Podcasts about fda center

Jamie Hartmann-Boyce and Nicola Lindson discuss emerging evidence in e-cigarette research and interview Steve Cook from the University of Michigan USA about the importance of correctly interpreting and assessing the available data. Associate Professor Jamie Hartmann-Boyce and Associate Professor Nicola Lindson discuss the new evidence in e-cigarette research and interview Dr Steven Cook from the Department of Epidemiology, School of Public Health University of Michigan and the Centre for Assessment of Tobacco Regulations, University of Michigan. In the May podcast Steve Cook discusses the methodological problems of cross-sectional data on the health effects of e-cigarette use a topic he addressed at the May 2025 EC Summit, Washington DC. Steve Cook underlines why all cross-sectional health effects studies should be interpreted with extreme caution unless they examine dose-response relationships and account for temporality and cigarette smoking confounding. Dr Cook emphasises the importance of other information such as smoking histories and health histories and the importance of developing a best practice to ensure that we minimize the risks associated with spurious association and maximise predictive accuracy. Steven Cook receives National Institute for Health (NIH) and Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) funding. This is not deemed a conflict of interest. EC Summit, Washington DC: https://www.e-cigarette-summit.com/program-2025/ Recent paper: 10.1016/j.isci.2025.111985 This podcast is a companion to the electronic cigarettes Cochrane living systematic review and Interventions for quitting vaping review and shares the evidence from the monthly searches. Our search for the EC for smoking cessation review carried out on 1st May 2025 found 1 ongoing (NCT06922617) and 1 linked study (DOI: 10.1101/2025.02.17.25322409). Our search for our interventions for quitting vaping review up to 1st May 2025 found 1 new (DOI 10.1001/jama.2025.3810) and 4 ongoing studies (DOI 10.2196/71961, KCT0010346, NCT06909500, NCT06929520). 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 of E-cigarettes for smoking cessation updated in January 2025 see: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub9/full For more information on the full Cochrane review of Interventions for quitting vaping published in January 2025 see: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD016058.pub2/full This podcast is supported by Cancer Research UK.

Mass firings at FDA Center for Tobacco Products including Director. Mother Nature hits Buffalo Trace Distillery & AJ Fernandez Cigars. Tariffs on cigar manufacturing countries, and Dames now want your GPS location. Cigar Selection: Raices Cubanas Clasico

Dr. Peter Marks is the director of the FDA Center for Biologics Evaluation and Research. Stephen Morrissey, the interviewer, is the Executive Managing Editor of the Journal. P.W. Marks, H.D. Marston, and L.R. Baden. End of a Declared Public Health Emergency — Implications for U.S. Emergency Use Authorizations. N Engl J Med 2023;388:1153-1155.

It's "In the News..." the only LIVE diabetes newscast! Top stories this week: FDA hints on 2021 D-tech timeline, the Freestyle Libre 2 app is approved, interchangeable insulin to cost less, an "astonishing" type 2 teen study and a big fall-off in use of metformin in people with type 2. Join us on Facebook live every Wednesday at 4:30pm EDT This week I was on the road, at the Podcast Movement convention. Sorry about the setting! Back in the home studio next week. Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode Transcription below: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days.  I'm on the road – again! This time I'm at podcast movement a big convention going on in Nashville.. so apologies if the audio and video are a little bit off but I think we're good enough. And As always, I'm going to link up my sources in the Facebook comments – where we are live – and in the show notes at d-c dot com when this airs as a podcast.. so you can read more when you have the time. XX In the News is brought to you by Real Good Foods! Excited to have them back as a sponsor – we're big fans. Real Food You Feel Good About Eating. XX Our top story this week… a brief comment about diabetes devices at the FDA might give a hint to some timelines we're all watching. FDA Center for Devices and Radiological Health head Jeffrey Shuren says COVID-19 remains a source of uncertainty. "Goal is to be back to normal as we roll into 2022," Shuren said. "But there are a lot of variables that could impact that… don't know if we'll get hit with another tsunami of submissions for full marketing authorization for a lot of the COVID products. Getting back on track, everything is moving for the diabetes submissions." Products in front of the FDA expected by year's end: Medtronic's 780G and Zeus CGM, Insulet's Omnipod 5, Tandem's bolus by phone and it's expected that Dexcom's G7 will be submitted soon. https://seekingalpha.com/news/3715640-fda-devices-head-says-progress-being-made-on-diabetes-devices-backlog XX The FDA did clear one diabetes product this past week.. Abott's Freestyle Libre 2 iOS app. The Libre 2 hardware was approved last year.. this is the app for Apple phones.. it gives users optional real time high and low alarms – still have to scan to see the actual values. It updates every minute – only CGM that does – and it lets caregivers remotely monitor. Freestyle Libre 2 has a 14 day wear.. no exact date on when the App will be available or when it'll be available for android users.   https://finance.yahoo.com/news/abbotts-freestyle-libre-2-ios-130000861.html XX Other side of the coin, Abbot will pay $160 million to resolve claims that two of its units submitted false claims to Medicare. The Justice Department said free glucose monitors were provided to get patients to order more testing supplies, and the companies routinely waived copayments. They were also accused of charging Medicare for ineligible patients and for more than 200 patients who were actually dead. https://www.reuters.com/business/healthcare-pharmaceuticals/us-says-abbott-units-pay-160-mln-resolve-alleged-false-medicare-claims-2021-08-02/ XX Back to the FDA.. for the first time, they're allowing a less expensive brand name insulin to be substituted for the original. Semglee – approved last year – is basically the same as Lantus but it's a lot less expensive. Semglee is now is the first-ever to earn the “interchangeable” designation Trusted Source, meaning it's fully approved to be substituted for Lantus at the pharmacy. No need to get permission from the doctor. This is the second copycat of Lantus; the first was Eli Lilly's Basaglar, launched in 2016. There is some new branding and labeling needed here, so expect a relaunch of Semglee by the end of this year. FYI the pens are a little different even if the insulin in them is the same. It's always a good idea to know what your doctor is prescribing and what your pharmacist is giving you.. even if it costs less. XX Big new studies focusing on children and teens with type 2 diabetes.. showing how different the disease can be in younger people. The studies, published July 29 in the New England Journal of Medicine, showed that within 15 years of a Type 2 diabetes diagnosis, 60% of participants had at least one diabetes-related complication, and nearly a third of participants had two or more. These Texas researchers call it astonishing and say it appears type 2 in youth is much more aggressive than in older people. These researchers say more treatment options are needed for younger people because lifestyle changes don't seem to be enough. The study also showed a lot of families don't have regular access to medication or health care providers. They say it was a diverse study representative of teens and kids in the US. https://medicalxpress.com/news/2021-08-young-adults-complications-diabetes.html   XX More to come, including new about people with diabetes who stop taking a very commonly prescribed medication..  but first, I want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Real Good Foods! We've been fans for a long time – Benny especially likes their ice cream. Real Good Foods makes delicious food you'll feel good about eating; high in protein, grain free and always made from real, nutrient dense ingredients. The labels are easy to read – because the ingredients aren't chemicals and fillers. Whether it's waffles or burrito bowls or stuffed chicken or the pizza that started it all.. I think you'll really love Real Good Foods. Learn more with the link in the FB comments or as always at d-c dot com. Back to the news…   XX Interesting research using artificial intelligence to catch diabetes eye issues earlier – when they're easier to treat. Changes in the blood vessels in the retina cause diabetic retinopathy, the most common diabetic eye disease and a leading cause of blindness in US adults. There are several studies and institutes looking at the use of A-I here, but these folks at the Indiana University School of Optometry say they're using information that is often ignored for diagnosis and it's making a big difference. The National Institutes of Health's National Eye Institute funded the work. https://www.futurity.org/biomarkers-diabetic-retinopathy-blindness-vision-2604812/ XX Nearly half of adults prescribed metformin after a new diagnosis of type 2 have stopped taking it by 1 year. The fall off is most dramatic during the first 30 days. These researchers say it didn't matter how long the prescription was written for and most who discontinued still had A1C's high enough to still need glucose lowering medication. They say as physicians quote - A lot of times we're quick to prescribe metformin and forget about it...Physicians might write a script for 3 months and three refills and not see the patient again for a year...We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they're getting early diabetes education." https://www.medscape.com/viewarticle/955893 XX That's In the News for this week.. if you like it, please share it! And quick note this is our 400th episode. I've been busy with some behind the scenes stuff and it caught up to me! A huge thank you to all of you.. incredible support from this community. Six years and 400 episodes is an accomplishment that I've only reached because of you. And join me wherever you get podcasts for our next episode -Tuesday –  I'm talking to Eoin Costello the host of his own diabetes podcast – about staying active or starting getting more fit with type 1. This week's interview – the one that's out right now – is a look at the features of Omnipod 5 – the newest hybrid closed loop system in front of the FDA. Thanks and I'll see you soon    

Richard Moscicki is the Executive Vice President for Science and Regulatory Advocacy and the Chief Medical Officer at Pharmaceutical Research and Manufacturers of America (PhRMA). Previously he was the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and the Chief Medical Officer at Genzyme Corporation. In this podcast, we discuss the U.S. R&D ecosystem and the vital roles that NIH and the private sector play in bringing new therapies to patients. Richard was previously at Massachusetts General Hospital (MGH) and Harvard Medical School, and this strong academic background combined with his industry knowledge gives him a unique perspective on both sides of public and industrial R&D, as well as how NIH developed intellectual property moves from the ‘Eureka' phase to becoming an actual medicine. Our conversation includes President Biden's new $6.5 billion proposal called ARPA-H, modeled on DARPA, specifically for drug discovery, and where those efforts would be best directed to facilitate needed medicines to address unmet medical needs. We also touch on how the rapid evaluation and approval of vaccines for COVID-19 could serve as an improved regulatory blueprint for accelerated evidence driven access to patients.

Matt and Dara are joined by Vox's Dylan Scott to learn about aducanumab, the new drug that was recently approved by the FDA for treating Alzheimer's disease despite a lack of evidence of its effectiveness, possibly serious side effects, and a jaw-droppingly high price tag. Matt, Dara, and Dylan discuss the situation in light of lessons learned, or not quite learned, from the global pandemic. Then, some research is discussed that evaluates the effects of work requirements on supplemental nutrition assistance program (SNAP) participation and the workforce. Resources: "The new Alzheimer's drug that could break Medicare" by Dylan Scott (June 10; Vox) "FDA's Decision to Approve New Treatment for Alzheimer's Disease" by Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research (June 7) "The maddening saga of how an Alzheimer's 'cabal' thwarted progress toward a cure for decades" by Sharon Begley (June 25, 2019; STAT News) "What the Rich Don't Want to Admit About the Poor" by Ezra Klein (June 13; New York Times) White paper: "Employed in a SNAP? The Impact of Work Requirements on Program Participation and Labor Supply" by Colin Grey, et al. (Sept. 2019) Hosts: Matt Yglesias (@mattyglesias), Slowboring.com Dara Lind (@DLind), Immigration Reporter, ProPublica Dylan Scott (@dylanlscott), Policy Reporter, Vox Credits: Erikk Geannikis, Editor and Producer As the Biden administration gears up, we'll help you understand this unprecedented burst of policymaking. Sign up for The Weeds newsletter each Friday: vox.com/weeds-newsletter. The Weeds is a Vox Media Podcast Network production. Want to support The Weeds? Please consider making a contribution to Vox: bit.ly/givepodcasts About Vox Vox is a news network that helps you cut through the noise and understand what's really driving the events in the headlines. Follow Us: Vox.com Facebook group: The Weeds Learn more about your ad choices. Visit podcastchoices.com/adchoices

Ken is joined by Mitch Zeller, Director, FDA Center for Tobacco Products  See omnystudio.com/listener for privacy information.

“It has been called the nanny state, but that is far too kind a term.  It is too cold, too cruel, too implacable, to illiberal to be a nanny.  It is the Nurse Ratched state.  Government has created a brutal system of mandated behaviorism, in which the state uses its immense powers to force targeted citizens to ‘voluntarily' accept a violation of their rights… The efforts to sustain affirmative action rest on these coercive methods.  So, too, do the efforts to enforce the decree that private workplaces be free of discriminatory, harassing, or even rude behavior.  The intrusions resulting from the Americans with Disabilities Act have mutated beyond sanity… Nursie knows best.”  -Michael Kelly The Biden Administration has formally announced it supports destroying the property rights to the COVID vaccine.  This is catastrophically shortsighted and bad policy. "Ninety percent of all Black Americans who smoke smoke menthol cigarettes."  -FDA Center for Tobacco Products head Mitch Zeller, explaining why he's banning something just because black people like it. “Every time the government tries to make life better for you, it uses force.  It makes criminals out of people who are not criminals.  Some poor mope who would like a large-size toilet in his house has to go out and smuggle one.  The guy who smokes a cigarette down the hall from you at his desk alone in his office with the door closed is a criminal.  Some mother who wants to talk to her 12-year-old in the front seat is a criminal also.  All these people are criminals now.  That's us.  Why do they have the right to make all of us criminals because we smoke, or want to have our kids sit next to us in the car?”  -Michael Kelly https://www.cnbc.com/2021/05/05/us-backs-covid-vaccine-intellectual-property-waivers-to-expand-access-to-shots-worldwide.html https://www.npr.org/2021/04/30/992298635/food-and-drug-administration-moves-to-ban-menthol-cigarettes

Dr. Derek Stitt speaks with FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks about cases of thrombosis after the Johnson & Johnson COVID-19 vaccine, potential risk factors, and suggestions for patient care.

Bakul Patel, Director of Digital Health at the FDA Center for Devices and Radiological Health, talks about conducting clinical trials over digital devices.

As part of the Pandemic Solutions: Virtual Speaker Series, KGI’s Rajesh Parti interviewed Dr. Steven Galson, Senior Vice President of Global Regulatory Affairs and Safety at Amgen. Dr. Galson has more than 20 years of experience in government service, including two years as acting Surgeon General of the United States. Previously, he served as director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation.

Mitch Zeller, JD, director of the U.S. Food and Drug Administration's (FDA's) Center for Tobacco Products, joins Lisa Kennedy Sheldon, PhD, APRN, AOCNP®, FAAN, ONS's clinical and scientific affairs liaison, to discuss tobacco's effect on American health, communication strategies for patients with cancer who want to quit, and what FDA is doing to mitigate its harm.  Music Credit: "Fireflies and Stardust" by Kevin MacLeod  Licensed under Creative Commons by Attribution 3.0  Episode Notes  Check out these resources from today's episode:  Complete this evaluation for free nursing continuing professional development. ONS E-Cigarettes and Vaping Position Statement  ONS-endorsed ISNCC Tobacco Position Statement  ONS Vaping Learning Library  Oncology Nursing Podcast Episode 55: The Youth Vaping Epidemic  Oncology Nursing Forum article: Smoking Prevalence and Management Among Cancer Survivors  ONS Voice article: Vaping, E-Cigarettes, and Flavored Tobacco Are Reversing 20 Years of Decreasing Smoking Rates  Mitch Zeller's biography  FDA Center for Tobacco Products  FDA Center for Tobacco Products' Youth Tobacco Prevention Plan  The first U.S. surgeon general's report on smoking (1964)  2014 Surgeon General's Report: The Health Consequences of Smoking—50 Years of Progress  National Academies of Sciences' Public Health Consequences of E-Cigarettes 2018 report  FDA's Real Cost campaign  FDA's Every Try Counts campaign 

Dr. David Acheson, is the founder and CEO of The Acheson Group and brings more than 30 years of medical and food safety research and experience to provide strategic advice as well as recall and crisis management support to food companies and ancillary technology companies on a global basis on all matters relating to food safety and food defense.   David graduated from the University of London Medical School and practiced internal medicine and infectious diseases in the United Kingdom until 1987 when he moved to the New England Medical Center and became an Associate Professor at Tufts University in Boston, studying the molecular pathogenesis of foodborne pathogens.   Prior to forming The Acheson Group, David served as the Chief Medical Officer at the U.S. Department of Agriculture Food Safety and Inspection Service and then joined the U.S. Food and Drug Administration (FDA) as the Chief Medical Officer at the FDA Center for Food Safety and Applied Nutrition (CFSAN). After serving as the director of CFSAN’s Office of Food Defense, Communication, and Emergency Response, David was appointed as the Assistant and then Associate Commissioner for Foods, which provided him an agency-wide leadership role for all food and feed issues and the responsibility for the development of the 2007 Food Protection Plan, which served as the basis for many of the authorities granted to FDA by the Food Safety Modernization Act.   From 2009 to 2013, he was a partner at Leavitt Partners where he managed Leavitt Partners Global Food Safety Solutions.  David has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. He is a sought-after speaker and regular guest on national news programs. He serves on a variety of boards and food safety advisory groups of several major food manufacturers. David was previously a guest on Food Safety Matters – episodes 12 and 45. In this episode of Food Safety Matters, we speak to David [11:31] about: Classifying RTE foods and how consumer behavior plays a critical role Challenges related to messaging and marketing tactics displayed on consumer packaging and how it can interfere with food safety perception Consumer vs. manufacturer responsibility when foodborne illness occurs How food processing trends, consumer behaviors, and regulations intertwine Steps a company can take to determine if their product is truly RTE Why consistently negative swabbing results is not a good thing How FDA responds to positive contamination findings in a plant The challenges associated with drilling down traceability to the item level Romaine lettuce and why leafy greens are such a tricky commodity Salmonella and the likelihood that it may officially become an adulterant David Acheson's Contributions to Food Safety Magazine Managing Risks in the Global Supply Chain  What Have We Learned about FSMA Implementation?  Are All Salmonella Created Equal? New Directions in Food Protection   ​Resource: Blog: What Does Marler's Salmonella Citizen Petition Mean to You? News Mentioned in This Episode USA Today: Inspections, Citations, Recalls Slashed: Coronavirus is Testing America's Food Safety Net [4:17] LGMA: Work Underway to Further Strengthen Food Safety Practices for Leafy Greens [9:19] LeafyGreenGuidance.com Keep Up with Food Safety Magazine Follow Us on Twitter @FoodSafetyMag and on Facebook  Subscribe to our magazine and our biweekly eNewsletter We Want to Hear From You! Please share your comments, questions, and suggestions. Tell us about yourself—we'd love to hear about your food safety challenges and successes. We want to get to know you! Here are a few ways to be in touch with us. Email us at podcast@foodsafetymagazine.com Record a voice memo on your phone and email it to us at podcast@foodsafetymagazine.com

Dr. David Acheson, is the founder and CEO of The Acheson Group and brings more than 30 years of medical and food safety research and experience to provide strategic advice as well as recall and crisis management support to food companies and ancillary technology companies on a global basis on all matters relating to food safety and food defense.   David graduated from the University of London Medical School and practiced internal medicine and infectious diseases in the United Kingdom until 1987 when he moved to the New England Medical Center and became an Associate Professor at Tufts University in Boston, studying the molecular pathogenesis of foodborne pathogens.   Prior to forming The Acheson Group, David served as the Chief Medical Officer at the U.S. Department of Agriculture Food Safety and Inspection Service and then joined the U.S. Food and Drug Administration (FDA) as the Chief Medical Officer at the FDA Center for Food Safety and Applied Nutrition (CFSAN). After serving as the director of CFSAN’s Office of Food Defense, Communication, and Emergency Response, David was appointed as the Assistant and then Associate Commissioner for Foods, which provided him an agency-wide leadership role for all food and feed issues and the responsibility for the development of the 2007 Food Protection Plan, which served as the basis for many of the authorities granted to FDA by the Food Safety Modernization Act.   From 2009 to 2013, he was a partner at Leavitt Partners where he managed Leavitt Partners Global Food Safety Solutions.  David has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. He is a sought-after speaker and regular guest on national news programs. He serves on a variety of boards and food safety advisory groups of several major food manufacturers.   In this episode of Food Safety Matters, we speak to David [32:48] about: The food industry's hesitation about speaking openly about food safety and the science behind it Consumers' lack of trust and understanding when it comes to food science How the media plays a role in shaping consumer attitudes about food safety Scientists and their traditional lack of ability to effectively communicate with consumers  The state of food safety today vs. years/decades ago Why it makes sense that today's food supply is safe despite an increasing number of recalls and outbreaks Balancing science, public health, consumer demand, and marketing messages The top misperceptions that consumers have about food We also speak with Hilary Thesmar (Food Marketing Institute) and Shelley Feist (The Partnership for Food Safety Education) [12:03] about: The recent 2019 Consumer Food Safety Education Conference How food processors and manufacturers benefit from the conference  How consumer food safety messaging is continuously improving Consumer behavior that goes against standard food safety practices Support from BAC Fighters Articles by David Acheson in Food Safety Magazine Why Don't We Learn More from Our Mistakes? Industry Perspectives of Proposed FSMA Rule on Preventive Controls News Mentioned in This Episode USDA FSIS Issues Meat Industry Best Practices for Responding to Customer Complaints [2:34]  Bumble Bee Tuna Using Blockchain Technology to Trace Fish Origin for Consumers [4:55]  Strawberries, Spinach, and Kale Top 2019 Dirty Dozen List [8:14] Keep Up with Food Safety Magazine Follow Us on Twitter @FoodSafetyMag and on Facebook  Subscribe to our magazine and our biweekly eNewsletter We Want to Hear From You! Please share your comments, questions, and suggestions. Tell us about yourself—we'd love to hear about your food safety challenges and successes. We want to get to you know you! Here are a few ways to be in touch with us. Email us at podcast@foodsafetymagazine.com Record a voice memo on your phone and email it to us at podcast@foodsafetymagazine.com

In this episode Dr. McFaddin explains the FDA Center for Veterinary Medicine (CVM) announcements released in September (Possible Link Between Oral Flea and Tick Preventatives and Seizures in Dogs) and in July (Possible Link Between Grain Free Diets and Heart Disease in Dogs). For further information about the FDA CVM Announcements visit their website or sign up for the email alerts when new releases are issued: https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/default.htm.

In partnership with IEEE EMBS. Virtual reality, prosthetics, biomedical engineering and research are just a few of the areas in which Dr. Heather Benz works on a day-to-day basis. As a biomedical engineer working as a Medical Device Staff Fellow at the FDA Center for Devices and Radiological Health, Dr. Benz experiences the sci-fi excitement that comes with working in new technology as well as using that technology to help people in need; her two passions. In this IEEE Brain podcast episode, Dr. Benz shares what it's like working with the FDA to improve the lives of patients, how she came to be a biomedical engineer and what it's like to be a woman in her field.

Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's Office of Surveillance and Epidemiology created and released a tool that makes FAERS data easier to query and retrieve. This new interactive dashboard is designed to expand access of FAERS data to the general public. Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, discusses the advantages of the tool as well as its limitations.

Dr. David Acheson, M.D., is the founder and CEO of The Acheson Group and brings more than 30 years of medical and food safety research and experience to provide strategic advice as well as recall and crisis management support to food companies and ancillary technology companies on a global basis on all matters relating to food safety and food defense.   David graduated from the University of London Medical School and practiced internal medicine and infectious diseases in the United Kingdom until 1987 when he moved to the New England Medical Center and became an Associate Professor at Tufts University in Boston, studying the molecular pathogenesis of foodborne pathogens.   Prior to forming The Acheson Group, David served as the Chief Medical Officer at the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) and then joined the U.S. Food and Drug Administration (FDA) as the Chief Medical Officer at the FDA Center for Food Safety and Applied Nutrition (CFSAN). After serving as the director of CFSAN’s Office of Food Defense, Communication and Emergency Response, David was appointed as the Assistant and then Associate Commissioner for Foods, which provided him an agency-wide leadership role for all food and feed issues and the responsibility for the development of the 2007 Food Protection Plan, which served as the basis for many of the authorities granted to FDA by the Food Safety Modernization Act (FSMA).   From 2009 to 2013 he was a partner at Leavitt Partners where he managed Leavitt Partners Global Food Safety Solutions.  David has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. He is a sought-after speaker and regular guest on national news programs. He serves on a variety of boards and food safety advisory groups of several major food manufacturers. In this episode of Food Safety Matters, we speak to David Acheson about: His role in building the 2007 Food Protection Plan and how it parallels FSMA The importance of the food safety crises that took place in 2006 and 2007 The differences between food fraud, food security, food defense and food adulteration, and how sometimes these instances do not necessarily implicate a public health risk His advice to food companies gearing up to comply with FSMA's food defense regulations Facing the realities of determining whether your food plant is at risk of committing a food-related crime How to advocate for more or better resources, and how to convince the C-suite to invest in food safety Balancing food safety goals with a company's other metrics—sales, margins, etc. The main challenges he sees facing food companies His views on announced vs. unannounced audits How the Peanut Corporation of America debacle helped shape FSMA's Preventive Controls rule and how it forced some food companies to rebuild their own supply and control programs His thoughts on how legal roadblocks keep food safety violations from ever coming to light Articles by David Acheson in Food Safety Magazine Why Don't We Learn More from Our Mistakes? https://www.foodsafetymagazine.com/magazine-archive1/junejuly-2014/why-dont-we-learn-more-from-our-mistakes/ Industry Perspectives of Proposed FSMA Rule on Preventive Controls https://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2013/industry-perceptions-of-proposed-fsma-rule-on-preventive-controls/ News Mentioned in This Episode FDA Reminds Public of Soy Nut Butter Recall https://www.foodsafetymagazine.com/news/fda-reminds-public-of-soy-nut-butter-recall/ Opponents Say USDA Reorganization has Multiple Problems http://www.foodsafetynews.com/2017/10/opponents-say-usda-reorganization-has-multiple-problems/#.We5sGpOnHUJ Raw Milk Dairy Out of Time to Appeal Retail License Suspension http://www.foodsafetynews.com/2017/10/raw-milk-dairy-out-of-time-to-appeal-retail-license-suspension/#.WeoVEhNSygR Why Is it So Hard to Track the Source of a Food Poisoning Outbreak? https://www.bostonglobe.com/magazine/2017/10/11/why-hard-track-source-food-poisoning-outbreak/6RD8EJru631SldqXHFx9mK/story.html Food Truck Commissary: The Foundation of a Mobile Business https://www.foodsafetymagazine.com/magazine-archive1/junejuly2016/food-truck-commissary-the-foundation-of-a-mobile-business/ Savor Safe Street Food https://www.foodsafetymagazine.com/magazine-archive1/junejuly-2015/savor-safe-street-food/

Dr. Louis Matis joined Pieris as the Senior Vice President and Chief Development Officer in August 2015, bringing more than 30 years of experience in basic and clinical biomedical research, regulatory affairs, drug development and executive leadership. Prior to joining Pieris, Dr. Matis served since June 2011 as Executive Director, Strategic Evaluation at Alexion Pharmaceuticals, where he also served from 1993 to 2000, during which time he advanced to the position of CSO and had a leading role in discovering the first-in-class complement inhibitor monoclonal antibody Soliris® (eculizumab). Before re-joining Alexion in 2011, Dr. Matis served as CEO of CGI Pharmaceuticals, Inc. from 2000 to 2006, and of the Immune Tolerance Institute from 2007 to 2010. Under Dr. Matis’ leadership, CGI raised over $60 million in venture capital financing, established five partnerships with top tier pharmaceutical and biotechnology companies, and developed novel small molecule kinase inhibitors for both autoimmune disease and cancer indications. From 1977 until joining Alexion in 1993, Dr. Matis held senior research and clinical positions at the National Cancer Institute, National Institutes of Health, and the FDA Center for Biologics Evaluation and Research. Dr. Matis holds a B.A. from Amherst College and an M.D. from the University of Pennsylvania, Perelman School of Medicine. He completed his clinical training in Internal Medicine at the University of Chicago Hospitals and Clinics, and in Medical Oncology at the NCI. Dr. Matis is the author of over 120 publications in the fields of immunology, cell and molecular biology, and clinical medicine.