From Lab to Patient, Garage to Market

Navigating FDA Compliance: A Guide for Life Sciences Startups with Troy Fugate

Is your startup ready for FDA scrutiny — or are you building on a shaky foundation? In this episode of From Lab to Patient, Garage to Market, Phil Crowley sits down with Troy Fugate, founder of Compliance Insight and a regulatory affairs veteran with over 30 years of experience in the life sciences industry. Troy breaks down what early-stage biotech and medical device companies get wrong about FDA compliance, why your CDMO relationship can make or break your product, and how to build a quality culture that regulators actually trust. In this episode: * Why compliance has to be built in from day one — not bolted on later * What to look for (and watch out for) when choosing a CDMO partner * The difference between phase-appropriate GMP and cutting corners * How AI is starting to reshape regulatory strategy Troy also shares practical advice for founders who are navigating the regulatory landscape for the first time — and what it really takes to earn FDA trust. 🔗 Learn more about Troy Fugate and Compliance Insight: compliance-insight.com 📧 Reach Troy directly: tfugate@compliance-insight.com [tfugate@compliance-insight.com] 📚 Get Phil's book Avoid Startup Failure! on Amazon [https://www.amazon.com/AVOID-STARTUP-FAILURE-Technology-Advantage-ebook/dp/B0F244DQ3V/ref=sr_1_2?crid=2X8UF8A0DOC0O&dib=eyJ2IjoiMSJ9.Yse7B8E01hMYJA1pI18BatDBReraTS5WkRP8D46mqdjJxcRbeanEIPSeBaEsQJG0OD9G8R6wYAPryTtFCrHOaDREgfFKotVRVyplZM3YTb5vB0XSKYnfA1N3AmURGXtOh-vryZf5xvi3P964YrDlx6A2L65HDvq-DhR0oIg6JGSOSh7Mel7T4DapETfHWOGCeJfJzGLSj9feIM_ApveOsgP0QxlQAt9vGohgPCcmizw.YZx2OUYFmXskxDTKuTPtiadXTi2hOq43SN6VG1DT2L0&dib_tag=se&keywords=avoid+startup+failure&qid=1781649137&sprefix=%2Caps%2C476&sr=8-2]

Maximizing Efficiency & Sustainability in Pharma with Dr. Joseph Armstrong

From Lab to Patient, Garage to Market with Philip Crowley, Episode 32 In this episode of the From Lab to Patient, Garage to Market, Phil Crowley speaks with Dr. Joseph Armstrong, Chief Marketing Officer and global head of business development for TCG GreenChem, a contract research and manufacturing services company. Tune in to the episode to hear about: * Dr. Armstrong’s path from Tennessee to roles including leading research at Merck * The difference between medicinal chemistry (what the compound is) and process chemistry (how to make it reproducibly, robustly, and at scale) * How TCG GreenChem helps produce active pharmaceutical ingredients for clinical phases and eventual commercialization, * How green chemistry principles reduce steps, waste, hazardous reagents, and cost while improving yields * Innovation through continuous flow chemistry, which can improve safety, sustainability, and efficiency * How AI can use experimental and development data to accelerate process development and drug advancement while still relying on human decision-making and creativity * An example where catalytic asymmetric synthesis accelerated an oncology compound into the clinic * Three tips for entrepreneurs: take calculated leaps, stop/look/listen before reacting under pressure, and prioritize relationships and culture Learn more about Dr. Joseph Armstrong: * Visit TCG GreenChem’s website: https://tcggreenchem.com [https://tcggreenchem.com] * Email Dr. Armstrong: Joseph.Armstrong@tcggreenchem.com [Joseph.Armstrong@tcggreenchem.com] * Connect with Dr. Armstrong on LinkedIn: https://www.linkedin.com/in/joe-armstrong-2329687 [https://www.linkedin.com/in/joe-armstrong-2329687] *********************************** Check out Phil’s book, “AVOID STARTUP FAILURE!: Learn The Top Ten Causes Of Failure For Technology Startups And How To Turn Them To Your Advantage”: https://www.amazon.com/AVOID-STARTUP-FAILURE-Technology-Advantage-ebook/dp/B0F244DQ3V [https://www.amazon.com/AVOID-STARTUP-FAILURE-Technology-Advantage-ebook/dp/B0F244DQ3V] About From Lab to Patient, Garage to Market: Your host Philip P. Crowley Esq. is the founder and Managing Partner at Crowley Law LLC, a boutique corporate law firm focused on helping emerging tech and life sciences startups launch and reach their full potential. In each episode of From Lab to Patient, Garage to Market, Philip invites professionals serving the tech startup market to discuss various issues of importance in the industry and their part in it. Watch or listen to more episodes of From Lab to Patient, Garage to Market: - Website: https://www.crowleylawllc.com [https://www.crowleylawllc.com] - YouTube: https://www.youtube.com/@CROWLEYLAWLLC-hv8v [https://www.youtube.com/@CROWLEYLAWLLC-hv8v] - Spotify: https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p [https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p] - Apple: https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609 [https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609] - iHeart Radio: https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171 [https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171] Connect and learn more from your host, Phil Crowley: - Connect with Phil on LinkedIn: https://www.linkedin.com/in/philcrowleynjny [https://www.linkedin.com/in/philcrowleynjny] - Visit Crowley Law’s website: https://crowleylawllc.com [https://crowleylawllc.com] - Follow Crowley Law LLC on LinkedIn: https://www.linkedin.com/company/lawofficeofphilippcrowleyllc [https://www.linkedin.com/company/lawofficeofphilippcrowleyllc] - Follow Crowley Law LLC on Facebook: https://www.facebook.com/CrowleyLaw [https://www.facebook.com/CrowleyLaw]

$10 Million Startup Secrets with Aaron Price

From Lab to Patient, Garage to Market with Philip Crowley, Episode 31 In this episode of “From Lab to Patient, Garage to Market,” Phil Crowley speaks with Aaron Price, CEO of TechUnited:NJ, an organization and community that's dedicated to supporting and publicizing the work of innovators in the Garden State. Aaron and his team have had a major role in enriching the early-stage technology market in New Jersey. Tune in to the episode to hear about:  * How Aaron and his fellow co-founders built a $10 million company without any outside investment  * The legislative victories in New Jersey that are making it easier for tech innovators and investors  * The importance of understanding the mechanics of venture capital before raising funds for your startup  * The two essential nuggets of advice Aaron Price gives to aspiring entrepreneurs  * How joining a supportive tech community can accelerate your business and help you avoid common pitfalls Learn more about Aaron Price:  * Visit TechUnited:NJ’s website: http://techunited.co [http://techunited.co⁠]  * Connect with Aaron on LinkedIn: https://www.linkedin.com/in/arprice [https://www.linkedin.com/in/arprice] *********************************** About From Lab to Patient, Garage to Market: Your host, Philip P. Crowley Esq. is the founder and Managing Partner at Crowley Law LLC, a boutique corporate law firm focused on helping emerging tech and life sciences startups launch and reach their full potential. In each episode of From Lab to Patient, Garage to Market, Philip invites professionals serving the tech startup market to discuss various issues of importance in the industry and their part in it. Watch or listen to more episodes of From Lab to Patient, Garage to Market:  - Website: https://www.crowleylawllc.com [https://www.crowleylawllc.com]  - YouTube: https://www.youtube.com/@CROWLEYLAWLLC-hv8v [https://www.youtube.com/@CROWLEYLAWLLC-hv8v]  - Spotify: https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p [https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p]  - Apple: https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609 [https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609]  - iHeart Radio: https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171 [https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171]   Connect and learn more from your host, Phil Crowley:  - Connect with Phil on LinkedIn: https://www.linkedin.com/in/philcrowleynjny [https://www.linkedin.com/in/philcrowleynjny]  - Visit Crowley Law’s website: https://crowleylawllc.com [https://crowleylawllc.com]  - Follow Crowley Law LLC on LinkedIn: Crowley Law LLC | LinkedIn [https://www.linkedin.com/company/lawofficeofphilippcrowleyllc]  - Follow Crowley Law LLC on Facebook: https://www.facebook.com/CrowleyLaw [https://www.facebook.com/CrowleyLaw]

How Hackers Get In: Lessons from Bob Michie

From Lab to Patient, Garage to Market with Philip Crowley, Episode 30 In this episode of the From Lab to Patient, Garage to Market, Phil Crowley speaks with Bob Michie, President of MetroMSP and best selling author. MetroMSP specializes in a wide range of services, including tailored IT services and solutions for small and medium businesses and their owners in Northern New Jersey. Bob is author of “Managing Your Business Risk in the Cybersecurity Minefield: Critical Strategies from 21 Cybersecurity.” Tune in to the episode to hear about: * Surprising tactics cybercriminals use to hack business email accounts and how you can spot the warning signs * How a simple mistake on a cyber insurance form can cost your company millions after a data breach * The role artificial intelligence plays in both defending against and enabling cyberattacks today * Why class action lawsuits against companies after data breaches are on the rise, and how you can protect your business * The most practical steps any organization can take right now to strengthen its cybersecurity posture Learn more about Bob Michie: * Visit Metro MSP’s website: https://www.metromsp.com * Connect with Bob on LinkedIn: https://www.linkedin.com/in/michiebob [https://www.linkedin.com/in/michiebob] * Email Bob: bob@metromsp.com [bob@metromsp.com] * Follow MetroMSP on YouTube: https://www.youtube.com/user/metromsp [https://www.youtube.com/user/metromsp] * Is Your Company a Major Risk to Get Hacked? Get our COMPLETELY FREE Infographic on '15 Ways to Protect Your Business From a Cyber Attack!' http://15ways.metroMSP.com [http://15ways.metroMSP.com] *********************************** About From Lab to Patient, Garage to Market: Your host Philip P. Crowley Esq. is the founder and Managing Partner at Crowley Law LLC, a boutique corporate law firm focused on helping emerging tech and life sciences startups launch and reach their full potential. In each episode of From Lab to Patient, Garage to Market, Philip invites professionals serving the tech startup market to discuss various issues of importance in the industry and their part in it. Watch or listen to more episodes of From Lab to Patient, Garage to Market: - Website: https://www.crowleylawllc.com [https://www.crowleylawllc.com] - YouTube: https://www.youtube.com/@CROWLEYLAWLLC-hv8v [https://www.youtube.com/@CROWLEYLAWLLC-hv8v] - Spotify: https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p [https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p] - Apple: https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609 [https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609] - iHeart Radio: https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171 [https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171] Connect and learn more from your host, Phil Crowley: - Connect with Phil on LinkedIn: https://www.linkedin.com/in/philcrowleynjny [https://www.linkedin.com/in/philcrowleynjny] - Visit Crowley Law’s website: https://crowleylawllc.com [https://crowleylawllc.com] - Follow Crowley Law LLC on LinkedIn: https://www.linkedin.com/company/lawofficeofphilippcrowleyllc [https://www.linkedin.com/company/lawofficeofphilippcrowleyllc] - Follow Crowley Law LLC on Facebook: https://www.facebook.com/CrowleyLaw [https://www.facebook.com/CrowleyLaw]

Avoid These Startup Patent Mistakes with Attorney Joshua Goldberg

From Lab to Patient, Garage to Market with Philip Crowley, Episode 29 In this episode of the From Lab to Patient, Garage to Market, Phil Crowley speaks with Joshua Goldberg, Co-Managing Partner at Nath, Goldberg and Meyer, also known as "The Green Patent Guy". Tune in to the episode to hear about: * The most common misconceptions people have about what a patent actually allows them to do * How innovators decide when and where to seek international patent protection for their inventions * Why it’s important for companies and inventors to build a portfolio of patents rather than relying on a single patent * Ways trade secrets and trademarks complement patents in protecting a company’s intellectual property * Practical steps startups should take to avoid common pitfalls in software development and intellectual property agreements Learn more about Joshua Goldberg: * Email Joshua: jgoldberg@nathlaw.com [jgoldberg@nathlaw.com] * Connect with Joshua on LinkedIn: https://www.linkedin.com/in/joshuabgoldberg [https://www.linkedin.com/in/joshuabgoldberg] * Subscribe to Nath, Goldberg & Meyer’s YouTube channel: https://www.youtube.com/@nathgoldbergmeyer5843 [https://www.youtube.com/@nathgoldbergmeyer5843] * Visit Nath, Goldberg & Meyer’s website: https://nathlaw.com [https://nathlaw.com] *********************************** About From Lab to Patient, Garage to Market: Your host Philip P. Crowley Esq. is the founder and Managing Partner at Crowley Law LLC, a boutique corporate law firm focused on helping emerging tech and life sciences startups launch and reach their full potential. In each episode of From Lab to Patient, Garage to Market, Philip invites professionals serving the tech startup market to discuss various issues of importance in the industry and their part in it. Watch or listen to more episodes of From Lab to Patient, Garage to Market: * Website: https://www.crowleylawllc.com [https://www.crowleylawllc.com] * YouTube: https://www.youtube.com/@CROWLEYLAWLLC-hv8v [https://www.youtube.com/@CROWLEYLAWLLC-hv8v] * Spotify: https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p [https://open.spotify.com/show/0FQvlE5kJgkaUxKRJIAZ9p] * Apple: https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609 [https://podcasts.apple.com/us/podcast/from-lab-to-patient-garage-to-market/id1766757609] * iHeart Radio: https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171 [https://www.iheart.com/podcast/269-from-lab-to-patient-garage-204980171] Connect and learn more from your host, Phil Crowley: * Connect with Phil on LinkedIn: https://www.linkedin.com/in/philcrowleynjny [https://www.linkedin.com/in/philcrowleynjny] * Visit Crowley Law’s website: https://crowleylawllc.com [https://crowleylawllc.com] * Follow Crowley Law LLC on LinkedIn: https://www.linkedin.com/company/lawofficeofphilippcrowleyllc/ [https://www.linkedin.com/company/lawofficeofphilippcrowleyllc/] * Follow Crowley Law LLC on Facebook: https://www.facebook.com/CrowleyLaw [https://www.facebook.com/CrowleyLaw]