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Legal Drugs Podcast

Author: Angela Stoyanovitch

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Every day, each of us is affected by legal drugs. The pharmaceutical industry is one of the strongest, richest and yet most mysterious industries in America. Why do some drugs make it to market and others don't? Why are some drugs so expensive? And what is the human effect of this industry? Join industry veteran Angela Stoyanovitch as she explores the complex systems in place and what it means for you and me.
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In this episode, Legal Drugs Podcast Host, Angela Stoyanovitch, speaks with Dr. Najah Abi-Gerges, head of AnaBios Corporation's R&D. Najah walks the audience through recent publications in collaboration with big pharma on the cardiotoxicity effects of three drugs that have been posed to treat COVID19. Cardiotoxicity studies are an important step in understanding the safety of a legal drug.  AnaBios uses their early-stage discovery and translational research model to test and compare Hydroxychloroquine, Chloroquine and Azithromycin in adult human primary cardiomyocytes. Cardio safety is especially personal to both Angela and Najah as both speak about their family history with heart disease.  More importantly, for areas and parts of the world where COVID vaccines will not be made available or accessible, viable treatments need to be accessed for potential risks in order to provide the best alternatives.  Link to Scientific Report article, NIH & FDA press releases from AnaBios;  NIH/NCATS Awards SBIR Grant to AnaBios FDA Inks Research Collaboration with AnaBios FDA Awards AnaBios Contract   This episode edited and produced by Margaret Beveridge.
Over the month of October 2020, Legal Drugs Podcast (LDP), a production of Legal Drugs Agency, LLC (LDA), was on a strategic sabbatical to give back and reorganize.  In this episode, Host, Angela Stoyanovitch, recaps the lasted COVID cure announcements with new drugs announced from both Pfizer and Moderna (biotech and pharma companies.) Unusually, their announcements included 90-95% efficacy of the vaccines which were developed at record speeds.  While drugs of any kind have had longer development periods in the past, Legal Drugs Podcast has continually highlighted that the increased speeds can be attributed to many variables - the most obvious is the use of technology, machine learning and A.I. for early drug discovery.  To the general public who is outside of the drug development industry, this all may seem mysterious and confusing but we explain that this is a manifestation of the use of creative scientific theory and understanding of DNA, etc. No longer will we rely on simple chemical compounding for drugs.  The future of legal drugs is curative drugs and we are in a space race within the biotech industry to find them! This is an exciting time in history to be a witness to such speedy developments and with a global threat such as the COVID-19 pandemic, the pressure (and funding) are on high! Together, we will continue to discuss these advancements in bite side portions as we have in the first 31 episodes of the show, Legal Drugs Podcast.  As Angela outlines in this episode, 32, we are looking to the future for more gene editing that will result in more gene and cell therapies. This Spring 2021, Legal Drugs Agency will produce a new livestream salon-styled intimate conference on gene therapies via LDA partner, PharmaSalon. If you know someone you'd like to recommend as a speaker, please reach out to our host, angela@legaldrugsagency.com. If you are in the market for a career change within the life sciences industry, specifically, the drug development and contract research organization niche, Angela would love to introduce you to our LDA partner, RPM ReSearch Solutions, for career coaching, resources and matching to open candidate roles.  This Fall 2020, we are launching our YouTube channel as a result of our efforts over the last month.  Stay tuned for more information and subscribe now @legaldrugspodcast on YouTube and Instagram to stay up to date on our announcements.   Thank you to those who have supported LDP as a patron on www.patreon.com/legaldrugspodcast.  Your support means the world to us and we wouldn't be here without your generous contributions that help us create more content.  Thank you!  Other sabbatical work includes two recordings with Angela on Lab Rat Chat, an interview with their podcast hosts where Angela dives deep into her career and life story - listen here for free; Chat with Legal Drugs Podcast on Lab Rat Chat Podcast - and a podcast panel discussion recording as a platform session for the National Annual Meeting for the American Association for Laboratory Animal Science (AALAS) - read more on page 26 of the virtual program; NAALAS Panel Discussion: Podcasting to the Public. Finally, LDA was established with the idea that we highlight the heartbeat of biomedical research and the drug development continuum. What do we do this work? Why do we study new drugs and how do we give back? No matter how you slice it, legal drugs has an impact on all of us.  For those of us deep in our drug development work or corporate lives, it is easy to lose touch with that heartbeat or the stories of people's lives we impact one way or another.  This is the legal drugs business we discuss here but what about the illegal drug business on the streets affecting people in great need due to addictions and mental illness. We all can have a positive impact (great or small) on each other's mental and emotional health. As Host Angela has a great passion for groups of both animals and women in need, she often volunteers for these various causes.  While on sabbatical these last 4-6 weeks, Angela describes a new event she hosted to raise hygiene donations for women on the streets. This fundraising event was called Girls Giving and it resulting in over $300 of tampons and sanitary napkins that will be distributed by Restore Global as organized by iServewithJoy nonprofits in the metro-Charlotte, NC area.  Thank you for listening, downloading and reviewing our episodes.  Check out our new landing page at www.podpage.com/site/legal-drugs-podcast for more episodes! 
In this episode of Legal Drugs Podcast, Host (NEW landing page www.podpage.com/site/legal-drugs-podcast), Angela Stoyanovitch,  interviews Tom Leach, Esq. Tom is the executive director of the New Jersey Association for Biomedical Research (NJABR) and the Pennsylvania Society for Biomedical Research (PSBR). In addition to biomedical research advocacy, Tom monitors legal and legislative develops related to animal welfare in New Jersey and across the country. Tom has extensive experience developing policy positions and legislative initiatives for association management and government affairs clients. Tom has more than fifteen years of experience working in state government and legal affairs. Tom began his career as an aide to New Jersey Governors Whitman and DiFrancesco in the Office of Constituent Relations and later served as a legislative aide to a New Jersey State Senator. Previously, Tom served as counsel to a large real estate brokerage firm. Tom received a BA in Political Science from the College of New Jersey and a JD from Seton Hall.   To learn more about the programs mentioned on the show, to go www.psbr.org, www.njabr.org and www.sparcscience.com (PSBR’s education program.)  If you are planning to attend the National American Association for Laboratory Animal Science (AALAS) this November, 2020, look for our session now published in the preliminary program for a panel discussion organized by Legal Drugs Agency, LLC (LDA) titled, “Podcasting to the Public and the Art of Storytelling” where panelists including Angela Stoyanovitch and Tom Leach will discuss the ins-and-outs of podcasting as a digital platform for laboratory animal science professionals for public insight. Sponsors of this discussion include Legal Drugs Agency, LLC. Additional resources can be found here;  https://www.aalas.org/national-meeting/general-information/meeting-program and https://issuu.com/aalasoffice/docs/2020_charlotte_preliminary_program_final.   If you’d like to become a patron of Legal Drugs Podcast, please log on to www.patreon.com/legaldrugspodcastto support us today.  We appreciate your patronage in advance.    This episode edited and produced by Margaret Beveridge.
Health professionals have started to recognize the importance of mental health as it relates to heart disease.  The American Heart Association (AHA) actually includes links to mediation and tips for a gratitude practice on their website.  See link here;  https://www.heart.org/en/healthy-living/healthy-lifestyle/mental-health-and-wellbeing For too long health professionals have ignored matters of mental health for our overall physical well-being as it includes our emotional, psychological, and social well-being. According to the information on the link above from the AHA, these things affects how we think, feel, and act along with how we handle stress, relate to others, and make choices. Legal Drugs Podcast host, Angela Stoyanovitch, sits down with her father Rockwell ("Rocky") J. Stoyanovitch, retired plumber and trade-skilled pipefitter, to discuss his third heart attack.  Rocky credits his late couple of heart attacks to the stress he endured in his life after going through a divorce.  Rocky underlines that on top of day-to-day relationship navigation, many in the world right now may be stressed due to changes we've seen with the economy, civil unrest and the corona virus pandemic. As a result, our mental health is a vital part of our overall well-being and in Rocky's case played a very significant role to his heart-health.  We are grateful to Rocky for sharing his story, once again, on the Legal Drugs Podcast.  Please check out Episode 3 to hear the first and fuller version of his health story and overcoming heart disease.  Episode 3 continues to be one of our leading episodes in terms of downloads and other statistics.  Please share our episode with a friend and subscribe wherever you get your podcast.   You can become a patron of Legal Drugs Podcast by joining www.patreon.com/legaldrugspodcast.  Thank you in advance for your support!
Legal Drugs Podcast host, Angela Stoyanovitch, interviews Tracy Lewis Parker, current President of the American Association for Laboratory Animal Science (AALAS) to discuss the organization's plan for a virtual meeting in lieu of the corona virus pandemic. The meeting was scheduled to take place in Charlotte, North Carolina, USA this October 2020. In this discussion, members and non-members of the AALAS community will learn about the many opportunities available for this year's National Meeting along with insight into Tracy's personal background and enthusiasm for AALAS' mission. Listeners will also learn more about laboratory animal science and gain insight into animal research as it relates to the legal drug business and drug development.  Every year since 1950, AALAS has held an annual National Meeting. During the five days of the meeting, members and nonmembers come together to enjoy the workshops, lectures, poster sessions, and exhibits. The program is designed to have topics relevant to the entire membership. Exhibitors have an opportunity to interact with AALAS members from the academic community, research institutions, government organizations, and commercial companies. The AALAS National Meeting is the largest gathering in the world of professionals concerned with the production, care, and use of laboratory animals. Tracy Parker, MBA, BS, CMAR, RLATG, CPIA, is Program Manager at Intuitive and President of AALAS.  She moved to California in 2018 after living her entire life on the east coast.  She started her career in lab animal at a CRO, first as a research technician and then as the company’s first training coordinator.  She moved to a pharmaceutical company in 2001 as a supervisor and, over the next 17 years, held positions of ascending responsibility.  She completed her MBA, achieved CMAR, CPIA and PMP certification while working full time and raising two kids.   Mentoring others is her passion.  Outside of work, you’ll most likely find her in a kayak, teaching a spin class, or kicked back with her rescue dogs, Luther and Xena and her recently adopted kittens, Miss McTosie and Smidgini. To learn more about the National Meeting for AALAS, go to; https://www.aalas.org/national-meeting.  To become a patron of Legal Drugs Podcast, join us at www.patreon.com/legaldrugspodcast.     
In this episode of Legal Drugs Podcast (NEW landing page www.podpage.com/site/legal-drugs-podcast), Angela Stoyanovitch, explores an alternative narrative to the field of laboratory animal research and helps to uncover mysteries animal research which is often quieted or ignored in the biotechnology sciences.  Ironically, it is much in part to the discoveries animals in research afford us that allow innovations to be explored and progressed forward in the biotechnology and biomedical research field. In an attempt to open up the conversation on this important step to drug development, Angela speaks with her guest Jeff Marshall (RBP, CBSP, SM (NRCM), a veterinary student with a unique background in biotechnology who has made it part of his mission to allow the public to form their own opinions based on the facts of lab animal science.   Jeff Marshall is a third-year veterinary student at Virginia Maryland College of Veterinary Medicine. Following his completion of a dual MS/BS degree in 2009 from the University of Nevada, Reno, Jeff has been involved in the field of comparative medicine in a variety of capacities. These experiences have included high-containment laboratory work as a research associate. Jeff has earned his certification as a Biological Safety Professional through the American Biological Safety Association (ABSA). He has also been a research compliance coordinator responsible for oversight for both Institutional Animal Care and Use Committees and Institutional Biosafety Committees. Once he completes his veterinary school, Jeff intends to become a laboratory animal veterinarian where he will continue to be an outspoken advocate for biomedical research and the animals that take part in it.  Jeff is the co-host and founder of Lab Rat Chat, a podcast dedicated to providing facts and an alternative narrative to the public regarding the necessity of humane and ethical animal research. Lab Rat Chat was made possible through the Michael D. Hayre Fellowship in Public Outreach, which is sponsored by the biomedical research advocacy group, Americans for Medical Progress (AMP.) You can listen to all of their episodes on www.labratchat.buzzsprout.com. Find them on Instagram @thelabratchat, Twitter @thelabratchat and Linkedin, Lab Rat Chat, to learn more!   If you are planning to attend the National American Association for Laboratory Animal Science (AALAS) this November, 2020, look for our session now published in the preliminary program for a panel discussion organized by Legal Drugs Agency, LLC (LDA) titled, “Podcasting to the Public and the Art of Storytelling” where panelists including Angela Stoyanovitch and Jeff Marshall will discuss the ins-and-outs of podcasting as a platform for laboratory animal science professionals. Sponsors of this discussion include LDA and AMP. Additional resources can be found here;  https://www.aalas.org/national-meeting/general-information/meeting-program and https://issuu.com/aalasoffice/docs/2020_charlotte_preliminary_program_final.  If you’d like to become a patron of Legal Drugs Podcast, please log on to www.patreon.com/legaldrugspodcastto support us today.  We appreciate your patronage in advance.   Episode edited and produced by Margaret Beveridge.
Learn more about AnaBios Coporation at anabios.com and let them know you heard about them on Legal Drugs Podcast.   
Meet Hannah Harrell, a 26-year-old self-advocating patient of Ehlers-Danlos syndrome or EDS. While EDS is considered a rare disease due to fewer than 200,000 US cases per year according to Mayo Clinic, EDS communities believe it is often misdiagnosed and that its prevalence is greater than currently known. EDS is a group of genetic disorders that affect the connective tissues supporting the skin, bones, blood vessels, and many other organs and tissues. The symptoms of EDS can range from mildly loose joints to life-threatening complications, and often causes lifelong chronic pain. While there is no cure for EDS, legal drugs can help manage and treat symptoms to prevent further complications.  However, finding a diagnosis and navigating the legal drugs available on the market for EDS patients often presents its own set of challenges. Because doctors are often not familiar with EDS or the side effects that affect EDS patients differently from other non-EDS patients, troubleshooting medications has been another layer of frustration for Hannah and her family.  According to www.ehlers-danlos.com, similar to a zebra who’s stripes are unique individual to individual, those with Ehlers-Danlos Syndrome each have a unique struggle with the disease, making no clear path for consistent treatment. . The EDS community adopted the zebra as its mascot because “sometimes when you hear hoofbeats, it really is a zebra.” Whereas, medical students are taught “When you hear hoofbeats behind you, don’t expect to see a zebra.” In other words, it is not the rule to pick a more unusual or surprising diagnosis. As a result, EDS patients spend years pursuing a correct diagnosis, often with legal drug treatment that may not be best for their disorder. EDS advocacy groups are currently working towards awareness and a time when medical professionals can more easily recognize EDS in their patients.  More on Hannah: Hannah lives in Charlotte, NC but grew up in Austin, TX and Shelby Township, Michigan as the eldest of three daughters.  She was homeschooled from the age of seven and loved to write and read about medical history. Surrounded by other family members who were “bendy and clumsy,” Hannah recalls seeing her mother, grandmother and great aunts often wrapped in ace-bandages in her early childhood. Diagnosed with narcolepsy by the age of eighteen, Hannah spent the next six years of her life seeking answers while battling with her health.  She, her mother and two younger sisters were all diagnosed with EDS in March 2018 at Baylor College of Medicine in Houston, TX. As a result of her journey, Hannah advocates for awareness of poorly understood and undertreated diseases. Hannah’s soapbox (ENFP) personality has proved to benefit her in her passion for chronic illness and EDS patient advocacy and awareness. She helps operate several EDS support groups both online and in the Charlotte, NC area. Hannah’s believes that the best help a chronic illness patient can find is to educate and advocate for themselves to the best of their ability. Other resources include www.practicalpainmanagement.com. To join Hannah’s Facebook group, go to; https://www.facebook.com/groups/NCCEGS/?ref=share. For additional resources on different types of EDS and genetic differences and markers, go to; https://themighty.com/2019/06/what-is-ehlers-danlos-syndrome/. This episode edited and produced by Margaret Beveridge.
On today’s sponsored episode of Legal Drugs Podcast, Host Angela Stoyanovitch, speaks with Lee Rosebush, Partner at Baker & Hostetler, LLP. Lee is one of the scheduled speakers at the upcoming compounding pharmacy live stream salon hosted by PharmaSalon.  To learn more about the Aug. 18-20th, 2020 event and to register, go to www.pharmasalon.com. Lee Rosebush is the Pharmacy & Reimbursement Team Leader and Co-Leader of the FDA Practice at Baker & Hostetler. With a unique background as a defense, regulatory, and registered patent attorney who has also worked as a pharmacist, Lee provides his clients with legal counsel that is grounded in first-hand experience. He possesses a unique understanding of the pharmaceutical industry (legal drugs business as we like to say) which, combined with his attention to detail and experience with biologics, medical device, and healthcare companies, gives clients a single source for regulatory and litigation counsel. He is a star when it comes to navigating legal, governmental, and pharmaceutical environments, which helps him to more easily reduce the time needed to secure operating licenses or assist drug manufacturers to avoid compliance actions from governmental agencies. For more on Lee, go to; https://www.bakerlaw.com/LeeHRosebush.  In this episode, Lee and Angela discuss some of the issues arising around outsourcing drug manufacturing abroad (where standards are different) and how the pandemic has exasperated these problems in the legal drug manufacturing business. The Outsourcing Facilities Association (OFA) is the trade association representing FDA-registered 503B outsourcing facilities who focus on providing patients and healthcare providers with safe and effective compounded medications. To learn more about the Outcoursing Facilities Association to go www.503bs.org. *As referenced on the episode, here is the link to Lee's article, Outsourcing U.S. Drug Manufacturing to China was a Mistake - A Lethal One [Opinion]; https://www.newsweek.com/pharmaceutical-manufacturing-america-china-lethal-mistake-1502008.  This episode edited and produced by Margaret Beveridge.
Legal Drugs Podcast host, Angela Stoyanovitch, talks with founder, Vivian Juter Frankel of PharmaSalon, a new conference creation company.  With Vivian's twenty years of conference organizing experience, PharmaSalon aims to offer a new way for experts to connect in their field. After hosting popular "unconference" sessions on topics that conference participants wanted to discuss, Vivian birthed the idea to launch PharmaSalon with an emphasis on smaller group meetings, a focus on fireside chats and collaborative learning (as opposed to a purely didactic conference style.) To learn more go to: www.pharmasalon.com.    On August 18th, 19th and 20th, 2020, PharmaSalon is launch their first live stream salon event titled, "Compounding Pharmacies; Achieving Quality Through Process and Procedure." To learn more about this event and to register, please go to: www.pharmasalon.com/compounding.    This episode was sponsored in part by PharmaSalon.  Check out their virtual conference style solutions and upcoming events on their website and follow them on Instagram @pharmasalon.    This episode was edited and produced by Margaret Beveridge. Follow her on Instagram: @maggiebev
On today’s episode of Legal Drugs Podcast, our host, Angela Stoyanovitch, is joined by Sarah Ives, Director of Contract Research at Distributed Bio based in San Francisco, CA. Sarah starred on the Netflix docuseries, Pandemic, produced by Zero Point Zero Productions, premiered on January 22, 2020. In this episode, Angela gets to know Sarah’s life in what Sarah describes as two phases; pre and post the Netflix show. After watching the show, Angela felt Sarah’s persona was relatable in that she, too, studied biology and decided to learn more about the legal drugs business in her career. In an effort to uncover more common ground, Angela asks Sarah to introduce herself and her humble beginnings as an undergraduate studying genetics with fruit flies. In this interview, Sarah and Angela relate in ways such as their non-science related studies in college, social life and networking, multiple hobbies, side jobs and the incredibly humble beginnings of scientific contribution for the greater good of society.   While Netflix has 182.8 million subscribers, Pandemic, became No. 7 on the most-watched TV shows on the Netflix service in the U.S. according to this article on Adweek.com by Kelsey Sutton on March 17, 2020: https://www.adweek.com/tv-video/pandemic-related-programming-surges-on-netflix-amid-coronavirus-spread/. Thanks to Sarah’s Netflix debut and success, she and her colleagues have appeared on several media outlets in the last couple of months. While Pandemic focused on the flu virus, Sarah explains that after Dr. Jacob Glanville (CEO of Distributed Bio) attended an annual biothreats meeting in Washington D.C. in January, he realized the novel coronavirus outbreak was not going to be confined lending way to highlight Distributed Bio’s therapeutic antibody discovery technologies for rapid pathogen response.   In this interview, Sarah announces Distributed Bio’s new press release that three independent laboratories have confirmed that multiple Centivax antibody therapeutic drug candidates are very potent neutralizers of the new coronavirus. Learn more at www.centivax.com/covid19. As Director of Contract Research, Sarah tells the story of Distributed Bio’s success as a self-funded biotechnology business, a rare business model for biotech companies which are usually funded by venture capital. She also discusses the Centivax universal influenza vaccine program, for, which she is the lead scientist. We are honored to highlight Sarah’s story and the efforts of this innovative biotechnology company on the Legal Drugs Podcast. To learn more about Sarah, https://www.distributedbio.com/sarah.  Please consider becoming a patron on www.patreon.com/legaldrugspodcast.  Follow us on Instagram and TikTok at @legaldrugspodcast or on LinkedIn at "Legal Drugs Agency." You can follow our host, Angela, on Twitter @stoyoy.    This episode edited and produced by Margaret Beveridge. 
Angela Stoyanovitch, host of the Legal Drugs Podcast, sits down with Dr. Tom Villani, PhD, Founder and Chief Science Officer at Visikol Inc. during the 58th annual meeting of the Society of Toxicology that took place in Baltimore, MD in March 2019. Angela and Tom record this bit in the booth during the ToxExpo exhibit hall to introduce their product, services and founding story.   When Tom was a graduate student studying medicinal chemistry at Rutgers University, his advisor frequented remote villages in Africa around thirties weeks a year collaborating with medicine men and women.  He returned with many varieties of plant material which they then had to classify by the plant’s genius and species. He describes their methods of determination as a sort of forensic investigation called botanical microscopy. When they attended a course to learn how to use this method, they discovered a “date rape” type-drug would be used in the methodology. This drug is called Chloral hydrate which has limited use as a sedative and hypnotic pharmaceutical drug but is a useful laboratory chemical reagent and precursor. While it has no legitimate medical use and is no longer available on the legal drug market.  Tom was shocked to learn this was the standard material used for botanical microscopy.  From there, he set out with his advisor to discover a product that was not an illegal narcotic.  After a few publications, he decided to spinoff a company to launch the product to be used to examine a variety of tissues and cells.  He made the first batch in his mom’s basement! After an entry on Wikipedia and a simple website, he onboarded a CEO, raised investment money and took his company, Visikol, Inc. to the next level. Eventually, they licensed the product to Thermo Fisher Scientific who calls the product, CytoVistatm Tissue Clearing Reagent. Today, the company focus on the services they offer to customers.  During the interview, Angela is handed a one-day-old mouse that was stained and cleared with their product. (Check out the photos on our social media accounts!) Tom explains there are many uses for this clearing agent including the examination of brain tissue, for example, and other neuroscience projects.  He points out a company across the exhibit hall that uses the product for their nerve on a chip model.  He describes the benefit of a tissue clearing technique as one that provides a full picture as opposed to a cross-section of the problem at hand.  Tom offers an analogy of determining an issue with your car but only seeing a cross-section picture.  It would be more difficult to diagnose this issue with the car without seeing the whole view.  He equates this to the value of tissue clearing techniques as being able to examine the area of disease within a tissue as opposed to a cross-section view. Rather than relying on statistical techniques to extrapolate what’s going on in tissues, Visikol’s product and service offers a way for researchers to count every cell and figure out exactly what’s going on at each point in a given tissue.   Learn more at www.visikol.com.  This episode edited and produced by Margaret Beveridge.
On today's episode of the Legal Drugs Podcast, host, Angela Stoyanovitch, spoke with entrepreneur and consultant, Jody DeBold of JD Preclinical Services. Jody speaks about the importance of building strong relationships with her clients in the early phases of the pharmaceutical process. It is important to Jody to work with strong groups who are focused on providing quality solutions while doing all they can to bring those solutions of value that improve patient care all the way to the marketplace. Jody's passion for helping people is undeniable. You may hear Jody and Angela get a little choked up when we start to think about the impact our industry has on everyone's lives. Jody's experience has been focused around early phase work which includes pharmacokinetics, histology, immunohistochemistry and pathology. This work involves different studies where animal and/or human tissues are evaluated for toxicity and other potential negative and positive affects a certain drug could have on the eventual patient.  Due to gaining knowledge and insight to how drugs make it to marketinside this mysterious industry, Jody has proudly been able to advise her own parents, who have suffered with disease and had to rely on legal drugs for support and treatment. Jody describes the importance of drug drug interaction studies and 24-hour studies, for example, to help doctors figure out the correct dosages for their patients.   This episode was recorded live at the Society of Toxicology annual meeting in Baltimore, MD in March 2019.  So please excuse some of the background noise as people walk behind us.  Regardless, I hope you can feel the purpose and impact that Jody provides to the human affect of the legal drugs business.  This episode edited and produced by Margaret Beveridge.
The new #COVID19 corona virus pandemic has changed the world as we knew it in many ways.  As scientists and government regulatory bodies rush to find a cure, treatment or therapy for those infected and affected by this new disease, we pause to reflect on the role that laboratory animals will play in bringing a new legal drug to market. While there may be exceptions to the rule (such as in the case of state legalized marijuana in the United States), legal drugs don’t hit the market without extensive safety and efficacy testing in animal models.  Animal research can be a taboo topic when so little information is known about the facts.  In this week’s episode, Legal Drugs Podcast host, Angela Stoyanovitch (B.A., LATG), introduces Dr. Cindy Buckmaster, PhD, CMAR, RLATG). Cindy is an outspoken advocate for necessary animal-based research and animal welfare.  She loves animals and honors the role they play in our lives.   In the mid 1990s Cindy left her tenure career as a high school science teacher to study how the brain supports learning and memory. All of her work was with monkeys. In this process, Cindy learned important truths about animals in research.  After earning her doctorate in Neurobiology and Behavior at SUNY Stony Brook and completing her postdoctoral work at the National Institutes of Health (NIH), Cindy decided she would dedicate her career to the compassionate and emotional connection we humans share with animals within biomedical research settings.  She noticed a lack of emotional validation of the natural bonds formed between animals and the people working with them and created training and education programs for researchers and laboratory animal professionals that focused on care that was excellent, as well as compassionate.  From there she set out to encourage cultural change within this niche space of biomedical research with laboratory animal science professionals worldwide that included the need to share their truth with the public. Cindy was the director of the animal care program at Baylor College of Medicine, among the largest in the nation, for over eight years and holds critical roles in the laboratory animal science field as Chair of Americans for Medical Progress (AMP), President of the Texas Society for Biomedical Research (TSBR), and Director of Public Outreach for the National Animal Interest Alliance (NAIA). Her advocacy efforts also including a term as president for the American Association for Laboratory Animal Science (AALAS), as well as the Laboratory Animal Welfare Training Exchange (LAWTE). We honor all of those healthcare and laboratory animal caregivers putting their lives on the line for our health and safety during this worldwide crisis.  We also honor the animals who are the real heroes in this story and who represent our biomedical future. To learn more about the field of laboratory animal science, you can go to this AALAS website:  https://care.aalas.org/ On the role of animals in research, you can learn more at the Americans for Medical Progress websitehere: https://www.amprogress.org/animalresearch/faqs/ here: https://www.amprogress.org/love-care-progress-video/ and here: https://www.comeseeourworld.org/ For more information on Dr. Peter Hotez, MD, PhD, we recommend you follow him on Twitter: https://twitter.com/PeterHotez?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor The source our of audio clip from Dr. Anthony Fauci was found here; https://fbresearch.org/covid-19-resources-page/ Thank you for supporting Legal Drugs Podcast! If you would like to become a patron, join us at patreon.com/legaldrugspodcast to make a monthly pledge.
In this week’s episode (19), Angela Stoyanovitch, host of Legal Drugs Podcast, expands on episode 18’s reflections of the corona virus pandemic that’s shutting down the world right now.  Angela notes that there is also a great opportunity to break rules of play for what it takes to get a drug to market with this new and urgent #COVID19 crisis. The Food and Drug Administration (FDA) in the U.S. has a compassionate drug use study (for Investigational New Drug or IND) for a new, unapproved drug to treat a seriously ill patient when no other treatments are available. Many biotechnology and pharmaceutical companies are working around the clock to come up with a new drug to cure or treat this disease.  This means some of the “rules” are being broken in order to come up with a breakthrough drug for this outbreak. Usually, it takes years to get a drug to market (10-20 years and $1-2B USD.) The process includes many years of animal testing, too.  Many biomedical researchers are concerned how quickly biotechnology is working towards a cure, perhaps skilling vital safety tests (in animals) before injecting into humans.  A lot is yet to be determined but two things remain true.  1) Corona virus is not a new virus, COVID19 is new. We have some previous research to go off of for this development. 2) With the use of deep machine learning, software and artificial intelligence for drug discovery and drug development, we can get a lot done in a shorter amount of time.  This pandemic may test the real issue of all time for the legal drug business which is how long will it take to get a vaccine or cure to market? For the latest updates on #COVID19, we recommend following the World Health Organization (WHO) on their website https://www.who.int. Become a patron member on patreon.com/legaldrugspodcast and get on the inside of Angela’s reflections, sneak peaks and a hand-written postcard (if you’d like!) Thanks for listening from around the world to Legal Drugs Podcast. This episode edited and produced by Margaret Beveridge.
The Hispanic Organization for Toxicologists (HOT) is a special interest group of the Society of Toxicology (SOT.) HOT was founded in 2004.  HOT is a group of toxicologists of Hispanic origin who interact with Spanish and Portuguese-speaking scientific communities with an emphasis on outreach to the Hispanic population.  They help relay information and awareness on toxicological news to global Hispanic communities. They focus on mentoring junior scientists and trainees and encourage and support collaboration among Hispanic toxicologists. https://www.toxicology.org/groups/sig/hot/index.asp(scroll down to find the Hispanic Organization of Toxicologist Award Fund) During the 58th annual meeting for SOT, Angela Stoyanovitch, host of Legal Drugs Podcast, reconnected with Dr. Robert Casillas, PhD, a biochemical toxicologist consulting on nonclinical research, former HOT President and was introduced to the new HOT President, Dr. Ranulfo Lemus Olalde, ScD, a human health toxicologist working with consumer products.  In this short interview, Angela learns about the mission of HOT and the role of toxicology in the world, today. Member of SOT and HOT would have gathered this week for the international meeting comprised of academic, government and commercial (pharmaceutical, for example) for the 59th Annual Meeting.  However, while authorities continue to maintain that the risk of exposure to COVID-19 is low, after lengthy and thoughtful deliberations, SOT leadership made the decision to cancel the SOT 59th Annual Meeting and ToxExpo scheduled to take place March 15–19, 2020, in Anaheim, California. Therefore, Legal Drugs Agency, LLC dedicates this Legal Drugs Podcast episode to members of SOT, HOT and all other special interest groups apart of SOT who were unable to travel to share news, updates and toxicological data with each other face-to-face this year.   If you’d like to contribute to HOT’s travel awards fund for future generations, please learn more about the goal to raise $25,000 to match Dr. Ranulfo Lemus Olalde’s initial endowment here; https://www.toxicology.org/endowment/docs/Resolution-HOT-AwardFund.pdf#search=%22hispanic%20organization%20of%20toxicologists%22 This episode of Legal Drugs Podcast edited and produced by Margaret Beveridge.
Have you heard the term life-science? What is the life-science industry? On this episode of Legal Drugs Podcast, Angela Stoyanovitch, host, interviews Ted Toburen, an independent consultant focused on global strategy development and execution at his firm, T Squared Consulting, LLC. With about 25 years of global animal health and animal nutrition experience, Ted describes and defines his view on the vastness of life science fields from pharma to animal health, vaccine manufacturing and agriculture practice with a niche in poultry health.  With a stent in executive search recruiting, Ted talks about how he networks at events such as the LaunchBio monthly gathering in Durham, NC for candidates and client recruitment for human to animal health areas of expertise.  Today, he is consulting on global developments of products that impact society’s health from food to legal drugs. He describes the importance of healthy food for humans and pets to ensure both physical and emotional health of humans.  His passion for animal science started with a job at a veterinarian hospital which led to many commercial roles for the top pharma, agriculture and animal health companies around the world!  This episode will give you insights into how the animal health industry relates to human interests and its role in the food chain. LaunchBio is a national network of life science innovators working for the benefit of human health and well-being. For more information about LaunchBio go to https://launchbio.org/. This episode of Legal Drugs Podcast is edited and produced by Margaret Beveridge.
During the largest health care conference in the year, JP Morgan and Biotech Showcase, Legal Drugs Podcast host, Angela Stoyanovitch, meets with visionary Ping Yeh, CEO and Co-Founder of StemoniX at a café in downtown San Francisco, CA,. StemoniX converts skin cells into stem cells for brain and heart cells that are referred to as human organoids or human microOrgan. You know we love to highlight the innovative aspects of the legal drugs business, so we are taking it up a notch! As an engineer and a survivor of cancer, Ping was trained in this business as a patient. He brings a unique mindset and experience to the table by thinking systematically and programmatically. Thanks to his project management experience, he creates a new approach that leads to a way to test cancer drugs never done before.  Today, much of the industry has adapted some of the ideas he had envisioned in 2014. Ping explains, when he had cancer, his heart had to be monitored due to the danger of the drugs. He wondered if there was a way to test these drugs to ensure they were safe and effective on humans without humans or animals playing the role of “guinea pig.”  He started doing his own research and reading as much as he could about the topic. At that time, he learned about a Nobel Prize winning method to convert skin cells to stem cells. He wondered why the industry wasn’t using this on a massive scale? This question led to the founding of his company.  He explored how to grow a lot of stem cells and how to use them to create safer drugs with the use of technology and software.   Today, Ping has been able to leverage champions in the industry to create a major swing in standard practices. He has been able to convert 80 customers (representing some of the top pharma companies in the world) who were previously (and predominately) using animal models. With augmented AI and a lot of software, such as machine learning (equations that predict which drugs are going to be safe or effective or not) Ping’s company, Stemonix, approaches products that reduce and refine the legal drugs business by skipping research steps through the converging of software and biology!  For more information, go to www.stemonix.com. Interested in supporting our podcast? Please consider making a monthly pledge as low as $1 by going to www.patreon.com/legaldrugspodcast.  Thank you for your support in advance!   This episode of Legal Drugs Podcast was edited and produced by Margaret Beveridge.
What does coding a computer and coding a human cell have in common? Jeff Galvin, CEO at American Gene Technologies International Inc. (AGT), explains to Legal Drugs Podcast host, Angela Stoyanovitch, during the week of JP Morgan/Biotech Showcase conference in downtown San Francisco, CA.  Check out Episode 14 “Funding the Future of Legal Drugs from the Streets of San Francisco; A Recap of The Biotech Showcase by Angela Stoyanovitch,” for more background content on the setting of this recorded interview. You will hear Angela describe the new surge of focus on gene and cell therapies which are a more targetd way of developing legal drugs, today. AGT has a mission to leverage the power of gene and cell therapy to reduce human suffering from serious human disease.  So, how do they do this and what does it have to do with technology?  Thanks to Jeff’s background as a Computer Scientist and Technologists, the most complex of ideas is made simple in this episode of the podcast.  You will learn what the human body or human cell have in common with the computer which uses zeros and ones to operate it’s systems and software.  Jeff explains that your cell is the ultimate, sophisticated organic computer. He breaks down letters such as ACTG which are the DNA nucleotides and draws a parallel to how cells can be hacked just like a computer.   What does this mean for the future of legal drugs? Gone are the days where chemists and drug developers mix together chemotherapies that simply aren’t working to cure disease. Now, with AGT’s new platform, using the fundamentals of software development, for finding new drug candidates and discovering new drugs, Jeff boasts that legal drugs can be developed more specifically and more profitably.  AGT is now a machine for cell and gene therapies. Jeff and the team at AGT are awaiting news from the U.S. Food and Drug Administration (FDA) to head to the clinic to test a new HIV cure (pending FDA approval after filing an IND – Investigational New Drug program for permission to start a human clinical trial.)  This episode of Legal Drugs Podcast was edited and produced by Margaret Beveridge. 
In this special one-year-anniversary edition of Legal Drugs Agency, LLC, producer of Legal Drugs Podcast, Podcast Host, Angela Stoyanovitch, walks you through her impressions on how commercial fundraising takes place, the future of legal drugs in development and new innovations on the horizon as it relates to our biologic systems and pharmaceutical developments.  Every year, the largest global healthcare conference takes place in and around the streets of downtown San Fransisco, California with over 12,000 participants networking their way around their next deal in biotechnology, digital health and or many other forms of innovation with the biggest banks of the world, venture capitalists and angel investors, for example.  It's an event much like speed-dating but for biotechs and bankers resulting in a marriage of science and finance at its best, sealed by the hope that technology brings to today's innovators and inventors.     At a meeting we once thought was reserved for C-suite executives only, we are honored to have uncovered personal stories from the latest in biotechnology innovations as a new media agency! Join us in celebrating Legal Drugs Agency's first year in business by considering corporate sponsorship, today.     Thank you to EBG Group and Demy-Colton for co-producing this amazingly executed conference as well as providing Legal Drugs Agency access to this incredible meeting for press and podcast coverage, introducing us to the latest trends in the market and the hottest biotech companies to watch in the new year! To learn more about the meeting, please go to https://informaconnect.com/biotech-showcase/, brought to you by informa Connect.    Please consider becoming a member of Legal Drugs Podcast on Patreon by joining us here; https://www.patreon.com/legaldrugspodcast.  Thank you in advance for your monthly contribution (as low as $1/month.) Your support and participation helps us travel to meetings such as The Biotech Showcase in order to report the latest in the legal drugs business.   Stay tuned for the upcoming episodes recorded LIVE with the CEO's of companies such as American Gene Technologies and Stemonix.  This episode edited and produced by Margaret Beveridge.
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