Tuesday, 31 October 2017

Drug Quality and Security Act and overseeing the safety of compounded drugs


In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.

The fungal meningitis outbreak underscores the need for robust oversight over human drug compounding, the importance of dispensing prescription drugs pursuant to valid prescriptions and the need for strong coordination with state regulatory partners to protect public health.

Since that outbreak and the subsequent enactment of the Drug Quality and Security Act (DQSA) on Nov. 27, 2013, the FDA has devoted significant resources to oversee compounding and implement the compounding provisions of the law. As of June 1, 2017, the FDA has conducted more than 400 inspections, including 109 inspections of outsourcing facilities; issued more than 150 warning letters advising compounders of significant violations of federal law; issued more than 50 letters referring inspectional findings to state regulatory agencies; overseen over 125 recalls involving compounded drugs; and worked with the Department of Justice on a number of civil and criminal enforcement actions.

As part of the implementation of DQSA, we have also issued 21 draft guidances, ten final guidances, three proposed rules, a final rule, and a draft memorandum of understanding. We have taken a risk-based approach to all of these efforts, in order to make sure that we are maximizing the public health purpose of these new provisions relative to the resources we use to achieve them, and any obligations that these new requirements place on market participants. These foundational regulations and guidance documents provide predictability and transparency to compounders, providers, and other enterprises; and inform them of how to comply with the law’s provisions in the most efficient manner.

Book offer:



These efforts are part of our commitment to doing all we can to protect the public from poorly compounded drugs. We will continue to actively oversee drug compounders and, when appropriate, initiate regulatory action as it fulfills the FDA public health mission on behalf of patients.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: US FDA

Posted by Dr. Tim Sandle

Monday, 30 October 2017

Review of MHRA GMP deficiencies


Tim Sandle has written a review for GMP Review looking at recent MHRA inspectorate findings relating to sterility assurance.

Reading and reviewing findings from regulatory inspections can help an organisation to develop best practices and to understand the current ‘hot topics’ in relation to regulatory inspections. Such reviews also allow an organisation to appreciate inspectorate trends and assess the impact on their sites. The latest MHRA GMP Inspection Deficiency Data Trend 2016 is notable for the number of findings under the umbrella term ‘sterility assurance’. This is a new deficiency group so this article examines a selection of these findings.

The reference is:

Sandle, T. (2017) MHRA annual deficiency review highlights sterility assurance issues, GMP Review, 16 92): 4-7

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle

Sunday, 29 October 2017

HEPA Versus ULPA


There are two primary types of air filters used in BSCs: HEPA (High Efficiency Particulate Air), and ULPA, (Ultra-Low Particulate Air). Understanding the similarities and differences between HEPA and ULPA aids in selecting the filter which offers the best combination of performance and capability for the specific needs of an organization.

Pharmaceutical Online has a useful article on this subject relating to safety cabinets, the article can be accessed here: Filters



Posted by Dr. Tim Sandle

Saturday, 28 October 2017

World Stroke Day


October 29 is World Stroke Day, a time to spotlight the deadly condition, warning signs and how to prevent it.

AliveCor, the creator of Kardia Mobile, a smartphone device that lets people like you and me get a full-picture of our heart health in under 30 seconds with the touch of a fingertip. Kardia instantly detects abnormal heart rhythms, a leading cause of stroke.

The AliveCor team has also put together some stroke prevention tips:

  1. Keep your blood pressure in check: A healthy diet low in sodium and cholesterol and high in fruit and veggies is crucial for this. An ideal reading is 120/80.
  2. Stay in shape: Obesity and related complications can increase risk for stroke, and, in most cases, even losing a few pounds can improve your health. Aim for a BMI (body mass index of) 25 or lower.
  3. Exercise regularly: Aside from helping you lower blood pressure and lose weight, exercise on its own can reduce the risk of stroke. Try to get some moderately intense activity at least three times a week. Even casual cardio -- like morning walks or taking the stairs -- is beneficial.
  4. Avoid smoking: If you’re a smoker, try to cut down or completely quit to greatly reduce your risk of stroke. This habit thickens blood and builds artery plaque, and quitting is a powerful way to take back your health.
  5. Identify and treat AFib: Atrial fibrillation (AFib) is an abnormal heart rhythm that greatly increases risk of stroke. Make an appointment at the doctor’s office to regularly get an EKG, or to save time and money, use an FDA-cleared smartphone device that reads your heart rhythm at home in seconds.

Posted by Dr. Tim Sandle

The Development of Compendial Rapid Sterility Tests


A stimulus article entitled "The Development of Compendial Rapid Sterility Tests"  arising from the work of the USP Modern Microbiological Method Expert Panel, co-chaired between Tony Cundell and Ed Tidswell, has been published in the Sept-Oct 2017 Pharmacopeial Forum.

It can be viewed free by registering on the USP website at www.usp.org


The new paradigm is a risk-based selection of a rapid sterility test for short-lived sterile products.

Special offer book for readers:

Friday, 27 October 2017

Pharmaceutical Microbiology Book




Pharmaceutical Microbiology

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.

The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.

- Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
- Presents the practical aspects of pharmaceutical microbiology testing
- Provides contamination control risks and remediation strategies, along with rapid microbiological methods
- Includes bioburden, endotoxin, and specific microbial risks
- Highlights relevant case studies and risk assessment scenarios

Title Index:

- Chapter 1: Introduction to Pharmaceutical Microbiology
- Chapter 2: Microbiology and Pharmaceuticals
- Chapter 3: GMP, regulations and standards
- Chapter 4: Laboratory management and design
- Chapter 5: Microbiological culture media
- Chapter 6: Basic microbiological laboratory techniques
- Chapter 7: Bioburden testing
- Chapter 8: Assessment of raw materials
- Chapter 9: Microbial identification
- Chapter 10: Assessment of pharmaceutical water systems
- Chapter 11: Endotoxin and pyrogen testing
- Chapter 12: Sterilisation and sterility assurance
- Chapter 13: Biological indicators
- Chapter 14: Antibiotic effectiveness testing and preservative efficacy testing
- Chapter 15: Disinfection
- Chapter 16: Cleanroom microbiology and contamination control
- Chapter 17: Rapid microbiological methods
- Chapter 18: Risk assessment and microbiology
- Chapter 19: Manufacturing and validation
- Chapter 20: Microbiological batch review
- Chapter 21: Microbiological audits
- Chapter 22: Microbial Challenges in the Pharmaceutical Industry
- Conclusion

See below:



Or order from Elsevier.

Posted by Dr. Tim Sandle

Thursday, 26 October 2017

Theory and Practice of Disease Diagnosis


A new book of interest:

The book provides theoretical and practical information for diseases diagnosis. It is a collaborative book to support IP Erasmus project MDHP, with partners from different countries from Europe. Thebook includes chapters by Professor Ilya Azizov, from Karaganda State Medical University, Kazakhstan, now Smolensk State Medical University, Russia, and Dr. Antonella Chesca and Dr. Tim Sandle.

The book has been written with support for professors and researches from prestigious universities.

Reference:


Chesca, A., Cengiz, M. and Sandle, T. (Eds.) Theory and Practice of Disease Diagnosis, LAP LAMBERT Academic Publishing, Germany, ISBN-13: 978-3330084384

For details see: Amazon UK or LAP Publishing

Posted by Dr. Tim Sandle

Wednesday, 25 October 2017

Pharmaceutical Microbiology: Current and Future Challenges


To meet regulatory expectations, the role of the microbiologist is essential. To add to this, the input from quality assurance personnel, engineers, and process specialists is required. Whilst there is a continuing need for monitoring of the environment and conducting standardized laboratory tests, industrial pharmaceutical microbiology has moved a great deal in the past decade to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimizing contamination and reactive, in terms of addressing microbial data deviations; and also ensuring that processes meet ‘quality by design’ principles.

This is the introduction to an article by Tim Sandle for the Journal of GxP Compliance (a special edition devoted to Microbiology).

The reference is:

Sandle, T. (2017) Pharmaceutical Microbiology: Current and Future Challenges, Journal of GxP Compliance, 21 (4): 1- 5: http://www.ivtnetwork.com/article/pharmaceutical-microbiology-current-and-future-challenges

The article, which looks at key factors set to influence the future of pharmaceutical microbiology, can be accessed here.

The special edition contains the following articles:

Approach for the Qualification of a Pharmaceutical Facility Autoclave by Tim Sandle

This paper discusses the key criteria for autoclave cycle development; the use of a matrix approach for qualifying an autoclave and the key parameters (thermometric and biological) for evaluating the success of the validation.

Establishing a Library of In-House Isolates by Jeanne Moldenhauer

For many companies, there have been questions on why an in-house library is necessary and how to set up this library of isolates. This paper describes the basis for needing this type of library as well as a way to establish this type of library.

Microbial Identification Strategy for Pharmaceutical Microbiology by Tim Sandle

This article addresses these points and provides a basis of the microbiologist in each pharmaceutical or healthcare organization to develop a microbial identification strategy.

Developing or Updating your Environmental Monitoring Program to Meet Current Regulatory Expectations by Jeanne Moldenhauer

Since the early 1990’s there has been an increased emphasis on the need for environmental monitoring by many different regulatory agencies. Learn what a total environmental monitoring program is to see where yours can improve.

Setting Environmental Limits for Mold Contamination by Jeanne Moldenhauer

Many individuals come into contact with airborne mold on a daily basis. In some facilities, employees travel between buildings on a campus going through the environment and are exposed to airborne contaminants.

The special edition can be accessed here.

Posted by Dr. Tim Sandle

Tuesday, 24 October 2017

50+ FDA acronyms that matter to your business




The Vaisala Measurement & Monitoring Program is offering a list of useful FDA acronyms. For further details see: Vaisala.

Monday, 23 October 2017

Assessment of Bacterial Endotoxin by Fluorescent Labeling



Tim Sandle has written a review of a new range of development tests that can detect bacterial species based on analysis of endotoxin. The review is published in American Pharmaceutical Review.

New research in the field of bacterial endotoxin allows for the rapid detection, and quantitative estimation of, different endotoxin species. This has long been thought theoretically possible due to similarities and differences with the chemical structure of the pyrogenicity and immunogenicity of lipopolysaccharide,1 but the technological means to achieve this could not be realized commercially, or reliably, until recently. A new technique, based on microchip electrophoretic methodology, can examine lipopolysaccharides for variations in the length and composition of the O-antigen and core oligosaccharide of the molecule; this is in addition to assessing the number and length of fatty acid chains in the Lipid A portion of lipopolysaccharide. When this information is computed and compared the new method allows for the determination of the bacterial strain of the endotoxin. The technology requires bacterial cells to be grown and a cellular lysate obtained; the probable species is then determined through molecular size comparison.

The reference is:

Sandle, T. (2017) Assessment of Bacterial Endotoxin by Fluorescent Labeling, American Pharmaceutical Review, Endotoxin Supplement, October 2007, pp1-3

For further details, please contact Tim Sandle

Posted by Dr. Tim Sandle

Sunday, 22 October 2017

An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments


Crystal Booth has written a useful article for Pharmaceutical Online looking at environmental monitoring and disinfection of aseptic processing environments. Here is an extract:

“Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. To prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology article series discusses some of those aspects. Parts 1 and 2 introduced cleanroom microbiology, discussed guidance documents and FDA observations, and summarized common sources of microbial contamination in cleanrooms. Part 3 provided an overview of cleanroom gowning procedures. This final article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning.”

The full article can be found here: Pharmaceutical Online

Posted by Dr. Tim Sandle

Saturday, 21 October 2017

Smartphone screen technology used to trick harmful bacteria


Conducting plastics found in smartphone screens can be used to trick the metabolism of pathogenic bacteria, report scientists. By adding or removing electrons from the plastic surface, bacteria may be tricked into growing more or less. The method may find widespread use in preventing bacterial infections in hospitals or improve effectiveness in wastewater management.

When bacteria attach to a surface they grow quickly into a thick film known as a biofilm. These biofilms frequently occur in our surroundings but are especially dangerous in hospitals where they can cause life threatening infections. Researchers have now aimed to address this problem by producing coatings for medical devices made from a cheap conducting plastic called PEDOT, which is what makes smartphone screens respond to touch. By applying a small voltage, the PEDOT surface was either flooded with electrons or left almost empty, which in turn affected the growth of Salmonella bacteria.

See:

Salvador Gomez-Carretero, Ben Libberton, Mikael Rhen, Agneta Richter-Dahlfors. Redox-active conducting polymers modulate Salmonella biofilm formation by controlling availability of electron acceptorsnpj Biofilms and Microbiomes, 2017; 3 (1) DOI: 10.1038/s41522-017-0027-0

Posted by Dr. Tim Sandle

Puerto Ricans Suffer Drug Shortages After Hurricane Maria


Pharma Industry of Puerto Rico

The pharmaceutical industry of Puerto Rico is, well, huge. In 2016, nearly three-quarters of the island’s exports were pharmaceuticals, with a total value of $14.5 billion USD.

A special guest post by Megan Ray Nichols.

Additionally, half of the world’s pharmaceutical companies operate in Puerto Rico. That means the devastation from Hurricane Maria had a catastrophic impact on an important industry.  

Historical Importance

Pharmaceutical production in Puerto Rico has been and remains one of the most crucial industries on the island. In the past, specifically the late 1960’s and 1970’s, the Puerto Rican area received pharmaceutical companies that wanted to take advantage of the now-expired federal tax incentive known as Section 936. This incentive paved the way for manufacturers to send their profits from Puerto Rican plants to their stateside branches without a requirement to pay any federal taxes.

Challenges began to appear within the market as several developments surfaced at once. Some of these included expired patents, cheaper manufactures, a rise in generic drug manufacturing and usage, and high production costs. As of 2014, the market share in Puerto Rico produced sixteen of the top twenty selling drugs in the mainland of the United States.

The Hurricane Season’s Effect

We talk about Puerto Rico because of the massive hurricane that has struck the region in September 2017. Hurricane Maria completely wiped out the island’s power grid, and experts say it could be anywhere from four to six months for power to be completely restored. While a lack of electricity no doubt affects millions of citizens, the negative impact on Puerto Rico’s infrastructure extends into other areas as well, including its pharmaceutical capabilities and facilities.

The extensive damage, despite occurring in September, has affected drug production in October 2017 and will possibly extend further down the year as the situation remains far from resolved. FDA commissioner Scott Gottlieb said in a statement: “Even the facilities that sustained relatively minor damage are running on generator power. They could be without commercial power for months while crews work to restore stable power to the island.”

He then goes on to report on the state of the generators in a majority of the facilities and how only partial operational capacity has been restored. He adds that the pre-existing shortages and disruptions will potentially extend due to the severity of Hurricane Maria. Producers are trying to get their production facilities online, but the entire island faces a continual uncertain power supply, while the availability of materials is becoming scarcer.

This means Puerto Rico’s economic recovery will slow overall while their manufacturing works at half capacity or less. Drug shortages will include treatments for cancer, rheumatoid arthritis and HIV, but the FDA has not named specific medicines. These shortages will also have an impact on U.S. hospitals and pharmacies in the weeks and months to come.

Puerto Rico’s Global Distribution Impact

It’s not only supply within Puerto Rico that’s a concern. The drug supply to the U.S. is threatened as well. Over half of all pharmaceutical products manufactured on the island are purchased and consumed by U.S. citizens, making the damage to the island's infrastructure a serious concern to U.S. health care. While the U.K. has not seen a direct reduction in their drug supply chains, officials of various organizations are monitoring the situation closely, confirming Puerto Rico’s position as a global drug supplier.

Potential Safeguards

The vital role that Puerto Rico plays as a drug manufacturer and distributor has inspired various ideas for safeguards against supply loss and delivery interruptions. Some of these solutions include more portable generators for power distribution, sealed storage options for extra drug supplies and products, and off-shore branches capable of picking up the production needs of certain pharmaceutical drugs in an emergency.

Due to the immediate effects and chaos hurricanes create where they hit, we tend to dismiss or overlook less prominent issues that surface during or after the storm. Beyond the flooding waters and displaced citizenry comes an interruption to everyday infrastructure and manufacturing. As a vital concern for citizens of all ages, the availability of medication prescriptions and production cannot afford weeks or months of interruption — something that has occurred in Puerto Rico ever since Hurricane Maria made landfall in September.  

Friday, 20 October 2017

Bacterial in-fighting provides new treatment for hospital infections


A bacteria that is a leading cause of death worldwide from hospital acquired infections following antibiotic treatment looks set to be brought down through its own sibling rivalry. New research from the University of Sheffield shows that Different strains of Clostridium difficile (C. diff) use tiny weapons to kill each other, and scientists from the UK and US have discovered how these work, enabling them to be engineered into an antimicrobial agent with the potential to prevent or cure C. diff infection.

Further study has shown when C. diff develops a resistance to these weapons, the bacteria can no longer cause infection, making them harmless. Like many bacteria, C. diff can make a weapon that is able to identify and kill competing C. diff strains. This weapon attaches to the surface of other C. diff cells and fires a harpoon-type needle through their membrane, causing the cell to die. The researchers have managed to engineer this weapon so that it can be mass produced in a stable form as a potential treatment or preventative for C. diff infections.

See:

Joseph A. Kirk, Dana Gebhart, Anthony M. Buckley, Stephen Lok, Dean Scholl, Gillian R. Douce, Gregory R. Govoni, Robert P. Fagan. New class of precision antimicrobials redefines role of Clostridium difficile S-layer in virulence and viabilityScience Translational Medicine, 2017; 9 (406): eaah6813 DOI: 10.1126/scitranslmed.aah6813

Posted by Dr. Tim Sandle

Thursday, 19 October 2017

Cilia: 'The bouncer' of bacteria


A new paper, from University of Southern California, elucidates the active role of cilia in regulating flow for bacteria filtering and enhancing chemical communication.

The paper, published in the Proceedings of the National Academy of Sciences, describes a framework for the role of fluid mechanics in letting symbiotic bacteria in an organism and enhancing chemical communication between the symbiont and the host organism. The results are contrary to previous research which assumes that cilia solely play a "clearance function." They could shed light on the role cilia -- which are the size of one hundredth of a single human hair -- play in human respiratory system and even in the reproductive systems and the brain. Their findings could also provide insights on how cilia dysfunction within organs affect for example, pulmonary conditions or infertility (how cilia help sperm reach eggs).

To learn about how cilia might work in the human body, Kanso, in collaboration with symbiosis expert McFall-Ngai and biofluid expert Janna Nawroth studied bobtail squid. The researchers examined how these squids in their nascent stage allow symbiotic bacteria Vibrio Fischeri to enter into their ciliated light organs, which play a crucial role in camouflaging the ink sacks of the otherwise translucent organism while they hunt for food at night. The scholars sought to know: why does this bacterium gain access and why do all bacteria fail to accumulate within the squid's light organ? In addition, they sought to explain what, if any, is the role of cilia in allowing access?

Researchers discovered that a vortical or "donut-like" flow generated by the cilia was kicking away most particles. The role of the fluid motion in filtering particles by size was verified using a physics-based mathematical model. One of the core findings was that there were two distinct flows taking place by two different types of cilia. Longer cilia move in a "wave-like" fashion which creates a vortical flow field that filters particles and then shorter cilia which beat randomly keep the particles in place and gently mix the local flow. This random motion by the cilia and fluid mixing enhance the chemical screening of bacteria. To further prove the important role played by cilia, the researchers also found that if cilia are "killed," particles will accumulate everywhere in the organism.

See:

Janna C. Nawroth, Hanliang Guo, Eric Koch, Elizabeth A. C. Heath-Heckman, John C. Hermanson, Edward G. Ruby, John O. Dabiri, Eva Kanso, Margaret McFall-Ngai. Motile cilia create fluid-mechanical microhabitats for the active recruitment of the host microbiomeProceedings of the National Academy of Sciences, 2017; 114 (36): 9510 DOI: 10.1073/pnas.1706926114

Posted by Dr. Tim Sandle

Wednesday, 18 October 2017

Microbiologist Wins International Prize for Biology


Rita Colwell, a Distinguished University Professor in the University of Maryland Institute for Advanced Computer Studies, has been named the 2017 laureate of the International Prize for Biology for her outstanding contributions to marine microbiology, bioinformatics, microbiomes and the understanding and prevention of cholera.

Colwell is the thirty-third recipient of the International Prize for Biology, generally recognized as one of the most prestigious honors a natural scientist can receive. Past laureates include such other renowned b
iologists as John B. Gurdon, Motoo Kimura, Edward O. Wilson, Ernst Mayr, and Thomas Cavalier-Smith.
In awarding the prize, Japan’s Society for the Promotion of Science honored Colwell as a pioneer in the use of computational tools and DNA sequencing to identify and classify marine bacteria and other microorganisms, work that helped lay the foundation for the bioinformatics revolution.

The prize also recognizes Colwell’s life-saving contributions to the understanding and prevention of cholera, an acute diarrheal disease, caused by ingestion of water or food contaminated with Vibrio cholera, which according to the World Health Organization is responsible for approximately 1 to 4 million illnesses and 20,000 to 140,000 deaths each year.

Colwell, whose career bridges the disciplines of microbiology, ecology, infectious disease, public health, and computer and satellite technology, continues to be a leader in bioinformatics, notably in understanding microbiomes and the application of this knowledge to human health and the diagnosis and treatment of disease. This includes her current work as founder and chairman of CosmosID, Inc., a microbial genomics company focused on molecular diagnostics of human pathogens and antimicrobial resistance.

“It is an extraordinary honor to be named recipient of the International Prize for Biology, a very special honor for a biologist,” said Colwell. “I am deeply grateful to the Japan Society for the Promotion of Science for this award. I have many friends and colleagues in Japan and look forward to continuing my many collaborations with them.”

The selection committee also cited Colwell's transformational work in these areas:

  • Establishing the taxonomy of vibrio bacteria, which includes Vibrio cholerae.
  • Identifying a previously unknown survival strategy of dormant vibrio cells, which the committee said "has had a profound influence on microbiology and medicine.”
  • Showing how climate change has expanded the habitat range of vibrios, and the occurrence of cholera.
  • Helping prevent the spread of cholera in developing countries by discovering and demonstrating an effective way to use the sari, the traditional dress of women on the Indian subcontinent, as a filter to remove vibrio-carrying plankton from drinking water drawn from ponds, rivers and other surface waters.

There is no Nobel Prize for biology, but Japan’s International Prize for Biology is one of three prizes often considered to be biology’s equivalent. The other two honors often placed in this category are the Balzan Prize and Crafoord Prize.

"We are extremely proud of Dr. Colwell's indelible impact on the field of biology and, more importantly, on human lives," said UMD Interim Vice President for Research Amitabh Varshney. "We applaud her fearless pursuit of translational research and life-saving solutions to global health challenges."

The International Prize for Biology was instituted in April 1985 by the Committee on the International Prize for Biology. The prize, consisting of a certificate, a medal and an award of 10-million yen (more than $90,000) is given to the recipient, along with an imperial gift, a silver vase bearing the imperial crest. The award presentation ceremony and a subsequent reception in honor of Colwell will held in late 2017 at the Japanese Academy in Japan.

Colwell joined the University of Maryland faculty in 1972 and has been a Distinguished University Professor at the University of Maryland and the Johns Hopkins University, Bloomberg School of Public Health since 2004. She is chairman emeritus at Canon US Life Sciences, Inc. She holds a dozen U.S. patents, most involving computational biology.

Colwell’s passion for science was obvious at an early age. As a sixth-grader, her school principal said to her, “You received the highest science test score ever.  You have a responsibility to meet your potential and you must go to college.” But this was in the 1940s, and discrimination against women, especially in the sciences, was an obstacle.  Hurdles she faced included a high school science teacher who told her not to bother with chemistry in college, as it was not a career suitable for women, and a department chair who denied her a master’s degree fellowship because they were “wasted on women.” Colwell’s steely determination to succeed was apparent, then and now.

Her decision to pursue a career in genetics introduced her to the emerging field of molecular biology and the very earliest use of computers in the pursuit of understanding complex biological systems. In the 1960s, Colwell was the first researcher in the U.S to develop a computer program to analyze bacteriological data. She continued and expanded this work at the University of Maryland beginning in 1972. Today, bioinformatics is used at the very forefront of biological scientific research due to her efforts, along with colleagues, to promote the use of computing tools to facilitate the study of biology.


Colwell’s lifelong passion for studying environmental microbiology, especially in marine environments was fostered by her childhood fascination with the ocean. This passion led to her discovery, in the 1970s, of the presence of Vibrio cholerae, the causative agent of cholera, in the waters of Chesapeake Bay. At the time, conventional wisdom held that cholera was spread from person to person, or from consuming tainted food or drinking water and that its presence in the environment could only be due to the release of sewage into rivers, lakes, streams, and other waters. She proved that the bacteria were native to the aquatic environment, attached to zooplankton, and that that certain bacteria, such as Vibrio species, are capable of entering a dormant state.

Colwell has received a great many awards and recognitions, including the 2017 Vannevar Bush Award given by the U.S. National Science Board; the 2010 Stockholm Water Prize awarded by the King of Sweden; the 2006 National Medal of Science awarded by the president of the United States; and the Order of the Rising Sun, Gold and Silver Star bestowed by the Emperor of Japan. She is the recipient of 61 honorary degrees from institutions of higher education and has a geological site in Antarctica, Colwell Massif, named in recognition of her work in the polar regions.

Colwell was the 11th director of the National Science Foundation and the first woman to head the agency. She also co-chaired the Committee on Science, National Science and Technology Council.  She has held numerous advisory positions in the U.S. government, nonprofit science policy organizations, and private foundations and has authored or co-authored 19 books and more than 800 scientific publications.

 Colwell also has served as chairman of the Board of Governors of the American Academy of Microbiology, president of the American Association for the Advancement of Science, Washington Academy of Sciences, American Society for Microbiology, Sigma Xi National Science Honorary Society, International Union of Microbiological Societies, and American Institute of Biological Sciences.  She is a member of the National Academy of Sciences, Royal Swedish Academy of Sciences, Royal Society of Canada, Royal Irish Academy, Bangladesh Academy of Science, Indian Academy of Science, American Academy of Arts and Sciences, American Philosophical Society and the National Academy of Inventors. 

Posted by Dr. Tim Sandle