Raleigh’s Global Specimen Solutions is growing its leadership team ahead of a number of product launches, according to founder and CEO Amelia Wall Warner.
The company has hired Gabriel Balint – owner of laboratory information management system-focused company BGASoft – as senior vice president of Software Development.
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In the HBO movie “The Immortal Life of Henrietta Lacks” based on the best-selling book written by Rebecca Skloot, text appears across the screen in the very last frame that reads “Patient consent is not required for research on human tissue obtained during medical treatment if the “donor’s” identify is removed”. The failure of John Hopkins University to obtain consent from Henrietta Lacks or her family for the use of her cells, which have come to be known as HeLa cells, is also mentioned throughout the movie. As captured by the emotional response of the family in this movie and the perspective of ethicists in the research community, this exemption can be very controversial given the uncertainty as to whether it offers the best protection of privacy to subjects involved in research. In fact, it was just at the beginning of this year that the Continue reading Informed consent perspective in light of the Henrietta Lacks movie
On January 19, 2017, the U.S. Department of Health and Human Services along with 15 other federal departments and agencies issued a revised Federal Policy for the Protection of Human Subjects referred to as the Common Rule. The intent of the revision, the first update since 1991, was to strengthen the protections of subjects participating in research while at the same time minimizing undue burden on researchers. At a recent webinar led by Pearl O’Rourke and Heather Pierce through PRIM&R, several key take-away messages were identified by GSS attendees and have been outlined below with some additional commentary on potential impact and considerations. Although it is important to be familiar with all the changes and updates in the policy, the primary focus here will be on those changes most relevant to research with biospecimens and informed consent.
Continue reading Updates to Common Rule
Amelia Wall Warner, CEO and Founder, of Global Specimen Solutions, Inc. has been named one of the top Women in Business by the Triangle Business Journal (TBJ) as a recipient of the 2017 Women in Business Awards. She was selected as one of 26 recipients of the award from an elite group of about 100 women who are successful leaders both in their business lives and through their service and commitment to the community. Amelia will be recognized by TBJ at an awards luncheon on April 21st.
Continue reading Amelia Wall Warner named as one of the top Women in Business by the Triangle Business Journal
New article on the American Society for Clinical Pharmacology & Therapeutics provides a cross-industry review of the complexity of informed consent for translational research conducted across jurisdictions in global research programs. Amelia Warner, CEO of Global Specimen Solutions, Inc. is a contributing Author.
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Bringing disruptive innovation into the marketplace is exciting for a new company. Day to day, innovation, process/product improvement and enhancement consume the start-up employee’s time, thoughts, and performance. Working in this culture is rewarding, fast-paced, and ever changing.
Continue reading Driving Disruptive Innovation- The Importance of Knowing Your Potential Customer
Bringing new business ideas to the market is tough. Even in the most innovative corporate cultures- there are significant ties to “how things have always been done”. Building vision for a better future for busy executives takes tenacity, time, and clarity of thought. It also requires unwavering belief in the ability of organizations and cultures to change.
Continue reading Creating Paradigm Shifts Across the Globe
Today there is a large drive to be everything to everyone. Clients want a strategic partner that can also provide all services they could possibly request and- let’s be honest- those of us in the service sector want to be that partner. However, by attempting to constantly develop every expertise in-house, companies can migrate so far from their innovative core that they are no longer effective partners and are replaced by the next commodity provider with powerful marketing teams.
Continue reading Value of Strategic Partnership- Avoiding Repeated Swings and Misses
I was lucky enough to attend an ELSI 2.0 sponsored conference at the Centre for Law and Genomics in Tasmania, Australia. It was an amazing event, allowing ethicists, researchers, attorneys, and commercial providers to discuss what aspects of genomic research and human specimen research should be regulated- but more on that soon!
During the conference, one clear area of fundamental disagreement emerged amongst attendees- the fundamental question of whether learning insights on the impact of disease in large populations was of benefit to participants in this type of study. In other words, does advancing information that would benefit the “greater good” of future generations of patients qualify as a benefit to an individual deciding to participate in human specimen research. The divide was clear- most researchers expressed a strong belief in the ability of research to advance medicine, and thus to benefit participants by allowing this rapid advancement of knowledge during the lifetime of the research participant and the research participant’s family’s lifetime. Some Ethicists, however, were more cautious about whether research truly advances medicine at all, pointing to multiple examples of erroneous conclusions that contributed to harmful therapies or incorrect treatments being employed in large populations. Interesting…
Continue reading The View From Here