Bedste Off Script Podcast-podcasts (2026)

1
AI and the Future of Drug Development 26:15

1d ago26:15

26:15

Artificial intelligence is rapidly reshaping drug development by accelerating timelines, enabling more complex biologics, and changing how therapies are designed, delivered, and scaled. But as innovation speeds up, manufacturers face new challenges around delivery platforms, regulatory expectations, and operational agility. In this episode of Off S…

1
Predictive Maintenance for a Modern Cold Chain 15:04

8d ago15:04

15:04

While pharma supply chains are becoming increasingly digitized, the cold chain segment continues to face major vulnerabilities, from aging infrastructure and equipment failures to new refrigerant regulations. As manufacturers work to protect temperature-sensitive products and avoid costly disruptions, predictive monitoring is emerging as a critical…

1
Building a Future for Curative Cell Therapies: Part Two 13:50

15d ago13:50

13:50

In this episode of Off Script, we continue our conversation with Jason Bock, co-founder and CEO of CTMC, diving deeper into the operational and manufacturing challenges shaping the future of curative cell therapies. Jason discusses how CTMC—through its partnership with MD Anderson Cancer Center—is eliminating inefficiencies across development timel…

1
Building a Future for Curative Cell Therapies: Part One 17:18

22d ago17:18

17:18

Autologous cell therapies have shown the promise of single-dose, curative treatments for patients with advanced cancers. But even with major scientific and regulatory progress, the field now faces its toughest challenge yet: achieving sustainable, scalable manufacturing for highly personalized therapies. In this episode of Off Script, we spoke with…

1
Modular Flow Chemistry and the Future of Continuous Manufacturing 16:30

29d ago16:30

16:30

Flow chemistry and modular continuous platforms are gaining momentum as pharma searches for faster, more flexible, and more sustainable ways to develop and scale small-molecule processes. Yet questions around integration, scale-up, and regulatory expectations continue to influence how quickly these technologies can be fully adopted. In this episode…

1
The Economics Behind U.S. Generic Drug Manufacturing: Part Two 16:16

1M ago16:16

16:16

In this episode of Off Script, we continue our conversation with John Murphy III, president and CEO of the Association for Accessible Medicines, to dig deeper into the vulnerabilities and structural challenges shaping U.S. generic and biosimilar drug production. Murphy examines the most fragile links in the supply chain — from the lack of domestic …

1
The Economics Behind U.S. Generic Drug Manufacturing: Part One 16:22

2M ago16:22

16:22

In this episode of Off Script, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, about the forces shaping the future of U.S. generic and biosimilar manufacturing. Murphy provides a high-level look at the pivotal shifts defining the generic drug landscape and breaks down the economic realities driving drug…

1
CGT Manufacturing Challenges and Opportunities 19:28

2M ago19:28

19:28

While the cell and gene therapy space represents one of the most exciting therapeutic frontiers in modern biopharma by offering highly personalized, transformative treatments, the sector still faces significant hurdles before it can achieve widespread commercialization. From steep manufacturing costs and a lack of standardization to persistent inef…

1
The State of CDMO Funding: 2025 in Review (Part Two) 17:17

2M ago17:17

17:17

In part two of our conversation with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, we explore how today’s CDMO funding trends are shaping the next phase of growth and specialization across the contract research and manufacturing ecosystem. Brian shares his perspective on: The outlook for cell and gene therapies, where clini…

1
The State of CDMO Funding: 2025 in Review (Part One) 22:03

2M ago22:03

22:03

As we near the end of 2025, the CDMO industry finds itself at a pivotal financial and strategic juncture — shaped by constrained funding, shifting demand, and renewed investor scrutiny. In this episode of Off Script, we speak with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, to examine how the year’s market and investment …

1
Corporate compliance involves more than just cGMP and quality 16:51

3M ago16:51

16:51

This episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Jana Falkenberg, senior legal counsel and corporate compliance officer at Vetter Pharma, a global contract development and manufacturing organization (CDMO) headquartered in Germany. Falkenberg, who is responsible for the continuous improvement of the compliance…

1
Charting Pharma Manufacturing Trends: Part Two 16:26

3M ago16:26

16:26

Building on insights from CRB’s Horizons: Life Sciences 2025 report, this second installment of our conversation with Peter Walters, Fellow of Advanced Therapies at CRB, explores the modalities driving forward momentum across the life sciences industry, the expanding role of standardization in manufacturing networks, and how tariffs and domestic in…

1
Charting Pharma Manufacturing Trends: Part One 13:16

3M ago13:16

13:16

Af Pharma Manufacturing

1
Editor’s (re)View: It matters if Big Pharma is fudging its US investment numbers 4:00

4M ago4:00

4:00

Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate?Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbe…

1
Can CDMOs keep up with the increasing demand for GLP-1 medications? 5:45

4M ago5:45

5:45

The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-me…

1
FDA’s program to speed up US manufacturing buildouts is short on detail 5:49

4M ago5:49

5:49

While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail…

1
New Jersey remains hot life sciences hub despite macroeconomic, funding headwinds 5:25

5M ago5:25

5:25

The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-he…

1
Critical Timing: Hikma’s Billion-Dollar U.S. Investment 6:44

6M ago6:44

6:44

Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicin…

1
Editor’s (re)View: Is the biopharma industry’s glass half empty or half full? 4:47

6M ago4:47

4:47

While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.Greg Slabodkin Read by Brittany Duncan Read Article Here: https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full…

1
Life sciences manufacturers overwhelmingly embrace smart tech: global survey 5:00

6M ago5:00

5:00

Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation. Greg Slabodkin Read by Brittany DuncanAf Pharma Manufacturing

1
Flow state: The evolving shape of continuous manufacturing 15:11

7M ago15:11

15:11

While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.Greg Slabodkin Read by Brittany Duncan Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing…

1
[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation 18:15

8M ago18:15

18:15

Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes. To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse…

1
Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs 4:26

8M ago4:26

4:26

The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.Af Pharma Manufacturing

1
Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly] 4:13

9M ago4:13

4:13

The good — Thermo Fisher opens center to boost cell therapy development The bad — FDA cites Aurobindo plant after Raleigh inspection The ugly — Trump probes pharma imports as tariff threat loomsAf Pharma Manufacturing

1
Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly] 4:10

9M ago4:10

4:10

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites The bad — U.S. urged to invest $15B to counter China’s biotech rise The ugly — Trump signals ‘major’ tariffs on pharm…

1
Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly] 3:18

10M ago3:18

3:18

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Cellares, Cabaletta validate automated CAR T production The bad — FDA warns Aspen over sterility issues The ugly — FDA rejects Hengrui, Elevar cancer combo again…

1
Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly] 3:44

10M ago3:44

3:44

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand. The bad — Merck KGaA’s CDMO business reports a decline The ugly — The FDA issues a warning letter …

1
Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [The good, the bad, the ugly] 3:54

11M ago3:54

3:54

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Eli Lilly expands manufacturing to boost supply The bad — FDA blocks imports from two Indian API makers over manufacturing violations The ugly — ICU Medical recalls potassium chloride injection bags…

1
Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly] 4:24

11M ago4:24

4:24

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Novartis boosts Slovenia investment to $3.6B The bad — Trump tariffs unsettle biopharma FDI The ugly — FDA warns Global Calcium, blocks US importsAf Pharma Manufacturing

1
FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly] 3:19

12M ago3:19

3:19

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Opdivo subcutaneous version The bad — Marinus Pharmaceuticals sells operations The ugly — Novo Nordisk pushes back against compounding pharmacies…

1
EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [The good, the bad, the ugly] 2:58

1y ago2:58

2:58

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — EU approves Novo-Catalent acquisition The bad — CDMO National Resilience announces layoffs The ugly — FDA investigates blood cancer reports in gene therapy patients…

1
FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly] 3:12

1y ago3:12

3:12

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Imkeldi oral solution The bad — Alector axes workforce The ugly — Novartis announcnes layoffsAf Pharma Manufacturing

1
FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly] 3:19

1y ago3:19

3:19

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA grants Regenxbio accelerated approval pathway for Duchenne gene therapy The bad — Neurogene reports patient death in Rett syndrome gene therapy trial The ugly — Halozyme withdraws acquisition pro…

1
PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly] 3:13

1y ago3:13

3:13

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — PTC secures FDA nod for brain-targeted gene therapy The bad — Kronos Bio halts CDK9 development The ugly — Marinus slashes 45% of workforce amid setbacks…

1
Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly] 3:35

1y ago3:35

3:35

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Ascendis, Novo ink partnership The bad — Court blocks Sun Pharma launch The ugly — FDA moves to delist phenylephrineAf Pharma Manufacturing

1
MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China [The good, the bad, the ugly] 2:57

1y ago2:57

2:57

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — MilliporeSigma expands ADC manufacturing The bad — EU fines Teva The ugly — AZ exec under investigationAf Pharma Manufacturing

1
[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs 14:59

1y ago14:59

14:59

Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics. Extended Release is an Off Script series to revisit con…

1
Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [The good, the bad, the ugly] 3:10

1y ago3:10

3:10

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Nucleus RadioPharma expands production with new sites The bad — FDA issues CRL to Camurus' hormone disorder drug The ugly — NHS rejects Alzheimer's drug over cost concerns…

1
FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [The good, the bad, the ugly] 2:50

1y ago2:50

2:50

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves AbbVie 24-hour Parkinson’s treatment The bad — Sage Therapeutics axes workforce The ugly — FDA halts Novavax's COVID-flu vaccine trialsAf Pharma Manufacturing

1
Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [The good, the bad, the ugly] 2:58

1y ago2:58

2:58

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Roche snags breast cancer FDA nod The bad — FDA places clinical hold on Kezar lupus nephritis drug trial The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection…

1
Gilead inks deal with generics manufacturers to expand HIV drug access, J&J announces layoffs, Amgen sued for hiding $10.7B tax bill [The good, the bad, the ugly] 4:00

1+ y ago4:00

4:00

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Gilead inks deal with generics manufacturers to expand HIV drug access The bad — J&J announces layoffs at New Brunswick headquarters The ugly — Amgen sued for hiding $10.7B tax bill…

1
FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [The good, the bad, the ugly] 3:37

1+ y ago3:37

3:37

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good —FDA approves BMS schizophrenia drug The bad — bluebird bio announces layoffs The ugly —J&J talc subsidiary files for bankruptcyAf Pharma Manufacturing

1
[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience 17:28

1+ y ago17:28

17:28

Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more. Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide u…

1
Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly] 3:24

1+ y ago3:24

3:24

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Novo Nordisk shares phase 2a trial data for obesity treatment The bad — Achilles Therapeutics to discontinue TIL-based therapy The ugly — Express Scripts files lawsuit against FTC…

1
[Solutions Spotlight] Optimizing contamination control in pharma facilities 12:32

1+ y ago12:32

12:32

Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures. To better understand thes…

1
Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly] 3:34

1+ y ago3:34

3:34

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Roche snags FDA nod for subcutaneous cancer immunotherapy The bad — Moderna to cut R&D expenses by $1.1B The ugly — Teva reaches $80M opioid settlement with Baltimore…

1
Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly] 4:12

1+ y ago4:12

4:12

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Pfizer, Valneva share phase 2 positive Lyme vax data The bad — IN8bio axes workforce, halts trial The ugly — AstraZeneca employees detained in ChinaAf Pharma Manufacturing

1
FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly] 3:30

1+ y ago3:30

3:30

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Illumina cancer biomarker test The bad — BioMarin reveals more layoffs The ugly — FDA hits API maker Global Calcium with 483Af Pharma Manufacturing

1
Pharma’s new age of longevity 4:15

1+ y ago4:15

4:15

The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discuss…

1
Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly] 3:41

1+ y ago3:41

3:41

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Emergent donates 50,000 doses of mpox vaccine to Africa The bad — FDA rejects Regeneron blood cancer bispecific antibody The ugly — China indicts Astellas exec for espionage…

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