Accelerating Preclinical Biologics Development
Accelerating Preclinical Biologics Development
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Thermo Fisher Scientific recently introduced Quick to ClinicTM solution for early biologic drug development. The solution aims to accelerate preclinical development, enabling biopharma companies to reach Phase I/First-In-Human trials and file for Investigational New Drug (IND) review in as little as 13 months from transfection.
To learn more about Quick to Clinic and how this enables biopharma companies to assess and balance risk, we spoke to Paul Jorjorian, vice president and general manager of biologics, pharma services, Thermo Fisher Scientific.
Ash Board (AB): What are the major obstacles that biopharma companies face when developing a new biologic?
Paul Jorjorian (PJ): Biopharma companies face several challenges when trying to advance biologics to the clinic. These include time, a lack of resources and cost. Companies need to file an IND application and complete Phase I/First-in-human trials as quickly as possible. Access to the proper resources and the expertise needed to navigate the complex and dynamic regulatory environment helps to keep the development cost down and increases the speed of the process. Thermo Fisher’s Quick to Clinic solution helps biologic developers reach these important milestones in as little as 13 months from transfection, while avoiding significant risks that would disrupt their goals while creating a strong foundation for future scale-up success.
AB: Can you explain what the Quick to Clinic solution platform includes, and what this provides biopharma companies?
PJ: Quick to Clinic is designed for new and emerging companies in the early development phase who are developing mammalian recombinant proteins to reach Phase I/FIH trials and help file for IND as quickly as possible. This solution places emphasis on speed and flexibility and getting molecules from discovery to IND in less than 13 months. Quick to Clinic leverages Thermo Fisher’s deep scientific and technical expertise, broad capabilities and state-of-the-art technology to offer accelerated and flexible solutions to get a biopharma company’s molecule to IND quickly.
Specifically, Quick to Clinic for biologics deploys high throughput automation technologies and is enabled by use of platform cell culture and purification processes and analytical methods, careful construction and parallelization of drug substance and drug product activities. The solution streamlines drug substance and drug product handover activities and pre-qualification of common vial formats. Quick to Clinic includes a high-yield expression system and robust process platform that prepares customers for long-term commercialization success.
AB: How does Quick to Clinic leverage Thermo Fisher’s experts and facilities?
PJ: Resources and expertise play a major role in getting drugs to market faster. Thermo Fisher’s global network of drug substance and drug product facilities and scientific experts, combined with our proven track record and more than 30 years of development and manufacturing experience, make us a trusted partner committed to drug development success. Our experience spans 240 recombinant proteins and monoclonal antibody products.
AB: The Quick to Clinic solution “may help biopharma companies reach Phase I trials in as little as 13 months”. How does this compare to the current timelines for this process?
PJ: Quick to Clinic offers time savings attributed to the ability to invest in state-of-the-art tools, technology and capabilities – and a proven track record with early development programs that make it possible to file faster and get to patients sooner. The solution provides biopharma companies with the supply assurance and foundational platform they need to see their therapy through to the clinic while mitigating risk, accelerating timelines and navigating a complex and changing regulatory environment.
AB: How does Quick to Clinic enable biopharma companies to assess and balance risk?
PJ: Quick to Clinic manages risk using a carefully constructed program backed by supply security from a company with a broad technology portfolio and deep scientific expertise. This leads to an assurance that biopharma companies do not have to sacrifice quality for speed. This is enabled by avoiding high-risk activities such as using stable pool material for the tox batch or use of modular viral clearance studies. Quick to Clinic also relies on templated, pre-prepared documentation such as development report and technology transfer protocols.
Paul Jorjorian was speaking to Dr. Ash Board, Editorial Director for Technology Networks