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PLENARY - Molecule to man (and woman): Speeding translation to human trials

Friday, November 30, 2012
8:00 AM - 9:00 AM
GH-Ballroom II-IV


Margaret Anderson, Executive Director, FasterCures


Christopher P. Austin, Director, National Center for Advancing Translational Sciences
Anna Barker, Director, Transformative Healthcare Networks, Co-Director, Complex Adaptive Systems Initiative and Professor, School of Life Sciences, Arizona State University
Dale Edgar, Vice President, Science and Technology Partnerships, Lilly Research Laboratories
Stelios Papadopoulos, Co-Founder and Chairman, Exelixis
Todd Sherer, CEO, The Michael J. Fox Foundation for Parkinson's Research

Needing teamwork for translation

Science is like football, said National Center for Advancing Translational Sciences (NCATS) Director Chris Austin during the Partnering for Cures panel, 'Molecule to Man (and Woman): Speeding Translation to Human Trials.' Translational science needs true teamwork, everyone in the ecosystem coming together – researchers, pharmaceutical companies, venture capital firms, patients groups, and government – in order for new treatments to be brought to trial faster. But, 'the incentive has always been for individual achievement,' Austin said. Instead of playing football, the scientific community is playing golf. And many hope the creation of NCATS will help change that.
'NCATS is a different beast,' Austin said. 'It was set up as a collaborative instrument. It's founding principle is that we have to do these very, very important things that no one else can do.' 

Anna Barker of the Arizona State University School of Life Sciences hopes that mission includes creating systems to speed up translation. 'We haven't thought about creating an end-to-end system that starts with the patient and ends with the patient,' she said. And a key to this system is requiring high quality at every level, for which she feels the scientific community needs standards. 'We have not thought about how to deliver molecular findings to patients in a high-quality, controlled way,' she said. 

Todd Sherer of the Michael J. Fox Foundation advised caution. 'The challenge is finding the balance between overstandardization vs. innovation,' he said.

Some steps that could speed translation involve solving problems that have no return on investment, so it is difficult for researchers or big companies to justify using the resources. 'How we use our resources has to be ever more strategic,' said Dale Edgar of Lilly Research Laboratories, who said his company is pursuing success by identifying 'pillars of excellence,' such as maintaining quality standards of practice for the data it stores.

Research decisions can't be made in a vacuum, said Stelios Papadopoulos of Exelixis, especially not in an investment vacuum. Decisions still must be made to get the maximum return on investment. 'I have not seen a compelling investment proposition to go in and engage in [translational research],' he said.

NCATS, which is free from needing to find a cure for a particular disease or make a particular return on investment, can help, said Austin. He feels this gives the agency an obligation to work on the general issues that will help advance translation.

The panelists agreed that true collaboration is key. Every stakeholder has to go 'all in' for the collaboration to work, cautioned panel moderator Margaret Anderson of FasterCures. Edgar pointed to the Innovative Medicines Initiative in Europe as a good example of all stakeholders working together to find and overcome critical gaps in driving innovation to the patient. He said the exciting thing about NCATS is 'thinking about the patient as the end point and not the next grant.' Innovation, he said, 'requires a line of sight to the patient from the earliest point.'

'Something NCATS brings to the table is leadership, galvanizing the industry and all of the players,' said Sherer. He advised Austin to plan for some early accomplishments in the next 18-24 months to prove to naysayers that the agency can affect change.

Edgar encouraged NCATS to continue to foster partnerships, because 'great things will happen.'

'The way you make these things work increasingly is to be inclusive,' said Barker. 'Get the best input you can up front from as many in the community as you can. Get as much buy-in as you can.'

And Austin is doing just that at NCATS. He reported that he is in talks now with stakeholders in 'concentric circles' in the process, including institute directors, academic institutions, patient groups, pharma, biotech, and VCs. As the agency develops, his goal is to keep the patient at the center of everything. 'Having patient involvement helps you stay on the critical path,' he said.