Pivotal Women in Pharmaceutical history

International Women’s Day is celebrated on the 8th of March every year. This year, we have decided to celebrate Gertrude Elion and Frances Oldham Kelsey; women who played a vital role in developments made in the Pharmaceutical industry.

 

Gertrude Elion

Gertrude Elion was an American Biochemist and Pharmacologist. She was born in New York, 1918. Elion graduated Hunter College in 1937 with a degree in Chemistry and New York University in 1941 with a Master of Science (MSc).

After a period working in food quality, Elion joined the Burroughs-Wellcome Pharmaceutical company to work with George H. Hitchings. During her time there, Elion and Hitchings used an innovative method to develop drugs, now known as rational drug design. This was a ground-breaking approach instead of trial and error drug development. In 1950, Elion developed two new leukaemia drugs, tioguanine and 6-MP, by working with purines.

During her career, Elion focussed on designing and developing drugs which destroyed or inhibited the reproduction of particular pathogens without harming normal cells. Elion’s developments include: (list from Wikipedia)

  • 6-mercaptopurine (Purinethol), the first treatment for leukaemia and used in organ transplantation
  • Azathioprine (Imuran), the first immuno-suppressive agent, used for organ transplants
  • Allopurinol (Zyloprim), for gout
  • Pyrimethamine (Daraprim), for malaria
  • Trimethoprim (Proloprim, Monoprim, others), for meningitis, septicemia, and bacterial infections of the urinary and respiratory tracts
  • Acyclovir (Zovirax), for viral herpes
  • Nelarabine for cancer treatment

In 1988, Elion shared the Nobel Prize in Physiology or Medicine with George H. Hitchings and Sir James Black for discoveries of “important new principles of drug treatment”.

 

Frances Oldham Kelsey

Frances Oldham Kelsey was a Canadian-American Pharmacologist and Physician. She was born in British Columbia in 1914 and attended McGill University, where she received a Bachelors degree (BSc) in Pharmacology in 1934, followed by a Masters (MSc) in Pharmacology in 1935. She then received a Doctorate (PhD) in Pharmacology in 1938 and a Doctor of Medicine (DM) in 1950.

In 1936, Kelsey began working in a new Pharmacology department at the University of Chicago, which was set up by E.M.K. Geiling. In her second year, Kelsey assisted Geiling with researching unusual deaths related to elixir sulfanilamide for the FDA. They found that using diethylene as a solvent caused 107 deaths, and the following year the United States Congress passed the Federal Food, Drug and Cosmetic Act of 1938.

A few years later in 1942, Kelsey was searching for a cure for malaria, which resulted in her learning that some drugs can pass through the placental barrier.

The Washington D.C. FDA hired Kelsey in 1960, with one of her first responsibilities being to review the application for the drug Thalidomide. Specifically, this was to be used for morning sickness in pregnant women. Kelsey withheld approval and requested further studies to explain a nervous system side effect that had been highlighted in an English study, despite it already being approved in European and African countries, and Canada.

When researchers concluded that Thalidomide caused birth defects as it crossed the placental barrier of pregnant women in Europe, The Washington Post printed that she was a heroine for withholding approval for the US. In 1962, John F. Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian Service, only the second woman to ever be presented this award.

Kelsey continued to work for the FDA until she retired in 2005. In 2010, she was awarded the first Drug Safety Excellence Award by the FDA. The award has since been named after her as the Dr. Frances O. Kelsey Drug Safety Excellence Award, and is to be presented to one FDA employee annually.

Both Gertrude Elion and Frances Oldham Kelsey have helped shape the way Pharmaceuticals are practiced and tested. Without their determination, research and development, some advancements wouldn’t have been made. It is great to see how vital women are to the Pharmaceutical industry, with Elion and Kelsey being just two examples.

 

References:

Commercial

Engineering

Health Economics & Outcomes Research

Manufacturing

Market Access, Pricing & Reimbursement

Medical Affairs

Quality Assurance

Regulatory Affairs

Scientific

Bioinformatics

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