Food Safety Counterterrorism Initiatives

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And as part of this reorganization in CBER, our commitments in working with CDRH in developing this process are currently under way, and we look forward, as I said, to sharing that with you soon.

This just gives you a sense of the products that have been coming to this area. We have literally over 1,000 types of cell and gene therapies applications, INDs, into the agency. While there is still not a lot of licensed products available, they are advancing in their clinical investigation. There's also a great advance in the science, so it's an iterative process, and it's extremely important that that CBER keep up with the science, i.e., our research review model, and I think it's really clear for us that you need to have people that understand the science that actually do the science that can help lead the way in developing policy and guidances, not only to ensure safety but to further the science along.

So clearly over the past six years there's been a large increase in this area, even in spite of some major issues that have been raised. Clearly in gene therapy, the death of Jesse Gelsinger [ph] has raised issues. The science is there. It needs to be actually augmented, basic research in this area that feeds into the FDA that we could use working with our colleagues both in government, such as NIH, where we have a lot of our laboratories, as well as with the industry and academic institutions that are developing these products. So I think we're looking at a very interactive development process.

So what is this new office going to do? Well, this new office is going to be responsible for conventional tissues. These are banked human tissues. And ultimately, as our tissue rules go forward, these will probably encapture reproductive tissues as well. We're looking at assisted reproductive technologies which is the complex manipulations of eggs and sperm and how they're going to be used in the future, as well as i mentioned, the tissue engineered products and stem cells. It will have all the cellular-based products that are currently regulated by CBER in these tissue-based products, gene therapies, xenotransplantation, which is the use of animal tissues, cells and organs. This is a particular area where we have now an advisory committee under the Secretary of HHS to deal with the unique zoonotic agents that might be of some concern.

We have, as I mentioned, the assisted reproduction area. To give you an example of this and some of the things going on in this area that raised FDA's attention to being manipulated in a way that we consider has important safety issues as well as in many ways looking at the success of these processes, where people are taking older women's eggs and actually taking out the cytoplasm and putting in the cytoplasm of younger women's eggs. And in fact, as many of you know, there's mitochondrial DNA in the ooplasm of these eggs, and in fact you're doing essentially gene transfer in some of these activities by introducing new genes.

So I think there's a lot of issues going on here. Clearly, the combination products is a big area that we are concerned about, and we think that this is really important, and are anxious to move this area forward. Obviously, we want to assure the safe identity, purity and potency of these products.

The expertise. We've had a lot of input from you on the Science Board. We thank you for that input. Many of you have contacted us with your ideas, and so this is still evolving, but some of the expertise that this new office has is in molecular and cell biology, viral and nonviral gene therapy vectors, nucleic acid chemistry, genomics, proteomics, tissue and organ regneeration, developmental and reproductive biology, stem cell biology and physiology, obviously, our clinical expertise and pharm/tox.

We look at our ability to regulate in this area as one that's going to require a lot of outreach and get a lot of scientific input, because clearly all these areas will have an evolution, and the Agency cannot handle this all on our own. We're going to have to rely on the interaction with scientists outside the Agency.

The Office of Cell, Tissue and Gene Therapies, the Acting Director is Dr. Phil Noguchi, who will be speaking to you shortly. Joyce Frye [ph] is the Acting Deputy. And the structure really deals with three primary divisions: the Division of Cellular and Gene Therapies, the Division of Human Tissues and the Division of Clinical Evaluation and Pharm/Tox.

I would just say while Phil was--at the time this slide was made the Director, Dr. Raj Puri, has been selected as the Acting Director. Raj is here. Where are you, Raj? Oh, there he is, right over there. And you'll see him. Dr. Ruth Solomon, who is the Division of Human Tissues, and Ruth's group will be continuing her work on the safety of banked human tissues, and certainly will continue as those areas expand, and a new Division of Clinical Evaluation, Pharmacology and Toxicology. Recently Phil has selected a new Acting Director for this, Dr. Cynthia Rask, who is--is Cynthia here? I don't see Cynthia, but we'll make sure she gets--she's doing the work. That's good. Somebody's got to be doing the work.

So under the Division of Cell and Gene Therapy, there's a cell therapy branch, a gene therapy branch, a lab of molecular immunology and virology, a lab of tumor biology. Many of our cellular products are used as therapeutic vaccines. A lab or immunology and developmental biology and a lab or stem cell biology.

All of these things, obviously have great importance in terms of not only looking at therapies, but certainly in coordination with novel vaccine protocols.

The Division of Pharm/Tox, again, Dr. Cynthia Rask, who's now in the upper box. And we're going to be recruiting for a person for Clinical Evaluation Branch. And we are very close to selecting new leadership on an acting basis for the Pharm/Tox Branch.

And then I just wanted to mention the Division of Human Tissues, and Dr. Ruth Solomon.

I'm going to stop my formal presentation at the moment, to just talk about the interrelationship of cellular therapies, and also the proposed reorganization of having the therapeutic products from CBER be considered moved to CDER. I have expressed to certainly Dr. Crawford and Dr. Lumpkin the concerns that I the Center Director, and certainly the staff at CBER have regarding this particular transition.

We believe that the therapeutic products that we are talking about currently in this transfer, which include cytokines, growth factors, monoclonal antibodies, and a number of enzymes, as well as other related products, have important public health benefit. And I really think that the science behind these and the scientific issues with these products are not all solved. And the need for having a research reviewer base model to deal with these issues continues to be important.

There is also a link in a relationship between these products and the ability of our new office to function. Many of the components in cell tissues and gene therapies require cytokines, growth factors, and monoclonal antibodies in order to propagate and use these new products. So in essence they are integrally linked.

When we had designed our new office, our office was designed so that these two offices were going to coordinate very closely within the Center for Biologics. That is, the clinical review, the review teams from our scientists in Dr. Rosenberg's group, which is therapeutic proteins, Dr. Webber's group, which is monoclonal antibody, to really support this as a whole program. We feel that it is a problem.

We also feel that many of our scientists under this scenario will leave the agency, and this is of grave concern to FDA beyond just the scope of the function of the new office.

I will not go into all the reasons. I want to link the predominant reasons to the new office that I'm here to discuss today. Dr. Crawford and I are in discussions on this, and will be further about the impact of this on the FDA as a whole. And I certainly wanted to make the Science Board aware of this. This is a very important issue, not only to the products we currently regulate in the Center for Biologics including the therapeutic proteins, but also the future of how we're going to deal with these new evolutions of new products.

So I'm going to stop here. I would like to introduce Dr. Phil Noguchi, who will come and discuss some of the specifics of the new office, and then I'd be happy to come back and answer any questions you might have. Thank you.

DR. NOGUCHI: Yes, thank you. I'm used to using a touch pad, so I didn't notice there was a mouse here.

Thank you very much. It is my distinct privilege to able to present to you today and give you both a personal view of what I see the office doing. But I can assure you that this personal view is just a slight variation of what you will find throughout the agency at every level. The reason I call it a simple complexity in an evolving world is literally my professional life has been at the Center for Biologics.

I was actually started as a medical student when I was part of the NIH, and the next year I came back to continue some of my research, and was told that we were part of the FDA. And not knowing anything at that time, I hardly noticed the change. But my boss then was Dr. John Petrucianni, and from John is really the philosophy of how we do business at FDA, and especially at Biologics. And as my own personal, kind of, this is about all I know how to do.

When I first started, John looked at me, and he said, "Well, let's see, you're young medical student. What's the problem, what's the issue, and what are you going to do about it?" And that basically is the same theory I've taken throughout the years and that we will continue to do throughout this particularly complex, or simplicity, or thus complex.

There will be three topics. I'm going to touch briefly on our counter-terrorism activities and show you how actually that weaves together directly into the function of the new office. I'll describe that, when we talk leveraging, I call it 'federal stone soup.' I mean we have enough to be able to create the regulatory framework, and create the regulations and the approval process, but we need everybody's help to contribute to this soup, so can finally have something that's useful at the end of the day.

And then finally I want to talk about patient-centered therapies. This sounds almost like individual tailored therapies, but it really is a little bit different. As I get to that, it's really that this society should be able to meet the needs of just one person who have the rarest genetic disease or other type of disease on earth. We have the capacity, we have the wherewithal, we have the approval mechanisms. All we need is the will to do that.

First of all, some of the efforts in counter-terrorism: Whether you're a victim of terrorism, whether it's physical, chemical, or biological, or you're a victim of disease or injury, you're going to need things that repair, replace, restore, and regenerate normal body functions, and that's partly what we do. For example, with the era of human tissues, we've had some rules on the books since 1993. Last year, we believe that there are 600 to 800 thousand tissue transplants, musculoskeletal transplants, that have been done.

With the increasing numbers of transplants being done, obviously there also comes the need to have a closer oversight over that, but in a way that does not impede the currently vastly usable supply that we have. We will be finalizing the rules for our tissue framework, which will in fact go beyond infectious disease control and will introduce some of the concepts Dr. Crawford has for the reinvention of good manufacturing practices. We call it good tissue practices. This will emphasize record keeping, tracking, and donors' eligibility rules, all within the context of infectious disease control.

Hematopoietic stem cell transplantation has gone on for quite a number of years and is certainly now being considered to be the standard of medicine in many places. Radiation so-called dirty bombs, as one example we know from Chernoble that were the technology better available to be able to delivery hematopoietic stem cells in a timely fashion, perhaps there would not be nearly as many tragedies at Chernoble as there was.

So we're actually taking a slightly different modified approach to this, because we do want to mobilize this industry, both for its medical needs for standard transplantation as well as for the future. We're reviewing data that has been submitted by a number of our partners out there in the academic center. We believe we have at least enough to begin to start to do what we called "deemed licensing," that is, in lieu of a formal premarket demonstration of safety and effectiveness and the attendant lengthy times for that, we do believe that some of this area can actually be done in a somewhat retrospective manner, but without sacrificing anything in terms of safety and effectiveness. We're not nearly done with this, but we will be bringing back our current efforts in this area, probably in the next several months, the beginning of next year.

When we say "deemed license" we will to make sure, of course, that in fact, even though we deem it and we don't have a formal premarket approval mechanism for it, that it does, in fact, talk about a safe and effective product. We have heard about other stem cells now.

Again for terrorism, counter-terrorism, some of the effects are really not known in the immediate sense. Anthrax has an immediate kind of a sequela, even though by the time you get the full-blown disease, the anthrax bacillus is simply nowhere to be found. There may be longer-term consequences from that, such as neurologic damage, pancreatic damage, or other tissue damage. We have been doing a lot in the area of embryonic stem cells and adult stem cells that are similar to these. We've held an FDA public workshop on that.

In your materials that I've passed out today, we're very proud that in the original primer for embryonic stem cell research, there is a Chapter 10, called the safety net for how you develop these things. This was authored by actually Donald Fink of the FDA, one of our staff members. And in fact when the report first came out, the first part of it that was leaked was actually Chapter 10, that is, how are we actually going to use this in the clinic. These are all the steps that need to take place.

We are going to continue to work on that and to work with the National Institutes of Health. We with the NIH have been meeting with the approval stem cell providers, both from a scientific basis as well as from a regulatory basis. It's been extraordinarily fruitful to make sure that the FDA and NIH are not only at the same table but we're asking the same questions, that in fact the NIH is realizing quite dramatically that they need to fund those types of studies that need to be done, so that we can have safe and effective products for something that we don't quite know how to do yet.

Even tumor vaccines. Now, tumor vaccines as a theoretic entity have been around for 30, 40, 50 years. We have one sponsor, Dr. Don Morton, who's been in it personally for 40 years, and we see some progress in it. If we can get Don Morgan to finally admit that "Well, of course you have to make these products under GMP quality" and he built his own facility for that and has now transferred that to the Cancer 'Vax' sponsorship, we think that this is coming to fruition.

Well, what does this have to do with counter-terrorism? Well, one of the long-term sequelae of a dirty bomb, and what we saw in Nagasaki and Tokyo, is obviously development of all sorts of malignancies. Perhaps one area of use for this would be in the area of tumor vaccines, both for the need of the public at large and for the need of the victims of terrorism. We are having an international workshop in 2003 to follow on a workshop we had earlier and we're beginning to start a partnership with industry to now start to get down to the real nitty-gritty issues. What exactly are going to be the release criteria? What exactly do you mean by 'potency' if in fact this is a tumor vaccine, but it's individualized, an autologous tumor vaccine?
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