A Matter Of Trust Asher May 2009


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An early discussion of ATM Health

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A Matter Of Trust Asher May 2009

  2. 2. Biomedical Information— A Matter of Trust A Q&A WITH HOWARD R. ASHER Can a new kind of ATM change global healthcare? 70 SCIENTIFIC AMERICAN | WORLDVIEWh;p://www.saworldview.com/ar+cle/biomedical‐informa+on‐‐a‐ma;er‐of‐trust‐a‐qanda‐with‐howard‐r‐‐asher  
  3. 3. H oward R. Asher, president and chief executive officer of Global Life Sciences in San Diego, Calif., not only watched, but participated in, the evolution of infor- IA OV mation technology (IT). He started in EG E NS product development at Pfizer, then Bax- A RM ter and Bayer before founding a series of B YC ION his own companies—now doing so for 30 R AT T years. During those years, Asher found US ILL that many technical advances depend on trust. Here, Worldview talks to Asher about trust in biomedical IT and how it might be enhanced. This is an edited ex- cerpt of that interview. What sparked your interest in IT? » MY INTEREST IN IT, essentially, occurred in the early eighties. In 1978, I founded Advanced Bioresearch Associates, ABA. We were helping a number of di erent types of companies with a number of devices. One was the rst human arti cial heart, which came out of Stanford. at arti cial heart was actually in machine code. So I had to gure out how to comfort the FDA with so ware and hardware as it related to an arti cial heart, which is a pretty signi cant product as trust goes. So it really kind of brought me out of the closet of IT and really got me into the concepts of things like so ware validation. In helping the FDA accept such technologies, I depended on a very simple word that’s guided me forevermore, and that’s trust. How do you trust the IT to do exactly what it claims it will, and—more important—that it wouldn’t harm somebody or cause a problem? What range of issues gets impacted by trust in today’s com- putational information from biotechnology? » IF WE TAKE A GLOBAL PERSPECTIVE and look© CARMEN SEGOVIA at the global biotechnology centers, they develop around medical universities that spill out information and tech- nology and IP, intellectual property. So much of that IP is coming out of academic institutions that have used com- putational tools to characterize some of the IP. e issue SCIENCE & TECHNOLOGY 71
  4. 4. there becomes interoperability if you will. As we take the How can the technology behind a money machine improve intellectual property that has been developed by computa- biotechnology? tional means, is it something that we—in the big sense of “general public”—can trust? » LET’S GO THROUGH A SCENARIO of what this might en, as we take that computational process and we look like in the future. What if right beside our money set move it into, say, an industrial environment that may our entire health record? So we have the automated teller actually start applying other computational processes to machine, ATM, and next to that we have the automated that core IP, we eventually get to a point where that is go- telemedicine machine, the new ATM of our medical infor- ing to be overviewed by a regulator. Of the 50 nations, mation from birth. What if we uploaded into our health- we have 49 various views of: How do I trust the primary care information our genotype and then—as we experi- information, be it information that characterized a com- ence the environment of life ongoing—we could add our pound or information that was gathered in the nonclini- phenotype? en, every dental X-ray, every medical record, cal studies that proved safety or demonstrated e cacy, every drug, everything we take is uploaded into our medi- cal record. en let’s imagine that we have hundreds of millions of people around the world with their medical records uploaded into their “ATM.”What if we uploaded into our What then could theoretically occurhealthcare information our geno- is that—just like we can check a box to say we are an organ donor—we couldtype and then—as we experience say that we are a genetic-information donor. en, we as an industry canthe environment of life ongoing— bene t from real human genomicwe could add our phenotype? and therapeutic information related to disease types. We could structure and stratify that data. It would be real human data at the genetic level. We could then look at how di erent drug and how do I trust the IT and statistical assessments therapeutics a ected di erent phenotypes and so on. We and all of the data management that has gone through could look at biomarkers and start harvesting real informa- not only the preclinical but including the clinical stages? tion associated with real disease. All of a sudden, we would From a regulator’s perspective, we want to trust that those have a goldmine of information that we would trust more are well-engineered, they are validated systems, and they when applying it to therapeutic compounds. are trustworthy in all respects. Do you say “trust more” in this case partly—or almost With so many stages where IT is involved, you get a pretty entirely—because the sample size would be big enough to big chain reaction in the requirement of trust. be really trustworthy? » THAT’S ABSOLUTELY TRUE. As I’ve been ying » EXACTLY. We would now be dealing with biostatistical around the world and visiting with companies in di er- signi cance that healthcare professionals must truly trust. ent countries, the issue of trust makes me ask: When have Not only would we understand the therapeutic dynamics, we—as the general public—experienced this before? Many but we would also understand the biomarker outliers. years ago, we’d take money to our branch of our bank and If we’re at the molecular level and the cellular level, deposit our cash. ey would put it in their vault, and if we might we be able to harvest out the information of where needed to remove some of that money, we had to go back something will therapeutically be e ective, what is the to that branch and that vault, from which the money was mechanism of action, and where might we get a bad out- provided back to us. But now, we have the global ATM. e come or unanticipated e ect that we’re not wanting? only IT that the general public—as a world public—will trust is the ATM. ey do not trust the telephone IT. ey don’t trust the credit-card IT. ey don’t trust many, many We hear a lot about the medical and pharmaceutical com- other billing mechanisms and other IT stu , but they do munities wanting to do things like personalized medicine trust the ATM. or gene therapy, but doing this e ectively seems to depend 72 SCIENTIFIC AMERICAN | WORLDVIEW
  5. 5. have become so stringent. en all of a sudden, we’re into a Phase III, not really getting the data that we really need, except at the organ level. We’re still in the art form of med- icine. We’re not in the science of medicine. We have to take some harsh looks at what is happen- ing to drug development and therapeutic development, and it’s not very pretty. We’re seeing about a 99.9 percent failure rate. So for, say, every 10,000 compounds targeted, we’re seeing one really get through the process and get market ap- provals. at’s horrifying when we look at the economics. Given those bad odds, how can biotechnology put your ATM analogy into operation to improve the situation? » WE COULD HARVEST the genomic and cellular data of humans, associate that with a disease, and look at the therapeutic potentials with computational predictive modeling. en, we could determine in the modeling what biomarkers are expressed, where a potential therapeutic would be most e ective in which population and equally important—if not more important—the populations we should avoid and actually contraindicate—meaning that if you have a speci c biomarker, you should not have this drug because it will be a bad outcome. Let’s talk about the toxicological information that we gain when we go through our current paradigm. We on—or even require— the kind of database of information are actually taking histology and toxicological informa- that you are describing. tion from animals. We are trying to associate that with humans. We are saying that the animal must be pure, a » THAT IS REALLY THE ESSENCE OF THE POINT. laboratory controlled animal—not anything re ective of e biotech industry is really at an embryonic state with a human, who would be eating all kinds of di erent diets, IT. Part of that is that when we are dealing with data that consuming all kinds of supplemental products, and envi- are at the cellular and genomic level, we very quickly start ronmentally they are exposed to everything under the sun. looking at petabytes of information and terabytes of data. So right there, just look at the contrast between the human One simplistic concept many times escapes us, and it is: We patient and that animal from which we’re gaining toxico- want to go from data to information and then to knowledge. logical knowledge. e information provided by that kind What’s happening is that the interpretation of volumes of of data is just wrong. data into truly meaningful and trustworthy information is not yet complete. We haven’t quite gured out how to make sure that we have adequate data sample sizes to make an in- It’s hard to miss the international potential behind your formational set of facts that we as a people can trust. en, idea of a medical ATM. If health information from around as we convert the information and set of facts that we can the world could be made available, a pharmaceutical trust—based on the adequacy of data—then we start get- company could access data from most anywhere. Likewise, ting into the knowledge that we as an industry so desper- this could bring better healthcare to developing countries ately need. Vioxx and many other drugs serve as troubling if more information were available about medical histories examples where we have not known what we did not know of their people. when we put a drug or therapeutic to the market.© AARON MCKINNEY e current mechanism, the current model, does not » ABSOLUTELY TRUE. If we are going to build a suc- work. We know that fact. We know that the animal data cessful therapeutic, it is nothing but naïve if we think that give us much misinformation. We know that some of the we only need to conduct our clinical assessments and our Phase I, Phase II clinical studies add to the misinforma- development within, let’s say, the United States. at is tion, partially because the inclusion and exclusion criteria very nearsighted. We have to be global. SCIENCE & TECHNOLOGY 73
  6. 6. Biomedical Information— A Matter of Trust A Q&A With Howard R. Asher Can a new kind of ATM change global healthcare? May 2009 h;p://www.saworldview.com/ar+cle/biomedical‐informa+on‐‐a‐ma;er‐of‐trust‐a‐qanda‐with‐howard‐r‐‐asher