Regulatory
The need for cross- regional regulatory expertise has increased alongside the trend towards conducting trials in the Asia-Pacific region
is to hire specialists trained to deal with the rules in particular places, or else rely on the expertise offered by regional offices. Similar specialisation is necessary to overcome varied custom regimes, with Walsh noting that at certain points in his career, he’s had to work in countries that demand each incoming shipment comes with its own import licences – an administrative nightmare that can sometimes take six months. With so much bureaucracy, it makes sense that the human touch is central to success. As White says, leaning on “trusted supplier partnerships” is a great way to mitigate worries around product quality or scheduling. At the same time, the boundless
$161bn
The forecasted value of the global drug discovery market by 2030
Precedence Research 10
internationalisation of comparator drugs means that some efforts are being made to harmonise regulations across national borders. In the European Union, for example, the so-called ‘Clinical Trials Regulation’ allows researchers to register their clinical trials through a single bloc-wide system. Working with like-minded regulators across 52 different jurisdictions. Meanwhile, the FDA is encouraging the cross- border harmonisation of inspection procedures. And if promoting globalisation is one tactic in the fight for more effective comparators, localism can prove equally alluring. If, after all, a comparator can be made in the country it’ll actually be used, Walsh and his colleagues need to worry far less about byzantine import licences. With that in mind, it’s no wonder a bipartisan effort is underway to boost domestic drug manufacturing in America, with their European cousins close behind.
Partnering up
The spirit of flexibility that typifies developments like the Clinical Trials Regulation can be witnessed elsewhere too. For Walsh, a great hope is the proliferation of new technology. Returning to his concerns around labelling, he envisages a world where non-natives could translate trial information digitally. In a similar vein, trial conveners could update the expiry dates of drugs from an office on the far side of the world, with the information fired immediately to the scannable barcode of the patient’s box of pills – not that ones and zeros are necessarily a panacea to all the sector’s problems. Especially in developing countries – India, for instance, has witnessed a ten-fold increase in trial registrations over the past three years – where Walsh warns subjects may lack the digital tools required for a tech-forward approach. All the same, both Walsh and White seem optimistic about the future of comparator drugs – not least given the changing philosophy of the industry at large. “The majority of large pharma have a clear process or policy on supply of their products for third-party clinical trials,” White explains. “This is a really important development in the supply of comparator products as it standardises access.” Walsh makes a similar point. “I think there’s going to be a lot of companies working together,” adding that sharing the comparator burden can help lower financial risk. That’s hardly immaterial when the average drug approval now costs upwards of $45m – and when the challenges to insiders like Walsh and White continue to swirl. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Anson_shutterstock/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45
