Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Introductory Module 1

FREE to Attend | Live & Recorded

Sign up

7 January 2026 | 60 mins | 1:00 PM UK

Introduction to Cell Therapy Development

• Overview of cell therapy types and therapeutic potential
• The evolving landscape of cell-based therapies in the biopharmaceutical industry
• Strategic considerations for entering the cell therapy space

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Day 1

9 February 2026 | 180 mins | 1:00 PM UK

Introduction to Cell Therapy Development

• Overview of cell therapy types and therapeutic potential
• The evolving landscape of cell-based therapies in the biopharmaceutical industry
• Strategic considerations for entering the cell therapy space

Pharmacology Challenges in Cell Therapy

• Understanding the pharmacodynamics and pharmacokinetics principles of cell-based therapies
• MoA of complex biologics
• Addressing challenges in reproducibility, potency, persistence, and distribution of therapeutic cells
• Assessing and mitigating risks related to immunogenicity and off-target effects

Day 2

10 February 2026 | 180 mins | 1:00 PM UK

Preclinical to Clinical Translation

• Key considerations for designing and executing preclinical studies
• Challenges in translating preclinical efficacy and safety data to human trials
• Strategies for optimising clinical trial design and patient selection

CMC and Scale-Up Challenges

• Understanding the complexities of cell therapy manufacturing
• Overcoming challenges in cell culture, expansion, and cryopreservation
• Strategies for ensuring consistency, quality control, and scalability of production
• Navigating supply chain and logistical hurdles

Day 3

11 February 2026 | 180 mins | 1:00 PM UK

Regulatory Considerations for Cell Therapies

• Overview of the regulatory framework for cell therapies in major markets (FDA, EMA, PMDA)
• Key regulatory requirements, including IND/IMPD submissions, clinical trial approvals, and BLA/MAA pathways
• Navigating orphan drug designations, expedited pathways, and regulatory incentives
• Post-approval regulatory considerations and lifecycle management

Leveraging Differentiation and Competitive Intelligence

• Tools in competitive intelligence monitoring and interpretation. What’s your edge?

Day 4

12 February 2026 | 180 mins | 1:00 PM UK

Strategic Insights for Successful Development

• Best practices for managing development timelines and budgets
• Strategic partnering and collaboration opportunities to enhance development
• Market access strategies, including pricing, reimbursement, and market positioning
• Case studies on successful cell therapy development and commercialization

Case Studies and Emerging Trends

• Real-world examples of overcoming challenges in cell therapy development
• Lessons learned from both successful and unsuccessful programs
• Emerging trends in cell therapy, including gene-edited cells, allogeneic therapies, and combination products

Gareth is an experienced biopharmaceutical R&D professional, drug hunter and global project lead with 10+ years of leadership in project/program management, portfolio governance and scientific strategy. He has a successful record of progressing complex, multi-million-dollar drug development programs through internal and external initiatives. He has furthered his practical experience in both Europe and the US, in clinical, pharmaceutical, VC and academic environments facilitating the preclinical -> clinical transition of novel medicinal products. Relevant former roles and institutions include Principal Investigator/Lecturer (Harvard Medical School & Boston Children’s Hospital), Fellow and Project Lead (Vertex Pharmaceuticals), Global Project Lead (Boehringer-Ingelheim) and Asset and Scientific Evolution Lead (invoX Pharma).

In his current role(s), he leads a dynamic cross-functional global team that pushes scientific and drug development boundaries, developing novel medicinal products and drug-device combinations (modality and indication agnostic), to meet unmet patient needs worldwide. He has a wealth of experience in establishing agile governance frameworks to oversee a diverse clinical and preclinical portfolio. Notably, he has extensive experience in translational biomarker strategies, indication expansions (repurposing), and effective tech-transfer for up-scale bioprocessing of biologics.

Overseeing a global team, Gareth has a proven track record in increasing pipeline visibility and executing external collaborations. He has bridged the gap between preclinical -> clinical, implementing novel ‘first-4-patient’ initiatives, such as 5’R research frameworks, relevant clinical biomarker strategies and optimising human dose prediction models to enhance the probability of success of medicinal products.