BioPharm International provides information and resources related to the development and manufacturing of biopharmaceuticals. Topics covered include analytics, manufacturing processes, quality assurance, and supply chain logistics.

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MJH Life Sciences®

BioPharm International | 1,926 followers on LinkedIn. Talking biopharmaceuticals, biotechnology, bioprocessing and related pharma manufacturing. | BioPharm International integrates the science and business of biopharmaceutical development, and manufacturing. We provide practical, peer-reviewed technical articles to enable biopharmaceutical professionals to perform their jobs more effectively. We believe that technical decisions are also business decisions and give readers the tools to make both sound business and technical decisions.

US Director New Process Technology at Arcadis

Emily Heffernan, PE

In Vivo CAR-T first dosing by Interius BioTherapeutics (B-cell Malignancies) alongside Autolus Therapeutics #CAR_T lupus treatment, short teaser below, see full 30 minute episode #6 here: https://lnkd.in/eV6CBDw7 , thanks again to Brian Feth CEO xcellbio & Jonathan D. Grinstein, PhD North America Editor Inside Precision Medicine , thanks also BioPharm International Pharmaceutical Technology MJH Life Sciences® #oncology #lupus #autoimmune #ATMP

Chris Spivey

See real case study examples where the hybrid approach was successfully implemented in this live virtual event featuring James Guerra, P.E. from G-CON . Save your seat now: https://ow.ly/L3wt50TQXFL

I joined Chris Spivey and the #behindtheheadlines crew for a look into the crystal ball....and lots to talk about. My hot takes on what the election means for biopharma are below - comments welcome! 1) Taxes: Trump is likely to favor stock market-friendly policies like reinstating tax cuts and lowering corporate taxes, pushing the IPO window open further, boosting investment 2) Spending: Some analysts think Trump will advocate to control federal spending. I actually don’t think he has an appetite for that. Trump's record leans toward high spending to drive popularity. Expect continued spending, with a likely rise in XBI over the next few years. 3) Inflation: A safe bet from his first presidency is that he will lean heavily on the Fed to reduce interest rates rapidly - great for biopharma in the short term, but risks economic overheating and a return to rising inflation 4) FTC regulation: Likely reduced FTC oversight, encouraging M&A activity. Lina Khan may be replaced quickly. 5) FDA regulation: Expect an attempt to control and likely restructure, particularly with Elon Musk leading a government efficiency commission. However, many decisions are made by career staff, buffering extreme changes. 6) HHS Leadership: Trump’s leadership picks may be unconventional, very possibly affecting evidence-based policies. He has promised to let RFK Jr. “go wild” on drug and food policy. Howard Lutnick, co-chair of Trump’s transition team, said on CNN that Kennedy was “not getting a job for HHS.” If he does, I think it will be short lived. Still a really bad situation. 7) Drug price negotiations / Inflation Reduction Act (IRA): The president-elect’s prior "Most Favored Nation" drug pricing policy died after attracting lawsuits. I suspect he will depriotize price controls and instead focus on PBMs as a way to drive down drug prices. 8) BioSecure Act: Trump likely supports this amid U.S.-China tensions. Unfortunately China is a big market, provides low cost preclinical and clinical services, and has become a source of high quality therapeutic leads. Access may be (deeply) affected. 9) Affordable Care Act: Repeal unlikely, but JD Vance has suggested letting insurers divide enrollees into different risk pools - could mean lower costs for some but higher costs for sicker patients. 10) Chronic disease focus: Trump aims to focus on chronic disease with a presidential commission, echoing RFK's focus on metabolic syndrome-related indications in the “Make America Healthy Again” platform. 11) Medicaid: Trump will likely revisit work requirements for Medicaid, though prior efforts faced legal challenges. Some states still have lawsuits fighting for this. 12) Reproductive rights: There's likely no polling benefit to further limits. He might find a way to force funding of IVF via insurance

Brian Feth

Presidential election ramifications for pharmaceuticals - when full episode is ready next week, see it here: https://lnkd.in/eV6CBDw7 on 'Behind the Headlines" episode 6. Hearty thanks to Brian Feth CEO at xcellbio Biosciences and Jonathan D. Grinstein, PhD North America Editor for Inside Precision Medicine We talked about a host of topics that included investor sentiment, FDA and Centers for Disease Control and Prevention streamlining, In vitro fertilization's future, U.S. Department of Health and Human Services (HHS) leadership, - not to mention #CGT therapies, and the Interius BioTherapeutics First Patient with in vivo Chimeric Antigen Receptor (CAR) Gene Therapy for B-cell Malignancies, alongside Autolus Therapeutics lupus treatment. BioPharm International Pharmaceutical Technology MJH Life Sciences®

I'm excited to attend next weeks #mRNA Superbowl i.e. - the 12th international mRNA health conference in Boston next week. - thanks BioNTech SE CureVac Moderna and INTERPLAN Congress, Meeting & Event Management AG for putting on this best in class show, more detail here: https://lnkd.in/ex2nN4-n shoutout to the excellence of the planning committee's Mustafa Diken Mathias Vormehr Patrick Baumhof Markus Zettl Eckhard Jankowsky Galit Alter Katalin Karikó Norbert Pardi Daniel Siegwart

Join us as we explore a lively discussion focused on cell and gene therapy topics in a recent Buy, Sell, Hold panel featured on BioPharm International . In part 1, Cellares co-founder and CEO, Fabian Gerlinghaus , joins a notable group of experts, including Dr. Claudia Zylberberg , Board Chair and Co-Founder of Arscience Biotherapeutics & Board Chair and Co-Founder of Akron Biosciences, and Benjamin McLeod , Director, Cell & Gene Therapy Segment, NanoMosaic, to discuss critical topics ranging from the importance of focusing on orphan diseases to the impact AI and quantum computing will have on innovation. Don't miss out on this valuable exchange of knowledge and innovation. View the full panel discussion here: https://lnkd.in/e5kRVRwV

Cellares

#Gefion , #Denmark 's first #AI #supercomputer is now operational! With funding from the Novo Nordisk Foundation and built on technology provided by NVIDIA , the new supercomputer went live in #Copenhagen in October and can now be used to #innovate #drugdiscovery . Click below for the story! https://ow.ly/y19v50TXzHh

Learn how rapid post-translational modification (PTM) characterization of charge isoforms can be used to guide decisions during early development in this live virtual event sponsored by SCIEX . Register now: https://ow.ly/Yne050TQX4t

Have you heard the news? Vianautis has inked a deal with Eli Lilly and Company ! The companies are teaming up to develop #precision #genetic #medicines . #ICYMI , read the story below! https://ow.ly/3POK50TXyGK

The Novo Nordisk Foundation announced that #Denmark has its first #AI #supercomputer , newly launched in #Copenhagen ! With NVIDIA technology, #Gefion is now live and can be applied to #drugdiscovery #innovation . Click below for the story. https://ow.ly/y19v50TXzHh

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