Asia Pacific’s drug development landscape is accelerating more than ever before. Emerging biotech companies now face multiple hurdles – from compressed timelines, choosing the right biomarkers, to transparency throughout the Investigational New Drug (IND) application.

It is critical to engage an experienced Contract Research Organisation (CRO). Partners with global knowledge and extensive experience in Asia Pacific including Japan, have a competitive advantage as they can help implement the best strategies in an efficient and cost-effective manner.

From considerations to achieve a successful IND to the critical role of biomarkers and leveraging regional trends, this article provides insights to tackle the challenges that a biotech company may encounter during the clinical trial process.

Key to a successful IND

A successful IND starts with a good development plan that includes a regulatory strategy. The plan would decide where and how an IND is filed and considers development activities, timeline of studies and expedited pathways. Contrary to popular belief, plausible scientific rationale does not equate to regulatory success as promising results may not be good enough for the US IND.

Companies must also fully understand FDA’s regulations and requirements to ensure an efficient IND application.  Although formal consultation meetings with FDA are not mandatory, it is highly recommended for companies who are in doubt about important CMC (Chemistry, Manufacturing and Control) issues and study design problems. Such meetings will help companies expedite their IND filing process.

A partnership with a reliable CRO is critical to avoid interruptions. Some biotech companies who picked a small CRO for their pre-IND and IND needed to make a switch midway as there were no therapeutic experts available to address FDA’s questions. A competent CRO can help companies identify potential risks and provide a mitigation plan to facilitate a smooth IND application process and interactions with FDA. This is critical for the IND review process as extensive evaluation and support from a therapeutic expert is needed.

As for clinical trials, many Chinese biotech companies in recent years have started moving their phase I clinical trials to Australia to bridge the Caucasian population in the EU or US. Clinical trials conducted in Australia do not require the typical regulatory application for IND while the data output meets global standards and requirements of international regulatory applications. This has made the clinical trial process efficient and ethical. Companies who also work with CROs perform better as they can exchange experiences and collaborate with those who have relevant experience.

IQVIA Biotech’s experience in rescuing many clinical trials in progress underscores the importance of biotech companies in selecting a CRO with deep therapeutic and scientific knowledge, exceptional expertise in trial design and execution globally to get their therapeutics to commercialization efficiently and cost-effectively.

Critical role of biomarkers in guiding drug development

Selecting the right biomarkers and determining how they are used is crucial for a successful protocol. Excessive biomarkers in a protocol complicates trial design and implementation in terms of costs, sample gathering, and data interpretation.

Some key questions to ask when selecting and determining a biomarker are:

1. Is the biomarker available? What is its robustness?
2. What platforms, instrumentations or methodologies should be used?
3. Where should testing be done, whether centralized, a single lab or in different lab networks to ensure stability of samples and data integrity?
4. Will the biomarker give insight to the efficacy and safety profile of the drug?

Early biomarker engagement not only helps to optimize information from biomarker testing, it also aids in the efficient alignment of critical milestones in clinical development given the tight timelines and cost restrictions of biomarker development. It is never too early to engage laboratories in conversation even before developing a protocol synopsis.

IQVIA’s laboratories can keep biotech companies informed about the ever-evolving regulatory requirements for biomarker testing and increasingly complex biomarker testing options. We have a deep knowledge of each biomarker’s intricacies and will help companies select the most suitable and cost-effective biomarker testing solutions.

Navigating the trends in Asia Pacific with a comprehensive biomarker strategy

Cell and gene therapy (CAGT) has been increasing in Asia Pacific and biomarker testing based on Immunophenotyping and Droplet Digital PCR can be used to monitor the drug persistence post dosing or even the vector of gene therapy. Many biotech companies are also adhering to international standards by using the right biomarkers in ways that FDA, EMEA or other regions will accept the data.

It is key that biotech companies engage CRO partners early in its drug development and select a strategic partner with extensive biomarker development experience, deep scientific expertise in end-to-end biomarker capabilities as well a global network of central labs to make the biomarker development and implementation process a collaborative and seamless effort.

Asia Pacific’s emerging biotech landscape is undergoing transformational changes and the move from pre- protocol to IND is an exciting, fast-paced, and demanding transition. It is imperative and beneficial to select a reliable CRO partner with an array of services, and one who can advise on pre-protocol biomarkers selection and offer strong support throughout the pre-IND and IND process. The right biomarkers, a strategic development plan and strong pre-IND will help ensure success.

For more information on new approaches and trends in the biotech landscape, do listen to our mini four-episode podcast series, Through the Biotech Lens: Molecule to Market, for Emerging Biopharma where industry stalwarts give an insightful perspective on biomarker selection, innovative trial designs, decentralised trials and the value of digital to advance patient centricity.

IQVIA Biotech and Q2 Solutions employ a flexible and adaptable approach to align with each customer’s needs. The process begins with the initial alignment meeting where we listen to our customer and have an open conversation in order to outline the approach and discuss the most efficient way to perform the study. This helps clarify the scope of the trial, allowing for the development of a sound strategy and to ensure the work is achieved in a timely, efficient manner. Our goal is to help our customers get their life-saving therapeutics to commercialization as efficiently and cost-effectively as possible so that patients can receive the treatments they need.

Contact us to discuss how we can help support your clinical trial.