PharmaVoice’s Crystal Ball: What’s next in drug innovation and clinical trials


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This is the second installment of a two-part series previewing pharma’s year ahead. Our first part examines how industry leaders see the financial market taking shape in 2024.

It’s an exciting time to be in the business of drug innovation.

The recent arrival of the world’s first approved CRISPR-based therapy has helped solidify the gene therapy movement and pave the way for more gene editing approaches. Other cutting-edge modalities such as cell therapies, antibody-drug conjugates and a new wave of RNA-based treatments are offering drug developers transformative tools for bringing more effective treatments — and even cures — to some of the world’s toughest diseases and conditions.

The continuing rise of the patient voice and emphasis on DEI are also poised to help the industry create impactful medicines in the coming years.

And as innovations around AI, data analysis and machine learning become more deeply embedded in these efforts, drug discovery and development is reaching groundbreaking levels of speed and efficiency.  

It’s no surprise that when we asked industry leaders to submit their outlooks for 2024, these themes were a common thread. Here’s how they see these trends translating into meaningful industry change in 2024.

Trends in drug innovation

More antibodies will come to market

Tahi Ahmadi

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Permission granted by Genmab

 

“The growth of new modalities such as antibody-drug conjugates, bispecific antibodies, and cell and gene therapies, are already making a larger presence in the investigational pipeline. The focus on these novel therapies indicates a move towards addressing previously difficult-to-treat diseases, including advanced cancer and rare diseases. With hundreds of antibodies undergoing pre-clinical and clinical development, it is anticipated that the number of antibody medications in clinical trials and approved by regulatory agencies will rise.”
Tahi Ahmadi, executive vice president, chief medical officer, head of experimental medicines, Genmab

Cell and gene therapy development will become more streamlined

Michelle Fraser

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Permission granted by Revvity

 

“With over 500 new cell and gene therapies entering clinical trials annually [and] their expedited time to market … this class of therapeutics [is positioned] for significant prominence. As we approach 2024, the prospect of witnessing a surge in approvals becomes increasingly imminent. Concurrently, the FDA’s proactive initiatives to bolster the advancement of these therapies promise to usher in a new era of standardization. Expectations include the streamlining of manufacturing processes, consolidation of protocols for testing Critical Quality Attributes, refined approaches to patient identification and enrolment and the evolution of companion diagnostics.”
Michelle Fraser, head, cell and gene therapy, Revvity

Delivery tech will push gene therapy into new space

R. Nolan Townsend,

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Permission granted by Lexeo Therapeutics

 

“The gene therapy environment has evolved rapidly and we are now seeing expansion into novel therapeutic areas like cardiovascular diseases, such as cardiomyopathies with genetic markers of disease. Innovation in delivery technology will continue to enable this shift, particularly AAV technology given the high transduction efficiency in cardiomyocytes, but we also predict advancement of novel delivery systems. At the same time, there has been a material shift in the regulatory landscape for both gene therapy and cardiovascular disease, with precedents now utilizing biomarkers as pivotal study endpoints as opposed to historical standards related to mortality and survival.”
R. Nolan Townsend, CEO, Lexeo Therapeutics

R&D will target the underlying causes of aging

Carrie Strom

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Permission granted by AbbVie

 

“Aging is the one health condition that has a prevalence rate of 100%. As a result, we are going to see more interest in how to address the underlying causes of aging to preserve vitality, mobility and physical appearance. This will lead to next-generation research and treatments that incorporate the underlying causes of aging versus merely addressing the signs and symptoms of the aging process to support health and longevity.”
Carrie Strom, senior vice president, AbbVie; president, Global Allergan Aesthetics

Next-generation mRNA is coming

Stefan Merlo

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Permission granted by CSL Seqirus

 

“As we move forward into 2024, we anticipate a continued focus on innovation in vaccines and with that, an interest in some of the newly emerging technologies such as self-amplifying mRNA (sa-mRNA). There is an ever-present need for flexible, effective vaccine technology and as demonstrated during the COVID-19 pandemic, mRNA technology can facilitate rapid and scalable vaccine development and distribution. The sa-mRNA technology adds to these benefits by offering the potential for stronger immune responses and longer duration of protection, while using significantly lower doses compared to conventional mRNA vaccines.”
Stefan Merlo, vice president, commercial development, CSL Seqirus

The obesity space will quickly evolve

Jayson Dallas

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Permission granted by Rivus Pharmaceuticals

 

“Obesity is the primary driver of metabolic diseases and, in 2024, will still account for more morbidity and mortality than all cancers combined. In 2024, we will continue to see the expansion of GLP-1 and other incretin-based approaches as the broader obesity market continues to grow. As we think about next generation approaches to treating metabolic diseases, there is a need to focus on molecular targets with new and alternate mechanisms, including those that work by safely increasing the metabolic rate. I also anticipate that machine learning and AI will play a critical role in the field, including in identifying new small molecules in a faster and more efficient way.”
Dr. Jayson Dallas, CEO, Rivus Pharmaceuticals

 

AMR investments will tick up

Margaret Borys

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Permission granted by Shionogi

 

“We predict a return to investment in antivirals and antibiotics to address current and future medical needs. COVID-19, the flu and RSV aren’t going away and the chance of getting sick with even one of these viruses is high. We need to start actively addressing the largely silent threat of antimicrobial resistance, which could cause up to 10 million deaths by 2050 according to the United Nations. New viral threats could emerge at any time, leading to future pandemics.”
Margaret Borys, senior vice president, chief commercial officer, Shionogi

More R&D will incorporate patient voices

Roger Palframan

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Permission granted by UCB

 

“In 2024, I expect our work in early research to be even more patient-centric. It’s vital for those who research and develop medicines to listen to and engage with people impacted by severe diseases, and go further by deep investigation into the pathways driving their disease using relevant disease models. We must meaningfully consider their lived experiences in the earliest stages of R&D to ensure we are developing medicines [that] positively change the way people are living with severe disease and focus on addressing the root biological causes of these conditions; these go hand in hand. This means connecting our research teams with people and their caregivers living with the conditions we’re researching.”
Roger Palframan, head of U.S. research, UCB

Maternal health innovation will gain steam

Colby Holtshouse

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Permission granted by Organon

 

“The maternal health crisis continues to pose serious risks for moms-to-be across the U.S. This unfortunate reality is particularly dangerous for Black women, who are three times more likely than white women to die from pregnancy-related complications. New initiatives inspire hope that 2024 will mark a turning point. For instance, innovations are coming to the fore … like the creation of an artificial womb, which the FDA is exploring as a potential approach to help premature babies survive. The White House’s ‘Birthing Friendly’ Hospitals Initiative is [also] an important step towards helping women find high-quality maternal care. And … the WHO is working alongside key public and private stakeholders on a solutions-driven, strategic roadmap to … improve maternal health outcomes. These developments create positive momentum … to address critical gaps in maternal health.”
Colby Holtshouse, global medtech commercial lead, Organon

Cancer care advances

More emphasis in oncology will be on early detection

Mohit Manrao

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Permission granted by AstraZeneca

 

“We know that the earlier we can detect and address cancer, the closer we may be to better outcomes. In the new year, I expect we’ll see a continued shift to earlier detection and intervention, both through improved access to cancer screenings and beginning treatment sooner in one’s cancer journey, as well as a supportive infrastructure that enables patient access to innovation and resources.”
Mohit Manrao, senior vice president, head, U.S. oncology, AstraZeneca

 

Successful oncology launches will be driven by tech

Stefanie Granado

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Permission granted by Takeda Oncology

 

“Digital and technological advancements will continue to accelerate in 2024. It will be up to us to responsibly leverage these tools to meet the needs of patients and providers more effectively. This will be particularly crucial for oncology companies to advance innovative R&D and optimize the delivery and use of new medicines. I predict the success of future product launches will be partially measured by the ability of developers to integrate digital processes into every step of delivering care — helping us solve potential challenges that may arise, increasing accessibility to a variety of patient populations, and eliminating barriers to care.”   
Stefanie Granado, head, U.S. oncology business unit, Takeda Oncology

 

Strides will be made with tough-to-treat cancers

Guo-Liang Yu

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Permission granted by Gracell Bio

 

“The industry is gearing up to address the persistent challenges of hard-to-treat and treatment-resistant cancers. For example, although PD(L)-1 inhibitors have demonstrated effectiveness for numerous NSCLC cases, certain forms of NSCLC don’t respond. In addition, resistance develops in patients who initially respond to certain therapies. To address this, companies are directing efforts toward these challenging forms of the disease, striving to provide better outcomes for all patients. With an emphasis on cutting-edge technology platforms and robust drug development portfolios, the sector is poised for substantial progress in 2024. The integration of sound mechanistic and scientific rationale in clinical trials, exploring both monotherapy and combination approaches, reflects a significant leap toward conquering difficult cancer types.”
Guo-Liang Yu, CEO, chairman, Gracell Bio



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