GlobalData Publishes FDA Regulatory Guidance and Strategy Report for Biotech Approval Pathways

Sydney - Novotech, the leading Asia Pacific centred biotech CRO has commissioned GlobalData to report on the evolving FDA approval processes for biotechs in Asia Pacific, Europe, and US, including typical impediments to success. 

The GlobalData report outlines the global approval landscape, pathways to approval, some frequent missteps to avoid, the importance of formulating a robust clinical development program, and what to expect from your CRO to optimize the process for success.

The new report Navigating the FDA Requirements: Capitalize on Regulatory Expertise To Simplify the Complex can be downloaded here. 

The report covers:
•    Global Approval Landscape
•    Outlining the Process of US FDA Approval
•    Variation in the Traditional Clinical Pathway
•    Expedited Approval Designations
•    Drug Approvals in the United States
•    Typical Impediments to Regulatory Success
•    Benefits of Partnership with CROs

The report also notes that the FDA has always placed a high priority on rigorous trial design, “however the FDA's definition of what constitutes "rigorous trial design" has evolved over time as new scientific and technological advances have emerged, as well as changes in regulatory requirements and the public health landscape at large”.

•    Increased emphasis on patient-centered outcomes: The FDA places greater emphasis on incorporating patient-centered outcomes into clinical trials, which involves assessing the impact of a treatment on patient-reported symptoms, quality of life, and other aspects that are important to patients. This shift has led to the development of new trial design approaches that focus on patient-reported outcomes, such as patient preference studies and patient-focused drug development.

•    Use of novel trial designs: The FDA has encouraged the use of novel trial designs that can increase the efficiency and effectiveness of clinical trials. Examples of these include adaptive designs, which allow for modifications of patients’ allocation in different arms of the trial, depending on interim results (adaptative randomization). This trial design, especially relevant when the primary endpoint can be measured quickly, became especially popular during the Covid pandemic. Platform trials allow for the simultaneous testing of multiple treatments for a given disease. These innovative trial designs present numerous statistical challenges, requiring solid expertise in order to be navigated.

•    Advances in data collection and analysis: Advances in technology have led to new methods for data collection and analysis, such as the use of wearable devices and electronic health records. These new data sources have the potential to improve trial design and reduce the burden on study participants associated with traditional trial paradigms. This is seen as a very promising path to speed-up clinical development.

•    Changes in regulatory requirements: Formal changes in regulatory requirements have also influenced the FDA's definition of rigorous trial design. For example, the FDA has issued guidance on the use of biomarkers in clinical trials, as well as on the collection of safety data in early-phase clinical trials.

Novotech has decades of biotech drug development experience, established site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. 

Consistent investment in advanced training and technology combines to deliver an exceptional full-service biotech CRO solution.

Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world’s leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. 

In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions that deliver exclusive benefits for sponsors.

Novotech, which has global CRO and regulatory consulting operations, announced at JPMorgan this year that it had acquired EastHORN, a European CRO with clinical, medical, and regulatory expertise in multiple strategically important locations across the continent. 

The acquisition is part of Novotech’s global expansion program. EastHORN was established in 2004 and has over 250 employees.

The acquisition of EastHORN, means biotech clients can access Novotech’s unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.