June 20-21, 2023 | Vienna, Austria | #VLGeneCell REGISTER NOW

CONFERENCE & EXHIBITION & EXPO

Key Practical Learning Points:

• Optimising and scaling vector production processes and
• Accelerating progress, CMC, and quality development of gene
performance
and cell therapies (GCT) products
• Enabling new technologies and processes coupled with
• Meeting consistent CGTP safety and efficiency criteria, regulatory
sophisticated CQAs
and GMP manufacturing standards

Dr. Behnam Ahmadian Baghbaderani, US

Dr. Amandine Breton, UK
Executive Director, Global Head of Process
Associate Director of Cell Process MSAT
Development, Cell and Gene Technologies
Orchard Therapeutics
Lonza
Dr. Branden Salinas, US
Dr. Angeliki Grammenos, BE
Senior Director, Manufacturing Science and
Global Regulatory Affairs Associate Project Lead
Technology
Debiopharm
Umoja Biopharma

Dr. Christiane Niederlaender, UK Dr. Matthias Bozza, DE

Vice President, Technical Associate Director, Gene Regulation
Parexel International Vector Biopharma AG

Chaminda Salgado, UK Dr. Carmen Brenner, BE

Vice President of CMC Director of Quality
T-Cypher Bio NOVADIP Biosciences S.A

Eugenio Montini, IT
Sara Mills, US
Group Leader
Principal
San Raffaele Telethon Institute for Gene
Dark Horse Consulting Inc.
Therapy

Dr. Richard Harbottle, DE Francesco Cicirello, US

Head of DNA Vector Research Director, Quality Assurance
German Cancer Research Centre (DKFZ) Evelo Biosciences

Dr. Ana Coroadinha, PT

Dr. Gregory Fiore, US
Head of Cell Line Development and Molecular
President & CEO
Biotechnology Lab
Exacis Biotherapeutics
IBET

Amnon Eylath, US Dr. Christopher P. Locher, US

VP Head of Global Quality President and CEO
Minovia Therapeutics Ltd Versatope Therapeutics, Inc.

Dr. Shi-Jiang (John) Lu, US Dr. Li Ou, US

President & CEO Vice President
HebeCell Corporation Genemagic Bio

Dr. Patricia Françon, FR SPONSORSHIP SPEAKING &

Chief Operating Officer
EXHIBITION OPPORTUNITIES AVAILABLE
Coave Therapeutics

Sponsor of the event:

2023 Vonlanthen Group of Companies. All Rights Reserved.

June 20-21, 2023 | Vienna, Austria | #VLGeneCell REGISTER NOW

CONFERENCE & EXHIBITION & EXPO

Sponsorship-related questions to: [email protected]

Introduction
Gene and cell therapies breakthroughs are advancing rapidly. • Critical aspects of establishing an efficient, consistent, and flexible
CMC strategy
Autologous and allogenic cell-based therapies, including CAR-T, TCR, NK-cells, • Controlling a product’s CQAs by controlling the process’ CPPs
TIL, viral and non-viral vector mediated therapies, and other ATMPs demonstrate • Emerging technologies improving effectiveness and CGTPs
tremendous progress. manufacturing processes and production
• Major considerations of easing the complexity of vector development
The full extent of their clinical impact, production, processes performance, and production
and efficiency hardly depend on the unique challenges related to CMC, • Crucial components of controlling and scaling manufacturing process
analytical, process development, automation, manufacturing, facility de- and operations for CGTPs
sign, aseptic processing, supply chain and others that developers of gene
and cell therapies must resolve. After the Summit, you will receive a digital certificate of attendance to
highlight the expertise you’ve gained from the event.
At the #VLGeneCell Summit, key experts, advisers, and practitioners will
focus primarily on:

Partner of the Event

Gene Therapy Net is the information resource for basic and clinical
research in gene therapy, and the site serves as a network for the
exchange of gene therapy information and breaking news items.
Visitors can keep track of the latest scientific papers, conference
announcements, gene therapy jobs, regulations and guidelines.

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

Adenovirus Compliance Product Characterisation

Adeno-Associated Virus (AAA) Gene Therapy Process Development
Advanced Therapy Medicinal Product (ATMP) GMP (Good Manufacturing Practices) Production Engineering
Analytics Gene Therapy Medicinal Products (GTMPs) Quality Assurance (QA)
Analytical Science Cell-Based Medicinal Products (CBMPs) Quality Control (QC)
Bioprocessing Immuno-Oncology Research and Development (R&D)
Biotherapeutics Immunology Regenerative Medicine
Chimeric Antigen Receptor T Cells (CAR-T) Immunology Chemistry Regulatory
Cell Engineering Immunotherapy Safety
Cell Therapy Lentivirus (LV) Scale Up
Cellular Immunotherapy Manufacturing Stem Cell
Cellular Therapy Market Access Supply Chain
Clinical Development Medical Affairs Tumor-Infiltrating Lymphocytes (TILs)
Chemistry, Manufacturing, and Control (CMC) Natural Killer Cells (NK-cells) Therapy T-Cell Receptor (TCR) Therapy
Commercialisation Non-Viral Vectors Viral Vector
Comparability Oncology

2023 Vonlanthen Group of Companies. All Rights Reserved.

Schedule
DAY 1 | June 20, 2023 | VIENNA, AUSTRIA | #VLGeneCell

08:00 Registration and Welcome Coffee 

09:00 Opening by Moderator 

Addressing regulatory challenges for gene- and cell-based therapies

• Common agency requests at CTA/IND filing
09:10 • Submission package to support CMC changes
• CTA/IND, faster QC release, alternative vector supplier
Dr. Angeliki Grammenos, BE | Global Regulatory Affairs Associate Project Lead | Debiopharm

09:40 SPEED NETWORKING

Regulatory life cycle considerations for cell and gene therapy products: Efficient strategies for a time-pressured environment
• Comparability for early- and late-clinical trial phases
10:10 • Development and consistency of analytical procedures over time
• Characterisation studies and the link to process validation
Dr. Christiane Niederlaender, UK | Vice President, Technical | Parexel International

10:40 NETWORKING / COFFEE / EXHIBITION BREAK

Development of commercially-viable cell and gene therapies: Key considerations from CDMO perspective
• Current hurdles impacting industrialisation of cell and gene therapies
11:00 • Some of the best practices to establish robust and reproducible manufacturing process and analytics for CGT applications
• Moving from clinical to commercial CGT and fundamental steps towards the commercialisation campaign
Dr. Behnam Ahmadian Baghbaderani, US | Executive Director, Global Head of Process Development, Cell and Gene Technologies | Lonza

Controlling manufacturing processes in pre-commercial and commercial autologous cell and gene therapy products
11:30
Dr. Amandine Breton, UK | Associate Director of Cell Process MSAT | Orchard Therapeutics

OPEN SPONSORSHIP OPPORTUNITIES

12:00 Sponsorhip-related questions to:

[email protected]

13:30 NETWORKING / COFFEE / EXHIBITION BREAK

13:00 BUSINESS LUNCH

Challenges in viral vector manufacturing

• Challenges in transient transfection production of viral vectors
• Lentiviral vector producer cell line development
14:00 • Challenges in upstream production
• Improving transduction efficiencies
Dr. Ana Coroadinha, PT | Head of Cell Line Development and Molecular Biotechnology Lab | IBET

LiBIS-seq for tracking the viral vector integration sites from blood-plasma cell-free DNA
• Genotoxicity associated to gene therapy treatments is an outstanding issue for the whole gene therapy field
• The identification and tracking of genetically-modified cells are fundamental for the assessment of the efficacy and safety of
14:30 gene therapy treatments and are required by regulatory authorities
• Blood plasma-derived cell-free DNA can be used to study and monitor the composition and fate of genetically modified cells
residing in solid tissues without the need to perform invasive solid biopsies
Eugenio Montini, IT | Group Leader | San Raffaele Telethon Institute for Gene Therapy

The differences between in vitro and in vivo gene delivery and the challenges
• Viral and non-viral gene therapy
15:00 • Safety concerns
Dr. Matthias Bozza, DE | Associate Director, Gene Regulation | Vector Biopharma AG

2023 Vonlanthen Group of Companies. All Rights Reserved.

Schedule
DAY 1 | June 20, 2023 | VIENNA, AUSTRIA | #VLGeneCell

OPEN SPONSORSHIP OPPORTUNITIES

15:30 Sponsorhip-related questions to:

[email protected]

16:00 NETWORKING / COFFEE / EXHIBITION BREAK

Navigating the CMC path to FIH for an in vivo lentiviral drug product
16:30
Dr. Branden Salinas, US | Senior Director, Manufacturing Science and Technology | Umoja Biopharma

cGMP manufacturing process development, risk analysis, CMC and regulatory filings
17:00
Sara Mills, US | Principal | Dark Horse Consulting Inc.

What might a decentralised supply chain look like?

• The talk explores possible questions about decentralisation of autologous gene modified cell therapies
• How might a decentralised supply chain disrupt CoGs and increase patient accessibility?
17:30 • What modifications to the regulatory landscape may be required and invitation to join a consortium for those interested in
decentralisation
Chaminda Salgado, UK | Vice President of CMC | T-Cypher Bio

Q&A / PANEL DISCUSSION (Dr. Gregory Fiore, US | President & CEO | Exacis Biotherapeutics AND ALL SPEAKERS OF THE DAY ARE
18:00 INVITED) & MODERATOR’S CLOSING REMARKS

18:30 NETWORKING / EXHIBITION BREAK

19:30 BUSINESS DINNER & NETWORKING

Sponsorship-related questions to: [email protected]

2023 Vonlanthen Group of Companies. All Rights Reserved.

Schedule
DAY 2 | June 21, 2023 | VIENNA, AUSTRIA | #VLGeneCell

08:00 Registration and Welcome Coffee 

08:20 Opening by Moderator 

DNA vector
08:25
Dr. Richard Harbottle, DE | Head of DNA Vector Research | German Cancer Research Centre (DKFZ)

08:55 AAV gene therapy

Manufacturing of AAV vectors and potential impacts on clinical outcomes

• Pros and cons of four major AAV production systems
09:25 • Key quality metrics that are relevant to AAV immunogenicity and toxicity
• Impacts of AAV quality on clinical outcomes
Dr. Li Ou, US | Vice President | Genemagic Bio

Therapeutic delivery with recombinant nano-vesicles

• Improved safety and tolerance by genetic engineering
09:25 • Surface display of antibodies and cell-targeting affibodies
• Scale up and purification with adapted bioreactor processes
Dr. Christopher P. Locher, US | President and CEO | Versatope Therapeutics, Inc.

OPEN SPONSORSHIP OPPORTUNITIES

10:15 Sponsorhip-related questions to:

[email protected]

10:35 NETWORKING / COFFEE / EXHIBITION BREAK

Quality assurance in ATMPs: Approaches to starting material qualification and contamination control
11:05
Francesco Cicirello, US | Director, Quality Assurance | Evelo Biosciences

Quality by design process analysis and development of an automated process in a closed system
• Development of an autologous therapeutic product intended for bone regeneration
11:30 • Application of the quality by design methodology to identify unit operations for which an improvement is a high target
• Process optimisation through the development of automated solutions in a closed system
Dr. Carmen Brenner, BE | Director of Quality | NOVADIP Biosciences S.A.

The challenges of maintaining consistent processes and proficiencies in manual cell therapy manufacturing
• Development of effective and implantable procedures
11:55 • Identifying root causes of failure
• When to consider moving from using biological safety cabinets to isolators, etc.
Amnon Eylath, US | VP Head of Global Quality | Minovia Therapeutics Ltd

2023 Vonlanthen Group of Companies. All Rights Reserved.

Schedule
DAY 2 | June 21, 2023 | VIENNA, AUSTRIA | #VLGeneCell

Scalable manufacture of CAR-NK cells from engineered pluripotent stem cells with 3D bioreactor
• A proprietary scalable 3D iPS-NK manufacture platform with defined, serum-free, and feeder-free conditions
12:20 • Genetically manipulated and engineered with CARs at pluripotent stage
• Development of next-generation 3D bioreactor platform and logistics
Dr. Shi-Jiang (John) Lu, US | President & CEO | HebeCell Corporation

12:45 Q&A / PANEL DISCUSSION (ALL SPEAKERS OF THE DAY ARE INVITED)

13:05 MODERATOR’S CLOSING REMARKS & END OF THE SUMMIT

13:10 NETWORKING / COFFEE / EXHIBITION BREAK

14:00 BUSINESS LUNCH

Program continues with the 6th Aseptic Processing Summit - #VLaseptic

6th Aseptic Processing Summit

June 21-22, 2023 | Vienna, Austria
#VLAseptic

At the this summit experts from the industry will highlight the
requirements to robust aseptic processing, targeted imple-
mentation strategies, recent experience on establishing
aseptic manufacturing processes for ATMPs and vaccines
in particularly, and adoption of innovative aseptic processing
technologies, including robotics.

REQUEST A BROCHURE*

* To request a brochure for this Summit, please contact our sales

person: [email protected].
We will send you the agenda via email.

Testimonials
What People Are Saying

PAST PAST PAST

Attendee Attendee Attendee

It was a well-prepared, practical review of the This conference brought many opportunities to The success of this summit & exhibition is in the
major issues affecting the cell and gene therapy exchange the contacts and the recent cases in excellent speakers board, emerging and critical
area, with recommendations from the experts in the field. Must attend for those looking to over- topics, and networking opportunities. I will be glad
the field of CGTPs. come the numerous challenges in the process of to attend it again
gene and cell therapies development and manu-
facturing.

Sponsorship-related questions to: [email protected]

2023 Vonlanthen Group of Companies. All Rights Reserved.