Off Script: A Pharma Manufacturing Podcast

Inside the FDA’s fateful Alzheimer’s decision

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 

Growing the biologic drug supply

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 this.

Learn more about Phylloceuticals at http://phylloceuticals.com.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/

Will the FDA keep moving at this breakneck pace?

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's wild ride through 2020

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 used:

CNBC: "How pharmaceutical companies are responding to the coronavirus outbreak"

CNA: "Pharmaceutical companies scramble to produce coronavirus vaccine"

CNBC: "The Race To Develop A Coronavirus Vaccine"

CBS News: "Trump to meet with pharmaceutical CEOs amid growing coronavirus outbreak"

CNBC: "Trump meets with big pharma to tackle coronavirus"

CBNC: "Moderna CEO Stephane Bancel on executive stock sales"

Saving the shrinking pipeline for antibiotics

The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the AMR Action Fund is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics.

Read the full transcript

Reaching undecided vaxxers: Can pharma simultaneously advance vaccines and public trust

As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.

Read the transcript here: https://bit.ly/34PEeb6

[Solutions Spotlight] Pharma’s drive towards more sustainable packaging

Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at Softbox Systems.

 

Read the full transcript: https://bit.ly/2JaQOsQ Learn more: https://bit.ly/2G8oWo3

Pharma's next big hurdle — distributing vaccines

It's been called the biggest logistical challenge of all time. What does pharma and the government need to do to quickly and successfully deliver COVID-19 vaccines into the waiting arms of Americans? Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out.

Read the full transcript here: https://bit.ly/3dJdhZs 

The United States of Generics

Should America reshore more generic drug manufacturing? Will it really keep our supply chains safe from disruptions? For our September cover story, we took a deep dive into these questions to untangle the arguments around reshoring generic drug production. Find out why we walked away so obsessed with Rosemary Gibson and why Phlow Corp. might be the company that settles the debate around reshoring once and for all.