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Artwork for Off Script: A Pharma Manufacturing Podcast

Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturing
Antibody Drug Conjugates
API Innovation Center
Rockwell Automation
Annex 1
Autonomous Bioprocessing
NX1
Drug Development
Automation
Robotics
Cell Therapy
Cell and Gene Therapy
Sequential Nano Precipitation (SNAP)
Lonza
High DAR Adcs
Dual Payload Adcs
Metoprolol
Lomasteen
FDA
Contamination Control
Isolators

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more!

PublishesWeeklyEpisodes125Founded6 years ago
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NewsBusiness News

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Artwork for Off Script: A Pharma Manufacturing Podcast

Latest Episodes

As peptide therapeutics become larger, more complex, and increasingly purity-sensitive, manufacturers are confronting a new layer of execution challenges. Long-chain peptides introduce compounding scale-up inefficiencies, increasingly fragile purific... more

As peptide pipelines continue expanding globally, pharmaceutical companies are increasingly turning to CDMOs earlier in the lifecycle to help manage growing technical and operational complexity. Outsourcing partners are being leaned on to support pro... more

As municipal water utilities increasingly shift from free chlorine to chloramine disinfection strategies, pharmaceutical manufacturers are facing new challenges in maintaining consistent, high-purity water systems. While chloramines provide utilities... more

As drug development grows increasingly complex, CDMOs are exploring new ways to streamline the path from early-stage formulation through commercial manufacturing. Rather than operating in isolated segments of the development lifecycle, some outsourci... more

Key Facts

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Recent Guests

David Leroux-Petersen
CEO of Corealis Pharma
Corealis Pharma
Episode: Can CDMO-to-CDMO Collaboration Simplify Drug Development?
JB Agnus
CCO of the CDMO division
Bora Pharmaceuticals
Episode: Can CDMO-to-CDMO Collaboration Simplify Drug Development?
Steve Cabano
President of Pathfinder
Pathfinder
Episode: Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part One
Mark Christopher
Vice President of Pathfinder and Head of Pathfinder's Pharmaceutical Division
Pathfinder
Episode: Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part One
Haley Johnson
Senior Manager of Product Management
West Pharmaceutical Services
Episode: Annex 1 and the Shift to Proactive Sterile Manufacturing
Bill Matakas
Vice President of Business Transformation
West Pharmaceutical Services
Episode: Annex 1 and the Shift to Proactive Sterile Manufacturing
Gil Roth
Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA)
Pharma & Biopharma Outsourcing Association (PBOA)
Episode: How U.S. Policy Is Reshaping Pharma Outsourcing
Mel Radford
Director of Life Sciences Global Accounts at Rockwell Automation
Rockwell Automation
Episode: Building the Foundation for Autonomous Bioprocessing
Brian Doty
Vice President of R&D and Programs at the API Innovation Center
API Innovation Center
Episode: Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply

Host

Andy Lundeen
Host of Off Script with a focus on pharma manufacturing and industry coverage.

Reviews

4.7 out of 5 stars from 13 ratings
  • An informative gem!

    Just discovered them through the schizophrenia episode and I’m so glad I did. A fresh, straightword and informative podcast. Perfect for those who want to learn about the latest insights of the industry in a concise manner.

    Apple Podcasts
    5
    hellomaleny
    United States2 years ago
  • Great Show!

    A total gem in Pharma Industry! Very knowledgeable and informative, the hosts and guests provides real insights that definitely work. Glad to find your podcast, I'm learning a lot!

    Apple Podcasts
    5
    Retchelle_Platforce
    Philippines3 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Guests and hosts are praised for real-world insights and practical discussions that translate to action.
Listeners describe the show as informative and concise, with clear takeaways for the pharma industry.
Praise for depth and breadth of topics, from policy to cutting-edge manufacturing technologies.
The content is seen as a valuable resource for staying current on regulatory, manufacturing, and supply chain topics.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#84
Italy/News/Business News
Apple Podcasts
#249
Germany/News/Business News
Apple Podcasts
#22
Belgium/News/Business News
Apple Podcasts
#162
Singapore/News/Business News
Apple Podcasts
#194
Japan/News/Business News
Apple Podcasts
#249
Spain/News/Business News

Talking Points

Recent interactions between the hosts and their guests.

How U.S. Policy Is Reshaping Pharma Outsourcing
Q: What should we watch in the next year or two regarding U.S. government policies and regulatory signals?
Watch regulatory policy stability, MFN pricing effects, and ongoing negotiations around GDUFA; political interference and executive actions on R&D could destabilize investor confidence and the CDMO market.
How U.S. Policy Is Reshaping Pharma Outsourcing
Q: How serious are FDA staffing concerns and could they affect drug review timelines?
Staffing reductions and leadership changes could slow reviews and increase timelines, potentially leading to more CRLs if reviewers are under pressure or risk-averse, which could affect investor confidence.
How U.S. Policy Is Reshaping Pharma Outsourcing
Q: What stands out to you about the pharma supply chain tariff schedule and its implications for sourcing strategies?
Tariffs create a trade-off where MFN pricing could reduce tariffs to zero, potentially making pricing strategy more influential than pure on-shoring; exceptions and carve-outs will limit the impact and require ongoing lobbying to clarify which activities count as on-shoring.
How U.S. Policy Is Reshaping Pharma Outsourcing
Q: How would you characterize the current policy environment for CDMOs and the outsourcing sector?
The policy environment is focused on in-house pharma and on-shoring, with MFN and pricing announcements shaping the landscape; CDMOs must highlight their role as force multipliers and push for tech transfer to count in on-shoring metrics.
Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part One
Q: Yeah, and to get the conversation started, how would you characterize the most significant structural weaknesses in today's global medicine supply chain, particularly in the context of current geopolitics and evolving US policy priorities?
The most significant weaknesses are twofold: persistent generic drug shortages driven by very low prices and production disruptions, and the national security risk from geographic concentration of starting materials, which creates single points of failure that could be exploited or disrupted by events or policy shifts.

Audience Metrics

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Frequently Asked Questions About This Podcast

What is This Podcast about and what kind of topics does it cover?

The show features in-depth conversations with industry leaders across pharmaceutical manufacturing, from CDMO collaborations and mega-scale capital projects to regulatory shifts, advanced manufacturing, and next-generation modalities like CGT and ADCs. Episodes frequently explore real-world governance, risk management, and implementation challenges—covering topics such as domestic manufacturing strategies, resilience of the medicine supply, automation and data-enabled manufacturing, and the evolving regulatory landscape. A standout is its focus on practical paths to scale, including governance models, supplier partnerships, and end-to-end solutions that bridge science, engineering, and policy. This makes it a strong listen for executives, e... more

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this podcast launched 6 years ago and published 125 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on this podcast?

Recent guests on this podcast include:

1. David Leroux-Petersen
2. JB Agnus
3. Steve Cabano
4. Mark Christopher
5. Haley Johnson
6. Bill Matakas
7. Gil Roth
8. Mel Radford

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