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An Alternative Model for Clinical Trial Product Management: Exploring Distribution and Dispensing

Managing limited supplies of an investigational agent in a clinical trial can present challenges. The typical practice is to ship inventory to the research pharmacy or the principal investigator’s office at clinical a site in anticipation of enrollment. One challenge is that the amount needed at study sites can only be estimated, and inadequate inventory may delay the study while providing extra is expensive and wasteful. In the meantime, the agent(s) and clinical supplies sit in storage until enrollment proceeds and dispensing begins. This ties up inventory and can create additional challenges with expiration dates. However, there is an alternative model of clinical trial support for consideration.

Topic: Clinical Trial Sample Management, Content: ..........

The Importance of Early Planning for Clinical Supplies: Part II

In Part I of this blog series, I identified some of the challenges in supporting clinical trials and a few reasons why early planning for clinical supplies is very important. In Part II, let’s look at three areas of clinical supply support that can greatly benefit from having the support team involved from the start and given ample time to design and contribute to the protocol:

Topic: Cold-Chain Logistics, Topic: Clinical Trial..........

The Importance of Early Planning for Clinical Supplies: Part I

Beating other investors to an offer or getting ample time to support a clinical trial can yield big benefits and returns. The advantages from the financial perspective can be fairly evident but the gains from having plenty of time to plan, design and implement support functions for clinical supplies may not be so obvious. In this two part blog series, I will discuss the challenge of supporting clinical trials and the importance of early planning for clinical supplies.

Topic: Cold-Chain Logistics, Topic: Clinical Trial..........

What You Need to Know About The Biomarkers Consortium

Established in 2006, The Biomarkers Consortium (BC) is a public-private partnership whose mission is to identify, develop and seek regulatory approval for new biological markers (biomarkers) to accelerate the detection, diagnosis and treatment of many diseases. These biomarkers support the development of new preventative medical measures, medical diagnostics and drug development.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Maximizing the Value of Biospecimens to Deliver New Therapies

In his position as Director and Head of Sample Management, Dr. Green is faced with a number of challenges, including AstraZeneca's transition from their research and development center in northwestern England, to a new research center to be built in Cambridge. The greater challenge going forward is, from Dr. Green's perspective, maximizing value from the biospecimens in the collection. This involves, among other issues, closing the gap in inventory management methods between the small molecule world and the world of biospecimens.

In this interview, Clive shares his perspective on biobanking, as it compares to managing a small molecule inventory, and challenges in the biospecimen supply chain.

Topic: Biobanking and Biorepository, Content: eBoo..........

Avoiding Hemolysis in Blood Sample Collection and Processing

Depending on your point of view, red blood cells, or erythrocytes, are throwaways and a nuisance, ruining a good blood specimen if the cells burst and contaminate the sample. On the other hand, erythrocytes have significant value in specific types of research, and if your objective is biobanking these cells in an intact state, then hemolysis and the need for a re-draw is equally as much to be avoided.

Erythrocyte cell membranes rupture easily, releasing hemoglobin and flooding the sample with potassium and other internal components. Fortunately, breakage of erythrocytes is easy to detect, as the hemoglobin turns the serum or plasma sample from pink to red, depending on the number of cells that have lysed.

Hemolysis is a primary driver of the need for re-draw, resulting in wasted time and resources. How can hemolysis be prevented?

Topic: Biobanking and Biorepository, Topic: Labora..........

Informed Consent for Use of De-Identified Biospecimens?

The Federal Government is revising the rules governing use of humans in research, specifically, Title 45 of the Code of Federal Regulations (CFR) part 46, Protection of Human Subjects. A Notice of Proposed Rulemaking (NPRM) was issued September 5, and comments are being accepted until December 7, 2015.

Changes in the rulings include new requirements for informed consent, including consent for the use of de-identified patient biospecimens, and the duties of Institutional Review Boards.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Top Translational Researchers of 2014

Nature recently released its list of the top 20 translational researchers for 2014, highlighting scientists whose work and patents facilitate new discoveries and advances in medicine and healthcare. The publication ranked biotech's top translational researchers according to patenting activity, using information supplied by the patent analytics firm, IP Checkups. This research directly impacts the role of personalized medicine and will help to identify the future wave of biotherapeutics and diagnostic tools in our industry. In this blog we'll review some of the research from five of these top researchers, and learn how their research is shaping our future.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Tackling Global Health Initiatives and HIV/AIDS at the PEPFAR Roundtable

Global health initiatives work to assess, monitor, and ultimately effect positive improvements in the well-being of citizens around the world. The battle against the spread of HIV/AIDs is one that has been in the news for decades and with organizations like the US President’s Emergency Plan for AIDS Relief (PEPFAR), global leaders are working together to combat this disease.

Recently, Thermo Fisher Scientific teamed up with the Business Council for International Understanding (BCIU) to host a roundtable discussion between leaders in the Global Health industry and Ambassador Deborah Birx, the US Global AIDS Coordinator in charge of overseeing and leading PEPFAR. PEPFAR is widely cited as the largest commitment by any nation to combat a single disease in history and is one of the most successful global health programs in the world.

In this blog I’ll give some insight into the roundtable discussion and review some of the key points global health leaders are addressing for those affected by HIV/AIDS.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Why GMP? An explanation of Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.

The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.

In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.

Topic: Biobanking and Biorepository, Topic: Qualif..........

Is “Controlling Pre-analytical Variability” an Elusive Target in Biobanking Urine Samples?

The wealth of information in urine samples makes this material critical for research, and for biobanking. The value of this humble waste product is evident from the fact that it is the third most-tested sample in diagnostic laboratories, after serum/plasma profiles and complete blood cell (CBC) counts. However, researchers collecting urine samples for storage and downstream analysis face the same issues as diagnostic laboratories—determining how reliable a test result can be, given the difficulty in controlling  pre-analytical variability.

Topic: Laboratory Processing, Topic: Clinical Tria..........

Walk to End HIV

Walk_to_End_HIVOn October 24, 2015, nearly 40 Thermo Fisher Scientific employees and their family and friends will take to the streets of Washington, DC to participate in the 2015 Walk to End HIV. Thermo Fisher Scientific is a proud Bronze level sponsor of this event which benefits Whitman-Walker Health, the District’s largest community-based provider of HIV services. The name for the charity walk and 5K run was changed in 2014 from “AIDS Walk” to “Walk to End HIV” to reflect the focus on testing and prevention and to present the cause as one with hope and optimism.

The Thermo Fisher Scientific Walk to End HIV team formed out of the offices of the AIDS Reagent Program (ARP). This government funded program is managed and staffed by Fisher BioServices and has been held by the company since its inception more than 25 years ago. The men and women at ARP work diligently to assist the scientific community in the effort to develop vaccines against HIV, provide better treatments for people living with AIDS and ultimately find a cure for the disease. ARP provides free research reagents to scientists working on HIV/AIDS all over the globe, positively impacting the research programs of over 1,000 different laboratories in 50 different countries.

Topic: Clinical Trial Sample Management