Τα καλύτερα Off Script Podcast podcast (2024)

1
Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly] 3:36

5d ago3:36

3:36

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 twice-yearly HIV shot delivers zero infections in trial The bad — Takeda epilepsy drug misses endpoints in trials The ugly — Eli Lilly goes after counterfeiters…

1
[Solutions Spotlight] Streamlining oral dose packaging design 32:44

9d ago32:44

32:44

By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset, drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase…

1
FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly] 4:25

11d ago4:25

4:25

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 AdComm backs Eli Lilly Alzheimer’s drug The bad — Pfizer gene therapy fails phase 3 Duchenne trial The ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic…

1
AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly] 3:44

19d 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 — AstraZeneca’s Tagrisso delivers 84% progression-free survival in trial The bad — BMS to let go of 863 employees at NJ site The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Ph…

1
J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly] 3:24

27d 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 — J&J depression drug aces late-stage trial The bad — Takeda plans layoffs at Massachusetts sites The ugly — FDA delays review of Sanofi-Regeneron's Dupixent in COPD…

1
Mining pharma's reshoring rush 4:27

1M ago4:27

4:27

When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster. During this podcast, Chief Content Director Karen Langhauser will share …

1
FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly] 3:30

1M 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 first interchangeable biosims to Regeneron Eylea The bad — Evotec exits gene therapy The ugly — J&J reports deaths in early-stage radioligand trial…

1
FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly] 3:49

1M ago3:49

3:49

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 Amgen T-cell engager for small cell lung cancer The bad — BioMarin announces 170 layoffs The ugly — FDA delays review of Ascendis hypoparathyroidism drug…

1
Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [The good, the bad, the ugly] 4:14

2M ago4:14

4:14

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 — Vertex submits NDA for CF drug The bad — MacroGenics reports patient deaths in prostate cancer ADC trial The ugly — FTC extends review of Novo-Catalent deal…

1
Neurocrine wins FDA nod for 'sprinkle' Ingrezza, Moderna-Metagenomi deal ends, Emergent's layoffs [The good, the bad, the ugly] 3:37

2M 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 — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation The bad — Moderna, Metagenomi end gene editing collab The ugly — Emergent announces layoffs, closes sites…

1
Novartis wins rare cancer pediatric indication, BMS layoffs, McKinsey under fire [The good, the bad, the ugly] 4:26

2M ago4:26

4:26

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 wins rare cancer pediatric indication for Lutathera The bad — BMS unveils cost-saving initiative, layoffs The ugly — McKinsey under fire for alleged role in opioid crisis…

1
GSK antibiotic hits phase 3 goals, Genentech-Adaptimmune collab ends, Par Pharma recall [The good, the bad, the ugly] 4:10

2M 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 — GSK antibiotic hits phase 3 goals in gonorrhea The bad — Genentech ends $3B Adaptimmune T-cell collab The ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination…

1
BMS schizophrenia drug shines, Novartis axes jobs, Lilly compounding suit dismissed [The good, the bad, the ugly] 5:01

2M ago5:01

5:01

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 — BMS schizophrenia drug shines in phase 3 trial The bad — Novartis to axe 680 jobs The ugly — Lilly compounding suit dismissedΑπό τον Pharma Manufacturing

1
2024 election's impact on manufacturing 32:57

3M ago32:57

32:57

Politics, whether we like them or not, weigh heavy on manufacturing’s future. In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another. During this podcast, we…

1
Basilea grabs FDA nod, Verve halts gene editing trial, Amylyx pulls ALS drug [The good, the bad, the ugly] 3:47

3M ago3:47

3:47

Editor's Review: Week of April 1 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 — Basilea Pharmaceutica receives FDA approval for its IV antibiotic The bad — Verve Therapeutics halts gene editing trial, again The ugly — Amylyx removes ALS treatment…

1
[The good, the bad, the ugly] Editor's Review week of March 25 3:45

3M ago3:45

3:45

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 Akebia Therapeutics' Vafseo anemia drug The bad — Bristol Myers Squibb's Crohn's disease drug disappoints The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment…

1
[The good, the bad, the ugly] Editor's Review week of March 18 5:31

3M ago5:31

5:31

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 — Orchard gene therapy wins first FDA nod for rare pediatric disease The bad — Abiomed recalls heart pump instructions due to perforation risks The ugly — J&J files lawsuit against a former employee fo…

1
[The good, the bad, the ugly] Editor's Review week of March 11 3:54

3M 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 — Madrigal wins first FDA nod for NASH The bad — Acadia abandons plans to expand pimavanserin indications The ugly — BIO backs BIOSECURE Act, boots WuXi…

1
[The good, the bad, the ugly] Editor's Review week of March 4 4:16

4M ago4:16

4:16

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 — Boehringer Ingelheim to cap out-of-pocket inhaler prices The bad — Amylyx ALS drug falls short in phase 3 trial The ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm…

1
[The good, the bad, the ugly] Editor's Review week of February 29 3:07

4M ago3:07

3:07

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 — Iovance has launches Amtagvi The bad — FDA rejected Theratechnologies HIV instramuscular injection The ugly — BioMarin receives a subpoena from the DOJ…

1
[The good, the bad, the ugly] Editor's Review week of February 23 3:55

4M ago3:55

3:55

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 — Amtagvi approval The bad — Rapt clinical hold The ugly — Novavax and Gavi settlementΑπό τον Pharma Manufacturing

1
Raising a modern CDMO 8:52

4M ago8:52

8:52

Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forg…

1
[Solutions Spotlight] Meeting today’s container closure integrity requirements 16:36

9M ago16:36

16:36

In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transpo…

1
[Solutions Spotlight] Ensuring quality during a syringe surge 13:15

11M ago13:15

13:15

In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection…

1
Hollywood's Creative Bankruptcy: Part 2 38:07

1y ago38:07

38:07

Let's be honest: Hollywood is out of ideas. From endless reboots and sequels, to anything that will make a quick buck, the studios, executives, and stars of today's silver screen are driving movie fans to their limit. How did we get here? Is there a way out? These are some of the questions that Conner and Brendan are ready to answer. In Part 2 of t…

1
Hollywood's Creative Bankruptcy: Part 1 38:41

1y ago38:41

38:41

Let's be honest: Hollywood is out of ideas. From endless reboots and sequels, to anything that will make a quick buck, the studios, executives, and stars of today's silver screen are driving movie fans to their limit. How did we get here? Is there a way out? These are some of the questions that Conner and Brendan are ready to answer. In Part 1 of t…

1
Episode 17: Point of Care Testing and Prescriptive Authority 17:09

1+ y ago17:09

17:09

This podcast episode will discuss resolution 2022.3- Expanding Pharmacist Point of Care Testing and Prescriptive Authority. This resolution was passed during the APhA-ASP House of Delegates Session at APhA Annual 2022. APhA-ASP National Policy Standing Committee, Rachel Dittrich, invites student pharmacists Dillon Solliday, Man Ha, and Cecily (Cece…

1
Episode 16: Online Health Information 21:26

1+ y ago21:26

21:26

National Policy Standing Committee member, Rachel Dittrich, is joined by three student pharmacists to discuss APhA-ASP Resolution 2022.2. Jeffrey Bezard, Dia Cabrera, and Alex Shanti discuss their tools and methods for collecting online health information and how to address misinformation.Από τον APhA-ASP

1
[Solutions Spotlight] Overcoming drug formulation challenges 23:43

1+ y ago23:43

23:43

In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at MilliporeSigma, to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel mod…

1
“We’re Back” feat. Star Wars: Andor 1:03:19

1+ y ago1:03:19

1:03:19

1 year, 2 months, and 16 days. That's how long it's been since we uploaded. It has been a minute, and a lot has happened since then. I'm sure it's been quite the 1 year, 2 months, and 16 days for you all as well. Did we retire? Yeah, for a while. Are we back? You bet. You begged and pleaded, so here we are. And we couldn't be more excited. But in o…

1
[Solutions Spotlight] Bringing pharma’s asset management into the digital age 25:23

1+ y ago25:23

25:23

For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Ka…

1
[Solutions Spotlight] How to overcome challenges in ophthalmic formulations 14:21

1+ y ago14:21

14:21

Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma. Learn more about MilliporeSigma: https://www.emdmillipore.com/US/en Read th…

1
[Solutions Spotlight] How digitalization can provide a competitive advantage 15:09

2y ago15:09

15:09

The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini f…

1
[Solutions Spotlight] Stop the stall: The time is now for predictive maintenance in pharma 12:20

2y ago12:20

12:20

Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gi…

1
Episode 15: Pharmacy Sustainability 24:55

2+ y ago24:55

24:55

National Policy Standing Committee Member Julia Miller is joined by 3 Virgina Commonwealth University student pharmacists Ladan Karim Nejad, Kayla Pangilinan, and Kelly Pratt. The four talk about pharmacy sustainability and what student pharmacists can do in their own lives to help make changes for our patients and the environment.…

1
[Solutions Spotlight] A groundbreaking approach to BET testing 25:22

2+ y ago25:22

25:22

Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, usherin…

1
[Solutions spotlight] A better way to measure critical attributes in bioreactors 13:17

2+ y ago13:17

13:17

In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientif…

1
Best of Bond... James Bond Draft 1:00:54

2+ y ago1:00:54

1:00:54

Conner has Dakota and Carson on to draft their favorite movies, villains, actors, and more from the beloved James Bond series. With No Time to Die coming to theaters on Oct. 8th the boys talk about what it means to play the character and how Daniel Craig has revolutionized the role. Thanks for listening to Off Script! If you enjoyed the episode, we…

1
[Solutions Spotlight] Special delivery: Lipid nanoparticles usher in new treatments 15:32

2+ y ago15:32

15:32

RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable …

1
Episode 14: A Pharmacist's Role in Opioid Use Disorder 32:42

2+ y ago32:42

32:42

National Policy Standing Committee Member Megan Wright is joined by Dr. Courtenay Wilson and final year student pharmacist Morgan Bizzell, both from UNC. Together the three speak about APhA-ASP resolution 2021.2 and medications for opioid use disorder. Listen to learn more about handling stigma associated with MOUD and how student pharmacists can g…

1
[Solutions Spotlight] Harnessing AI to improve workplace ergonomics 17:30

3y ago17:30

17:30

Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many …

1
The Suicide Squad Review: Emphasis on the "The"! 44:23

3y ago44:23

44:23

No offense to David Ayer...but what a difference a director can make! In this episode, Conner and Brendan are joined by special guest Carson to talk about the all-new, all-different The Suicide Squad, helmed by none other than Marvel's own James Gunn. This movie is quite a ride from beginning to end (literally), and the guys are back to break it al…

1
The Month of Marvel Mayhem! 52:02

3y ago52:02

52:02

What a month July has been for Marvel! They are kicking off the summer season with a bang, dropping both Black Widow, their first movie in a full year, and the final episodes of Loki, one of the most talked-about shows since...well...WandaVision! In this episode, Conner and Brendan are talking about both. If you're ready for a wild ride of Marvel i…

1
Luca and the Pixar Identity Crisis 28:54

3y ago28:54

28:54

Pixar is back yet again with Luca, it's 24th feature film (yes that's right, more than the MCU!). And guess what? In traditional Pixar fashion, there’s a lot to like. It's full of heartwarming moments and things for the whole family to enjoy. It also brings up an interesting theory...is Pixar having an identity crisis? And if so, is Luca the movie …

1
Is it time to call the dogs off drug testing? 22:27

3y ago22:27

22:27

Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development. Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/ Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufa…

1
See It or Skip It: Loki Ep. 1 (No Spoilers) 15:27

3y ago15:27

15:27

We are Off Script, and we are burdened with glorious purpose...of talking all about the premiere of Loki on Disney+! With some crazy, chaotic moments and all-around fun, it might actually give us some insight into where the MCU is headed. And don't worry, like all of our See It or Skip It's, this episode is spoiler-free, so you can hear it from us …

1
The One About the Friends Reunion 21:50

3y ago21:50

21:50

Could we BE any more excited?? For the first time in 17 years, the cast of Friends is back together again! Brendan and Adri are here to break down the heartwarming and nostalgia-filled reunion special, including their favorite moments, tidbits, and inside secrets. And most importantly, they ask: Will there ever be a show quite like this again? List…

1
Cruella Review: The Disney Wears Prada 34:47

3y ago34:47

34:47

Movies are officially back! Of course, you know Disney had to be in on the fun. And speaking of fun, Brendan and Adri are diving into Cruella in this episode! This fast-paced, fashion drama tells the fascinating origin story of one of the greatest Disney villains of all time, and we're diving into all of the hijinks. If you're as excited as we are …

1
Drugs down the drain 33:12

3y ago33:12

33:12

When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste. Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-…

1
[Solutions Spotlight] Elevating quality inspection with AI 16:22

3y ago16:22

16:22

The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and G…

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