Bio-ethics line

At what stage do advances in stem cell therapies risk crossing the bio-ethics line?

The past 12 months have seen successes in stem cell therapies but as the medical practices advance, fears are rising that, with regards to bio-ethics, they are going too far. This week the international stem cell industry has been busy celebrating the 8th annual ‘Stem Cell Awareness Day’. It has been a great opportunity to showcase some of the exceptional …

investment in cell therapies

Promising scale and market success for cell therapies after large financial injection

In a report released this week, by BCC Research, it was forecasted that the global market for stem cells (including cell therapies) is to reach US $10.6 billion in 2018. However with currently no medicines, based on stem cells, having yet received marketing authorisation from the EMA*, or the FDA*, how are we going to get there? In 2013, the stem cell …

Off the shelf cell therapies – what could go wrong?

This was a while back but I cannot help bringing it up again as cryopreservation is basic to the development of cell therapies – the future for unmet medical need: "What is lost or gained with cryopreservation that could give an advantage/disadvantage to minimally manipulated cells (and an argument for regulation of SCs as drugs)?" Two things came to mind …

Increasing struggles in cell therapies manufacturing as production ramps up

Even though there has been an increasing number of cell therapies advancing to late-stage clinical development, several aspects of cell therapy development continue to present considerable challenges for large scale commercialization. It is clear that production of biologics in general carries higher risks than of small molecules pharmaceuticals and this becomes even more evident as production of cell therapies ramps …

Ministry of Science invites you to Stem Cells & Regenerative Medicine London Meet Up

It’s finally happening. The Ministry of Science is in session! That’s right, Stem Cell friends, mark your calendars for Tuesday, 26 March, because you are invited to the Ministry of Science' first ever World Stem Cells & Regenerative Medicine London Meet Up! RSVP now. I'll be hosting our 8th annual World Stem Cells & Regenerative Medicine Congress in May as …

Download Presentation: A roadmap for advancing pre-clinical research through to the clinic

The 7th Annual World Stem Cells & Regenerative Medicine Congress bought together senior level executives and opinion leaders from around the globe to further their knowledge and engage in discussion on a variety of topics. Attendees at this highly successful event were fortunate enough to hear this exciting presentation delivered by Frank-Roman Lauter, Head of Business Development, Berlin-Brandenburg Centre for …

Seed funding start-ups in Emerging Technologies: perspectives on cell therapeutics

Syndicate Innovation Venturing: “Bringing together actors from complementary economic sectors in a ‘non-zero sum game' partnership to conduct seed funding in technology areas with blockbuster potential” Alain Vertes, General Managing Partner & Co-founder at Park BioVentures (and previous Global Alliance Director at Roche) delivered a presentation at the 2012 World Stem Cells & Regenerative Medicine Congress to discuss strategic biotech …

Pharma perspective on safety concerns as stem cells as therapeutic agents grow

Michaela Sharpe, Head of Cell Safety at Pfizer, delivered an interesting presentation last week at the World Stem Cells & Regenerative Medicine Congress about  the development and implementation of innovative safety strategies in the context of the pharmaceutical industry. Considering how, for example, disease models be harnessed in pivotal safety studies and the regulatory requirements for drug safety data in …

Concept of value and recommendations for cell therapies – NICE & Centres for Medicare & Medicade Services perspective

Mark Campbell and Louis Jacques delivered a presentation last week at the last day of the World Stem Cells & Regenerative Medicine Congress about perspective of value in cell based therapies. Setting out its history and approach to selection and routing, beginning with engagement (discussing promising products), moving to notification and proceeding to selection and routing. As to selection for …

Paula Salmikangas at Finnish Medicines Research discussed the quality of the manufacturing process

Yesterday, at World Stem Cells & Regenerative Medicine Congress 2012, Paula Salmikangas, Co-ordinating Senior Research, Finnish Medicines Research, Vice Chair, Committee for Advanced Therapies (CAT), presented the regulators principle manufacturing issues of cell therapies. Dr Salmikangas’s focus was upon manufacturing quality and the key challenges that need to be addressed: Bioequivalence: how do you show full quality compatibility between cell …