Podcasts about regulatory science

Send us a textOn this episode we speak with Dr. Jesse Goodman about the spread of the H5N1 virus.  We will discuss what a virus is, how viruses migrate from animal populations to humans and assess the chances for a new pandemic.Jesse L. Goodman, M.D., M.P.H., directs Georgetown COMPASS, which focuses on science based policy and research to address unmet public health needs with an emphasis on product development and access and antimicrobial resistance and stewardship. Until February 2014 he served as the Chief Scientist of the US Food and Drug Administration (FDA), a position he assumed in 2009 along with Deputy Commissioner for Science and Public Health (2009-2012). As FDA's Chief Scientist he had broad responsibility for strategic leadership of crosscutting scientific and public health efforts, including developing and implementing FDA's Strategic Plan for Regulatory Science and FDA's public health preparedness and response and medical countermeasures efforts.A graduate of Harvard, Dr. Goodman received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training in Medicine, Infectious Diseases and Oncology at the Hospital of the University of Pennsylvania and at the University of California in Los Angeles (UCLA), where he was also Chief Medical Resident. https:/natureandsciencepodcast.com

We welcome Meredith Brown-Tuttle to AI Uncovered.  Meredith is the Chief Regulatory Strategist at Regulatorium, where she applies her 33 years of experience in the pharmaceutical and biologics industry. She specializes in working with small and medium-sized drug, biologic and combination product companies to navigate global regulatory strategy, intelligence and submission requirements. With a strong focus on innovation, Meredith is dedicated to revolutionizing regulatory science by integrating AI and in silico modeling into every stage of drug development. Most recently, Meredith has focused on advancing global regulatory science through the development of AI tools, aiming to streamline submission processes and improve outcomes for the industry. Her vision includes a future where entirely digital INDs, BLAs and NDAs become standard practice, supported by the widespread use of in silico modeling, digital twins and federated data sharing to enable collaboration without compromising proprietary information.In this episode, Tim  and Meredith explore the evolving landscape of global regulatory strategy and how AI can revolutionize regulatory science. Meredith shares insights from her extensive career, including her experience in crafting INDs and NDAs, her thoughts on transforming data validation standards across the industry and providing strategic guidance to companies navigating complex regulatory requirements. She also delves into the challenges and opportunities presented by AI. In addition to her work at Regulatorium, Meredith serves as a board member at the Alliance for Artificial Intelligence in Healthcare (AAIH), showcasing her commitment to leveraging innovation in regulatory affairs. Meredith is also an accomplished author of over 70 articles and two books, and she has trained thousands of professionals on writing INDs and conducting effective regulatory submissions. Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

On this episode host Fred Goldstein invites Elizabeth Powers, Vice President and General Manager, Regulatory Science and Study Innovation at IQVIA, to discuss Real World Evidence. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

On this episode of the IPhO Podcast, we're joined by Marla Quintana, PharmD, RPh, a second-year Regulatory Sciences Advertising and Promotion Fellow at Biogen/MCPHS; Ibrahim Hegazy, PharmD, a second-year GRA/RAI Regulatory Strategy Fellow at Merck/Rutgers; and Lana Zaki, BPS, PharmD, a Rutgers fellowship alumna who completed her fellowship in Regulatory Affairs Global Labeling Strategy at Novartis. Each guest shares personal anecdotes from their journey into regulatory affairs, starting with fellowship experiences that shaped their careers in pharma. They explore the diverse areas within regulatory sciences—advertising and promotion, regulatory strategy, and global labeling—offering insights into how these functions come together to support product development and market access. Additionally, Marla, Ibrahim, and Lana discuss the challenges and rewards of their work, the skills they've found essential for success, and their advice for PharmD graduates looking to break into the industry.

In this episode of the Safer Chemicals Podcast, we dive into ECHA's new initiatives in advancing non-animal testing methods through the New Approach Methodologies Framework Contract.Our guests, Sylvia Escher from the Fraunhofer Institute for Toxicology and Experimental Medicine, and Tomasz Sobanski from ECHA's Alternative Methods Team, discuss research projects aimed at transforming how chemicals are assessed for safety.Useful linksECHA to investigate new test method potentially replacing toxicity testing with fish - ECHA news 13 November 2024Animal testing under the REACH Regulation**************Subscribe to our YouTube channelSubscribe to our Safer Chemicals PodcastSubscribe to our newsFollow us on:TwitterFacebookLinkedInVisit our website Disclaimer: Views expressed by interviewees do not necessarily represent the official position of the European Chemicals Agency. All content is up to date at the time of publication.Hosted by Ausha. See ausha.co/privacy-policy for more information.

DON'T BAN SMOKELESS TOBACCO PRODUCTS, DENVER The City Council is considering a ban, but I've got an actual doctor, Dr. Brian Erkkila, Director of Regulatory Science at Swedish Match North America to be exact, who says that banning those products takes away an important option smokers use to quit smoking. I'm talking to him today about it, but you can read about the proposed ban here and here. He joins me at 1pm.

Jamie Hartmann-Boyce and Nicola Lindson discuss emerging evidence in e-cigarette research and interview Stephen Higgins from the University of Vermont Associate Professor Jamie Hartmann-Boyce and Associate Professor Nicola Lindson discuss the new evidence in e-cigarette research and interview Professor Stephen Higgins from the University of Vermont Tobacco Center of Regulatory Science, Burlington, USA. Professor Stephen Higgins uses the concepts and methods of behavioural economics and behavioural pharmacology to investigate tobacco, illicit drugs, and other health-related risk behaviours in vulnerable populations. In the October podcast Stephen Higgins describes his recent studies on reduced nicotine cigarettes and e-cigarettes in high-risk populations. Their three randomised clinical trials involved 326 participants. They found that decreases in cigarettes smoked daily, resulting from smoking cigarettes with reduced nicotine content, were significantly larger when adults from at-risk populations had access to e-cigarettes in their preferred flavours. Their study findings indicate that access to preferred flavoured e-cigarettes has the potential to enhance the effect of a nicotine-reduction policy on cigarette smoking in populations with psychiatric conditions or lower education level who are at greatest risk for smoking and associated harm. This podcast is a companion to the electronic cigarettes Cochrane living systematic review and shares the evidence from the monthly searches. Our literature searches carried out on 1st October found: 2 new studies. The study by Higgins et al described on this podcast (DOI: 10.1001/jamanetworkopen.2024.31731) and DOI: 10.1093/ntr/ntae212. We also found 3 linked papers (10.2196/58260, 10.1111/add.16633, 10.1038/s41415-024-7850-5) For further details see our webpage under 'Monthly search findings': https://www.cebm.ox.ac.uk/research/electronic-cigarettes-for-smoking-cessation-cochrane-living-systematic-review-1 For more information on the full Cochrane review updated in January 2024 see: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub8/full This podcast is supported by Cancer Research UK

In this episode of the Safer Chemicals Podcast, host Adam Elwan is joined by Roberto Scazzola, the Chair of ECHA's Risk Assessment Committee and Maria Ottati who chairs the Socio-Economic Analysis Committee to discuss the ongoing efforts and challenges in regulating harmful chemicals.The episode focuses on the universal PFAS restriction proposal, addressing its persistency and health impacts, and the committees' approach to evaluating different sectors in batches.They also explore the initial discussions on harmonising the classification and labelling of talc, and the steps towards recommending occupational exposure limits for bisphenol A (BPA).Tune in for the latest updates on the committees' work in protecting health and the environment, their socio-economic implications, and the vital role of stakeholder contributions in this complex process.Useful linksMore episodes on the committees for risk assessment and socio-economic analysis Give us feedback MoreJune RAC and SEAC meeting highlights  - ECHA news, 13 June 2024Agenda of RAC's meeting   [PDF] [EN] Agenda of SEAC's meeting  [PDF] [EN] REACH restriction process Harmonised classification and labelling Risk Assessment Committee Socio-Economic Analysis Committee**************Subscribe to our YouTube channelSubscribe to our Safer Chemicals PodcastSubscribe to our newsFollow us on:TwitterFacebookLinkedInVisit our website Disclaimer: Views expressed by interviewees do not necessarily represent the official position of the European Chemicals Agency. All content is up to date at the time of publication.Hosted by Ausha. See ausha.co/privacy-policy for more information.

Bert Leufkens is emeritus hoogleraar Regulatory Science and Pharmaceutical Policy  en voormalig voorzitter van het College ter Beoordeling van Geneesmiddelen (CBG).***Volg Leaders in Life Sciences via de website.Volg Leaders in Life Sciences via LinkedIn.Bezoek www.henkjanout.nl voor meer informatie over de host.***Vragen, suggesties of feedback? Graag! Stuur een email naar: henkjan.out@me.com***Vind jij de Leaders in Life Sciences podcast leuk? Dan zouden we het enorm waarderen als je een recensie zou willen achterlaten op Apple Podcasts of een vijf sterren beoordeling zou willen geven op Spotify.Jouw steun betekent veel voor ons, omdat het anderen kan aanmoedigen om de podcast ook te gaan beluisteren. Heel erg bedankt!***Leaders in Life Sciences wordt mede mogelijk gemaakt door Pivot Park, Pedersen & Partners, Johnson & Johnson, en Scribes Tax Lawyers.

David Morin, DFO's Director General of Ocean and Regulatory Science, says new report finds that salmon escapes on parts of Nfld's south coast pose high risk to salmon abundance and genetics + Doreen Taylor of the Seafood Shop in Churchill Square on Good Friday fish traditions

Brian Erkkila, Director of Regulatory Science for Swedish Match, joins Kurt & Anthony to discuss his testimony on a bill in committee, considering banning flavored tobacco products.

Join us for an enlightening conversation with Jessica Braymiller Knapp, PhD, an expert in prevention science and a dedicated tobacco researcher. Dive into the core of addiction, prevention science, and more.Jessica L. Braymiller (she/her) is a clinical assistant professor and public health researcher focused on understanding nicotine and cannabis use among adolescents and young adults. Her current work centers on e-cigarette use/vaping and associated health outcomes, other emerging modes of tobacco and cannabis delivery, and device characteristics that facilitate initiation and continued use of both substances. Prior to joining the faculty in Community Health and Health Behavior, Dr. Braymiller was a postdoctoral scholar at the University of Southern California in the Tobacco Center of Regulatory Science. Dr. Braymiller completed her PhD in Biobehavioral Health and her MS in Biobehavioral Health at The Pennsylvania State University. She received her BA in Psychology from Mercyhurst University.Credits:Hosts/Writer: Sarah Robinson, MPH Guest:  Jessica Braymiller Knapp, MS, PhDProduction Assistant/Audio Editor: Sarah Robinson, MPH Theme Music: Dr. Sungmin Shin, DMA Follow us!Official WebpageBuzzsproutSpotifyApple PodcastsYoutubeInstagramFacebookTwitter

Recorded at NC Life Sciences Organization's Annual Meeting, our hosts Heather and Lauren welcome Dr. Ehsan Samei and Dr. Susan Halabi, leaders of the new Triangle CERSI, which stands for the Center of Excellence in Regulatory Science & Innovation. We discuss Triangle CERSI's collaborative efforts with the FDA & Universities, their commitment to training the future generation of scientists, and how they make regulatory science more efficient, proficient, & cost effective. Listen to episode 167 now!

In this episode of Wheelchair Nerds, we're joined by Bobby Brown, a clinical psychologist and end user, and Kara Kopplin, Director of Regulatory Science for Permobil to discuss how science meets application in wheelchair cushion design. Bobby shares his personal journey of discovering the immense importance of selecting the perfect cushion for his needs, while Kara provides valuable insights into the rich history of ROHO and the underlying principles that drive their innovative designs.

In this episode, Ellie Schwab and Pam Divack discuss all things clinical trial innovation, real-world evidence, and the future of tech and healthcare, with Craig Lipset. Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Mr Lipset was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Mr Lipset designed and launched multiple industry firsts — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants. He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research, the MedStar Health Research Institute, and the People-Centered Research Foundation (the central office for PCORnet), as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. The Healthcare Community at Kellogg is always looking to collaborate with industry leaders. To learn more about Healthscape or the Kellogg Healthcare Club, please contact Pam Divack. 

This episode features an interview with Dr. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr. Young discussed with Xtalks in this podcast episode.Dr. Young is Processa's initial founder, President of R&D and former President and CEO. He has over 30 years of pharmaceutical research, drug development and corporate experience. He served on the Board of Directors and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. He has also served on FDA Advisory Committees and has been a key team member on more than 30 NDA/supplemental NDA approvals. Dr. Young received his Pharm D-PhD with emphasis in Pharmacokinetics and Pharmaceutical Sciences from the University of Southern California.Tune into this episode to hear from Dr. Young about Processa's developmental pipeline and the promise of personalized, next generation chemotherapies. Learn about Processa's regulatory science approach to drug development and the changing landscape of cancer treatment.For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, host Shikha Jain, MD, speaks with Cardinal Health's Parisa Asgarisabet, PhD and Scott Swain, PhD, MPH about benefits and uses of real-world evidence, the issue of diversity in clinical trials and more. •    Welcome to another exciting episode of Oncology Overdrive 1:11 •    About Swain 1:26 •    About Asgarisabet 2:45 •    The interview 3:30 •    About Swain and how you ended up at Cardinal Health 3:50 •    About Asgarisabet's journey and how she ended up at Cardinal Health 5:09 •    What is Cardinal Health and why should people know about the work they are doing? 6:37 •    How is the work Cardinal Health is doing directly applicable to practicing oncologists?  7:30  •    Jain, Asgarisabet, and Swain on Representation of age, race and ethnicity in real-world evidence (RWE), randomized clinical trial (RCT), and Surveillance, Epidemiology, and End Results (SEER) cancer patient registry data in advanced renal cell carcinoma (aRCC). 10:32 •    How can we scale real world data in a bigger way and make this the standard as opposed to the exception? 14:02  •    Jain and Swain on diversity, equity, and inclusion in the clinical trials design space 17:57 •    Asgarisabet and Swain on the economic implications of a lack of diversity in clinical trials 19:53 •    Swain and Jain on the importance of community engagement and outreach in achieving diversity of backgrounds in clinical trials 24:42 •    What do you think are the next steps to implement real world data in order to make a larger impact? 27:38 •    Should real world data be used in concert with randomized controlled trials or should this data be used independently? 29:02 •    When we talk about these types of transformation in how we look at diseases and deciding the best plan of action, do you anticipate there being a challenge with insurance companies approving treatments using real world data? 30:27 •    If someone could only listen to the last two minutes of this episode, what would you want them to take away? 35:18 •    How to contact Swain and Asgarisabet 37:57 •    Thanks for listening 39:13 Scott Swain, PhD, MPH is a Director of Regulatory Science and Real-world Evidence with Cardinal Health. Parisa Asgarisabet, PhD is a Lead statistician in the Real-World Evidence & Insights team at Cardinal Health. We'd love to hear from you! Send your comments/questions to Dr. Jain at oncologyoverdrive@healio.com. Follow Healio on Twitter and LinkedIn: @HemOncToday and https://www.linkedin.com/company/hemonctoday/. Follow Dr. Jain on Twitter: @ShikhaJainMD. Asgarisabet can be reached via LinkedIn or via email parisa.asgarisabet@cardinalhealth.com. Swain can be reached via LinkedIn or via email scott.swain@cardinalhealth.com. Disclosures:  Jain reports no relevant financial disclosures. Asgarisabet and Swain are employees and shareholders of Cardinal Health.

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In this episode, we delve into the realm of AI regulation and its impact on the future of medical AI innovation in UK. Joining me is the esteemed Professor Stephen Gilbert, a medical device regulatory science academic. During our discussion, we explore: The necessity for innovative regulatory approaches in the AI domain The diverging paths of EU and US regulatory strategies Challenges posed by the EU MDR approach and its horizontal regulatory system Pioneering approaches to regulation, emphasising system rather than product-level oversight Relevant publicatons: https://www.jmir.org/2023/1/e43682 https://www.nature.com/articles/s41591-023-02412-6https://www.sciencedirect.com/science/article/pii/S2949761223000421

Dr. Namandjé Bumpus, Ph.D. is U.S. Food and Drug Administration's (FDA) Chief Scientist ( https://www.fda.gov/about-fda/fda-organization/namandje-bumpus ). The Office of the Chief Scientist supports the research foundation, science, and innovation that underpins the FDA's regulatory mission. It does this through a broad framework that encompasses scientific collaborations, laboratory safety, the transfer of FDA inventions to the private sector, scientific integrity in FDA policy- and decision-making, the professional development of regulatory scientists, and its core research component—the FDA's National Center for Toxicological Research—which generates the vital data that the FDA requires for its regulatory decision-making and development of sound regulatory policy. Before joining the FDA, Dr. Bumpus was the E.K. Marshall and Thomas H. Maren Professor and chair of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. She served previously as associate dean for basic research in the Johns Hopkins University School of Medicine. Dr. Bumpus' research has focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology. Dr. Bumpus joined the faculty at Johns Hopkins in 2010 as an assistant professor. She earned a bachelor's degree in biology at Occidental College in 2003, a doctorate in pharmacology at the University of Michigan in 2007 and completed a postdoctoral fellowship in molecular and experimental medicine at The Scripps Research Institute in La Jolla, CA in 2010. Dr. Bumpus currently serves as president-elect of the American Society for Pharmacology and Experimental Therapeutics. She previously served as chair of the NIH Xenobiotic and Nutrient Disposition and Action study section. Her many honors include the Leon I. Goldberg Award from the American Society for Clinical Pharmacology and Therapeutics, the James Gillette Award from the International Society for the Study of Xenobiotics, the John J. Abel Award in Pharmacology from the American Society for Pharmacology and Experimental Therapeutics and the Presidential Early Career Award for Scientists and Engineers, which is the highest honor bestowed by the United States government on early career scientists and engineers. Dr. Bumpus is an elected fellow of the American Association for the Advancement of Science. She became a Member of the National Academy of Medicine, Class of 2022, one of the highest honors in the fields of health, science and medicine. Support the show

Tia Lyles-Williams, D.Sc. is a Two-Time Life Science Start-Up Founder – Founder & CEO of LucasPye BIO, a Contract Development Manufacturing Organization (CDMO); and Founder & CEO of HelaPlex, the 1st Commercial Life Science Accelerator for Seed-Level Life Science Start-Ups and Virtual Biotechnology Companies. In fact, LucasPye BIO is a strategic partner of Thomas Jefferson University's Jefferson Institute for Bioprocessing (JIB). Dr. Lyles-Williams is the 1st African American Queer Woman to own and lead a biopharmaceutical manufacturing company – 68 years after the 1st African American Man, Dr. Percy Lavon Julian with his company, Julian Laboratories, Inc. in Chicago, IL. She received her Bachelor of Science in Biology from Howard University, Master of Science in Entertainment Business from Full Sail University, and a Master of Science in Regulatory Science from University Southern California. On May 12, 2022, Dr. Lyles-Williams was conferred as an Honorary Doctorate in The Sciences from the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, PA. Most recently, Dr. Lyles-Williams participated as a panelist at The White House discussion Biotechnology and the Bioeconomy in the U.S. via the U.S. White House Summit on Biotechnology and Biomanufacturing. Link: https://youtu.be/U2bdz5HE1zM Dr. Lyles-Williams has been working in the biotechnology / biopharmaceutical industry for 22+ years – including formerly interning at the National Institutes of Health (NIH) as well as a former contractor at Walter Reed Army Institute of Research (WRAIR in Silver Spring, MD). Her former employers include Human Genome Sciences, Inc. (now GSK) – Rockville, MD; Amgen, Inc. – Thousand Oaks, CA; Baxter BioScience (now Takeda) – Thousand Oaks, CA; Avid Bioservices – Tustin, CA; Lonza Pharma & Biotech – Portsmouth, NH; and Jazz Pharmaceuticals, PLC – Philadelphia, PA. Find Dr. Tia Online! https://www.linkedin.com/in/tia-l-596a484/ https://www.lucaspyebio.com/ If you're enjoying Entrepreneur's Enigma, please give us a review on the podcast directory of your choice. We're on all of them and these reviews really help others find the show. Also, if you're getting value from the show and want to buy me a coffee, go to the show notes to get the link to get me a coffee to keep me awake, while I work on bringing you more great episodes to your ears. →  https://gmwd.us/buy-me-a-coffee Follow Seth Online: Seth | Digital Marketer (@s3th.me) • Instagram: Instagram.com/s3th.me Seth Goldstein | LinkedIn: LinkedIn.com/in/sethmgoldstein Seth on Mastodon: https://masto.ai/@phillycodehound Learn more about your ad choices. Visit megaphone.fm/adchoices

As the podcast hosts insights from our very own audience this week, we are extending three additional conversations from recent reviews of a particularly exciting NASH-TAG 2023. This session features dialogue from a one-on-one interview with Donna Cryer, hosted by Roger Green.The episode begins with Roger mentioning what he found to be one of the most striking statistics from the meeting: an IQVIA study captured only 200,000 total ICD-10 codes for NASH in a total US population that should have yielded 16 million such codes. To Donna, this underscores a significant need: we have to find physicians that want to treat patients. As she puts it, “it would do more harm than good” to send patients to doctors' offices before doctors are activated to screen and treat. Roger identifies a dilemma: if patients aren't visiting doctors, doctors will not feel motivated to learn. However, if patients are seen by unmotivated doctors, a negative information loop emerges. Donna notes lessons from the hepatitis care cascade and that at the outset, there is the need to screen an “enriched population” with higher probability of NASH. Roger suggests this is easier in the US, where electronic health records are standard. In much of the rest of the world, ALT tests are not part of a standard blood panel and too many records are on paper. Donna then emphasizes the need to dramatically increase advocacy and energy among medical stakeholders. She also points to what drug and diagnostic companies can do to energize physician practices to identify the patients needing treatment after a drug is approved. Finally, Roger asks Donna to rate her level of enthusiasm emerging from NASH-TAG. He offers a scale ranging from 1 to 6, where 1 represents “thoroughly depressed” and 6 represents “over the moon.” Her response addresses organization around regulatory science in a way that makes what is undeniable inevitable. Surf on to hear her gauge.…This week, Surfing NASH has focused on community engagement and incorporating insights and perspectives from the listeners. If you enjoy our content, we kindly ask that you submit a review wherever you download our episodes. We also encourage our audience to write us questions and look forward to integrating your on-ground experiences and ideas in the weekly discourse. Most important of all, we whole-heartedly thank you for your continued support as we set out to put a major dent in Fatty Liver disease in 2023 and beyond.Stay safe and surf on!

NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend's conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.This conversation consists exclusively of an exchange between Donna Cryer and Roger Green. The session begins by Donna noting that while the data is cause for enthusiasm, she is concerned that this alone does not guarantee an inevitable approval. In addition to good data, she suggests, is the need for good regulatory science. As she points out, Intercept hit its endpoints in 2020, yet no approval was gained at the time. “Good regulatory science” is, in her words, conclusive, granular and contains a simplified message. Roger asks for an example of what might not constitute good regulatory science. This leads Donna to recall that the fireside chat, although titled regulatory, focused more on clinical trial designs than how to prepare for advisory committees, health technology assessments and Phase 4 trials. She notes that during this discussion, a good question surfaced regarding how equipoise will change once drugs are approved. The implication: what FDA is currently seeking in Phase 4 becomes unrealistic once drugs reach the market. At this point, Roger returns to Scott Friedman's comment about the “straitjacket of biopsy” and how that impacts thoughts around trial design and “proof.” Donna adds that real-world evidence is the up-to-date approach these days, and it will be available once we have more experience with the medicines. As the session winds down, Roger goes back to the adiponectin analyses predicting non-response as being his favorite part of the meeting and explains why. Donna shares that one of her favorite moments came when Claude Sirlin, a radiologist, asked how they can become more involved here. Roger responds that radiology may succeed biopsy as a “hard standard” of efficacy. In the final moments, Donna discusses some of the presented data and questions that embodied a public health perspective. 

For our look back at NASH-TAG 2023, Jörn Schattenberg and Roger Green are joined by Amy Articolo and Naim Alkhouri for a discussion which dives into the therapeutic efficacy of recently announced data on resmetirom, NITs, bariatric surgery and more. Adjoining this session is a bonus interview with Donna Cryer on her impressions and key takeaways which largely look into the movement of regulatory science. In combination, this two-part episode encompasses contrasting and thought-provoking perspectives on addressing the opportunities and challenges in moving the Fatty Liver field forward.Naim opens the first conversation by noting the positivity emitted, echoing Scott Friedman's position that momentum from Madrigal's emerging data on resmetirom animated the wider program. In addition, he highlights that granularity around Intercept's study of patient response to obeticholic acid (OCA) revealed improvements among the F3 population. For Naim, OCA is a drug he has envisioned to be applied toward advanced disease and serves undermet needs of F3 patients. He concludes that in the wake of these aforementioned results, there remains plenty of opportunity to improve and other biotechs “are still in the game” with the energy to back them.At this point, Jörn underscores the strong presence of academia and involvement of various consortia as further evidence of progress. Amy joins to comment on the vibrant and dynamic discussions around NITs and how to enrich trials. She suggests that the dialogue has reflected the advancements of the field and how work can be enhanced with collective contribution. This leads to thoughts on pharmacodynamic change and demonstrating value to payers. Roger distills a main idea: if only 24% of patients show a one-level regression of fibrosis in a given period of time, there is much to learn about the other 76%. Conversation continues around narrowing the indeterminate zone and improving biomarker concordance in NITs. After exploring considerations in moving beyond biopsy, the group investigates the role of bariatric surgery. While recognizing the validity of bariatric surgery as a treatment option, Naim points to a brighter future of preventative hepatology whereby action precedes BMI levels of 50 and higher. At the end of the session, Roger asks each panelist for one unexpected thing that might happen in the next year.In the following interview, Donna opens with a powerful statement: hope is not a strategy, and optimism is not inevitability. Specifically, she is determined to match the trajectory of regulatory science to that of the momentous energies emerging from clinical science. In doing so, relationships and open lines of communication are key for meeting agreed endpoints. Next, the two talk about addressing the indeterminate zone in a different context and opportunities for harnessing real-world evidence. As this conversation moves forward, it becomes clear that Donna is committed to connecting patients to care today, and not only after a drug approval. In closing, she fields the same question as the preceding panelists, but offers a very different answer. Surf on to find out. 

This week, we welcome three guests at the forefront of tobacco regulatory control, tobacco-related health disparities, and public engagement and education. Dr. Pebbles Fagan (Univ. of Arkansas), Mitch Zeller (FDA), and Kathy Crosby (FDA) join to share about public health efforts as well as their efforts to impact individuals and society through their professional, volunteer, … Continue reading Tobacco Regulatory Science, Health Equity, Mental Health and Public Engagement w/ Pebbles Fagan, Mitch Zeller & Kathy Crosby →

Transformative BioScience Innovations Shaping Southern Arizona E18 In this episode of AZTechCast, the official podcast of the Arizona Technology Council, accomplished bioscience leaders from the BIO5 Institute at The University of Arizona, Souvie BioDelivery and Critical Path Institute joined Council president and CEO, Steve Zylstra, to discuss the innovative bioscience innovations shaping Southern Arizona. These […] The post Transformative BioScience Innovations Shaping Southern Arizona E18 appeared first on Business RadioX ®.

In this episode, we interview Dr. Larisa Rudenko, a research affiliate at the Program on Emerging Technologies at MIT and a co-founder of BioPolicy Solutions LLC. We talk to Dr. Rudenko about her career developing regulatory guidance for genetically engineered organisms for the FDA, public perception of genetically engineered products, and tips for engineering biology trainees interested in science policy careers.For more information about EBRC, visit our website at ebrc.org. If you are interested in getting involved with the EBRC Student and Postdoc Association, fill out a membership application for graduate students and postdocs or for undergraduates and join today!

I was joined by Mr. Michael Katz, Director of Quality for Viz.aiMichael has a Bachelors of Science in Human Biology from Boise State and Masters Degree in Regulatory Science from John Hopkins.His career is off to an impressive start having joined the Med-Tech industry in 2016 as a Regulatory Affairs Analyst.In 2018 he had the opportunity to make his way into the exploding Software as a Medical Device sector today and serves as the Director of Quality for a company called Viz.aiFor those unfamiliar, Viz.Ai the company was inspired by a patient who underwent a successful brain surgery but yet died because the surgery came too late. Dr. Chris Mansi, at Stanford Business School, joined forces with machine learning post-doc Dr David Golan and together they founded Viz.Ai with a goal of using artificial intelligence to make healthcare work faster and smarter. Not just to change, but to radically transform it. In essence, the organization uses AI to synchronize stroke care, reducing systemic delays that stand between patients and life-saving treatments.Some key highlights we discussed:-How did he get into the RA/QA space to begin with?-So many want to get into SaMD and are frustrated by the catch 22 of needing experience to gain experience. How did he land his role with Viz.ai?- It begs the question, are companies overlooking talent that very well could be successful and do a great job for the organization just because they haven't worked in a SaMD environment before?-What learning curve has he been going through as it relates to SaMD specifically?-Has he hired folks from outside the SaMD space? Did they face similar learning curves, or other challenges that he hadn't thought of prior to hiring them?-What has he found different, if anything about building a Quality (and Regulatory) program in a SaMD environment vs. a traditional Medical Device Company?

Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB.  Previously she served as senior vice president, research, at the Brigham and Women's Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research integrity.  She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH. In addition to her academic responsibilities, she currently serves on the Board of Directors of Vivli, Inc., a non-profit organization founded by the MRCT Center dedicated to global clinical trial sharing; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research.  Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), on the Board of Public Responsibility in Medicine and Research (PRIM&R), and as chair of the Secretary's Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 240 publications and has served on the editorial boards of a number of journals including Current Protocols of Immunology, Blood, Therapeutic Innovation and Regulatory Science, Ethics and Human Research. Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School. Please join me in welcoming Dr. Barbara Bierer on the Clinical Trial Podcast.  This episode is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

Big Tech companies such as Google, Amazon and Microsoft are moving into AI healthcare services in a big way. But can we trust private, for-profit, companies to use our data properly? Prof Allyson Pollock, director of the Newcastle University Centre for Excellence in Regulatory Science in the UK, tell the BBC's Ed Butler she is alarmed at the rate healthcare services are being privatised in the country. And Nicholson Price, Professor at the University of Michigan School of Law in the US, warns that the stakes are different when tech companies collect healthcare than say marketing information. But Dr Robert Wachter, Professor and Chair of the Department of Medicine at the University of California, San Francisco, says that though these concerns are real, it may be a price we have to pay for better healthcare in the future. Producers: Frey Lindsay, Laurence Knight. (Image credit: Getty Creative)

In April 2021, the Regulatory Information Management (RIM) Working Group of DIA's Regulatory Affairs Community issued Version 2.0 of the RIM Whitepaper that provides insights relating to eleven key regulatory capability areas including RIM implementation considerations, processes, and best practices. The Whitepaper also provides context for the RIM Reference Model in development. “One of the key aspects of the model is standardizing terminology and relationships between information,” explains IQVIA Senior Regulatory Affairs Director Donald Palmer in this conversation moderated by Ennov Director of Product Management Kathie Clark. “It puts the stake in the ground in terms of the basic data elements required to support regulatory in its business process and also other functional areas which depend on regulatory,” continues Venkatraman Balasubramanian, Senior Vice President, Life Sciences, Orion Innovation. “If we can put the best practices out there, we all align on the hope that this will allow industry to bring life-saving or life-improving medications and therapies to patients faster. We're hoping to make a big difference,” concludes Pat Shafer, Managing Director, FTI Consulting.

Lowering prescription drug prices continues to be a hot topic. Spending on biologic products, which includes most vaccines and gene therapies, was estimated at $125 billion in the United States in 2018, representing about a quarter of total pharmaceutical spending.Biosimilars, follow-on products to biologic drugs with essentially the same molecular composition to produce comparable clinical effects, are viewed by many as a way to promote competition and bring down drug prices. But the biosimilar market is young, with half of the 10 key product classes seeing marketing entry in 2018 or later. Understanding the evolving market for biosimilars is the topic of this episode of A Health Podyssey.Ariel Dora Stern, associate professor at Harvard Business School and a faculty affiliate of the Harvard-MIT Center for Regulatory Science, and coauthors published a paper in the June 2021 issue of Health Affairs examining how quickly biosimilars and follow-on products gained market share and the subsequent trajectory of drug prices.Listen to Health Affairs Editor-in-Chief Alan Weil interview Dr. Stern on what biosimilars are and how the pharmaceutical market is evolving in response to their market entry. This episode is sponsored by the Rural Health Research Gateway at the University of North Dakota.Pre-order your copy of the July 2021 issue of Health Affairs.Subscribe: RSS | Apple Podcasts | Spotify | Stitcher | Google Podcasts

Angus Mitchell Oration 2021 ADJUCT PROFESSOR JOHN SKERRITT Deputy Secretary, Health Products Division (NTGA, Office of Drug Control) "The COVID-19 pandemic response in Australia and the region: vaccines, medicines and masks…where to from here?" Dr Skerritt has a high national profile dealing with the pandemic and generously agreed to fly down to deliver the 2021 Angus Mitchell Oration. Not only is he an eminent public servant but he has strong personal links with Rotary making him doubly suitable to be our Centenary Angus Mitchell Orator. He was awarded a Rotary Ambassadorial Scholarship (then known as a Rotary Foundation Fellowship) for post-doctoral work in pharmacology and neurology at the University of Michigan, USA to build on his PhD from The University of Sydney. In 2012 he was honoured internationally by Rotary International being the world wide winner of the ”Global Alumni Service to Humanity Award” for his contribution to greater understanding and peace through service to humanity. Only one other Australian has been so recognised – our former member Dr Alex Buchanan. John's Global Alumni Service award was made for two streams of contribution – contributions in research in health, agricultural and environmental sciences plus achievements as a leader of Australia's overseas development assistance (aid) program. While Deputy Secretary in the Victorian Government from 2009-2012 – overseeing emergency management, biosecurity, fisheries, and regional economic development through agribusiness in the former Department of Primary Industries, he was a member of Hampton Rotary Club. Effectively he remains an Honorary Member of that Club, as while he works in Canberra during the week, his weekend home is in Melbourne. He comes down for a number of weekend Rotary activities, including their popular monthly Farmers Markets. His wife, Amanda Hill is current President of the Rotary Club of Hampton. He has an extraordinarily broad range of experience in medical, agricultural and environmental policy as well as regulation, research management, technology application and commercialisation. In the 1990's he held senior management positions in CSIRO and Cooperative Research Centres. Dr Skerritt has been involved in international development assistance projects from the mid-1980s until the present, and from 1999-2009 he was Deputy CEO of the Australian Centre for International Agricultural Research, and had overall management of about $2 billion in international aid projects. He has significant experience on boards of international and national organisations. From 2005-2012 he was Board member and then Chair of the International Water Management Institute, and he is currently Vice Chair of the International Coalition of Medicines Regulatory Authorities and Chair of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science. As well as his PhD in Pharmacology from Sydney University where he was the first University Medallist in that discipline in 150 years, he is an adjunct Professor of the Universities of Sydney, Queensland and Canberra – in medicine, agriculture/food and pharmacy respectively. He was elected a Fellow of the Academy of Technological Sciences and Engineering and a Fellow of the Institute of Public Administration (Victoria). With such an extraordinary range of skills, experience and plus his sustained connections to Rotary, we are privileged that John Skerritt is the Centenary Angus Mitchell Orator.

Dr. Shauna White is the epitome of Black Girl Magic!  She is the pharmacy regulatory boss of D.C. and has broken so many barriers and opened doors for women in pharmacy.  Listen in to hear her amazing journey and how she makes self-care for doctors a priority.   It’s always a fun chat with 3 friends TALK, but it's extra special when we get to talk with another Black woman in pharmacy.   During Dr. Shauna’s episode, you will learn: All about regulatory pharmacy Parasucos and D.C. style How she followed her family’s legacy  Advice for any current pharmacy student Her yearly self care ritual of playing Mas at Trinidad carnival Links mentioned in the show:   Federal Drug Administration (FDA) Internship Program United States Pharmacopeia (USP) Internship Program National Association of Boards of Pharmacy (NABP)  Trinidad Carnival ABOUT DR. SHAUNA WHITE: Shauna White, PharmD, RPh, MS is the Executive Director of the District of Columbia Board of Pharmacy and Program Manager of the Pharmaceutical Division at DC Health.  She is responsible for regulating the practice of pharmacy and the drug supply chain in the District of Columbia.  Dr. White is licensed to practice pharmacy in the District of Columbia and Maryland.  Dr. White serves as an experiential learning preceptor for Howard University College of Pharmacy.  She is active in the National Association of Boards of Pharmacy where she serves on the Law Enforcement and Legislative Committee.  She is also active in the National Association of State Controlled Substance Authorities.  She has a Bachelor of Science in Biology from Xavier University of Louisiana and a Doctorate in Pharmacy and Masters in Regulatory Science from the University of Maryland, Baltimore.   She is a member of Alpha Kappa Alpha Sorority, Incorporated. Born in Washington DC and raised in Prince Georges County Maryland, Dr. White gives back to her community by volunteering with local churches and serving as a mentor to high school students. In her spare time, she enjoys hiking, traveling and spending time with family and friends.   Connect with Dr. Shauna White on LinkedIn Connect with Dr. Courtney, Dr. Leah, Dr. Sylvia: www.instagram.com/3friendsTALK www.3friendsTALK.com https://www.facebook.com/3friendsTALK

Craig Lipset is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. He is co-chair for the Decentralized Trials & Research Alliance, serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. Craig has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive's Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.

Die Regulatory Science ist die Wissenschaft der Regulierungen. Das klingt sehr trocken und die Frage drängt sich auf, für was diese Wissenschaft gut sein soll. Professor Haimerl und Professor Johner zeigen in dieser Episode, weshalb diese Wissenschaft ebenso relevant wie lebendig und für uns alle von Bedeutung ist. Sie grenzen die Regulatory Science von der Regulatory Affairs ab und beleuchten den Stand der Wissenschaft in den USA und in Europa. Die Episode informiert auch über aktuelle Themen.

“How can we find drugs to treat COVID as fast as possible? The master protocol is to me the obvious example,” suggests Lisa LaVange, Professor and Chair of the Department of Biostatistics at UNC Chapel Hill and former Director of the Office of Biostatistics at CDER, FDA. “They do require quite a bit more upfront planning but those that are launched and have been running for a while have been able to study a large number of drugs in a really smart way.” Lisa serves on the Therapeutics Clinical Committee and as Co-Chair of the Master Protocol Subcommittee for Accelerating COVID-19 Therapeutic Innovations & Vaccines (ACTIV) and was interviewed by Richard Zink, Vice President, Data Management, Biostatistics, Statistical Programming at Lexitas and Associate Editor of Therapeutic Innovation and Regulatory Science.

Our guests today are Dr. Alastair Denniston and Dr. Xiao Liu. Together they discuss their work on SPIRIT-AI and CONSORT-AI, two pioneering sets of guidelines that help researchers conduct and report AI clinical trials in a safe, transparent manner.Dr. Alastair Denniston is a consultant ophthalmologist, an honorary professor at University Hospitals Birmingham and the Centre for Regulatory Science and Innovation at the University of Birmingham. Dr. Xiao Liu is an ophthalmology resident and clinical researcher at the University of Birmingham and University Hospitals Birmingham.Pranav and Adriel first discuss why clinical trial guidelines are necessary and then provide context for the interview, which starts at 7:20. If you like what you hear, let a friend know, subscribe wherever you get your podcasts, and connect with us on Twitter @AIHealthPodcast.

Welcome back to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. In this episode our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around risk curious concept, and expand into the why’s and why not’s and the views of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk management process, a top-down approach to building culture, and the need for critical thinking and risk-based decision making.  Links to Risk Revolution Takeaways:The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-managementKnowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledgeLink to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin. Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics. Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Fact Check My Feed: What’s Up With These COVID-19 Mutations? It’s a new year, and that means there’s a whole slew of new COVID-19 news to dive into, including an overwhelming amount of new information about vaccines and mutations. The U.S. has now administered roughly five million doses of COVID-19 vaccines, far behind the nation’s goal of vaccinating 20 million by the end of 2020. The two approved COVID-19 vaccines, one from Pfizer and one from Moderna, are intended to be given over the course of two doses. But there’s a discussion within the medical community about whether or not both doses are necessary for every patient.  Mutations are also an increasing concern. Variants from the U.K. and South Africa are concerning epidemiologists, and appear to be spreading. Though there’s no proof that either are more deadly, they may be more infectious. Joining Ira to explain is Angela Rasmussen, a virologist at Georgetown University’s Center for Global Health Science and Security, based in Seattle, Washington.   Can Cells Rewind The Wrinkles Of Time? As a cell ages, its DNA goes through a process called “methylation”—gaining extra methyl chemical groups. These groups can affect how the genes’ encoded information is expressed, without actually changing the sequence of genes. In work published in Nature, researchers explore whether reversing that methylation can reprogram the cells back to a more youthful state. They used modified adenoviruses to introduce three specific transcription factors into mouse retinal ganglion cells, a type of neuron found in the eye. These transcription factors helped revert the cell to a more immature state—and also seemed to let the cell behave in a more ‘youthful’ way. David Sinclair, a professor of genetics at Harvard Medical School and one of the authors of the study, joins Ira to discuss what the work means, and what it could tell scientists about the aging process.   Trump’s New EPA ‘Transparency’ Rule Could Hamper Science This week, the Environmental Protection Agency passed the “Strengthening Transparency in Regulatory Science” rule. EPA Administrator Andrew Wheeler stated that “the American public has the right to know what scientific studies underline the Agency’s regulatory decisions.” But critics say that this outgoing policy by the Trump administration can be used to hamper new environmental regulations. Amy Nordrum lines out the policy and other science headlines from the week.    

Welcome to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. On this episode our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, covering some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from here time as an agent at MHRA. Links to Risk Revolution Takeaways:The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-managementKnowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledgeLink to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin. Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics. Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Danesha Seth Carley, Director of CERSA talks with Adrian Percy about the goals for the future of regulatory science and her experience in pollinator health. See Danesha's brand new book on Pollinator Gardens here: https://uncpress.org/book/9781469659411/pollinator-gardening-for-the-south/ @AgTech360 agtech360@gmail.com go.ncsu.edu/CERSA southernipm.org

This week, Stacey is joined by Lori Richter and Nuala Calnan to talk about risk management and quality management. This is the first episode in the QRM Corner series. We will cover some of the basics of Quality Risk Management in today’s episode and subsequently move on to “deep dives” focused on some of the more intricate and nuanced areas of Risk Management in future episodes.• ICH Q9 Quality Risk Management Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management • Annex 1 Manufacture of Sterile Medicinal Products: https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf • WHO Risk Management Guidance: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf?ua=1 • European Medicines Agency Risk Management Guidance Format: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf • European Medicines Agency Risk Management Plans: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

This week, Stacey is joined by Marty Lipa, Executive Director Knowledge Management, Merck & Co. Stacey and Marty discuss the importance of “managing knowledge as an asset” in the pharmaceutical industry and learn how every company can begin to capitalize on this very important product.1. Link to ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf 2. Link to find out more about the Knowledge Transfer Enhancement Framework (Chapter 6): https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1011&context=ditpress 3. Effective Knowledge Transfer During Biopharmaceutical Technology Transfer: https://www.ivtnetwork.com/article/effective-knowledge-transfer-during-biopharmaceutical-technology-transfer 4. Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers: https://www.ivtnetwork.com/article/managing-knowledge-and-risk-%E2%80%93-literature-review-interdependency-qrm-and-km-ich-q10-enablers Marty has over 25 years’ industry experience and 12 years’ experience in Knowledge Management. He has published several industry specific works and is currently pursuing his Ph.D. at Technological University Dublin in Pharmaceutical and Regulatory Science with an emphasis on Knowledge Management. Lipa also leads the Knowledge Management Center of Excellence for the Manufacturing Division of Merck & Co., Inc.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. This makes her an ideal person to co-chair an industry-patient-advocacy group called the Working Group on Regulatory Science, a part of the EveryLife Foundation for Rare Disorders that seeks to advance the development of treatment and diagnostic opportunities for rare disease patients through science-driven public policy.Tuberous sclerosis, a rare genetic disorder, affects one in every 6,000 newborns in the United States. It is a disorder that causes benign growth in almost any tissue; it’s of particular concern when it occurs in the brain, lungs or kidneys. Some people who have tuberous sclerosis may have learning problems or difficult-to-control seizures. Her daughter—one of a pair of twins—was diagnosed in utero. She’s doing well, although the speech and language disorders associated with the condition have made it hard to access the curriculum in school. Dr. Carlton talks about the challenges of developing new treatments for rare diseases and the approaches taken to try to overcome them. She also talks about her daughter’s disease, and how families can bring their best to their journey as they adapt to support their child. Based on her experience as a parent and advocate—as well as her experience in the industry—she has this advice for families: “Take a breath.” Drug development is slow, especially in rare diseases. “You are in for a marathon of supporting your child.” When possible, connect with other parents and advocacy groups. Or build your own tribe—work, friends, family, etc. “You have to be healthy and rested enough to do this. You have to be at your best.” She’s often asked how she manages to keep going. “I don’t know how I wouldn’t do it. You’ve been given this gift of a special child. Now it’s time to find your tribe and push ahead.”Her advice for a biotech company considering launch of a clinical trial for a rare disease? Nobody knows more about a patient’s journey, the patient’s experience, than the patient—or a parent or caregiver. “Just listen to what patients are saying. You are going to learn a lot.”Lisa Carlton, PhD, has previously worked in regulatory roles at the National Institutes of Health, Otsuka Pharmaceuticals and International Partnership for Microbicides. She is currently serving as Vice President of Global Regulatory Affairs at REGENXBIO, a gene therapy-focused biotech company with headquarters in Rockville, MD. Lisa received her PhD in Pharmaceutics and MS in Medicinal Chemistry from the University of North Carolina in Chapel Hill and a BS in Biochemistry from North Carolina State University.

Mone’ Brown is a well rounded clinical research professional who has a passion in many different areas of clinical research. Her passion is Regulatory Affairs in addition to monitoring. She has held roles from Regulatory Affairs Document Specialist, Clinical Research Coordinator as well as Project Manager. She holds a Master's of Science in Regulatory Science. She was unfortunately laid in March of 2020. Someone hire this woman before it’s too late! In this episode we discuss the jump for CRC to CRA, the delicate balance between quantity and quality, the value of diversifying your experience, the challenges of job hunting during a pandemic and the importance of integrity.

In 2018, the Environmental Protection Agency proposed a rule entitled “Strengthening Transparency in Regulatory Science.” The proposal garnered over 9,000 unique public comments. On March 18, 2020, EPA published a supplemental notice of proposed rulemaking that, among other things, states that the EPA would be required to make public important information underlying both significant regulatory actions and influential scientific information disseminated by the Agency. Why is this EPA effort to promote transparency important? Why is it controversial? This episode will discuss and evaluate the proposed rule in light of the March 2020 supplementary notice.Featuring: - Dr. Richard B. Belzer, Associate Fellow, R Street Institute- Prof. Adam White, Assistant Professor and Executive Director, The C. Boyden Gray Center for the Study of the Administrative State, George Mason University Antonin Scalia Law School- [Moderator] Daren Bakst, Senior Research Fellow, The Heritage FoundationVisit our website – www.RegProject.org – to learn more, view all of our content, and connect with us on social media.

In 2018, the Environmental Protection Agency proposed a rule entitled “Strengthening Transparency in Regulatory Science.” The proposal garnered over 9,000 unique public comments. On March 18, 2020, EPA published a supplemental notice of proposed rulemaking that, among other things, states that the EPA would be required to make public important information underlying both significant regulatory actions and influential scientific information disseminated by the Agency. Why is this EPA effort to promote transparency important? Why is it controversial? This episode will discuss and evaluate the proposed rule in light of the March 2020 supplementary notice.Featuring: - Dr. Richard B. Belzer, Associate Fellow, R Street Institute- Prof. Adam White, Assistant Professor and Executive Director, The C. Boyden Gray Center for the Study of the Administrative State, George Mason University Antonin Scalia Law School- [Moderator] Daren Bakst, Senior Research Fellow, The Heritage FoundationVisit our website – www.RegProject.org – to learn more, view all of our content, and connect with us on social media.

Michael Sinha, MD, JD, MPH, research fellow, Harvard-MIT Center for Regulatory Science, dissects the legality of international and domestic travel bans from a health policy perspective, the nuances of state-level authority to enforce a lockdown, the rights of health care workers to refuse reporting to work in the absence of ample and appropriate PPEs, and more.

In this episode, Michael Sinha, Research Fellow at the Harvard-MIT Center for Regulatory Science at Harvard Medical School and Visiting Scholar at the Center for Health Policy and Law at Northeastern University School of Law, discusses three of his articles, "The Perils of Panic: Ebola, HIV, and the Intersection of Global Health and Law," published in 2016 in the American Journal of Law and Medicine, "A Panic Foretold," published in 2016 in Critical Public Health, and his most recent work, "Covid-19 -- The Law and Limits of Quarantine," published in the New England Journal of Medicine earlier this month. Dr. Sinha starts by relating the history of American responses--political, public, and in the public health sphere--to outbreaks of diseases such as AIDS and Ebola. He discusses the usual reaction on the part of the public to outbreaks of new illnesses and how such a reaction hinders efforts to halt the spread of illness. He then discusses quarantines that may be implemented by both state and federal governments, recognizing that there are likely uncertain constitutional limitations on using such given that the United States has not experienced a serious a pandemic like Covid-19 since the early 1900s. Dr. Sinha is on Twitter at @DrSinhaEsq.This episode was hosted by Maybell Romero, Assistant Professor of Law at the Northern Illinois University College of Law. Romero is on Twitter at @MaybellRomero. See acast.com/privacy for privacy and opt-out information.

What top priorities can medical device professionals and patients expect in 2020 from the Center for Devices and Radiological Health (CDRH)? Today’s guest is Mike Drues from Vascular Sciences. We discuss the recent FDA report that outlines CDRH’s regulatory science priorities, all of which are important, some more than others. However, there are a couple big ones missing. Listen to this episode for actionable tips on how you can develop your own list of priorities for 2020. Some of the highlights of the show include: - A comparison of historical context from the same reports in 2016 and 2017 to 2020, identifies 8 out of 10 of the same top priorities: - Big Data, biocompatibility, real-world evidence, clinical performance, clinical trial design, computational modeling, patient input, and digital health/cybersecurity. - What two priorities are missing in 2020 report? - Reprocessing reusable medical devices: Not all devices are properly reprocessed to prevent deaths and cross-contamination between patients. - Human factors and usability: Companies still struggle with the concept of making medical devices easy to use and/or understand. - Why did these two priorities drop off 2020 list? A lack of high-profile reports from popular press about companies and medical devices causing problems. - What two top priorities from past reports reappear for 2020? Healthcare-associated infections, and precision medicine and biomarkers. - Medical device industry should develop its own list of top usable and actionable priorities. Effective communication with FDA may result in a consensus.

Word leaked a few weeks ago that the EPA is poised to finalize a rule to limit the types of scientific studies that can be used to create new regulations. The proposal -- named “Strengthening Transparency in Regulatory Science” -- would require public health researchers to release their raw scientific data in order for their work to be considered when the EPA sets regulations. These regulations dictate things like how much pollution companies can release into the air and water. When the rule was first proposed, the agency received nearly 600,000 comments, the vast majority of them in opposition.  One of those came from Dr. Mary Rice, a pulmonary and critical care physician at Beth Israel Deaconess Medical Center.  She also studies the effects of air pollution on lung health. On November 14th, Dr. Rice was one of 5 scientists to testify before the House Science Committee on the proposed rule.

Eric is currently Chief Science Officer at Datavant and Visiting Scientist at the Department of Biomedical Informatics at Harvard Medical School. Most recently, Eric was Senior Vice President Data Sciences at Takeda R&D. Previously, Eric was the Executive Director of the Center for Biomedical Informatics and the Countway Library of Medicine at Harvard Medical School. Eric served as the CIO and Chief Scientist (Informatics) at the U.S. Food and Drug Administration. Eric has also served as Senior Bioinformatics Advisor at Precision for Medicine, as the Chair of the ASCO CancerLinQ technology advisory and on the Editorial Board of the DIA flagship journal, Journal of Regulatory Science and Innnovation Prior to FDA, Eric was Senior Vice President of R&D IT at J&J Pharmaceuticals R&D. Eric also held the posts of Vice President R&D Informatics, Vice President and CIO, Director of Research IT, Assistant Director and Director of Drug Discovery Research at J&J. Eric has a PhD in chemical and biochemical engineering from Drexel University. Learn more about the CNS Summit and follow us on Twitter (@cnssummit). Listen to this episode on Health Podcast Network.

From its inception, science has been at the core of the EPA’s mission. It’s used science about the health effects of industrial pollution to make our air and water cleaner. But EPA administrator Scott Pruitt wants to limit what kinds of research the agency can use when making regulations. To that end, he has introduced the Strengthening Transparency in Regulatory Science rule. Transparency--sounds pretty good, right? But with this new rule, the agency would limit what kinds of research it can use when making regulations. EPA scientists would no longer be allowed to use studies that don’t make their raw data available to the public. That includes most public health studies because these often use confidential patient information that is generally shielded from public view. On top of that, the rule would exempt certain types of industry-funded science. This has many scientists furious. Nearly 1,000 of them signed a letter calling the proposal a way to run “political interference in science-based decision making.” To learn more about this issue, we turned to someone who ran a big science program at the EPA. Bernard Goldstein was assistant administrator for research and development at the agency during the Reagan administration. He’s now a professor emeritus at the University of Pittsburgh’s Graduate School of Public Health.

One basis of modern medicine is that low doses of many chemicals are beneficial, while higher ones are toxic. And yet a great disparity has evolved with the regulation of many entities — including carcinogens, ionizing radiation, and toxics. Their regulation is based on the notion that that a single molecule or photon is as capable of inducing cancer as the billionth one. How has this disparity happened — with low, beneficial doses being treated and regulated the same way as higher ones? What is correct?One highly compelling look at this subject has emerged from Dr. Edward Calabrese’s painstaking and voluminous research. Using recently declassified Atomic Energy Commission documents, Calabrese details the establishment of the linear no-threshold model at the height of the Cold War, when thermonuclear bombs were routinely detonated in the atmosphere, resulting in radioactive fallout. His is a spellbinding story of what is often called “noble cause corruption” of science, and of how difficult it is to correct when backed by the might of the federal government. See acast.com/privacy for privacy and opt-out information.

The EPA’s most costly air-pollution and global-warming regulations are justified by the belief that small particles in outdoor air, like soot and dust, kill people. Based upon internal EPA documents and original research, Steven Milloy, publisher of the widely read blog JunkScience.com, will demonstrate that the agency’s belief does not pass scientific muster. As has been the case with climate change research, the dangerous liaison between regulatory agencies and academia has again resulted in a substantial distortion of reality. Please join us for a probing critique of science in service to regulatory overreach. See acast.com/privacy for privacy and opt-out information.

Pre-recorded Tonight our incredible special guest is Dr. Ira Shoulson founder of the Parkinson Study Group and the Huntington Study Group. Dr. Shoulson is Professor of Neurology, Pharmacology and Human Science and Director of the Program for Regulatory Science and Medicine (PRSM) at Georgetown University.

Listen NowIn 2009 the Congress overwhelmingly passed landmark legislation (commontly termed the "Tobacco Control Act") that included banning flavored cigarettes - except menthol.  Instead, the Congress called upon the FDA to first study the use of menthol before taking action.   In 2011 the FDA released an initial report, the conclusions of which were widely interpreted.  Two weeks ago the FDA released a subsequent report again finding the menthol/mint flavor helps people acquire the tobacco/nicotine addiction but did not increase the risk of disease compared to smoking non-menthol cigarettes.  Neither report recommended banning or restricting the use of menthol. During this 24-minute podcast Andrea Villanti and Diane Canova discuss why menthol was exempted in the 2009 legislation, the findings of the 2011 Tobacco Products Scientific Advisory Committee, why the FDA chose to follow up with a report of their own (released July 23rd) and what it found, various confounding factors including an international trade dispute concerning the importation of clove cigarettes and ultimately their take on whether and when the FDA will either ban or regulate menthol's use.       Dr. Andrea Villanti is an Associate Director for Regulatory Science and Policy at the Schroeder Institute for Tobacco Research and Policy Studies at Legacy Foundation and holds an adjunct faculty appointment in the Department of Health, Behavior and Society at the Johns Hopkins Bloomberg School of Public Health.  Her work concerns translational research to improve tobacco control policy and program decision-making with a specific focus on young adult cessation.  Since the passage of the 2009 Family Smoking Prevention and Tobacco Control Act, she has been actively engaged in research on the impact of menthol cigarettes on tobacco use behaviors.  Dr. Villanti received her doctorate in Social and Behavioral Sciences the Johns Hopkins Bloomberg School of Public Health and she received both her Master's in Public Health and BA in Medical Ethics from Columbia University.Ms. Diane Canova is currently Vice President of Government Affairs at the Legacy Foundation. Previously, Diane served as Vice President of Policy and Programs with the Partnership for Prevention.  Prior still she served as Vice President of Advocacy for the American Heart Association and as Director of Government Relations for the American Red Cross.  Ms. Canova is a founding board member and immediate past chair of the Center for Lobbying in the Public Interest (CLPI) and frequent lecturer on nonprofit leadership and advocacy.  She received her JD from the Brandeis School of Law at the University of Louisville and her BS in Education from Kent State.   This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thehealthcarepolicypodcast.com

Pre-recorded... Tonight our incredible special guest is Dr. Ira Shoulson founder of the Parkinson Study Group and the Huntington Study Group. Be sure to listen to our first interview with Dr. Shoulson on May 9, 2011. Dr. Shoulson is Professor of Neurology, Pharmacology and Human Science and Director of the Program for Regulatory Science and Medicine (PRSM) at Georgetown University. www.huntington-study-group.org

Tonight our incredible special guest is Dr. Ira Shoulson founder of the Parkinson Study Group and the Huntington Study Group. Be sure to listen to our first interview with Dr. Shoulson on May 9, 2011. Dr. Shoulson is Professor of Neurology, Pharmacology and Human Science and Director of the Program for Regulatory Science and Medicine (PRSM) at Georgetown University.

Monday, May 9, 2011 - Our incredible special guest is Ira Shoulson, MD Professor of Neurology, Pharmacology and Human Science and Director of the Program for Regulatory Science and Medicine (PRSM) at Georgetown University – new full-time academic positions effective January 1, 2011.  Previously, Dr Shoulson was the Louis C. Lasagna Professor of Experimental Therapeutics and Professor of Neurology, Pharmacology and Medicine at the University of Rochester School of Medicine & Dentistry in Rochester, New York.  He received his MD degree (1971) and postdoctoral training in medicine (1971-73) and neurology (1975-77) at the University of Rochester and in experimental therapeutics at the National Institutes of Health (1973-75).  Dr. Shoulson founded the Parkinson Study Group (www.parkinson-strudy-group.org) in 1985 and the Huntington Study Group (www.huntington-study-group.org) in 1994 -- international academic consortia devoted to research and development of treatments for Parkinson's disease, Huntington's disease and related neurodegenerative and neurogenetic disorders.  He has served as principal investigator of the National Institutes of Health-sponsored trials "Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism" (DATATOP), the “Prospective Huntington At Risk Observational Study” (PHAROS), and more than 25 other controlled multi-center studies.  He was formerly a member of the National Institute of Neurological Disorders and Stroke Council and president of the American Society for Experimental NeuroTherapeutics (ASENT) He is currently associate editor of Archives of Neurology and a member of the Institute of Medicine of the National Academy of Sciences.  He has authored over 280 scientific reports.