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Tuesday, September 16, 2008

Regenerative Medicine Industry in Need of a Voice?


Chris Mason (University of London) and I would like to get you talking.

Chris and his co-author Peter Dunhill have recently published an Editorial in the journal Regenerative Medicine entitled "The need for a regen industry voice".

They make a number of cogent arguments why the regen industry needs more to support its maturation than is currently provided by the existing organizations which represent pieces but not the whole of the regen industry. This is not to be critical of their support and, indeed, much acknowledgment must be given to their commitments to the industry. It is simply to suggest that it is not enough going forward and to pose the query - what does the regen industry need and how can we best put that in place?

They start by delineating some of the activities they believe could be addressed by an industry association (or cabal of industry associations) working on behalf of what they have have termed the “regen” sector. This is drawn largely from what has been done in the larger biotech sector.
Box 1 – Potential roles of an industry association addressing the regen sector

Business issues
1. Supporting pioneer companies who lack the critical mass to address the many issues that affect them.
2. Organising promotion of both technology push and market pull.
3. Helping to ensure sensibly drafted regulation and planning towards unified international agreement on regulations.
4. Working to achieve a balance on patents and disclosure of intellectual property which encourages risk taking entrepreneurs but does not block broad progress.
5. Addressing issues of reimbursement and health insurance and the necessity of cost assessment based on the short and longer term.
6. Cooperating to formulate national and international standards for terminology and technology.

Broader issues
7. Achieving a sensible expectation from regenerative medicine by being both proactive and also reactive to events and by avoiding hype.
8. Acting to address unethical and unregulated medical tourism and dubious practices.
9. Helping to build bridges between academics, clinicians and companies, and providing professional education.
10. Providing soundly based comment on difficult issues such as the use of embryo derived cells.
11. Facilitating dialogue between those developing human cell-based therapies and others addressing options such as gene based treatment and those using molecular agents.
Some of the issues facing existing associations in addressing the regen sector are summarized in Box 2.
Box 2 - Issues for existing biotech industrial associations contemplating embracing regen

1. Will biotech industry association members accept some diversion of resources to regen needs?
2. Is it possible for existing association to represent regen companies in the differing environments of the USA, EU and other key regions such as Asia?
3. Will there be conflicts of interest with biotech in encouraging investment from pharma and venture funds?
4. Could a biotech/pharma image on issues such as generics/biosimilars affect regen negatively?
5. Does regenerative medicine represent an opportunity to seek a better public-private partnership in medicine which would help all of the pharmaceutical sector?
They conclude as follows:
At present it would seem there is a real prospect that the existing biotech industrial association could provide at least some of what is needed. However, to achieve the roles summarised in Box 1 will take a core of interested, knowledgeable people who come together regularly with some secretariat help.

It will not be enough to just add occasional sessions to association internal discussions or public events though the latter does help to raise profile. As indicated earlier there are aspects where professional associations of scientists and clinicians can help as in educating their members on the new opportunities which regenerative medicine represents. They may also be important in arguing for sensible regulations and in helping to maintaining high professional standards. However, the interests of new companies need organisations with commercial and reimbursement issues deeply embedded in their instincts.

Though we seek solely to promote discussion, perhaps one possible attractive solution will be for regen companies to work hard to create proactive and effective groups within existing biotech associations. These could have the advantage of access to central resources but would allow a focus on those distinctive issues related to regen companies. Possibly too, where there are high local concentrations of regen companies it will be possible for them to have both some self-organised functions and an affiliation with national biotech organisations. From the comments we have received from those who have no particular vested interest, this approach seems to have support.

It has been suggested to us that without the equivalent of an Amgen or a Genentech no amount of work on associations or groups will really move the field forward. Though such a development plainly would help, the nurturing of regen to become the third arm of pharmaceuticals alongside small molecule drugs and biopharmaceuticals will be a patient process.

Developing supportive infrastructure and an articulate vision will help to clear obstacles that presently hold back the full flowering of early companies. It is in this sense that the issue is urgent. Whatever its form, regen needs a voice and we believe it needs it now.
I helped ISCT create its Cell Therapy Commercialization Committee to assist in addressing some of the needs Chris and Peter outline. But there are several obvious restrictions on that group's abilities, not the least of which are (a) it only pertains to the cell therapy sector of the regen industry, and (b) I try to chair the group in a volunteer capacity while keeping a day job or two and as the past few months have demonstrated that does not allow much time. I'm the first to acknowledge its limitations.

We'd like to hear from you on any of this but specifically we need input on two simple-to-state but not-easy-to-answer questions:
What kind of infrastructure and/or actions do you believe the industry needs (from existing or new orgs) to assist in its maturation?

What form (org, group, etc) would best beget and support that infrastructure and/or action?
Post your thoughts and comments

It's your industry. Make it what you want. Let's give it what it needs.

Let's talk.

--Lee

1 comment:

Callooh said...

Think transparency into business models is a good idea (of course being mindful of IP issues). It invites VC scrutiny and can increase credibility.

Do think reaching the public is important at the outset. There's a lot of confusion about what regen med can do. If the industry wants to avoid the anti-pharma backlash it needs to involve consumers early and demonstrate that public concern is not at odds with an economic bottom line.

The patent issue is a tough one--though I'd argue that restrictive licensing practices are the real problem not the patents themselves.