By Angela Stoyanovitch
The podcast currently has 34 episodes available.
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, [email protected].
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.
The podcast currently has 34 episodes available.