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Mastering Development and Regulatory Strategies in Cell Therapy
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Mastering Development and Regulatory Strategies in Cell Therapy

Dates in 2025 | Register Your Interest

Master the scientific, regulatory, and strategic complexities of cell therapy development to accelerate progress from bench to bedside – Click Here to Download the Agenda

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

The field of cell therapy holds transformative potential for treating a wide range of diseases. However, it also presents unique and complex challenges that can hinder the development and commercialisation of these innovative therapies. The course Mastering Development and Regulatory Challenges in Cell Therapy is designed to equip biotech and pharmaceutical professionals with the in-depth knowledge and strategic insights needed to navigate the complexities of developing cell-based therapies.

 

By the end of this course, participants will have gained a comprehensive understanding of cell therapy and how to address the key challenges in developing cell-based therapeutics. They will be equipped to make strategic decisions that improve the probability of success, reduce risks, and support the effective development of complex cell therapy approaches.

 

Learn more about how we deliver live online training.

Key Learning Objectives

 

  • Understand the pharmacological challenges unique to cell therapies, including their complex mechanisms of action and variability.
  • Address the difficulties involved in translating preclinical findings into clinical applications.
  • Explore the critical challenges related to Chemistry, Manufacturing, and Controls (CMC), including the scale-up of cell-based products
  • Examine the regulatory landscape for cell therapies, including key requirements and global considerations.
  • Gain strategic insights for the successful development, commercialisation, and lifecycle management of cell-based therapies.

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

2025 Dates TBC

2-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Course Information

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Day 1

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

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 2

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?

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.

This course is designed for professionals involved in the development, manufacturing, and regulation of cell-based therapies, including those in R&D, clinical development, regulatory affairs, quality assurance, manufacturing, and business development within small biotech and large pharmaceuticals.

 

It is also beneficial for senior executives who want to improve their understanding of the development process to improve commercial decision-making.

Register Early To Save

 

Enrol before 18 October to save 20% (November Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Download the Agenda

 

You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.

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Dates in 2025 | Register Your Interest

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