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Showing of Streams
9:45am - 10:30am

Morning Coffee and Networking

Showing of Streams
12:35pm - 1:40pm

Networking Luncheon in the Poster & Exhibition Hall

Showing of Streams
3:10pm - 4:00pm

Afternoon Coffee Break

Showing of Streams
5:30pm - 6:30pm

Cocktail Reception in the Poster and Exhibition Hall

6:30pm - 6:35pm
End of Conference Day Two

End of Conference Day Two

8:00am - 8:05am 5 mins
Cell and Gene Therapy Bioprocessing
Chairperson's Opening Remarks
8:00am - 8:05am 5 mins
Cell and Gene Therapy Commercialization
Chairperson's Opening Remarks
8:00am - 8:05am 5 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Chairperson's Opening Remarks
8:05am - 8:35am 30 mins
Cell and Gene Therapy Bioprocessing
It Depends: Understanding the Science and History behind the Regulations
  • Nancy Markovitz - Assoc. Director, Regulatory Affairs CMC, Nantkwest, USA
more
8:05am - 8:35am 30 mins
Cell and Gene Therapy Commercialization
It Depends: Understanding the Science and History behind the Regulations
  • Nancy Markovitz - Assoc. Director, Regulatory Affairs CMC, Nantkwest, USA
more
8:05am - 8:35am 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
It Depends: Understanding the Science and History behind the Regulations
  • Nancy Markovitz - Assoc. Director, Regulatory Affairs CMC, Nantkwest, USA
more
8:35am - 9:25am 50 mins
Cell and Gene Therapy Bioprocessing
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
more

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations

Topics to be covered include:

  • IND’s and BLA’s – expectations
  • Raw materials and viral safety considerations
  • Autologous therapies – who should take the burden? The manufacturer or the supplier?
  • CE marking
  • Process development and new process implementation – what do the regulators think?
  • Analytics and CMC – Potency assays, comparability etc.
8:35am - 9:25am 50 mins
Cell and Gene Therapy Commercialization
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
more

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations

Topics to be covered include:

  • IND’s and BLA’s – expectations
  • Raw materials and viral safety considerations
  • Autologous therapies – who should take the burden? The manufacturer or the supplier?
  • CE marking
  • Process development and new process implementation – what do the regulators think?
  • Analytics and CMC – Potency assays, comparability etc.
8:35am - 9:25am 50 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
more

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations

Topics to be covered include:

  • IND’s and BLA’s – expectations
  • Raw materials and viral safety considerations
  • Autologous therapies – who should take the burden? The manufacturer or the supplier?
  • CE marking
  • Process development and new process implementation – what do the regulators think?
  • Analytics and CMC – Potency assays, comparability etc.
9:25am - 9:45am 20 mins
Cell and Gene Therapy Bioprocessing
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

9:25am - 9:45am 20 mins
Cell and Gene Therapy Commercialization
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

9:25am - 9:45am 20 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Spotlight presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

9:45am - 10:30am 45 mins
Morning Coffee and Networking
10:30am - 11:00am 30 mins
Cell and Gene Therapy Bioprocessing
Adopting Various Manufacturing Closed Systems to Gene Modified T Cell Therapies
  • Ali Mohamed - VP, CMC, Immatics, USA
more
  • Immatics developed a proprietary tumor antigen targets discovery platform, XPRESIDENT®
  • The platform identifies novel tumor-specific targets and TCR candidate. It also screens TCR candidates based on these targets against off-target toxicities in absence of reliable in vivo models
  • Natural and engineered TCRs against these tumor targets have been used in various Immatics’ Adoptive Cellular Therapy programs in “First In Man” clinical trials
  • Extensive process development was carried out using primary T cells derived from multiple healthy donors and cancer patients to optimize each step in the manufacturing of TCR T cells for 3 clinical trials (IMA101, IMA201, IMA202, and IMA203)
  • Manufacturing for engineered TCR T cell therapies has been adapted into 3 different closed systems with for future phases of clinical trials with excellent results
10:30am - 11:30am 60 mins
Cell and Gene Therapy Commercialization
Dual Dialogue: When to make the decision to either insource or outsource
  • Lior Raviv - Vice President of Development, Pluristem Therapeutics Inc.
  • Chris Gemmiti, Ph.D. - Head of Operations, Sentien Biotechnologies Inc.
more

Talk One: Becoming cell therapy Makers - Opportunities and challenges in “in house” manufacturing of cell therapy products

Confirmed speaker: Lior Raviv, Vice President Development, Pluristem, Israel 


Talk Two: Phase-Appropriate Manufacturing - finding the right balance between internal and external manufacturing as a cell therapy company grows

Confirmed speaker: Chris Gemmiti, VP Operations, Sentien Biotechnologies, Inc., USA 



10:30am - 11:00am 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
The Balancing Act: Engineering vs. Tinkering Platform Processes with GMP Manufacturing in Mind
  • Pratik Jaluria - Executive Director, Process Development and Manufacturing, Adverum, USA
more

At Adverum, our focus is on bringing innovation to patients in need. With that mindset, we are leveraging our next-generation adeno-associated virus (AAV)-based directed evolution platform to identify and develop new therapies. Within Process Development, we have built an adaptable platform process that works across multiple therapeutic constructs, at varying scales. As we continue to develop new products, we are assessing new technologies to refine and improve our platform, while preserving aspects that enable versatility. In this talk, we will review aspects of our platform process and provide insight into potential changes that are under consideration, based on our scale-up experiences.

11:00am - 11:30am 30 mins
Cell and Gene Therapy Bioprocessing
The economics of closed systems – Ensuring reproducibility
  • Ohad Karnieli, Ph.D., MBA - CEO, Atvio Biotech
more
  • How can showing reproducibility then lead to a more economical scale up or out process?
  • Using closed systems to make facilities more economical
  • How does having a closed system impact autologous manufacturing and how does this affect the design of the plant?
11:00am - 11:30am 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Developing a scaled process for manufacturing stem cell derived islets
  • Austin Thiel - Senior Principal Scientist, Semma Therapeutics, USA
more
  • ESCs as starting material, allogeneic approach, selection of clinical line
  • Differentiation optimization Scale-up to bioreactors
  • Raw materials for cGMP manufacturing (evaluation, cost, supply chain)
  •  Path to commercialization
11:30am - 12:00pm 30 mins
Cell and Gene Therapy Bioprocessing
Automation Expert Panel
  • Ohad Karnieli, Ph.D., MBA - CEO, Atvio Biotech
  • Ali Mohamed - VP, CMC, Immatics, USA
  • Lior Raviv - Vice President of Development, Pluristem Therapeutics Inc.
  • Tamara Monesmith - Senior Director, Cellular Process Development, Editas Medicine, USA
  • Tristan Thwaites - Lead Technical Scientist, Cell and Gene Therapy Catapult, UK
more
  • Case studies/feedback on closed systems in general
  • Is there a need to have closed systems in clean rooms?
  • Process automated sampling
  • What can we learn from automation for MAbs?
  • How do you make thinks connectable between different devices?
  • Automation linked to cost of goods
11:30am - 12:00pm 30 mins
Cell and Gene Therapy Commercialization
Capabilities of blood centres and banks – Could they be CMO’s of the future?
  • Wouter Van t’Hof - Cord Blood Bank Director, Cleveland Cord Blood Centre, USA
more
  • What are the capabilities of blood centres and the blood banking industries?
  • What is the leverage for them to become CMO’s?
  • What changes need to be made to infrastructure to make this happen?
11:30am - 12:00pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Ensuring enough supply and magnitude in terms of patient and dose increase
  • Someet Narang - Senior Scientist, MedImmune, USA
more
12:05pm - 12:35pm 30 mins
Cell and Gene Therapy Bioprocessing
Spotlight Presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

12:05pm - 12:35pm 30 mins
Cell and Gene Therapy Commercialization
Spotlight Presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

12:05pm - 12:35pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Spotlight Presentation
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

12:35pm - 1:40pm 65 mins
Networking Luncheon in the Poster & Exhibition Hall
1:40pm - 2:40pm 60 mins
Cell and Gene Therapy Bioprocessing
Dual Dialogue: Cost of goods calculations for cell therapy products
  • Nick Timmins, PhD - Vice President, Process Science, Bluerock Therapeutics
  • Boaz Leshem - Vice President, Operations and Manufacturing, Pluristem, Israel
more

Talk One : Better processes with “better” cells – engineering cells for enhanced manufacturability. 

While much of the focus of gene engineering in the CGT field is on therapeutic activities, synthetic biology presents a significant opportunity to augment our approaches to cell manufacturing.  How might we employ cell engineering strategies to improve product quality, reduce COGs, or better understand and control our manufacturing processes?

Confirmed speaker: Nick Timmins, VP Process Sciences, BlueRock Therapeutics, Canada 

 

Talk Two: Title TBC

Confirmed speaker: Boaz Leshem, Vice President, Operations and Manufacturing, Pluristem, Israel 

1:40pm - 2:10pm 30 mins
Cell and Gene Therapy Commercialization
CDMO Expert led panel: How do you choose your development partner?
  • Chris Gemmiti, Ph.D. - Head of Operations, Sentien Biotechnologies Inc.
  • Lior Raviv - Vice President of Development, Pluristem Therapeutics Inc.
  • David Peritt - Chief Technology Officer, Sigilon Therapeutics, USA
  • Wouter Van t’Hof - Cord Blood Bank Director, Cleveland Cord Blood Centre, USA
more
  • How do you choose your CDMO
  • What capabilities should they have?
  • Centralised manufacturing
  • Regional manufacturing
  • Local manufacturing
  • Considerations for autologous, allogeneic and gene therapy products
  • Tech transfer of processes to new facilities
1:40pm - 2:10pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Low Cost Automation to Drive Efficiency and Reproducibility: Case Studies
  • Shashi Murthy, PhD - Professor of Chemical Engineering & Sherman Center Director, Northeastern University
more

In basic and preclinical research associated with cell therapy, most cell processing is performed manually, straining resources as well as posing challenges in reproducibility and consistency.  With dendritic cell based therapies as the context, several case studies will be presented to illustrate how simple automation solutions can overcome these constraints as well as help optimize future larger scale process development.

2:10pm - 2:40pm 30 mins
Cell and Gene Therapy Commercialization
Key success factors for planning and building a facility for cell therapies
  • Knut Niss - Chief Technology Officer, Mustang Bio, USA
more
  • Case Study 
2:10pm - 2:40pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Leveraging Academic and Commercial Contract Manufacturing Organizations to Facilitate Accelerated FDA Approvals
  • Linda Kelley - Senior Member & Cell Therapy Facility Director, Moffitt Cancer Center
more

The 21st Century Cures Act and the FDA mandate for accelerating the approval process for cellular therapies has impact on the approach to GMP manufacturing for early phase clinical trials. We have embraced an academic and industry partnership to facilitate multicenter clinical trials using Tumor Infiltrating Lymphocytes (TIL) and CAR-T cells for liquid and solid tumors. Through a combination of process improvements intended to shorten product manufacturing time, as well as innovative implementation of GMP practices, we have maximized the contribution of academic and contract manufacturing organizations to support multiple on-going trials intended to receive accelerated FDA approval for a new cellular therapy.

2:40pm - 3:10pm 30 mins
Cell and Gene Therapy Bioprocessing
Technology Workshop from PBS Biotech
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

2:40pm - 3:10pm 30 mins
Cell and Gene Therapy Commercialization
Technology Workshop
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

2:40pm - 3:10pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Technology Workshop
more

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Jennifer Wickett, Tel: +1 857 504 6694; Email: jennifer.wickett@knect365.com

3:10pm - 4:00pm 50 mins
Afternoon Coffee Break
4:00pm - 4:30pm 30 mins
Cell and Gene Therapy Bioprocessing
Meeting the challenge of delivering autologous therapies in the commercial sector
more
  • Case study
  • What is the future for autologous therapies?
  • Are they commercially viable
  • What are the strategies for ensuring that they are?
4:00pm - 4:30pm 30 mins
Cell and Gene Therapy Commercialization
Developing a commercially-ready process for viral vector manufacturing
  • John Kerwin - Manufacturing Scientist, Gene Therapy, Biogen, USA
more
  • What can we apply from the 30+ years of biologics manufacturing?
  • Strategies for developing a validation plan
  • Leveraging platforms to provide manufacturing efficiencies
  • Supply of raw materials and viral banks for low cadence products


4:00pm - 4:30pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Current state of play for the cell therapy industry in the clinic – stats and facts
  • Patricia Reilly - Head, Intelligence Alliances and Product Unification, Pharma intelligence, Informa
more
4:30pm - 5:00pm 30 mins
Cell and Gene Therapy Bioprocessing
Delivering new investigational medicinal products to the clinic through next-generation allogeneic cell therapies
  • Bryan Utter - Procurement Manager, GMP Solutions, Cellectis Inc., USA
more
4:30pm - 5:00pm 30 mins
Cell and Gene Therapy Commercialization
Strategies to Deliver Scalable and Reliable Lentiviral Vector Biomanufacturing
  • Jeffrey Bartlett - Chief Scientifc Officer, Senior Vice President, Research and Development , Calimmune, Inc., USA
more

Large-scale clinical production of lentiviral vectors (LV) using current good manufacturing practice (cGMP) methods comes with significant challenges. We have established the CytegrityTM stable cell line system for LV bioproduction and have defined key process, quality and regulatory parameters needed to achieve desired productivity and quality across multiples scales and different bioproduction systems. This approach has allowed scalable bioproduction of LV required for Phase I and II clinical trials, while paving the way for future commercialization.

4:30pm - 5:00pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
What academia are looking for in a development partner
  • Olive Sturtevant - Administrative Director of Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA
more
  • Case study
  • What are academia doing the research looking for in a business partner?
  • How can these partnerships work to drive success?
5:00pm - 5:30pm 30 mins
Cell and Gene Therapy Bioprocessing
The next wave of cell therapy product – Allogeneic manufacturing solutions
  • Yajin (Jenny) Ni - Associate Research Fellow, Director Manufacturing Process Development Lead, Allogene Therapeutics, Inc., USA
more
  • Strategies for manufacturing an ‘off the shelf’ product
  • Regulatory perspectives on this
  • How can you ensure large batch sizes
  • Scaling out solutions
5:00pm - 5:30pm 30 mins
Cell and Gene Therapy Commercialization
Solving challenges in lentiviral vector manufacturing
  • Hanna Leinonen - Senior Scientist, Kuopio Center for Gene and Cell Therapy, Finland
more

For a long time commercial scale viral vector manufacturing was a bottleneck in the field. Biggest challenges were related to those vectors, such as lentiviral vectors, requiring plasmid transfection of adherent cells in big volumes. We have developed a commercial scale lentiviral vector manufacturing process utilizing PEIpro® based four plasmid transfection and the iCELLis® fixed-bed bioreactor for adherent 293T cells. iCELLis Nano (2.67-4 m2) was used for optimizing several production parameters for scale-up. For scalable LV production, perfusion rate control by measuring cell metabolite concentrations in the bioreactor leads to higher productivity and reduced costs. Optimization of transfection conditions, cell seeding density for targeted cell concentration during transfection, use of low compaction fixed-bed and lowering the culture pH have a positive effect on LV productivity. Developed process was scaled up into iCELLis500 and were able to show the real commercial scale lentiviral vector manufacturing in commercial scale yielding >10^16 viral particles. Commercial scale upstream process development was followed by development of scalable downstream process. Virus containing medium was harvested by perfusion, concentrated and diafiltrated by tangential flow filtration and virus was purified using anion exchange chromatography. These results show for the first time that plasmid transfection of adherent cells in iCELLis bioreactor is scalable from bench level to clinical scale LV production.

5:00pm - 5:30pm 30 mins
Pre-clinical and Clinical Development for Cell and Gene Therapies
Discussion Panel: Driving collaboration for development in cell and gene therapy
  • Linda Kelley - Senior Member & Cell Therapy Facility Director, Moffitt Cancer Center
  • Olive Sturtevant - Administrative Director of Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA
more
5:30pm - 6:30pm 60 mins
Cocktail Reception in the Poster and Exhibition Hall
6:30pm - 6:35pm 5 mins
End of Conference Day Two