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Point-of-Care Autologous Manufacturing: Breakthrough Model or Regulatory Nightmare?
Can autologous cell therapy manufacturing move to the point of care, and what would it take to make regulators, manufacturers, investors, and patients accept it?
The Aim
Autologous cell therapies remain slow, expensive, and operationally complex. Centralised manufacturing creates delays, logistics risk, high cost, and limited patient access.
The aim of this hackathon is to challenge participants to design a realistic point-of-care or near-patient manufacturing model that could be implemented within real-world regulatory, clinical, manufacturing, CMC, and patient-access constraints.
The session is designed to move beyond familiar industry statements such as “we need more automation” or “CMC should be considered earlier.” Instead, each group must produce a practical, defensible solution that addresses what would actually need to change for point-of-care autologous manufacturing to become viable.

The Format
The hackathon will bring together four pre-selected groups, each with approximately 10 participants.
Participants will be selected from across the CGT ecosystem, including:
• Manufacturing
• Automation
• CMC
• Regulatory affairs / ex-regulators
• Clinical development
• Patient advocacy
From:
• Big Pharma
• Investors
• Technology and platform companies
• Startup CEOs / founders
Each group will be asked to develop a solution to the same core challenge:
Design a realistic point-of-care or near-patient autologous cell therapy manufacturing model that could be accepted by regulators, adopted by manufacturers, supported by investors, and valued by patients.
Each group should appoint a group leader / spokesperson who will present the team’s proposed solution during the presentation session.
6 Key Questions Each Group Must Address
Manufacturing
What parts of the workflow can realistically move closer to the patient?
Automation
What must be automated to make point-of-care manufacturing safe, reproducible, and scalable?
Regulatory
What evidence would MHRA, FDA, or other regulators need to approve or accept this model?
CMC
How would the model maintain comparability, quality control, release testing, chain of identity, and chain of custody?
Clinical
How would this reduce vein-to-vein time and improve patient access?
Patient Impact
Does this genuinely get therapies to patients faster, or does it create another complex system?
The Agenda
09:25 – 10:00
Chair’s Welcome and Challenge Briefing
The session chair introduces the hackathon concept, outlines the central challenge, and explains the expected output from each group.
The chair should emphasise that the goal is not to produce generic recommendations, but to create a realistic and potentially provocative model that could be challenged by regulators, manufacturers, investors, clinicians, and patients.
Group Hackathon Discussion
Participants work in four pre-selected groups of approximately 10 people.
Each group should discuss and develop:
- The proposed point-of-care or near-patient manufacturing model
- The manufacturing workflow
- The automation requirements
- The CMC and quality strategy
- The regulatory evidence package
- The clinical and patient-access benefit
- The biggest risks or blockers
- The one change the industry would need to make for this model to work
Each group should appoint a leader to present the proposed solution.
10:15 – 11:15
Morning Break
11:40 – 12:30
Each group leader presents their team’s solution.
Each presentation should cover:
- The group’s proposed model
- Why it is different from current centralised manufacturing
- What would need to change operationally
- What regulators would need to see
- How patients benefit
- The biggest unresolved risk
Judging and Scoring
A panel of judges will score each group’s proposed solution and select the winning team.
Suggested judging panel:
• Regulatory / ex-regulator representative
• Manufacturing or CMC expert
• Automation / technology expert
• Patient advocacy representative
The winning team will be the group with the strongest combination of ambition, practicality, regulatory realism, and patient impact.
|
Clarity and originality of the proposed model |
1–5 |
|
Manufacturing and operational feasibility |
1–5 |
|
Regulatory realism |
1–5 |
|
CMC and quality strategy |
1–5 |
|
Patient impact and access benefit |
1–5 |
|
Ability to challenge conventional thinking |
1–5 |
Maximum score: 35 points
Desired Outcome
By the end of the session, the audience should leave with a sharper understanding of whether point-of-care autologous manufacturing is a credible future model, what barriers must be overcome, and what practical steps would be needed to move from concept to implementation.
The hackathon should generate a debate-led, actionable output rather than a generic discussion on automation or manufacturing efficiency.
What is Point-of-care autologous manufacturing?
It means making a patient’s own cell therapy at or very near the hospital/clinic where the patient is treated, rather than sending the patient’s cells to a distant central manufacturing facility.
In simple terms:

Autologous means the therapy is made from the patient’s own cells. For example, a patient’s immune cells are collected, modified or expanded, and then given back to the same patient.

Manufacturing means the process of turning those collected cells into a finished therapy. This may involve cell isolation, activation, gene modification, expansion, washing, formulation, quality testing, and release.

Point-of-care means the manufacturing happens close to the patient, often within a hospital, treatment centre, specialist clinic, or nearby manufacturing unit.
Key Event Highlights
An unmissable journey awaits you: from award winning speakers and insightful workshops to an exclusive gala dinner. Discover the moments that will transform your Cell experience.
Key Event Highlights
An unmissable journey awaits you: from celebrated keynote speakers and insightful fireside chats, to an exclusive gala dinner at London's Science Museum. Discover the moments that will transform your NextGen Biomed experience.
Explore dynamic panels, engaging roundtables, and hands-on workshops designed to drive innovation and foster collaboration, including:
Panel Discussion: What Is The Next Game Changer In Antibody Engineering?
Moderator: Karen Silence, Head Preclinical Product Development, ArgenX
Panellists include Berit Olsen Krogh, Senior Research Fellow; and Lundbeck Andrew Buchanan, Principal Scientist, AstraZeneca
Roundtable: Regulatory Insights On Bringing A Peptide To Human Trials
Moderator: Paul Reid, Co-Founder & Chief Scientific Officer, Celtic Bio
Workshop: Development Of Targeted Delivery Systems
Two Presentations, followed by a Panel Discussion on 'The Next Chapter Of Oligonucleotide Delivery'
Moderator: Steve Hood, Senior Director, Oligonucleotide ADME Strategy, GSK
Panel Discussion: Navigating The Paradigm Shift Towards Greener Approaches
Moderator: Walter Cabri, Full Professor of Organic Chemistry, University of Bologna
Panellists include Daniel Sejer Pedersen, Chemical Development Specialist CMC API Development, Novo Nordisk;
Anna Maria Papini, Full Professor & Group Leader, University of Florence;
Louis Diorazio, Senior Principal Scientist, New Modalities, AstraZeneca;
Alessandra Tolomelli, Associate Professor, University of Bologna
Presentation: How The RNA Technologies Could Help To Prevent Infectious Diseases And Could Be Applied To Various Chronic Disease Immunotherapies?
Presented by: Daniel Larocque, Innovation Lead, Innovation and Emerging Science, Sanofi
Speakers of NextGen Biomed 2025 Included:
Explore dynamic panels, engaging roundtables, and hands-on workshops designed to drive innovation and foster collaboration, including:
Panel Discussion: What Is The Next Game Changer In Antibody Engineering?
Moderator: Karen Silence, Head Preclinical Product Development, ArgenX
Panellists include Berit Olsen Krogh, Senior Research Fellow; and Lundbeck Andrew Buchanan, Principal Scientist, AstraZeneca
Roundtable: Regulatory Insights On Bringing A Peptide To Human Trials
Moderator: Paul Reid, Co-Founder & Chief Scientific Officer, Celtic Bio
Workshop: Development Of Targeted Delivery Systems
Two Presentations, followed by a Panel Discussion on 'The Next Chapter Of Oligonucleotide Delivery'
Moderator: Steve Hood, Senior Director, Oligonucleotide ADME Strategy, GSK
Panel Discussion: Navigating The Paradigm Shift Towards Greener Approaches
Moderator: Walter Cabri, Full Professor of Organic Chemistry, University of Bologna
Panellists include Daniel Sejer Pedersen, Chemical Development Specialist CMC API Development, Novo Nordisk;
Anna Maria Papini, Full Professor & Group Leader, University of Florence;
Louis Diorazio, Senior Principal Scientist, New Modalities, AstraZeneca;
Alessandra Tolomelli, Associate Professor, University of Bologna
Presentation: How The RNA Technologies Could Help To Prevent Infectious Diseases And Could Be Applied To Various Chronic Disease Immunotherapies?
Presented by: Daniel Larocque, Innovation Lead, Innovation and Emerging Science, Sanofi
Who is Speaking at NextGen Biomed 2025?
Interested in Sponsoring NextGen Biomed?
Become a driving force in accelerating the next generation of biologics and immunotherapy medicines to patients. NextGen Biomed offers a unique platform to enhance your brand visibility and connect with thousands of pharma, biotech, and R&D experts. Our branded event opportunities, immersive experiences, and content services enable you to engage, educate, and collaborate with the community shaping the future of biomedicine today.
Interested in Sponsoring NextGen Biomed?
Become a driving force in accelerating the next generation of biologics and immunotherapy medicines to patients. NextGen Biomed offers a unique platform to enhance your brand visibility and connect with thousands of pharma, biotech, and R&D experts. Our branded event opportunities, immersive experiences, and content services enable you to engage, educate, and collaborate with the community shaping the future of biomedicine today.
Our Esteemed Sponsors for NextGen Biomed 2025
Gold Sponsors
Silver Sponsors
Bronze Sponsors
Network & Programme Sponsors
Start-Ups
The 1-2-1s are the best thing about Oxford Global events, well organised and good number of relevant contacts. Good high level contacts from big companies.
Advanced Therapies Specialist Team Leader,
Genscript
Biologics 2024 has been one of the best events I have attended so far in my career.
Territorial Sales Manager UK,
ACROBiosystems Co., Ltd.
Impressed by the effort to bring people together.
Business Development Director,
Bioassay
Nice set-up, with good support for exhibitors
Director of Client Relations,
ImmunoPrecise
The start-up zone provides a unique opportunity for you to exhibit, network, and pitch to our global audience of pharma, biotech, and investment professionals.
It's designed for start-ups from across the biologics space, working on cutting-edge therapies, innovative platform technologies, products, and solutions and is an ideal platform to share your business plans and promote your science.
There are two options, based on the type of your organisation with prices starting from £1,500 (+VAT) for companies with own therapeutic research pipeline and registration from £3,500 (+VAT) available for companies offering solutions, services or platform technologies.
For further information and to get started submit the application form below.
Criteria:
To qualify your company must be:
- Therapeutic Start-Up, Emerging Technology OR Service Start-Up
- Operating No More Than 5 Years
- 0 – 30 employees
- Pre-Series A Funding
Successful applications receive:
- 1 Full Conference Pass
- 10-Minute Presentation Opportunity
- 1x1m Space in Start-Up Zone
- Logo Featured on Event Website & App as a Participating Start-Up
- Ability to Arrange Peer to Peer Meetings via the Congress App
The NextGen Biomed Best Poster Presentation Competition & Award includes the best poster presentation award and is intended to honour an outstanding individual performance for a scientific work by either an early career or established scientist, including PhD student and PostDocs.
Please submit your poster presentation by no later than 13th January 2025 in the below category:
- Protein/Antibody Engineering
- Bioanalysis & Characterisation
- Next Generation Biotherapeutics
- Peptides Chemistry & Therapeutics
- Oligonucleotides Chemistry & Therapeutics
- Sustainable Chemistry & Manufacturing
-
- Open to all scientists, including students (PhD), PostDocs, and established researchers representing pharma & biotech companies and/or academic institutions
- Applicants must be the first AND presenting author of the submitted paper and register for the meeting by 13th January 2025
- ONLY ONE submission per person will be accepted. If authors submit multiple abstracts for consideration for the competition, only one abstract will be taken into consideration
Applicants must follow the procedure as follows:
- Register and submit an abstract by 13th January 2025 using the registration link to the right on this page. Please ensure you add the poster display option on the registration page to secure your admission into the Best Poster Competition & Award
- Once registered you will be provided with the online abstract submission form
- Prepare the poster or platform and present it (The poster presenter should be at the poster during all breaks.)
- The winner with the highest scores will be announced at the Morning Networking Break on Day 3 of the event
The poster presentations will be evaluated by everyone attending the event on the basis of originality of the approach and quality of the work (e.g. appropriate methodology, interpretation of results, conclusiveness). Attendees will be allowed to cast one vote by selecting their favourite work in the poster area. All votes will be counted at the end of Day 2 at 5pm and results will be announced during the morning networking break on Day 3. .
The winner receiving the highest scores will be announced on Day 3 and will be given a trophy as well as £600 contribution towards travel & accommodation costs to attend the 2026 NextGen Biomed event. Oxford Global will also provide winners with PLUS Pass – 12 months access to our digital content platform providing access to on-demand presentations, exclusive reports and highlights.
Join the Hackathon
Sit on one of four pre-selected teams tackling one of Cell & Gene Therapy's toughest questions: can autologous manufacturing move to the point of care? Register to attend Cell 2026 and be in the room.
Interested in Sponsoring?
Put your brand alongside the manufacturers, regulators, investors, and patient advocates shaping the future of point-of-care autologous therapy.


