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{EDC} Developer

Specializing in Pharmaceutical Technologies

Clirinx EDC Demo

Quick overview of Clirinx EDC

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation of EDC systems, please contact us

 

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Castor EDC Demo

Castor EDC Training and Support

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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InForm EDC Features and Functionality

InForm 4.x Training
Learn the differences between 4.5 and 4.6 and new features

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Solving Data Collection Challenges

Cross-partnership between sponsors and CROs for the collection and analysis of clinical trial data are complex. As a result there are a number of issues encountered during the running of  trial.

As with many projects, standardization projects like CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

 Data Collection

According to the WHO, data collection is defined as the ongoing systematic collection, analysis, and interpretation of health data necessary for designing, implementing, and evaluating public health prevention programs.

Sources of data: primarily case report books or (e)CRF forms, laboratory data and patient report data or diaries.

 Challenges of data collection

It is important for the CROs / service providers to be aware of the potential challenges they may face when using different data collection methods for partnership clinical studies. Having several clients does not mean having several standards or naming conventions. This is the main reason why CDISC is here. So why are many CROs or service providers not using CDISC standards?

Another challenge is time limitations. Some clinical trials run for just a few weeks / months.

It may be found difficult to understand the partnership in the amount of time they have. Hence, most CROs and service providers prefer to perform manual mapping at the end of the trial, hence, re-work and manual work.

Funding also plays a key challenge for CDISC-compliance data collection study. Small researchers or biotechnology companies that do not have the resources in-house, out-sourced this task to CROs or service providers and are not interested whether it is compliance as long as it is save them money. But would it save money now instead of later in the close-out phase?

Anayansi Gamboa - Data Status

 

 

 

 

 

If there is a shortage of funding this may not allow the CRO or service provider all the opportunities that would assist them in capturing the information they need as per CDISC standards.

We really don’t have the level of expertise or the person dedicated to this that would bring, you know, the whole thing to fruition on the scale in which it’s envisioned – Researcher

Role of the Library

There is a clear need for libraries (GL) to move beyond passively providing technology to embrace the changes within the industry. The librarian functions as one of the most important of medical educators. This role is frequently unrecognized, and for that reason, too little attention is given to this role. There has been too little attention paid to the research role that should be played by the librarian. With the development of new methods of information storage and dissemination, it is imperative that the persons primarily responsible for this function should be actively engaged in research. We have little information at the present time as to the relative effectiveness of these various media. We need research in this area. Librarians should assume an active role in incorporating into their area of responsibility the various types of storage media. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC232677/]

Review and Revise

At the review and revise stage it might be useful for the CRO or service provider to consider what the main issues are when collecting and organizing the data on the study. Some of these issues include: ensuring sponsors, partners and key stakeholders were engaged in the scoping phase and defining its purpose; the objectives have been considered; the appropriate data collection methods have been used; the data has been verified through the use of multiple sources and that sponsors have approved the data that is used in the final clinical data report.

Current data management systems must be fundamentally improved so that they can meet the capacity demand for secure storage and transmission of research data. And while there can be no definitive tools and guideline, it is certain that we must start using CDISC-standards from the data collection step to avoid re-inventing the wheel each time a new sponsor or clinical researcher ask you to run their clinical trial.

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Medrio eClinical – Integrated SaaS platform for eClinical

Since 2005, Medrio has offered an integrated SaaS platform for eClinical with a fully hosted Electronic Data Capture (EDC) system.

Some of the features provided by Medrio are:

Faster  – No programming required and you can build and deploy studies in days not weeks.

Medrio’s unique Electronic Data Capture (EDC) model optimizes time and investment by providing users with fast study startup and deployment times and easy mid-study changes. Medrio studies are built using our web-based platform and can be configured 100% through a web browser using drag-and-drop functions, eliminating the need for custom programming. Build your study in days, not weeks or months.

More Control – Build studies completely online and view live data anytime, anywhere .

Medrio’s web-based, customizable interface is designed for researchers to build and configure studies without reliance on software programmers. Study management capability is made easier as users can access live data anytime and anywhere with an internet connection. Data managers can make mid-study changes, control data integrity and utilize reporting tools, making study management faster, more accessible, and more efficient.

Configure – Medrio gives you unprecedented speed and agility in building your study.

  • Intuitive point-and-click interface
  • Extensive form libraries, variables, and templates
  • Dynamic form rules and custom skip logic
  • Easy mid-study changes

Collect Data -Sites appreciate the ease of use and simplicity in entering data.

  • Enter data from anywhere via a browser
  • Intuitive workflow and task list
  • Double-data entry to support Paper or Hybrid studies
  • Real-time edit checks for accuracy Manage

Manage -Data Managers have increased visibility throughout the study and instant access to their data and task list.

  • Control data integrity with range checks and queries
  • Configurable field level and form level monitoring
  • Query management, alerts, and dynamic schedules
  • Role-based access and user management

Analyze & Export –Capturing and managing data in real-time with a unified database gives you full control.

  • Ad-hoc reporting and analysis
  • On demand export to SAS, Tab-delimited, and others
  • Standard and custom reports; Patient casebooks
  • Submission-ready reports and data sets

Medrio is unique in that you’ll be able to have full control of your study from beginning to end without relying on Medrio.

For further information about Medrio products and services, please contact Medrio directly.  If you are looking for a study builder to support your clinical trials and study build using Medrio, please use the contact form.

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinica.

Trademarks and Copyright
All trademarks on this web site are the property of the {EDC} Developer, unless otherwise noted or in any other way perceivable as third party rights. The logos and trademarks or other materials used on this article are property of Medrio.

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Successful Interview – Get The Job That You Want

Lifetime entrepreneurs, consultants and freelancers have a real problem of working for someone else or working a 9-5 office environment. Who could you work for right now and be happy? But if you find yourself invited to attend an in-person interview, I have listed some suggestions for a successful interview.

Steps for a successful interview:

  1. Build Rapport — very obvious, but it warrants mentioning. First impressions mean so much, so be friendly and open. Be sure to shake hands with each person you are interviewing with and introduce you. You might also ask for a card at this point.

  2. Establish needs — This is as much the opportunity to learn about us as for us to learn about you. Establishing what we are specifically looking for will help you target your answers regarding your own qualifications. Asking questions also shows your interest. Have 3 questions prepared before the interview. You will want to have different questions for each person, if known in advance. This shows you’ve done your homework and reinforces your interest in the company. Have them memorized, but if you get stuck or nervous, you can refer back to these questions.

    Take the time to review the website:CLIENT WEBSITE: check the company’s website prior to the interview.

  1. Flesh out concerns — At the end of the interview, ask if there are any questions or concerns about your qualifications. Be direct about asking, “Do you have any concerns about my qualifications?” This gives you the opportunity to answer these questions or concerns on the spot.

  2. Ask for the job — At the end of the interview, let them know the level of your interest. Let them know you want the job. This lets the interviewer(s) know exactly where you stand. It also makes you stand out in his/her (the interviewer) mind.

  3. Restate your interest — best in the form of an emailed “Thank You.” The “Thank You” e-mail should be a brief email to the interviewer(s) to highlight the strengths you’ll bring to the position and restate your interest. I will expect a call after your interview, so you can provide a summary of your interview experience.

Don’t be shy about your qualifications. Be direct and be prepared.

  • Bring paper and a pen, as well as two (2) copies of your resume, one in case an interviewer needs one and the other for you to be able to reference for dates, etc. Be prepared, you might be meeting with multiple people, bring extra copies of your resume in case they need copies as well.

  • Don’t discuss the “What’s in it for me questions?” – in terms of salary, benefits, vacation. It is NOT appropriate to discuss these questions even if the interviewer opens this discussion topic. If the interviewer persists, please consider the following response: “the financial arrangement has already been discussed and confirmed between my agency and myself. I assure you that I am very interested in this opportunity.” or “I would prefer to discuss the salary requirements when an offer is made”.

Remember that when you go for a job interview, you are not asking them to pay you money. You are offering a PROFIT!

anayansigamboa-you are hired

Remember, it cost the company double to hire you (hiring, training, firing, benefits, etc). You are making the company money and providing value.

GOOD LUCK! and tell me about it in the comments!

Anayansi Gamboa specializes in Pharmaceutical Technologies and is available for short-term contracts or ad-hoc requests.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

I am someone who influence my own development. I look for a company where I have the opportunity to pursue my interests across functions and geographies, and where a job title is not considered the final definition of who I am, but the starting point.

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The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials. Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients. Anayansi Gamboa - Clinical Data Management Process If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations. Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion: Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica – Open Source and Oracle Clinical.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Source:

SAS Institute
CDISC

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Project Plan: CDISC Implementation

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle – from planning, through execution, to completion.

1) Define Scope: This is where you’re tested on everything that has to do with getting a project up and running: what’s in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you’re delivering matches what you wrote down in the scope statement.

2) Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

Project Tasks  (Work packages) Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3) Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few. A sample of the project plan is shown below:

project plan sample
image from Meta‐Xceed paper about CDISC

4) Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project. The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also  due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in:  ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

test plan-cdisc

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project. riskplan

5) Transformation Specification: Dataset transformation is a process in which a set of source datasets and its variables are changed to  meet new standard requirements. Some changes will occur during this step: For example, variable name must be 8 chars long. The variable label must not be more than 40 chars in length. Combining values from multiple sources (datasets) into on variable.

6) Applying Transformation: This is done according to specification however, this document is active during the duration of a project and can change. There are now many tools available to help with this tasks as it could be time consuming and resource intensive to update the source code (SAS) manually. Transdata, CDISCXpres, SAS CDIDefine-it; just to name a few.

7) Verification Reports: The validation test plan will detail the specific test cases that need to be implemented  to ensure quality of the transformation. For example, a common report is the “Duplicate Variable” report.

8) Special Purpose Domain: CDISC has several special purpose domains: CO (comments), RELREC (related records or relationship between two datasets) and SUPPQUAL (supplemental qualifiers for non-standards variables).

9) Data Definition Documentation: In order to understand what all the variables are and how they are derived, we need a annotation document. This is the document that will be included during data submission. SAS PROC CONTENTS can help in the generation of this type of metadata documentation. The last step in the project plan for CDISC implementation is to generate the documentation in either PDF  or XML format.

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

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What Is In A Name Besides Letters?

Disclaimer: This is based on a fictional story in this fictional world.

Deciding on a name for your company or product is among the first steps an entrepreneur takes. Entrepreneurs often angst over the perfect name for their EDC tool. That name is a break or make deal for many. Your users will either identify with it or completely turn the other way and use your competitor’s EDC system.

It seems straightforward. Who wouldn’t want to stand out?

A rose by any other name is still a rose…

Let’s look at some Mythological names for several {EDC} systems.

  1. Medidata Rave: “Rave” at first thought, it is not an unique name. The traditional meaning of ‘Rave’ was to show signs of madness or delirium (rave. (n.d.). The American Heritage® Dictionary of Idioms by Christine Ammer) but most recent and contemporary meaning is ‘wild party’. For many of us, during the college years, we associated the word ‘Rave’ with underground parties, fun, entertainment and much more. I have been to several White Sensation parties here in Europe. Rave is my favorite name by far.
  2. Cmed Timaeus: Timaeus resonates with ‘Amadeus’. You know, the famous ‘Mozart’, Austrian composer, widely recognized as one of the greatest composers in the history of Western music. If you were born near the 80’s music era then this music video will come to mind.
  3. RDC: In contracts, RDC is “running down” clause, provides coverage for legal liability of either the shipper or the common carrier for claims arising out of collisions. Oracle RDC stands for ‘Remote data capture’. It is easy to remember and catchy.
  4. InForm: Is it ‘information forward’? Information in the form? InForm has been around for several years now. It started becoming popular in the 90s. There has been several modifications and upgrades but the name has stayed the same. It is now part of a group of systems own by Oracle.
  5. OpenClinica: I believe this name refers to the ‘open’ source capability of this tool. Open-source software (OSS) is computer software with its source code made available with a license in which the copyright holder provides the rights to study, change and distribute the software to anyone and for any purpose. (St. Laurent, Andrew M. (2008). Understanding Open Source and Free Software Licensing. O’Reilly Media. p. 4. ). I believe some users may confuse this name with Oracle Clinical, another popular CDM system.
  6. ClinCase: In computer science, CASE tools can be used for simple operations such as routine coding from an appropriately detailed design in a specific programming language, or for more complex tasks such as incorporating an expert system to enforce design rules and eliminate software defects and redundancies before the coding phase. (“CASE”. Encyclopædia Britannica. Encyclopædia Britannica Online). I personally has not used this tool but was asked recently so I added it to the fictious name list.
  7. RedCap: This is a catchy name as well. It can infer many meanings. Cap for capital letters, the cap or ceiling placed on mortgage rates, to protect or to seal? the hat that you wear, a member of the military police. Some further research, wikipedia has the following description of ‘redcap': Redcaps are said to murder travellers who stray into their homes and dye their hats with their victims’ blood (from which they get their name) (Briggs, Katherine M. (1967). The Fairies in English Tradition and Literature. London: University of Chicago Press. p. 57) Regardless of definition, it is still a creative name.

You want a name that your employees and customers will want to say

Should You File For a Trademark? Here is some information about trademarks.

Having a brandable business name is one of the reason for the growth of business. Every EDC system is different and choosing the right name is key on getting the attention your {EDC} tool deserves.

One final reminder. When searching the list of fictitious names (also called “doing business as,” or DBAs) for your county and looking for names in your “class” (or industry) on the U.S. Patent and Trademark Office website (www.uspto.gov), be sure to look up variations on spellings, too, because names that sound alike can’t be registered in the same class. Also check Register.com to see which Internet domain names remain available.

what happens when you find out that your {EDC} name is also the name of another business in a different city/state? Keep it simple, as short as possible (check domain availability) and don’t play too much with spelling alternatives.

What is your favorite {EDC} name? Can a name make or break your chances of business success?

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

 

Credit: The title of this article was an inspiration from a recent readingKate Of Gaia With Michael McCracken – What Is In A Name Besides Letters.” What an eye opening that was.

Fair Use Notice: This blog/article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

 

 

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FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

Lung cancer is the leading cause of cancer-related death among men and women in the U.S. and, though more common in men, the number of deaths from lung cancer in women is increasing. According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year. NSCLC is the most common type of lung cancer. Mutations in the EGFR gene are present in about 10 percent of NSCLC tumors.

Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with certain EGFR mutations. It is intended for the treatment of patients whose tumors express the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations). The therascreen EGFR RGQ PCR Kit was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa.

The FDA granted Iressa orphan product designation for the treatment of EGFR mutation-positive metastatic NSCLC. Orphan product designation is given to drugs intended to treat rare diseases, which provides financial incentives – like tax credits, user fee waivers, and eligibility for market exclusivity – to promote their development.

The efficacy and safety of Iressa for this use was demonstrated in a multi-center, single-arm clinical trial of 106 patients with previously untreated, EGFR mutation-positive metastatic NSCLC. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced complete and partial shrinkage or disappearance of the tumors after treatment. Participants received Iressa 250 mg once daily. Results showed that tumors shrank in about 50 percent of patients after treatment and this effect lasted an average of six months. The response rates were similar in patients whether their tumors had EGFR exon 19 deletions or exon 21 L858R substitution mutations.

For more information, please visit: Iressa

Device Approvals: Edwards SAPIEN 3 Transcatheter Heart Valve

The FDA has recently approved the Edwards SAPIEN 3 Transcatheter Heart Valve to be marketed.  The Edwards SAPIEN 3 Transcatheter Heart Valve (often referred to as SAPIEN 3 THV) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The SAPIEN 3 THV is the third generation of the SAPIEN THV that FDA originally approved in 2011. The device has a major design change that adds a skirt at the base of the valve frame to minimize leakage around the valve.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Particulate Matter

Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Device Approvals: activL® Artificial Disc

The FDA recently approved the activL® Artificial Disc to be marketed.  The activL® Artificial Disc is an implant that replaces the function of a damaged or diseased spinal disc. The activL® consists of two metal (cobalt-chromium with a titanium coating) endplates surrounding a plastic (polyethylene) insert. The endplates attach to the patient’s vertebrae, and the plastic insert fits between them. The insert is designed to move during daily activities.

For more information check FDA.com

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA Approves REXULTI® (Brexpiprazole) for the Treatment of Schizophrenia and Adjunctive Treatment of Major Depressive Disorder  

On July 10, 2015, the FDA approved REXULTI (brexpiprazole) immediate-release tablets for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder (MDD).

Dosage and Administration

  • Treatment of Schizophrenia: The recommended starting dose for REXULTI in the treatment of patients with schizophrenia is 1 mg once daily (QD). The dose should be increased to 2 mg after Day 4 and may subsequently be increased to 4 mg after Day 7 based on the patient’s clinical response and tolerability. The maximum recommended dose is 4 mg QD.
  • Adjunctive Treatment of MDD: The recommended starting dose for REXULTI as adjunctive treatment for MDD is 0.5 mg/day or 1 mg QD. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. The maximum recommended dose is 3 mg QD.
  • REXULTI can be administered with or without food.

General Pharmacokinetics and Pharmacodynamics of Brexpiprazole

The mechanism of action of brexpiprazole is unknown.  However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

  • Dose Proportionality: Brexpiprazole Cmax and AUC are approximately dose proportional after oral administration in the therapeutic dosage range.
  • Accumulation: About 4-fold at steady state (time to steady state 10 to 12 days)
  • Absolute bioavailability (tablets): 95% (Tmax within 4 hours).
  • Plasma protein binding: Greater than 99%.
  • Terminal half-life (mean): 91 hours at steady state.
  • Metabolism: Extensive. Predominately by CYP3A and CYP2D6.
  • Excretion: About 14% and less than 1% of the dose is excreted as unchanged parent drug in the feces and urine, respectively.
  • Exposure-safety: At a dose 3 times the maximum recommended dose, REXULTI does not prolong the QT interval to any clinically relevant extent.

Drug Interaction Potential

  • An approximately 2-fold increase in brexpiprazole exposure (AUC) was observed following coadministration of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole) with REXULTI. Decrease the REXULTI dosage by half if coadministration is required.
  • An approximately 2-fold increase in brexpiprazole exposure was observed following coadministration of a strong CYP2D6 inhibitor (e.g., quinidine, fluoxetine, paroxetine) with REXULTI. Decrease the REXULTI dosage by half if coadministration is required for the treatment of schizophrenia. A REXULTI dosage reduction is not required with coadministration in patients with MDD because this effect was factored into the general dosing recommendations (i.e., coadministration was permitted without dosage adjustment in the clinical trials supporting this indication).
  • An approximately 5.1-fold increase in steady-state brexpiprazole exposure is expected when extensive CYP2D6 metabolizers are coadministered REXULTI with both strong CYP2D6 and CYP3A4 inhibitors. Similarly, an approximately 4.8-fold increase in steady-state brexpiprazole exposure is expected when poor CYP2D6 metabolizers are coadministered REXULTI with strong CYP3A4 inhibitors. Decrease the REXULTI dosage by 75% if coadministration is required in patients with these polymorphisms.
  • An approximately 73% decrease in brexpiprazole exposure was observed following coadministration with a strong CYP3A4 inducer (e.g., rifampin, carbamazepine, phenytoin) with REXULTI. Double the REXULTI dosage one to two weeks following strong CYP3A4 inducer coadministration.

Use in Specific Populations

  • A 26%, 73%, and 4% increase in brexpiprazole exposure was observed in subjects with mild, moderate, and severe hepatic impairment compared to subjects with normal hepatic function, respectively. The maximum recommended REXULTI dosage for patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) is 2 mg QD for patients with MDD and 3 mg QD for patients with schizophrenia.
  • A 7%, 71%, and 72% increase in brexpiprazole exposure was observed or predicted in subjects or patients with mild, moderate, and severe renal impairment compared to subjects with normal renal function. The maximum recommended REXULTI dosage for patients with moderate or severe renal impairment (i.e., creatinine clearance less than 60 mL /minute) is 2 mg QD for patients with MDD and 3 mg QD for patients with schizophrenia.
  • Half of the usual dosage is recommended for patients with known CYP2D6 poor metabolizer status.

Safety and Efficacy

The efficacy and safety of REXULTI in schizophrenia was demonstrated in two 6-week controlled studies in adult patients at doses of 2 to 4 mg administered orally once daily. The primary efficacy endpoint in schizophrenia trials is change in PANSS Total Score from baseline to week 6. The efficacy and safety of REXULTI as an adjunctive therapy for MDD was evaluated in two 6-week controlled studies in adult patients at doses of 1 to 3 mg administered once daily, with one trial showing statistical superiority of REXULTI over placebo. The primary efficacy endpoint in MDD trials is the mean change in MADRS Total Score from baseline to week 6. Safety profiles were similar in MDD and schizophrenia patients. The most common treatment emergent adverse events were increased weight, headache, akathisia, somnolence, fatigue, anxiety, and increased appetite.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. July 24, 2015.

More Information:  http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455865.htm

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

FDA approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., an Amgen subsidiary) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple ymemloa who have received one to three prior lines of therapy. July 24, 2015.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455873.htm

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

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