Rising IND submissions are driving preclinical CRO market growth in Asia. Charlene Chen shares three criteria when selecting a CRO partner that can take you from preclinical through Phase II and beyond.
by Charlene Chen
Asia is fast becoming a robust biotech and pharmaceutical research hub. The region now hosts 23.6 per cent of the world’s pharmaceutical companies, according to Pharma Intelligence.1
And, many of the thousands of small biotech companies located around the globe are looking to Asia to support their research and development needs.
China-based venture capital (VC) funds are pouring billions into private U.S.-based biotech firms with the goal of bringing drugs to market in Asia and the U.S. simultaneously.
By 2025, Taiwan plans to develop and market 20 new drugs.2 To achieve this goal, the Taiwanese Ministry for Health and Welfare Food and Drug Administration (TFDA) has simplified its First In Human (FIH) regulatory approval process, reducing timelines to just 30 business days. Additionally, India has emerged as a leading destination for clinical trials and drug development research.
Investments in biotech have also been on the rise for several years. With billions of dollars funding drug discovery and development worldwide, the U.S. Food and Drug Administration (FDA) is seeing a rise in investigational new drug (IND) applications.3 In fact, IND submissions increased by 49 per cent in 2018. This trend aligns with Market Research Future’s (MRFR) prediction4 that the preclinical CRO market in Asia will see significant growth, particularly in the areas of bioanalysis and drug metabolism and pharmacokinetics (DMPK) studies to accommodate the increased demand for pharmacokinetic services to support toxicology tests for IND-enabling studies.
Asian biotech companies that plan to keep research and development in Asia, as well as biotech and pharmaceutical companies around the globe that are considering outsourcing to Asia, need to closely scrutinise CRO candidates to ensure the selected partner is equipped with the necessary preclinical expertise and facilities to do that work that enables sponsors to open INDs.
Here are three criteria to reflect when selecting a CRO partner that can take you from preclinical through Phase II and beyond. To make the short list, CRO candidates should have:
1. A Formal IND Package Offering
Too often, companies underestimate the complexity of preparing and filing an IND application with the FDA. The CROs you are considering should understand the intricacies involved with regulatory submissions and be able to execute a well-conceived preclinical program that delivers a professionally packaged, detailed assessment of your drug candidate.
Before a new drug candidate can be administered to humans, a series of preclinical studies must be conducted to characterise the compound, and these IND-enabling studies must be included in the submission. Some sponsors are taking a piecemeal approach to preparing and filing an IND application. It is more effective to partner with a single CRO that delivers a comprehensive preclinical strategy as the IND submission process is complex and it requires several different preclinical studies that all closely align with FDA guidance.
The program needs to be closely managed to ensure your IND application meets all the FDA’s requirements and is properly prepared in English. Without this level of proficiency, you will most likely experience delays or problems getting your submission through FDA reviews. One way to vet partners is to ask how many IND dossiers the team has submitted. CROs that can point to at least 35 IND dossiers submitted should make the short list.
2. Skilled, Hands-on Scientists With Preclinical Expertise
Preparing for an IND filing is all about ensuring new drug candidates can safely be administered to humans and there are several studies required to be conducted.
The safety evaluation for new chemical entity (NCE) for an IND package includes genetic toxicology, general toxicology, safety pharmacology, and reproductive toxicology studies. Genetic toxicology is to evaluate if the new drug candidate induces potential genetic damage. General toxicity studies provide the overall safety profile of the drug candidate in both rodents and non-rodents. Safety pharmacology assesses the potential effects on respiratory, cardiovascular and CNS function. Developmental and reproductive toxicology is needed to assess the impact on the different stages of the reproductive cycle.
Both in vitro and in vivo are required. In most cases, the FDA requires general toxicology studies to be conducted in two species – rodent and non-rodent – prior to moving to dosing humans. Therefore, it is important the CRO selected has in vitro and in vivo expertise and access to the right animal models in the most relevant species.
The team should consider how this new drug candidate will be applied in humans. What is the intended clinical use with the consideration of dosing route, duration and frequency? Can it be manufactured in large quantities safely and consistently?
This work requires a team comprised of experts including experienced technicians, veterinarians, toxicologists, clinical pharmacologists and U.S. board-certified pathologists. When sponsors spend millions of dollars on research and development, and have millions more on the line, they want to ensure they work with a CRO that has scientists skilled in each of these areas working on their studies. During the selection process, it is important to meet and talk with the team members who will be involved in the study day-to-day. Interview the team to gain an understanding their experience and their process for handling studies.
3. A Global Presence With Full-Service Capabilities
A CRO with full-service, global capabilities can more effectively implement global quality expectations in compliance with China FDA, Taiwan FDA, US FDA, and European Medicines Agency (EMA) registration.
With a global CRO, you can do the preclinical work in one part of the world and conduct clinical trials in other parts of the world. For example, you may choose to conduct First in Human (FIH) studies in Asia, where you have conducted your preclinical testing with price advantage. Then, you move it to the Netherlands where you may have an opportunity to test in humans while you are awaiting IND approvals. Or, you may choose to conduct FIH clinical trials in the U.S. The point is, you can choose the most advantageous location based on your specific needs, with a seamless knowledge transfer within the same organisation.
Similarly, proof of concept studies and later-phase clinical trials are more complex and require patients with specific disease indications. Therefore, you must go where the patients are readily available. For example, Asia is shaping up to be a vaccine powerhouse and trials in Asia can generate high-quality clinical data. Or, you may decide you want to move your clinical trials to the U.S. where there is experience dosing subjects with vaccines for viruses such as Zika and Ebola.
When you are vetting CRO candidates, global capabilities are important. However, you will also want to consider the benefits that come with an agile partner – a hands-on, senior team of scientists working on your studies every day with the flexibility to custom-build research studies to fit your specific needs, budget and timeline.
The global outlook for drug development is as stronger than ever. Selecting a single CRO that has the preclinical expertise and facilities to enable you to open an IND and take you through Phase II and beyond, is a critical decision that requires scrutiny. Effective CRO selection can make all the difference in getting your promising new drug compound across the finish line. Choose wisely. [APBN]
About the Author
Charlene Chen is the deputy general manager and head of CTPS at QPS Taiwan.