Nexxus Scotland

SME Toolbox: Commercialising Regenerative Medicine

Issues we should have addressed earlier...

Continuing the Nexxus SME Toolbox series, and featuring a presentation from
Dr Michael Leek, of Lab2Launch, who has spent the last 17 years commercialising several different RegenMed products which ranged from allogeneic ‘skin substitutes’ to autologous stem cell treatments. Throughout this period Dr Leek has recognised a number of occasions where product development and clinical progress were significantly delayed as a consequence of unforeseen issues.

With the benefit of hindsight, many of these issues could have been successfully addressed earlier – ‘had we only known what they were...’

Complications in the development process will be reviewed – these generally fall into one of the following six categories (examples will be given):-

1.     Regulatory

• Regulation of minimally manipulated autologous therapies
• EU legislation, consequence of the new Advanced Therapies Directive
• Working with the FDA (at the earliest opportunity, importance of pre-IND meetings)
• What happens when current regulations don’t cater for the process/therapy being developed?

2.     Quality

• Implementing a Quality System
• What happens when insufficient (autologous)  product is available for quality testing?
• Assay development (in-process and end-of-product)
• Validation issues (implementing DQ, IQ, OQ,PQ and process validation)
• Product specifications (incoming materials and release criteria, parametric release)

3.     Manufacturing

• Translation from lab to clinic, (re-)formulation with clinical-grade reagents, implementing GMP
• Batch sizes and scaling up/out of the process (choice of facility)
• Sourcing key raw materials, contingency planning and back-up suppliers
• Reducing the incidence of batch failure
• Minimising contamination (especially from autologous products)
• Managing clean room shut downs and product supply

4.     Clinical

• Preparing clinical trail submissions
• Managing CRO’s and their costs
• Meeting expectation with regard to recruitment rates
• Appropriate inclusion  & exclusion criteria (and criteria shift)
• Selecting the best mix of physicians

5.     Logistics

• Cold chain shipping of short shelf-life products
• Minimising shipping delays (especially at customs)
• Shipping validation (ensuring product is viable on arrival at the clinic)
• Good Distribution Practice

6.     Commercial

• Keeping investors satisfied
• Modelling cost of goods and average selling price
• Identifying hidden costs (associated with quality testing, shipping etc)
• Understanding reimbursement
• Finding the right partner / distributor

Programme

Download the event programme and speaker biography.

Venue

For directions to the Apex Hotel on Waterloo Place, please see their website.

Registration

As always, Nexxus events are free to attend, please click the orange 'book online' button on the right column of this page to complete a short booking form.

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