Global CEO Initiative: Andrea Pfeifer & George Vradenburg. Working together on the global fight to stop Alzheimer’s disease




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Video title: Global CEO Initiative: Andrea Pfeifer & George Vradenburg. Working together on the global fight to stop Alzheimer’s disease
Released on: April 30, 2014. © PharmaTelevision Ltd
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  • Summary
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In this episode of PharmaTelevision News Review, filmed at Bio Conference 2013, in Chicago, USA, Fintan Walton talks to Andrea Pfeifer & George Vradenburg from the Global CEO Initiative
Andrea's perspective: Fundamental understanding of Alzheimer's disease
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BIO Convention, in Chicago, in 2013. On this show I have Andrea Pfeifer, who is CEO of a company called AC Immune and I've got George Vradenburg, who is the Conveyer of the CEO Initiative for Alzheimer's which we will talk about more about in the few moments. So I just turn to you Andrea, because obviously as I said you are the CEO of a company that's actually got an active program in Alzheimer's let's just look at the Alzheimer's disease itself and some of the primary elements that particular are our basic understanding of Alzheimer's as a disease at a molecular level, it's sort of very general terms, I mean where are we, how close are we in fundamentally understanding the Alzheimer's problem?
Andrea Pfeifer:
It's a very difficult question and a very complex question which I am trying to respond to, so you have to know that Alzheimer's is a neurodegenerative terminal disease that lose, where you lose your memory, your cognition, your personality and finally you'll die of the disease. Linked to that is that you lose actually neurons in the brains, the brain actually shows atrophy, it loses volume and this is in fact the first step if you like in a long process which can take up to 10-years, we don't know the causes and this is in fact the huge problem for developing drugs, however there are two proteins linked to the disease, one is the beta-amyloid and one is the tau, the beta-amyloid forms the plaques, the tau forms the tangles.
Fintan Walton:
Sure, so but, so we've got some idea of the underlying basis to the disease, but the full understanding of the disease is still pretty far away?
Andrea Pfeifer:
This is correct, on the other hand there are more and more genetic links, in fact we have now genetic families, who have particular mutations in the beta-amyloid gene for example and all of these populations who have a genetic predisposition actually get the disease faster and they get it 100%, so the genetic link actually supports the fact that for example beta-amyloid is positively to the disease.
George's perspective: Progress towards potential cure of Alzheimer's
Fintan Walton:
Okay, now you've obviously got a program that's specifically directed towards hopefully an approach to therapy for Alzheimer's, we will come back to that in the moment, but George if I can turn to you, as you your own background as you are a Chairman of US against Alzheimer's and I suppose you see things more from a patients perspective, could you give us from your perspective describe this disease in terms of how it affects patients and how they perceive how progress has been made towards a potential cure?
George Vradenburg:
Well our patients experience, as Andrea has described, a very slow degenerative process and the first instance they tend to begin they lose their memory, but they also suffer from hallucination, and delusions, and paranoia and then as they progress they begin to lose the ability to perform daily functions of life, their books, the transportation they can't drive, there are a variety of things they can't do and then it begins to progress beyond that and then they can't go the bathroom themselves, they become incontinent, they can't take a bath or take a shower without help, so they become physically greater and greater dependent and eventually their body and their brain forgets how to swallow, it forgets how to have some basic bodily functions and as Andrea points out they die of the disease. From a patients point of view progress has been achingly slow, achingly slow. The entire innovation system is sluggish, business as usual is not working, funding levels are too low, particularly compared to other diseases, but too low generally and the whole process of getting from discovery through drug evaluation at regulatory agencies and then reimbursement agencies they're slow, sluggish, broken and since governments are under stress they are cutting back on their reimbursement efforts, so there in fact the incentives to get into the business, understand the business for industry are weakening.
Fintan Walton:
Right, so it sounds that patients groups are pretty frustrated?
George Vradenburg:
And they are getting angry.
Fintan Walton:
And they are getting angry, so obviously you are seeing that, how do you get around that problem, I mean what are you recommending?
George Vradenburg:
Well I think it's time to get the patients involved, in most of the recent trials have failed, at least in the general consensus of the industry, because they were targeted mild to moderate victims, when actually over dementia has already taken over and destroyed so much of the brain that in fact no intervention is going to be successful, so science is now telling us to move earlier in that process, that means to people who've just barely began to suffer cognitive impairments or even earlier before there are any symptoms that requires patients to be more engaged because you are going to have a hard time doing clinical trials among people who have no symptoms of the disease unless you engage us and say this is the way you can do battle against this disease, has killed a family member or a friend so engage us.
Fintan Walton:
So is that targeted at a government level, government has to get more involved or how do you see it operated?
George Vradenburg:
Well government needs to fund better, government needs to be sensitive to the fact that we need a basic research establishment that's looking towards the patient rather than towards the publications, it needs to be sympathetic on the regulatory and reimbursement point of view, but now we are also aiming our advocacy at the research community and at industry.
AC Immune's approach towards finding appropriate therapy for Alzheimer's
Fintan Walton:
Okay, Andrea you're industry just tell us very briefly how your company is taking the approach to finding a appropriate therapy for Alzheimer's?
Andrea Pfeifer:
So we've just mentioned I mean that two targets if you like which are relatively well defined so one is the Abeta, the other one is tau both are potentially causative involved in the disease and we are as a company are actually targeting both. Now you have to understand that both proteins are part of your normal body, so these proteins have a role in your body and actually the difficulty is to discriminate between the healthy part of this protein and the unhealthy part and we have a technology which allows us to target the pathological, the sick form of these proteins and provide the treatments are more specific safer, I think this is one of the reasons also that our antibody, it's the Abeta, was in fact chosen by a independent committee for the first ever preventive clinical trial, and as George just said this is a clinical trial in healthy patients but they all go into Alzheimer's because they have a genetic defect, obviously could only give very safe drugs to these people because they are still healthy, so this is in fact the challenge to go early and early but because we have no real biomarker available you have as a first step to use populations who have a higher risk to get the disease.
Fintan Walton:
Sure and that's that in itself is an incumberance.
Andrea Pfeifer:
Yes.
Awareness, resources and obstacles about Alzheimer's
Fintan Walton:
Okay, so George, sometimes you know Alzheimer's has got a, there is a stigma attached to Alzheimer's, I mean obviously that's one of the obstacles, how are you going to get over that obstacle, how big is the problem?
George Vradenburg:
It is a huge problem because families tend to protect their loved one, when their love ones gets diagnosis of Alzheimer's they get pulled out of their social circles, they get pulled of a public arena and then the caregiver gets swallowed up and then so the entire family sort of collapses socially and the patient themselves is too disabled or impaired to be an advocate, the family caregiver tends to be too exhausted to be an advocate, so greater awareness, greater sense that there is hope, that if you talk about this disease something will be done about it, if you get early detection of the disease you are more likely to be available for a treatment when the treatment hits the market, so it's very important to reduce the stigma attached to the disease and to increase the awareness of the disease. We've seen this with Ronald Reagan who himself was courageous as soon as he was diagnosed he went public on it, but his wife began to protect him from seeing him after he had the disease. Margaret Thatcher you know there was criticism of the movie about her in part because we didn't want to destroy our memory of Margaret Thatcher as a powerful vibrant woman and so there is this sense of almost criticism about talking about her early stages of her dementia in the movie about her and of course we did not know about that in depth, because for the last several years she has been totally out of public view, so the sense of stigma, the sense of isolation, the sense of not talking about it is something we have to overcome.
Fintan Walton:
So Andrea, how do we get more resource into this?
Andrea Pfeifer:
Well I think as George just mentioned he spoke about awareness, he spoke about the stigmatization of the disease, first we must be willing to speak out and actually to enhance in the society the awareness of that if you work on the disease, if you overcome the negatives actually we create financial benefits for the society, we create less pain in the families, so actually the benefits of treating the disease or preventing the disease must be known to society and today we are not speaking about it, so feel the very first point to overcome this problem of not having enough funding is actually to make the society aware that it could be very positive to take the disease. The other aspect is when you think about that today we spend about 5 billion per year on cardiovascular disease, 4 billion on cancer, and we spent 460 million on Alzheimer that the dimension of a disease and the impact we spend about 600 billion today which what we spend on Alzheimer's is just not proportionate, in proper proportion, so I think there must be more money from governments, there must be more money from institutions like the World Bank, the European Investment Fund, individuals who actually are willing to support this fight of society against this disease.
Fintan Walton:
So it's worth funding, it's worth investing?
Andrea Pfeifer:
It's worth investing for in fact overcoming the pain of the families and the patients, but it's also worth investing for the society, because the society will not be able to deal with this big problem.
Aims and goals of CEO Initiative
Fintan Walton:
Okay, so George, there is an initiative taken and one of the reason were we are here talking about is this the thing that you are a conveyor of which is the a CEO Initiative, could you just tell us what's behind the CEO Initiative?
George Vradenburg:
Well governments around the world are basically stepping up seeing this as a major problem not just a health problem, but a fiscal problem because of the cost to government of supporting aging chronic disease centric populations, so they are saying we need to step up the game and they are inviting industry to do it that with them and so the Global CEO Initiative on Alzheimer's that Andrea and I are part of is basically industry's response to that, they themselves see the same problem not only the pharmaceuticals want systems that are unable them to be responsive to this unmet health need, but they are also from financial institutions to general corporations to IT companies want to begin to transform the entire biomedical research system so that is more digital oriented, more speed oriented, more responsive to consumers, so industry is prepared now and is saying to governments we will step up with you to try and meet this US national goal of stopping the disease by 2025, so The Global CEO Initiative is responding to that enquiry, but also the enquiries that we are getting from governments in Europe, and in Asia to do the same thing.
Fintan Walton:
So what actions are you expecting these CEO's to take and obviously joining your advocacy presumably is one, what are the other?
George Vradenburg:
Well there are several, but one important one is how they can share data on their failed trials, so that in fact we can learn faster and fail less frequently, amazingly based upon a study done, 50% of the clinical trials conducted on Alzheimer's were conducted on mechanisms of action that had previously have been involved in another clinical trial and failed, but the second trier didn't know about it, because there was no disclosure of that data from the first failure, right, so if in fact companies begin to share data and say our problem here is not that we want to keep this so close to the vest, our problem is that we have huge populations that have this unmet medical need, so we need to share data in a precompetitive, structured way that makes sense so that we can fail faster, learn faster, and get to a cure faster. So that's one. Clinical trial recruitment is another, there is a sluggishness and cost associated with recruiting for these clinical trials, so finding mechanisms where companies can recruit their own employees and their retirees to join these clinical trials, to have other mechanisms by which we can set up global registries that people willing to participate in clinical trials that's another mechanism by which patients can assist industry in getting to a cure faster.
Fintan Walton:
So fascinating and Andrea obviously you've joined this initiative, what do you see? Obviously George just described the overall aim of the CEO Initiative, how would you like to see this proceed? What sort of milestones do you like to see achieved over the next few years?
Andrea Pfeifer:
I think it is very important as George already said that we sort of revolutionize the way how we do clinical trials, I mean today the trials are too long, they are too expensive, in fact to a point where small company like ours cannot do any more Phase II trials so this has to be different, here we need to work together with other industries but also with the institutions, academia who have by the way also important populations which industry could potentially use for doing trials, we need better research, we need more research, I mean one of the key aspects today is that we do not have biomarker for the early diagnosis of Alzheimer and when you look now from our industry point of view, if you start with a population of people where 40% might not get the disease, but you still have to include them because you have not a better biomarker, you can see how much is wasted which would not be if you have better biomarkers, so biomarkers have to be increased and the other aspect is we need simply more money, we need more money for innovations, we need more innovations, we need different funding mechanisms and industry cannot carry this whole burden by itself.
Future plans and programs of CEO initiative
Fintan Walton:
Okay, and George obviously taking on an initiative like this is huge, I mean you are not just targeting presumably companies in the US you are looking at companies outside the US as well?
George Vradenburg:
Including AC Immune which is a Swiss.
Fintan Walton:
AC Immune it's a Swiss based company, so from an organizational point of view how this is going to actually work and how can viewers who are watching this make their contribution to ensuring that this initiative delivers on its aims and its goals?
George Vradenburg:
There are two kinds of reactions there, first we need more companies involved, we have 10 now but our aim is 15 to 20, we want to, don't want to be too big.
Fintan Walton:
Okay.
George Vradenburg:
Secondly we do want companies to join with us and with other companies who are already committed, J&J, and GE being two, to actually solicit their employees and their retirees to sign up for either clinical trial registries or to sign up for clinical trials.Tthat would expedite the heck out of getting clinical trials speeded up. And third there are a number of initiatives that we'll undertake with big data companies to try and understand how it is that we can develop new models, in silico models of predicting the disease for predicting those who are at risk for the disease and otherwise gaining wide spread patient engagement in the solution along with industry. We need innovators like Andrea here and her company, but they need support, they need support in clinical trial recruitment, they need support with the selected biomarkers, they need support in terms of a system that will support the speed of getting that product to market, so that's what we want to do as a patient organization but that's why we are partnering with industry to get those thing done because their interest in getting to market faster our interest in getting a cure faster coincide.
Fintan Walton:
Okay, so obviously this initiative is off the ground now?
George Vradenburg:
It is.
Fintan Walton:
And underway, well how long do you see this running forward, is this going to go forever, 10-years. 20-years or until Alzheimer's is ultimately?
George Vradenburg:
Well my first answer is it will go as long as we are adding value to the equation, if we can't add value to what we are trying to achieve then this initiative will dissipate and wither, right, if in fact we begin to get traction on number of these initiatives then it will go until we get a cure, now hopefully that's 2025, so that's not forever, but it's ambitious to think we can do this for another 10 to 12-years, but I would hope that this system begins to reform, to speed up, to get more resource into it and then we can step aside as an initiative, this is not a separate organization, it's very much a collaborative, it is lightly staffed and it's built for speed and impact, it's not built for life long, I am not going to live forever and none, you know so we need to move fast.
Fintan Walton:
Andrea and George, thank you very much indeed for coming on the show.
George Vradenburg:
You're welcome.
Andrea Pfeifer:
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).
Andrea Pfeifer
Chief Executive Officer
At the time of this PTV interview Andrea Pfeifer serves as Chief Executive Officer of AC Immune. Dr. Andrea Pfeifer co-founded AC Immune in 2003 and serves as CEO. Dr. Pfeifer is a member of the WEF Global Agenda Council and was nominated as Swiss Entrepreneur of the Year. She previously headed Nestl"'s Global Research function. She also is a professor at the Ecole Polytechnique F"d"rale de Lausanne, Switzerland. Dr. Pfeifer completed her doctoral studies in Pharmacy and Pharmacology at the University of W"rzburg, Germany, and she has published more than 200 papers and abstracts in leading scientific journals.
George Vradenburg
Convener
At the time of this PTV interview George Vradenburg serves as President of Vradenburg Foundation and Convener of The Global CEO Initiative on Alzheimer's Disease (CEOi). George Vradenburg is a civic activist and philanthropist, driven by a passion for public service. President of the Vradenburg Foundation, he founded US against Alzheimer's, a national disease advocacy network, and chairs the Geoffrey Beene Foundation's Geoffrey Beene Gives Back Alzheimer's Initiative on early diagnosis. Vradenburg is also chairman of the board of The Phillips Collection in Washington, D.C., a member of the Council on Foreign Relations, and co-founder and vice chairman of the Chesapeake Crescent Initiative.
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.
AC Immune
AC Immune SA is a Swiss-based biopharmaceutical company and a leader in Alzheimer"s Disease drug development. We are developing innovative therapeutics with "best in class" potential against Alzheimer"s Disease and other conformational diseases along three axes: vaccines, antibodies and small molecules. The anti-Abeta antibodycrenezumab for passive immunization is partnered with Genentech and has been selected for the first groundbreaking Alzheimer's prevention trial. We continue to develop in house the vaccineACI-24. These two programs in clinical development are focused on Alzheimer's disease and are backed by a rich portfolio of preclinical compounds. A preclinical stage anti-Tau antibody is partnered with Genentech. Our therapeutic molecules are also leveraged for Alzheimer"s Diseasediagnostic and other central nervous system (CNS) and non-CNS diseases, such as Glaucoma. Since its foundation in 2003, the company has raised CHF 64 million from private investors. Two out-licensing agreements with Genentech were closed in 2006 and 2012 for potential values of more than US$ 300 million and more than CHF 400 million respectively. Our team of 50 professionals is based on the site of the Polytechnique Federale (EPFL) in Lausanne, Switzerland.
The Global CEO Initiative on Alzheimer's Disease (CEOi)
The Global CEO Initiative on Alzheimer's Disease (CEOi) is an organization of private-sector leaders who have joined together to provide business leadership in the fight against Alzheimer's. The CEO Initiative seeks to partner with public leaders to transform the disease from a social, health, and economic crisis into an opportunity for healthy aging and innovation in research and care. The CEO Initiative believes that, during this era of aging populations, it will take visionary, coordinated, goal-oriented leadership of public and private leaders working together to solve our greatest challenges. www.ceoalzheimersinitiative.org