Last week I posted my list of 2017 forecasts for the stem cell field. Today a couple of days into 2017 I’ m more focused on hope than realism. Exactly what would I wish for in the stem cell and regenerative medicine arena in the coming year?
More stem cell clinical trial data posted plus published. There are few things as thrilling as stem cell and regenerative medicine clinical studies across the full spectrum of stem cell types which includes adult, embryonic, and IPSC. But we need to have real trial data be peer reviewed and published at least posted. Clinical trial updates only by press release aren’t helpful to patients or the field.
Clinicaltrials. gov adapts. This vital resource associated with trial listings adjusts to new realities. It possibly filters its listings to screen out for-profit articles that aren’ t real trials or it provides a lot more practically useful information such as at a minimum clear indications associated with whether a listing has an IND (this doesn’ t have to violate any confidentiality rules) and whether the listing needs payment as an inclusion criteria. See our interview with the leader of Clinicaltrials. gov.
FDA speaks clearly. No matter the FDA does or does not do in terms of real stem cell & regenerative medicine-related actions in 2017, it is clear about it. This year I hope the FDA offers concrete, consistent explanations in the public domain that don’ capital t require an FDA-ese jargon dictionary to try to understand.
FDA and its CBER center are constant with good & poor citizens of the stem cell arena. The particular FDA has a tough job overall and its CBER department focusing on biologics including stem cells has its own specific challenging task set. However , for years CBER has held different players in the stem cell arena to different guidelines and expectations. Paradoxically, essentially the better a citizen you might be, the more the FDA expects from you. On the flip side, if you are say for example a stem cell clinic with no intention of following the guidelines (no BLA, no IND, no pre-IND, no experience in stem cells, no data, etc . ) CBER has historically generally left you alone.
What the heck? That’ s got to change.
Of course the FDA and CBER are not police, yet by analogy imagine if police devoted fewer sources and tended to take less action proportionately as individuals behaved worse and worse, and were conversely most rigid with the most law-abiding citizens? It makes no sense.
FDA accelerated review or fast track, etc . associated with stem cell product. We can all hope there is a strong enough stem cell/regenerative medicine product and that the particular FDA considers it expeditiously enough (e. g. below Cures Act provisions) that we can see in 2017 the stem cell product get into the fast track somehow.
Less hype on all sides. If one can get away with hype and perhaps almost certainly only pay a price like a correction or retraction at most simply years down the road on the academic side or no price in any way in the direct-to-consumer arena of clinics, some people are going to keep on hyping up a storm. However , hype is poor all around and is selfish. I’ d wish to see less of it in the first place in the stem cell world in 2017. Scientists as well as the media can talk about new, outstanding findings (see beneath in next section) without invoking miracles or excessively aspirational language.
Loads of exciting documents. You can have your great published science with no hype. For this year I expect we’ ll discover dozens of very cool stem cell papers that are at the same time not really hyped. As a scientist, for me reading new, interesting information in papers is a real joy.