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Biomarkers can be defined and utilized for many purposes.  There are disease biomarkers as well as mechanistic or pharmacological biomarkers.  To reduce attrition and better understand a therapeutic, it is essential to be able to monitor the effectiveness of the therapeutic during drug development. Measurement of biomarker levels related to...

Just a few short days ago, nobody could have conceived the level of disruption that we would have to endure in the way we work and live for the next several weeks. The rapidly changing COVID-19 challenge is accelerating our need to adjust and adapt to keep our health and...

Wednesday, April 22, 2020 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central) 60 min   Often, when confronted with outsourcing and looking for laboratories for your discovery projects, turnaround times and cost are two very important factors. Quality and reliability of data generated are of course essential as well. How do...

Pharmacokinetic modeling during the drug development process is essential for determining whether an administered drug substance has the necessary characteristics to meet its intended medical use. Typically for small molecules, this is based on time/concentration data generated from biological samples following analysis using LC-MS/MS.   One of the principal challenges...

Even before the President’s announcement on Friday, KCAS was receiving calls from customers and colleagues with concerns about the way the world’s recent health and safety concerns would affect business continuity. Rapidly changing updates over the last few weeks about the way everyone should handle these trying times have led to...

Some clients share with us that what keeps them up at night is how much of their projects (and what type of platforms/technologies) their bioanalytical lab can reliably perform. Some clients invest years of time in engineering & characterizing reagents, researching sample storage & transportation, and performing the methods -...

There is a new and growing focus on drug development at KCAS. Our clients - both pharma and biotech research organizations - have depended on KCAS to provide bioanalytical services for over four decades. We call this new focus a “Powder-to-Report” approach.   KCAS is unleashing its dedicated Discovery group,...

Friday, February 28, 2020 | 12pm EST (NA) / 5pm GMT (UK) / 6pm CET (EU-Central) 60 min   There are many bioanalytical contract research organizations (CROs) that will provide quality bioanalytical services for a single project or perhaps even a single program for support of drug development. But how does a biopharma company trust...

In our daily life we interact with many different people who help us by applying their expertise to deliver things we would otherwise struggle with. Often the differentiator for us, as consumers, is how we feel we’ve been treated by the people who are working on our behalf. The first...

What level of regulatory oversight is needed for bioanalytical flow cytometry in support of drug development, specifically cell and gene therapies?   Drug development is dependent upon robust and reproducible bioanalytical results. In 2017 the first FDA approved, commercially available cellular therapy in the United States, Novartis' Chimeric antigen receptor...

Biomarkers are key drivers in the drug development process.  Frequently, developing a panel of biomarkers to test a particular mechanism or hypothesis is critical to the success of a drug.  At KCAS, we develop assays for custom panels or individual biomarkers based on client needs and can also assist with...

      As the field of oncology has evolved, the toxicity of therapeutic agents has driven the development of drugs that target and kill tumors compared to more general therapies that can also impact healthy cells. Principal amongst these therapies is the use of antibody-drug conjugates (ADCs) that are...

Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication helps ensure the dose form results for your GLP studies are delivered on time.   At KCAS, our scientific expertise allows us to develop methods that achieve your study requirements. Our...

KCAS is a solution-based company. We are focused on the delivery of high quality scientific and defendable data, able to meet or exceed client’s timelines and expectations. One of the main reasons we are able to deliver on even the most challenging projects and programs, is the technical breadth and...

How will your background in science play a role in your new Senior Scientific Advisor position? I feel that my skill set has evolved consistently since my graduate degrees where I’ve learned different yet complimentary lessons about data presentation, data interpretation, marketing, customer partnering, optimizing operational processes, customer management and...

At KCAS, our Discovery group performs bioanalytical / biomarker method development that can include any of the various components required for a validated method under the GLP guidelines.  So why is Discovery group needed?  The beginning stage of drug development is a stage of trial and error.  It is generally...

Biomarker is a broad term and can mean so many different things depending upon the scientific discipline. For Bioanalytical biomarker analysis - and specifically for CROs equipped with 9 different platforms to measure biomarkers and a cell culture suite with up to 19 color flow cytometry all under one roof...

Have you ever wished you could tailor your project to your research needs instead of taking what you can get from a CRO?  Here at KCAS, our Discovery team prides itself on having the flexibility to meet client’s needs by designing the experiments with feedback from our sponsors. Our team of...

KCAS is a progressive growing contract research organization with dedicated groups in pharmaceutical services to perform early stage discovery rapid method development and analysis, as well as, regulated preclinical and clinical phases, with support offered through NDA submission. We have an arsenal of top of the line instrumentation with a...

Original Time and Date of Webinar: Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST Event Overview: In this webcast, learn how the FDA Bioanalytical Method Validation Guidance (May 2018), the FDA Immunogenicity Testing of Therapeutic Protein Products (January 2019), and the February...

Incurred Sample Reanalysis (ISR) has become a process check for a bioanalytical method’s performance and should be a routine step in the process of developing a new method. More importantly, having a low Incurred Sample Reanalysis (ISR) failure rate from your Contract Research Organization (CRO) is important for several reasons: It shows repeatability and robustness of...

How confident are you in your CRO’s support of your drug discovery program? Maybe you should take a closer look... Support of drug discovery programs is essential in providing integrated drug development services.  The key is having the expertise to also be able tackle not only complex matrices but any...

At KCAS, we work with Director, VP, and C-level pharmaceutical and biotech executives that need to measure their drug or the effect of their drug in biological matrix. Many of our customers rely on us to help design a strategic bioanalytical plan: a purposeful approach that flexes depending on regulatory...

Biomarker are key drivers in the drug development process.  Frequently, developing a panel of biomarkers to test a particular mechanism or hypothesis is critical to the success of a drug.  At KCAS, we develop assays for custom panels or individual biomarkers based on client needs and can also assist with...

The paradigm of drug development outsourcing is in a period of rapid transition coupled with a growing market in a competitive space. Today’s service providers are hardly recognizable from a decade ago and if the continued evolution in the market is any indicator, it is safe to say the next...

Everyone likes to claim they offer fast turnaround times, but clients often come to KCAS having been burned by the lack of timeliness on their Discovery projects. At KCAS, we incorporate our clients’ priorities at the top of our priorities. We have put together a Discovery team with decades of...

Animal health programs have consistently been supported by KCAS with increasing study complexities although they have constituted a small percentage of the overall pharmaceutical development, these programs have consistently been supported by KCAS with increasing study complexities.   ANIMAL HEALTH - LABORATORY SUPPORT KCAS is not only centrally located in...

The bioanalytical landscape for support of biopharmaceuticals (biologics or large molecules) and biomarker testing is an ever changing map. The industry is currently focused on low level sensitivity, data integrity, and compliance with the new FDA guidelines that regulated bioanalysis must keep up with.   While attending the 2018 Workshop...

Protein characterization is a broad term describing the profile or fingerprint of a large molecule’s (or biologic’s) physical, chemical, and biological properties. Characterization of the protein will test the purity, activity, and the quantity of the protein. Methods for quantification include chromatography methods such as high-performance liquid chromatography (HPLC) or...

If you’re running a clinical or preclinical study, there are many components that you need to think about, plan, and execute. One is “what the heck do I do with these samples we’re collecting” – especially if they’re rare or limited. But even if samples are not rare or limited,...

Adoption of technology has a life cycle that typically follows a bell-shaped curve. There are early adopters, early majority, late majority, and laggards. Adopting technology early comes with a risk, as not all technologies are widely adopted and many are very short lived. Adopting late also comes with a risk,...

As the Bioanalytical support for drug development continues to grow, more and more scientists are requiring more complex assays. Two examples are cell based assays and what we refer to as live cell assays.   Typically a cell based assay requires culturing of cells for several days prior to being...

The FDA has not approved marijuana for any indication, as it continues to retain Schedule I designation.  However, a key component of marijuana (D9-Tetrahydrocannabinol or THC) and several synthetic analogues have been approved by the FDA or are under clinical investigation.  Whether the FDA will consider approving marijuana in the...

The FDA has regulated cigarettes, smokeless and loose tobacco since 2009 under the Tobacco Control Act. In 2016, the FDA finalized a rule for the regulation of all tobacco products, making it illegal to sell e-cigarettes, cigars and hookah tobacco to anyone under 18 and requiring retailers to check photo...

Immuno-oncology is a growing field. The goal is to augment the patient’s immune system to attack the cancer cells. The current lines of treatment for cancer are radiation, chemotherapy, and surgical resection. If these treatments do not work, physicians can seek alternative treatments, such as immune-oncology therapeutics. Two emerging immune-oncology...

Once again we find ourselves wrapping up our 2017 goals and  and tallying the year's performance. Simultaneously, we are filled with excitement looking forward to the New Year and to the promises it will bring to the pharmaceutical industry and the CRO community. According to Reuters, 2017 was one of...

KCAS is the first GLP laboratory to qualify all 54 biomarkers offered as a V-Plex (Validated Plex) by MSD. The a la carte style allows for customization of panels that will fit the exact needs of a study. Additionally, KCAS can perform fit-for purpose GLP validation of any of these...

Several important classes of drugs are inherently unstable in biological fluids. Examples include alkylating agents, cytostatic nucleosides, drugs with ester, aldehyde, thiol, nitroxyl or lactone functional groups, and small molecule compounds with unstable metabolites, such as acylglucuronides.   The rate at which an analyte degrades in blood, other biological fluids,...

Want to meet our presenting author, a business development representative or a senior scientific officer? Send us a note to set up a meeting   Find KCAS We are located at booth 2424 marked by an orange star KCAS' Poster Presentations Tuesday, November 14, 2017 Noon - 1:00 PM  ...

The 505(b)(2) drug development path, in contrast to traditional development of a new, never been approved drug (described under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act) or ANDA (described under Section 505(j) of the Act) for a generic drug that is no longer under patent protection, is an...

Tissue and tumor sample testing are valuable matrix to test for drug levels (PK) and biomarkers (PD). They are understudied in my opinion as far too many studies result in no data or uninterpretable data. The root cause is a break down in how the tissue was collected, processed, and...

Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions. First, can control tissue be easily obtained in bulk quantities or should a surrogate tissue approach be considered? Second, what sample processing procedures should be considered relative to the known stability of...

Measuring new biotherapeutic modalities such as cellular therapies are not well defined in the regulatory landscape. Currently no white papers or guidelines are available to help navigate the murky waters of quantifying new modalities, which is why the AAPS PK focus group has set a course toward providing the field...

In pursuit of KCAS’ Mission to provide reliable and defendable data, quality is one of our core values. It is the responsibility of every employee to provide an always improving, high-level performance in all we do. Our independent Quality Assurance Unit (QAU) assures management that Operations is performing in conformance...

Immunogenicity, why do we keep talking about it?  Immunogenicity can, in the simplest of terms, be described as a subject’s ability to generate antibodies specific to the dosed protein therapeutic.  While stating it this way understates the complexity of the immune system and the methods needed to detect and characterize...

Surprisingly, there are a number of drug development companies that do not obtain stable isotope-labeled internal standards (SIL-IS) for their bioanalytical methods. Instead they settle for using a surrogate internal standard (a compound that closely resembles the measured analyte) which can lead to unreliable data and be detrimental to a...

What you don’t know about how an off-the-shelf Biomarker kit is evaluated and qualified can significantly compromise your biomarker data. Running the kit using the manufacturer’s instructions without systematically testing the accuracy/precision (A/P), range of quantification (ROQ), dilutional linearity (DL), stability, and selectivity can jeopardized the interpretation of the results. The...

Like the old adage, “you get out of it what you put into it,” good study design is a prerequisite of good data. To boost the chances of generating accurate and informative facts over the course of a study, it is key to consider all of the supporting parameters that...

Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and...

There is regulatory requirement that the cumulative time a frozen pharmacokinetic sample has been thawed – from the time it’s removed from the freezer to the time it’s returned – be documented. Freeze/thaw cycle data is not deemed sufficient alone, since a study sample might have been thawed for extended...

Which anticoagulant is right for your flow cytometry analytes? The answer depends. That’s just one of the questions we address in the short video below. Watch on to learn about how we evaluated several anti-coagulants to determine epitope stability, permitting the use of remote collection agencies and shipping samples to...

It can often be difficult for women to make reliable judgements in estimating their menstrual blood loss.  In addition, feminine hygiene products have dramatically changed to wick blood away from the surface, obscuring visual assessments.  Both of these factors have a large impact in clinical trials, where menstrual blood loss...

The challenges and obstacles to including flow cytometry in multi-center clinical trials are well-known. The solutions the KCAS team offers can eliminate risks commonly associated with lost or delayed shipments and allow for batching, which reduces the overall cost of conducting flow cytometric testing. As a result, our customers can...

The Department of Health and Human Services (HHS) has issued long awaited, comprehensive update on how medical research should be conducted. The Common Rule, 45 CFR 46 subpart A, issued 26 years ago and established basic protections for human subjects in research conducted by or supported by the HHS and...

In May 2016, the FDA extended its authority to all tobacco products in an effort “to improve public health and protect future generations from the risks of tobacco use.” The Center for Tobacco Products (CTP), a branch of the FDA, now has regulatory authority over cigarettes, smokeless tobacco, e-cigarettes (electronic nicotine...

In today’s drug development arena, massive, multinational CROs dominate the industry. They offer a “one stop shop” suite of services covering Early Development to Phase IV Clinical Trials and everything in between.   Although multinational CROs are the powerhouse of drug development, their size limits their flexibility. Due to their...

Biomarkers are not new, nor are there a shortage of labs to provide testing. However, finding a CRO that can produce defendable data is not as easy as it sounds. KCAS Bioanalytical and Biomarker Services is one of the first labs to offer a qualified method for measuring 30 biomarkers in...

Future submissions of data for nonclinical studies must now comply with the FDA’s recently published SEND guideline (Standard for Exchange of Nonclinical Data).  This complex reporting format has resulted in a multitude of questions and concerns from our customers planning GLP animal studies.  Has your organization begun a dialogue with your CRO...

Many of our clients come to us because other CROs have provided meaningless flow cytometry PD assay results. This could be due to poor panel design, inability to compensate correctly, or lack of controls for the assays. Others state their current CRO is unable to get the PK, ADA, biomarker or PD...

KCAS has engaged and recruited a world class Advisory Council to work closely with the KCAS leadership team. KCAS is committed to cultivating expertise and increasing capacity to support the industry’s needs for a mid-size functional service CRO with the proficiency to serve small and mid-size pharmaceutical and biotech organizations....