POPULARITY
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.A court has halted the Trump administration's plans to reduce and lay off employees in government agencies, citing a lack of authority. Meanwhile, a report called "Make American Healthy Again" criticizes pharmaceutical lobbying, GLP-1s, and vaccines. The report also addresses rising autism rates and over-medication of children. Bio-Rad is redefining antibody discovery with their Pioneer Antibody Discovery Platform.In other news, Merus' bispecific shows promise in head-and-neck cancer, while Congress narrowly passes a tax bill with changes to IRA penalties and negotiation exemptions for orphan drugs. The FDA vaccine advisors agree on a COVID-19 vaccine as a new framework looms, and GSK wins expansion for Nucala after an FDA delay. Lilly expresses concern as CMS leaves obesity drugs out of Medicare coverage, and Sanofi acquires Vigil for $470 million upfront. And that's all for today's updates in the pharmaceutical and biotech world. Stay tuned for more essential news in our next episode.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Moderna has withdrawn its application for a combination flu and COVID-19 vaccine after discussions with the FDA. The vaccine had shown efficacy in eliciting antibodies, but the company decided to pull the application. In the biotech market, executives from NextGen companies discussed strategies for surviving in what they described as a "moribund" market during a webinar. Biospace's nextgen companies are thriving in a challenging biotech market. Executives discuss survival strategies in the webinar "Are We There Yet?" Pfizer's $6 billion China deal stands out in a competitive market, with Novartis' $4 billion partnership following closely. Biopharma companies are facing pressure to cut assets early due to rising development costs and regulatory hurdles. Lotte Biologics offers specialized end-to-end services at its ADC facility in Syracuse, NY. Other top stories include the FDA's new risk-based approach to COVID-19 vaccines, Genentech's investment in Orionis, and Bio-Rad's new center for excellence for biotherapeutic antibody discovery. Roche's Genentech recently did not win adcomm backing for an expansion. Pfizer has made a deal in China, and RFK claims ignorance about HHS research cuts during a hearing. The top 5 most active corporate VCs in pharma are also highlighted. Additionally, upcoming events and job opportunities in the biotech industry are featured.In conclusion, the biotech market is presenting challenges for companies, but there are opportunities for growth and strategic partnerships. Stay tuned for more updates on regulatory changes, investment deals, and industry trends in the world of Pharma and Biotech. Thank you for listening to Pharma and Biotech daily.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a $6 billion bet on acquiring 3SBio's PD-1/VEGF antibody, despite being a late entrant to the space. This deal comes after Pfizer's partnership with Summit Therapeutics, causing some confusion about the pharma company's overall strategy. Meanwhile, the success of a CRISPR baby has highlighted the lack of FDA-approved treatments for the 15 million children with rare diseases. Most rare conditions do not even have a treatment pipeline. Bio-Rad is redefining antibody discovery through their Pioneer™ Antibody Discovery Platform, which accelerates programs and identifies clinical-quality candidates with industry-leading timelines. FDA Commissioner Marty Makary has expressed support for psychedelic therapies for neuropsychiatric conditions, noting significant benefits for patients. The most favored nation executive order issued by Trump may face legal challenges and unintended consequences for the healthcare sector and patient access. Overall, these developments in the pharmaceutical and biotech industries highlight ongoing challenges and opportunities in drug development and treatment for rare diseases.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron has acquired ownership of 23andme for $256 million, promising to comply with consumer privacy policies. Makary's proposed rare disease pathway has sparked hope but raised questions among experts. At the American Society of Gene and Cell Therapy meeting, the first personalized in vivo CRISPR therapy was reported. The FDA has cleared the first Alzheimer's blood test, potentially boosting uptake of Alzheimer's disease therapies. Bio-Rad's new Center for Excellence is redefining antibody discovery with their Pioneer Antibody Discovery Platform. FDA regulations are unlikely to save money for the industry, and Applied Therapeutics' rare disease treatment has failed in late-stage trials. The memory gap in forgotten diseases is making a dangerous comeback, and Novo CEO's sudden exit has raised concerns among analysts.FDA Commissioner Marty Makary's proposal for a 'conditional approval' pathway for rare diseases has sparked hope among biopharma companies, but experts are raising concerns about safety, access, and liability due to a lack of details. The FDA and NIH are accelerating the shift away from animal research, which has raised questions about safety and implementation. Meanwhile, FDA cuts have led to chaos in planning for upcoming advisory committee meetings. The Trump administration's efforts to slash regulations may not necessarily benefit the industry as anticipated. Sarepta is seeking to strengthen its case for Elevidys with data in older kids, while other companies such as Incyte and Lilly are making progress with their drug approvals. Overall, the biopharma industry is facing challenges and uncertainties in navigating the evolving regulatory landscape.
Retinal neurons derived from human stem cells are a promising source of replacement cells for regenerating damaged or diseased retinas. As scientists progress toward translation of cell therapies for restoring vision, they encounter challenges, including how to deliver the cells, ensure that they integrate appropriately with host tissue, and enable proper function after transplantation. In this episode, Iris Kulbatski from The Scientist spoke with Deepak Lamba, a distinguished scientist in the department of immunology and regenerative medicine at Genentech and an associate adjunct professor at the University of California, San Francisco, to learn more about how advances in cell culture models and associated technologies help researchers progress towards retinal cell therapy. The Scientist Speaks is a podcast produced by The Scientist's Creative Services Team. Our podcast is by scientists and for scientists. Once a month, we bring you the stories behind news-worthy molecular biology research. This month's episode is sponsored by Bio-Rad.
Join Michelle Martin on her tour of markets! Hosted by Michelle Martin with guest Willie Keng, author of Dividend Titan finance blog; both discuss OCBC's and UOB's share buybacks, and why DBS is absent from the list. Explore the changes in the S&P 500 as Palantir, Dell, and Erie Indemnity make their debut while American Airlines, Etsy, and Bio-Rad exit. Plus, a deep dive into the market impact of meme stocks like GameStop, and key local performers such as Food Empire and 99 Speed Mart's IPO.See omnystudio.com/listener for privacy information.
Biotherapeutics are transforming healthcare for over 350 million patients globally, tackling everything from cancer and diabetes to rare diseases. Human embryonic kidney (HEK) 293 cells play a key role in the manufacturing of many of these life-changing products. However, they are not without their challenges. In this episode of The Top Line, sponsored by Bio-Rad, Dipika Gurnani, Global Product Manager at Digital Biology Group, discusses the critical need to accurately quantify HEK293 DNA in biotherapeutics to ensure patient safety and regulatory compliance. Gurnani highlights the risks of residual DNA integrating into a patient's genome, potentially causing cancer or genetic abnormalities. She also addresses the limitations of traditional quantification methods like qPCR, which can be time-consuming and prone to errors. We also look at some key innovations in the field, such as Bio-Rad's Vericheck ddPCR HEK293 Residual DNA Quantification Kit that can minimize false positives by specifically targeting HEK293 DNA. For deeper insights into these challenges and innovations, listen to the full episode.See omnystudio.com/listener for privacy information.
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.
Dr. Harold Han is Chief Science Officer and co-founder of Vertosa, and the pioneer in water compatible cannabinoid ingredients for infused products. Harold designed the industrial leading cannabis emulsions that are widely applied in the cannabis beverage brands. Harold holds 16 patents in emulsion applications, and prior to founding Vertosa, he led a team that developed the emulsification oil for Bio Rad's Digital Droplet PCR system. Harold also publishes a regular series explaining the science of cannabis for product makers under the monicker "The Happy Chemist" — a nickname you'll understand after you watch the interview. One of his recent articles describes the different factors that contribute to cannabis beverage potency loss, which is a challenge for beverage brands. In fact, in regulated markets it's common to see a 10-15% variation in potency compared to the label claim. In unregulated hemp-derived beverages, it can be even higher. During the conversation we discuss The difference between cannabis beverages and alcoholic beverages What happens when cannabinoids oxidize How to put THC into water-based products using physical and chemical processes How every aspect of the supply chain can lead to potency loss in cannabis beverages Which beverage ingredients hasten potency loss How packaging conditions can affect scalping and oxidation rates Thanks to This Episode's Sponsor: Vertosa Vertosa creates industry-leading active ingredients for infused product makers. Their patent-pending nano- and micro-emulsions are carefully designed for the specific needs of each customer, and their pre-suspended aqueous solutions empower them to create incredibly homogenous and stable products while maximizing bioavailability, clarity, and taste. Learn more at Vertosa.com Additional Resources Happy Chemist Article Series The Cannabis Beverage Manufacturing Handbook Review the Podcast CannMed Archive
Lauren Drouin is the director of analytical development and the Genomic Medicine Unit at Alexion AstraZeneca Rare Disease. As a dynamic scientist with unique expertise in current research and industry trends for gene therapies, Drouin is passionate about driving progress within the rare disease field and advancing products from preclinical development into the clinic and beyond. In this Science Philosophy in a Flash podcast episode brought to you by Bio-Rad, The Scientist's Creative Services Team spoke with Drouin to learn more about her interest in adeno-associated virus (AAV) biology, and what motivated her journey from academia to patient-focused analytical development research. Science Philosophy in a Flash is a series of mini podcasts produced by The Scientist's Creative Services Team. With a focus on the people behind the science, this podcast highlights researchers' unique outlook on what motivates their pursuit of science and what it means to be a scientist. This episode is brought to you by Bio-Rad.
Dr. Renee Brissette from Bio-Rad answers questions from a recent webinar highlighting Bio-Rad's bioanalytical services.
All of us in the life sciences are in the business of making the world healthier. The instruments and reagents we sell and the technologies and therapies that result save lives. A scientist (after a lot of research) will look at a disease or problem and say, “I think I can find a way to fix that.”Can we, as an industry, look at trade shows like a scientist would, and ask, “How can we do this better and stick to our mission of making the world at least less sick if not healthier?”If you've been with me for a while, you know I have a love-hate relationship with trade shows. When I was a MarCom director, events were by far the biggest part of my budget. I imagined all the other awesome campaigns I could execute with that money. And then there is the waste. The stuff that ends up in the hotel trash before you get back on the plane and the shipping of huge amounts of equipment all over the world.On the other hand, if a lot of customers are going to be in one place at the same time… it makes sense to take your offering to them. And human connection is important. I know it's important because this episode came out of my trip to ADLM, the event formerly known as AACC.Stuart Warrington is the CEO of Envoke. They create virtual demos to make your instruments accessible at more events and present a consistent story across the customer journey. More on that below.Stuart is a filmmaker. He has been created videos for the likes of Thermo and Bio-Rad. Videos used to have a longer useful lifespan. Then his customers wanted new content at a faster pace that was more engaging. Stuart suggested video games. “No. That's not it.”“How about a virtual demo?“Yes!” It turns out those are basically the same thing just packaged differently. (They are both virtual experiences that tell a story with the user as the hero.) Stories are the key here. (The crowd cheers.)People need to tell their own story, right? And sales and training and all that is about that. It's like, how can I communicate the message of what this thing does in the most accurate possible way? And you need to give people freedom to craft that story. And that's why we do things the way we do them.We make this story block library and it's loads of little clips. And in each clip tells its own individual message. And then your user, your sales rep, your engineer, your trainer can take from that library and craft this story. It might be about a really specific bit of qPCR on the qPCR devices in the platform. And you know your customer only really cares about that. So we give you the opportunity to just pull those bits in and tell a story that is about your product with your product rather than PowerPoint presentations and brochures and videos and things like that. It just takes that to a slightly higher level and it also then starts saving you loads of money on shipping. Right?The result is that consistent experience for the user from the web to sales to training to maintenance and service. We talked about training people the same way pilots train. On a simulation. They can make mistakes without breaking an expensive piece of kit.Not subscribed yet? It would mean a lot to me.Thanks for spending some time here, either way.In addition to the contribution to sustainability without shipping products, the ability to customize a story improves the sales process. So one of our customers built a storyline for the event from the story block library. So they built something that was like, this is what we want to talk about. This is the story we're telling here. But then what it also did was they put on a QR code, so that you scan the QR code as your customer, and what you do is, you walk away with a different storyline that's specific for you, that's just about the thing that you were talking to him about.It's all come from the same place, we've just pitched it slightly differently. So it's all come from that story block library, we've just created specific storylines for different environments. And one of those environments is, “I need something a little bit better to take away and show to my boss.” And they take, they scan the QR code, they get their demo, and it's just for them, it's tailored for them, and they walk away and they show their boss, and it's a path to sales, right?This sounds better than walking away with a PDF or printed literature that the boss has no interest in reading.What is the path to this magical virtual future? For now, Stuart thinks companies will continue to send at least some products to events. The change comes from the bottom up where they no longer send instruments to smaller shows or remote locations. At some point, customers and salespeople see the benefit of this approach and hopefully, we all get more creative about how to use our space at larger events. Instead of bringing one instrument or a few, companies could present their entire catalog or larger configured solutions.This is only one way that we can improve the trade show experience and get a better return on investment. In an upcoming episode, we talk a little bit about the interactions that happen in the booth and how they can be improved as well. Your deepest insights are your best branding. I'd love to help you share them. Chat with me about custom content for your life science brand. Or visit my website.Intro Music stefsax / CC BY 2.5 This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com
This is the latest episode of the free DDW narrated podcast, “Important therapies for the future of immunotherapy", which covers two articles written for Volume 23, Issue 3 – Summer 2022 of DDW. They are called “Improving quality control for CAR T cell therapies”, and “The importance of LAG-3 to the future of immunotherapy”. The first article includes insight from Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. The second article is an interview between Lu Rahman and Frederic Triebel, CSO, Immutep, who also discovered LAG-3.
David Cristofaro founded Actionable Research in 2001 with the goal of developing marketing research solutions custom-tailored to the unique requirements of clients. His natural passion for discovering the attitudes and emotions behind the opinions and behaviors of the people around him is a perfect fit for marketing research, a field that allows David to think about the things he enjoys thinking about most. David has performed, designed and/or coached well over 375 primary research projects over the last 22 years, for companies including Johnson and Johnson, 3M Healthcare, Align Technology, Bio-Rad, NVIDIA, and many others. During his time off, David actively explores his passion for music – be it writing or performing on drums. His band, The Rewinders, recently released their third album, The Rewinders 3, which can be found on Spotify. David's other interests include hot yoga, wake surfing, spending time with his 6 children and keeping up with the latest trends in the healthcare and technology marketplaces. David holds a degree in Chemical Engineering from the University of California, Los Angeles. -- Critical Mass Business Talk Show is Orange County, CA's longest-running business talk show, focused on offering value and insight to middle-market business leaders in the OC and beyond. Hosted by Ric Franzi, business partner at Renaissance Executive Forums Orange County. Learn more about Ric at www.ricfranzi.com. Catch up on past Critical Mass Business Talk Show interviews... YouTube: https://lnkd.in/gHKT2gmF LinkedIn: https://lnkd.in/g2PzRhjQ Podbean: https://lnkd.in/eWpNVRi Apple Podcasts: https://lnkd.in/gRd_863w Spotify: https://lnkd.in/gruexU6m #orangecountyca #mastermind #ceopeergroups #peergroups #peerlearning
The A Better HR Business podcast looks at how consultants and tech firms in the broad Human Resources field grow their businesses; and how they help employers get the best out of their people. Today we're joined on the show by Terrell Holmes, Founder of The Good Org, a coaching business that helps executives and teams in industry-leading tech organizations and start-ups weather the storms that come with rapid growth and major change. To do this, Terrell leverages his 15 years of working directly in the tech and marketing industries; facilitating programs for Stanford Graduate School of Business (GSB); and working with companies like Apple, Bio-Rad, and Kongregate Games. Terrell is an organization development consultant who champions insight and communication as catalysts for change. Over 15 years in Marketing Technology, Terrell identified recurring issues in communication and relationship management, leading to the establishment of The Good Org, LLC to tackle these challenges head-on. By employing cutting-edge evidence-based practices, Terrell strives for tangible real-world impact. Clients such as Apple, The City of Berkeley, eBay, Kaiser Permanente, Kongregate, and The State of California have benefitted from his expertise in leadership development, group dynamics, change management, and behavior. To further his vision of transforming the American work landscape, Terrell engages in various professional pursuits. These include serving as a Peacebuilding Consultant, an Adjunct Professor of Organization Development at the University of San Francisco's Masagung Graduate School of Management, and an Interpersonal Dynamics Group Facilitator at Stanford's Graduate School of Business. With 16 years of experience in advertising and marketing technology, Terrell possesses a unique understanding of the intricate complexities faced by rapidly-evolving organizations. He holds a Master of Science in Organization Development (MSOD) from the University of San Francisco, complemented by a Bachelor of Arts in interdisciplinary studies from Virginia Tech. The Good Org offers the right solutions for individuals and companies seeking transformation. Their team of experienced coaches, trainers, and Organization Development practitioners can assist in assessing organizational goals and designing customized interventions to ensure their achievement. The Good Org provides a range of services, including Power Sessions, 1:1 Leadership Development Coaching Package, and OD Consulting Services, all aimed at propelling employees and organizations to new heights. With their expertise and tailored approach, The Good Org empowers clients to unlock their full potential and drive meaningful change within their organizations. In a wide-ranging discussion, Terrell and I talked about: ☑️ Workplace situations and challenges that The Good Org helps business leaders to solve. ☑️ How does Terrell's coaching approach differ from traditional transformational leadership strategies in the tech industry? ☑️ The advantages of combining executive coaching with org development consulting work. ☑️ And much more. Thanks, Terrell! Visit The Good Org now. For the video version, show notes and to see details of my previous guests, check out the podcast page here: www.GetMoreHRClients.com/Podcast WANT MORE CUSTOMERS OR CLIENTS? Want more clients for your HR-related consultancy or HR Tech business? Check out: www.GetMoreHRClients.com/Services. WANT TO START AN HR BUSINESS? Want to launch your own consulting business in the broad Human Resources sector? Check out: www.GetMoreHRClients.com/Start for resources.
Jeremy Agresti has spent his career developing tools to drastically change the pace of biology with massive-throughput measurements using microfluidics. His seminal contributions as pioneer of miniaturizing biology with microfluidics have resulted in a large number of publications and patents, which have been cited more than 9,000 times, and form the foundation of several companies in the space. His work has allowed Amyris to bring their biofuels and chemicals to market faster, and for companies like Bio-Rad, Illumina and 10x Genomics to bring new single-cell genomics tools and clinical diagnostic tests to market. Jeremy is a co-founder and advisor to Slingshot Biosciences and founder and CTO Triplebar, where he leads a team of scientists and engineers to leverage the power of evolution to bring new biology-produced products to the world and build a sustainable future for the planet. --- Support this podcast: https://podcasters.spotify.com/pod/show/futurefoodshow/support
In this podcast today I will discuss the company Bio Rad! Listen to the podcast for details! --- Support this podcast: https://podcasters.spotify.com/pod/show/thressa-sweat/support
Mario is SVP RA/QA at Bio-Rad Laboratories and has witnessed first-hand the medical device industry evolving over the past 30 years. He is extremely knowledgeable when it comes to building a successful culture of quality.Tune in to this episode to find out how to develop a winning culture of quality yourself!He covers:Culture of quality - a definitionMeasuring a culture of quality - key KPIs and metricsKey steps to building a good culture of quality What does a bad culture of quality look likeActionable tips for improving the culture of quality at your own companyAnd more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.
Join us on a journey to the forefront of therapeutic antibody development. In this sneak peek episode you'll gain insights into how scientists and specialists at Bio-Rad are revolutionizing the biopharmaceutical industry through their customized approach to antibody discovery. Discover how the Pioneer Antibody Discovery platform is leading the development of exclusive, high-quality biologic candidates and providing unique advantages over commercially available discovery solutions. Full episode HERE.
Startup Tri-Valley is thrilled to present the co-founders of Avestria VC, a Raydiant Oximetry early stage investor, and Tri-Valley-adjacent residents. Their thesis is to focus on the unseen opportunity presented by female founders in healthcare and by entrepreneurs focused on developing solutions for women's health. Our conversation was so rich with information for Tri-Valley founders, we kept rolling for over an hour. As a result, we bring you not one, but two parts so you can experience the full value that Managing Partner Linda Greub and Partner, Tracy Dooley, MD, have to to offer. Part 1 sets the stage for how Linda and Tracy came to found Avestria VC and quite a bit about their thesis closing with advice on what makes a good CEO and Board. Part 2 continues with concrete advice for founders. Linda Greub is the Co-Founder and Managing Partner of Avestria VC. She's a fifth-generation Bay Area native who has spent the past 30+ years investing in public and private life science companies as an institutional investor, a corporate M&A executive, a hedge fund analyst, and a private venture investor.She invested over $3.2B of equity capital at Tudor Investments and Essex Investment Management, built profitable equity research franchise in healthcare at Banc of America Securities and Pacific Growth Equities, and led M&A at both Novartis Diagnostics and Applied Biosystems, including the $5.1B cash and stock sale of ABI to Life Technologies Corp. in 2008. She has also held corporate development and finance roles at a number of venture-backed life science companies, including VitaPath Genetics, Singulex, Raindance Technologies (sold to Bio-Rad), and Linkage Biosciences (sold to Thermo Fisher). In addition to finance, operations, and M&A, Linda's expertise extends to the life sciences, specifically in diagnostics, genomics, healthcare services, and life science tools. In 2019, Linda co-founded Avestria.Tracy Dooley, MD, Partner and Co-Founder of Avestria VC, was raised in the melting pot of the Bay Area before attending USC to major in biomedical engineering, Tracy took to heart Theodore von Kármán's famous quote: “Scientists discover the world that exists; engineers create the world that never was.” In pursuit of creating a better world, she headed to medical school at Stanford where she quickly experienced firsthand the challenges of getting innovative products into the hands of clinicians to ultimately improve patient care. Pivoting to industry, Tracy spent several years in healthcare M&A, then moved to Novartis Diagnostics, where she worked with Linda. As Chief of Staff to the President, she led strategy and built out the innovation pipeline, then headed global operations. More recently Tracy has been focused in digital health, where she advised a range of organizations, from early-stage startups to the Novartis Digital Accelerator Lab and the Bill and Melinda Gates Foundation, before joining Avestria.
Startup Tri-Valley is thrilled to present the co-founders of Avestria VC, a Raydiant Oximetry early stage investor, and Tri-Valley-adjacent residents. Their thesis is to focus on the unseen opportunity presented by female founders in healthcare and by entrepreneurs focused on developing solutions for women's health. Our conversation was so rich with information for Tri-Valley founders, we kept rolling for over an hour. As a result, we bring you not one, but two parts so you can experience the full value that Managing Partner Linda Greub and Partner, Tracy Dooley, MD, have to to offer. Part 1 sets the stage for how Linda and Tracy came to found Avestria VC and quite a bit about their thesis closing with advice on what makes a good CEO and Board. Part 2 continues with concrete advice for founders. Linda Greub is the Co-Founder and Managing Partner of Avestria VC. She's a fifth-generation Bay Area native who has spent the past 30+ years investing in public and private life science companies as an institutional investor, a corporate M&A executive, a hedge fund analyst, and a private venture investor.She invested over $3.2B of equity capital at Tudor Investments and Essex Investment Management, built profitable equity research franchise in healthcare at Banc of America Securities and Pacific Growth Equities, and led M&A at both Novartis Diagnostics and Applied Biosystems, including the $5.1B cash and stock sale of ABI to Life Technologies Corp. in 2008. She has also held corporate development and finance roles at a number of venture-backed life science companies, including VitaPath Genetics, Singulex, Raindance Technologies (sold to Bio-Rad), and Linkage Biosciences (sold to Thermo Fisher). In addition to finance, operations, and M&A, Linda's expertise extends to the life sciences, specifically in diagnostics, genomics, healthcare services, and life science tools. In 2019, Linda co-founded Avestria.Tracy Dooley, MD, Partner and Co-Founder of Avestria VC, was raised in the melting pot of the Bay Area before attending USC to major in biomedical engineering, Tracy took to heart Theodore von Kármán's famous quote: “Scientists discover the world that exists; engineers create the world that never was.” In pursuit of creating a better world, she headed to medical school at Stanford where she quickly experienced firsthand the challenges of getting innovative products into the hands of clinicians to ultimately improve patient care. Pivoting to industry, Tracy spent several years in healthcare M&A, then moved to Novartis Diagnostics, where she worked with Linda. As Chief of Staff to the President, she led strategy and built out the innovation pipeline, then headed global operations. More recently Tracy has been focused in digital health, where she advised a range of organizations, from early-stage startups to the Novartis Digital Accelerator Lab and the Bill and Melinda Gates Foundation, before joining Avestria.
Today's episode of the Leader's Agenda brings together 3 seasoned practitioners, Suzanne Giroux, Vice President, PMO - R&D at BD, Mehdi Hirji, VP, Portfolio & Program Management at Bio-Rad, and Gary Chin, VP, Innovation & Product Development at Action for Results, hosted by Tarja Huuskonen, to discuss one of the hottest topics in the life sciences industry: outcome driven innovation and value driven project management. In this thorough and collaborative conversation, our panel explores: what it takes to adopt a truly value-driven approach to product development projects, how to measure the results and difference between an average project and a best-in-class project, and ultimately, how sustainable value is created over the long term. Finally... we explore whether or not the result we measure be meeting a launch date and other internal deliverables or we should look beyond that. Should we instead ask what value the product and project brought to the customer, the patient, and the business, measuring those metrics? What do you think? Let us know in the comments below!
In this episode of Talking Techniques, supported by Bio-Rad, we discuss a key component of many gene therapies: recombinant adeno-associated viruses (rAAVs) and their production. These viruses act as efficient, accurate delivery vesicles for the gene therapy's plasmid. Speaking to Associate Director of Biopharma Product Marketing at Bio-Rad Laboratories, Mark White, we take a look the different expression systems used for their production and compare their advantages, before looking at some of the challenges involved in the production rAAVs, such as host cell contamination. Discover the tools that can help minimize host cell contamination and differentiate between nuclease resistant and nuclease reactive contaminant DNA and find out about some of the most exciting developments in rAAV technologies. Contents:The role of rAAVs in gene therapies: 00:40-02:15 The production of rAAVs and gene therapies: 02:15-03:30 Why are HEK cells so popular for cell therapy production? 03:30-05:45 HEK vs SF9 Insect cell expression systems: 05:45-06:45 Challenges in cell therapy expression systems: 06:45-08:05 Host DNA contamination: 08:05-10:30 The risks of host DNA contamination: 10:30-12:45 Key techniques to minimize host DNA contamination: 12:45-14:40 The advantages of ddPCR in gene therapy production: 14:40-17:50 Distinguishing between nuclease resistant and nuclease reactive host cell DNA: 17:50-19:10 The most exciting developments in rAAV technology: 19:10-20:20 What is one thing you would ask for to improve rAAV and gene therapy development 20:20-26:38
In this episode of Talking Techniques, supported by Bio-Rad, we discuss a key component of many gene therapies: recombinant adeno-associated viruses (rAAVs) and their production. These viruses act as efficient, accurate delivery vesicles for the gene therapy's plasmid.Speaking to Associate Director of Biopharma Product Marketing at Bio-Rad Laboratories, Mark White, we take a look at the different expression systems used for their production and compare their advantages, before looking at some of the challenges involved in the production rAAVs, such as host-cell contamination.Discover the tools that can help minimize host-cell contamination and differentiate between nuclease resistant and nuclease reactive contaminant DNA and find out about some of the most exciting developments in rAAV technologies. Contents:The role of rAAVs in gene therapies: 00:40-02:15The production of rAAVs and gene therapies: 02:15-03:30Why are HEK cells so popular for cell therapy production? 03:30-05:45HEK vs SF9 Insect cell expression systems: 05:45-06:45Challenges in cell therapy expression systems: 06:45-08:05Host DNA contamination: 08:05-10:30The risks of host DNA contamination: 10:30-12:45Key techniques to minimize host DNA contamination: 12:45-14:40The advantages of ddPCR in gene therapy production: 14:40-17:50Distinguishing between nuclease resistant and nuclease reactive host cell DNA: 17:50-19:10The most exciting developments in rAAV technology: 19:10-20:20What is one thing you would ask for to improve rAAV and gene therapy development 20:20-26:38 See acast.com/privacy for privacy and opt-out information.
#40 — Brad Amos, Emeritus Scientist at the MRC Laboratory of Molecular Biology, joins Peter O'Toole in this episode of The Microscopists to discuss his varied career, from zoologist to confocal microscope designer to amateur artist. We'll discover how Brad developed the confocal microscope taken up by Bio-Rad, as well as the Mesolens microscope, which he is using in his work as Visiting Professor at the University of Strathclyde. We'll hear how Brad has never fully retired and how his artwork ended up on a stamp for the Ascension Islands. Brad also reveals how he has played Robin Hood, the Pope, and Boris Johnson is his legendary lab skits and where to put your hands when scuba diving with sharks! Tune in now to learn more about Brad's inspiring career. Watch or Listen to all episodes of The Microscopists here: http://bit.ly/the-microscopists-yt #TheMicroscopists #microscopy #imageanalysis
#40 — Brad Amos, Emeritus Scientist at the MRC Laboratory of Molecular Biology, joins Peter O'Toole in this episode of The Microscopists to discuss his varied career, from zoologist to confocal microscope designer to amateur artist. We'll discover how Brad developed the confocal microscope taken up by Bio-Rad, as well as the Mesolens microscope, which he is using in his work as Visiting Professor at the University of Strathclyde. We'll hear how Brad has never fully retired and how his artwork ended up on a stamp for the Ascension Islands. Brad also reveals how he has played Robin Hood, the Pope, and Boris Johnson is his legendary lab skits and where to put your hands when scuba diving with sharks!Tune in now to learn more about Brad's inspiring career.Watch or Listen to all episodes of The Microscopists here: https://themicroscopists.bitesizebio.com/
In this episode, supported by BioRad, we explore cell proliferation monitoring and its role in drug discovery, guided by the expert advice of Rachel Preston, Product Development researcher at Bio-Rad. We discuss techniques available to monitor cell proliferation, their advantages and disadvantages and the importance of selecting the right combination of techniques for different experimental targets. Rachel also provides some tips for best practice and some pitfalls to avoid regarding DNA damage and highlights the importance of good quality antibodies in cell proliferation assays. Don't miss out on the most exciting applications of cell proliferation today, and find out what still needs to be improved for cell proliferation assays to continue driving drug discovery forward; all in the first episode of Season 3 of Talking Techniques! Contents: Intro: 00:00-00:34Why measure cell proliferation in drug discovery? 00:34-2:20Techniques involved in the detection of cell proliferation: 02:20-04:20The advantages and disadvantages of different techniques: 04:20-06:50 Selecting the most appropriate technique: 06:50-09:30How do you account for DNA damage in these assays? 09:30-11:00The best combination of techniques for drug screening studies: 11:00-12:00The biggest developments in technologies for cell proliferation monitoring: 12:00-14:15 Exciting findings of cell proliferation studies in cancer research: 14:15-15:35What element of cell proliferation detection and monitoring would you choose to improve? 15:35-17:40Closing remarks: 17:40-19:10
In this episode, supported by BioRad, we explore cell proliferation monitoring and its role in drug discovery, guided by the expert advice of Rachel Preston, Product Development researcher at Bio-Rad. We discuss techniques available to monitor cell proliferation, their advantages and disadvantages and the importance of selecting the right combination of techniques for different experimental targets. Rachel also provides some tips for best practice and some pitfalls to avoid regarding DNA damage and highlights the importance of good quality antibodies in cell proliferation assays.Don't miss out on the most exciting applications of cell proliferation today, and find out what still needs to be improved for cell proliferation assays to continue driving drug discovery forward; all in the first episode of Season 3 of Talking Techniques!Contents: Intro: 00:00-00:34Why measure cell proliferation in drug discovery? 00:34-2:20Techniques involved in the detection of cell proliferation: 02:20-04:20The advantages and disadvantages of different techniques: 04:20-06:50 Selecting the most appropriate technique: 06:50-09:30How do you account for DNA damage in these assays? 09:30-11:00The best combination of techniques for drug screening studies: 11:00-12:00The biggest developments in technologies for cell proliferation monitoring: 12:00-14:15 Exciting findings of cell proliferation studies in cancer research: 14:15-15:35What element of cell proliferation detection and monitoring would you choose to improve? 15:35-17:40Closing remarks: 17:40-19:10 See acast.com/privacy for privacy and opt-out information.
I mercati rimbalzano, positivi tutti gli asset finanziari, mentre le volatilità si sgonfiano ma rimangono ancora in territori di incertezza.In linea con le aspettative i dati sul Q3 di Euro Area, mentre scende il sentiment index in Germania.00:00 Introduzione alla puntata di oggi 01:00 Salgono i mercati, fine della paura ? 03:30 A che punto sono le volatilità ?05:10 Che cos'è il Tick Index e cosa ci indica 09:30 Come stanno performando i vari settori 10:10 Update petrolio, cosa sta succedendo ? 13:45 Analisi sul natural gas 16:30 Pubblicazioni sul canale telegram e webinar di domenica 19:15 Fidarsi delle proprie opinioni è un rischio? 25:40 I trade che ho aperto mentre i mercati scendevano 27:00 Avere un processo, ecco l'importanza 28:30 Fiducia sull'economia 29:20 Perchè non mi sta piacendo il movimento di Bitcoin 32:59 Q&A “ I consumer staples hanno avuto una grande ripresa, stiamo scontando Q1 e Q2?”35:00 Q&A “ Analisi su Bio RAD “ 38:00 Saluti finali
PCR has evolved rapidly over the last few years, an evolution that has been dramatically accelerated by the COVID-19 pandemic. New technologies and approaches have been brought to the fore and the full range of applications for which this technique can be applied have been highlighted, from diagnostics to basic disease research and immunology. This episode explores this evolution, looking at how challenges presented by the pandemic forced the hand of researchers to think outside the box and build on lesser-known PCR technologies. Here, Eddy van Collenburg, Market Development Specialist at Bio-Rad, provides his insight into how ddPCR rose to prevalence during this time and explains how the technology is being used to enable trade, detect new variants and is being used outside of the pandemic. Discover the key role that ddPCR can play in gene therapy research, liquid biopsies, cancer research, single-cell studies and more, in this fascinating overview of the development of PCR and where the technique can go in the future. Contents: Introduction: 00:00-01:30Why was qPCR established as the gold standard for detection? 01:30-03:40Limitations of qPCR during the pandemic 03:40-05:05New varieties of PCR for faster results: 05:05-05:40New varieties for more accurate results: 05:40-06:45ddPCR working principle and advantages: 06:45-09:00Nonclinical ddPCR applications for COVID-19: 09:00-10:45ddPCR in variant detection: 10:45-12:05ddPCR in gene therapy research: 11:05-12:30Liquid biopsy and cancer research: 12:30-15:20Combining ddPCR with NGS in research: 15:20-16:15What are some of the applications of ddPCR that you find most exciting? 16:15-17:10 Applications of ddPCR in single-cell studies 17:10-21:00Improvements in ddPCR: 21:00-21:45 Tips for best practice when using ddPCR: 21:45-22:50What would you ask for to improve ddPCR? 21:50-24:20
Oral Arguments for the Court of Appeals for the Federal Circuit
Bio-Rad Laboratories, Inc. v. ITC
ペア実験、実験プロトコルと動画、キリのいい数字、人工と天然、書き出し文、オススメされた漫画を読んでいない問題について話しました。Show notes Researchat.fm ep75…“「この分野は専門外なのですが」「この分野は初心者なのですが」等から始まる研究者のはなし方について思うことを言い合いました。 “ Researchat.fmのTwitterアカウント…#researchatfm をつけてつぶやいていただけると対応しやすいです。 Researchat.fmのお便りフォーム…こちらのお便りフォームからもお便りを出していただけます。 Researchat.fm ep82 ペアプログラミングに関するコメント (Twitter)…ep82に関していただいたペアプログラミングに関するコメント。@naoharuさんありがとうございます。 ペアプログラミング (Wikipedia) Googleの哲学…遅いより速いほうがいい。 Bio-Rad…みんな大好きBio-Rad ウェスタンブロッティング (Wikipedia) ウェスタンのゲル…作るのがめんどくさい。失敗しやすい。分子生物学初心者の鬼門。 Nature Protocols JoVE Cookpad クラシル 為末大 (Wikipedia) 進数 (Wikipedia) ウィスキーの熟成スタートアップに関する記事…Bespoken Spiritsという企業 Afineur…コピルアクにインスピレーションをうけ、バクテリアによってコーヒーを発酵させるこで新時代のコーヒーを作るスタートアップ。 龍涎香 (Wikipedia) 青春あるでひど…科学ポッドキャストの先達。知識の引き出しとトークのキレがやばい。アダルト科学相談室。 Big Hall (Wikipedia)…南アフリカ共和国のキンバリーに存在するダイヤモンド採掘のために掘られた穴。 De Beers…デビアス ダイヤモンドの4C…デビアスと4Cについて。 lab grown diamond…lightboxが商標。 デビアスの人工ダイヤモンド … 識者によると同一カラットのダイヤであれば天然ダイヤの1/5程度の値段とのこと。 コラ半島超深度掘削坑…ロシアの穴 マンションポエム … “1000作品以上集めてわかった「マンションポエム」に隠された“ワナ”” by 大山顕さん マンションポエム…「空にそびえる鉄の城」っていう歌詞が思い浮かびました。声はマジンガーZのオリジナルではなく、証言のYou the Rockさんの方でしたが。 DPZ…デイリーポータルZ。最高のサイトである。 地味ハロウィン…DPZ主催。海外のツイッターでもかなり話題になっていた。 天久聖一 (Wikipedia)…天久の前に天久なし、天久の後に天久なし。 書き出し小説大賞…天久先生がDPZで主催している最高の知的ゲーム。一行小説。tadasuも以前投稿していた。 書き出し小説大賞 (Amazon)…書き出し小説の珠玉作品まとめ 挫折を経て、猫は丸くなった。(Amazon)…書き出し小説の珠玉作品まとめ vol.2 バカドリル (Wikipedia)…平成史に燦々と輝くバカドリル。天久聖一先生とタナカカツキ先生の作品。 バカドリル (Amazon) バカはサイレンで泣く…SPA!といえばバカサイ。天久先生、椎名先生、せきしろ先生による投稿コーナー。昔はゴメス氏も。30年近く経つも、電気グルーヴのANNの残り香を楽しめる。対抗は伊集院さんのラジオかファミ通町内会か。tadasuは高校生時代に投稿していた時期があり、少し掲載された。書き出し小説の元になったような回に掲載されたのがうれしかった。 バカはサイレンで泣く09 (Amazon)…少しネタが載っていてうれしい。自分語りばかりですいません。 バカはサイレンで泣く13…前書きがかっこよすぎる。 ノーベル賞とファミリーネームの都市伝説…AとBという人が同じ年に論文を出しているとA(2000), B(2000)という引用がされやすいため、Aの方が重要に見えて、結果的にcitationも増え、Bの評価が不当に下がってしまったという話。 スパイダーバース (Amazon) 日本酒のサブスクサービスの苦難 (Togetter)…非常に勉強になるまとめ Editorial notes ネットワークの調子が悪く遅延があり、ゆっくりゆるふわに話しました。(soh) ダイアモンドなのかダイヤモンドなのか。油井が読めなくて油田って言っちゃいました。(tadasu)
My guest this week is Damon Tighe, former National Institute of Health and Human Genome Project researcher and current Bio-Rad educator and training specialist. Damon's extensive history with working with public and private biotech projects over the years has yielded a treasure trove of valuable knowledge that he enthusiastically gives back to the community. In this episode, Damon and I cover a wide-array of topics ranging from the evolution of biotech over the last decade, how software is quickly becoming a must-have skill for future biotech workers, the need for more discussion around policy-making philosophy when it comes to human genome editing, the impact of patents on biotech research and how more open innovation in the industry can accelerate biotech research. We barely scratched the surface of what Damon has to share! Enjoy!
This episode of Conversations with ..Scientists--Bye-Bye Bunny-- is about research into diseases such as COVID-19 and neurological diseases, too. It's about the antibodies in our bodies. And it's about research antibodies. And it explores the possibility of perhaps generating and producing research antibodies without the use of animals. It includes Dr. Alison Gray from Afability and the University of Nottingham, Dr. Katie Crosby from Cell Signaling Technology, Dr. Alejandra Solache from Abcam, Dr. Carl Ascoli from Rockland Immunochemicals, Dr Andrew Bradbury from Specifica, Dr. Achim Knappik from Bio-Rad, Dr Aled Edwards from the University of Toronto, Dr. Fridtjof Lund-Johansen from Oslo University Hospital, and Dr. Peter McPherson from McGill University.
Walter Bosschieter is Finance Director at Bio-Rad in Zurich. In this episode, he covers: - The difference between working environments in the Netherlands and Switzerland - How he motivates his teams through positivity and encouragement - The attributes he looks for when recruiting The EMEA Recruitment Podcast with Paul Toms and Jenny Callum will take you through every aspect of recruitment. Looking at both sides of the process, Paul and Jenny will be offering career-changing advice to the job-seeker and essential exposure to recruitment ‘best practice’ for the hiring employer, giving each party an insight and understanding into the perspective of the other. This podcast is brought to you by EMEA - At EMEA Recruitment we are specialists in Finance, BI & Data, HR, Procurement, Supply Chain and Operations Recruitment at Middle-Management to Executive levels across Switzerland, The Netherlands and the wider EMEA & US region. With offices in Zug, Amsterdam and Nottingham our consultants are well networked and can offer knowledgeable advice within these regions. If you want to reach out to Walter, you can connect with him through LinkedIn on https://www.linkedin.com/in/walterbosschieter/ The podcast is hosted by founder of EMEA; Paul Toms and Executive Recruiter and Recruitment Marketing Specialist; Jenny Callum. To find out more about EMEA recruitment visit https://emearecruitment.eu/, follow EMEA Recruitment on LinkedIn or connect with Paul on LinkedIn at https://www.linkedin.com/in/paultomsemea/ or Jenny at https://www.linkedin.com/in/jennycallumemea/.
This podcast from Bio-Rad highlights five important things to consider when you are selecting secondary antibodies for multiplexing experiments.
Do you know the frequency of your population of interest? Learn about the impact of cell frequency on flow cytometry experiments and how you can optimize your conditions to improve detection of rare populations in this podcast from Bio-Rad.
Bio-Rad antibody expert, Michael Schwenkert, talks about the challenges for bioanalysis of CAR-T cells and how they can be addressed by the design and generation of customized anti-idiotypic antibodies.
In this podcast, learn how to prepare blood samples ready for flow cytometry experiments with Bio-Rad’s top three tips.
A number of different assay types exist for studying cell proliferation but which technique is best for you? In this podcast, Bio-Rad reviews three popular methods: using thymidine analogs, quantifying DNA content, and detecting cell proliferation markers.
The SUMO (small ubiquitin-related modified protein) family of proteins have been linked to cell cycle progression since their discovery. Bio-Rad’s top tips for studying this transient post translational modification feature in our podcast.
What makes BrdU a popular tool for neurogenesis research and how can you use it successfully in your experiments? Learn about Bio-Rad’s practical tips for controlling your BrdU experiments in our podcast.
Topic Discussed : Mergers and acquisiton landscape in the Lifescience Industry Speaker : Khushbu JainKey Takeaways: Pharma companies are seeking radical and immediate growth through M&A. Conversely, we can expect a lower volume of total deals but a higher average deal value Diagnostic and research tools segments on the other hand can extract value from inorganic growth by thinking beyond data curation and more about deriving & utilizing insightsOn that note, I hope you enjoyed this session.Please join us for future podcasts and become a member of our Leadership CouncilEmail us at digital@frost.com. Thank you for your time.Related Keywords: Mergers and Acquisitions in Life Science, mega-mergers, mega-acquisitions, M&A in pharma, M&A in biopharma, M&A in contract research organizations, M&A in contract development and manufacturing organizations, M&A in diagnostics, cell and gene therapy, patient engagement 2.0, patient centricity, connected health, Medication Adherence, Remote Monitoring, Tele Health, Direct to Consumer Genetic Testing, Companion Diagnostic & Biomarker Discovery, Liquid Biopsy, Cell and Gene Therapy, Pharmacogenomics, Artificial Intelligence, Big Data, RWE, Blockchain, IIoT, Outsourcing, X-as-a-Service, Data Monetization, Private equity investment, FAMGA, non-traditional healthcare players, fortune 50, Charles River, Eurofins Scientific, ICON Plc, IQVIA, LabCorp, Parexel, PPD, PRA Health, Syneos Health (INC Research and inVentiv Health), Wuxi Apptech, AMRI, Patheon, Cambrex, Catalent, Lonza, Piramal, Recipharm, Samsung Biologics, Siegfried, BioXcellence , Bio-Rad, Thermo Fisher, Perkin Elmer, Agilent Technologies, Qiagen, Danaher, Sysmex, Roche Diagnostics, Illumina, Becton Dickinson, bioMerieux, Pfizer, Roche, AstraZeneca, GSK, Novartis, Merck, Sanofi, AbbVie, Bristol-Myers Squibb, Jefferies Financial Group, Montagu Private Equity, Nordic Capital, Capstone, Catapult Partners Website: www.frost.com See acast.com/privacy for privacy and opt-out information.
The call, email or tip comes into your office; an employee reports suspicious activity somewhere across the globe. That activity might well turn into a Foreign Corrupt Practices Act (FCPA) issue for your company. As the Chief Compliance Officer (CCO), it will be up to you to begin the process which will determine, in many instances, how the company will respond going forward. This month’s podcast series will provide to you all the steps you will need to consider going forward. This scenario was driven home in a FCPA enforcement action brought by the Securities and Exchange Commission (SEC) in July 2015 involving Mead Johnson Nutrition Company (Mead Johnson). In that case, the company performed two internal investigations into allegations that its Chinese business unit was engaged in conduct which violated the FCPA. Unfortunately the first investigation, performed in 2011 did not turn up any evidence of FCPA violations. It was not until 2013, when the SEC made an inquiry to the company that it performed an adequate internal investigation which uncovered FCPA violations. Similarly, consider Zimmer Biomet, which (when it was only Biomet) resolved an FCPA violation in 2012 for nearly $23MM and entered into a Deferred Prosecution Agreement (DPA). Within the year, Biomet notified its Monitor that it has found evidence of additional FCPA violations, which in turn violated the terms and conditions of the DPA. However these additional violations by the company (now Zimmer Biomet) turned out to have been actions which occurred in 2010, well before the initial DPA but were not uncovered in the company’s worldwide investigation which led to the first settlement. Zimmer Biomet paid an additional $13MM for this oversight and extended out both the DPA and the Monitorship, all because the company had failed to fully investigate itself thoroughly. The 2012 FCPA Guidance states the following on investigations, “Moreover, once an allegation is made, companies should have in place an efficient, reliable, and properly funded process for investigating the allegation and documenting the company’s response, including any disciplinary or remediation measures taken.” That is simply it. This simple introduction was expanded upon in the Justice Department’s Evaluation of Corporate Compliance Programs (Evaluation) released in February. Prong 7 in the makes the following inquiries: Effectiveness of the Reporting Mechanism – How has the company collected, analyzed, and used information from its reporting mechanisms? How has the company assessed the seriousness of the allegations it received? Has the compliance function had full access to reporting and investigative information? Properly Scoped Investigation by Qualified Personnel – How has the company ensured that the investigations have been properly scoped, and were independent, objective, appropriately conducted, and properly documented? Response to Investigations – Has the company’s investigation been used to identify root causes, system vulnerabilities, and accountability lapses, including among supervisory manager and senior executives? What has been the process for responding to investigative findings? How high up in the company do investigative findings go? The Mead Johnson and Zimmer Biomet matters are but two examples which make clear the need to have robust, integrated investigations. Marc Bohn, writing in the FCPA Blog, said about the Mead Johnson matter, “Investigations that lack sufficient depth, resources, or forethought can pose significant risk because they increase the likelihood that something critical will be overlooked, potentially permitting misconduct to continue unabated.” Both Mead Johnson and Zimmer Biomet point to the critical nature of FCPA investigations and why the government takes this requirement so rigorously. But more than protecting a company from liability under the FCPA, in the internationalized world of global compliance investigations are becoming more important. Bio-Rad recently announced that its FCPA settlement was a “risk-factor” which required public disclosure under US securities law. In the domestic arena, internal investigations can go a long way towards helping a company move past a public relations debacle or perhaps abate negative publicity. One need only consider the recently released internal investigation report commissioned by the Wells Fargo Board of Directors around the bank’s fraudulent accounts scandal. The report was merciless in its criticism of certain structural and cultural failures at the bank. It named names of culpable former senior executives at the company. However one thing it did not address were allegations from multiple whistleblowers who claimed to have reported the fraudulent conduct and were ignored or actively retaliated against. If the internal investigation turns out to have white washed these whistleblowers, the financial penalty and negative public reaction could be both swift and severe. Corrupt investigations are never a good thing for a company as they can disrupt business relationships and future opportunities. Yet today they are even more important. In the month of June I will be exploring how you can create, design and implement a robust investigation protocol for an internal investigation and when you should bring in outside counsel for an independent investigation. I will consider the Board of Director’s role in investigations and other corporate functions such as internal audit, IT and legal in any investigation. I will review special issues such as privilege, Upjohn and Miranda warnings and data privacy. As Hallmark Seven of the Ten Elements of an Effective Compliance program states, in part, “An effective compliance program should include a mechanism for an organization’s employees and others to report suspected or actual misconduct or violations of the company’s policies on a confidential basis and without fear of retaliation” and Prong 7 of the Evaluation also deals with reporting; I will consider hotlines. Both their implementation and use in a best practices compliance program. I will feature several compliance practitioners, both lawyers and non-lawyers, who will relate how they developed their investigative strategies and navigated various stakeholders to obtain positive results for their clients. Three Key Takeaways Failure to thoroughly and properly investigations allegations of corruption can be costly. The internationalization of global anti-corruption enforcement makes performing robust investigations even more important. Use the month of June to learn about key aspects of investigations and internal reporting mechanisms. Learn more about your ad choices. Visit megaphone.fm/adchoices
Erin Quill discusses with Wilson Mattos and Dan Elder (Nova Coast) Bio-Rad HA Cluster & ZLM Solutions.
Tierärztliche Fakultät - Digitale Hochschulschriften der LMU - Teil 02/07
Zum Nachweis von PrPc und PrPsc wurde eine Kapillarelektrophorese-Immunofluoreszenz-Methode (CE-LIF) etabliert und mit konventionellen Verfahren (ELISA, Westernblot, Dot-EIA) verglichen. Zur CE-LIF wurde der monoklonale Antikörper F89 und ein Fluoreszenz-markiertes Peptid (FITC-P3) eingesetzt. Die Nachweisgrenze für rekombinantes bovines PrPc liegt bei 1 pg/Test. Zur Anreicherung von PrPsc aus Hirn und Liquor wurden (Ultra-) Zentrifugations-, Extraktions- (HFIP) und Chromatographieverfahren (HPLC, Festphasenextraktion) einzeln oder in Kom-binationen geprüft; darüber hinaus wurden Anreicherungsversuche mit Affinität- bzw. Immu-nomagnetischer Separation vorgenommen. Die Überprüfung des PrPsc-Gehaltes ausgewählter Extrakte im Vergleich zum Ausgangsma-terial mittels ELISA ergab deutliche Substanzverluste. Eine selektive Bindung von PrPsc an Dynabeads® gekoppeltem Plasminogen konnte nicht nachgewiesen werden. Dagegen wurde eine Anlagerung an Antikörper-beschichteten Beads festgestellt. Allerdings war die Bin-dungskapazität der Beads bei Versuchen in mit in PBS gelöstem PrPc oder PrPsc höher als bei vergleichbaren Versuchen mit Liquor. Bei der kapillarelektrophoretischen Analyse erwiesen sich alle mittels einfacher Probenauf-bereitung hergestellten Extrakte als ungeeignet. Sie führten entweder zu technischen Prob-lemen (Verstopfung der Kapillare; Durchbrennen) oder zu Interferenzen im Elektrophe-rogramm, die eine Auswertung nicht ermöglichten. Die Aufbereitung mittels HPLC ergab zwar verwendbare Präparationen, allerdings variierte die Retentionszeit von PrPsc derart stark, dass dieses Verfahren nicht weiter eingesetzt wurde. Bezüglich der Verwertbarkeit von CE-LIF wurden die besten Resultate mit Hilfe einer Aufreinigung nach Bio-Rad® mit an-schließender Festphasenextraktion erzielt. Während der Nachweis von PrPsc mittels CE-LIF aus Hirngewebe eindeutig gelang, führte die Untersuchung des Liquors eines bekannt BSE-positiven Tieres zu keinem eindeutigen Ergebnis. Prinzipiell ist die CE-LIF zum Nachweis von PrPsc geeignet. Allerdings handelt es sich dabei um ein sehr störanfälliges Verfahren. Die Sensitivität kann deutlich erhöht werden, wenn die Konzentration von PrPsc in kleine Volumina noch besser gelingt.