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MJH Life Sciences®

Pharmaceutical Technology | 5,137 followers on LinkedIn. Bringing you the latest in global pharmaceutical development and manufacturing industry. | Pharmaceutical Technology is the authoritative source of peer-reviewed research and expert analyses for scientists, engineers, and managers engaged in process development, manufacturing, formulation and drug delivery, API synthesis, analytical technology and testing, packaging, IT, outsourcing, and regulatory compliance in the pharmaceutical and biotechnology industries.

Susan Schniepp

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Dr. Heidi M. Mansour, Ph.D. RPh, FAIMBE, SMNAI

Eastern Sales Manager; Pharmaceutical Technology and Pharmaceutical Technology Europe

Joel Kern

Independent Pharmaceuticals Professional

Katharina Picker-Freyer

Pharmaceutical Technology

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®

Chris Spivey

Join Experts from Vectura Group to discuss how biologic formulations can be tailored and refined for lung delivery, whether in liquid or dry powder format. Save your seat: https://ow.ly/pILj50TYqTQ

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel. https://lnkd.in/eS8UaZ7r

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

Avid Bioservices has entered into a merger agreement, valued at approximately $1.1 billion, with GHO Capital Partners and Ampersand Capital Partners. https://lnkd.in/e3pTD626

Gain insights on the science behind solubility enhancement using the Dispersome® technology in this live virtual event sponsored by Zerion Pharma and Hovione . Register now: https://lnkd.in/gSixXCpp

Check out this upcoming live webcast from Pharmaceutical Technology® to explore how biologic drugs, traditionally developed for injectable use, can be optimized for lung delivery through innovative formulation strategies. #Biologics #Formulation

Recognize the role of excipients in stabilization of biologic APIs with experts from Lonza in this live virtual event. Register now: https://lnkd.in/eciYKiHD

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

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