RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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Fda Regulation Podcasts
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
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A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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Welcome to The Sidley Podcast. Join us as we bring a unique perspective to complex issues at the intersection of law and business.
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FDA Imports
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Welcome to The Quality Grind Podcast, presented by Medvacon! Join hosts Joe Toscano, President of Medvacon, and Mike Kent, Director of Learning Platforms, as they (we) have some fun while tackling topics related to the “everyday grind” within Life Science industries. Featuring conversations with key industry players, they’ll dive into their unique problem-solving strategies, career paths and personal interests. Most importantly, their (our) goal is to cultivate a community where information ...
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A Ropes & Gray (RopesTalk) podcast series focused on the world of unfair import investigations at the U.S. International Trade Commission (ITC).
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Co -hosted by Glenn Hunzinger, US Health Industries leader, and Jennifer Colapietro, Consulting Commercial Leader, the Next in Health podcast series offers insights on the most important issues facing pharma, medtech and healthcare. PwC business leaders discuss the latest trends and their impact on health industries, whether it’s policy, AI, innovation, care delivery, business model reinvention or bold moves for the future. If it’s happening in health industries, we’re talking about it.
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Anesthesiology News will be publishing a new season of our popular podcast series, “On the Case” and “Ask the Experts.” “On the Case” is a review series that features the authors of our popular case report series. We hear the behind-the-scenes story on the most unique clinical case studies published in the magazine directly from the professionals who managed them. The first episode of this new season features an interview with L. Jane Stewart, MD, JD, MPH, who co-wrote a case report about a ...
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Dietitian Melinda Hemmelgarn helps listeners “think beyond their plates,” connect the dots between food, health and agriculture, and find food truth.
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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Food Safety Matters is a podcast for food safety professionals hosted by the Food Safety Magazine editorial team – the leading media brand in food safety for over 20 years. Each episode will feature a conversation with a food safety professional sharing their experiences and insights into the important job of safeguarding the world’s food supply.
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On the "Making it to Market" podcast, we discuss everything about brand inception and product/service creation through to commercialization. Industry experts and business owners are invited to share their insights and best practices related to business planning, legal and regulatory considerations, manufacturing, supply chain, marketing, merchandising, B2B buyer methodology and B2C consumer psychology.
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16 Minutes on the News is a short news podcast where we cover the top headlines of the week, the a16z podcast way -- why are these topics in the news; what's real, what's hype from our vantage point; and what are our experts' quick takes on these trends? About the a16z Podcast: Discusses tech and culture trends, news, and the future -- especially as ‘software eats the world’. It features industry experts, business leaders, and other interesting thinkers and voices from around the world. This ...
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What the Big Beautiful Bill Means for Trial Sites
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Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare …
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Will Potter, investigative journalist and author of Little Red Barns: Hiding the Truth from Farm to Fable, discusses the connections between factory farms and authoritarianism. (Part 2 of 2)
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Did you know that powerful language and imagery are distractions from the reality of industrialized agriculture? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Will Potter, investigative journalist and author of Little Red Barns: Hiding the Truth from Farm to Fable. Potter discusses the connection…
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Strategic Dealmaking in Health: Navigating Midyear Trends in 2025
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, connects with Nick Donkar, PwC’s U.S. Health Services Deals Leader, and Roel Van den Akker, PwC’s Pharma and Life Sciences Deals Leader, to discuss the 2025 midyear deals outlook across health services and pharma and life sciences. They explore how macroeconomic trends, regulatory pressure…
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Multidimensional Data Reversion: Implementing AI—Balancing Risks and Opportunities
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On this bonus episode of Ropes & Gray’s Insights Lab’s Multidimensional Data Reversion podcast series, Shannon Capone Kirk and David Yanofsky are joined by Michelle DiMartino, a cultural psychologist, to discuss the challenges and human factors involved in AI adoption. Michelle provides insights into the psychological responses to AI, explaining ho…
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In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by: Routinely waiving co-pays without documenting financial hardship, Shipping unrequested supplies, Allegedly paying kickbacks to boost …
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Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconsti…
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The Truth About Plant-Based Food: Why Europe Is 5 Years Ahead of the US
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Plant-based proteins have come a long way from being niche products to becoming viable, mainstream alternatives. This transformation is being shaped by both advancing technologies and shifting consumer expectations around sustainability, health, and taste. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams …
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Ep. 197. Jatin Patel: Lessons Learned and Best Practices for Handling a Recall
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Jatin Patel is the Head of Operations at FGS Ingredients Ltd. He has over two decades of extensive experience in the food industry and has been a cornerstone of FGS Ingredients for the past 11 years. A qualified ACCA Accountant, Jatin combines his strong financial acumen with an in-depth understanding of food industry operations. He holds a Level 3…
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Episode Summary: In this tactical episode, FDA regulatory attorney Benjamin L. England explains the critical differences between FDA import refusals and Customs and Border Protection (CBP) seizures, and what businesses can do when their products are detained, refused, or seized. From legal definitions to strategic responses and mistakes to avoid, B…
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Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met. To stay compliant, speake…
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Will Potter, investigative journalist and author of Little Red Bars: Hiding the Truth from Farm to Fable, will discuss “ag-gag” and other legislation designed to hide abuses in industrial livestock operations ...
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Did you know that livestock abuse is widespread on factory farms? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Will Potter, investigative journalist and author of Little Red Bars: Hiding the Truth from Farm to Fable. Potter will discuss “ag-gag” and other legislation designed to hide widespread …
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Are My Meds Real? Counterfeit Production on the Rise
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As many popular medications in the United States have continued to increase in price, there has been a related rise in the number of counterfeit medications being produced and sold, specifically online. Reports of fraudulent medications include opioids, cancer drugs, erectile dysfunction medications and weight-loss medications. As such, both the FD…
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Navigating Cell & Gene Therapy: The Quality Path to a Bright Future
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Send us a text In this episode of the Quality Grind Podcast, hosts Joe Toscano and Mike Kent conclude their four-part series on Cell and Gene Therapy with guest Ray Kaczmarek. They discuss the importance of building relationships and implementing solid quality systems across the development lifecycle. Ray shares his pragmatic views on ensuring qual…
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The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance. In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare.…
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Pamela Miller, MS, Founder and Executive Director of Alaska Community Action on Toxics
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Did you know that people living in arctic regions have some of the highest body burdens of toxic chemicals? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Pamela Miller, MS, Founder and Executive Director of Alaska Community Action on Toxics and Co-Chair of the International Pollutants Elimination…
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Medicare Advantage: Enforcement Activity & Broker Arrangements
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On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone are joined by litigation & enforcement partner Andrew O’Connor for a two-part discussion, with this first episode focused on recent enforcement activity and broker arrangements in the Medicare Advantage (“MA”) space. They delve into the Oak Street settlement, …
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Should You Use AI to Draft Informed Consent?
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Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organiz…
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Navigating Cell & Gene Therapy: Cultivating Partnerships and Progress
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Send us a text Welcome to Part 3 of Medvacon’s 4-part series entitled “Navigating Cell & Gene Therapy”, where Joe and Mike continue their visit with industry leader Ray Kaczmarek. In this episode, the 3 dive deep into the significance of disciplined development, strong supply chains, and well-cultivated partnerships within the cell and gene therapy…
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R&G Dugout: The House v. NCAA Settlement—Tax Implications for Colleges and Universities
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On this episode of the R&G Dugout podcast, Ropes & Gray intellectual property transactions partner and a leader of the firm’s sports industry initiative Erica Han is joined by tax attorneys Gil Ghatan, Kendi Ozmon and Franziska Hertel, who lead the firm’s tax-exempt organizations practice. Together, they discuss the tax implications of the House v.…
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Why Traditional Customer Data Is Dead—The New Playbook for Retail Success with Russ Hawkins
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On this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, Lydia Adams sits down with Russ Hawkins, President and CEO of Agilence Inc., to explore how data analytics and AI are reshaping the way restaurants and retailers operate. Russ shares how businesses are turning massive amounts of data into clear, actionable insights that dri…
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Ep. 196. Dr. Lane Highbarger: How the FDA Workforce Cuts May Impact Food Safety
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Lane Highbarger, Ph.D. worked for 26 years in the food additive regulatory and compliance field with the U.S. Food and Drug Administration (FDA), serving as lead microbiologist in FDA's Office of Food Additive Safety (OFAS). He is also an expert in food additive regulations and served as the regulatory review scientist for regulatory submissions at…
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Beyond Silos: Unifying Quality & Regulatory
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Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Paul Palmer, pharmaceutical consultant and Director at Pharma Quality Services, and David Kalb, Associate Technical Solution Director here at Ennov. Together, we explore two timely q…
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Alumni @ RopesTalk: Conversation with Dan Krockmalnic, Boston Globe Media
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On this episode of Ropes & Gray’s Alumni @ RopesTalk podcast, employment, executive compensation, and benefits partner Megan Bisk is joined by alum Dan Krockmalnic, chief operating officer and general counsel at Boston Globe Media. Dan shares his journey from Big Law to his current leadership role, discussing his transition from litigation associat…
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Could You Survive a Surprise Pharmacy Audit?
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Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm. Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not …
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In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective a…
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Sandra Brooke, Ph.D., Florida State University’s Coastal and Marine Laboratory discusses oysters.
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Did you know that oysters are not only popular items at seafood festivals, but vital to the health of our estuaries? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Sandra Brooke, Ph.D., research faculty at Florida State University’s Coastal and Marine Laboratory and scientific director and lead in…
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Understanding FDA Expectations for Combination Products
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In this episode of RCA Radio, host Brandon Miller sits down with Jessica Schafersman, a design and development expert at RCA®, to break down the increasingly complex world of combination products—those that blend drugs, devices, or biologics. Jessica shares insights on why these products are uniquely challenging, the regulatory expectations compani…
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Lean Principles and Regulated Life Sciences - Part 2
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Send us a text Join host Mike Kent and special guest Jose Mora as they continue to explore the application of Lean principles within regulated life science environments. In this episode, they explore seven key benefits of Lean: quality and compliance, throughput and operating expense reduction, speed to market, flexibility and adaptability, continu…
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$14M Fine Says This “Free” Offer Wasn’t Legal
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In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid. This wasn’t just bad billing—it was a ma…
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FlexXray: How External X-Ray Inspection Helps Close the Gap on Foreign Material
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Kye Luker serves as the Chief Product Officer at FlexXray, where he leads the development of the company's innovative X-ray inspection process and technology. With over two decades of experience in the service, CPG, food, and beverage industries, Kye brings a wealth of knowledge in continuous improvement, quality assurance, and formulations to his …
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Nonprofit Pharma Exists. Here is how it works
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In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multip…
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Justin Swanson and Federal Efforts to Ban Hemp
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Jonathan Miller interviews Justin Swanson, President of the Midwest Hemp Council, about legislation being considered by the House Appropriations Committee that could ban most consumable hemp products. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered…
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In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particula…
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Basel Musharbash, antitrust and trade regulation lawyer discusses fertilizer and consolidation in the agricultural sector. (Part 2 of 2)
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Did you know that consolidation in the fertilizer industry results in environmental harm and less choice for farmers? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Basel Musharbash, antitrust and trade regulation lawyer, and author of Kings Over the Necessaries of Life: Monopolization and the Eli…
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Whistleblowing in Clinical Trials: Is It Worth the Risk?
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In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors. They discuss examples…
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Culture & Compliance Chronicles: Humanizing Compliance—Creative Approaches with Nicole Rose
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On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, are joined by Nicole Rose, a compliance specialist and creative artist based in Australia who shares her unique insights on how creativity helps solve compliance challenges. Nicole d…
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Navigating Cell & Gene Therapy: Accelerating Development and Innovation
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Send us a text Welcome back to the Grind, where Joe and Mike continue their exploration of Cell & Gene Therapy with expert Ray Kaczmarek. In this episode, part 2 of our 4-part series, Ray provides perspective on navigating the development process, highlighting some key factors for success – robust science, integrous data and stage-appropriate syste…
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The 5-Step Food Safety Framework That's Transforming State Garden with Dinesh Babu
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Building a strong food safety culture requires deep organizational commitment and the systematic implementation of best practices across every level of operations. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams is joined by Dinesh Babu, Vice President of Quality and Food Safety at State Garden, for an i…
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Ep. 195. Dr. Christopher Daubert: The Value of a Food Science Education
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Christopher R. Daubert, Ph.D., serves as the President of the Institute of Food Technologists (IFT) and as the Vice Chancellor and Dean of the College of Agriculture, Food, and Natural Resources at the University of Missouri (Mizzou), as well as a Professor in the Division of Food Systems and Bioengineering. He joined Mizzou from North Carolina Sta…
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Fully Invested: Exchange Act Registered Private Funds (’34 Act)
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On this episode of Fully Invested, Ropes & Gray asset management partner Jessica Marlin and capital markets counsel Marc Rotter discuss ’34 Act Registered Private Funds. These funds register under the Securities Exchange Act of 1934 and disclose information publicly, while remaining exempt from the Investment Company Act of 1940. Jessica and Marc e…
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The Right Way to Do Medical Affairs on LinkedIn
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In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn handles. Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receivi…
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Are We Paying Clinical Trial Patients Enough?
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In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more? Key Takeaways: The Coercion Concern Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. H…
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Basel Musharbash, antitrust and trade regulation lawyer, discusses the high price of eggs. (Part 1 of 2)
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Did you know that consolidation in our food and agriculture systems has more to do with the price of eggs than bird flu? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Basel Musharbash, antitrust and trade regulation lawyer, and author of Kings Over the Necessaries of Life: Monopolization and the …
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Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying…
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Navigating Cell & Gene Therapy: Setting the Stage for Success
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Send us a text Welcome to The Grind! Hosts Joe Toscano and Mike Kent caught up with special guest Ray Kaczmarek in San Diego for an insightful discussion highlighting the complexities and dynamic nature of Cell and Gene Therapy. In this episode, the first in a 4-part series, Ray shares his experiences from military service to multiple C-suite roles…
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Taking a closer look at the Most Favored Nation Pricing Executive Order
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, and Phil Scalfani, PwC’s Pharmaceutical and Life Sciences Consulting Leader, discuss the Trump administration’s executive order on Most Favored Nation (MFN) drug pricing and its far-reaching implications across the healthcare ecosystem. They break down what MFN pricing could mean for pharm…
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Elanco: Diagnostics and the Role of Testing in Ensuring Food Safety
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Savannah Applegate, Ph.D. is a Senior Consultant at Elanco Poultry Food Safety. Dr. Applegate received her B.S. degree in Meat Science from Ohio State University and her M.S. degree and Ph.D. in Applied Food Microbiology from Texas Tech University. Her areas of expertise are meat and poultry food safety, and she specializes in diagnostics and patho…
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Frank Santos and What's Next for Hemp in Texas
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Jonathan Miller interviews Austin, Texas lobbyist Frank Santos, about the ever-changing state of play for hemp policy in Texas. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: What is Senate Bill 3 and how did it pass the legislatur…
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Unpacking Screen Fail Payments in Research
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In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic. From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that pay…
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Peter Lurie, MD, MPH Executive Director of the Center for Science in the Public Interest discusses food dyes, the FDA and RFK.
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Did you know that some food dyes can have a negative influence children’s behavior? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Peter Lurie, MD, MPH, President and Executive Director of the Center for Science in the Public Interest (CSPI), a non-profit food and health watchdog organization base…
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