The recently released update to the International Council for Harmonisation M12 guidelines provides a consistent approach to drug-drug interaction studies across different regulatory agencies. The new guidelines replace regional and local ones and set a global standard for addressing drug-drug interactions. We spoke to Michael Templin, Senior Principal Scientific Advisor for Charles River Laboratories; and Marko Andric, Senior Business Development Director, Late Discovery, for Charles River Laboratories; about the new guidelines, changes drug developers will need to make in their approach to pre-clinical development, and the tools and technologies that might help them comply. A related webinar on the guidelines can be found at www2.criver.com/l/60962/2024-11-05/n5wj6y

ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?

Originally Uploaded October 24th, reloaded December 1st.
For Media Business Episode 80:
Tony Conley has a three-part conversation welcoming Rodney Palmer Owner of 8 Biggby Coffee locations, Co-owner of Mercy Ambulance, Motivational Speaker & Coach, Former varsity basketball coach at Williamston High School.

Questions included:

How is the coffee business?

How do you find quality employees?

What are the biggest challenges for small businesses in Michigan?

Tony Conley interviews Rodney Dean Palmer, owner of 8 Biggby Coffees in Michigan, on the Michigan Business Network. Palmer discusses his business experiences, challenges in the Michigan business climate, and insights into running a successful franchise. He highlights the impact of regulations on small businesses, citing a $400,000 cost increase due to governmental overrides on a $1.2 million coffee shop project in Belding. Palmer shares his journey into the Biggby Coffee business, emphasizing the importance of following the franchise system. He also discusses the hiring process, the skills required for baristas, and the importance of creating a positive work environment. Palmer stresses the need for personal growth in leadership and the importance of building relationships with employees. The conversation also touches on the challenges faced by small businesses in Michigan and potential improvements to make the state more business-friendly.

Introduction to Rodney Dean Palmer and Biggby Coffee
Tony Conley introduces Rodney Dean Palmer, owner of 8 Biggby coffees throughout Michigan. Palmer is also starting a public speaking business as a motivational speaker.

Michigan Business Climate and Regulatory Challenges
Palmer discusses the challenging business climate in Michigan, particularly focusing on excessive regulations. He cites an example where governmental overrides increased the cost of a $1.2 million coffee shop project in Belding by $400,000.

Biggby Coffee Business and Training Process
Palmer shares how he got into the Biggby Coffee business through his son's influence. He describes the six-week training process for new franchisees, including four weeks of barista training and two weeks of management training.

Challenges and Rewards of Owning Biggby Coffees
Palmer discusses the challenges and rewards of owning multiple Biggby coffee shops. He emphasizes the importance of following the franchise system and the joy of engaging with customers and serving high-quality coffee.

Hiring Process and Employee Management
Palmer talks about the hiring process for baristas and the importance of creating a positive work environment. He stresses the need to build relationships with employees and support their personal growth.

Leadership and Small Business Management
The conversation shifts to leadership and management in small businesses. Palmer emphasizes the importance of personal growth for leaders and building strong relationships with employees.

Improving Michigan's Business Climate
Palmer discusses potential improvements to make Michigan more small business-friendly, including reducing regulations and simplifying the tax code. He compares Michigan's business climate unfavorably to other states like Indiana and Ohio.

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Media Business | Rodney Palmer, Biggby Coffee - How Media Deals w/ Challenges in Business Climate

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

Related Links:

https://insights.citeline.com/medtech-insight/pickleball-smart-homes-brain-games-caregiving-agetech-take-centerstage-at-aarps-ces-2025-presence-CIGK5RS7EVG2XH3XBQSUYDQXI4/

Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push

MENA Consultancy provides expert legal, corporate, and regulatory solutions across the UAE, GCC, and East Africa. With decades of experience, we offer cost-effective, tailored services for startups, SMEs, and global corporations. Let us handle the details while you focus on growth.

Why Choose MENA Consultancy?

Citeline’s expert panel of reporters and analysts unpack the biggest deals, trends, and innovations from the JP Morgan Healthcare Conference. Discover what these developments mean for you and the future of the industry in 2025 and beyond. 

Podcast: JPM Tracked and Unpacked

We’re excited to welcome Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments.

In this episode, Tim and Oeystein delve into the challenges of adopting AI in regulated settings, the complexity of validating GenAI tools, and the transition from traditional processes to AI-augmented systems. They also explore Oeystein’s work with the IMPALA Consortium and the importance of cross-industry collaboration to identify and scale high-value use cases for Generative AI.

Before his current role, Oeystein served as a Product Owner in Analytics at Merck IT, building analytics platforms and integrating data science across systems. He also contributed as a Machine Learning Subject Matter Expert to TransCelerate’s Intelligent Automation Group, advancing AI applications in pharmacovigilance.

Oeystein brings a rare blend of technical expertise and regulatory insight. He’s passionate about helping teams adopt AI responsibly and transparently—ensuring innovation aligns with quality across the pharmaceutical landscape.

Oeystein Kjoersvik - Auditing AI: Quality, Compliance & the Role of GenAI in Pharma

Created with Google NotebookLM and voiced completely by two AI synthesized actors (2025), this 23 minute 'podcast' explores the US Gramm-Leach-Bliley Act and brings this complex legislation down-to-Earth for all financial institutions, based on Kathryn L. Shut's Masters' Thesis, "GLBA Compliance Roadmap ... " (2024).

GLBA Compliance Roadmap for Financial Institutions (Kathryn Shut, MLS, MBA)

In this episode of "Counsel That Cares," Arjan Peters from Capstone moderates a conversation with his colleague Grace Totman, Holland & Knight healthcare attorney John Saran and Association for Responsible Healthcare Investment CEO Regan Parker about the evolving landscape of private equity investments in healthcare. They explore recent federal and state regulatory developments, including transaction reporting laws, antitrust scrutiny by the Federal Trade Commission (FTC) and notable battleground states pushing new legislation. The episode also highlights the impact of public perception shaped by high-profile healthcare closures, importance of transparent investment narratives and strategic approaches for investors to proactively engage with regulators and policymakers. Speakers emphasize that despite regulatory challenges, private equity plays a crucial role in sustaining and innovating the healthcare industry, encouraging stakeholders to document positive outcomes and advocate for balanced, informed policies that enable continued investment and growth.

Navigating the New Landscape of Private Equity in Healthcare

Small biotech companies are facing tough times, shrinking funding and uncertain futures. But beneath the surface, quiet forces of innovation and resilience are rising. This episode explores how biotechs ignite innovation despite economic headwinds, regulatory uncertainty, and fierce competition.

Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights.

View the video series and find out more information here: https://www.citeline.com/biotech

How to Survive Innovation Pressure in Today’s Biotech Landscape

Astellas is doubling down on gene therapy while others retreat. Richard Wilson, SVP Primary Focus Lead, Genetic Regulation at Astellas, joins In Vivo to discuss why the company believes AAV technology will transform medicine despite current industry headwinds.

🎯 Key Topics:
- Why Astellas opened a massive new gene therapy manufacturing facility
- Building an end-to-end AAV platform from research to commercial
- Strategic partnerships driving CNS and rare disease programs
- Maintaining team morale in a challenging investment climate
- Regulatory outlook and the path to commercial success

Richard also plays a role in Astellas' West Coast Innovation Center and serves on the Alliance for Regenerative Medicine board. He shares insights on manufacturing at scale, patient-centric culture, and the long-term potential of gene therapy.

Perfect for biotech investors, pharma executives, and anyone tracking the evolution of genetic medicines.

🔗 More insights: insights.citeline.com/in-vivo

Astellas Doubles Down on Gene Therapy Despite Industry Headwinds

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

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.

Welcome to TIMKAT Entertainment on Soundcloud!

Founded in October 2007 by father and daughter jazz musicians and industry professionals, Tim Ballard (1948-2009) and Kathryn Ballard Shut (President), TIMKAT's vision and mission thrive in promoting and supporting world-class independent jazz and soul in all their forms.  

Follow us for live updates on Twitter @timkatent or email us at timkatent@gmail.com. 

The Home of Business in Michigan. Get on-demand access to audio programs, articles and resources presented by savvy business leaders and industry experts.

The Big4Bio Podcast shares podcasts that give insight and information about/from biotech and life science leaders and organizations within the Big4Bio regions. Check out our Playlists to hear podcasts by region.

New tracks tagged #regulatory