Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

Behind the Headlines, Episode 19: CGT Cost Pressures, BioNTech’s CureVac Move, and Spain’s CAR-T Model

 is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In this episode, three experts from across the advanced therapy ecosystem examine the commercial growing pains of cell and gene therapies (CGTs), ongoing efforts to drive down costs, and what BioNTech’s recent bid for CureVac reveals about the messenger RNA (mRNA) landscape. Fabian Gerlinghaus, CEO of Cellares; Alexander Seyf, co-founder and CEO of Autolomous; and Knut Steffensen, director of the Karolinska Institutet and University Hospital ATMP Center, offer their perspectives on the urgent need for better integration across the therapeutic value chain.

Fragmentation and redundancy in CGT manufacturing

The panel highlights persistent inefficiencies in CGT manufacturing, including duplicated facilities, fragmented digital workflows, and increasing strain from external cost pressures such as energy prices and tariffs. The lack of shared infrastructure and harmonized systems continues to hamper scalability and access, while high manufacturing costs remain a major barrier for both developers and patients.

Academic CAR-T and the Spanish hospital model

Turning to alternative models, the panel discussed the emergence of in-house academic chimeric antigen receptor (CAR)-T manufacturing in Spain, enabled by regulatory flexibility that allows production in Grade C cleanrooms rather than more costly Grade B facilities. This approach—used in Spanish hospital centers—has reduced the per-treatment cost to under €100,000, in contrast to commercial products exceeding US$400,000. The academic model also benefits from a more integrated, “bench-to-bedside” design that improves coordination between research, manufacturing, and clinical care (1).

The discussion concluded with the implications of BioNTech’s proposed acquisition of CureVac (2). While some speculate the move is related to an ongoing patent dispute, the panel suggested the transaction also reflects broader strategic concerns, including a cooling vaccine market and a desire to bolster oncology capabilities and mRNA manufacturing scale. The CureVac deal may signal a shift in acquisition strategies across the mRNA sector as companies look to shore up competitive advantages in a rapidly evolving field.

Watch the full episode above for more insights into the evolving biopharma landscape, and catch up on previous episodes of

1. Li, F. Spain’s Hospital-Based CAR-T Goes Global: A Therapy, a System, or a New Paradigm? April 14, 2025, 

2. BioNTech. BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer. Press Release. 

Videos

Fabian Gerlinghaus, Alexander Seyf, and Knut Steffensen go behind the headlines and dive into the advanced therapy ecosystem. 

Jon Ellis and Simon Vanstone, PhD go behind the headlines to explore the latest M&A activity and what tariffs and funding changes could mean for mRNA and beyond. 

Behind the Headlines, Episode 18: Sanofi, GSK Go Big in M&A, mRNA Momentum Falters, and More

In episode 18, we’re joined by panelists Jon Ellis, co-founder and CEO of Trenchant Bio, and Simon Vanstone, PhD, consultant at SiVan Consulting Ltd, who analyze the latest wave of industry-shaping headlines—unpacking strategic acquisitions, biotech innovations, and the geopolitical currents impacting global biopharma operations.

The panelists began by spotlighting several significant deals making headlines recently. 

 of Blueprint Medicines—valued at $9.1 billion—raised eyebrows not just for its scale but also for the return to a more traditional modality (1). CEO Paul Hudson called the deal “a strategic step forward” in bolstering the company’s rare disease and immunology portfolio. Ellis noted the irony of a tyrosine kinase inhibitor—once the poster child of earlier biotech waves—commanding a nearly 30% premium on Blueprint’s prior share price.

Next, Eli Lilly’s $1 billion acquisition of SiteOne Therapeutics’ non-opioid Nav1.8 inhibitor added further momentum to non-addictive pain management R&D (2). Vanstone noted the strategic fit given SiteOne’s previous collaboration with Vertex on the Journavx compound.

The acquisition watch continued with GSK’s announcement of a deal worth up to $2 billion for a candidate targeting alcohol-related liver disease (ALD)—a condition affecting more than 26 million people globally (3). The drug comes via Boston Pharmaceuticals and signals GSK’s continued push into unmet needs within hepatology.

The conversation shifted to less celebratory news: the challenges posed by growing tariffs and cooling sentiment toward mRNA-based 

. With reports that the U.S. government had canceled $700 million in funding for Moderna’s bird flu vaccine program (4), Ellis and Vanstone emphasized the importance of collaborative strategies to insulate emerging therapies—particularly in cell and gene therapy—from supply chain disruptions and funding volatility.

Finally, the episode spotlighted Nomic Bio’s launch of the Omni 1000, a breakthrough platform for high-plex proteomics (5). With the ability to quantify 1,000 proteins at just $50 per sample, the technology promises to democratize large-scale proteomic studies. “Pairing plasma proteomics with health outcomes at scale has the potential to revolutionize the way we treat patients,” said Allie Greenplate, PhD, the director of Strategic Alliance and Operations for Immune Health at the University of Pennsylvania’s Perelman School of Medicine.

Watch the full episode above for more insights into the evolving biopharma landscape, and catch up on previous episodes of 

Sanofi to acquire Blueprint Medicines, expanding portfolio in rare immunological disease and adding early-stage pipeline in immunology. Sanofi. Press release. June 2, 2025. 

https://www.globenewswire.com/news-release/2025/06/02/3091538/0/en/Press-Release-Sanofi-to-acquire-Blueprint-Medicines-expanding-portfolio-in-rare-immunological-disease-and-adding-early-stage-pipeline-in-immunology.html

Lilly to expand its pain pipeline with acquisition of SiteOne Therapeutics. Eli Lilly. Press release. May 27, 2025. https://investor.lilly.com/news-releases/news-release-details/lilly-expand-its-pain-pipeline-acquisition-siteone-therapeutics

GSK to acquireefimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Boston Pharmaceuticals. Press release. May 14, 2025. https://www.businesswire.com/news/home/20250513598541/en/GSK-to-acquire-efimosfermin-a-phase-III-ready-potential-best-in-class-specialty-medicine-to-treat-and-prevent-progression-of-steatotic-liver-disease-SLD

Moderna Announces Update on Investigational Pandemic Influenza Program. Moderna. Press release. May 28, 2025. 

https://investors.modernatx.com/news/news-details/2025/Moderna-Announces-Update-on-Investigational-Pandemic-Influenza-Program-/default.aspx

Nomic Bio Debuts $50 Proteome with Absolute Quantification Through Launch of Omni 1000. Nomic Bio. Press release. May 13, 2025. https://www.businesswire.com/news/home/20250513956212/en/Nomic-Bio-Debuts-$50-Proteome-with-Absolute-Quantification-Through-Launch-of-Omni-1000

Jon Ellis and Simon Vanstone, PhD, go behind the headlines to explore the latest M&A activity and what tariffs and funding changes could mean for mRNA and beyond.

Jamie Baumgartner, Jonathan Grinstein, and John Wilkerson go behind the headlines to discuss the implications of personalized gene-editing therapies, more HHS policy and funding updates, and the latest tariff-related investments. 

Behind the Headlines, Episode 17: Bespoke CRISPR Therapy, Executive Order Fallout, and more

In episode 17, we’re joined by panelists Jamie Baumgartner, President and CEO of Keystone Symposia on Molecular & Cellular Biology; Jonathan D. Grinstein, PhD, North American Editor for Inside Precision Medicine; and John Wilkerson, Washington correspondent for 

. The panelists dove into the beating heart of the life science ecosystem, discussing why researchers are currently attending conferences, what knowledge they are sharing, and what gaps in their knowledge they are looking to fill.

American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

, which was recently held in New Orleans, was the chosen vehicle to announce a world first in 

 therapeutics. Scores of people have already benefited from receiving CRISPR-based therapies for genetic conditions such as sickle cell disease. In this case, collaboration among clinicians, scientists, and physicians helped create a custom-tailored therapy to address an infant with CPS1 deficiency. “This compromised his ability to process the nitrogen-containing compounds produced when the body breaks down protein. As a result, his blood had high levels of ammonia, a compound that is particularly toxic to the brain,” according to a news briefing from 

. (1) “In just six months, Muldoon received his first dose. After that initial dose, Muldoon could safely eat the amount of protein recommended for his age.” (1). Although a big success, the panel considered what the probabilities are for cost lowering, alongside widespread access deployment.

Policy changes at the Department of Health and Human Services (HHS), funding cuts, and tariffs were also discussed, with Sanofi following suit by announcing a 5-year, $20 billion investment into US manufacturing (2). However, the “most favored nation” proposed executive order caused Roche to announce it is beginning to rethink its own $50 billion investment announcement a week earlier (3, 4). 

1. Ledfod, H. World’s first personalized CRISPR therapy given to baby with genetic disease. 

. May 15, 2025. https://www.nature.com/articles/d41586-025-01496-z

2. Sanofi to invest at least $20 billion in the US through 2030, growing investments in science and expanding domestic manufacturing. Press release. Sanofi. Published May 14, 2025. https://www.prnewswire.com/news-releases/sanofi-to-invest-at-least-20-billion-in-the-us-through-2030-growing-investments-in-science-and-expanding-domestic-manufacturing-302455566.html

3. Roche warns that it needs to reconsider its U.S. investments due to Trump's drug pricing order. Bloomberg. May 16, 2025. 

https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans?embedded-checkout=true

4. Franco, M. Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know. Holland and Knight. May 14, 2025. 

https://www.hklaw.com/en/insights/publications/2025/05/trump-administration-revives-most-favored-nation-drug-pricing

Behind the Headlines, Episode 17: Bespoke CRISPR Therapy, Executive Order Fallout, and More

Behind the Headlines Episode 16: NIH Funding, Re-Shoring, Tariffs, and Cell and Gene Therapies

Behind the Headlines is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In this episode, Donald Ingber, MD, PhD, founding director of Wyss Institute at Harvard University and co-founder of Emulate, Inc.; Miguel Forte, MD, PhD, president of the International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics;Ali Pashazadeh, founder of Treehill Partners; and Adam Inche, PhD, CEO and founder of Lentitek, examine the fast-changing landscape of manufacturing re-shoring, tariffs, National Institutes of Health (NIH) budget cuts, and the outlook for cell and gene therapies (CGTs).

In a growing series of announcements, Roche joins the chorus of press releases announcing manufacturing investment into the United States pharmaceutical sector, pledging to spend approximately $50 Billion over five years and creating more than 12,000 manufacturing jobs (1). Novartis also announced investment in the US in April (2). These announcements improved leverage for Swiss President Karin Keller Sutter, who meet with senior US officials in Washington in April to try to reduce a threatened 31% US tariff on Swiss exports. Sutter argued these tariffs should be offset by considering the amount of medical device and diagnostic products made in the US by Roche, which are exporting all around the world.

"Our investments have also been aligned with the Swiss government and form part of the ongoing discussions between the US and Switzerland," a Roche spokesperson said (1), with the 12,000 new positions, including 6500 in construction and 1000 at new and expanded facilities, according to Roche (1). Regeneron also pledged $3 billion to Fujifilm to manufacture pharmaceuticals in the US (3). 

The NIH is convulsing from deep fiscal and workforce cuts under the Trump administration. The new 15% cap on indirect cost reimbursements eliminates “$4 billion from over 2800 hospitals, universities, and research institutions nationwide, including utilities, maintenance, equipment purchases, and administrative support that laboratories need to produce high-quality research” (4). Whereas Harvard University, suffering uncertainty from a federal funding freeze, fought back in the courts stating, “Scientific advancement and the pursuit of knowledge fuel America’s innovation, economic success, and global leadership. The commitment to expanding human understanding is foundational at American universities, including Harvard, the Nation’s oldest institution of higher learning” (5).

And we round out the panel discussion with a look at the recent decline in investment for the CGT sector, in contrast to the burgeoning glucagon-like peptide-1 (GLP-1) class of weight loss drugs, when in overall global biopharma venture funding rose to $27 billion in 2024 from $23.2 billion in 2023. Cancer remained the top sector at $10.3 billion, according to DealForma (6).

1. Revill, J, Roche to Invest $50 Billion in US to Avoid Trump Tariffs, Create 12,000 Jobs. 

2. Wingrove, P. Novartis Plans to Invest $23 Billion in US Sites as Trump Renews Drug Tariff Threats. 

. April 11, 2025.https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-plans-invest-23-billion-us-plants-trump-renews-drug-tariff-threats-2025-04-10/

3. GEN. FUJIFILM Diosynth Biotechnologies and Regeneron Sign 10-year, $3+ Billion U.S. Manufacturing Deal. 

4. Sabet, C.J.Medical Research Funding Cuts Will Save Money and Spend Lives, Correspondence, 2025 405 (10487) p1337-1338, April 19, 2025, 

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00544-6/fulltext

5. Harvard. Harvard Funding Freeze Order Complaint. In The United States District Court for the District Of Massachusetts. Complaint for Declaratory and Injunctive Relief. Harvard.edu. 

https://www.harvard.edu/research-funding/wp-content/uploads/sites/16/2025/04/Harvard-Funding-Freeze-Order-Complaint.pdf

6. Beasley, D, Gene Therapy Loses Luster as Investors Eye Quicker Returns from Weight-loss Drugs. 

Donald Ingber, MD, PhD; Miguel Forte, MD, PhD; Ali Pashazadeh, MRCS, MBA; and Adam Inche, PhD, MBA go behind the headlines to examine the fast-changing landscape of manufacturing re-shoring, tariffs, NIH budget cuts, and the outlook for cell and gene therapies. 

Behind the Headlines Episode 15–Neuroscience, Weight-Loss Drugs, and Tariffs

In episode 15, Mike Exton, CEO and board director, Lexicon Pharmaceuticals; Andrew Thomson, CEO and co-founder, Modulate Bio; Konstantinos Tsioris, co-founder and president, OneCyte Biotechnologies; and Cheryl Barton, director, Pharmavision, discuss the advancement of neuroscience, developments in weight loss drugs, and the evolving political climate’s impact on the industry.

Neuroscience is “having a moment”, according to the panel, with advancements, such as Vertex’s Journavx, a non-opioid treatment for moderate to severe acute pain (1). The panel wondered if this is the beginning of a set of new central nervous system (CNS) breakthroughs. As evidence, the panel pointed to Professor Sergiu Pasca of Stanford, 

’s work to replicate one of the most prominent human nervous pathways for sensing pain, which their licensing office is calling an “assembloid”, in a lab dish (2). The researchers noted that missing in these assembloids, importantly, “were organoids representing other brain regions that are critical to the discomfort experienced by people who are in pain. The assembloids themselves don’t ‘feel’ any pain,” Pasca said. “They transmit nervous signals that need to be further processed by other centers in our brains for us to experience the unpleasant, aversive feeling of pain” (2).

In a roundup of headline news, the panel shared their opinions on pharmaceutical tariffs and their stock market ramifications, including reshoring of manufacturing opportunities and also infrastructure investments, such as Novartis’ new spending of approximately $23 billion in infrastructure in the United States (3). The panel also examined weight loss drug fluctuations, including Pfizer discontinuing development of experimental weight-loss pill danuglipron, due to drug-induced toxicity in a trial patient (4), while Lexicon Pharmaceuticals stands to gain up to $1 billion ($75 million upfront payment) from an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders (5).

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

GEN. Key Neural Pain-Sensing Pathway Recreated in a Lab Dish. Genetic Engineering News. 

Genetic Engineering and Biotechnology News

Ohlen, E. This Pharma Giant Will Invest $23 Billion in the U.S. It’s a Sign Trump’s Tariffs Are Working. 

Beasley, D. Pfizer Ends Development of Weight-loss Pill Danuglipron. 

Lexicon Pharmaceuticals Announces Exclusive License Agreement with Novo Nordisk for LX9851. 

Mike Exton, Andrew Thomson, Konstantinos Tsioris, and Cheryl Barton go behind the headlines to discuss the advancement of neuroscience, weight-loss drugs, and the evolving political climate’s impact on the industry.

: Behind the Headlines Episode 14–Investment Trends, Policy Realignments, and Vaccines

In episode 14, panelists Christian Cobaugh, PhD, CSO and founder of Vernal Biosciences; Eswar Iyer, PhD, co-founder and CSO, Aikium Inc., and Vincenzo Antignani, PhD, Technical training lead, Asahi Kasei Bioprocess America, Inc., adjunct facility Northeastern University & Governing Committee (GC) Member, NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals, discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old. 

Performance advances in both China and India have led to renewed investments from other countries into both infrastructure and licensing agreements. Novo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion (1). In addition, AstraZeneca is committing up to $11 billion to Chinese Collaborations including a Beijing R&D Hub (2).

Changing skills requirements for future workforce in a time of turmoil was a major consideration for the panel, appearing and reappearing throughout the conversation. It included the re-folding of recently fired National Institutes of Health workers, as Robert F. Kennedy, Jr. pursues his plans to slash the Department of Health and Human Services’ workforce by 25%, implement massive reorganization, and consolidate authorities, creating a new agency for a ‘Healthy America’ (3).

Conversation also turned to attitudes toward messenger RNA, as the United States outlines plans to end vaccine funds for poor countries, in parallel to several other efforts to frame vaccines as just-one-choice-among-many-options, to discuss with one’s healthcare provider (4).

Lastly, 23andMe’s future in bankruptcy protection after having held, at its highest, a market valuation of $6 billion dollars, was bruited about. The panel also examined the company’s chances of legally selling customer genomic data as a lift raft, and also, what the demise of such a pioneering company means in the overall commercial landscape at this time.

Click the video above to watch the discussion.

1. Sunny, M. Novo Bets on 'Triple G' Obesity Drug in up to $2 billion Deal with Chinese Biotech. 

https://finance.yahoo.com/news/novo-licenses-chinese-biotechs-obesity-102141800.html

2. Philippidis, A. AstraZeneza Commits Up to $11B+ to Chinese Collaborations, Beijing R&D Hub, 

https://www.genengnews.com/topics/drug-discovery/astrazeneza-commits-up-to-11b-to-chinese-collaborations-beijing-rd-hub

3 Owermohle, S.; Lawrence, L.; and Bannow, T. RFK Jr. Plans to Slash HHS Workforce by 25% in Massive Reorganization. 

https://www.statnews.com/2025/03/27/rfk-jr-10000-job-cuts-hhs-restructuring-health-agency-impacts-cdc-fdaG-nih-cms

4Kirchgaessner, S.; Glenza, J. Trump Administration at ‘War’ with mRNA Technology: Scientists Alarmed Vaccine Skeptics Could Kill Research. 

https://www.theguardian.com/us-news/2025/mar/27/trump-vaccine-skeptics-research-funding

5. Satija, B.; Shah, A.; Misra, S. DNA Testing Firm 23andMe Files for Bankruptcy as Demand Dries Up. 

https://www.reuters.com/business/healthcare-pharmaceuticals/dna-testing-firm-23andme-files-chapter-11-bankruptcy-sell-itself-2025-03-24/

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old. 

Chris Spivey

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