Latest / Get Real with Jim Weiss / Dr. Richard Pazdur on the Future of Cancer Treatment

Transcript

Dr. Richard Pazdur on the Future of Cancer Treatment · Get Real with Jim Weiss

0:00
Speaker 1: Well, I think you can't but walk away from this
0:02
Speaker 1: episode with some optimism around the treatment of cancer. I
0:06
Speaker 1: think we're in a real period of breakthrough from diagnosis
0:11
Speaker 1: to treatment, and as you know, the industry begins to
0:15
Speaker 1: move from a treatment oriented, you know industry to a
0:19
Speaker 1: prevention oriented industry, which is going to align with where
0:23
Speaker 1: healthcare is going and the consumerization of healthcare. A guy
0:27
Speaker 1: like Rick Pastor, who gets the people part as well
0:30
Speaker 1: as you know, the business and and the you know,
0:33
Speaker 1: science of doing all this, that combination is interesting. He's
0:38
Speaker 1: sort of the intersection like it is that get real
0:42
Speaker 1: of you know, health, heart and business, you know, all
0:47
Speaker 1: of that together. That's what we do here. You know,
0:50
Speaker 1: we talk to people who are kind of at that
0:53
Speaker 1: you know, interesting you know, crossroads and intersection of those
0:58
Speaker 1: things that make the world a healthier place in a
1:01
Speaker 1: lot of different ways. And you know, we'll lead into
1:04
Speaker 1: other podcasts that we've done on financial health and all
1:07
Speaker 1: the other things that that we look at in terms
1:10
Speaker 1: of health that I don't think people think impact health
1:14
Speaker 1: the way it does. But is there anything more important
1:16
Speaker 1: than your health? And a guy like Rick pass on
1:19
Speaker 1: that wall for us at the FDA, But even if
1:22
Speaker 1: he doesn't stay there, he's going to have influence in
1:27
Speaker 1: the private sector and in the investing sector to help
1:31
Speaker 1: us advance further faster. I really believe that. But we
1:35
Speaker 1: got to tap more of those people. We can't. We
1:38
Speaker 1: can't let them go anywhere and hang up their spurs.
1:41
Speaker 1: That's the biggest worry I have right that, the the
1:44
Speaker 1: intelligence that we've gained over the years, AI or otherwise,
1:49
Speaker 1: you know, might just want to go fishing, and you know,
1:53
Speaker 1: we need them to go fishing, but also stay out
1:55
Speaker 1: here and fight the good fight, because you know, it
1:58
Speaker 1: never ends, right, it never ends. I mean, the cycle
2:01
Speaker 1: of life continues and we have to keep fighting to
2:04
Speaker 1: make the world a healthier place. Thanks so much for
2:09
Speaker 1: coming to get real. You're always real, so this is
2:11
Speaker 1: not a hard thing for you.
2:13
Speaker 2: Maybe too real, Okay.
2:15
Speaker 1: It's baby too real. But most of the time when
2:17
Speaker 1: I do these, I like to kind of look back
2:19
Speaker 1: and talk about the early work and how that informed
2:22
Speaker 1: how you got into the FDA, which you've spent so
2:25
Speaker 1: many years at. How did your early work launch you.
2:28
Speaker 1: First you have a fellowship at Rush Saint Luke's, then
2:31
Speaker 1: you're on the faculty of Wayne State, and finally you're
2:34
Speaker 1: an oncologist at MD Anderson Cancer Center. Tell us how
2:39
Speaker 1: did all that work inform what you do today.
2:41
Speaker 2: I'm originally from the South Side of Chicago. Went to
2:44
Speaker 2: my undergraduate at Northwestern, then went to medical school at Iola,
2:48
Speaker 2: then went part of my fellowship at Rush, then went
2:50
Speaker 2: to the University of Chicago. So I hit almost all
2:53
Speaker 2: of the Chicago institutions and probably a quintessential Chicago south
2:59
Speaker 2: side guy speak. I always wanted to go into academic medicine,
3:03
Speaker 2: and it's interesting in Chicago at that time, and I'm
3:06
Speaker 2: talking about nineteen seventy nine, nineteen eighty, nineteen eighty one,
3:12
Speaker 2: oncology was a much different place, so to speak. There
3:15
Speaker 2: were very few drugs. All of the drugs were cited
3:18
Speaker 2: toxic drugs. And I was very interested in academic medicine
3:22
Speaker 2: and particularly drug development. And interestingly enough, Detroit had probably
3:28
Speaker 2: a much bigger program at Wayne State than any place
3:31
Speaker 2: in Chicago. And that's kind of surprising to most people
3:33
Speaker 2: because people consider Chicago a much larger city than Detroit.
3:38
Speaker 2: But Detroit really didn't have the competition between the multiple
3:41
Speaker 2: medical centers that Chicago faced, so they had a big
3:45
Speaker 2: program a big program in phase one drug development, Phase
3:48
Speaker 2: two drug program cicon tracts, and I really got interested
3:54
Speaker 2: in that, ran the fellowship program there. So started my
3:57
Speaker 2: career in drug development and really a career in GI oncology.
4:02
Speaker 2: A job opened up at m d Anderson, and luckily
4:05
Speaker 2: enough I formed a relationship with one of my professors
4:10
Speaker 2: at University of Chicago during my fellowship there, and he
4:14
Speaker 2: had moved to MD Anderson. So that was my segue
4:17
Speaker 2: into MD Anderson in the late nineteen eighty so to speak.
4:22
Speaker 2: And then I continue basically the same thing. Was very
4:25
Speaker 2: interested in medical education, trained a lot of fellows, some
4:29
Speaker 2: of them are leaders in oncology today, got interested in
4:33
Speaker 2: drug development, went to the FDA with several drug companies,
4:38
Speaker 2: and understood really the importance of the FDA and the
4:41
Speaker 2: drug development picture, so to speak. Here tofore, I had
4:44
Speaker 2: no idea what the FDA was. If somebody asked me
4:48
Speaker 2: early in my career would I be working at the FDA,
4:50
Speaker 2: and my answer would be, what is the FDA? Okay?
4:54
Speaker 2: I had no idea what it was. And really it
4:56
Speaker 2: was really through that interaction with the pharmaceutical companies, going
4:59
Speaker 2: there with them, I really saw the importance of the
5:02
Speaker 2: FDA in drug development. I had a clear vision of
5:07
Speaker 2: when I took the job what I wanted it to be.
5:09
Speaker 2: I wanted to be interactive with the outside community. I
5:13
Speaker 2: thought it was really to isolate it in its decision making,
5:18
Speaker 2: and it really needed to have somebody that had a
5:22
Speaker 2: vision of really bringing the agency out into the oncology world,
5:26
Speaker 2: so to speak.
5:27
Speaker 1: Was there a patient or a moment with the patient
5:29
Speaker 1: to change how you thought about drug development and approval
5:32
Speaker 1: that inspired you to really make waves in Washington to
5:35
Speaker 1: working with patients make you reconsider speed and risk when
5:39
Speaker 1: the stakes are life and.
5:40
Speaker 2: Death, not only one patient, but many patients. I think
5:43
Speaker 2: many people that are treating on collegests feel many times
5:47
Speaker 2: a sense of frustration when they see a really important
5:50
Speaker 2: drug that is going through phase one phase two drug
5:54
Speaker 2: development and they know a patient would respond to it,
5:57
Speaker 2: but it's not available. We have other programs, such as
6:01
Speaker 2: expanded access programs, but many pharmaceutical companies don't participate in
6:05
Speaker 2: those or it's very difficult to get those drugs. So
6:09
Speaker 2: there's always that sense of frustration and tension between the
6:13
Speaker 2: amount of information that one would need for a drug approval. Okay,
6:17
Speaker 2: versus access that a patient needs. And I remember when
6:22
Speaker 2: I was in Houston, a neighbor of mine when I
6:24
Speaker 2: was at MD Anderson had a friend that had colon
6:27
Speaker 2: cancer and really would be a primed patient for benefit
6:31
Speaker 2: with oxelli platten and patients simply couldn't get it. I
6:35
Speaker 2: understood the frustration that that patient had. As the physician
6:39
Speaker 2: of that patient, I also understood the frustration. I really
6:42
Speaker 2: wanted a much more fluid system where you had a
6:47
Speaker 2: greater communication between the commercial sponsors of drugs the FDA.
6:53
Speaker 2: I frequently found that the sponsors when they came to
6:56
Speaker 2: FDA meetings left the meetings and they really didn't have
7:01
Speaker 2: a clear idea of what was going on, and there
7:05
Speaker 2: was this kind of kabookie dance that was being performed
7:08
Speaker 2: between the FDA and the sponsor. What questions they were
7:12
Speaker 2: going to ask, what questions they didn't ask. So I
7:15
Speaker 2: just thought like, let's just get the cards on the table,
7:18
Speaker 2: so to speak, and let's kind of be honest of
7:20
Speaker 2: where we want to go. The dreadit word that I
7:22
Speaker 2: always feared during these meetings with the sponsors and the
7:26
Speaker 2: FDAs this is a review issue, which is pretty much
7:30
Speaker 2: a cop out where we just don't want to comment
7:32
Speaker 2: on something.
7:33
Speaker 1: Well, you grew the FDA's oncology function from a small
7:36
Speaker 1: division into a large organization across specialties. What did that
7:41
Speaker 1: approach due to creating breakthroughs that change the way cancer
7:45
Speaker 1: was treated? From axaliplatin and the one. I mean, we
7:49
Speaker 1: still have all those things, right, We still have all
7:52
Speaker 1: the temo.
7:52
Speaker 2: Car It was intimately inbo I shouldn't say intimately, but
7:56
Speaker 2: professionally involved with most of the cytotoxic drugs development in
8:00
Speaker 2: the eighties and the nineties gym side of being ACXILEI
8:03
Speaker 2: plantin cape side of being taxe tier taxol, so I
8:07
Speaker 2: knew those drugs. Basically, I think what happened here. When
8:11
Speaker 2: I came to the agency, we had about ten medical oncologists,
8:15
Speaker 2: and before I left we had over one hundred, so
8:18
Speaker 2: a tenfold increment in the number of oncologists that were
8:22
Speaker 2: working there. What really happened was the breakthroughs in oncology
8:28
Speaker 2: based on the science that was developing over decades, and
8:32
Speaker 2: what we saw beginning with the development and the approval
8:37
Speaker 2: of a MATINEB targeted therapies velcade for the initial treatment
8:42
Speaker 2: of myeloma, rather was a really understanding of the diseases,
8:48
Speaker 2: the therapies, how they interacted with each other. It wasn't
8:53
Speaker 2: just the development of let's take a drug that just
8:56
Speaker 2: kills cells and let's see what tumors it works in
9:00
Speaker 2: what I would call a Roulette wheel of drug development
9:03
Speaker 2: and a Rulett wheel of drug discovery. There was much
9:07
Speaker 2: more of a conceptual approach of this drug is going
9:10
Speaker 2: to act in this tumor because of this biomarker. This
9:13
Speaker 2: therapy is going to work because we understand the molecular
9:17
Speaker 2: or the immiological underpinnings of the disease and the patient
9:21
Speaker 2: that has it.
9:22
Speaker 1: I mean, what were those breakthroughs that spat and supported
9:24
Speaker 1: the way cancer treatments were approved.
9:27
Speaker 2: I think the most important one was really the use
9:29
Speaker 2: of accelerated approval, and this was originally developed in the
9:35
Speaker 2: late nineteen nineties for AIDS basically due to the crisis
9:40
Speaker 2: and the epidemic that the agent the nation was facing
9:44
Speaker 2: of people that didn't have any other therapies. They were
9:47
Speaker 2: putting tremendous pressure on the agency. There's a famous movie,
9:52
Speaker 2: The Dallas Buyers Club basically that dealt with this whole
9:56
Speaker 2: area or time period, and it just focused, you know,
10:00
Speaker 2: we needed to do a better job for getting patients
10:03
Speaker 2: therapies with life threatening diseases. So accelerated approval was originally
10:07
Speaker 2: developed in AIDS and the treatment of HIV infections, I
10:11
Speaker 2: should say, but quickly became a really counterstone or a
10:16
Speaker 2: foundation of medical oncology where almost every sponsor that has
10:21
Speaker 2: a novel drug is now coming and thinking of how
10:23
Speaker 2: they can first get an accelerated approval based on an
10:27
Speaker 2: earlier clinical endpoint, then developed the drug along the way.
10:31
Speaker 2: And I think this had a tremendous impact over this
10:34
Speaker 2: twenty five year period of time, really focusing on the
10:38
Speaker 2: fact that these were life threatening diseases that patients needed it.
10:43
Speaker 2: Having come from the South Side of Chicago Gym, I
10:46
Speaker 2: never wanted to be in a position where somebody that
10:51
Speaker 2: worked their life in a steel mill and Gary, Indiana
10:55
Speaker 2: paid their taxes, was suffering from a serious life threatening
10:59
Speaker 2: disease is cancer, dying of the therapy, dying of the disease,
11:03
Speaker 2: and the government was saying no to them. Basically, that
11:07
Speaker 2: was not a situation I wanted to be in. So
11:10
Speaker 2: we really tried to really expedite the development of these
11:15
Speaker 2: drugs through the accelerated approval pathway. Now, of course there
11:18
Speaker 2: were some problems along the way with accelerated approvals, okay,
11:22
Speaker 2: which we had to address. We had to address those,
11:25
Speaker 2: and some people didn't like it. First of all, people
11:28
Speaker 2: have to realize that the accelerated approval program, and I
11:31
Speaker 2: mentioned this many times, was not an economic incentive program
11:35
Speaker 2: for the pharmaceutical industry, no matter how they wanted to
11:39
Speaker 2: interpret it. It was really a patient focus program of
11:43
Speaker 2: how to get early and important drugs out to patients
11:47
Speaker 2: in an expeditious manner. It wasn't that everyone, every Tom,
11:51
Speaker 2: Dick and Harry that is developing a drug should have
11:54
Speaker 2: an accelerated approval and that the pharmaceutical firms were entitled
11:58
Speaker 2: to it. It was not an entitlement. It was based
12:01
Speaker 2: on the un medical need that we were pursuing. So
12:05
Speaker 2: part of this was the efforts to have the confirmatory trials,
12:09
Speaker 2: because if we remember, with accelerated approval, there is an
12:13
Speaker 2: approval based on an earlier clinical endpoint and then a
12:16
Speaker 2: need to develop the drug further with an ongoing clinical trial,
12:20
Speaker 2: and this was important for these trials to be underway.
12:24
Speaker 2: We really noticed very early on, especially with some of
12:27
Speaker 2: the smaller biotech companies that they wanted to get the
12:31
Speaker 2: approval first and then well, let's talk about later the
12:36
Speaker 2: confirmatory study, and that later sometimes meant never, or when
12:41
Speaker 2: we sold the drug to somebody else, that this was
12:44
Speaker 2: going to become their headache. And then there was a
12:47
Speaker 2: inordinate delay in the completion or even the initiation of
12:53
Speaker 2: the confirmatory trial. So this led us about two years
12:56
Speaker 2: ago really to work with Congress saying these trials had
13:00
Speaker 2: to be ongoing, we should take a look at the
13:02
Speaker 2: accelerated approval program as a package, the accelerated approval study
13:08
Speaker 2: and the confirmatory evidence. And sometimes this could even be
13:11
Speaker 2: done in one study, such as model that they pioneered
13:16
Speaker 2: in the HIV arena, where you have an ongoing randomized
13:21
Speaker 2: study and an earlier look at response rate or an
13:24
Speaker 2: earlier clinical endpoint, and then follow off that same trial
13:27
Speaker 2: for the demonstration of clinical benefit. But the accelerated approval
13:31
Speaker 2: program over this past twenty five years has been a
13:35
Speaker 2: evolution in our thinking, and people have to realize this.
13:39
Speaker 2: It wasn't cut and dry. It had to evolve. There
13:42
Speaker 2: were some mistakes obviously of drugs that had marginal efficacy.
13:46
Speaker 2: We took to odex, they didn't pan out and they
13:49
Speaker 2: had to be removed from the market.
13:51
Speaker 1: Basically, I mean, you'd think, given all the number of
13:54
Speaker 1: drugs that went through the system, there'd be more that
13:56
Speaker 1: wouldn't make it, but so many days. So you were
13:59
Speaker 1: a director of the Office of Hematology and Oncology, which
14:02
Speaker 1: involved in to the Oncology Center of Excellence, part of
14:06
Speaker 1: the Cancer Moonshot. Can you remind my listeners what Cancer
14:10
Speaker 1: Moonshot is and why it started and where does it
14:14
Speaker 1: stand today?
14:14
Speaker 2: Where are we Well, like any presidential initiative, it's only
14:20
Speaker 2: as good as the person that's in office that initiates it.
14:23
Speaker 2: This was under Joe Biden and he had, because of
14:28
Speaker 2: his son's illness fighting brain tumors, had a big interest
14:32
Speaker 2: in oncology and the treatment of malignant diseases. So the
14:37
Speaker 2: Moonshot program was launched really to bring together all of
14:42
Speaker 2: the stakeholders including industry, academics, patient groups, the FDA, the NCI,
14:49
Speaker 2: the NIHDMS, et cetera. Everybody was involved with this to
14:53
Speaker 2: see how we can expedite drug development so to speak.
14:57
Speaker 2: And I remember very clearly A. Kayleif was the commissioner
15:02
Speaker 2: at that time, and he wandered down to my office
15:05
Speaker 2: and sat down and said, Rick, what do you think
15:08
Speaker 2: we should do for our cancer moonshot from the FDA?
15:13
Speaker 2: And I said, Rob, I got the perfect idea. I
15:17
Speaker 2: have been thinking about this ever since I walked into
15:21
Speaker 2: the FDA in nineteen ninety nine and twenty years later.
15:25
Speaker 2: Let me tell you what we should do. And that
15:28
Speaker 2: was the Center of Excellence, of the oncology Center of Excellence.
15:32
Speaker 2: I really thought we really needed to bring forward the
15:37
Speaker 2: and have a cohesive package of looking at how we
15:41
Speaker 2: could leverage the unique strengths of the FDA in drug development,
15:46
Speaker 2: have adequate resources that the moonshot gave to us. So
15:51
Speaker 2: this allowed us to develop many many programs, Project Orbis,
15:56
Speaker 2: Project PRAGMATICA, Project facilitate a ton of different projects. I
16:00
Speaker 2: always state, and we had a relatively small budget at
16:03
Speaker 2: that time, less than twenty million dollars, and we I
16:07
Speaker 2: think we're the best bargain that the US public ever
16:10
Speaker 2: had for a buck that was spent and allocate it
16:14
Speaker 2: with so many projects and moving things forward.
16:17
Speaker 1: Well, now that you're out, are they still doing it?
16:19
Speaker 1: I mean that office still functional.
16:21
Speaker 2: Well, Unfortunately, many of the programs may have some sunset
16:25
Speaker 2: it okay, But I think the majority of the programs
16:29
Speaker 2: are intact. The important ones such as Project Orbis, which
16:33
Speaker 2: is our international program, Project Facilitate, which is used to
16:39
Speaker 2: help patients with single patient IDs maneuver that whole complex
16:44
Speaker 2: and difficulty of getting in contact with drug companies, IRBs, physicians, etc.
16:51
Speaker 2: It's not an easy process, and Project Facilitate attempts that
16:55
Speaker 2: our outreach to the community, our outreach for patient engage
17:00
Speaker 2: with our academic groups, with educational activities. We have various
17:05
Speaker 2: fellowships both for with ASCO, with AACR, with the American
17:10
Speaker 2: Statistical Association, with pediatric groups that bring in people that
17:16
Speaker 2: are in those groups and are practicing physicians and give
17:18
Speaker 2: them a highlight of what is going on at the
17:21
Speaker 2: FDA so they understand kind of our regulatory thinking. So
17:25
Speaker 2: the vast majority of the programs are intact. Obviously, it's
17:28
Speaker 2: a concern to me that many of the key people
17:31
Speaker 2: that were running these programs have left, and I think
17:34
Speaker 2: that this is a very critical time for the agency
17:37
Speaker 2: really to take a look at where it's going, particularly
17:40
Speaker 2: with the last year which has been obviously very tumultuous.
17:45
Speaker 1: Well you left, I mean where do you go from here?
17:48
Speaker 1: What are you doing now? I mean, you're not at
17:50
Speaker 1: the agency or you able to impact that at all.
17:52
Speaker 2: I try to as much as possible. Obviously, as a
17:55
Speaker 2: federal employee that has left the agency, there are legal
17:59
Speaker 2: restraints on me. I can't go back to the agency.
18:02
Speaker 2: That's actually a criminal offense to go back and try
18:06
Speaker 2: to lobby the agency products that I have worked on
18:10
Speaker 2: and the issues that I have worked on. But I've
18:12
Speaker 2: really taken a look at working with the other stakeholders.
18:17
Speaker 2: These include AACR, the Friends of Cancer Research, various pharmaceutical
18:22
Speaker 2: companies giving them regulatory advice. And this has been a
18:25
Speaker 2: really eye opening experience for me, especially working with companies.
18:30
Speaker 2: It's interesting because I did that before twenty five years ago, right,
18:37
Speaker 2: and it's kind of I'm coming full circle after this
18:41
Speaker 2: twenty five year experience of being a consultant to various
18:46
Speaker 2: pharmaceutical companies as well as academic groups. I really want
18:50
Speaker 2: to emphasize this as well as venture capital firms and
18:54
Speaker 2: people that are investing in the drug development world, so
18:57
Speaker 2: to speak, which I find is a fascinating kind of
19:00
Speaker 2: area because that area really is the foundation sometimes of
19:04
Speaker 2: drugs that we will see earlier and how people make
19:08
Speaker 2: decisions of winners or losers very early on in that environment.
19:13
Speaker 2: It's particularly interesting, especially since there tends to be little information.
19:18
Speaker 2: When people have to make a decision regarding hundreds of
19:21
Speaker 2: millions of dollars.
19:22
Speaker 1: It sounds like you've got some advice for And you know,
19:25
Speaker 1: we've just seen like three decisions. One was the flu
19:29
Speaker 1: vaccine with maderna. Then there was unicure, which just broke
19:33
Speaker 1: today in Huntington's disease. There's now inability to go back
19:37
Speaker 1: in and then replemuing how to cancer drug that was
19:41
Speaker 1: I guess initially rejected and now there's a reconsideration of
19:46
Speaker 1: that file for a rare cancer disorder. So what's changing,
19:51
Speaker 1: I mean, what's opening up.
19:52
Speaker 2: One has got to be very aware that there needs
19:56
Speaker 2: to be a wall between political issue and the review
20:01
Speaker 2: issues here, and I think that this administration now has
20:07
Speaker 2: realized this, and we'll do everything in its effort really
20:11
Speaker 2: to kind of cement that plug that breach in the wall,
20:17
Speaker 2: so to speak. It is very important that we have
20:21
Speaker 2: an agency that people feel that the decisions are being
20:26
Speaker 2: made by the career staff, not because of political interference,
20:31
Speaker 2: not because somebody called this person in this political organization
20:36
Speaker 2: or that person in this organization, and it is using
20:40
Speaker 2: undue influence. That being said, once that wall is breached
20:46
Speaker 2: and it has been okay, let's face it, that is
20:49
Speaker 2: not open to debate, Okay, it is imperative that we
20:54
Speaker 2: have maintained due diligence that that does not happen again. Okay,
21:00
Speaker 2: because the tendency is to repeat things. Obviously, when somebody
21:05
Speaker 2: gets a decision they don't like it from the FDA,
21:08
Speaker 2: no matter how logical it is. They've invested a lot
21:11
Speaker 2: of money in this, they have an obligation to their stakeholders,
21:16
Speaker 2: et cetera, to use the maximum amount of influence here.
21:20
Speaker 2: So once that wall has been breached, okay, or damn
21:23
Speaker 2: has been breached, one has to have a heightened degree
21:27
Speaker 2: of responsibility that that is maintained, that wall between the
21:33
Speaker 2: politicals versus the review staff. And I think that that
21:38
Speaker 2: is extremely important. I have always stayed in multiple frameworks
21:43
Speaker 2: or multiple discussions that I don't believe the centered directors
21:47
Speaker 2: need to be involved with an individual decision on a drug,
21:51
Speaker 2: let alone a commissioner or anybody in the office of
21:55
Speaker 2: the Commissioner. I really think one should let the review
21:58
Speaker 2: staff do their work, come to the conclusion, take it
22:02
Speaker 2: to an advisory committee, then let's make a final decision.
22:06
Speaker 2: If a company doesn't like it, there's a dispute resolution
22:10
Speaker 2: process that could follow. Then these other people could become
22:13
Speaker 2: involved with it. It is highly problematic, and this has
22:17
Speaker 2: occurred before this administration when center directors were getting involved
22:22
Speaker 2: with regulatory decisions. Why this drug and not other drugs?
22:27
Speaker 2: You got to answer me that question. You can't just
22:29
Speaker 2: pick and choose where you want to jump into the
22:32
Speaker 2: regulatory process here. So this is extremely important that we
22:37
Speaker 2: maintain a very organized process here. And I know it's
22:43
Speaker 2: very tempting because people have done this to me. Call
22:46
Speaker 2: me up when I was a center director and say, oh, Rick,
22:50
Speaker 2: you're such of an intelligent guy, you're so smart, and
22:53
Speaker 2: that review division they don't know what they're doing. You
22:57
Speaker 2: could help us get this drug approved. They were wrong
23:00
Speaker 2: on this and this, and my answer to them was
23:04
Speaker 2: happy to discuss this. But everybody's going to be at
23:07
Speaker 2: the table. I am not having exparteiit communications either with
23:11
Speaker 2: the company or with patient groups, etc. Let's have everybody together.
23:17
Speaker 2: There's always two sides to every single issue here, and
23:22
Speaker 2: it just is a very convoluted, messy issue when one
23:27
Speaker 2: is having these behind the door conversations. I don't care
23:32
Speaker 2: whether it's with pharma, patient groups, patient advocacy groups, whatever
23:37
Speaker 2: you're saying. We have to trust the process, right, Yes,
23:40
Speaker 2: as long as that's.
23:41
Speaker 1: Being done in the way that you're envisioning it. So,
23:45
Speaker 1: there's been a lot of talk about China, and I
23:47
Speaker 1: wanted to get your historical and current view. Did you
23:51
Speaker 1: when you were at the Agency do a lot of
23:53
Speaker 1: collaborative work with China with everyone talking and then kind
23:57
Speaker 1: of what's your take on their biotech industry and how
24:00
Speaker 1: it's impacting the way we do regulatory business here.
24:04
Speaker 2: Well, I have always been a proponent of international drug development, Okay,
24:09
Speaker 2: I have emphasized repeatedly, and I think this is in
24:12
Speaker 2: line with major pharmaceutical companies to do multi regional trials.
24:17
Speaker 2: We in the United States are a diverse population with
24:20
Speaker 2: immigrant populations even though they may have lived here for
24:24
Speaker 2: many years. So we need that diversity that only exists
24:27
Speaker 2: through doing multi regional trials in Asia, North America, Europe,
24:32
Speaker 2: South America, Central America, Africa, And so I've been always
24:36
Speaker 2: a proponent of that we started out with our cluster calls.
24:41
Speaker 2: I initiated those. I think Oncology was the first to
24:44
Speaker 2: initiate this with the EMA. It then morphed out to Canada, Australia, Japan, Switzerland,
24:53
Speaker 2: and so a lot of countries were involved in probably
24:55
Speaker 2: missing some, but we had frank discussions. We never had
24:59
Speaker 2: that discussion with China for the most part in these
25:03
Speaker 2: cluster calls because there was not a confidentiality agreement with China.
25:09
Speaker 2: That being said, we did have I monthly meetings with
25:13
Speaker 2: China to discuss basically large regulatory issues of where we
25:18
Speaker 2: were going with specific programs, and these were not understood,
25:23
Speaker 2: not products specific, but mostly big areas of how accelerated
25:28
Speaker 2: approval was developed, how we were implementing breakthrough therapies, how
25:33
Speaker 2: we saw maybe a statistical analysis on a general basis. Okay,
25:39
Speaker 2: So there was some dialogue there where we started our
25:44
Speaker 2: venue with looking at oncology and China began about ten
25:49
Speaker 2: years ago where we really saw, and this was unique
25:52
Speaker 2: to oncology, a large input of early studies being done
25:58
Speaker 2: asking for IDs studies that were being done in China,
26:03
Speaker 2: and we really didn't know why they wanted an I
26:05
Speaker 2: and d if the study was being done in China,
26:08
Speaker 2: we looked at it, granted them if appropriate, etc. But
26:11
Speaker 2: we really did start seeing this long before this current
26:15
Speaker 2: discussion was going. I have had a twenty year period
26:20
Speaker 2: of time looking at China, and what I would say
26:23
Speaker 2: is that I've done like three different analysis of what
26:27
Speaker 2: was going on. The first analysis was really early on
26:31
Speaker 2: when China was simply doing generic drugs and many of
26:35
Speaker 2: people in China didn't even trust those generic drugs because
26:38
Speaker 2: of the manufacturing difficulties. The second major area was ME
26:43
Speaker 2: two PD one drugs, and we had a odac on
26:47
Speaker 2: Sentilla MAB basically outlined the problems with that. There were
26:52
Speaker 2: significant problems with those drugs of repeating clinical trials in
26:58
Speaker 2: China where you already knew the results. This produced a
27:01
Speaker 2: lot of uncomfortable feelings with the originators and the people
27:06
Speaker 2: that originated these drugs and the clinical trials that somebody
27:10
Speaker 2: was just taking breasically their intellectual property and redoing it
27:14
Speaker 2: in a foreign country. It also had some ethical issues
27:18
Speaker 2: that people were being given control arms that we knew
27:21
Speaker 2: were inferior, especially when they were up to a year
27:24
Speaker 2: improvement and overall survival. So that was that middle portion,
27:29
Speaker 2: and now we're at a period of time when we
27:32
Speaker 2: had a situation where there are truly innovative drugs coming
27:35
Speaker 2: out of China. And I think that this is a
27:39
Speaker 2: wake up call for the United States. I don't view
27:43
Speaker 2: China as an enemy, and I think it is very
27:47
Speaker 2: irresponsible for US as a country to blame somebody for success. Basically,
27:54
Speaker 2: I think it's a wake up call. We should say
27:57
Speaker 2: what we can do to prove ourselves, how we can
28:02
Speaker 2: become more competitive in the United States. And there are
28:07
Speaker 2: areas that we can improve on a very basic fundamental level.
28:12
Speaker 2: The use of central IRBs rather than individual IRBs for
28:16
Speaker 2: multi regional trials. The use of central contracting rather than
28:22
Speaker 2: taking nine months to establish a contract with a given institution.
28:26
Speaker 2: The embedding clinical trials and electronic healthcare records, I think
28:31
Speaker 2: is very important, where we would actually have a portal
28:34
Speaker 2: which would identify patients within electronic healthcare record that would
28:39
Speaker 2: be eligible for the study, have that patient flag for
28:43
Speaker 2: the physician to discuss that trial with the patient, have
28:46
Speaker 2: the informed consent captured in the electronic health care record,
28:50
Speaker 2: the orders written in the electronic healthcare record, the x
28:54
Speaker 2: rays read and reviewed by multiple radiologists within that record
28:59
Speaker 2: and then bring that data into a cloud outside of
29:03
Speaker 2: the electronic healthcare record which the drug company would have,
29:07
Speaker 2: and that would be submitted to the FDA or any
29:09
Speaker 2: other regulatory agency. So we really have to think about
29:13
Speaker 2: how we can improve our self. And I think that
29:16
Speaker 2: this is a wake up call that really I hope
29:19
Speaker 2: HHS really realizes that we need to look at our
29:24
Speaker 2: own issues here rather than what's going on in China. Now,
29:28
Speaker 2: we could look at China and Australia because they do
29:31
Speaker 2: many early phase one studies relatively rapidly, of what are
29:36
Speaker 2: some of the techniques that they have had, and see
29:38
Speaker 2: if they fit into our US system.
29:40
Speaker 1: Right, I mean, they're working, they're bringing good things. So
29:43
Speaker 1: it sounds like you agreed that US and China can
29:45
Speaker 1: and should collaborate to expedite Oh definitely.
29:48
Speaker 2: I think we would be remiss if we said we're
29:51
Speaker 2: closing the door and we're not going to be at
29:53
Speaker 2: the table. And various people have written about this, either
29:57
Speaker 2: make clinical trials go to Europe basically have a deleterious
30:02
Speaker 2: effect on our biotech industry because most of the standard
30:06
Speaker 2: or large companies, whether we talk about ELI Lilly, which
30:10
Speaker 2: most people consider a quintessential US company but really has
30:14
Speaker 2: an international perspective, az merk, Pfiz, or you name it.
30:19
Speaker 2: They're all international companies and therefore they have to answer
30:23
Speaker 2: to not only the United States, but multiple regulatory authorities.
30:28
Speaker 2: And we can't be in a predicament where we say
30:30
Speaker 2: we want twenty percent of patients, we want this percentage,
30:33
Speaker 2: we want that percentage. We have to take a look
30:35
Speaker 2: at a broader picture here that we will gain more
30:39
Speaker 2: information about collaborating and bringing drugs rapidly out of China
30:45
Speaker 2: with the appropriate caveats that their intellectual property and financial
30:50
Speaker 2: situations are addressed, but bring those drugs outside as quickly
30:55
Speaker 2: as possible into these multi regional trials. Most people don't
30:59
Speaker 2: understand that this use of multi regional trials for the
31:03
Speaker 2: regulatory agencies gives us confidence because we take a look
31:08
Speaker 2: at the data that's coming from China, how does it
31:11
Speaker 2: compare in consistency with what is being done here in
31:15
Speaker 2: the United States into other areas. And that's how one
31:18
Speaker 2: builds regulatory trust. One does not build regulatory trust by
31:23
Speaker 2: sending an army of inspectors to China. You're never going
31:27
Speaker 2: to inspect all of sites or all of the patients.
31:30
Speaker 2: It has to be done on a much bigger level, basically,
31:33
Speaker 2: and that is through the participation and having confidence with
31:37
Speaker 2: the investigators from China with the sites, etc. And they're
31:43
Speaker 2: developing very rapidly their medical oncology portfolio, and so nobody
31:49
Speaker 2: is going to want to say that the FDA is
31:52
Speaker 2: not going to approve a drug because it's just done
31:57
Speaker 2: in China and deny people a potential great advance. If
32:02
Speaker 2: you are dealing with a life threatening disease, a fatal
32:07
Speaker 2: disease most of the time, and there's a drug that
32:10
Speaker 2: has a big effect, I don't care where it comes from. Okay,
32:15
Speaker 2: I want that drug and I'm willing to take a chance, basically,
32:18
Speaker 2: And I think that's what most people would say.
32:21
Speaker 1: Yeah. Well, so it's a half class full view and
32:24
Speaker 1: clearly one that makes sense for patients, which is what
32:28
Speaker 1: you said. Many of the best regulatory policies that you've
32:32
Speaker 1: come up with are about taking care of them, speaking
32:35
Speaker 1: of which, my wife died from KRS cancer. So we'll
32:38
Speaker 1: talk half bluss full and some empty. Are you excited
32:42
Speaker 1: about it as I am, or hopeful or should we
32:45
Speaker 1: be optimistic are there some watch outs. Let's talk about
32:49
Speaker 1: that a little bit.
32:50
Speaker 2: Well, my brother died last year of pancreatic cancer, okay,
32:54
Speaker 2: and he got standard chemotherapy, and to be honest with you,
32:58
Speaker 2: I think it didn't help him. It hastened his death.
33:01
Speaker 2: My brother died of a therapy related toxicity. So I
33:05
Speaker 2: can't I'm not an advocate necessarily for the standard of
33:08
Speaker 2: care here, and I have personal experience with that disease.
33:13
Speaker 2: I'm very optimistic and really view this as a transformative therapy.
33:19
Speaker 2: Note I am not using the word breakthrough, okay, because
33:24
Speaker 2: this breakthrough designation has suffered from great inflation. So to speak,
33:30
Speaker 2: the way the law is written, it has to be
33:32
Speaker 2: better than available therapy. So a drug where the standard
33:36
Speaker 2: therapy has a response rate of twenty percent and a
33:39
Speaker 2: new drug has a response rate of thirty percent would
33:42
Speaker 2: get a breakthrough therapy. That isn't what most people think
33:45
Speaker 2: about a breakthrough therapy. So I'd rather use the word
33:49
Speaker 2: when I talk about this drug, and I don't ever
33:53
Speaker 2: use drug names, but this drug from Revment basically is
33:58
Speaker 2: a transformative therapy. And I think that this is incumbent
34:03
Speaker 2: upon the people at the FDA to really understand how
34:09
Speaker 2: to use that philosophy of a breakthrough therapy, What was
34:13
Speaker 2: the purpose of a breakthrough therapy? All hands on how
34:17
Speaker 2: to think outside of the box here, and you've already demonstrated,
34:22
Speaker 2: hopefully when it goes to regulatory review. An effect on
34:27
Speaker 2: overall survival, a big effect on overall survival. The drug
34:32
Speaker 2: is clearly active. It has improvement in response rate, progression
34:36
Speaker 2: free survival. So a definite active drug that we have
34:40
Speaker 2: here that will truly impact the disease. How to develop
34:44
Speaker 2: that in the most expeditious fashion That may break some china,
34:49
Speaker 2: so to speak, in regulatory thinking and in academic circles,
34:54
Speaker 2: But I think we always have to act in terms
34:57
Speaker 2: of what is best for the patient, and should we
35:00
Speaker 2: move this up relatively quickly looking at response rates and
35:04
Speaker 2: potentially even looking at external controls. Subsequent trials moving this
35:09
Speaker 2: into an earlier disease setting are fraught with the introduction
35:14
Speaker 2: of bias because people know about this drug in a
35:18
Speaker 2: randomized trial using standard chemotherapy. Nobody's going to want to
35:23
Speaker 2: go on the standard chemotherapy that's facing a death sentence
35:27
Speaker 2: here with pancreatic cancer. So there's going to be the
35:30
Speaker 2: introduction of bias, and we've seen that before with many
35:33
Speaker 2: patients when they are randomized to the control arm of
35:38
Speaker 2: standard chemotherapy, will just say no, which will ruin the
35:42
Speaker 2: randomization process, or their physicians will say, okay, you could
35:47
Speaker 2: take standard chemotherapy for one or two courses and then
35:51
Speaker 2: you progress before the radiographic progression. So they're introducing a
35:55
Speaker 2: bias there. So it's going to be a very convoluted
35:59
Speaker 2: trial to understand. I hope that's not the case. I
36:03
Speaker 2: think we could think outside of the box. This is
36:06
Speaker 2: an excellent example of using an external control. Because I'm
36:11
Speaker 2: not a proponent necessarily of external controls. I believe in
36:15
Speaker 2: randomized trials. External controls are fine when you have small populations,
36:20
Speaker 2: when you can't do randomized trials when you have just
36:22
Speaker 2: a handful of patients, But all equally important is when
36:26
Speaker 2: you can't do a randomized trial because equopois does not exist.
36:30
Speaker 2: And by equopois, I mean the person coming into the
36:33
Speaker 2: trial has to believe that the two therapies or the
36:36
Speaker 2: three therapies are basically the same. Okay, there's no difference
36:40
Speaker 2: between and I think most people that are coming into
36:42
Speaker 2: this trial are not going to have that belief, and
36:45
Speaker 2: they're going to use this trial to get access to
36:48
Speaker 2: a first line therapy with this drug.
36:50
Speaker 1: And it's a telltale side effect, right that you get
36:54
Speaker 1: a rash. I mean you're going to be able.
36:55
Speaker 2: To tell with Yeah, it's not going to be a
36:56
Speaker 2: blinded trial anyway. It won't be a blinded trial because
37:00
Speaker 2: obviously there's different treatment schedules, etc. And it'd be ridiculous
37:04
Speaker 2: to try to do a dummy control or something, and
37:07
Speaker 2: there's no reason to do it because here again, the
37:10
Speaker 2: demonstration of overall survival is also going to be difficult
37:13
Speaker 2: because most of the patients that have progressed will receive
37:17
Speaker 2: the drug since it might be approved on a second
37:20
Speaker 2: line situation or through an expanded access program. So this
37:24
Speaker 2: is going to be I think people have to before
37:26
Speaker 2: they launch into a trial, really have to think of
37:29
Speaker 2: how this is going to be dealt with, so to speak,
37:32
Speaker 2: and not just said, Okay, this is the way we
37:35
Speaker 2: do things. We do the second line study, and now
37:38
Speaker 2: we're going to do a randomized first line study. I
37:42
Speaker 2: know the academic people like this, they're going to be
37:44
Speaker 2: highly critical of me. I know the regulatory agencies will
37:47
Speaker 2: be highly critical of me.
37:49
Speaker 1: But like, so what so you're basically saying, we have
37:54
Speaker 1: to come at this one. We have to think outside
37:56
Speaker 1: of the box here differently because it's so transfer formative,
38:00
Speaker 1: and so maybe it's similar to that era of aids
38:03
Speaker 1: that you talked about earlier. Right as those drugs came in,
38:06
Speaker 1: we had to adapt a lot of what we were doing.
38:10
Speaker 1: The pharmaceutical companies have to adapt too. There's a big
38:13
Speaker 1: patent cliff coming for so many of these companies. What
38:17
Speaker 1: does it mean for pharmaceutical companies and patients that patent cliff?
38:22
Speaker 1: Is that good for us? Bad for us? Something we
38:24
Speaker 1: need to be worried about.
38:26
Speaker 2: Well, it's bad for the profits potentially, but it again
38:29
Speaker 2: is a wake up call that one cannot just be
38:33
Speaker 2: reliant on a single drug or several drugs. I view
38:37
Speaker 2: it as a potential positive because it pushes companies to
38:42
Speaker 2: take a look at innovative products from smaller companies, hoping
38:48
Speaker 2: to interact with them earlier than later, taking greater risk
38:53
Speaker 2: and perhaps shared risk with these companies and developing these drugs,
38:58
Speaker 2: both here in the United States but also in China.
39:02
Speaker 2: And I think here again we have to take a
39:04
Speaker 2: look at this global picture of getting things and not
39:08
Speaker 2: just being us centric, so to speak, and really take
39:14
Speaker 2: a look at the bigger picture. But I think it
39:17
Speaker 2: is what it is, and embrace it, folks. It's not
39:20
Speaker 2: going to change these patent cliffs. So it's a kick
39:23
Speaker 2: in the butt to like start thinking earlier and interacting
39:27
Speaker 2: and searching out these ideas. And the companies are doing this.
39:30
Speaker 2: They don't need my advice certainly on this. They have
39:33
Speaker 2: regulatory efforts, etc.
39:35
Speaker 1: Do we think AI changes the game as well here?
39:38
Speaker 2: I think one of the things that we have to
39:40
Speaker 2: take a look at with AI and that I'm very
39:42
Speaker 2: interested in, is because it can take a look at
39:46
Speaker 2: the genome of the patient, all of the medical conditions,
39:49
Speaker 2: the whole gamish, so to speak. The patients that respond
39:53
Speaker 2: to a particular Why why does patient A respond and
39:56
Speaker 2: not patient B, our patient A, B and C respond
40:00
Speaker 2: but not D and F. So I think that's one
40:03
Speaker 2: of the realms that I'm really interested in, is those
40:06
Speaker 2: exceptional responders. Okay, why does somebody respond to a drug
40:11
Speaker 2: when the other person doesn't? What is about that person?
40:14
Speaker 2: And it could be quite complicated in interaction of several variables,
40:18
Speaker 2: genetics of the patients versus the tumor versus other comorbid diseases.
40:25
Speaker 2: God knows what it is, but I think that that's
40:27
Speaker 2: an issue the area of drug discovery. I think this
40:30
Speaker 2: is going to play a part in the approval process.
40:34
Speaker 2: I think we're going to be taking a look at
40:36
Speaker 2: the FDA at a much different FDA staff has smaller staff.
40:42
Speaker 2: You don't need hundreds of statisticians to run survival curves, etc.
40:46
Speaker 2: In elimination of different patient groups to take a look
40:49
Speaker 2: at if effects aren't preserved, could easily be done by
40:53
Speaker 2: AI in a matter of seconds. For the medical reviewer.
40:57
Speaker 2: The excessive documentation, which I have been totally against throughout
41:02
Speaker 2: my career. We're not secretaries here, we're scientists, and like,
41:06
Speaker 2: we don't need hundreds and hundreds of pages repeating the
41:09
Speaker 2: same thing. That's going to go out of the way.
41:12
Speaker 2: So I view this as potentially a positive issue. Obviously,
41:16
Speaker 2: with everything, it has to be handled in a logical fashion.
41:21
Speaker 2: There's a difference between I always point out artificial intelligence
41:25
Speaker 2: and real wisdom, and only humans have real wisdom, but
41:30
Speaker 2: they can be as you pointed out married here.
41:32
Speaker 1: Yeah, that's my view certainly, and it makes sense for FDA.
41:36
Speaker 1: I always end with this question, and then there's some
41:39
Speaker 1: fun ones. I asked, what are you getting real about
41:42
Speaker 1: right now? Personally and professionally.
41:45
Speaker 2: Real about the fact that I'm aging and I have
41:49
Speaker 2: to be cognizant of that. And when you're aging and
41:53
Speaker 2: have had losses. My wife passed away, obviously, you know
41:58
Speaker 2: about that. My brother passed away recently, friends and family.
42:02
Speaker 2: You get real about the time that you have here
42:07
Speaker 2: and you want to make the best of it because
42:09
Speaker 2: you wake up every day and tomorrow is not a promise,
42:14
Speaker 2: so to speak, or is not guaranteed, I should say,
42:17
Speaker 2: so it really is. As you get older, you really
42:20
Speaker 2: emphasize the interactions that you have and the meaningful interactions
42:25
Speaker 2: that you have with people. And one of the fun
42:28
Speaker 2: things that I have with this new portion in my career,
42:32
Speaker 2: I'm meeting so many new and interesting people that I
42:36
Speaker 2: would have never ever ever come in contact with at
42:39
Speaker 2: the FDA, the whole investment banking community so to speak,
42:43
Speaker 2: that I would never have been involved with, and interesting characters.
42:47
Speaker 2: They're interesting people in the pharma world, interesting people in
42:51
Speaker 2: the advocacy world that I would never have been in.
42:54
Speaker 2: So the issue to answer your question is getting real
42:58
Speaker 2: with we all have a limited time time period on life,
43:01
Speaker 2: and as you get older this becomes a greater and
43:05
Speaker 2: greater realization.
43:07
Speaker 1: So a couple of fun question, what's the favorite What
43:10
Speaker 1: is your favorite type of vacation when you take time off?
43:14
Speaker 1: If you take time off.
43:16
Speaker 2: Oh, I take time off. I love to go to Chicago. Wow,
43:22
Speaker 2: I'm a Chicago native and I love to go back
43:26
Speaker 2: to the city to see how it's changed. I have
43:29
Speaker 2: family there that you know about, obviously, yes, and not
43:33
Speaker 2: a lot of them, and love to visit them. Love
43:37
Speaker 2: to see my relatives. My biggest kick that I got
43:43
Speaker 2: several years ago, I arranged a dinner party for my
43:49
Speaker 2: past high school English teachers, so three of them came.
43:54
Speaker 2: I used to be in journalism in high school. I
43:58
Speaker 2: ran the high school newspaper, and my biggest kick was
44:02
Speaker 2: to have dinner with my high school journalism teacher. Obviously,
44:07
Speaker 2: she started out she was a very young person when
44:10
Speaker 2: I was a student. We were probably five or six
44:14
Speaker 2: years difference in age, and it was just fascinating to
44:18
Speaker 2: renew that type of relationship. My vacations are not so
44:23
Speaker 2: much built around places but people. I love to go
44:28
Speaker 2: to France, Okay, not for see France but to be
44:33
Speaker 2: with people that I know there that were friends in
44:36
Speaker 2: the pharmaceutical industry and academic medicine that I had developed
44:40
Speaker 2: over time. But it's really not about a place. It's
44:44
Speaker 2: about the people that I want to see and encourage
44:48
Speaker 2: and develop those relationships.
44:50
Speaker 1: Well, the people make the place. I guess that's probably true.
44:53
Speaker 1: If there was an album that's the soundtrack of your life,
44:56
Speaker 1: what would that be.
44:57
Speaker 2: Let's see, it has to be disco. Okay, how about
45:03
Speaker 2: I Will Survive by Gloria gainor.
45:07
Speaker 1: Wow me tremendously last year? What you've gone through? I
45:13
Speaker 1: guess is I will survive. That's right, man, I'm so
45:19
Speaker 1: glad to hear that. And if you were in another
45:21
Speaker 1: line of work, what would it be.
45:24
Speaker 2: Oh, that's easy sociologists. Many people don't realize this about me,
45:28
Speaker 2: But in fact I was talking about this at another
45:31
Speaker 2: talk that I gave to Astra Zenecoalag this week, and
45:34
Speaker 2: it was a leadership course and one of the questions
45:38
Speaker 2: was who inspired you the most? And it had to
45:41
Speaker 2: do with a sociologist that I worked with. Her name
45:43
Speaker 2: was Zena Smith Lawe in the early nineteen seventies, and
45:48
Speaker 2: she was really my model for leadership. She really understood people.
45:52
Speaker 2: She had a passion for her work. She understood that
45:56
Speaker 2: really to promote people's careers, you had to understand them
46:00
Speaker 2: and what they wanted to do, and what their springs
46:03
Speaker 2: and weaknesses were. And really I worked on several projects
46:08
Speaker 2: and independent studies on ethnicity and social mobility within the
46:12
Speaker 2: city of Chicago, going back to my Chicago theme in
46:16
Speaker 2: the early nineteen seventy seventy seventy one, seventy two with her,
46:20
Speaker 2: and it was just a fascinating time. Met a lot
46:23
Speaker 2: of great people in that community, and I would love
46:28
Speaker 2: to go back to that. But you can't do everything
46:31
Speaker 2: in your life.
46:32
Speaker 1: No, you can't. You know. It was really great to
46:34
Speaker 1: have you on the podcast, and I'm really looking forward
46:36
Speaker 1: to working with you on wherever you end up next,
46:40
Speaker 1: doing whatever you're doing. This has been really fun and
46:43
Speaker 1: I hope you come back soon.
46:44
Speaker 2: Okay, pleasure.
46:47
Speaker 1: Hey everyone, thanks for watching. I really appreciate that you
46:49
Speaker 1: take the time to listen to this and tune in,
46:53
Speaker 1: so please subscribe, follow I've got a lot of amazing guests.
46:57
Speaker 1: You're going to learn a lot and you're going to
46:59
Speaker 1: feel a lot better because you did it.