Biotech GLP Industry Pharmaceutical

Keys for selecting preclinical drug candidate

Selecting a preclinical candidate is a critical step in drug development. It is a million dollars decision.  It involves choosing the most promising drug molecule from a pool of candidates to move forward for further testing. Obviously, the...
Biotech Industry Pharmaceutical

What does BD do and how to become a BD in biotech

In the world of biotech, a Business Development (BD) professional plays a critical role in forging strategic partnerships, identifying and securing licensing deals, and driving the overall growth of the company. Here’s a breakdown of their...
Industry

What does project manager do in pharmaceutical companies

Project managers in pharmaceutical companies play a crucial role in bringing new drugs and treatments to market. Their duties encompass a wide range, overseeing the entire drug development process from conception to potential sale. Here’s a...
Industry Pharmaceutical Regulation

Fluorine in the Spotlight – Review of the FDA’s 2023 New Drug

The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new molecular entities (NMEs) and new therapeutic biological products in 2023, including 33 small molecule drugs. Of these 33 small molecule drugs, 11 contain at...
Biotech Industry Pharmaceutical

The consideration of working with pharmaceutical contract service organizations

The pharmaceutical industry has witnessed a paradigm shift, with contract service organizations (CSOs) emerging as powerful contributors across the spectrum of research, development, and manufacturing. These partnerships unlock access to specialized expertise, infrastructure, and economies of scale....
Biotech Industry

The biotech company numbers by the country

First of all, this article is just a recap of the OECD statistics. If you are interested in the topic, I would recommend a nice article at Labbiotech. The OECD’s latest update on key biotech indicators highlights rising...
cGMP Industry Pharmaceutical

The importance of CMC in Drug Development

Drug development is a long, expensive, and risky process. The drug development process mainly includes: Target identification, Discovery, Preclinical pharmaceutical research (IND), Clinical trials (Phases I, II, and III) , NDA/BLA and comercial Launch. CMC (Chemistry Manufacturing & Control) is a very important part of drug approval....
Industry Pharmaceutical PopSci

Test BARD for the topic of Weight loss Drug

Recently, the weight loss drug is at the spotlight. I just want to test how Google Bard will tell me about this topic. So I got three questions and three answers. It only helps understand the...
Biotech Industry Pharmaceutical

What are the FDA approved drugs for Alzheimer disease

There are currently five FDA-approved drugs for the treatment of Alzheimer’s disease: Donepezil (Aricept) is a cholinesterase inhibitor that helps to increase the levels of acetylcholine in the brain. Acetylcholine is a neurotransmitter that is involved in...
Industry Pharmaceutical Regulation

Whether human research can be conducted without IND

It is a a simple question, but people usually forget to ask when they enter the pharmaceutical industry.  Yes, human research can be conducted without an IND(investigational new drug) in certain cases. The FDA has a...