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Contracting Abroad: FDA-Approved Capacity, Faster Clinical Trial Enrollment and Lower Cost

There’s no doubt: India is a pharmaceutical powerhouse when it comes to global outsourcing. Its pharma and biopharma customers are as diverse as the range of services and benefits available to them.

Outsourcing research and manufacturing isn’t a new phenomenon by any stretch. With every tightening of the capital markets over the last twenty years – combined with the rising costs of life sciences development and the emergence of virtual pharma companies – the demand for pharma outsourcing services has grown…and continues to grow.

Why Do Pharma Companies Outsource Abroad?

Life sciences have become progressively more specialized in recent decades, further driving the need for outside providers. And pharmaceutical companies are increasingly turning abroad, for a number of reasons:

1. Outsourcing Abroad – World Class Regulatory Compliance

The last twenty years have seen a tremendous change in how international CROs and CMOs are viewed from a regulatory standpoint. As pharma has grown increasingly global, so has regulatory compliance. In fact, today CROs/CMOs abroad are seen as comparable (or even better, in some cases) to their Western European and U.S. counterparts.

Firms like Neuland which deal with an international clientele must comply with a vast range of regulatory requirements….whether it’s the U.S. FDA, Japanese or European regulatory agencies or another. This diversity of regulatory experience drives a more global understanding of regulatory hurdles, and the best way to meet them – whether it’s in a single market today or multiple regulatory markets tomorrow.

CROs/CMOs abroad will often face the same regulatory hurdles you may be familiar with (e.g., FDA). But they’ll also have a history of compliance with other potential markets, which can prove to be a valuable resource during the planning, strategy and development phases.

2. Faster Clinical Trial Enrollment

A key benefit to contracting research and/or manufacturing services abroad is the faster clinical trial enrollment times. India, for example, has seen the number of clinical trials grow at a compound annual rate of 30+% over each of the last ten years. The Indian clinical trials market as a whole has also grown at 30% – double the average worldwide, largely due to their speed advantage over U.S. and Europe-based trials.

Recently, awareness of clinical trial recruitment techniques in emerging markets has raised concerns – and with good reason. Given the speed, cost, capacity and capability advantages of global outsourcing, limiting the use of global CROs/CMOs isn’t the right answer. Pharma companies should expect, however, that best-in-class contract research organizations are aware of unscrupulous clinical trial recruitment techniques and have procedures in place to address such concerns.

3. Lower Costs

One of the key considerations during a drug development project is cost, and outsourcing abroad can offer tremendous cost savings. As I’ve written before, cost can depend on the length of project and volume of sample materials needed – which is why it’s critical to understand the cost structure of any outsourced research or manufacturing.

We’ve helped a few potential clients understand why it would be less expensive for them to have peptides produced locally in the Eastern U.S., rather than commit to us. In each of those cases, the decision came down to cost due to the lower volumes of material – Neuland’s significantly faster turnaround times wouldn’t have made enough of a difference for them to warrant paying slightly more. It’s why we encourage life sciences firms to pay particular attention to cost issues – the answer isn’t always obvious.

Has your pharma company gone global? What drove the decision to outsource (or not) abroad?

 

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