Hello again, everyone. Welcome to another episode of Executive Platforms’ Blueprint Podcast Series. I’m Geoff Micks, Head of Content and Research. Today, Teresa Gorecki from Compliance Architects joins me.

We’re discussing current issues and pharmaceutical manufacturing trends. Teresa’s insights from last year set a high benchmark, and I’m excited to continue our conversation. Read the interview below or watch the video below.

Compliance Architects: A One-Stop Shop for Industry Guidance

Geoff: Teresa, let’s start by discussing key issues and trends your organization addresses with clients.

Teresa: Absolutely. Over the past year, we’ve worked with device companies under warning letters and drug companies with significant compliance gaps, and we’ve ventured into exciting fields like cell and gene therapy, regenerative medicine, and transformational medicine. These areas involve highly specialized manufacturing processes, sometimes on a very small scale, like creating personalized cancer vaccines.

Global Reach and Innovative Therapies

Teresa: We’ve expanded globally, helping companies worldwide with personalized vaccines for cancer and various cell and gene therapies. Notably, we assisted a company in obtaining approval for a tissue therapy to implant tissue into an infant without an immune system. There’s an ongoing discussion about regulatory harmonization at a macro level, though I doubt complete harmonization will occur soon. However, we will see more collaborative efforts and innovative manufacturing methods.

Regulatory Collaboration and Emerging Technologies

Geoff: With these new treatments, is there an opportunity to start fresh with regulations?

Teresa: Drafting new regulations is challenging, but providing good guidance is feasible. The FDA is offering more interactive webinars and case studies, allowing real-time engagement and advice. This collaborative approach is crucial for advancing new therapies, especially in gene and cell therapy.

Personalized Medicine: A Game Changer

Geoff: It’s exciting to think about these breakthroughs. Personalized medicine is transforming treatment approaches.

Teresa: Indeed. Personalized vaccines for cancer, gene therapies for rare diseases, and advanced treatments for conditions like Parkinson’s and Alzheimer’s are changing lives. Unlike traditional pharmaceuticals that manage symptoms, these therapies can potentially eliminate diseases.

AI and Virtual Training: The Future of Pharmaceutical Manufacturing

Geoff: AI seems to be a significant enabler in this space.

Teresa: Absolutely. AI can streamline processes like change control, ensuring compliance and efficiency. For example, an intelligent form connected to various data sources can guide companies through regulatory requirements, minimizing manual input and enhancing accuracy. Virtual training reduces training time and improves effectiveness, especially in sterile environments.

Small Companies and Capital Challenges

Geoff: Smaller companies face unique challenges. How can they navigate these issues?

Teresa: Capital is a significant challenge. Venture capital typically funds drug development and clinical trials but often overlooks infrastructure needs. Small companies must partner with contract manufacturers and labs that have invested in enabling technologies. This approach ensures smoother regulatory approval and reliable product supply.

The Role of Compliance Architects

Geoff: How can Compliance Architects assist in this journey?

Teresa: We offer deep industry expertise, helping companies from pre-clinical development to market launch. For instance, we’ve assisted companies with complex device requirements and guided them through regulatory processes. Our experience ensures that even small companies can navigate regulatory challenges efficiently.

Getting Started with Compliance Architects

Geoff: How can companies look to start reaching out to you?

Teresa: Visit our website at www.compliancearchitects.com or connect with us on LinkedIn. We’re always ready to discuss your needs and offer guidance.

Final Thoughts

Geoff: Any final thoughts for our listeners?

Teresa: If you’re working with new technologies, engage with regulators early and often. Partnering with the FDA and good consultants will expedite your path to market and ensure that life-changing therapies reach those in need.

Geoff: Teresa, thank you for your invaluable insights.

Teresa: Thank you, Geoff. It’s been a pleasure.

Geoff: You’ve been listening to another Executive Platforms’ Blueprint Podcast Series episode. I’m Geoff Micks. Let’s do it again soon.

Want to learn more about Teresa? Check out her about page here.

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