The Silent Epidemic of Diabetes in China by Tom Hedberg

BACKGROUND

There are frequently heavy prices to pay for cultures embracing the lifestyle of Western nations, particularly of the US. China’s rapid economic and social expansion during the past 30 years has led to unwanted and heretofore unknown health consequences. The first epidemiological investigation of diabetes in China in 1980 showed a diabetes prevalence of 1%. By 2009, however, that prevalence had grown to 10%, and diabetes has since become the third largest chronic disease in China after cancer and cardiovascular pathologies.¹ According to the International Diabetes Federation, while diabetes is skyrocketing in China, the nation is still largely unprepared for the expected increase in diabetes-related comorbidities and complications. Fortunately, these complications have not yet become as widespread as the core disorder.

Early NDA Planning for Small to Mid-sized Companies by Susan Manley

The final phase 3 studies are ongoing with a planned completion in 12 to 18 months. Your board is looking to the submission date with great excitement. Your company has made it this far – is time to relax? No, not yet! Your company has not prepared a US NDA in several years or, even more concerning, has never prepared an NDA. What can you do now to ensure a smooth trip to the submission and beyond?  

Applications of Machine Learning in Healthcare: Scalable Treatment Solutions for Cancer Patients by Michael Cobb

A decade ago, Ms. Gitika Srivastava and Dr. Naresh Ramarajan learned that their close relatives had been diagnosed with cancer. In response, the two co-founded a company that uses machine learning to transform how patients make cancer treatment decisions. 

There are many barriers to democratize access to cancer care. Finding the right diagnosis, the best doctors, and the most applicable treatment is already a challenging task for patients with access to insurance and healthcare resources in developed countries. In developing countries, such as India, each of these tasks becomes exponentially more difficult.

Strategies to Approaching CMC New Product Development and Manufacturing Outsourcing Resources by David Bergstrom

If your company is developing a new product, your team will—at some point—have to consider a CMC (Chemistry, Manufacturing & Controls) and outsourcing strategy. How should your company develop such a strategy?

Business Model and Corporate Strategy

A Perspective on the Development of the Treatment of Our Next Epidemic - Brian Harvey, MD, Ph.D

Background 

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the industrialized world [1]. The phenotypes of the disease extend from nonalcoholic fatty liver (NAFL) to nonalcoholic steatohepatitis (NASH), the latter of which progresses to liver fibrosis and end-stage cirrhosis [2]. 

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