The ClinSmart Blog

5 Key Trends Shaping the Future of Drug Development

Posted by Ray Tobey, Chief Medical Officer on Sep 20, 2017 9:00:00 AM

The FDA’s Center for Drug Evaluation and Research (CDER) offers an all-encompassing bundle of information that is of interest to the pharmaceutical industry to help get their drug on the market.  If you are interested in general educational resources related to this field, you should take a look at the CDER Small Business and Industry Assistance (SBIA) Learn portal that offers a series of presentations and webinars on topics such as regulatory issues, generics development, etc.

We thought the presentation provided earlier this year by the Director of CDER, Dr. Janet Woodcock, entitled the “The Future of Drug Development” was quite interesting, so we wanted to share some of the highlights. 

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Topics: fda, drug development

Immunotherapy Will Have A Diverse Impact In Respiratory Disease Trials

Posted by Ray Tobey, Chief Medical Officer on Sep 13, 2017 11:00:00 AM

Pictured: A schematic of how immunotherapy could be used against respiratory allergies. Published by Sari Sabban in “Development of an in vitro model system for studying the interaction of Equus caballus IgE with its high-affinity Fc epsilon RI receptor.” [Licensed under CC BY-SA 3.0], via Wikimedia Commons.

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Topics: clinical trials, immunotherapy, respiratory

Immunotherapy’s Clinical Trial Impact In Endocrinology Is Still In Flux

Posted by Ray Tobey, Chief Medical Officer on Sep 6, 2017 11:00:00 AM

Immunotherapy’s whirlwind of clinical trial successes and failures show no signs of abating.[1]

Each passing week finds more immunotherapy trials entered into the ledger, and many of these trials are now exploring new territory: endocrine related disorders. The endocrine system is a challenging environment for immunotherapies for some reasons, ranging from lack of basic research to paradoxical toxic reactions.

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Topics: clinical trials, immunotherapy, endocrinology

What Are the Consequences of Fabricating Clinical Trial Data?

Posted by Ray Tobey, Chief Medical Officer on Aug 30, 2017 9:57:19 AM

From time to time we hear about situations where investigators are involved with the fabrication of clinical trial data.  Not only is this unethical because culprits are potentially putting peoples lives at risk, but it is against the law.  We wanted to share our first hand experience with an investigator in a situation like this and the respective consequences of such actions.

 

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Topics: CRO, contract research, investigators, data

Thank You to the Local Community - August Fundraiser Event Recap

Posted by Nicole Dooley on Aug 23, 2017 1:17:58 PM

On August 17th, 2017 ClinSmart hosted a Happy Hour Fundraiser for the local biotech community.  It was a great chance for professionals to beat the heat, enjoy a drink, and get to know each other in the name of a good cause.

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Topics: ALS, biotech, biopharma, community

5 Tips for Evaluating the Best CRO for Your Needs

Posted by Ray Tobey, Chief Medical Officer on Aug 16, 2017 11:10:54 AM

The trend of outsourcing in both small biotech and large pharmaceutical companies is moving upward.  In fact, Contract Pharma’s 2016 Annual Outsourcing Survey showed that 80% of their 315 executive pharmaceutical respondents indicated an increase demand for outsourcing with the number one reason to focus more on core competencies (1).   

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Topics: CRO, contract research

A Simple Guide to Designing an Effective Dose Response Study

Posted by Ray Tobey, Chief Medical Officer on Aug 10, 2017 10:04:00 AM

For safe and effective use of new drugs, clinicians need to determine the appropriate starting dose and the best way to adjust dosage to the needs of a particular patient.  But where does one begin to find the appropriate starting dose? The answer is by designing an effective dose response study.  Information from this type of study will allow you to determine the relationship among dosesdrug effectiveness and acceptable undesirable effects Here is a simple guideline to help you get started on developing this type of study for your new and innovative drug. 

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Topics: Dosing, clinical study, clinical trials

Are You Ready for a Phase I, First in Human Safety Trial?

Posted by Ray Tobey, Chief Medical Officer on Jul 13, 2017 6:36:18 PM

So, you have a novel drug ready for Phase I First in Human safety trial.  What dose should you start with that will be reasonable and acceptable to the FDA?  The answer revolves around safety for the individual subject.  For example, despite relatively innocuous findings in the animal testing stages, you will not have a clue that the drug produces headaches in a person.  

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How Early Should Patients be Enrolled in Clinical Trials of an Investigational Substance

Posted by James Perhach, Director of Clinical Development & Research on Jun 20, 2017 12:42:00 PM

Traditional early clinical development programs have utilized normal healthy volunteers of both sexes in an escalating single-dose trial. These trials are often use small samples (6 to 12 volunteers including placebo per treatment arm) and may not provide a reflection of how the biopharma candidate will affect the targeted clinical population. However, the trials in this population do provide some value in giving an estimate of how well the test substance is tolerated without any significant safety problem.

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The Investigator Checklist: What Makes a Good Investigator for a CRO?

Posted by Ray Tobey, Chief Medical Officer on Jun 14, 2017 9:56:40 PM

When starting a clinical trial for an investigative drug, one of the most critical steps for the CRO is the selection of investigators.  Here are the characteristics we look for in this process.  

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