Off Script: A Pharma Manufacturing Podcast

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 

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 for allegedly taking over 1,000 files to Pfizer

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

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

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

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 settlement 

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 forging the future of pharma. During this podcast, Chi...

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 transport requirements.  Read the transcript: https://www...

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 solutions can help.  Read the transcript: https:/...

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 modalities and predictive formulation, and how these...

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? Karen Langhauser is joined by Ethan Smith, general m...

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 the transcript: https://pharmamanufacturing.com/2...

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 from Stevanato Group. Learn more about Stevanato Gr...

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 Gilulah, pharma machine health lead at Augury Read t...

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, ushering in the next generation of BET. Learn more about...

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 Scientific's gas analysis mass spectrometry product range...

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 the drug delivery of RNA-based therapeutics. Karen...

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 companies might overlook this aspect of workplace...

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-manufacturing-podcast/is-it-time-to-call-the-dogs-off-dr...

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-manufacturing-podcast/drugs-down-the-drain  

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 Giacomo Girotto, vision inspection project manager...

If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation. Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision  

The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change thi...

What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down? We caught up a long-time regulatory expert to find out. Read the transcript.

Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic. Read the transcript . Audio clips...