“The industry is back, and we’re uniquely positioned to provide end-to-end services, including clinical trials. That’s what we mean by CDMO plus CRO – it’s a complete 360-degree set of operations,” says Dr. Anil Kane, Executive Director and Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific.
Dr. Kane leads Thermo Fisher’s technical and scientific initiatives, bringing extensive experience in pharmaceutical development and manufacturing. His expertise spans multiple modalities, from small molecules to advanced therapies, positioning him at the forefront of innovative drug development solutions.
Speaking to the PharmaSource podcast at CPHI Milan, Dr. Kane explained Thermo Fisher’s latest initiative, Accelerator™ Drug Development, which combines their Contract Development and Manufacturing Organisation (CDMO) capabilities with Contract Research Organisation (CRO) services from their PPD acquisition. This integrated approach aims to streamline the complex journey from pre-clinical development to commercialisation, offering a truly connected and customisable suite of services.
Comprehensive CRO / CDMO Integration
The 2021 acquisition of PPD marked a pivotal moment in Thermo Fisher’s evolution, enabling the creation of a comprehensive service offering that spans the entire drug development spectrum. This integration brings together:
- Drug substance development
- Drug product development
- Clinical trial packaging and labeling services
- Full clinical trial management
- Specialised GMP laboratory testing
- Regulatory documentation support
“This combination of services brings efficiency, reducing cost and time for our partners to run drug development from very early stage, through clinical phases, to approval and bringing medicines to patients faster,” explains Kane. “We help our clients even put documentations together for IND, NDA, and other regulatory submissions.”
Multi-Modal Flexibility and Expertise
The platform’s versatility sets it apart in the market, with capabilities extending across all major therapeutic modalities. Kane emphasises this flexibility: “Whether it’s LNG, viral vectors, mRNA, small molecules, or biologics, the same process has to be carried out – testing safety, efficacy, dose finding, proving effectiveness in patients, starting with small numbers and then larger clinical studies.”
This comprehensive approach provides particular value across the spectrum of pharmaceutical development, from traditional small molecule development to cutting-edge cell and gene therapy programs. The platform seamlessly accommodates mRNA therapeutics and viral vector production, ensuring consistent quality and efficiency regardless of the modality.
Operational Excellence Through Unity
A significant advantage of this integrated approach is the elimination of common industry pain points, particularly around technical transfers and quality system transitions. Kane elaborates on these benefits:
“Within one company, there are no barriers. The industry has seen when things are transferred from one company to another, one partner to the other, there is always a potential risk of incomplete transfers. This is within one company, so the people within the two divisions or experts can be brought together much easier than bringing or trying to bring experts from multiple organisations.”
Key operational advantages include:
- Improved confidentiality management
- Simplified contracting processes
- Unified quality systems
- Streamlined logistics
- Enhanced knowledge retention
- Reduced technology transfer risks
Future Market Trends and Industry Direction
Looking ahead to 2025 and beyond, Kane identifies several key industry trends shaping pharmaceutical development. The landscape continues to evolve with emerging modalities, particularly in mRNA technologies and cell and gene therapy platforms. However, Kane emphasises the enduring importance of traditional approaches:
“Oral solids are still here to stay and are the most patient-friendly dosage forms.”
The development of sterile injectable dosage forms and pre-filled syringes remains crucial for both biologics and small molecules, highlighting the continued relevance of traditional delivery systems alongside innovative approaches.
The industry’s therapeutic focus continues to expand, with significant attention directed toward oncology, immunology, and neurological conditions. Kane notes particular momentum in weight loss and diabetes management programs, reflecting growing market demands in these areas.
Post-Pandemic Recovery and Market Outlook
Kane offers an optimistic view of the industry’s trajectory: “The pandemic is behind us. As you can see, the large presence here – I think the industry is back.” He emphasises that the focus has returned to addressing fundamental market demands and unmet medical needs.
Thermo Fisher’s strategy aligns perfectly with this recovery phase, positioning the company to support accelerated development timelines while maintaining cost-effectiveness. Their integrated approach facilitates efficient regulatory pathways and rapid commercialisation strategies, essential elements in today’s competitive pharmaceutical landscape.
“We are here as Thermo Fisher, as one of the leading CDMOs and CROs, to bring their medications to clinical proof of concept faster and bring them to approval and to bring them to patients,” Kane concludes, underlining the company’s commitment to advancing pharmaceutical development across all modalities and therapeutic areas.
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