Podcasts about regulatory strategy

In Episode #198 of the PricePlow Podcast, we sit down with Nora Khaldi, founder and CEO of Nuritas, the groundbreaking company revolutionizing ingredient discovery through artificial intelligence and peptide science. Nora’s journey from pure mathematician and computer scientist to pioneering AI-driven nutrition innovation represents a fascinating intersection of technology and human health. Most listeners know Nuritas from PeptiStrong, the natural anabolic peptide ingredient derived from fava beans that’s making waves in the sports nutrition industry. But there’s so much more to the Nuritas story. This episode explores how Nora, a mathematician, identified a fundamental problem in the supplement industry: an inability to create truly new ingredients to address rapidly evolving consumer health trends. Traditional ingredient development takes decades and costs hundreds of millions of dollars, making innovation nearly impossible for the nutrition sector. Nora explains how Nuritas spent seven to eight years building proprietary AI technology called Magnifier, which integrates machine learning, proteomics, peptidomics, and molecular biology to identify bioactive peptides in nature. The conversation covers the company’s entire peptide portfolio, including PeptiSleep, PeptiYouth, PeptiControl, and the upcoming PeptiPump, along with the clinical science, regulatory challenges, and manufacturing processes behind each ingredient. https://blog.priceplow.com/podcast/nora-khaldi-nuritas-198 Video: Nora Khaldi on AI-Powered Peptide Discovery https://www.youtube.com/watch?v=TJ7Mmft2maA Detailed Show Notes: From Mathematics to Peptide Innovation (0:00) – Introduction: The Mathematician Who Revolutionized Peptide Discovery (0:30) – The Innovation Gap in Supplement Ingredients (2:30) – The Data Problem: Why AI Was Essential (4:45) – Timeline and Technology Development: Before ChatGPT (6:15) – Building Proprietary Data from Scratch (8:45) – Beyond Efficacy: The Complete Ingredient Development Equation (10:15) – What Is a Peptide? Understanding Nature’s Signaling Molecules (12:00) – PeptiStrong: From Discovery to Market (15:30) – Clinical Validation and Human Studies (18:45) – Manufacturing and Extraction Processes (22:00) – Regulatory Strategy and Patent Protection (25:15) – PeptiSleep: Addressing the Sleep Crisis (28:30) – PeptiSleep Mechanisms and Clinical Insights (32:00) – PeptiYouth: Beauty from Within (35:45) – PeptiProtect: Supporting Immune Function (39:15) – PeptiControl: Glucose Management Innovation (43:00) – The Future: PeptiPump and Beyond (46:30) – The Role of Early Adopters and Market Education (50:00) – Strength and Bone Density: Interconnected Health (53:30) – From Ideation to Market: The Complete Journey (57:15) – Supply Chain and Manufacturing Partners (1:00:45) – Market Trends: Beauty, Sleep, and Metabolic Health (1:04:15) – Holistic Health: The Future of Personalized Wellness (1:08:00) – Consumer Education and Scientifi… Read more on the PricePlow Blog

In this episode, we sit down with Ben Ivers (Boeing's Director of Emerging Technologies & Regulatory Strategy) to unpack a deceptively simple idea: airspace modernization isn't optional anymore and the tech to enable “automated flight rules” (AFR) is largely ready today. Ben argues the hard part isn't the technology, but introducing a new flight mode alongside VFR and IFR that can scale drones, eVTOLs, and future autonomous operations without turning the sky into sanitized corridors reserved for “new entrants.” He explains why Boeing is forced to think in decades and why action now matters if modernization isn't to remain perpetually out of reach.We get practical on what AFR actually means: less “AI making decisions,” more machine-guided coordination built on trusted data exchange and automated conflict management. Ben connects AFR to UTM/U-space (“crawl, walk, run”), walks through “before vs after” scenarios across GA, airlines, drones, and urban air mobility, and pinpoints the real bottlenecks, i.e. reliable communications, latency, surveillance, micro-weather, and certified digital services. We close on where value may accrue in a digitized airspace: new third-party services, higher throughput, and an “additive” roadmap that grows the aviation ecosystem rather than excluding parts of it.

We love to hear from our listeners. Send us a message.Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and gene therapies. Their conversation covers the importance of defining a therapy's intended role (curative, chronic, or adjunctive) early in development, the different regulatory expectations based on disease context and patient population, and the crucial impact of unmet medical need on regulatory flexibility. Swietlicka emphasizes the necessity of a clear, scientifically sound regulatory narrative, especially when precedent is lacking, and advocates for early, robust investment in CMC to minimize risks. They also explore the complexities of using surrogate endpoints, planning for long-term patient follow-up under uncertainty, and the value of integrating commercial considerations from the outset. Swietlicka calls for cell and gene therapy developers to adopt a commercial mindset and proactive regulatory engagement to achieve clinical and commercial success.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

Stephen Grootes speaks to Tony Sio, head of Regulatory Strategy and Innovation at Nasdaq's Anti-Financial Crime division, about the new SA Market Surveillance Code of Conduct, aimed at strengthening processes and controls to combat evolving trends in market manipulation and make the market more attractive to global investors. The Money Show is a podcast hosted by well-known journalist and radio presenter, Stephen Grootes. He explores the latest economic trends, business developments, investment opportunities, and personal finance strategies. Each episode features engaging conversations with top newsmakers, industry experts, financial advisors, entrepreneurs, and politicians, offering you thought-provoking insights to navigate the ever-changing financial landscape. Thank you for listening to a podcast from The Money Show Listen live Primedia+ weekdays from 18:00 and 20:00 (SA Time) to The Money Show with Stephen Grootes broadcast on 702 https://buff.ly/gk3y0Kj and CapeTalk https://buff.ly/NnFM3Nk For more from the show, go to https://buff.ly/7QpH0jY or find all the catch-up podcasts here https://buff.ly/PlhvUVe Subscribe to The Money Show Daily Newsletter and the Weekly Business Wrap here https://buff.ly/v5mfetc The Money Show is brought to you by Absa Follow us on social media 702 on Facebook: https://www.facebook.com/TalkRadio702702 on TikTok: https://www.tiktok.com/@talkradio702702 on Instagram: https://www.instagram.com/talkradio702/702 on X: https://x.com/CapeTalk702 on YouTube: https://www.youtube.com/@radio702 CapeTalk on Facebook: https://www.facebook.com/CapeTalkCapeTalk on TikTok: https://www.tiktok.com/@capetalkCapeTalk on Instagram: https://www.instagram.com/CapeTalk on X: https://x.com/Radio702CapeTalk on YouTube: https://www.youtube.com/@CapeTalk567See omnystudio.com/listener for privacy information.

Stephen Grootes speaks to Tony Sio, head of Regulatory Strategy and Innovation at Nasdaq's Anti-Financial Crime division, about the new Market Surveillance Code of Conduct, aimed at strengthening processes and controls to make the market more attractive to global investors. The Money Show is a podcast hosted by well-known journalist and radio presenter, Stephen Grootes. He explores the latest economic trends, business developments, investment opportunities, and personal finance strategies. Each episode features engaging conversations with top newsmakers, industry experts, financial advisors, entrepreneurs, and politicians, offering you thought-provoking insights to navigate the ever-changing financial landscape. Thank you for listening to a podcast from The Money Show Listen live Primedia+ weekdays from 18:00 and 20:00 (SA Time) to The Money Show with Stephen Grootes broadcast on 702 https://buff.ly/gk3y0Kj and CapeTalk https://buff.ly/NnFM3Nk For more from the show, go to https://buff.ly/7QpH0jY or find all the catch-up podcasts here https://buff.ly/PlhvUVe Subscribe to The Money Show Daily Newsletter and the Weekly Business Wrap here https://buff.ly/v5mfetc The Money Show is brought to you by Absa Follow us on social media 702 on Facebook: https://www.facebook.com/TalkRadio702702 on TikTok: https://www.tiktok.com/@talkradio702702 on Instagram: https://www.instagram.com/talkradio702/702 on X: https://x.com/CapeTalk702 on YouTube: https://www.youtube.com/@radio702 CapeTalk on Facebook: https://www.facebook.com/CapeTalkCapeTalk on TikTok: https://www.tiktok.com/@capetalkCapeTalk on Instagram: https://www.instagram.com/CapeTalk on X: https://x.com/Radio702CapeTalk on YouTube: https://www.youtube.com/@CapeTalk567See omnystudio.com/listener for privacy information.

We love to hear from our listeners. Send us a message.On this episode of Cell & Gene: The Podcast, Host Erin Harris welcomes Monika Swietlicka, Principal, Regulatory Strategy at Halloran Consulting Group to discuss the key regulatory challenges facing cell and gene therapy companies. Swietlicka highlights manufacturing complexity and clinical trial design limitations. On gene editing, she notes that the FDA is focused on off-target effects and demands robust data, including functional validation. She emphasizes the importance of early definition of critical quality attributes and a strong comparability strategy to ensure product consistency. She also underscores the growing role of real-world evidence, especially in rare disease settings with limited clinical trial data.Subscribe to the podcast!Apple | Spotify | YouTube

Send us a textIn this episode of the METUS Tech Show, the boys speak with Senior Director of Regulatory Strategy for Mitsubishi Electric US, Dana Fischer, as he updates us IRA, tax credits, and other governmental stuff.  We manage to sneak in a little ice cream too.Check out our youtube channel called the METUS Training Network.Thanks for listening! Please visit www.mitsubishicomfort.comContact us at metustechshow@hvac.mea.com

In this episode of Current Account, Clay is joined by Jenny Cosco, Global Head of Government Relations & Regulatory Strategy at LSEG, to discuss recent trends related to market risk and vulnerability. Jenny and Clay discuss some of the key market trends in 2025, how deeply volatile trends could be the pattern of the future, how markets seem to be combating volatility with resilience, regulatory frameworks that may bolster market stability and resilience, an overview of front-of-mind regulatory and market issues and much more. This IIF Podcast was hosted by Clay Lowery, Executive Vice President, Research and Policy, with production and research contributions from Christian Klein, Digital Graphics and Production Associate and Miranda Silverman, Senior Program Assistant.

On 4 December 2024 Future of Finance hosted a one-day event at the offices of AON in London. Entitled Digital asset custody: What do asset managers and asset owners need to know about digital asset custody and custodians?, the event attracted 160 registrants from asset managers, banks, custodian banks, digital asset custodians, exchanges, financial market infrastructures, insurers, investment consultants, law firms, regulators and technology vendors. This is an account of what they and the panellists contributed to the seven sessions that day, both live and in the multiple-choice questionnaire they completed in advance, the results of which are also published here.The panellists for this discussion were John Siena, Associate General Counsel and Co-Head of Regulatory Strategy at Brown Brothers Harriman (BBH); Monica Gogna, Partner and Head of the Financial Institutions Law Group at EY; Romin Dabir, partner at Reed Smith; and Yvonne Deane Harte, Director for Secondary Markets and Post Trade policy at UK Finance. Hosted on Acast. See acast.com/privacy for more information.

The UK's new digital markets competition regime came into force on 1 January 2025 and the Competition and Markets Authority (‘CMA') is already exercising its responsibilities in this area.  Join Robert MacDougall from Deloitte's EMEA Centre for Regulatory Strategy as he delves into how the UK's new digital markets regime is being implemented along with Cat Batchelor from the CMA's Digital Markets Unit. Learn more about the CMA's approach to pace, predictability, proportionality and process, featuring a range of insights for companies interested in this new digital regulatory framework. Don't miss this engaging and informative discussion!

In this episode, Ari speaks with Caroline Hill, Senior Director of Global Policy and Regulatory Strategy at Circle, about Circle's commitment to building with compliance at its core and the future of stablecoin regulation in the United States and globally. Caroline reflects on how her experience at the US Treasury shapes her perspective on regulatory policy and compliance strategy. Today's Guest: Caroline Hill, Senior Director of Global Policy and Regulatory Strategy, Circle Host: Ari Redbord, Global Head of Policy, TRM Labs

Liz kicks off this year's Medical Device Training Journey by interviewing Kelly Carty, who advises medical device companies on regulatory strategy throughout the product lifecycle. During their conversation, they dive deep into the clinical trials process, from how to develop the IFU to implementing best practices into a procedure, and how mandatory training can be a mitigation measure in the risk management process. Join Kelly and Liz as they discuss how a strong regulatary strategy can ensure companies have the best data, documents, and procedural steps to support their products. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle. Related Resources: Kelly Carty is a Co-founder of MedTech Strategy Advisors, LLC, a consulting company that advises medical device companies on regulatory strategy development and execution throughout the product lifecycle. Kelly spent 22 years working in the medical devices industry at companies ranging from small startups to large, well-established companies with a wide variety of devices and complex issues. She held positions of increasing responsibility, ultimately ending as the Head of Regulatory Strategy – Body Aesthetics for Allergan Aesthetics, an Abbvie Company. Following her time in industry, Kelly moved into consulting at Veranex, Inc. where she worked closely with her Co-Founder, Nada Hanafi. Together, Kelly and Nada routinely interface with FDA for their clients on novel product designs, pending submissions, and postmarket issues. Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠ Kelly Carty ⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠ About Cumby Consulting:    Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

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.

The 2025 edition of the annual Financial Markets Regulatory Outlook sets out the most important regulatory and supervisory themes in 2025 – both for the industry as a whole, and at the sector level. Tune in to listen to a robust discussion between host Liam Girvan (Associate Director, EMEA Centre for Regulatory Strategy), Suchitra Nair (Partner, EMEA Centre for Regulatory Strategy) and David Strachan (Advisor, EMEA Centre for Regulatory Strategy), on the key regulatory and supervisory trends that will impact the financial services industry in 2025 – the discussion covers both, a bird's eye view on major trends and mini dives into key issues affecting sectors. Buckle up!  the insights in this episode are intended to help C-suite individuals at financial services firms prepare for strategic decision making, risk management and implementation.

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP.00:00 Introduction and Welcome00:26 Meet Marta: CEO of Radius Research00:58 Understanding Target Product Profiles (TPPs)01:44 The Importance of TPPs in Drug Development01:59 Defining a TPP03:22 TPP as a Strategic Document05:28 TPP in Preclinical and Clinical Stages07:09 Challenges and Misconceptions in TPP Development14:27 Regulatory Considerations for TPPs14:53 Sections of a TPP39:07 Understanding Toxicology Evaluations39:34 FDA Requirements for Pre-IND Talks39:51 TPP and Toxicity Thresholds41:41 Go/No-Go Criteria in TPP42:50 PKPD and Drug Distribution45:40 Drug Formulation and Quality Attributes46:36 Regulatory Strategy and 505(b)(2) Pathway52:34 Differentiation and Risk Assessment01:03:42 Transition from Discovery to Development01:07:48 Combination Products and Delivery Systems01:09:35 Conclusion and Contact InformationMarta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. She can be reached at mnew@radyusresearch.com

An academic-turned-practitioner, Michelle Frasher, PhD, CAMS brings over 20 years of subject expertise in geopolitics, finance, terrorism, and data privacy with leadership experience in leading multi-disciplinary teams to build AML/CFT and Sanctions compliance products and services for a global clientele. She is currently the Head of Compliance and Regulatory Strategy at the AI regulatory technology firm, Silent Eight, and previously held key leadership positions at LexisNexis Risk Solutions as Director of Global Content for WorldCompliance, and Sr. Director of Financial Crime Compliance Practice at Moody's Analytics, where she led program implementation, regulatory analysis and engagement, product development, and client consultations on best practices across multiple business lines and sectors. An experienced speaker and author, Dr. Frasher's work has been featured in Harvard Business Review, American Banker, CoinDesk's Consensus, and SWIFT's Sibos, among others. She is an expert with the EU AML/CFT Global Facility on Beneficial Ownership, Privacy and Data Sharing, an external analyst with Oxford Analytica, a Forbes Business Council Member, and a standing member of the Privacy Research Group at the NYU School of Law. Frasher earned a PhD in history focusing on International Political Economy from Texas A&M University, holds multiple MA and BA degrees in political science, history, and foreign languages, and is a Certified Anti-Money Laundering Specialist. In 2014, she was Fulbright-Schuman Scholar to Belgium and Malta (sponsored by the US State Department and European Commission) on US-EU financial data sharing for transatlantic counter-terrorism cooperation. Listen to this insightful RIA episode with Dr. Michelle Frasher about navigating financial crime compliance with AI. Here is what to expect on this week's show: - How Silent Eight uses human-centered and explainable AI to help global banks detect and manage risks related to money laundering, financing terrorism, and sanctions. - How Silent Eight's AI solutions provide a comprehensive audit trail, ensuring transparency and regulatory compliance. - Why it's critical to translate complex regulations into actionable policies and procedures for financial institutions. - How the new AML/CFT regulatory rules for RIAs take effect on January 1st, 2026, with significant implications for the industry. - How the evolving regulatory environment underscores the need for RIAs to enhance their compliance procedures and staff training. Connect with Dr. Frasher: Links Mentioned: https://www.silenteight.com/ X: @_SilentEight LinkedIn: linkedin.com/company/silenteight Learn more about your ad choices. Visit megaphone.fm/adchoices

In this special edition of The Clean Energy Revolution, we bring you highlights from a panel discussion, ‘Women Leading the Energy Transition', hosted at New York University during Climate Week.The discussion is moderated by Sandy Grace, Vice President of US Policy and Regulatory Strategy for National Grid, who sits down to talk with women working in various roles addressing the clean energy transition.You'll hear from panellists including Naomi Boness (Stanford University), Hadia Sheerazi (Rocky Mountain Institute), Amy Myers Jaffe (NYU), and one of this podcast's co-hosts Dr. Carolyn Kissane (NYU), as they share their career journeys, current challenges, and opportunities needed to ensure a robust, equitable and sustainable energy transition.Be sure to tune in to hear about the impactful work happening in policy, academia, NGOs, and startups, as well as the incredible and inspirational stories of some of the women at the forefront of the energy transition. This special episode is not to be missed.

This ToxChats© episode is part of a series on the different career paths in the field of toxicology. In this episode, we interview Dr. Marcus Delatte on his career path to his current position as the Vice President of Regulatory Strategy at the consulting company, Allucent. Dr. Delatte also shares his experiences as a pharmaceutical consultant in toxicology.

Connecting more clean energy projects to the electricity grid is one of the most critical issues in driving the clean energy transition. Legacy ‘first come first served' approaches, along with a rapid growth in the number of projects looking to connect, have led to stalled, or "zombie" projects waiting in the queue to be connected - so what's being done to resolve this? Across the world, it's estimated we'll need 11,000 gigawatts by 2030 to triple renewable energy capacity. In the UK, electricity capacity may need to double by 2030 to achieve net zero goals, and in the US, renewable electricity deployment needs to significantly ramp up to achieve a zero-carbon energy supply. To discuss the rise in connection applications and the plans to accommodate them, Laura speaks to Ruth Shaw, Customer and Stakeholder Experience Manager in Electricity Transmission at National Grid. Together they look at groundbreaking projects like Dogger Bank – the world's largest offshore wind farm – and how these projects are providing the blueprint for a streamlined connections process. On the other side of the Atlantic, Carolyn is joined by Sandy Grace, Vice President of US Policy and Regulatory Strategy for National Grid, to uncover how the US is tackling similar challenges. Innovative solutions like bi-directional flows and vehicle-to-grid technology are poised to revolutionize the grid. Sandy explains how they work, and analyses the need for regulatory reforms to speed up connections to the grid. Find out more about the upgrades to the grid happening in the UK and US at https://www.nationalgrid.com/the-great-grid-upgrade and https://upstateupgrade.nationalgrid.com/

The extremely wide remit of Consumer Duty has meant that firms across financial services have had their hands full over the last couple of years – but what's next? After the July 2023 deadline, what do firms need to focus on? identifying vulnerable consumers, assessing price and value, and ensuring that robust data is available to monitor and prove good outcomes, are just a few of the things that firms will need to continue work on. In this episode of Regulated Radio, host Isha Gupta interviews experts Kareline Daguer, Director of Insurance at the EMEA Centre for Regulatory Strategy, Charlotte Wightwick Head of Conduct at the ABI and Paul Fraser, Director, and Consumer Duty lead for investment management at Deloitte on this issue.

Let us know how we're doing - text us feedback or thoughts on episode contentIn order to meet the ambitious climate goals as enshrined in New York's Climate Leadership and Community Protection Act (CLCPA), the state is about to embark upon a far reaching program to ratchet down emissions from heavy emitters. The Cap and Invest program has a lot of similarities to RGGI and other Cap & Trade efforts, with some key nuances on how New York is planning on using this tool to transition to a clean energy economy.Karsten Barde, Director of US Policy and Regulatory Strategy for National Grid, joins Paul to discuss the construct of the program, who it's likely to impact, and what to expect as it navigates its way through this preliminary structuring phase.For further reference:Karsten BardeNew York Cap and InvestRegional Greenhouse Gas InitiativePreproposal Stakeholder Outreach - Preliminary Scenario AnalysesFollow Paul on LinkedIn.

The 2024 Sustainability Regulation Outlook report is now live! It covers the key implications of sustainability related regulations across financial services and non-financial services. The report contains key insights on pivotal topics with crucial consequences for financial services and the real economy such as decarbonisation, greenwashing, sustainability reporting and circularity. In this episode, Isha Gupta from the EMEA Centre for Regulatory Strategy is joined by authors of the report and senior managers in Deloitte's Sustainability Regulation Hub, Magda Puzniak-Holford and Ramon Bravo Gonzalez to discuss what firms should be focusing on to prepare for the deluge of sustainability related regulations. The trio are privileged to be joined by Jane Gimber, Head of Sustainability from Fleishman Hillard a consulting firm based in Brussels, who provides key insights on the impact that the upcoming European Parliamentary elections will have on all of this.

In light of the SEC's new climate-related disclosure rule, the ESG Talk and Off the Books podcast crews huddled to make sense of it all.In this episode, Steve Soter asks Mandi McReynolds, head of ESG at Workiva, and Andie Wood, Vice President of Regulatory Strategy at Workiva, for their thoughts.Then Jonathan Gregory, North America Controller at The Hershey Co., and Alan Wilson, Partner at WilmerHale, share their initial reactions, what surprised them in the rule, and some of their questions about the rule in the weeks and months to come.Subscribe to ESG Talk and Off the Books as we continue the conversation in the year ahead.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with Parexel regulatory experts Mwango Kashoki, M.D., Senior Vice President, Global Head of Regulatory Strategy, and Steve Winitsky, M.D., Vice President, Technical - Regulatory Strategy, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.   To learn more about the topics in this episode:  FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe Amid high-profile CAR-T safety probe, FDA's Peter Marks offers first glimpse at data under review  See omnystudio.com/listener for privacy information.

In this episode, we meet Zina, a remarkable woman who overcame immense challenges to carve her own path. Uprooted from her Ugandan home, Zina found herself in a new land, facing changes in culture and having to ground herself in her life. Yet, she persevered, fueled by her unwavering dedication. Zina's story is one of resilience, passion, and a relentless pursuit of knowledge. Dive into her captivating tale, discover her unique perspective on healthcare innovation, and regulatory strategy, and learn how her journey continues as she embarks on a new chapter in the exciting world of digital health!Support the show

The first Space Force Guardian is going to space this August as part of the NASA SpaceX Crew-9 mission to the International Space Station. Rocket Lab is looking to raise $275 million by offering financial securities known as Convertible Senior Notes. NOAA's Office of Space Commerce and SpaceX have entered into a no-exchange-of-funds Cooperative Research and Development Agreement (CRADA), for research and development activities related to automated collision avoidance and satellite conjunction assessment screenings, and more. Remember to leave us a 5-star rating and review in your favorite podcast app. Miss an episode? Sign-up for our weekly intelligence roundup, Signals and Space, and you'll never miss a beat. And be sure to follow T-Minus on LinkedIn and Instagram. T-Minus Guest Our guest today is Valerie Vasquez, Director of Global Public Policy and Regulatory Strategy at True Anomaly. You can connect with Val on LinkedIn and learn more about True Anomaly on their website. Selected Reading Space Force Guardian set to launch to International Space Station on NASA mission Rocket Lab Announces Proposed Offering of $275 Million Convertible Senior Notes | Business Wire NOAA, SpaceX Enter Cooperative Agreement for Automated Collision Avoidance R&D Space Force to start charging more spaceport fees this summer Space Development Agency Awards Momentus Contract Modification to Develop Defense Applications for Vigoride Orbital Service Vehicle | Business Wire  “Pact for the Future” UN Office for Outer Space Affairs and Exolaunch sign agreement to launch CubeSats into space POLARIS Update  ispace Signs Memorandum of Understanding with mu Space for Future Lunar Missions America, China and Russia are locked in a new struggle over space Launch Records Topple in 2024 with Busiest January of Space Age Florida-based BlackStar Orbital unveils southern Arizona spacecraft factory The Space Race | National Geographic Documentary Films T-Minus Crew Survey We want to hear from you! Please complete our 4 question survey. It'll help us get better and deliver you the most mission-critical space intel every day. Want to hear your company in the show? You too can reach the most influential leaders and operators in the industry. Here's our media kit. Contact us at space@n2k.com to request more info. Want to join us for an interview? Please send your pitch to space-editor@n2k.com and include your name, affiliation, and topic proposal. T-Minus is a production of N2K Networks, your source for strategic workforce intelligence. © N2K Networks, Inc. Learn more about your ad choices. Visit megaphone.fm/adchoices

On this episode of the inSecurities podcast, Chris and Kurt chat with Martha Legg Miller, the Vice President of Public Policy and Regulatory Strategy at Fidelity Investments and former Director of the SEC's Office of the Advocate for Small Business Capital Formation. Martha talks about the role of the Advocate for Small Business Capital Formation, highlights key takeaways from the Office's 2023 Annual Report, and discusses recent SEC rulemaking proposals, including the Predictive Data Analytics (PDA) and Climate Risk Disclosure rules.

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.Highlights of the episode include:Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian young men, resulted in compromised health outcomes for others.Evolution and Transparency of the FDA: Nada traced the journey of the FDA, illustrating its transformation towards greater transparency and predictability. Emphasizing the human touch behind FDA's decisions, she dispelled the myth of the FDA being an impersonal "black box".Global Regulatory Movements: Highlighting a shift in the MedTech landscape, Nada pointed to the trend of global regulatory harmonization, particularly noticeable in the realm of software-based medical devices.Importance of User-Centered Design: Nada and the panel emphasized the significance of involving patients early in the design phase. Using tools like personas and human factor tables can lead to products that truly cater to users' needs, ensuring both usability and safety.Embracing Learning in MedTech: Nada's hope for companies to learn from past oversights and adapt to changing regulations stressed the crucial role of iteration and learning in medical device innovation.Navigating Modern MedTech Challenges: From addressing the significance of thorough documentation practices to discussing the challenges of regulating AI-driven medical devices, the discussion underscored the ever-evolving MedTech arena and the imperative need for regulators to stay updated.This episode paints a comprehensive picture of the medical device industry, addressing both its challenges and its advancements.Quote:"Medical devices shouldn't be designed with a one-size-fits-all approach. We've seen firsthand the impact of biases, like with pulse oximeters. It's crucial that we validate devices across diverse populations to ensure safety and efficacy for all."Reference Links:Nada HanafiMedTech ColorMedTech InnovatorVeranexEtienne NicholsTrue Quality RoadshowGreenlight Guru AcademyGreenlight Guru Software

Lex interviews seasoned fintech expert Teana Baker-Taylor - Circle VP of Policy and Regulatory Strategy EMEA. Circle began as a peer-to-peer payments technology company that now manages stablecoin USDC, a cryptocurrency the value of which is pegged to the U.S. dollar. Teana discusses her journey from traditional finance to the frontier of blockchain and crypto exchanges. Together Lex and Teana explore the tangible economic impacts of banking and navigate the complex digital asset landscape, focusing on the unique role of USDC as a leading stablecoin. Additionally, they touch on the underlying mechanics of USDC and the intrinsic investment risks in the stablecoin space. Concluding by pondering the potential of stablecoins like USDC in the emerging metaverse, a new digital realm with endless possibilities. MENTIONED IN THE CONVERSATION Circle's Website: https://bit.ly/3CwWfL5Teana's LinkedIn profile: https://bit.ly/3Nw8yxF Topics: crypto, blockchain, tokenization, web3, defi, stablecoins, metaverse, AR/VR Companies: Circle, USDC, Eurocoin, Terra Luna, Metamask, Apple ABOUT THE FINTECH BLUEPRINT 

On this episode of the METUS Tech Show, we bring on Director of Regulatory Strategy for Mitsubishi Electric, Dana Fisher. Dana provides us with important refrigerant and IRA updates.Thanks for listening! Please visit www.mitsubishicomfort.comContact us at metustechshow@hvac.mea.comThanks for listening! Please visit www.mitsubishicomfort.comContact us at metustechshow@hvac.mea.com

The FDA Group's CEO, Nick Capman, sits down with Regulatory Attorney Christine P. Bump to discuss the current regulatory landscape for medical devices and the importance of developing a thoughtful regulatory strategy. Discussion points include: » The three classifications of medical devices and the various regulatory submission types — each with different risk levels, required data, costs, and approval timelines. » The costs associated with FDA approval. » Why it's important to craft a regulatory strategy early, even at the product concept stage, to determine device functionality and anticipate FDA requirements. » The challenges that the rapidly evolving nature of software, algorithms, and AI present for the FDA's traditional device paradigm. » The benefits of pre-submission meetings with the FDA, which provide valuable feedback and insights to streamline the submission process. » The differences between regulatory attorneys and consultants. » The common pitfalls for companies navigating the FDA approval process, such as insufficient budgeting and lack in-house expertise. » The importance of planning well in advance and adjusting operational goals to align with regulatory requirements. » The importance of understanding product claims to avoid regulatory complications. Christine is a regulatory attorney with more than 15 years of experience developing and implementing FDA strategies for cutting-edge technologies. As the founder of Penn Avenue Law & Policy, she focuses on devices, software as a medical device, digital health, diagnostics, wellness, genetics and genomics, and advertising and promotion. She advises CEOs, scientists, and teams of all levels regarding regulatory pathways, clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She counsels a variety of clients, including start-ups, national and multi-national corporations, venture capital groups, and portfolio companies on navigating the FDA process. https://www.pennavenuelaw.com/ Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The Inflation Reduction Act allocates billions for home and building upgrades over the next ten years; these rebates and incentives can cut energy bills, reduce energy burdens, improve public health, and slash emissions, but state and tribal governments must work quickly to develop and implement well-designed programs to realize their full potential. This episode features energy policy researchers Dr. Yunus Kinkhabwala of PSE Healthy Energy and Dr. Arjun Makhijani of the Institute for Energy and Environmental Research, as well as heat pump and energy efficiency expert Dana Fischer with Mitsubishi Electric US discussing program design, data-driven approaches, and strategies that help people, especially low- to moderate income households and underserved communities, benefit from new funding. Guest BiosDr. Arjun Makhijani, PhD is the President of the Institute for Energy and Environmental Research holds a Ph.D. in engineering (specialization: nuclear fusion) from the University of California at Berkeley. He has produced many studies and articles on nuclear fuel cycle related issues. He is the principal author of the first study  on energy conservation potential in the U.S. economy. Most recently, Dr, Makhijani has authored Carbon-Free and Nuclear-Free: A Roadmap for U.S. Energy Policy (IEER Press), the first analysis of a transition to a U.S. economy based completely on renewable energy. He is the principal editor of Nuclear Wastelands and the principal author of Mending the Ozone Hole, both published by MIT Press.Dr. Yunus Kinkhabwala, PhD is a Senior Data Scientist, PSE Healthy Energy, where he develops sophisticated data-driven models to guide decision making and policy. Projects include optimizing the geospatial siting of solar and storage resilience hubs for vulnerable populations and estimating detailed household energy usages and costs to investigate impacts of policy scenarios aimed at improving energy affordability for low-income households. He received his PhD in Applied Physics from Cornell University as a National Science Foundation Graduate Research Fellow and holds a BS in Physics from the University of Illinois at Urbana-Champaign. Dana Fischer is the Director of Regulatory Strategy at Mitsubishi Electric US and has been with Mitsubishi Electric for 5 years working with individual homeowners and utility and industry organization and to the US Secretary of Energy. He was the Program Manager of the Home Energy Savings Program at Efficiency Maine and established the still active residential rebate and loan programs for weatherization, conventional heating systems, and heat pumps. He also has background in municipal finance, solar thermal, and ultra-high purity manufacturing.To dig in deeper, check out these must-read resources: Energy Affordability in Maryland: Integrating Public Health, Equity, and Climate | PSE Healthy Energy (February 2023)Mitsubishi Electric http://us.mitsubishielectric.comPSE Healthy Energy https://www.psehealthyenergy.orgInstitute for Energy and Environmental Research https://ieer.orgEfficiency Maine Heat Pump Program https://www.efficiencymaine.com/about-heat-pumps/

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today's episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they're ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I'm a biomedical engineer first and a regulatory consultant second. And that's the order we should think about these things.”“Even though I'm a regulatory consultant, I'm not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What's the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today's episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn't regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it's developed.”“If the hospital does one thing, they're treated one way; if a company does exactly the same thing, they're treated another way. Something's not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Finance, meet Sustainability. On this episode of the podcast, I spoke with Andromeda (Andie) Wood who is Vice President for Regulatory Strategy for Workiva. She is an expert in the role of technology in corporate reporting, taxonomy design and data modelling, and holds a wealth of knowledge and deep understanding of the impact of EU and UK regulation on global firms, particularly in the areas of corporate transparency and ESG. There is an undeniable global shift towards greater standardisation in reporting ESG initiatives across markets.As it stands, corporate reporting comprises the financial statements and management reports of companies, including non-financial and corporate governance statements, as well as country-by-country reporting. Under the new directive, reports would also include sustainability information.While new standards consolidate several diverse formats previously used for reporting on ESG progress, Andie explains why transforming standards will cultivate a more hygienic reporting culture that will champion ESG results.We covered a lot of ground in this podcast, such as:Push for improvement: These new standards address a worrying lack of clarity on how to report on sustainability, including information on methodology requirements, to more accurately highlight failure pointsFuture-proof ESG reporting: They will help businesses to mitigate challenges and prepare for the unknown by implementing processes that establish flexibility and controlAcknowledging that ESG plays a direct role in top-line growth: New standards establish critical business success factors, highlighting the role of ESG and encouraging businesses to integrate it into the overall business strategyMoving towards international comparability: An incremental, but mindful, transition towards transparent reporting will help to build up a rich history of reporting across regions which investors can use to better judge business progress, both individually and competitivelyThis was an interesting podcast and introduced me to the link between finance and sustainability.More on AndieAndie on LinkedInAndie on TwitterAndie's insights at WorkivaYour Host: Actionable Futurist® Andrew GrillFor more on Andrew - what he speaks about and recent talks, please visit ActionableFuturist.com Andrew's Social ChannelsAndrew on LinkedIn@AndrewGrill on Twitter @Andrew.Grill on InstagramKeynote speeches hereAndrew's upcoming book

Tim & John welcome Dana Fischer, Director, Regulatory Strategy for Mitsubishi Electric, to the show to talk about the regulatory environment, heat pumps, and the what Mitsu is doing to help train and educate contractors.#appetiteforconstructionpodcast #appetiteforconstruction #mechanicalhub #plumbingperspective #construction #constructionindustry #supportthetrades #trades #plumbing #skilledtrades #residentialconstruction #commercialconstruction #industryforecast #2023forecast #heatpumps #governmentregulations #minisplits #vrf Subscribe to the Appetite for Construction podcast at any of your favorite streaming channels.

In this regulatory wrap up from ESG Talk, host Mandi McReynolds is joined by her Workiva colleagues, Andromeda Wood, Vice President of Regulatory Strategy, and Steve Soter, Senior Industry Principal. Andie and Steve share their takes on ESG regulation in the EU and US, including CSRD and recent developments by the SEC.  Resources: 1) Andromeda Wood, CSRD Debrief - https://www.workiva.com/blog/csrd-debrief-whos-impacted-and-how-prepare  2) Steve Soter, podcast co-host Off the Books  https://podcasts.apple.com/us/podcast/off-the-books/id1505814699  3) COP27 and What's Next for ESG ft. Paul Dickinson, CDP - https://podcasts.apple.com/us/podcast/esg-talk/id1622905439?i=1000588129567  4) The ROI of Sustainability ft. Tensie Whelan, NYU Stern Center for Sustainable Business - https://podcasts.apple.com/us/podcast/esg-talk/id1622905439?i=1000585631997 

Our latest paper explores the key regulatory considerations across four key thematic areas: consumers, data, resilience, and governance and accountability, and how these will affect firms' strategies around embedded finance. In this episode, Suchitra Nair from the Centre for Regulatory Strategy and Richard Kibble, UK Banking Leader, discuss the current embedded finance landscape, the risks, opportunities and strategic considerations for firms. Our guests then offer some predictions for what they expect to see in the embedded finance market over the next 12-months.

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn't? Those are the questions that today's guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.Some of the highlights of this episode include:What regulatory strategy is and what it isn'tWhy a good regulatory strategy is so importantWhat competitive regulatory strategy isThe mistake of focusing on only one companyHow the EU MDR is affecting regulatory strategyWhat causes delays in complying with regulationsThe industry record on post-market surveillanceReimbursement and regulatory strategyMemorable quotes from Mike Drues:“Let's not forget my old friend, competitive regulatory strategy.”“It's never too soon, in my opinion, to start thinking about regulatory strategy.”“As a general rule, we have done an abysmal job on post-market surveillance across the board.”“I consider this whole thing to be a poker game, in every sense of the word.”Links:Mike Drues LinkedInHow to Construct an Effective Regulatory Strategy Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this episode we're speaking with Jim O'Sullivan, VP Regulatory Strategy and Special Projects at Matternet. In case you missed it, Matternet became the first commercial delivery drone manufacturer to receive type certification from the FAA in September 2022. This is an important industry milestone because, according to the FAA, operators that want to provide a regular commercial delivery service beyond visual line of sight need to run their operations under a Part 135 air carrier operating license…and this in turn requires type certified drones. So, we asked Jim to join us and talk about the drone type certification process: what it looks like, how long it took, all the twists and turns along the way, including the remaining challenge of certifying so called associated elements, meaning all parts of the drone system that do not fly, such as the ground control station and the datalink. We also talk about the commercial drone industry broadly: state of the market today and upcoming milestones. And for those of you thinking about starting a drone business, you'll want to hear Jim's advice. 

In this episode, Ti Benson and Duane Mancini discuss global regulatory strategy, the current landscape in the EU, MDSAP, hidden expenses, terminology, and so much more. Ti Benson LinkedIn LeanRAQA Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.Some of the highlights of this episode include:Fundraising: Figure out who you want to raise capital from, what should be in your pitch deck, and what questions will investors ask about problems/solutions.When trying to raise money, startups need to know that there are three types of investors—good, neutral, and bad. Sometimes, bad investors are hard to spot.When considering acquiring a company, some of the top things strategics look at is how you capture more clients, build your team, incorporate a quality management system (QMS), and handle regulatory challenges.If you are selling products to a hospital system, you will need to check three things—physician/clinician (especially nurses) ownership, patient improvement, and economic benefit.Build, develop, and invest in your team by finding people who complement your weaknesses. Don't be afraid to fractionalize. One of the most important thing you can do for your company is to find advisors, partners, and mentors with large professional networks.When people are raising money, unless you are raising from a high net worth individual or angel group, be strategic with who you want to raise money. Venture Capitalists have a responsibility to spend (invest) their money just like you have a responsibility to raise it.Clients need to understand that regulatory fits into their business, clinical, reimbursement, and commercialization strategies—all those things work together and overlap, so make sure to ask the right questions to the right expert.Memorable quotes from Duane Mancini:“The #1 thing we try to tell all of our startups when they're going out to raise money is there's three types of investors. There's good, neutral, and bad. You really want to avoid bad.”“For those first few investors, you want to find a good investor. Someone who's going to bring something else to the table. Fill a knowledge or network gap that you don't have. Understand what your mission is for the company and how they are going to support it.”“We talk to a lot of investors and a lot of entrepreneurs, and the one thing we've learned is that there is more than one way to raise money. However, there are patterns.” “Regulatory fits into your business strategy, fits into your clinical strategy, fits into your commercialization strategy—all those things work together and overlap.”Links:Duane Mancini on LinkedInProject MedtechProject Medtech PodcastEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - 510(k) ClearancesFDA - Premarket Approval (PMA)Build by Tony FadellGG AcademyMedTech NationGreenlight Guru

In this episode, Rob Packard and Duane Mancini discuss the current landscape of regulatory requirements in the EU, evolution of regulatory in the EU, the MDR, what is a notified body, post market surveillance in the US, global regulatory strategy, and so much more. Rob Packard LinkedIn Medical Device Academy Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this conversation, we will be speaking with Ian Springsteel, who is the Director of U.S. Regulatory Strategy at the National Grid. In this capacity, Ian develops and oversees regulatory strategy and implementation of new programs and petitions to U.S. regulators. His areas of focus include: electric vehicles and electrification of heat, solar incentive programs, grid modernization, and energy storage. In this conversation we discuss several of the programs he developed within those technology areas and also dive into what inspired Ian to get involved in the Energy Sector to begin with. Hope you enjoy my conversation with Mr. Ian Springsteel!

Putting The Stability Back Into Stablecoins In this episode of Public Key, our host, Ian Andrews (CMO at Chainalysis) is joined by Caroline Hill, Director of Global Policy and Regulatory Strategy, at Circle, who brings her 7+ years of US Treasury Department experience to discuss the regulatory regime around stablecoins, the impact of rushing to create CBDCs and Circle's ambition to be the most regulated stablecoin.  The conversation highlights that not all stablecoins are created equal and touches on the epic failure of the Terra LUNA stablecoin and how more transparency regarding reserves is needed. She also covers some of the exciting and innovative products coming out of Circle including Verite and the Euro stablecoin, EUROC.  Minute-by-minute episode breakdown (2:15) – Caroline's origin story going from detecting sanction evaders to innovative financial technologies helping with remittances (5:45) – Why the USA financial system is fine but far from being innovative leader (9:45) – Does international policy and regulation in crypto foster financial innovation  (14:11) – The stability behind USDC and the use case for stablecoins  (18:25) – Would CBDCs be a good idea for government, private sectors, traditional FIs and financial inclusion? (23:55) – Is China weaponizing their CBDC and making mitigating sanctions evasion more difficult  (25:00) –Not all stablecoins are stable and not all created equally  (28:15) – How digital identity can be privacy preserving yet meet AML requirements without creating vulnerable honeypots (30:10) – Conducting “follow the money” investigations with stablecoins  Related resources Check out more resources provided by Chainalysis that perfectly complement this episode of the Public Key. Report:The Chainalysis State of Web3 Report Webinar: The State of Web: Watch On Demand (with Ethan McMahon and Kim Grauer) Circle Blog: Circle Yield. Built Differently. Circle Blog: Reflections on Europe's Markets in Crypto-Assets Framework (MICA) Website: Verite: Decentralized identity for crypto finance Circle Blog:Circle's newest stablecoin, Euro Coin (EUROC) is here Circle Blog: Information about Circle's reserves and redemptions Speakers on today's episode Ian Andrews * Host * (Chief Marketing Officer, Chainalysis) https://www.linkedin.com/in/ianhandrews Caroline Hill (Director of Global Policy and Regulatory Strategy, Circle) https://www.linkedin.com/in/caroline-hill-4a1b7814 This website may contain links to third-party sites that are not under the control of Chainalysis, Inc. or its affiliates (collectively “Chainalysis”). Access to such information does not imply association with, endorsement of, approval of, or recommendation by Chainalysis of the site or its operators, and Chainalysis is not responsible for the products, services, or other content hosted therein. Our podcasts are for informational purposes only, and are not intended to provide legal, tax, financial, or investment advice. Listeners should consult their own advisors before making these types of decisions. Chainalysis has no responsibility or liability for any decision made or any other acts or omissions in connection with your use of this material. Chainalysis does not guarantee or warrant the accuracy, completeness, timeliness, suitability or validity of the information in any particular podcast and will not be responsible for any claim attributable to errors, omissions, or other inaccuracies of any part of such material.  Unless stated otherwise, reference to any specific product or entity does not constitute an endorsement or recommendation by Chainalysis. The views expressed by guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent. Views and opinions expressed by Chainalysis employees are those of the employees and do not necessarily reflect the views of the company.   

Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn't limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn't change is change itself - applies both in life and regulatory.  Today we're going deeper into how to modernize regulatory affairs, specifically for medtech. James Gianoutsos is the Founder & President of RimSys - a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamlined submissions to monitoring market status, RimSys can save RA teams hours and hours. Any life sciences founder listening in can learn from James's experience jumping into entrepreneurship from his career in Quality/Regulatory and how to get to market faster utilizing digital technologies.  Enjoy!About James GiantoutsosJames Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James' professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.About RimsysRimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn't there a better way to do this?” Like all RA teams, they spent hours looking for information, manually managed global product registrations, and struggled to keep up with changing regulations and standards. The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.Show noteshttps://www.rimsys.io/Rimsys Series A postJames Giantoutsos LinkedInQualio WebsitePrevious episodes: https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez

Angel-scale biotech is exploding: Learn More Practicing urologist and founder Jeremy Wiygul, MD believes millions of people are suffering needlessly due to the inadequate delivery of effective treatment, among these his own wife. Pelex aims to use new technology to integrate existing resources and greatly enhance patient outcomes for people with pelvic floor problems such as incontinence. A fun chat with a compelling founder. Sponsors: Purdue University entrepreneurship and Peter Fasse, patent attorney at Fish & Richardson Highlights: Sal Daher Introduces Jeremy Wiygul, MD Founder of Pelex “...up to 60 million Americans are affected by one form or another of pelvic floor disorders.” Pelex Combines a Connected Device and a Telehealth Platform to Provide Effective Care Pelex Intends to Bring Together the Right Provider, the Right Treatment and the Right Delivery of Care Consumer-Grade Pelvic Floor Devices Are Hit or Miss Parallels to Imago Rehab Which Delivers Physical Therapy Remotely via a Connected Device Connected with Jeremy Wiygul via Chrissy Glover of Imago Rehab Jeremy Wiygul's Own Physical Rehab Informs His Work Why Would a Urologist with a Practice in New Your City Found a Startup? What's the Innovation Pelex Is Bringing to Market? The Regulatory Strategy to Build Value in the Long Run “...we feel very strongly that our outcomes are going to be above, and significantly better than any other service that's out there.” Strategy with Regards to Intellectual Property The Combination of Practitioner, Care and Delivery Has the Potential to Build a Brand Based on Dramatic Improvements in Outcomes for Patients If the Wife of an Urologist Struggles to Get the Right Care in Her Husband's Specialty, There's Obviously a Problem Contact jeremy@pelex-med.com if You Have the Problem or Want to Help Exit Strategy The Power of Bringing the Right Technology to Market at the Right Time Learn More at https://pelexhealth.com/ Thanks Chrissy Glover of Imago Rehab for the Introduction to Jeremy Wiygul Topics: biotech, discovering entrepreneurship, software

On this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbursement considerations for Startups Importance of Regulatory Strategy for Startups Project Medtech and Medtech Money Podcasts Startup Symposiums Combination Products Startups Startup Symposium in Columbus, OH on 15-Jun-2022 - Register here Book Recommendation: Your Life Depends on It: What You can do to make better choices about your health Link ------------------------------------------------------------------------------------------------------------------------------------------------------ Duane Mancini is a chemist by training and holds a Master of Science degree in Medicinal Chemistry from the University of Toledo.  He started his medical device career at NAMSA as a technical advisor who specialized in overall biological safety planning including the use of chemical characterization to reduce the amount of biocompatibility testing needed for approval. He then moved into a senior technical advisor role at NAMSA and worked with clients on regulatory, reimbursement, and clinical strategies.  This unique and end-to-end background enabled him to be chosen to help lead NAMSA's MRO team.  In this role, he applied the NAMSA MRO approach (end to end CRO services) to medical device companies in order to accelerate time to market.  This role required working with mostly medical device start-up companies in developing and executing a get-to-market strategy. Duane then worked for Labcorp on the Medical Device and Diagnostic team as a Business Development Director bringing regulatory, reimbursement, pre-clinical and clinical support to his Medtech clients. He is currently the CEO and Managing Partner of Project Medtech.  Project Medtech is a media and advisory firm that is committed to supporting the delivery and development of innovative medical technology.

In the weeks since the invasion of Ukraine, the US and others have levied heavy sanctions against Russia. Financial businesses, including crypto firms, are now expected to comply with regulations by blocking a growing number of sanctioned entities. Some businesses, like PayPal and Revolut, have chosen to block Russian users altogether, despite this not being a requirement under the current sanctions regime. Others, like Kraken, have made it clear that while they block all sanctioned entities, they will continue to serve Russian users until political forces definitively direct them to stop. And still others, like FTX, have chosen to cut off some Russian accounts that aren't on the sanction list in addition to the sanctioned entities but continue to serve most Russian users. The varying approaches to sanctions compliance have left some wondering where the lines are, both legally and ethically. Meanwhile, some lawmakers are floating proposals to empower the Treasury to bar crypto services providers from transacting with any addresses associated with Russia.  In this week's episode of Policy Scoop, The Block's Aislinn Keely sits down with a sanctions expert and the legal chiefs from Kraken and FTX to parse out the complexities around Russian sanctions and the impact on the crypto industry as it stands today. Episode 24 of Season 4 of The Scoop was recorded remotely with The Block's Aislinn Keely and Marco Santori, CLO at Kraken, Caroline Brown, former White House sanctions attorney at Crowell & Moring, & Mark Wetjen, Head of Policy and Regulatory Strategy at FTX.US. Listen below, and subscribe to The Scoop on Apple, Spotify, Google Podcasts, Stitcher or wherever you listen to podcasts. Email feedback and revision requests to podcast@theblockcrypto.com. This episode is brought to you by our sponsors Fireblocks, Coinbase Prime & Chainalysis Fireblocks is an enterprise-grade platform delivering a secure infrastructure for moving, storing, and issuing digital assets. Fireblocks enables exchanges, lending desks, custodians, banks, trading desks, and hedge funds to securely scale digital asset operations through the Fireblocks Network and MPC-based Wallet Infrastructure. Fireblocks serves over 725 financial institutions, has secured the transfer of over $1.5 trillion in digital assets, and has a unique insurance policy that covers assets in storage & transit. For more information, please visit www.fireblocks.com. About Coinbase Prime Coinbase Prime is an integrated solution that provides institutional investors with an advanced trading platform, secure custody, and prime services to manage all their crypto assets in one place. Coinbase Prime fully integrates crypto trading and custody on a single platform, and gives clients the best all-in pricing in their network using their proprietary Smart Order Router and algorithmic execution. For more information, visit www.coinbase.com/prime. About Chainalysis Chainalysis is the blockchain data platform. We provide data, software, services, and research to government agencies, exchanges, financial institutions, and insurance and cybersecurity companies in over 60 countries. Our data powers investigation, compliance, and market intelligence software that has been used to solve some of the world's most high-profile criminal cases and grow consumer access to cryptocurrency safely. Backed by Accel, Addition, Benchmark, Coatue, Paradigm, Ribbit, and other leading firms in venture capital, Chainalysis builds trust in blockchains to promote more financial freedom with less risk. For more information, visit www.chainalysis.com.