Emerging Modalities and Strategic Innovation in the Biopharma R&D Landscape

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The biopharmaceutical R&D landscape has undergone significant transformation in the past decade, as evidenced by unprecedented diversity in the industry’s pipeline composition as well as current therapeutic approaches. In today’s biopharma R&D environment, there is a critical shift from traditional primary-care focus to a more nuanced, specialty-driven landscape.

Pipeline composition and modality evolution

Today’s biopharmaceutical pipeline represents a complex, multifaceted approach to therapeutic development, notes Kevin Dondarski, principal, Life Sciences R&D, at Deloitte Consulting. He observes that, where previous generations concentrated on narrow therapeutic domains, current research spans a broad spectrum of modalities and mechanisms of action. “If I think about where we are today, there is such a diverse blend of different modalities, but also mechanisms of action, that are in the holistic industry pipeline. Simply from an oncology standpoint, [for example], we’ve seen a proliferation of antibody drug conjugates [ADCs],” Dondarski remarks.

He emphasizes that, in oncology alone, the industry is witnessing widespread innovation, not only in ADCs, but also in next-generation programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors, Bruton’s tyrosine kinase (BTK) inhibitors, and Kirsten rat sarcoma viral oncogene homolog G12C mutation (KRAS G12) inhibitors. In addition, Dondarski explains, immunology research has expanded dramatically, with research investigations intensively targeting multiple interleukin (IL) pathways, including IL-5, IL-6, IL-13, and IL-17.

Meanwhile, Maryland Franklin, PhD, vice-president and enterprise head, Cell and Gene Therapy, Labcorp, emphasizes the significant contribution of cell and gene therapies (CGTs) to the transformation of the biopharma R&D landscape. The entrance of the first CGTs on the market were characterized by groundbreaking scientific and technological advancements, which continue in the ongoing development of new CGTs.

“Most of the cell and gene therapy products being developed today are highly innovative compared to traditional therapeutics. You’re using live cells and/or adding, deleting, or even correcting genetic material, and this is so different from small molecules or even traditional monoclonal antibodies,” Franklin states.

Franklin points to two particularly promising approaches in CGT that are emerging in clinical development: in-vivo chimeric antigen receptor T-cell (CAR-T) delivery and advanced gene editing strategies. She emphasizes that these technologies aim to address critical challenges in safety and manufacturing complexity that have historically limited CGT progress.

“Two of the most new and innovative approaches very early in clinical development are in-vivo CAR-T delivery, and some of the newer gene editing strategies that improve on limitations with CRISPR/Cas9 [clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9] systems, [such as] base editing and prime editing,” says Franklin. “In both instances, we’re seeing the industry work on solutions to address safety concerns and substantial complexities and challenges that we face in manufacturing these products.”

Innovation drivers

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, highlights a few key drivers of innovation in new modality development for biopharmaceuticals. These drivers include a strong interest by industry for targeted molecular delivery mechanisms coupled with increased investment in precision therapeutics. In addition, advanced technologies such as artificial intelligence (AI) and digitalization technologies are pushing the drug discovery process to reach the next generation of these therapeutics. Also, current market dynamics and the regulatory support environment are favorable toward development of next-generation therapeutics.

Read this article in BioPharm International’s Next-Generation Biotherapeutics eBook.

About the author

Feliza Mirasol is science editor at BioPharm International.

Article Details

BioPharm International®
Next-Generation Biotherapeutics eBook
April 2025
Pages: 4–7

Citation

When referring to this article, please cite it as Mirasol, F. Emerging Modalities and Strategic Innovation in the Biopharma R&D Landscape. BioPharm International Next-Generation Biotherapeutics eBook, April 2025.