AND GENE THERAPY WORKSHOP

Sponsored by Pfizer
{Gaudi 2}

4:15pm – 5:00pm
Scientific advances and concerns about dosage and delivery are driving progress in gene editing and gene therapy. This wide-ranging workshop will cover the evolution of vectors and multiple approaches to gene-editing, as well as the expanding set of diseases that can be treated with a larger set of technologies.

Chair:

Bob Smith, Senior Vice President, Global Gene Therapy Business, Pfizer

Speakers:

Fred Chereau, President and CEO, LogicBio Therapeutics

Michael Linden, Ph.D., Founder and Chief Scientific Officer, Handl Therapeutics; UCB Gene Therapy Platform Leadership

Mark McClung, Executive Vice President and Chief Operating Officer, Sangamo Therapeutics

Durhane Wong-Rieger, Ph.D., Board Chair, Rare Diseases International

5:00pm | PROGRAM AND PARTNERING CLOSES

5:30pm – 8:00pm | WINE TASTING RECEPTION

Sponsored by Biopharma Excellence by PharmaLex and Oxford Biomedica

8:30am – 12:00pm | ARM EU COMMITTEE MEETINGS

Open to ARM Members Only

EUROPEAN ADVISORY COMMITTEE
{Granados}

8:30am – 10:00am

EUROPEAN MARKET ACCESS AND VALUE COMMITTEE
{Granados}

10:00am – 11:00am

EUROPEAN REGULATORY AFFAIRS COMMITTEE
{Granados}

11:00am – 12:00pm

ON-DEMAND VIRTUAL CONTENT

Available Beginning Wednesday, April 20, 2022

PRE-RECORDED VIRTUAL COMPANY PRESENTATIONS

Pre-recorded virtual company presentations will be available on-demand within the platform for all delegates to view starting April 20, 2022.

 

Accelerated BiosciencesAmicus Therapeutics | Arbor Biotechnologies | Aruvant Sciences | AVROBIOBioCentriqCabaletta Bio | Caribou BiosciencesCellusionCharles River Laboratories | GenprexKrystal Biotech | Prescient TherapeuticsRejuvenate Bio | SantenStandards Coordinating BodyUltragenyx

IN-PERSON PROGRAM AND LIVESTREAM

8:00am – 9:00am | REGISTRATION

Sponsored by BioLife Solutions, Catalent, VectorBuilder and World Courier

9:00am | GENERAL SESSION AND PARTNERING OPENS

WELCOME REMARKS
{Gaudi 3}

9:00am – 9:30am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

Cell and Gene Therapies for EU Patients:

Stella Kyriakides, European Commissioner for Health and Food Safety

PLENARY SESSION: HOW CAN WE SUCCESSFULLY COMMERCIALIZE ATMPS IN EUROPE?
{Gaudi 3}

9:30am – 10:30am
Launching new advanced therapies in Europe requires working across national boundaries with a diverse set of HTAs and payers. Several promising products have been withdrawn at the EU level. Hear from trailblazing cell and gene therapy developers about their launch experiences and their commercial strategies for success.

Chair:

Sven Kili, M.D., CEO, Antion Biosciences

Speakers:

Robin Kenselaar, Senior Vice President and General Manager, EMEA, Orchard Therapeutics

Klaus Langhoff-Roos, Corporate Vice President, Cell Therapy Commercial Unit, Novo Nordisk
Sissel Rodahl, Senior Vice President Commercial Operations, GenSight Biologics
Dick Sundh, Head of Australia, Canada, and Europe, Kite Pharma

10:30am – 11:00am | MORNING BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

11:00am – 12:30pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{Gaudi 3}

11:00am – 11:15amCynata Therapeutics
11:15am – 11:30amBone Therapeutics
11:30am – 11:45amSernova
11:45am – 12:00pmBlueRock Therapeutics
12:00pm – 12:15pmAdaptimmune
12:15pm – 12:30pmOxford Biomedica

COMPANY PRESENTATIONS

{Gaudi 2}

11:00am – 11:15am SparingVision
11:15am – 11:30am Genethon
11:30am – 11:45am Ncardia
11:45am – 12:00pm VectorY
12:00pm – 12:15pm CTI Clinical Trial & Consulting
12:15pm – 12:30pm AskBio

12:30pm – 1:45pm | LUNCH

Sponsored by Andelyn Biosciences

1:45pm – 3:15pm | CONCURRENT TRACKS

PAYING FOR THE COMING WAVE OF ATMPS
{Gaudi 3}

1:45pm – 2:45pm
With the European Medicines Agency set to approve between 10-20 new ATMPs every year starting in 2025, how are payers preparing and what does this mean for patients? This panel will discuss establishing earlier dialogues among developers, payers, and HTA authorities, as well as addressing cross-border barriers that can delay patient access. Panelists will also discuss the balance between evaluating the long-term safety and efficacy of ATMPs and the value these transformative therapies can deliver to patients.

Chair:

Francis Pang, Vice President and Head, Global Market Access, Orchard Therapeutics

Speakers:

Yann Le Cam, CEO, EURORDIS-Rare Diseases Europe

Ulf Maywald, Pharm.D., Head, Drug and Digital Health Apps, Supply and Reimbursement, AOK PLUS, Germany

Valérie Paris, President, Economic and Public Health Committee (CEESP), Haute Autorité de Santé, France

COMPANY PRESENTATIONS

{Gaudi 2}

1:45pm – 2:00pm Coave Therapeutics
2:00pm – 2:15pm Forge Biologics
2:15pm – 2:30pm TreeFrog Therapeutics
2:30pm – 2:45pm Aspect Biosystems

TACKLING THE GLOBAL VIRAL VECTOR SHORTAGE – A CGT ECONOMIC DEVELOPMENT CASE STUDY
{Gaudi 3}

2:45pm – 3:15pm
Gene therapy development requires targeted manufacturing capabilities. Selecting the appropriate CDMO is a critical step. Viralgen and the Basque Country government created a unique ecosystem that addresses higher customer expectations and growing regulatory requirements.

Chair:

Nicole Faust, Ph.D., CEO, CEVEC Pharmaceuticals

Speakers:

Javier García, General Partner, Columbus Venture Partners; CEO, Viralgen Vector Core

Gotzone Sagardui, Minister of Health, Basque Government

COMPANY PRESENTATIONS

{Gaudi 2}

2:45pm – 3:00pmVivet Therapeutics
3:00pm – 3:15pmLogicBio

3:15pm – 3:45pm | AFTERNOON BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

3:45pm – 5:30pm | CONCURRENT TRACKS

INVESTMENT TRENDS IN EUROPE’S CELL AND GENE THERAPY SECTOR

{Gaudi 3}

3:45pm – 4:45pm
What is the state of investment in cell and gene therapy in Europe and the outlook for the rest of 2022 and beyond? This panel will discuss the availability and deployment of capital, from the perspective of venture capital, mergers and acquisitions, and contract manufacturing.

Chair:

Matthew Durdy, CEO, Cell and Gene Therapy Catapult

Speakers:

Dmitry Kuzmin, Ph.D., Managing Partner, 4BIO Capital

Alberto Santagostino, Senior Vice President, Head of Cell and Gene Technologies, Lonza Pharma & Biotech

Isabelle Scarabin, Director, Business Development and Licensing Officer, Bayer AG

Alan Selby, Managing Director, Torreya

COMPANY PRESENTATIONS

{Gaudi 2}

3:45pm – 4:00pmVERIGRAFT
4:00pm – 4:15pmThe Technology Partnership
4:15pm – 4:30pmCryoport Systems
4:30pm – 4:45pmCatamaran Bio

THE NEXT NORMAL: PREDICTIONS FOR THE FUTURE OF ADVANCED MEDICINES WORKSHOP

Sponsored by Precision ADVANCE
{Gaudi 3}

4:45pm – 5:30pm
This panel discussion will focus on the sector’s continued success and challenges that may lie ahead in research and development, manufacturing, regulatory, pricing, and reimbursement. We will also hear from experts about new emerging technologies like gene editing, non-viral delivery methods, and allogeneic cell therapies. This panel will feature insights from industry leaders on the future of advanced medicines including:

– Innovation in research and development

– Implementing next-generation technologies

– Manufacturing and talent bottlenecks

– The evolution of reimbursement payment models

Chair:

Anshul Mangal, President, Project Farma and Precision ADVANCE

Speakers:

Robert Ang, President and CEO, Vor Biopharma

Deb Phippard, Ph.D., Chief Scientific Officer, Precision for Medicine

Brent Rice, Senior Vice President and Chief Commercial Officer, Autolus Therapeutics

Johanna Rossell, Chief Commercial Officer, Enzyvant Therapeutics

TRANSLATING FROM LAB TO GMP PRODUCTION NEEDS FOR SMALL-BATCH MANUFACTURING OF NOVEL THERAPIES WORKSHOP

Sponsored by SmartLabs
{Gaudi 2}

4:45pm – 5:30pm
This session discusses the challenges of translating novel cell and gene therapies from lab research into process development and then to clinical-stage cGMP. Solving for these manufacturing needs requires significant upfront planning and capital, and can be challenging to understand what the best option is for your unique problem. Join this session to hear experts discuss:

– Do you outsource to a CMO / CDMO?

– Do you build or lease your own facility?

– Do you access a hybrid approach to cGMP?

– How do you prioritize quality, speed, IP protection, and other important considerations?

– How does your team evaluate each of these models?

Chair:

Brian Taylor, Executive Vice President, BioPharma Solutions, SmartLabs

Speakers:

Scott Cross, Senior Principal, Dark Horse Consulting Group

Tania Pereira Chilima, Ph.D., Chief Technology Officer, Univercells Technologies

Stephen Ward, Ph.D., Chief Manufacturing Officer, Cell and Gene Therapy Catapult

5:30pm | PROGRAM AND PARTNERING CLOSES

6:00pm – 9:00pm | NETWORKING BASH

Sponsored by Dark Horse Consulting

8:00am – 9:00am | REGISTRATION

Sponsored by BioLife Solutions, Catalent, VectorBuilder and World Courier

9:00am | GENERAL SESSION AND PARTNERING OPENS

WELCOME REMARKS

{Gaudi 3}

9:00am – 9:15am

Speaker:

Janet Lambert, CEO, Alliance for Regenerative Medicine (ARM)

9:15am – 10:45am | CONCURRENT TRACKS

GLOBAL ATMP COMPETITIVENESS: SPOTLIGHT ON THE EUROPEAN UNION
{Gaudi 3}

9:15am – 10:15am
The forecast for the global ATMP sector is positive, with record financings, growth in developer and clinical trial numbers, and regulators poised to approve a growing number of cell and gene therapies. In this session, panelists will discuss the EU’s outlook amid growing global competition. Where does the EU stand in the race to the top? Join policymakers as they discuss key regulatory and legislative policies under consideration, including the implementation of the EU’s Pharmaceutical Strategy, which refers to ATMPs as “milestones of major progress” but also stresses affordability.

Chair:

Paige Bischoff, Senior Vice President, Global Public Affairs, Alliance for Regenerative Medicine (ARM)

Speakers:

Christian Desaintes, Ph.D., Policy Officer, Health Innovations and Ecosystems, European Commission DG RTD

Ana Hidalgo-Simon, M.D., Ph.D., Head of Advanced Therapies, European Medicines Agency (EMA)

Andrzej Ryś, M.D., Director, Health Systems, Medical Products and Innovation, DG SANTE, European Commission

Susana Solís Pérez, Member of the European Parliament (MEP)

COMPANY PRESENTATIONS

{Gaudi 2}

9:15am – 9:30amAnocca
9:30am – 9:45amLuminary Therapeutics
9:45am – 10:00amPDC*line Pharma
10:00am – 10:15amFraunhofer IZI

NAVIGATING GENE THERAPY COMMERCIALIZATION AND REIMBURSEMENT HURDLES IN EUROPE

{Gaudi 3}

10:15am – 10:45am

Chair:

Bob Smith, Senior Vice President, Global Gene Therapy Business, Pfizer

Speaker:

Mike Fraser, General Manager, Europe, Middle East, and Africa, Novartis Gene Therapies

COMPANY PRESENTATIONS

{Gaudi 2}

10:15am – 10:30amAvectas
10:30am – 10:45amExothera

10:45am – 11:15am | MORNING BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

11:15am – 12:15pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{Gaudi 3}

11:15am – 11:30amSangamo Therapeutics
11:30am – 11:45amAutolus
11:45am – 12:00pmAstellas Pharma
12:00pm – 12:15pmGenSight Biologics

COMPANY PRESENTATIONS

{Gaudi 2}

11:15am – 11:30amEG 427
11:30am – 11:45amMarken
11:45am – 12:00pmQuell Therapeutics
12:00pm – 12:15pmEnzyvant Therapeutics

12:15pm – 1:30pm | LUNCH

Sponsored by Jellagen

1:30pm – 3:00pm | CONCURRENT TRACKS

WHAT DOES IT TAKE TO SUCCESSFULLY BUILD AN ADVANCED THERAPY COMPANY IN EUROPE?
{Gaudi 3}

1:30pm – 2:30pm
Seasoned advanced therapy leaders will discuss the unique challenges to building a successful company in Europe. Topics include how to secure financing, building a successful pipeline and business strategy, finding and hiring the best talent, when to make capital investments (e.g. manufacturing facilities), and interacting with the regulators. The panelists will share their experiences including lessons learned and obstacles they’ve overcome.

Chair:

Alexander Vos, CEO, VectorY Therapeutics

Speakers:

Julia Berretta, Ph.D., CEO, Genespire

Stéphane Boissel, President and CEO, SparingVision
Miguel Forte, M.D., Ph.D., CEO, Bone Therapeutics
Kasper Møller, Ph.D., Chief Technical Officer, AGC Biologics
Christopher Vann, Senior Vice President and Chief Operating Officer, Autolus Therapeutics

COMPANY PRESENTATIONS

{Gaudi 2}

1:30pm – 1:45pmCEVEC
1:45pm – 2:00pmSynthego
2:00pm – 2:15pmMammoth Biosciences
2:15pm – 2:30pmCellaïon

COMPANY PRESENTATIONS

{Gaudi 3}

2:30pm – 2:45pmMatricelf
2:45pm – 3:00pmVor Biopharma

COMPANY PRESENTATIONS

{Gaudi 2}

2:30pm – 2:45pmL7 Informatics
2:45pm – 3:00pmMission Bio

3:00pm – 3:30pm | AFTERNOON BREAK

Sponsored by Akron Biotech, Miltenyi Biotec, Notch Therapeutics and ProPharma Group

3:30pm – 5:00pm | CONCURRENT TRACKS

COMPANY PRESENTATIONS

{Gaudi 3}

3:30pm – 3:45pmAGTC
3:45pm – 4:00pmMiromatrix
4:00pm – 4:15pmSensorion

COMPANY PRESENTATIONS
{Gaudi 2}

3:30pm – 3:45pmWuXi Advanced Therapies
3:45pm – 4:00pmAndelyn Biosciences
4:00pm – 4:15pmKytopen

THE POWER OF PROCESS KNOWLEDGE: BUILDING WORKFLOWS TO ACHIEVE PREDICTABLE MANUFACTURING OUTCOMES WORKSHOP

Sponsored by Sartorius
{Gaudi 3}

4:15pm – 5:00pm

The recent success of cell-based therapies is generating momentum to overcome bottlenecks in bringing these innovative therapies to market faster. Traditional approaches often rely on manual operations that lead to insufficient process and cell characterization and ultimately extend development time. Further, disjointed workflows across upstream, downstream, and data analysis processes impede the generation of critical insights for future scale-up. Building process knowledge is foundational to developing streamlined workflows throughout R&D, process development, and manufacturing to deliver on the promise of cell-based therapies. Join this session to hear from experts on:

– Building a framework early in development to achieve clinical goals

– The importance of gaining process knowledge to reduce product variability

– Designing scalable workflows that maintain cell product quality

Chair:

Andres Castillo, Cell and Gene Process Manager, Sartorius

Speakers:

Jessica Carmen, Ph.D., Business Development Advisor, Oxford Biomedica

Jason C. Foster, CEO and Executive Director, Ori Biotech

François Gianelli, Pharm.D., Senior Director, CMC and Quality, Voisin Consulting Life Sciences

Andy Holt, Chief Commercial Officer, Ncardia

David Smith, President and Chief Commercial Officer, Akron Biotech

CURRENT CHALLENGES, OPPORTUNITIES AND TRENDS IN GENE EDITING AND GENE THERAPY WORKSHOP

Sponsored by Pfizer
{Gaudi 2}

4:15pm – 5:00pm
Scientific advances and concerns about dosage and delivery are driving progress in gene editing and gene therapy. This wide-ranging workshop will cover the evolution of vectors and multiple approaches to gene-editing, as well as the expanding set of diseases that can be treated with a larger set of technologies.

Chair:

Bob Smith, Senior Vice President, Global Gene Therapy Business, Pfizer

Speakers:

Fred Chereau, President and CEO, LogicBio Therapeutics

Michael Linden, Ph.D., Founder and Chief Scientific Officer, Handl Therapeutics; UCB Gene Therapy Platform Leadership

Mark McClung, Executive Vice President and Chief Operating Officer, Sangamo Therapeutics

Durhane Wong-Rieger, Ph.D., Board Chair, Rare Diseases International

5:00pm | PROGRAM AND PARTNERING CLOSES

5:30pm – 8:00pm | WINE TASTING RECEPTION

Sponsored by Biopharma Excellence by PharmaLex and Oxford Biomedica

8:30am – 12:00pm | ARM EU COMMITTEE MEETINGS

Open to ARM Members Only

EUROPEAN ADVISORY COMMITTEE
{Granados}

8:30am – 10:00am

EUROPEAN MARKET ACCESS AND VALUE COMMITTEE
{Granados}

10:00am – 11:00am

EUROPEAN REGULATORY AFFAIRS COMMITTEE
{Granados}

11:00am – 12:00pm

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