Pre-Conference Workshops

Interactive Workshops

9am - 12pm
Workshop A: Managing the Transition into the Clinic

For regenerative medicine products, there are lots of factors to consider in translating preclinical research into effective and commercial clinical applications.

Translational research in regenerative medicine requires a knowledge driven ecosystem inclusive of basic scientists, clinical researchers, clinicians, regulatory specialists, engineers and manufacturing staff designed to foster viable ideas with sound data into tangible improvements in the healthcare field.

Attend this session to:

  • Discuss the many factors involved in successful translation of therapies to clinic including: manufacturing, regulatory considerations, enabling technology and reimbursement
  • Explore the general infrastructure to take a product from POC to Phase II clinical trials
  • Understand how to optimize analysis for translational candidates to address the most relevant issues including efficacy of the POC model, published literature in the area or research, intellectual property and other commercialized products.

Who is this session for?

This workshop is for all cell therapy and regenerative medicine developers who currently have products in preclinical research and are looking to transition into the clinic. It will also be beneficial for companies in earlier clinical trials who want to expand on their knowledge of regulatory and reimbursement considerations for early stage programs.

This workshop will cover everything you need to know about the considerations for transition into the clinic and will enable you to translate your research into successful therapies.

1pm - 4pm
Workshop B: Your Product is Approved…Now What?

For regenerative medicine products there are many factors to consider ensuring rapid uptake of your new therapy by physicians. Even after you have achieved regulatory approval and gained reimbursement, success is not guaranteed.

This workshop will cover everything you need to know about market facing challenges for cellular regenerative medicines. Discussing the case study of Apligraf® the first bio-engineered cell based product to receive FDA approval, this session will look at some of the key pitfalls for these therapies.

Attend this session to:

  • Understand what can you do prior to approval to enable uptake of your regenerative medicine therapy
  • Outline and discuss the next stages you need to consider after gaining market approval for your product
  • Understand how you can improve your collaborations with physician groups and effectively present your products to health care organizations 
  • Explore the case study of Apligraf® as an example of a commercialized product and understated the hurdles it had to overcome in order to ensure patient uptake

Who is this session for?

This session is designed to help companies who have achieved regulatory approval for their products who want to improve their understanding of market facing challenges. It will also be beneficial for cell therapy and regenerative medicine developers who currently have products in clinical trials who want to gain an appreciation of the later stage challenges.

Attend this workshop and address the factors you need to consider when planning your commercial strategies to ensure uptake of your therapy.