PharmaTelevision - Garry Neil, TransCelerate: Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines

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Video title: Garry Neil, TransCelerate: Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines

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In this episode of PharmaTelevision News Review filmed at BioPharm America in Boston, Fintan Walton talks to Garry Neil the Interim CEO of the newly founded non-profit organisation, TransCelerate BioPharma Inc

TransCelerate: A not for profit organization formed for addressing issues and bottlenecks of pharmaceutical industry

Fintan Walton:

Hello and welcome to PharmaTelevision News Review here at BioPharm America, in Boston 2012. On this show I have Garry Neil, who is the CEO of a new not for profit organization called TransCelerate BioPharma, welcome.

Garry Neil:

Thank you. Glad to be here.

Fintan Walton:

Good. Now it actually just announced today I believe that TransCelerateexists, it's an organization, a not for profit organization which at the moment has 10 members [PharmaDeals ID = 48776] if I can call them that, who are some of them which are some of the biggest pharmaceutical companies in the world it's a whole list of them, this organization has been formed to do what Garry?

Garry Neil:

It's been formed to address some of the bottlenecks that we all face across the industry in R&D and specifically and where we're starting is looking at clinical trials execution where we spend a lot of money, where things take a long time and where we're continually worried about things like quality issues as well. So we are wanting to address these issues on behalf of the entire industry and we think we can do that by addressing things like data standards, training standards and certification for investigators, looking at trying to create a common portal for all investigators to use with the different industry sponsors, even finding ways to more efficiently provide a comparative drug for clinical trials who require that. So we are looking at a number of these as the initial projects for our attention and then longer-term we can see there are lot of other areas and other bottlenecks that we could also try to address.

Fintan Walton:

So basically the key driver for this is to address one of the biggest issues in the pharmaceutical industry which is how long it takes to get a drug to market, and how much it costs to get a drug to market?

Garry Neil:

That's right.

Fintan Walton:

So obviously a very important driver. Now the way the thing is organized as I understand it is that companies can join TransCelerate, they provide some of the funding for all of these various projects that are gonna be investigated and initiated and you are also looking for new members?

Garry Neil:

We definitely are, we had no intention of ever making this an exclusive organization, we want to make it open to all biopharmaceutical companies who would like to join, whether they are big, medium sized or small, because we thing these issues really affect the entire industry.

Organizational structure and functioning

Fintan Walton:

Right, so just first of all just want to get some idea of how this is organized then we will go into the actual objectives of it. So at the moment there are there is a board that's pulled together and they are representatives for some of these companies that have already joined TransCelerate?

Garry Neil:

That's right, we have the 10 chartered members have taken board seats in most cases they are the heads of R&D of these companies, in other cases they have designated someone else very senior on their staff, it's an R&D organization and our charter and membership agreement allows us to have a certain number of board seats, there is a membership agreement with a tiered membership fee depending on how large the company is and the size of it's R&D spend, which we felt was very fair because it's proportional to the amount of benefit that each individual company might get, and in addition to that membership fee provides the capital that we need to be able to create the company and operate it efficiently, but most of the work is going to be done by experts from these companies who are being seconded, sometimes their entire FTE efforts sometimes part of it, so we'll have experts and we have them right now where we've been working for a little while even as the incorporation was going forward on these different projects and work streams.

Fintan Walton:

Is it a virtual organization or is it one that's going to be housed and occupy lots of floors in offices and so forth?

Garry Neil:

Yes, well it won't be entirely virtual but we are trying to keep it very lean and capital efficient, so really the only employee that we'll have full time is the CEO at the moment, will look at expanding staff as we need it. We are being supported by consultants and other project managers, we have legal counsel which we need particularly for issues like antitrust and to advice us and financial support, and we've set up a series of board committees, a finance committee, a membership committee and the other committees that any organization would need to operate efficiently. There is also an operations committee which was formed by the actual people that are doing the work so the leaders of the organizations that need various work streams so we can scale that as well. So we are operating it like a real corporation, it's a paradigm we are all familiar with in the industry.

Fintan Walton:

Right, you can all agree on?

Garry Neil:

We can all agree on. Yes and we'll have a physical location, so we are going to be located in Philadelphia which is relatively central to most of our membership and in a location which will make it really accessible by car, train, plane, however people need to come in.

Basis of Identification and selection of projects

Fintan Walton:

Right, very much so. So let's just look at then at the objectives, because you have set yourselves a goal which is quite a big mountain to climb and you've set out on the first five steps that you are looking at, the first five projects that you've identified. So are those the ones that are, are these chosen on the basis because they are ones that are a reasonably achievable in the short-term versus the bigger chunks that may actually take years and years and years to achieve?

Garry Neil:

Yes, we looked at this as we started getting ready to set this up to look at the feasibility and tractability and value that we could deliver to the membership and the entire eco system and the experts from clinical trials came in and we identified about 30 projects, these five though looked like they had the most near-term tractability and that we could really sink our teeth into it right away. So we've identified some milestones and some deliverables even some for the end of this year but by the mid of 2013 we think we can start to have some really meaningful deliverables from all five of these projects and if we continue to progress those then we'll be looking at an additional set of 5 or 10 that we might like to do as well.

TransCelerate 's Interaction and relationship with regulatory agencies

Fintan Walton:

Right, now obviously you are all working together it's a collaborative program, but obviously then the other group that need to be involved are the regulatory bodies, because obviously ultimately they are the ones that tick the boxes in terms of what things can be achieved and what things can't be achieved, so are they can they became members or are they the organization by which you have specific consultive meetings with and so forth?

Garry Neil:

Well we see them as well as a number of other key organizations as key stakeholders in the ecosystem. So this organization is set up for biopharmaceutical companies to become members, that way we can organize ourselves, we can have a structure that enables the interaction with the other members of the ecosystem. It's a little harder for regulatory agencies for example to interact with us as individual companies who have business before them being regulated by them so this organization as a non-profit doesn't have that as a complication, but we intend to work not only with the regulatory agencies to the extent they can and want to work with us, but also with the academic community, with other non-profit organizations who've been active in the clinical trials field, with the patient advocacy community, with the CRO's, so there are number of really key stakeholders that we want to be able to work with, we know we can't do all of this on our own.

Vision and plans over the next five-years

Fintan Walton:

Sure, so looking at the vision for the organization, setting that out, what is the vision for the next five-years? What do you think is achievable let's say within the next five-years?

Garry Neil:

We believe that we can make substantial progress against some setting standards, developing some common tool sets and for example a qualification and of investigators sites and training of investigator sites or creating a common investigator portal, we think we can make real progress against setting those things up in the near-term and longer-term we also think we can have quite a bit of impact on trying to establish a much more robust and efficient infrastructure for doing clinical trials, not just in the US but around the world, and if that can help to raise quality standards, to shorten timelines, to accelerate innovation to patients and yes even bring some of the costs down that's gonna enable a lot more drugs to be developed, things that might not be able to be developed right now because there are some of these barriers. So we think that within five-years we should be having a substantial impact on all of those important milestones and deliverables.

Fintan Walton:

Garry Neil, thank you very much indeed for coming on the show.

Garry Neil:

Thank you.

Fintan Walton

Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).

Garry Neil

Chief Executive Officer

At the time of this PTV interview Garry Neil serves as CEO of TransCelerate BioPharma. Garry Neil, M.D. has over thirty years of clinical development experience in the science, medicine and pharmaceutical industries, with approximately twenty years of pharmaceutical, science and technology research and development at Johnson & Johnson, AstraZeneca, Merck KgaA and Astra Merck. Prior to joining Apple Tree in 2012, Garrywas Corporate Vice President of Science & Technology at Johnson & Johnson from 2007-2011and before that Group President, Johnson & Johnson Pharmaceutical Research and Development from 2005 to 2007. Prior to becoming Group President, Garry held other senior positions at Johnson & Johnson .From 1993-2002, he held various other senior positions at AstraZeneca, EMD Pharmaceuticals and Merck KGaA. Garry also held a number of academic posts at a number of academic institutes including the Ludwig Institute for Cancer Research, the University of Toronto, the University of Iowa College of Medicine and the University of Pennsylvania (adjunct). Under his leadership a number of important new medicines for the treatment of cancer, anemia, infections, central nervous system and psychiatric disorders, pain, and genitourinary and gastrointestinal diseases, gained initial or new and/or expanded indication approvals. Garry has written more than 50 articles and book chapters. He holds a Bachelor of Science degree from the University of Saskatchewan and a medical degree from the University of Saskatchewan College of Medicine and completed his postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. Garry also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic. He is a Fellow of the American College of Physicians, a Fellow of the American College of Gastroenterology, a member of the American Association of Immunologists, and the Society for Clinical Trials, and a member of the Executive Committee of the Clinical Trials Transformation Initiative. Garry is also CEO of a new procompetitive cross-industry organization designed to improve the effectiveness and efficiency of industrial biopharmaceutical R&D, TransCelerate Biopharma Inc. (TBI) . Garry is a member of the Boards of the Reagan Udall Foundation, the Foundation for the NIH and is a member of the Science Management review Board of the NIH. He was Chairman of, the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee, Chairman of the PhRMA Foundation Board, and Chairman of the Scientific Advisory Board of the Center for Advanced Biotechnology and Medicine (Rutgers). He is also the 2007 discovery awardee of the American Geriatrics Society.

PharmaVentures

PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialization.

TransCelerate BioPharma

TransCelerate BioPharma evolved from relationships fostered via the Hever Group, a forum for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. TransCelerate was incorporated in early August 2012 and will file for non-profit status this fall. The Board of Directors includes R&D heads of ten member companies. Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. TransCelerate's headquarters will be located in Philadelphia, PA.