Eli Lilly & Co.

Founding members will help shape the company's scientific and technology roadmap to deliver more efficient, automated, and cost-effective CDMO solutions, enabling biotech partners to bring transformative cell therapies to patients faster. PRINCETON, N.J., Aug. 28, 2025 /PRNewswire/ -- Made Scientific, a leading U.S.-based contract development and manufacturing organization (CDMO) specializing in cell therapies, today announced the formation of its Scientific Advisory Board (SAB) with the appointments of Miguel Forte, M.D., Ph.D., Paul K. Wotton, Ph.D., Shishir Gadam, Ph.D., and Young K. Hong M.D. The SAB will play a pivotal role in advancing Made's vision to redefine cell therapy manufacturing and testing. By bringing together multi-disciplinary leaders experienced across the domain of cell therapy product translation, bioprocess and analytical technologies, and regulatory and clinical application, the Board will provide strategic guidance to strengthen Made's CDMO platform and accelerate innovation for its customers. Their insights will help drive strategic initiatives at Made focused on lowering the cost of goods (COGS) for cell therapies and enabling partners to deliver more accessible, reliable, and transformative therapies to patients globally. Made Scientific plans to further expand the SAB later this year. "The establishment of our Scientific Advisory Board marks a pivotal moment in our commitment to innovation," said Syed T. Husain, Chairman and CEO of Made Scientific. "Miguel, Paul, Shishir, and Young each bring world-class expertise across cell therapy, manufacturing science, commercialization, and clinical practice. Their guidance will directly shape our service priorities, ensuring we deliver advanced, accessible, and scalable solutions for patients globally." ABOUT MIGUEL FORTE Miguel Forte, M.D., Ph.D., is CEO of Kiji Therapeutics and President of the International Society for Cell & Gene Therapy (ISCT). Prior to joining Kiji Therapeutics, he was CEO of Bone Therapeutics and Zelluna Immunotherapy, and CMO/COO of TxCell. Dr. Forte also served at the European Medicines Agency (EMA) and holds leadership roles with the Alliance for Regenerative Medicine. He earned his M.D. from the University of Lisbon and Ph.D. from the University of Birmingham. ABOUT PAUL K. WOTTON Paul K. Wotton, Ph.D., currently serves as CEO and Chairman of RBL LLC, a Houston-based biotech accelerator, and Executive Director of the Biotech Launch Pad at Rice University. He also serves on the boards of Vericel Corporation, Cynata Therapeutics, Morphocell Technologies, and Combined Therapeutics. Dr. Wotton's past executive leadership includes CEO roles at Obsidian Therapeutics, Sigilon Therapeutics (acquired by Eli Lilly), Ocata Therapeutics (acquired by Astellas), Antares Pharma, and Topigen Pharmaceuticals. He received his Ph.D. in Pharmaceutical Sciences from the University of Nottingham. ABOUT SHISHIR GADAM Shishir Gadam, Ph.D., is Chief Technical Officer at Marea Therapeutics and former Head of Technical Operations at Cargo Therapeutics, where he built manufacturing infrastructure and advanced novel CAR-T programs. Previously he was Global Head of Cell Therapy MS&T at Juno Therapeutics (acquired by Bristol Myers Squibb), playing a key role in launching two commercial CAR-T therapies. Dr. Gadam's earlier roles include biologics development at Genentech and Roche. He holds a Ph.D. in Biochemical Engineering from Rensselaer Polytechnic Institute. ABOUT YOUNG K. HONG Young K. Hong, M.D., is a dual board-certified general surgeon and surgical oncologist/hepatopancreatobiliary surgeon at Cooper University Hospital and MD Anderson Cancer Center at Cooper. He serves as Director of Clinical Research and Cellular Therapy, Assistant Director of Surgical Research, and Director of the Surgical Outcomes Research Group. Dr. Hong is site Principal Investigator for adoptive cellular therapy clinical trials in metastatic melanoma, head and neck, and non-small cell lung carcinoma. His lab studies epigenetic modulation of immunotherapy in pancreatic adenocarcinoma and hepatocellular carcinoma. He completed three fellowships, including the Clinical Immunotherapy and Surgical Oncology Fellowship at the NIH/NCI, and earned his M.D. from Virginia Commonwealth University School of Medicine and MPH in Health Policy from the University of Louisville. Dr. Hong is widely published in immunotherapy and surgical oncology and active on national research committees and editorial boards, including Annals of Surgical Oncology. With the launch of the SAB and continued investments in state-of-the-art manufacturing platforms, next-generation analytics, and experienced leadership, Made Scientific remains focused on its mission: Defy Limits. Deliver Results. For more information, visit madescientific.com or contact [email protected]. About Made Scientific Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors. SOURCE Made Scientific, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Coming off a series of setbacks in amyloidosis and a recent round of layoffs, Prothena is hoping that early data for its Alzheimer's disease (AD) candidate — as well as the potential of a preclinical asset — will attract a partner. The drugmaker shared results on Thursday from the Phase I ASCENT clinical programme, which is evaluating varying dose levels of a once-monthly, subcutaneous anti–beta-amyloid monoclonal antibody (mAb), PRX012, in patients with early symptomatic AD.While Prothena said the candidate was similarly capable of clearing amyloid plaques compared with the two marketed mAbs, Eli Lilly's Kisunla (donanemab-azbt) and Eisai and Biogen's Leqembi (lecanemab), it was linked to higher overall rates of amyloid-related imaging abnormalities with oedema or effusion (ARIA-E).As a result, the company described PRX012 as having a "non-competitive ARIA-E profile" in patients with early symptomatic AD. Still, Chief Development Officer Chad Swanson reiterated Prothena's goal to secure a partnership to advance development of PRX012, as well as its preclinical beta-amyloid transferrin receptor (TfR) antibody PRX012-TfR.The biotech said that observations from ASCENT, as well as feasibility studies of PRX012-TfR, suggest the antibody "may represent an opportunity to significantly lower the risk of ARIA and quickly reduce amyloid plaque with a once-monthly subcutaneous administration," with findings in mice models demonstrating "increased brain exposure and…rapid targeting of beta-amyloid plaques."Plaque attackThursday's readout included data from 228 participants in the ASCENT-2 portion of the programme with early symptomatic AD who were either heterozygous for APOE4, or non-carriers. Individuals who are homozygous for the gene are at higher risk to experience ARIA when receiving an anti–beta-amyloid mAb.Participants were randomised to receive either a 45-mg, 70-mg, 200-mg or 400-mg dose of   PRX012, or placebo. In the 400-mg dose cohort, PRX012 reduced amyloid PET levels to a mean of 27.47 centiloids (CL) at month 12; Kisunla has a defined amyloid negativity threshold of ≤24.1 CL, and Leqembi's is ≤30 CL. However, 41.7% of patients in the high-dose group experienced ARIA-E. Lilly recently presented data from a modified titration schedule of Kisunla showing a 14% incidence rate for the complication (see – Physician Views Results: Kisunla widens its lead over Leqembi with new, safer dosing).Prothena said it does not plan on sharing additional data from ASCENT while it hunts for a partner on its AD assets.

With a steep price hike looming, Eli Lilly has reportedly told its two British wholesalers to temporarily halt new orders of GIP/GLP-1 co-agonist Mounjaro (tirzepatide) amid surging demand for the diabetes and weight-loss drug. The move, effective August 27, means pharmacies will be unable to restock until September 1, when the new list prices for Mounjaro – rising by as much as 170% – take effect.In a letter to customers published by UK news outlet LBC, distributor Phoenix Medical Supplies said, "Due to the unprecedented demand that has been experienced since this announcement, Eli Lilly have requested that we implement an order freeze on Mounjaro products for all customers… Normal ordering processing for these products will recommence on Monday, 1st September and order processed after this date will be invoiced at the new list prices." The second British wholesaler is AAH.The increases, disclosed earlier this month, will push the monthly cost of the highest dose from about £122 ($165) to £330 ($446) for private patients, while the NHS has a separate deal.Lilly has characterised the move as part of a broader "rebalancing" of international drug pricing following pressure from the Trump administration to narrow the gap between US and European medicine costs. For related analysis, see – Spotlight On: Trump asks Big Pharma to comply with US pricing goals, but can he enforce them?'Panic buying'Dervis Gurol, owner of Healthy-U Pharmacy in East Sussex, said that customers appear to be stockpiling the drug in ways reminiscent of early in the COVID-19 pandemic. "For the last two weeks now, people have tried to register with multiple pharmacies to obtain the same drug from multiple places because they're panic buying," he is quoted as saying by LBC. "It's almost like the toilet paper scenario we had at Covid times."Meanwhile, according to the report, a Lilly spokesperson said "there are legal protections in place, enforced by the [UK's Medicines and Healthcare products Regulatory Agency], to prevent inappropriate stockpiling of medicines by providers. We encourage patients to only order based on their current treatment plan, to reduce the risk of localised disruption."