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

Chris Spivey

Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics,

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 episode 24, Aaron B. Cowley, PhD, CSO, Recipharm Advanced Bio; Renee A. Hart, president and CBO, LumaCyte; and Vibha Jawa, PhD, FAAPS, CSO, EpiVax, look at the recent round of Mega-Deals, in part driven by Big Pharma patent cliffs, but also a need to cover-every-technology-and-expertise-base for complex manufacturing of advanced therapy medicinal products.

In this current spate of M&A activity, the panel examines AbbVie’s acquisition of Gilgamesh Pharmaceuticals’ investigational therapy, Bretisilocin, for $1.2 billion (1); Enlaza Therapeutics’ collaboration with Vertex Pharmaceuticals for the development of war-lock drug conjugates and T-cell engagers (worth up to $2 billion) (2); and Argo BioPharma’s agreement with Novartis (a combined potential value of up to $5.2 billion), for “long-acting siRNAs which are designed to deeply and durably target disease-causing proteins represent an important paradigm shift in prevention and treatment of cardiovascular diseases” (3).

Because of its more direct impact on pharmaceutical chemistry, manufacturing, and controls and process analytical technology, the panel spent significant time to understanding the reasons the Waters-Becton Dickinson Mega Deal, valued around $17.5 Billion (4). On balance, it was thought the recurring revenue and regulatory knowledge in precision medicine and diagnostics afforded by Becton Dickson was the largest attraction for Waters to move ahead on this deal.

The panel rounds out the discussion asking what are the bright new technologies arriving, and what we’d wish for in our Christmas stockings come December.

AbbVie. AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline. Press Release. Aug. 25, 2025 

https://news.abbvie.com/2025-08-25-AbbVie-to-Acquire-Gilgamesh-Pharmaceuticals-Bretisilocin,-a-Novel,-Investigational-Therapy-for-Major-Depressive-Disorder,-Expanding-Psychiatry-Pipeline

Enlaza Therapeutics. Enlaza Therapeutics Announces Strategic Collaboration with Vertex Pharmaceuticals to Develop War-Lock Drug Conjugates and T-Cell Engagers for Improved Conditioning and Certain Autoimmune Diseases. Press Release. Sept. 2, 2025, 

https://enlazatx.com/press_release/enlaza-therapeutics-announces-strategic-collaboration-with-vertex-pharmaceuticals-to-develop-war-lock-drug-conjugates-and-t-cell-engagers-for-improved-conditioning-and-certain-autoimmune-diseases/

Argo Biopharma. Argo Biopharma Announces Multi-Asset License and Option Agreements with Novartis for Novel Molecules for Cardiovascular Diseases. Press Release. Sept. 3, 2025 

https://www.argobiopharma.com/news/153.html

Waters. Waters and BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science and Diagnostics Leader Focused on Regulated, High-Volume Testing. Press Release. July 14, 2025. 

https://ir.waters.com/News--Events/newsroom/news-details/2025/Waters-and-BDs-Biosciences--Diagnostic-Solutions-Business-to-Combine-Creating-a-Life-Science-and-Diagnostics-Leader-Focused-on-Regulated-High-Volume-Testing/default.aspx

Videos

Aaron Crowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs. 

Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics, Billion Dollar Deals Push Further Consolidation or Collapse, and an Analytics Wish List

 Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.

Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

 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 episode 23, the panel analyzes how looming patent cliffs, rising trade pressures, and a new wave of in vivo platforms are reshaping the biotech deal landscape. Benjamin McLeod, founder of Convey BIO, and Sebastian Lykke Skafte Andersen, managing director and founder of ClarityNorth Partners, examine how recent headlines signal deeper structural shifts for pharma commercialization and manufacturing strategy.

The panel begins by spotlighting Merck’s $10 billion acquisition of Verona Pharma (1) as a clear example of dealmaking driven by pricing headwinds. With the 

Most-Favored Nation (MFN) executive order

 pushing U.S. drug prices toward European benchmarks, biopharma buyers are racing to acquire late-stage, revenue-generating assets ahead of price compression. As margins come under threat, preemptive M&A is becoming a go-to strategy for portfolio fortification.

In Vivo CAR-T Moves Closer to Center Stage

Attention then turns to the in vivo cell therapy frontier. Gilead’s Kite Pharma recently acquired Interius Biotherapeutics for $350 million (2), adding a modular in vivo CAR-T platform aimed at broadening therapeutic applications and improving scalability. Cindy Perettie, executive vice president at Kite, highlighted the potential for combining Interius’ novel platform with Kite’s established infrastructure to accelerate in vivo therapeutic development.

AstraZeneca’s massive $50 billion U.S. investment

 as a strategic response to escalating U.S. 

, some exceeding 250%. The company’s pivot marks a larger industry trend toward reshoring biomanufacturing as a form of industrial policy, not just portfolio strategy. Beyond portfolio diversification, AstraZeneca’s U.S. expansion includes GLP-1 pipeline growth, CGT infrastructure, and regulatory optimization through increased U.S.-based trials.

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

References 
1. Merck to Acquire Verona Pharma, Expanding its Portfolio to Include Ohtuvayre® (ensifentrine), a First-In-Class COPD Maintenance Treatment for Adults and Expected to Drive Growth into the Next Decade. Press Release. Merck. July 9, 2025. https://www.merck.com/news/merck-to-acquire-verona-pharma-expanding-its-portfolio-to-include-ohtuvayre-ensifentrine-a-first-in-class-copd-maintenance-treatment-for-adults-and-expected-to-drive-growth-into-the-next-dec/
2. Kite to Acquire Interius BioTherapeutics to Advance In Vivo Platform. Press release. InteriusBioTherapeutics. August 21, 2025. https://interiusbio.com/press-release/kite-to-acquire-interius-biotherapeutics-to-advance-in-vivo-platform/

Panel discussion addressing shifting policy and its impact on the future of chronic disease, diagnostics, and next-generation cell and gene therapies

Behind the Headlines, Episode 22: Chronic Disease Priorities, Biomarker Breakthroughs, and CGT-RLT Synergies

In episode 22, Jonathan D. Grinstein, PhD, North American Editor for 

; Manfred Scholz, PhD, President of Scholz Consulting Partners; and Erik Wiklund, PhD, CEO of Circio, tackle a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies. They explore what’s rising, what’s receding, and what’s next for precision medicine.

The discussion opens with reflections on a growing realignment in U.S. healthcare priorities—from high-profile acute care innovations toward more long-term strategies for managing chronic illness. The panel agrees that the shift is overdue, citing a large body of data pointing to the long-term burden of untreated and under-managed conditions across the country (1). This shift occurs against a backdrop of geopolitical tensions, including tariffs and widespread staff layoffs affecting the life sciences workforce.

The panel then takes a full-circle look at diagnostics—highlighting both high-opportunity fields and high-need gaps. In addition to established companion diagnostics and biomarker work, attention is turning to emerging tools like dried blood spot testing and acoustic ejection mass spectrometry, which promise faster and more accessible protein biomarker quantification (2).

The regulatory environment for cell and gene therapy continues to evolve. The panel notes the FDA’s recent move to halt Sarepta’s Elevidys distribution and place multiple trials on hold after reported deaths (3), while also citing broader 

 within the agency’s biologics arm. In this climate, in vivo approaches are gaining traction. Examples include Orbital Therapeutics’ non-human primate data for its in vivo CAR-T program in autoimmune disease (4) and ARTBIO’s $132 million Series B raise to advance its radioligand therapy (RLT) platform. While some see RLT as a more promising route for solid tumors, others—like ARTBIO’s Emanuele Ostuni, PhD—suggest that the modalities may work best in tandem. “The alpha particle modality essentially creates a small explosion of antigens in the tumor, which do recruit T cells—a situation ripe with synergistic potential,” he told 

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

Combating America’s Chronic Disease Epidemic. Rand. March 5, 2025.  

https://www.rand.org/pubs/commentary/2025/03/combating-americas-chronic-disease-epidemic.html

Van Puyvelde B, Hunter C, Zhgamadze M. “Acoustic ejection mass spectrometry empowers ultra-fast protein biomarker quantification.” 

. 2024 Jun 15;15(1):5114. doi: 10.1038/s41467-024-48563-z

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold. FDA. News release. July 18, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-requests-sarepta-therapeutics-suspend-distribution-elevidys-and-places-clinical-trials-hold

Orbital Therapeutics Presents Non-Human Primate Data for In Vivo CAR-T Therapy. Orbital Therapeutics. News release. July 22, 2025. 

https://www.orbitaltx.com/orbital-therapeutics-presents-non-human-primate-data-for-in-vivo-car-t-therapy-with-potential-best-in-class-profile-for-autoimmune-disease/

Grinstein, J. “From CAR-T to RLT: Enhancing Precision Oncology with ARTBIO’s Radioligands.” 

https://www.insideprecisionmedicine.com/topics/oncology/from-car-t-to-rlt-enhancing-precision-oncology-with-artbios-radioligands/

Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies.

Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers

In episode 21, the panel explores how major deals, policy volatility, and investment shifts are redrawing the life sciences map. Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News and Inside Precision Medicine; Hari Pujar, PhD, Chief Operating Officer of Tessera Therapeutics; and Josh Schimmer, MD, Biotech Equity Research Analyst and Managing Director at Cantor Fitzgerald, unpack the deeper implications behind this past week's biggest headlines.

The panel opens with analysis of the announced 

 in a $17.5 billion deal aimed at building a more vertically integrated life sciences powerhouse. The move underscores growing industry appetite for consolidation across instrumentation, diagnostics, and biologics-enabling technologies (1).

Merck Expands Respiratory Portfolio with Verona Acquisition

Attention then turns to Merck’s $10 billion acquisition of Verona Pharma, bringing Ohtuvayre—its FDA-approved COPD drug—into Merck’s respiratory portfolio. The panel notes this as a strategic hedge against Merck’s looming Keytruda patent expiry. “The Merck deal looks good at first glance,” said Kevin Gade, COO at Bahl & Gaynor. “Given their home run with Prometheus and Winrevair, this (Ohtuvayre) looks like a potential complementary therapy” (2).

Policy Risks and AI Deployment in Biopharma

The conversation also touches on external pressures, including potential 200% tariffs that have sent companies scrambling to develop contingency plans (3). On the tech front, panelists assess how artificial intelligence is being deployed across discovery, development, and operational pipelines—and where its value is already being realized.

To round out the episode, panelists highlight some of today’s most active biotech investment targets: psychedelic compounds, Chinese follow-on products, and small molecule drugs aimed at unmet clinical needs.

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

Waters and BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science and Diagnostics Leader Focused on Regulated, High-Volume Testing. News release. BD. July 14, 2025. https://investors.bd.com/news-events/press-releases/detail/892/waters-and-bds-biosciences-diagnostic-solutions-business-to-combine-creating-a-life-science-and-diagnostics-leader-focused-on-regulated-high-volume-testing

Merck to Acquire Verona Pharma, Expanding its Portfolio to Include Ohtuvayre® (ensifentrine), a First-In-Class COPD Maintenance Treatment for Adults and Expected to Drive Growth into the Next Decade. News release. Merck. July 9, 2025. https://www.merck.com/news/merck-to-acquire-verona-pharma-expanding-its-portfolio-to-include-ohtuvayre-ensifentrine-a-first-in-class-copd-maintenance-treatment-for-adults-and-expected-to-drive-growth-into-the-next-dec/

Gilchrest, K. Trump’s 200% Tariff Threat Leaves Pharma Firms Scrambling with Scenario Planning. CNBC. July 11, 2025. https://www.cnbc.com/2025/07/11/trump-200percent-pharma-tariffs-threaten-to-push-up-drug-prices-hit-margins.html

Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More

 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 episode 20, the panel explores a new wave of developments in CAR-T innovation, biopharma dealmaking, and the evolving role of information in translational medicine. Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and Bryce Sady, VP of Product Development at PSL Group, unpack key headlines and examine the long-term implications shaping scientific progress and patient access.

CAR-T’s Next Chapter: From Solid Tumors to Regulatory Streamlining

The panel begins by examining the growing promise of CAR-T in solid tumors—a space long considered too complex or hostile for cell therapies. Recent data and development activity are challenging that view: Gilead Sciences reports 62% tumor shrinkage in glioblastoma (1); Affini-T Therapeutics is targeting KRAS mutations (2); and Immatics is advancing its pipeline into PRAME-positive tumors (3).

In parallel, the FDA announced it has removed Risk Evaluation and Mitigation Strategies (REMS) requirements for autologous CAR-T cell therapies. This decision, widely welcomed by the ATMP field, is expected to reduce the reporting burden on healthcare providers, broaden access, and help drive down overall treatment costs (4).

Strategic Acquisitions: AbbVie and Eli Lilly Bet Big

The panelists also explore the rationale behind two major acquisitions. AbbVie announced a $2.1 billion deal to acquire Capstan Therapeutics, strengthening its cell therapy and immunology portfolio (5). Meanwhile, Eli Lilly acquired Verve Therapeutics, whose VERVE-102 program is being positioned as a potential first-in-class in vivo gene editing therapy for cardiovascular disease. According to Lilly’s leadership, the treatment could help shift care from a chronic model to a one-time intervention (6).

The discussion closed with reflections on two systemic shifts: the ongoing talent exodus from the United States—driven in part by cuts to basic research funding—and the transformation of how research findings are shared and applied. Panelists discussed how modern publishing models, data capture technologies, and changes in information flow influence the pace and impact of translational medicine.

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

Bagley, S.J., Desai, A.S., Fraietta, J.A. et al. Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Rα2 in recurrent glioblastoma: a phase 1 trial.

. Published online June 1, 2025. DOI:10.1038/s41591-025-03745-0

Affini-T Therapeutics presents preclinical data from its programs targeting oncogenic drivers KRAS and TP53 at AACR. Press release. Affini-T Therapeutics. April 24, 2025. 

https://affinittx.com/press-releases/affini-t-therapeutics-presents-preclinical-data-from-its-programs-targeting-oncogenic-drivers-kras-and-tp53-at-aacr/

Immatics IMA203 PRAME cell therapy data presented at 2025 ASCO annual meeting continues to show strong anti-tumor activity and durability in patients with metastatic melanoma. Press release. Immatics. May 31, 2025. https://investors.immatics.com/news-releases/news-release-details/immatics-ima203-prame-cell-therapy-data-presented-2025-asco 

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T Cell Immunotherapies. FDA Safety Communication; June 26, 2025. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology. Press release. AbbVie. June 30, 2025; https://news.abbvie.com/2025-06-30-AbbVie-to-Acquire-Capstan-Therapeutics,-Further-Strengthening-Commitment-to-Transforming-Patient-Care-in-Immunology

Lilly to Acquire Verve Therapeutics to Advance One-Time Treatments for People With High Cardiovascular Risk. Press release. Eli Lilly & Company. June 17, 2025; https://investor.lilly.com/news-releases/news-release-details/lilly-acquire-verve-therapeutics-advance-one-time-treatments

Sascha Berger, private biopharmaceutical investor; Shannon Eaker, CTO of Xcellbio; Edwin Stone, CEO of Cellular Origins; and Bryce Sady, VP of Product Development at PSL Group go behind the headlines to talk CAR-T advancements, exciting M&A developments, and the impact of lost research funding on innovation. 

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

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. 

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

Chris Spivey

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