Explore every episode of the podcast Pharmaceutical Executive

Treasury proposes adding biotechnology to its Outbound Investment Security Program, a pharma funding roundup covers Gilead’s $1.275 billion acquisition of an oral IL-23R inhibitor from PepStar and Zymeworks’ licensing deal with Roche, and Incubate’s John Stanford on why MFN is an offer pharma can’t refuse.

Biopharma manufacturing today is being asked to move faster, accommodate increasingly complex modalities, and respond more readily to changing development timelines and demand forecasts — all while maintaining reliable, compliant, and cost-effective supply. In this episode of the Pharm Exec Podcast, Dave Maraldo, Ph.D., executive vice president and president of the Merck Manufacturing Division, draws on 27 years at the company to explore that evolution. He discusses Merck’s major U.S. capacity investments; its approach to balancing internal capabilities with strategic manufacturing partners; and the closer integration of research, development, and production.

Joining Mike Christel, group managing editor, MJH Life Sciences, Maraldo also examines the practical impact of digital tools and artificial intelligence and how Merck is building greater agility and resilience into its global supply network. He reflects ahead as well on what the next generation of manufacturing talent will require and why he thinks patient needs will move closer and closer to the shop floor.

FDA grants Ultomiris accelerated approval for primary immunoglobulin A nephropathy, a pharma funding roundup covers Alcon’s $550 million acquisition of Neurotech and AI Proteins’ collaboration with Astellas, and Incubate’s John Stanford on which therapeutic areas MFN deals might hit hardest.

A new ICER and West Health report finds median drug launch prices climbed to $257,000, the FDA approves GSK’s Hibsago as the first functional-cure therapy for chronic hepatitis B, and CSL names Deborah Waterhouse as CEO and managing director.

METiS TechBio and Eli Lilly collaborate on next-generation LNP delivery technology, Incubate’s John Stanford on how MFN deals may shape future pharma decisions, and the FDA grants accelerated approval to GSK’s Jemperli for MSI-H/dMMR locally advanced rectal cancer.

Merck KGaA, Darmstadt, Germany, acquires Silence Therapeutics for $1.3 billion, Hansoh Pharma and Roche expand their ADC partnership in a deal worth over $15 billion, and an EMA panel backs Lilly’s Foundayo for obesity and type 2 diabetes in Europe.

Gilead and Vir Biotechnology strike a $1.87 billion T-cell engager collaboration, and Fox Rothschild’s Marc Wagner examines what slows manufacturers’ response to rising drug demand and how compounding pharmacies help fill the resulting gaps.

Experts warn prediction markets are exposing gaps in pharma vendor confidentiality agreements, Roche licenses Rona Therapeutics’ obesity RNAi candidate while Pfizer partners with Enodia Therapeutics on Sec61 inhibitors, and PaxSafe’s Mark Talens makes the case for acting on imperfect supply chain data.

Bausch + Lomb names Thomas Appio interim CEO as Brent Saunders departs, a Pharm Exec interview explores how AI is reshaping entry-level apprenticeship in professional services, and a LogiPharma 2026 conversation makes the case against waiting for perfect data to deploy AI in pharma supply chains.

The FDA approves Roche’s Tecentriq for a subset of colon cancer patients, TRexBio and Retension Pharmaceuticals price new IPOs, and a Pharmaceutical Executive feature examines what it takes to turn precision medicine’s biological gains into deliverable therapies.

Ultragenyx sells a rare pediatric disease priority review voucher for $210 million, Viatris acquires Pacira BioSciences for $1.65 billion, and Peter Young surveys a steadying biopharma outlook.

Caribou Biosciences discontinues its two allogeneic CAR-T programs, Kamal Biswas makes the case for continuous quality management maturity, and FDA approves Pfizer’s Tukysa as a first-line maintenance therapy in HER2-positive breast cancer.

Shionogi, Gate Bioscience, and Alector post a trio of new deals, Rajul Jain makes the case for social listening as a medical affairs strategic tool, and Doceree's Vijay Adapala argues that HCP engagement is a systems-design problem, not a communications one.

Can artificial intelligence help turn what many believe is clinical development’s biggest variable — and most prevailing bottleneck — into a more predictable process? In this episode of the Pharm Exec podcast, Matt Walz, CEO of Trialbee, a patient recruitment company, joins Mike Christel, group managing editor, MJH Life Sciences, to discuss how AI is enhancing medical screening, clinical workflows, and enrollment planning. The conversation explores the need for clearer regulatory expectations, human oversight, and workforce training — and why predicting enrollment costs and timelines, Walz believes, could offer one of AI’s most consequential opportunities in clinical trials. 

Walz also shares how Trialbee is deploying AI on both the patient-facing and operational sides of its business and explains how conversational tools are helping teams move from the world of dashboards to more specific answers.  

Jewel Jones warns that pharma catches patient disengagement too late, CSL and Alentis Therapeutics join Jiangsu Nhwa and Somnivera in a day of new licensing deals, and Corxel's Bo Liang calls GLP-1's leap to bariatric-surgery-level efficacy the biggest surprise in obesity medicine.

Foghorn Therapeutics and Eli Lilly discontinue their SMARCA2 degrader program, Novartis licenses Abogen's autoimmune mRNA therapy while AstraZeneca, Daiichi Sankyo, and Summit Therapeutics team up on a breast cancer combination trial, and Corxel's Bo Liang makes the case for oral GLP-1 therapies.

Regeneron and Sanofi expand their antibody alliance with four new drug candidates, FDA approves Camzyos for adolescents with obstructive hypertrophic cardiomyopathy, and Michael Abrams questions digital health's savings claims to employers.

Novo Nordisk data show real-world weight loss after switching to its oral semaglutide pill, FDA's peptide rulemaking stalls while its enforcement arm targets compounded peptide sellers, and Avi Pardo flags a compliance blind spot in field teams' text messages with doctors.

In this episode of Leading Edge with Ken Banta, Jeremy Levin, D.Phil, MB BChir, co-founder and executive chairman of Ovid Therapeutics, joins Banta, The Vanguard Network founder and CEO, for a wide-ranging and candid discussion on the challenges confronting the U.S. biotechnology industry and the leadership required to strengthen its future.

Drawing from Levin’s book, Biotech in the Balance: Saving a Strategic Industry in an Age of Distrust, the prominent and outspoken biopharma leader argues that biotechnology is facing pressures that extend well beyond the traditional cycles of capital and investment. The conversation with Banta and Pharmaceutical Executive's Mike Christel turns squarely to leadership and the industry's relationship with the public. Levin challenges pharma and biotech executives to communicate more clearly what their organizations contribute to patients and society — but stresses that communication must be backed by meaningful action. "Mission without method is a waste of time,” he asserts.

Banta and Levin also explore the responsibility of corporate boards, how executive incentives can shape organizational priorities and whether the traditional emphasis on shareholder value adequately reflects the broader societal obligations of healthcare companies.  

New U.S. guidance carves out tariff exemptions for specialty pharmaceuticals, Pharming's Fabrice Chouraqui steps down as CEO amid a board rift, and a dealmaking roundup covers Hengrui Pharma's licensing agreement with Novo Nordisk and AstraZeneca's investment in Summit Therapeutics.

Merck licenses a preclinical KRAS G12D inhibitor from SciBrunch, FDA approves Olumiant, Juvmo, and Atebrioz across three separate indications, and Matthew Montes de Oca makes the case for compounding pharmacies to set their own safety standards.

FDA approves Merck and Eisai's Welireg-Lenvima combination for advanced kidney cancer, a platform-deal roundup covers Novo Nordisk, Genentech, and Roche's tie-ups with Nanexa, Earendil Labs, and Atavistik Bio, and Ron Lanton examines the fight to regulate pharmacy benefit managers.

InnoCare Pharma and Eli Lilly ink a multibillion-dollar research collaboration, FDA approves Lilly's once-weekly insulin Onswik for type 2 diabetes, and Jen Lamppa talks fixing clinical trial patient enrollment with real-world data.

EVERSANA's Jen Norton talks about how AI is reshaping market access strategy, a new analysis from MIT and Harvard Business School names clinical data harmonization as the real barrier to enterprise AI adoption in life sciences, and Novo Nordisk's CEO says he's open to a direct NYSE listing.

Nine major European drugmakers warn the region risks losing pharma investment, Novartis licenses a preclinical radioligand therapy asset from BoomRay Pharmaceuticals, and Rafaat Rahmani argues that the costliest competitive intelligence failure is missing the moment a strategic assumption goes wrong.

FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.

FDA approves Kerendia as the first new treatment for kidney disease in type 1 diabetes in decades, Novo, Roche, and Aethlon Medical strike major deals and mergers with Orbis Medicines, Dualitas Therapeutics, and North Immunology, and Thani Jambulingam of Saint Joseph's University examines the fight to control the GLP-1 patient journey.

Novo teams up with Anthropic on AI-driven drug discovery, Sling Therapeutics and Circle Pharma close major financing rounds, and IQVIA's Phil Ford makes the case for reimagining medical content as a loop rather than a pipeline.

GSK is acquiring a trispecific T-cell engager from Chimagen Biosciences and Sanofi expanding its manufacturing partnership with Cheplapharm, Stewart Gandolf discusses why pharma marketing now has to write for both people and AI, and Dr. Elena Christofides explains why cortisol dysregulation may be the hidden reason some diabetes patients fail to respond to incretin therapies.

Cellectis pivots from CAR-T to in vivo gene editing, Novo Nordisk rebrands as "Novo" to sharpen its competitive edge in obesity and diabetes care, and Wendy Short Bartie of Bristol Myers Squibb makes the case for reputation as a strategic currency.

Novartis investors intensify pressure on the company's M&A strategy after a string of trial failures, Michelle Carnahan argues health care needs an orchestration layer rather than more point solutions, and Nacho Quinones and Aisling O'Loughlin make the case for synthetic advisory boards in biopharma decision-making.

In this episode of Pricing & Policy with Model N, Jesse Mendelsohn, senior vice president at Model N, joins host Mike Christel to examine the growing stakes surrounding the 340B Drug Pricing Program — and how claims data, rebate models and legal challenges are shaping manufacturers’ response. Mendelsohn explains drugmaker concerns about overlapping discounts, the gaps in claims visibility that make them difficult to identify and the push to verify dispensing before paying a 340B rebate (all three at the heart of industry revenue leakage issues). Throughout the conversation, Mendelsohn considers what it will take to bring greater accountability and predictability to the program while preserving its underlying purpose.

00:53 - The evolution of 340B  

03:39 - Understanding program's growth and impact 

07:27 - Manufacturer challenges/complexities in compliance 

10:43 - 340B's twisting path: Rebate pilots and more

15:44 - Pharma as key stakeholder 

18:25 - Claims collection hurdles 

20:56 - Lilly and industry strategy shifts 

23:19 - Assessing the litigation landscape 

25:37 - 340B's role in pricing pie, GTN management

29:20 - Fueling future debate? The two drivers

Aptar Pharma and Aceso Therapeutics team up to advance an inhaled cystic fibrosis therapy, Moonwalk Biosciences raises a $70 million Series B for its fat-targeted obesity platform, and Sebastian Arana of MilliporeSigma talks through the real cost of manufacturing flexibility.

Ionis wins FDA approval for Zanvastro, the first disease-modifying treatment for Alexander disease, Pharmaceutical Executive’s weekly biotech roundup gathers analyst reaction to the week's biggest stories, and Nate Hill of Strive Pharmacy talks through the regulatory uncertainty around compounded peptides.

Ultragenyx shares plunge after apazunersen fails its Phase III trial in Angelman syndrome, Mark Cziraky of Carelon Research talks through the mechanics of analyzing linked real-world data sets, and Melanie Whittington joins The Ron Lanton Report to argue biopharma policy needs to stay tethered to patients, not abstractions.

Melanie Whittington, managing director and head of the Leerink Center for Pharmacoeconomics, joins Ron Lanton to argue that biopharmaceutical policy only makes sense when traced back to its purpose.

Novartis and Bristol Myers Squibb pause autoimmune CAR-T trials over safety concerns, a dealmaking roundup covers Alteogen's licensing deal with Novartis, NewBiologix's gene therapy partnership with Synastra, and RedHill's acquisition of Rebyota and Clenpiq from Ferring, and Lexi Cogswell and Tom Rotolo make the case for real-world insights in obesity medical strategy.

The Trump administration adds nine drugmakers to its Most Favored Nation pricing program, GSK advances its dual-antigen mRNA flu vaccine into Phase III, and Simcere Zaiming licenses its tri-specific antibody Sim0660 to Roche for up to $1.53 billion.

Eli Lilly agrees to acquire Merida Biosciences for up to $2.875 billion, BioNTech halts a Phase II trial of its cancer immunotherapy Cevumeran, and Parth Khanna argues that more competitive data doesn't mean better intelligence in pharma.

FDA approves three new therapies spanning autoimmune disease, HIV, and cardiovascular risk, DualityBio and Teva strike major biopharma deals, and Israel Ortiz makes the case for preventive maintenance in manufacturing.

Osivax and GC Biopharma team up on a next-generation flu vaccine, K2 Therapeutics' Ying Huang talks through why so few drugs make it to market, and the Trump administration opens a new round of Medicaid drug pricing deals.

A new Eli Lilly study links Zepbound to lower healthcare costs in older adults with obesity, Biohaven and Haisco strike major licensing deals with SK Biopharmaceuticals and Sentivera, and Raviv Pryluk makes the case for rethinking clinical trial sample sizing.

FDA approves Imaavy as the first treatment for warm autoimmune hemolytic anemia, McKesson agrees to acquire Precision Medicine Group as Lundbeck partners with Eversana on AI-driven commercialization, and Adam Bartley examines how integrated GMP operating models are reshaping outsourced manufacturing.

Hanmi Pharm licenses its obesity drug candidate HM17321 to Genentech, James LaValle weighs in after FDA advisors back most nominated peptides for the compounding bulks list, and Ivo Carre examines how tau- and microglia-targeted therapies are reshaping the Alzheimer's pipeline beyond amyloid.

Amplitude Therapeutics and Chai Discovery ink AI and RNA collaborations with Eli Lilly and Bristol Myers Squibb, Norstella's Dan Chancellor makes the case for dealmaking as a survival skill, and this week's rare disease approvals and a $322 million biosimilar deal reveal where pharma strategy is heading.

A partnership roundup covers deals from IntraGel Therapeutics/UroGen Pharma and Lupin/Tenpoint Therapeutics, FDA approves Regeneron's Pasatru for fibrodysplasia ossificans progressiva, and RELEX's Rohit Tripathi discusses reshoring pharma manufacturing.

President Trump moves to nominate Heidi Overton as FDA commissioner, Ron Lanton weighs in on drug pricing's collision with trade policy, and Mohd Haque looks at how pharma leaders are scaling AI across the drug lifecycle.

LEO Pharma, BioMarin, OmniAb, and Chugai post a busy week of pharma dealmaking, RELEX's Rohit Tripathi weighs in on who ultimately pays for tariff-driven input costs, and Spherix Global Insights' Sybil Mead unpacks IRA-driven formulary pressure spreading across payer portfolios.