Podcasts about prolacta bioscience

Dr. Shoreh Ershadi is the founder of ANITAGING Institute of California and a renowned expert in clinical biochemistry and pharmacology with over 40 years of experience. Dr. Ershadi shares her compelling journey from Iran to the United States, highlighting her unexpected entry into medical technology and the numerous challenges she faced as a woman in science. From setting up clinical labs and pioneering AIDS testing to founding her own antiaging company, Dr. Ershadi discusses her relentless pursuit of scientific innovation and passion for improving human health. The conversation also touches on her entrepreneurial ventures, the role of art in her life, and her vision for a healthier future driven by natural apoptosis-promoting supplements. Guest links: www.Apoptosis.us | www.facebook.com/apoptosisnutraceuticals | www.instagram.com/apoptosisnutraceuticals | www.threads.com/apoptosisnutraceuticals  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 037 - Dr. Shoreh Ershadi [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm so excited to introduce you to my guest, Dr. Shoreh Ershadi. With over 40 years of expertise in clinical biochemistry and pharmacology, Dr. Ershadi stands at the forefront of scientific innovation in the field of nutraceuticals and supplements. Board certified by the American Academy of Antiaging Medicine and holding dual doctorate degrees, Dr. Ershadi brings a wealth of knowledge and experience to the world. Dr. Ershadi's distinguished credentials, including National Registry in Clinical Chemistry and Toxicology and American Society of Clinical Pathology certifications, underscore her dedication to precision and quality in laboratory practices. Her visionary leadership and unwavering passion for advancing human health has made her a trusted authority in the field. All right. Well, Shoreh, thank you so much for being here today. I'm so excited to speak with you. [00:01:51] Dr. Shoreh Ershadi: Thank you for having me. I'm very excited to talk to you, especially that you're going to talk about medical technology. And that is something that I have been doing or working at for, I would say over 30 years, easy. 1988, I got my license in California. So it's what, 32 years? [00:02:17] Lindsey Dinneen: Yeah. Excellent. Oh my goodness. Well, this leads perfectly into my first question and that is, can you tell us a little bit about yourself and your background and how you got into medtech? [00:02:29] Dr. Shoreh Ershadi: Okay. That is interesting because I was born in Iran and I studied pharmacology. And before I was graduated, the Department of Health in Iran was hiring pharmacists, pharmacologists. So we all went and took the exam and we passed the exam. We were still at the final stages of doing the thesis and going through final stages of graduation. And then they called me and a few other people for an interview. Apparently I had a high mark in the test, which I did not know. So when we went for the interview, and I went to an American school and then later to a British school in Iran, so I was speaking English. At the interview, there was a gentleman who was back in Iran from United States, and he was a PhD in clinical biochemistry, and he asked me to read something in English. And I read it, and he thought that I had it by heart or something, so he flipped the book and found a more difficult page and said, "Okay, read this," and I read that, and he said, "Okay, I'm hiring you for the reference lab." I had absolutely no clue what he was talking about, what was reference lab. I had no intention to even work for Department of Health because I was not even graduated at that time. And then they said, "Okay, start on such and such date." And when I went there the first day, he said he spoke in English and he said, "You're overqualified." Oh my God. What? I mean, it was funny. Without even planning to get into laboratory, I got into the reference lab of Department of Health. And what he was planning to do was to bring College of American Pathologists, the proficiency testing to all the laboratories in Iran. And he wanted someone who would speak English and who could communicate. So first day of my job, I wrote a letter to College of American Pathologists and I said, "Hi, hello, I'm Shoreh Ershadi, I want to buy a thousand proficiency kits." And of course they responded. So just like that, I got into clinical laboratory. And I became the Director of the Quality Control for Department of Health. And that was before the revolution. So, that was my exciting start into laboratory. [00:05:25] Lindsey Dinneen: Yeah, that's an incredible story. Thank you for sharing that. And [00:05:28] Dr. Shoreh Ershadi: Not voluntarily, but serendipitously, yes. [00:05:34] Lindsey Dinneen: There you go. So then at some point, you came to the U. S. and was that transition really difficult? Was it frustrating? Were you excited? Nervous? [00:05:47] Dr. Shoreh Ershadi: There was a part in between before coming to U. S. There was another test by W. H. O., World Health Organization. So I took that test and I passed that test and I got a scholarship to go to medical school in England to do a master's degree. And when I went there, I told them, "I already have a doctorate in pharmacology. I don't want master's. I want to do PhD." And after a few weeks, they said, "Okay, fine, go to PhD. You don't need to do master." So I was in England for about four years. I did my PhD in clinical biochemistry. And I went back to Iran. That was exactly during the revolution. So while I was studying in England, the country in Iran was on fire. It was, things going crazy everywhere. But I went back and I got married. I had my son in Iran, and I was working in a clinical laboratory in one of the best hospitals in Iran, and it got very difficult for women to work. They were saying, " Now you have to wear a scarf. Now, you can't see male patients, you can only talk to female patients." It was not right. So, 1984, I came to United States, I came to California, and with some friends in Iran who had a clinical laboratory, and they were here before me and had started a lab in Orange County, California. I started a branch of the lab in Westwood, in Los Angeles. So that was my first job or position and that was my entrepreneurial side, which now I wouldn't dare to start a life, but then I did. [00:07:51] Lindsey Dinneen: You didn't know the difference then. [00:07:53] Dr. Shoreh Ershadi: Well, yes, I didn't know. I mean, it was a lot easier, I would say. At that point. The lab was not even accepting Medicare or Medi Cal. It was private insurance. I was doing the billing. I was getting the information. I was drawing the patients. I was separating the samples and sending them to the reference lab that was actually running the tests. But I was doing stat CBCs and I was in a medical building and so all the doctors were so nice to send the samples down to me. It worked. So [00:08:33] Lindsey Dinneen: Amazing. Oh my. [00:08:34] Dr. Shoreh Ershadi: Amazing. Yes. Now it sounds really amazing. It's surreal in a way. Yeah. [00:08:42] Lindsey Dinneen: Yeah. Yeah. Well, so, so with that lab and embracing this entrepreneurial journey, and I'm so thankful it worked out so well for you, but were there any moments where you just thought, okay, I've, I, you have such an amazing background. You're so highly educated, you're brilliant. And then you're starting this entrepreneurial journey, which is kind of a different skill set in a way. How was that transition of becoming kind of your own boss and being in charge of everything? [00:09:12] Dr. Shoreh Ershadi: That was pure ignorance. I mean, now I can say then, I thought I knew what I was doing, but it was a fast learning. First that I was in a different country, that I had never been in the United States. Second, that I had a three year old son that I brought with me and my then husband never came, so I got a divorce and I became a single mom. So, and nobody else was from my family was here. So it was very difficult because I had to take him to daycare and then come work and then go pick him up. And then there was a war, the Iraq war had started in Iran and my parents were in Iran and I was going through a divorce, so it was turmoil. And I had to work and learn in a way it was good because it didn't give me time to think about anything else. It was just forward, no looking sideways, no looking backwards. It was just moving forward. But then again, something else happened that made it even more interesting. One of the days that I was at the lab, some guy came and said, "CDL, Central Diagnostic Lab, is looking for a technical director and they've asked me to come and talk to you." I had absolutely no clue if anyone knew me or knew of me or it was the, I mean, a lot of things happened, which, I mean, I'm happy now, but then it changed my life tremendously. And I don't think I've ever talked to anyone about this in this detail. So, Lindsey, I would say you're the first person I'm telling the story of my life. But anyways, I went for an interview and I got hired right away. I had the lab, so I hired someone to do the work that I was doing in the lab. And then I started working at CDL, Central Diagnostic Labs, which was the largest privately owned lab in the United States at that time. There were 1, 200 employees. So that was a very interesting experience on its own because I was introduced to a world that I did not even know what was going on. So, and that was during AIDS testing. Bio-Rad had just come up with Western blot testing and we did the clinical trial, which was very easy in those days. We had AIDS patients and we had a lot of AIDS samples accumulated or saved frozen and we used them to validate the Western blot by Bio-Rad and I went on National TV 1988 and I said, "CDL is the first lab in the world that is doing a confirmation for HIV AIDS testing." So then, that was major. [00:12:40] Lindsey Dinneen: Yes. [00:12:43] Dr. Shoreh Ershadi: But then, then my family came. My father passed away here. It was, again, a lot of complications going on. And one of the other people that I knew asked me to go and partner with them in a lab. Again, my entrepreneurial part took over and I went for the partnership, and I started from scratch. I started Path Labs practically from scratch. There were two pathologists working with Los Alamitos Hospital, and I went there and I started a lab from just buying test tubes, buying, from absolutely nothing. I was there for six years, I think. six or eight years with Path Labs. That was not so successful. After that, I went to Specialty Labs, which is now Quest. Specialty wanted to start a toxicology lab. So, Path Lab was sold. But there was no money made with the partnership and all that. So that was not a very successful six, eight years of my life. Specialty was good. I went to Specialty and I started Department of Toxicology. I don't know if you remember or you were familiar with specialty. Dr. Peters was there and he was the founder, James Peters. He did only immunology testing. They would receive samples and send out everything else to other labs and only do the immunological tests or some specialty tests. When I started the toxicology department, we started getting samples from all over the world. We were running heavy metals and all that. We had an ICP MS and I started running ICP, and the main test that I developed there was measuring iron in the liver biopsy of patients with hemochromatosis. So we would get one spot, in tip of the needle of the liver and then do a measurement and measure the amount of toxicity with iron in hemochromatosis, which was great. I wrote a paper and we were working with Mayo Clinic and they developed the test. So that was very exciting. Then I started the automated lab because all the chemistry. And all the hematology was going out, was sent out. So that brought a lot of money into the lab, but that was not my lab. It was Dr. Peter's lab. It was wonderful. It was nice. But he was the entrepreneur there. So in the year 2000, I started ANTIAGING Institute of California. After passing the specialist chemist license in California, I got National Registry in Certified Chemistry, Certified Toxicology, and then I took the board exam with American Academy of Antiaging Medicine. And that was again entrepreneurial and I started the company, that would be 25 years ago. I've done a lot of consultation. I've been director of lab during COVID. I went back to city health. And I was Director of City Health running 4, 000 COVID patients a night for airports, for schools, for traveling, for a lot of stuff. And then I worked with Siemens Healthineers on regulations for IVDR. So all the kits that Siemens had, over 700 reagent kits that were sold to the laboratories, they need to get the CE mark to be able to be sold in Europe under the new IVDR regulations. And a lot of it had to go through FDA as well because FDA had to approve if there were any changes made to the kits. So I've done a lot of regulation works. I've done a lot of hands on COVID tests, covered it all. Actually, something else that was very interesting. And this, for MedTechs, I would think this would be interesting to know that it's not just one position. And there's so much you can do, if you want to expand your horizon. For about a year, I helped set up extremely high complex laboratory for testing mother's milk, for making milk bank from mother's milk for NICU for children who were born early and the formulas did not work with them. Some of them were so tiny, less than a pound. And so mother's milk bank, it's called Prolacta Bioscience, the company. And I worked there to establish the clinical lab and to get a license for clear and stuff like that. So. [00:18:21] Lindsey Dinneen: Oh! [00:18:21] Dr. Shoreh Ershadi: A lot of good work going into my up and down career, I would say. [00:18:28] Lindsey Dinneen: I love it. Well, first of all, I'm so honored that you were willing to share so much with me. That is. I really appreciate it. And I really appreciate you being willing to talk about some of the amazing moments you've had and the really high, " Yay, we did this," but also some of the moments where it was a little bit tougher and even you being honest and transparent about, the one company didn't do as well as you would have hoped, but you kept going and you are a living testament to resilience and adaptation. [00:18:59] Dr. Shoreh Ershadi: There is no other choice. I would hope that people would have many choices. I mean, you always make choices in life. Even now, this is a choice to talk to you and I appreciate the opportunity because, if I would choose or if I wouldn't know about you, that would be a totally different episode in my life. So I'm open to take chances. You can say that with my experience, living in three different continents and moving and just leaving Iran and coming to us with a three year old, not being here ever before. And then, just jumping in and, but there was no other choice except for moving forward, or we can say, except for success. Because failure was not an option. What would I do? There was nowhere to go back. Sometimes you may have an option to make a U turn and say, "Okay, I don't like this. I want to do something else. I want to stay home." There was no option, no going back. So it was only forward. [00:20:09] Lindsey Dinneen: Yes, absolutely. So, coming here and like you said, having to move forward and I appreciated what you said, you kind of, you couldn't look to the side, you couldn't look back. You had to keep moving forward. How did you go about building a community that could support you, that you could be friends with, and colleagues with, and feel supported coming in from, not having that. [00:20:36] Dr. Shoreh Ershadi: And that was not very difficult. There were many difficult times during that, that I mean, I don't mind talking about it, being a woman, being a young woman, being from a different background there was a lot of resistance. And I see that today as well. I mean, I can't say, "Oh, here I'm in L. A. and Los Angeles is so easy." It's not. I am hoping that women would not maybe experience all the difficulties that I went through. But we're talking about 40 years ago. I came to The States actually July 22nd would be exactly 40 years. I left Iran July 1st, 1984. So this is the 40th anniversary. Being a woman, I thought, when I went to England one of the first things, the professor was my direct supervisor when I worked with him. And I know you can see my face. This is 40 years later. I have no claims, but the professor told me, "You're a beautiful woman. Why do you want to study? Why are you here for PhD?" And I thought that was the greatest insult in my life. So I fought with that professor for four years. [00:22:15] Lindsey Dinneen: No, I'm sorry. [00:22:17] Dr. Shoreh Ershadi: That wasn't easy, but it was so difficult to prove that I am not just a woman or a pretty girl or a young girl or a young woman, or. That was a major fight. I would say that was as difficult as fighting the revolution in Iran, because you wouldn't expect a British professor to say that to you. And I was the only girl, a PhD student, all the others were guys, and this was medical school. And to me, that was very surprising because when I went to University of Tehran, we had probably more girls than guys in the class. Girls were very prone to education in Iran, and they still are. There's still, I think, 60, 65 percent girls in universities, even here. But to hear that was very difficult. That experience repeated itself. in United States over and over till today that I can say I don't feel old. I'm antiaging, but now that I'm an old woman, I still feel that I have to prove myself that I am equal. And sometimes I would say I'm better, but, just to be honest and modest, you want to be treated equal. And that is very difficult. [00:23:53] Lindsey Dinneen: Yeah. Yeah, you're absolutely right. And As much as I would wish things were improving rapidly, I'm not so sure that they are, but what have you found has been helpful in terms of, helping people understand who might come with a bias, but who, helping those people understand, "No I have this education. I am very capable." What are some strategies that you have found that have worked really well for you? [00:24:22] Dr. Shoreh Ershadi: Not many. I have to be honest with you. I mean, if there are a few people, few women, a few even men who are, would be following the conversation, I want them to know that this is not easy. And maybe a part of my success is that I'm a fighter. And I didn't surrender, but I didn't smile my way up. I fought with everyone that went in that direction. And I don't want to get into details, but many of the stronger men would think that if they flirt with you, if they take you out, if they buy dinner for you, then you're going to do what they say. And my story is, just, I have my guards up and I fought. I wouldn't recommend people to fight. Maybe they can find a better solution. I did not find many. Maybe the reason of working separate and starting my own company, maybe one of the major reasons was that I would not have to say yes to power that I did not want to say yes. I worked very hard. I worked hard, long hours. Medtechs, you have to stay there to get the results out. One Christmas. I stayed from December 24th for I would say 72 hours in the lab, maybe two, three hours shower and sleep and go back because we had a lot of toxicology tests that were waiting and results had to go out. And the probe in the I-C-P-M-S was broken. There was no one to replace it during Christmas. It was, we had to borrow from somewhere, FedEx shipping it. Those things happen, you know that, and you have to work hard. It wasn't an easy journey to say, "Oh, I worked four hours a day." And they said, "Thank you. You're so good. Go home." It wasn't like that. [00:26:44] Lindsey Dinneen: Right. Right. Yeah. Well, thank you. I appreciate you sharing that. And so one thing that was really interesting to me, I was looking at your LinkedIn profile and I see that art is a big part of your life in addition to the science and I saw you listed painting and sculpting and I'm wondering how-- well a couple of things-- how did you first get involved in art? And secondly, do you feel that is helpful in terms of having a sort of therapeutic thing to do that kind of maybe helps with some of those harder moments where it's a little frustrating? [00:27:23] Dr. Shoreh Ershadi: Very helpful. But I was as a kid, I started painting at a very young age. And I was always coloring and painting and making things and all that. And my father, a very educated father, he had two master's degree from a University of Texas and came back to Iran. And that's why, we spoke English and we went to English school. So my father was educated and open minded, I can say. But he always said that "You should study art. And don't go to medicine, you'll get old." He passed away in 1988, and I always, when I started Antiaging, I always said "Okay, if you're looking, you will see that I'm antiaging, I didn't age, I went to medical school, I did all the studies." But my logic, first that I love to do this, I mean, it wasn't just you know, forcing myself. I love science. And to this day I do a lot of research. I play with science. You can see the labels are all fancy. I do the paintings. I do all of that. But my logic, more than being scientific, was that this was a career and art would not be a self supporting career, even at younger age. But I always said that if I was a doctor, I could paint, but if I was an artist, I could not do the scientific part or the medical part that I was interested in. But after the divorce, I was in a relationship for 14 years. And I was working hard, raising a son, being a single mother and all that. When that relationship ended after 14 years, the art just popped out. I started painting, sculpting. It was not under control. You can see that, things happen to me, things come out in a certain period. Maybe, I push them down, force them to stay within me, and then they just pop out in different directions. So art came out itself. But there was a period in between that there was no art. Maybe there was too much stress. Maybe there was a lot of, and right now there's no art. Right now it's more entrepreneurial, starting, scientific, all that. But the art pops out every now and then. [00:30:07] Lindsey Dinneen: That's great. Yeah. So speaking of, what you're doing now, I was wondering if you could share a little bit about your company and maybe what you're excited about for its future as you continue along this path. [00:30:19] Dr. Shoreh Ershadi: Okay. That is, this is now where all the passion is. So everything that I have forced inside for all my life is now just coming out into Apoptosis. Apoptosis is a Greek word and it means "falling of the leaves." In science apoptosis, if you Google it, you'll see it means "programmed cell death." So in our bodies in creation or creator or whichever you wanna put it, and I'm sure being a medtech and all the audience, they know there are thousands of reactions inside the body are happening for me just to sit here and breathe and talk. There are thousands and thousands of enzymes and catalysts and metals and oh, whatever is going on. Programmed cell death or apoptosis is a main part of survival. So it's the future of antiaging because we all-- first of all that life expectancy is much longer now. Longevity is longer and younger people do not want to get old. So, at some point I would say my grandmother's generation and my mother is now 95 years old and she's, thank God, healthy and walking and all that, but even she does not want to get old. So, the image of being old and sick is combined together. But we can age without being sick, without getting Alzheimer's, without losing our memory, without getting all these different kinds of diseases. And one major problem is cancer that was much higher with older people and now the statistic is showing that cancer is happening in younger and younger generations. So what apoptosis does is that it's a program in the body. I did not make it. I wish I did, but it's happening all the time. And apoptosis is getting rid of cancer cells, getting rid of damaged cells, getting rid of neurons that cannot connect and synapses with other neurons to take the message over. So if we encourage apoptosis, then all the damaged cells are removed just like falling leaves. They're removed from the body and they're replaced with new energized healthy new cells. Every 10 years, our entire body is regenerated. So why do we get old? We should always stay at a 10 year age. So at 20 years old, we have recycled cells that even though we're growing, growth and youth is defined as between 20 to 25. From 25 to 30, it's sort of stable. There's a plateau. After 30, we start the aging process. So now, as 30 to 60, is still considered not so deep slip going down. It's sort of a plateau up to 60. And then after 60, 70, 80, 90, people are beginning to age. And it shows, I mean, with different diseases, with wrinkles, with memory loss, with all that. So what I'm doing, I'm using nature's product, plant based products, and this has been proven in science that these plants support apoptosis. So, as we get older, just like all the other reactions, apoptosis does not happen at its ultimate way that it should happen. But if we encourage it, for example, we have here, this one is brain beet. This is all beet roots, and it's an organic product. It's all plant based, but it releases nitric oxide. And it works the same way that Viagra works, but it opens all the arteries, it opens the circulation to the brain, to the heart, so why not use it? Why not promote apoptosis the way nature has programmed it in our body, just help it to work better. So that is all my passion right now. [00:35:28] Lindsey Dinneen: Excellent. Excellent. Well, I love that. Thank you for sharing a little bit about it. I'm excited for our listeners to go and learn more about it and, see how they can maybe also take part in the antiaging movement. [00:35:41] Dr. Shoreh Ershadi: Yes, they can partner with us and I would be thrilled. Actually, this is something that maybe I have learned during the long life experience, is that the more partners you have, the more friends you have, the more you share your knowledge, the better it is. Because at some point, it was like people wanted to keep everything to themselves and they didn't want to share or, but right now it's totally different. If they go to Apoptosis.us, they can go to the science section, they can read the papers. And if they would like to partner, I'll be thrilled to work with as many people as possible and take the message out. Yeah, this is a healthy message. This is something that we should all be talking about. [00:36:36] Lindsey Dinneen: Indeed, we should. Yes. Thank you. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach? [00:36:56] Dr. Shoreh Ershadi: Well, the million dollar would be great. [00:36:59] Lindsey Dinneen: Indeed. [00:37:00] Dr. Shoreh Ershadi: Yes. Yeah. Would we all want that. But yes, I think that right now, as I said, I would use the million dollars to talk about apoptosis all over because I see even young children, every time I see St. Jude's children, and thank you for your donation to Save the Children. I admire that. And I'm hoping that all the children in the world would have a good, healthy future. The world is crazy. You can look at it right now and see that, I can say my experience has been crazy. It doesn't get any better. It's always up and down. Things are happening all over everywhere in the world. And I would like to talk about health, talk about antiaging, talk about Apoptosis and educate more and more of the young people to learn and to avoid all the toxins that we are creating and we have created, with what we're doing with industry and go back to a plant based life, go back to nature, enjoy nature, go back to art, if possible, all the good things that we can do with our lives. [00:38:21] Lindsey Dinneen: Yes, absolutely. And then, how do you wish to be remembered after you leave this world? [00:38:29] Dr. Shoreh Ershadi: Oh, wow. That's a very difficult... a fighter? Survivor? Yep. Strong women? I would support women all the way. Now in Iran, they're saying, Woman Life Freedom. I'm sure you've heard about that. And I cannot tolerate, to see women covered all over with a window to see outside. To me, that is very disturbing. So I would like to see equal opportunity for women and I would like to maybe be remembered as a survivor. [00:39:14] Lindsey Dinneen: Yes, absolutely. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:39:24] Dr. Shoreh Ershadi: Oh, my granddaughter and my grandson. Yes, I have a five year old granddaughter. Her name is Julia and she is my sunshine. She is my life. The grandson is three months old. He's still too young, but he's getting there. [00:39:45] Lindsey Dinneen: Aw! [00:39:48] Dr. Shoreh Ershadi: Getting emotional. [00:39:51] Lindsey Dinneen: I'm so glad. It's that's beautiful. That's wonderful. [00:39:56] Dr. Shoreh Ershadi: Yes, that is continuation of the fight. That is when you see that what you've done is worth the fight, worth the hard work. [00:40:08] Lindsey Dinneen: Absolutely. Absolutely. Yes. Well, this has been amazing. I so appreciate you telling your story and sharing some of it that maybe you haven't done before, and that's I feel very honored. [00:40:23] Dr. Shoreh Ershadi: Yes. [00:40:24] Lindsey Dinneen: Thank you. Thank you for trusting me. [00:40:28] Dr. Shoreh Ershadi: Well, thank you for bringing all of this out. This has been sitting there suffocating, maybe. [00:40:36] Lindsey Dinneen: Yeah. [00:40:37] Dr. Shoreh Ershadi: Thank you. [00:40:38] Lindsey Dinneen: Absolutely. And we are so honored, you mentioned this, but to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world. [00:41:06] Dr. Shoreh Ershadi: Thank you so much, and thank you for having me, and thank you for making me tell the story. Thank you, Lindsey. [00:41:15] Lindsey Dinneen: Of course. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we'll catch you next time. [00:41:29] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this episode, Holly & Kristin talk with Deborah Shames about: Early career experiences that created the platform for Deborah's commitment to showing up confident and polished. It wasn't an easy road for Deborah either!  An amazing story of commitment and courage. Deborah's passion for helping others (and especially women) feel confident, prepared, and competent in their roles as executives, leaders and entrepreneurs. The secrets to being “memorable” when you present. The things women need to let go of to show up as confident, competent and authentic.  Key Takeaways When you need to address an audience or present a topic, always know your intention. Right before you present, review your intention for the meeting or presention, not the content. Never write out, read or memorize your content as this comes across as inauthentic Pick only three items that you want to cover in your content as this makes remembering content easier and doesn't overwhelm your audience with too many messages.   Deborah Shames, Prior to co-founding Eloqui with David Booth, Deborah was an award-winning film and television director. She founded the only female owned production company in the San Francisco Bay Area-- Focal Point Productions, which she ran for 15 years. Deborah directed luminaries including Wendie Malick, Rita Moreno, Danny Glover, and Angela Lansbury.   Deborah coaches female executives on presentation and communication skills. She preps authors, CEO's and executives before media tours, and works with celebrity and on-air talent at major television studios. Deborah is frequently engaged prior to national sales meetings or product launches as a keynote speaker or coach, and for leadership development training. Eloqui trains companies to deliver with style and passion. Their clients include CUNA Mutual, Amgen, Prolacta BioScience, OneAmerica, Northern Trust, Mattel, Samsung Chemical, and Hyundai Hata, as well as law, financial and insurance firms. Deborah enjoys coaching individuals to identify their strengths, utilize their authentic voice and drive business. Eloqui also serves non-profits, especially around fund raising. From the Pancreatic Cancer Action Network, Global GLOW, and the Arthritis Foundation to Ability First, Deborah trains the CEO and senior management teams as well as volunteers. Her latest non-profit client is THORN, founded by Demi Moore and Ashton Kutcher. Demi also calls on Deborah for coaching before her public appearances. Deborah received a “Consultant of the Year” award by the San Fernando Valley Business Journal. When not working, Deborah travels, does photography, hikes in the mountains, and makes jewelry. Deborah and her partner David wrote: Own the Room: Business Presentations that Persuade, Engage, and Get Results that was published by McGraw-Hill and is now it's in third printing. It is considered a business bestseller. And Deborah's latest book is for women professionals: Out Front: How Women can Become Engaging, Memorable and Fearless Speakers and was published by BenBella Books.   Connect with Deborah: Email:             dshames@eloqui.biz LinkedIn:        https://www.linkedin.com/in/deborahshames/ Website:         www.outfront.biz Twitter:          https://twitter.com/women_outfront Facebook:      https://www.facebook.com/womenoutfront   Guest Resource Links: Check out Eloqui's Services at: www.eloqui.biz Don't forget to sign up for their amazing weekly newsletter while you're on the website.  17 years and going strong! Books: Out Front: How Women Can Become Engaging, Memorable and Fearless Speakers Out Front: How Women Can Become Engaging, Memorable, and Fearless Speakers: Shames, Deborah: 9781941631676: Amazon.com: Books Own the Room: Business Presentations that Persuade, Engage, and Get Results   Own the Room: Business Presentations that Persuade, Engage, and Get Results: Booth, David, Shames, Deborah, Desberg, Peter: 9780071628594: Amazon.com: Books   UPLIFTING WOMEN HOSTS Kristin Strunk and Holly Teska Your co-hosts of the UPLIFTING WOMEN PODCAST, Holly Teska & Kristin Strunk, are women who UPLIFT other women at work and in the world.  Every other week they bring uplifting women guests to share their personal stories of challenge and triumph to inform and inspire their listeners.  The podcast also features guests who have played a significant role in honoring women and their place in the world by serving as promoters, sponsors, and coaches to the many women in their personal and professional lives. Join Holly and Kristin as they hear how their guests navigate the world of career aspirations, life, love, and family. Get advice from successful women who have figured out their own version of "secret sauce" to create the life they love. Holly believes the world needs the best leaders it can build; those who demonstrate integrity, empathy, humility, vision, positivity, and confidence. This type of leader brings out the best in others and delivers outstanding results. Holly feels we need everyone to perform at 100% to making our world a better place. Holly's experience in leadership, executive coaching, and talent development is the foundation of her career.  She has helped bright and motivated leaders become the very best versions of themselves. Through direct feedback, reflection, experimentation, and honest conversation, she will push you to excel at what you were called to do. Holly is especially committed to helping women navigate the choppy waters of today's fast-paced workplace and evolving world conditions but works with many different individuals and situations.  She welcomes inquiries for leadership and executive coaching and speaking engagements. Kristin's experiences have led her to the simple conclusion that leadership is simple - maybe not always easy, but simple.  Her work supporting leaders in finding their voices inspired her to find her own voice in the space of employee experience and leadership development.  She often hears the question that isn't being asked and is skilled at facilitating conversations and building relationships.  She has helped executives lead organizational transformations involving employee engagement, technology, and the new "Future of Work."  Follow her hashtag #responsibleleadership on social media to learn more about simple things leaders can do to build relationships and have a lasting positive impact. Website:         www.upliftingwomen.net Connect with Holly: LinkedIn:         https://www.linkedin.com/in/hollyteska Twitter:           https://twitter.com/HollyTeska Facebook:       https://www.facebook.com/holly.teska Instagram:      https://instagram.com/HollyTeska Personal Website:         www.hollyteska.com Email:              holly@upliftingwomen.net   Connect with Kristin: LinkedIn:         https://www.linkedin.com/in/kristin-strunk Twitter:           https://twitter.com/leadadvisor Facebook:       https://www.facebook.com/kristin.t.strunk Instagram:      https://instagram.com/ktuttlestrunk Personal Website:         https://regentleadershipgroup.com/ Email:              kristin@upliftingwomen.net  

In this episode:Scott Eaker describes the stringent screening process for breastmilk donors to become Prolacta donors. Prolacta’s testing and manufacturing practices provide the safest and highest quality nutritional products for neonatal care. Bio:Scott Eaker is the chief operations officer at Prolacta Bioscience, responsible for operations, quality, regulatory affairs, and supply chain. Prior to Prolacta, Eaker worked at Baxter Healthcare, overseeing the development and deployment of standardized quality systems across multiple biologic and medical device manufacturing facilities in the U.S. and Europe.

Kelli speaks with the CEO of Prolacta Bioscience, Scott Elster, about the process used by Prolacta and who the company serves. Scott speaks about the nutritional needs of NICU babies and explains where Prolacta obtains the milk it uses and how women can donate their milk.

Kelli speaks with the CEO of Prolacta Bioscience, Scott Elster, about the process used by Prolacta and who the company serves. Scott speaks about the nutritional needs of NICU babies and explains where Prolacta obtains the milk it uses and how women can donate their milk.

In this episode: How parents can avoid letting stress and anxiety take over and find their footing in the NICU. Advice for empowering yourself as a parent and becoming your baby’s advocate. How to embrace your feelings of guilt and inadequacy, for they are normal, but to let go of the expectations you one had for your pregnancy/baby. Guilt about fears of caring for a disabled child. This episode is sponsored by Prolacta Bioscience. 

In This Episode: Kelli’s overwhelming emotions upon meeting her micropreemie son Jackson for the first time. What is anticipatory grief and what does it mean for NICU parents? What emotions can parents expect when faced with a NICU experience/meeting their baby for the first time? The different ways in which grief and shame manifest themselves in NICU parents. How moms and dads process guilt/grief differently. This episode is sponsored by Prolacta Bioscience. 

In this episode: How parents can avoid letting stress and anxiety take over and find their footing in the NICU. Advice for empowering yourself as a parent and becoming your baby's advocate. How to embrace your feelings of guilt and inadequacy, for they are normal, but to let go of the expectations you one had for your pregnancy/baby. Guilt about fears of caring for a disabled child. This episode is sponsored by Prolacta Bioscience. 

In This Episode: Kelli's overwhelming emotions upon meeting her micropreemie son Jackson for the first time. What is anticipatory grief and what does it mean for NICU parents? What emotions can parents expect when faced with a NICU experience/meeting their baby for the first time? The different ways in which grief and shame manifest themselves in NICU parents. How moms and dads process guilt/grief differently. This episode is sponsored by Prolacta Bioscience. 

Host: Renée Simone Yolanda Allen, MD, MHSc., FACOG Babies born before 37 weeks gestation face many challenges in their first weeks of life. For premature babies to thrive in the NICU, the American Academy of Pediatrics recommends all preterm babies weighing less than 1500 grams be fed human milk. However, this recommendation creates a dilemma for mothers who are unable to supply their own breast milk and must therefore turn to donation programs to feed their babies. Dr. Renee Allen chats with Scott Elster, CEO of Prolacta Bioscience, about the goals of breast milk donor programs to improve health outcomes for critically ill preemies, while also reducing NICU costs.

Host: Renée Simone Yolanda Allen, MD, MHSc., FACOG Babies born before 37 weeks gestation face many challenges in their first weeks of life. For premature babies to thrive in the NICU, the American Academy of Pediatrics recommends all preterm babies weighing less than 1500 grams be fed human milk. However, this recommendation creates a dilemma for mothers who are unable to supply their own breast milk and must therefore turn to donation programs to feed their babies. Dr. Renee Allen chats with Scott Elster, CEO of Prolacta Bioscience, about the goals of breast milk donor programs to improve health outcomes for critically ill preemies, while also reducing NICU costs.

Dr. Martin Lee. Photo courtesy of Prolacta Bioscience. Episode 4 features Dr. Martin Lee, Vice President of Clinical Research and Development at Prolacta Bioscience. During this episode, Dr. Lee provides a comprehensive overview of a 100% or exclusive human milk diet in the prevention of NEC in extremely premature babies, those weighing less than 1250 grams (2 pounds 12 ounces) and who have the greatest risk for developing the disease. He discusses: * His transition from the blood industry to Prolacta, which developed of the world’s first human milk-based human milk fortifier * What constitutes a 100% or exclusive human milk diet * The clinical evidence showing a 70% reduction in NEC, an 8-fold reduction in surgical NEC, and a 4-fold reduction in mortality through the use of exclusive human milk diet * The importance of safety in the breast milk industry, including Prolacta’s rigorous product testing and donor safety profiles which parallel blood industry standards. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] STEPHANIE VAUGHAN, HOST: Welcome to Episode 4 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org. Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. Today, my guest will be Dr. Martin Lee, Vice President of Clinical Research and Development at Prolacta Bioscience, which “creates specialty formulations made from human milk for the nutritional needs of premature infants in neonatal intensive care units.” Last October (2014), while attending the annual Preemie Parent Summit in Phoenix, Arizona, I had the pleasure of meeting Prolacta’s Chief Executive Officer Scott Elster. During our conversation, I was invited on a tour of the company. A few weeks later, along with a group of representatives from various preemie organizations throughout the country, I flew out California to tour Prolacta’s human milk processing facility, and to learn more about the people and research behind the company. I was highly impressed by all aspects of Prolacta from the manufacturing plant itself to the rigorous testing their products undergo throughout their processing. Even more impressive to me is the fact that everyone that we met at Prolacta has a personal connection to prematurity. The CEO himself is the parent of twins born prematurely. And, I was shocked to learn that one of the key reasons the company was formed, and their products developed, was to reduce the incidence Necrotizing Enterocolitis. The company’s reason for existing is the prevention of NEC. And the research presented to us by Dr. Lee was stunning. So when we began producing this series, it was only fitting to invite Dr. Lee to share the benefits of an exclusive human milk diet to premature infants and the clinical research supporting its use. With that in mind, let me introduce my guest today. This is Dr. Martin Lee from Prolacta Bioscience. And I’m so glad you could be with me here today. How are you? MARTIN LEE, GUEST: Good. How are you doing Stephanie? STEPHANIE: Good, good. So in previous podcasts, we’ve talked to doctors that are attending neonatologists and researchers. So I would like to give you the opportunity to give a little bit of your background and how you got involved with research in NEC. DR. LEE: OK. Absolutely. Well, I spent probably most of my career doing clinical research with various types of pharmaceutical and biotech products. I started with a company you’ve probably heard of called Baxter approximately 35 years ago, and I spent a good number of years working with them. And how that’s relevant to our discussion today is I was working with their group that manufactures blood products, and obviously blood is a significant human fluid, has many of the same issues with regards to safety that we have with breast milk. And so I learned a lot about some of the testing that needs to be done, some of the safety factors that we need to consider. And then I would say about 15 years ago, I met someone who was talking about forming a company who basically wanted to bring breast milk and breast milk products to premature infants so that they would have the benefit of receiving 100% human milk diet, particularly the smallest of the small premature infants. So together we started the company Prolacta. And the whole idea of course in starting the company was to put it‚…I think the most important thing was to put it on a firm clinical scientific basis. And that meant doing really important well-designed clinical trials to evaluate the most important morbidities like NEC, in particular, and even mortality in premature infants, infants certainly that had a high risk of both of those consequences of prematurity. STEPHANIE: OK. Maybe not all of the people that will be listening fully understand…what is an exclusively human milk-based diet? Can you get into that a little bit? DR. LEE: Absolutely. So obviously we know‚…we meaning pretty much the world understands that the best thing a newborn baby can be fed is mother’s milk. And for term babies, that is obviously going to be sufficient. They’re born at the right time and usually at a sufficient weight and mother’s milk has all the good things in it that help the baby to grow, help their immune system to develop, help their organs to develop, importantly it helps their brain to grow at the right rate. But a premature baby by definition is born too soon. And we specialize‚…the work that we’ve done at Prolacta,…specializes in the infants that are born as much as 27 weeks or 12 weeks premature so 27 weeks since the time of gestation. When those babies are born, they have a lot of problems obviously because they’ve come out of the womb way too early. And one of the things that of course they are is way too small. The average baby that we’ve studied in our research trials is less than a thousand grams. That’s around two pounds. Now most people know that the average baby is 6-7-8 pounds. And so they’re born so small that what happens is that mother’s milk which of course comes in when the baby’s born‚…nature didn’t intend mother’s milk to be able to feed these type of babies. This is an unfortunate consequence of something that happened with the mother, something that‚…injury, genetics, whatever it is that would cause a baby to be born premature, the milk comes in, but it cannot feed that baby well enough. And what I mean by that is the baby needs to grow. He needs to grow a lot. The baby needs to have their immune system protected by the mom’s milk, and so on and so forth. So obviously we always talk about mother’s milk being the thing for a newborn baby. It’s not enough for these premature infants. So what they need is what we call a fortifier, something with a little extra kick to the baby. And there are fortifiers that have been on the market for a long time. They’re made by the formula companies. And naturally these fortifiers are made from cow’s milk. And cow’s milk is not the best thing for a premature infant. It may not be the best thing for babies in general, but besides the point, it’s certainly not the best thing for a premature infant. So when we’re talking about 100% or exclusive human milk diet, we’re talking about mom’s milk; we’re talking about a fortifier which is necessary for the baby to grow and to be protected from infection and so on and so forth. That comes from human milk. And what Prolacta did was develop the world’s first human-milk human milk fortifier. And in fact, it sounds like a mouthful because when we talk about human milk fortifier, general people realize or may not realize that that’s a cow’s milk-based fortifier. We make the one from human milk. So that’s what we mean by 100% diet. And then one other thing just to add to that, Stephanie, is sometimes mom’s milk doesn’t come in enough or the baby wants it or needs to eat more, get more milk, so then there’s donor milk involved too. And that’s another aspect of the 100% diet. And of course donor milk is coming from other moms, which again provides the additional nutrition that the baby needs. And there you have the entire spectrum of what we mean by 100% human milk diet. STEPHANIE: OK. Thank you. Yeah, I know that there’s probably a bit of confusion amongst parents new to the NICU that human milk fortifier is a fortifier put into human milk, and not necessarily made with human milk. So I know that that does tend to cause a little confusion. DR. LEE: Right. STEPHANIE: So thank you for clarifying that. DR. LEE: Sure. STEPHANIE: So I guess I’ll ask you to go into a little bit of the research because I find it fascinating. As you know, we were out to your facility in November and I thought that this is a fabulous company. I was not aware of it when our babies were in the NICU and I will just make a tiny note that I know you’ve got significant statistics showing the benefit of human milk and exclusive human milk. Unfortunately for Morgan, he fell in to that other small percentage that I did pump. But he developed NEC so rapidly at four days old being born at 28 weeks. At four days old he developed NEC and I don’t think he had two feedings. So there are babies that get it even when all attempts are made to have an exclusive human milk diet. DR. LEE: Sure. STEPHANIE: And I also know that my other son, Shaymus, his milk was fortified, and to be honest, I’m sure it probably wasn’t with an exclusive human milk fortifier. So just some things to sort of give everyone background. And again, that was, you know, four years ago, 2010-2011. DR. LEE: Sure. I hope…I assume they’re doing OK today, right? STEPHANIE: Yes, yes. Everybody’s doing very well today… DR. LEE: Excellent. Excellent. STEPHANIE: which I think is why I’m so personally‚…my personal opinion is that your products are wonderful and, you know, things being what they were then versus now, I would definitely advocate for 100% human milk diet and advocate for this if I was a parent in the NICU now. So I think it’s great to get this information out to people. DR. LEE: Sure. Absolutely. So your question concerned the type of studies we did. Well, as I said to begin our conversation, we recognized that the only way that people‚…the medical community, both neonatologists, nurses, lactation people‚…would appreciate and realize the importance of what 100% human milk diet does and helps as far as the baby is concerned is to do proper research. As I said earlier, my experience is in the pharmaceutical and biotech industries where doing formal randomized controlled all the kinds of bells and whistles that need to be done when you need to license a drug or a biologic for marketing in this country and other places in the world as well. That’s standard stuff. So when we set out to do these studies, we said what we’re doing here is just as important, just as the need for rigor has to be here as it would be in any other kind of situation where you’re testing a new medical intervention. And that’s what this is. So we decided right off the bat we would get together the best of the best as far as the neonatologists in this country are concerned, and we brought them together and we set up a protocol. And basically the protocol was based on a very simple premise. It is 100% human milk diet better than feeding a baby mom’s milk fortifying then with standard human milk fortifier and then if all else fails or at least maybe not be sufficient than using formula. That’s standard practice for premature infants in this country. It was in 2007 when we started this trial and to a large extent it still is today. So it’s 100% human milk diet standard of care which includes cow’s milk based fortifier and formula. Babies in this study were randomized which is‚…you know, it’s a fairly simple term, but just to make sure everybody understands what I mean by that, the decision when a parent agreed to have their baby be participating in the study which group they get into, the Prolacta or the 100% diet versus standard of care was essentially a coin flip, not literally of course, but that’s the basis. Now why do you do that? Because that’s the best way to design studies. It provides an unbiased approach to making the decision of treatment of nutritional treatment, taking it out of the hands of anybody and putting it in the hands of strictly chance. So you randomize babies. There was a sufficient number of babies in the first study we did. There was over 200 babies that were randomized and I think it was 12 centers around the country. And what we were looking for in this study was whether or not they develop NEC and that was the most significant endpoint of the study. There were other things that we looked at. We looked at how much parenteral nutrition they received. We looked at other things. We looked at sepsis. We looked at‚…which is essentially bacterial infection that circulates in the bloodstream. We looked at hospital days. We looked at days on a respirator/ventilator and so on and so forth. But the main endpoint in this study was Necrotizing Enterocolitis. Now, the babies, by the way, that we used in this study or the babies that constituted the population of the study were babies under 1250 grams (2 pounds 12 ounces) down to 500 grams (1 pound 1 ounce). Very simple reason for that. I think many of the people listening will know that there’s a classification of premature infancy called very low birth weight. And that’s babies under 1500 grams (3 pounds 4.91 ounces). But we said, you know, we want to get the babies that have the highest risk of NEC. So we didn’t use, if you will, the heaviest babies in that weight category because they have, it turns out, the lowest risk of NEC out of all very low birth weight babies. So we took away that 1250-gram group. We also didn’t go below 500 grams because unfortunately, babies born less than 500 grams which is really about a pound or less have unfortunately not a high chance of either succeeding in life really and survival or they have a lot of other problems that make it very difficult to evaluate then. So it was 500 to 1250. That’s basically, I think, the most important aspect. And like I said, they were randomized. We followed them for a period of 90 days, maximum 90 days. Babies could have gotten off the study earlier if they got on to mostly oral nutrition which of course hopefully babies all do because they start off with what’s called parenteral nutrition which means they get their feed essentially through intravenous feeding. They then transition off of that onto enteral feeding which is typically a tube that goes either through their nose or directly through their mouth into their stomach. And that’s called enteral feeding. And then they go to oral feeding. So babies who are on for 90 days or if they got to oral feeding sooner, then they were off the study. Very simply, just to summarize what constitutes a fairly complex study to manage, we found a magnificent reduction in Necrotizing Enterocolitis. The babies in the standard of care group had a NEC rate of about 16%. Or put simply, that one in every six babies develop NEC that got some sort of cow’s milk protein or cow’s milk diet. The babies who got 100% diet was less than 6%. That 16 to 6 is about 70% reduction, and that is phenomenal. We’ve had some of the really very famous neonatologists told us that they don’t see‚…you don’t see that kind of reduction with really any intervention that they’re used to seeing. You just don’t see that. You see incremental things. But now all of a sudden we cut NEC by 70% by doing this. And it even gets more impressive when you consider that the majority of babies or at least half the babies who develop NEC have to go on to have surgery. STEPHANIE: Right. DR. LEE: And that is a really serious consequence not only just from the fact that a premature infant has to go on to major surgery and they take out part of their digestive tract. But even worse, they have a reasonably high mortality rate. So in this study, the rate of NEC surgery of all those babies that were in the two groups, it was at 11% in the standard of care arm and only just over 1% in the Prolacta arm. We reduced the rate of NEC surgery by eight fold, I mean just an incredible difference. Virtually wiped out NEC surgery in this study. STEPHANIE: That’s amazing. DR. LEE: Yeah. I mean, we expected to see something really good. We didn’t expect‚…I guess you could say well we should have expected‚…but it was beyond our expectations, wildest dreams to show this kind of effect. Now a lot of people have looked at this data and said well that’s interesting, and maybe that’s real. But can you‚…you know, can you do it again? And the answer is yeah. We did it again because that first study that I just described, these were only babies who were getting‚… which are most babies‚… who were getting some breast milk from their mom. But there are a small cohort of‚… I don’t know quite what the percentage is in this country, but there’s a percentage of babies who don’t get any breast milk. There’s various reasons. Mom is sick. Mom’s not available. So on and so forth. So we also did a second study in which we only treated babies or fed babies who had to get their nutrition either one of two ways. Since breast milk wasn’t available, they got formula. Soon as they were able to get enteral feeding, in other words the tube feeding, they got formula. That’s one group. The 100% arm, same thing, except here, instead of getting mom’s milk, they got donor milk, and then they got the fortified. So it was a real stark comparison. Only human milk, only formula. And it was a very small study. It was only‚…that first study, I don’t know if I mentioned or made clear, that was a 200-baby study. Pretty big study. STEPHANIE: Yes. Um-hmm. DR LEE: This study was only 53 babies partly because it was very, very hard to find these babies. I mean, we would sign up a mom, they would agree to put their baby on, and then they realized gee, I really want to feed my baby. I really want to give them breast milk. And of course, that’s fine. That’s great. STEPHANIE: Right, right. DR LEE: But they can’t participate in the study. STEPHANIE: Right. DR LEE: So we had a hard time finding. But we eventually did it. Took us three years to find 53 babies, but we did, and you know what? We found the same significant difference, particularly in the surgical NEC. There were‚…in the control arm, there were 24 babies, and four of them had to go on to surgery for NEC. That’s one in six. So about 16%. In the Prolacta arm, in the 100% milk arm, nothing, no surgeries, nothing. One case in NEC overall, but no surgery. So that turned out to be wow. That’s the kicker. Two separate studies, two different classes of babies, breast milk, no breast milk, doesn’t matter. When you give a baby that’s born premature like this, this weight category, less than 1250 grams, and you feed them with only human milk, they’re going to do better. And it even turns out when you start putting all the data together an extra‚…I hate to call it a bonus‚…but an extra important key outcome was that mortality was reduced. Mortality fortunately in this baby population is pretty low. It’s about 8% overall because of the prematurity, of course. We reduced that to 2%. So a four-fold reduction in mortality. So now when you put it all together, what do you have? You have prevention of the major morbidity‚…that is NEC‚…of prematurity, and you prevent mortality. And how can you really ask for anything more from a nutritional approach to these really fragile infants. STEPHANIE: Right. Right. No, I totally agree. And as I said before, my personal opinion, you know, as the mother of a surgical NEC survivor, I would advocate for this if we had to do it again. It’s definitely phenomenal. DR. LEE: Yeah, it’s almost this kind of effect you would expect to see if this was a pharmaceutical breakthrough or some new wonder drug or some sort of biotechnologically-produced intervention. But all it is is feeding the babies properly. I mean it’s such a fundamentally sound, logical‚…this is what nature wanted these babies to get. STEPHANIE: Right, right. DR. LEE: Babies should get human milk, nothing else. STEPHANIE: Now you had mentioned previously the difference between donor milk and then your human milk nutritional products. Can you‚…when I hear conversations, I sort of always think it’s like comparing apples and oranges. You know, it’s almost two different things. So can you clarify what the difference is with donor milk and your products? DR. LEE: Well, again, I’m sorry to be maybe not entirely clear. We make a donor milk product. Essentially, all our products are made from donor milk, both the fortifier, of course, and we make a simple donor milk product that is formulated to have 20 calories per ounce which is what doctors and nurses and dieticians believe they’re giving the baby when they feed the baby either mom’s milk or milk from another person. So donor milk is essentially the equivalent of mom’s milk other than the fact, of course, it comes from another mom. But however‚…and in fact, the American Academy of Pediatrics has said the best thing for a baby is mom’s milk. But if mom’s milk is not available, then donor milk is good. STEPHANIE: Right. DR. LEE: But the problem, of course, and one of the I guess you could say‚…I’m trying to think of the right word. Bad things that people associate with donor milk is well it comes from somebody else, and how do I know that person is the right person to provide milk for my baby? And that’s one of the key things that we had at the center of what we did at Prolacta from the beginning, which was to have a safety profile that was beyond reproach. I mean, we do things as far as testing the moms, testing the milk, that nobody else who ever handles breast milk does pure and simple. I’ll give you some examples. One of the things that I thought of very early on is because, again, remember I told you I came from the blood industry and they test blood and they test donors obviously every which way you can think of. But there’s one additional problem that donors who provide milk have in a sense that blood donors don’t. When you take blood from a donor, you’re seeing the person and it’s blood coming out of their vein and it’s coming right into a bag and you know whose it is. But a milk donor, she donates at home, pumps at home, puts it into containers, and then sends it wherever the donor, the milk bank, might be. In our case, it’s here at Prolacta. They’ll send it to us, and here’s the problem. How do we know it’s that person’s milk? STEPHANIE: Right. DR. LEE: How do we know it’s the person who we screened and did all the blood testing on to start with, that it’s her milk. So we do something very, very unique. We actually have the mom provide a DNA sample, they do a little cheek swab, they put a little stick essentially in there, and scrape off a little tissue from inside their cheek, send it to us so we have a profile. Now she sends us her milk, and when she sends us her milk, we can actually match it up. And now we know it’s that safe mom’s milk, all right? Now you might ask what’s the point? I mean what self-respecting individual is going to send somebody else’s milk to you? And the answer is nobody, for the most part I can say almost universally, will do that intentionally. But there are mistakes. I mean one of the things we’ve seen is moms that are lactating, sometimes there’s a couple of women in a neighborhood, and they’re all doing the same thing. And somebody’s freezer will become full with milk, and they’ll say to their neighbor, “Can I put my milk in your freezer?” And they said, “Sure, no problem.” And she’s got her own milk in there. And then they go to ship milk and lo and behold, there’s somebody else’s in there. We love that‚…we love the moms, but we have to be sure that every mom that donates is a mom that’s free of all of the nasty things that could be in blood because those things could be in milk as well like AIDS and hepatitis and syphilis and all those kinds of things that we should be concerned about. Even as an adult you certainly want to get blood from someone like that. You certainly don’t want to give that to this fragile premature infant. STEPHANIE: Right, right. DR. LEE: So going back to your original question about what we do versus donor milk, that’s all one in the same, I think you could safely say. Everything is based on the concept of donors and the milk that they provide and the safety of that milk supply being tested from any way you can think of so that every product that’s made from human milk is as safe as possible based on all of the different protocols that are used. And that includes other things besides DNA testing. It includes drug testing; it includes testing for whether the mom smokes because they may tell you they don’t smoke, but we’ve seen that instance where there’s byproducts of nicotine in the milk, and that’s not good for a baby. So we do that kind of testing. It’s just a laundry list of things to make that as safe as possible. STEPHANIE: Right. And I guess‚…I’m sorry‚…I guess to clarify my original question, I was speaking specifically about your fortifiers versus human milk. If you could explain a little bit the difference of that‚…I mean this was a very good‚…I can’t think of the word‚…a very good deviation, but yeah. When I was saying apples and oranges, I meant donor milk versus fortifier. DR. LEE: OK. I’m sorry. STEPHANIE: No, that’s OK. DR. LEE: The fortifier essentially‚…if you want to keep it very simple, the fortifier is just very concentrated milk. STEPHANIE: OK. DR. LEE: So essentially, what you do to make the fortifier is you take milk, you filter it to get rid of a lot of the fluid so that you concentrate the protein, you concentrate some of the other important nutrients in there. And that way the baby can get extra, like we say, protein, extra other nutrients in a very, very small volume. So for example, in our typical fortifier which we call Prolact +4, if you add that to mother’s milk in a ratio 80% mother’s milk to 20% fortifier, assuming mother’s milk is about 20 calories per ounce, you’re going to add 4 additional calories for that baby in that small volume which is a lot. So then we can actually do even more than that. We can do a +6, six calories, we can do +8 and even +10. That kind of product is for the babies that are the most fluid restricted. They can get 30 calories per ounce in the same volume that milk that originally was 20 calories per ounce was. So that’s really important for those babies, for example, that have heart defects who can’t take in a lot of fluid or babies for whatever reason are fluid restricted. STEPHANIE: OK. Thank you. DR. LEE: Sure. STEPHANIE: Yeah, that was‚… I think it’s important for parents and family members that might be in the NICU to be able to have a conversation with their doctor and fully understand what’s being given to their baby and be able to ask the right questions. So would there be anything else that you would want to add if you were talking to a parent who’s got a baby in the NICU right now for them to be able to advocate best practices for their baby? DR. LEE: I think that the simple issue for a parent under these circumstances is to ask the doctor based on all of the evidence that’s out there, clinical evidence,…and that’s how doctors make decisions. We talk about evidence-based medicine. This is based on the best evidence that the doctor is aware of, what’s the best way to feed my baby? And having said that, you know, the evidence that we’ve discussed here today is for those smallest of the small. For a larger baby, this is not necessarily‚…it’s not that it’s wrong. It may not be necessary, but when you’re dealing with the smallest babies and the ones that are struggling to survive and grow and thrive and get to where you want all babies to get to, to childhood and so on, then you have to ask the doctor the question what is the best way that our baby can get out of that NICU, that Neonatal Intensive Care Unit, and get home and be with his or her parents. That’s really, I think, the fundamental question. And the doctors should be able to answer that question based on the evidence that exists for the diet that the baby should be fed. STEPHANIE: Right. Thank you. Yeah, I think this is a really great conversation for any parent in the NICU, especially those, like you said, the smallest that are at the highest risk for developing NEC and as you said, other issues as well. And it’s‚…it can only be a benefit in my opinion. DR. LEE: Absolutely. And just to add to that, they should also ask the question‚…because there are other sources of nutrition, and there are other places from which milk can be attained we know about, for instance, women sharing milk on the Internet, milk sharing sites. You’ve got to be extremely careful. You’ve got to ask the question not only what’s best for my baby from the point of view of effectiveness, but also what’s the safest for my baby. And you want to be sure that the source, where that milk is coming from, where those products are coming from, comes from a place where you can say everything possible based on modern technology has been done to protect that milk, protect the safety of that milk. And I think that’s really critical. I think there was a story the other day‚…I forget which show, where it came up in one newspaper or another‚…about‚…oh, I know what it was. It was an article that was published that basically looked at milk samples. They actually collected milk on one of these sharing sites, and they found a large percentage of them had nicotine in the milk, had other things, other bad things that you don’t want a baby to have in that milk. So you’ve really got to ask that question what’s the best? What’s the safest for my baby as well? STEPHANIE: Right. Right. And Prolacta has provided us some material, some reference materials for sharing. So I will say that we’re going to be posting those on our website and will have them in the show notes as well. And I really appreciate you taking the time to talk to me today. If there’s anything else at all that you would like to add, please feel free. DR. LEE: Well, I just want to thank you for the opportunity to let obviously the parents out there know that we’re here for one very, very simple reason. I mean I know it may sound kind of corny, but we said from the day we opened the doors at Prolacta that we’re here to save babies, and I think we’ve done our job in that regard. And we’ve proven that that’s the case. So I’m really‚…I’ve worked, as you heard me say, for 35 years doing clinical and medical research, and I’m very, very proud to say that this is, I think, my best story to tell out of all that long career. STEPHANIE: Right. And as I said, I was out in the facility, took the tour in November, and we were very impressed with your company. And like I said, if I had to do it all over again, I would certainly be asking these questions and in my opinion, I think this is a phenomenal company. And your rigor in testing and your facility are top notch. So thank you. LEE: Well, thank you. Thank you. I really appreciate that, and it means an awful lot to me and to obviously everybody that works at Prolacta. STEPHANIE: Right. So thank you for joining us. And hopefully we’ll talk again soon. LEE: Alright. Thanks so much, Steph. STEPHANIE: In closing, I’d like to share a few thoughts about today’s conversation with Dr. Lee. Recently, I’ve seen a lot written about the use of donor milk, human milk products, and the emerging breast milk industry. Often times, the opinions expressed about Prolacta are solely related to cost: the expensive of Prolacta’s products versus those coming from nonprofit donor milk banks. In my opinion, the cost of using Prolacta’s human milk-based human milk fortifier far outweighs the potential risks of not using it, and any discussion about cost needs to be framed within the context of total cost of care. As Dr. Lee mentioned, Prolacta’s human milk-based nutritional products are intended for extremely premature infants who weigh less than 1250 grams (2 pounds 12 ounces) at birth. My son Morgan weighed 2 pounds 5.5 ounces at birth; my son Shaymus weighed 2 pounds 7 ounces. Prolacta openly shares that the typical cost of using their human milk-based human milk fortifier for these babies is $10,000. That, however, is only a fraction of Morgan’s and Shaymus’ total cost of care. Each of whose exceeded $1 million. In actual numbers, the cost of an exclusive human milk diet using Prolacta’s human milk-based human milk fortifier would have been less than one percent of Morgan’s total cost of care, and less than one percent of Shaymus’ total cost of care. And while Morgan’s case shows that no current preventative strategy for NEC is 100% effective, research shows that access to, and the use of, an exclusive human milk diet significantly reduces the risk of NEC in the majority of extremely premature infants. Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org. If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you! Additional resources: Prolacta Bioscience, Inc. What Is Necrotizing Enterocolitis? N.p.: Prolacta Bioscience, 2015. Print. Prolacta Bioscience, Inc. 100% Human Milk: The Best Nutrition. N.p.: Prolacta Bioscience, 2014. Print. Prolacta Bioscience, Inc. Nutrition for Premature Babies. N.p.: Prolacta Bioscience, 2014. Print. Prolacta Bioscience. Premature Babies: What to Expect. N.p.: Prolacta Bioscience, 2014. Print. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.