Archive by category | Regulatory

Death row for drug development costs estimates?

Death row for drug development costs estimates?

Last week, FDA Director of CDER, Janet Woodcock, lectured to a full house at the Mission Bay campus of the University of California – San Francisco.  She spoke on ways academic research centers could play a larger role in the development of new medical technologies.  I very much enjoyed the talk, the slides for which are available here.  Read more

Demystifying China: Understanding the Chinese IND approval process

Demystifying China: Understanding the Chinese IND approval process

Last year, several inquiries to us at Modular R&D, where I am a managing partner, were from companies new to China, on the subject of filing clinical trial applications. We hear comments such as “It’s taking too long,” “I cannot give out this information,” and “Why do I need to do an expensive long-tox study for a phase II?”  These are usually expressed in great frustration. So we did a workshop recently at the ChinaTrials conference, and worked with experts in regulatory affairs and preclinical studies from US, Europe and China, to look at the Chinese IND process in detail, especially how it compares to the US investigational new drug (IND) application and EU Clinical Trial Application (CTA).  Read more

Brazil Feeds the World

Brazil Feeds the World

Brazil produces almost 150 million tons of grain in 50 million hectares, and it multiplied grain production by four in the last four decades. It can double again that figure without destroying the Amazon or the Cerrado. Here’s how. This started in 1965, when Brazil established its first law to regulate the commercialization of seeds. When the Brazilian Enterprise for Agricultural Research (EMBRAPA) was created in the mid seventies, Brazil started training plant cell, molecular, and developmental biologists. Then Sectoral Funds were created in the ’90s for areas such as biotechnology and agribusiness. Without those developments, the seed industry would  … Read more