Directions in Discovery and Development

//Directions in Discovery and Development

Directions in Discovery and Development

This issue of Directions in Discovery and Development covers topics in the Discovery arena, with a focus on ocular disease, metabolic disease, drug metabolism, and pharmacokinetics (DMPK). Our Experimental Therapeutics program provides Sponsors with a collaborative approach to evaluating efficacy, proof-of-concept, and translational sciences in many therapeutic areas and covers a wide range of indications.

In this issue, we discuss models that are increasingly relevant in today’s patient population: age-related macular degeneration and diabetes. In the DMPK discussions, we extend the challenge relative to an important issue facing the pharmaceutical industry: Drugs don’t fail soon enough! In the development process, considerable preclinical and clinical resources are often invested before a company realizes that the candidate will not succeed in the marketplace. MPI Research has the comprehensive expertise and capabilities necessary to assist our Sponsors improve the success rate of their compounds that reach the clinic.

The Next World War – Defeating Diabetes

Here’s a shocking fact: 346 million people worldwide have diabetes. More than 90 percent of them—including an increasing number of children—have type 2 diabetes, putting them at greater risk for heart disease, stroke, blindness, neuropathy, kidney failure, and death.1 The rising obesity rate—more than doubled since 1980—is driving much of this global epidemic.2 Bioscience researchers around the world are waging war on diabetes, and MPI Research is providing some key weaponry in this battle: fast, accurate, and innovative preclinical models to help advance the most promising treatments. MPI Research stands with you on the battlefield against this deadly disease—and like you, we will never surrender. read more…

Take a Peek at our High-Throughput AMD Model

Many baby boomers are entering their twilight years at risk of losing their sight because of age-related eye diseases. Among the most debilitating is age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 55 in developed nations. In the United States alone, 13 million people are at some stage of the disease.1 The “dry” form of AMD is the most common, affecting 85-90% of patients with advanced AMD.2 It is characterized by the accumulation of deposits (drusen) between the retina and its blood supply (choroid), ultimately resulting in islands of dead retina (geographic atrophy). Developing effective new treatments for dry AMD means that researchers need accurate safety and efficacy models to evaluate potential therapies. At MPI Research, our ophthalmology team has established a rodent model that applies blue light to generate pathological features mimicking dry AMD. This is a high-throughput in vivo model allowing Sponsors to gather data quickly and accurately, leading to better and faster decisions about compound candidates. Let MPI Research “open your eyes”.  read more…

Douse the Flames of Inflammation

As scientists, we know that inflammation is a good thing. It’s how the body’s immune system kick-starts the healing process. But too much of a good thing can be painful, damaging, and even deadly. Unregulated inflammation, which is the root of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, pulmonary fibrosis, and hundreds of other conditions, affects millions of people worldwide. The pain of these conditions can range from annoying to debilitating, causing suffering and often the inability to work or enjoy life. MPI Research, one of the world’s leading preclinical research organizations, sets the pace for providing technical expertise and modeling for Sponsors developing new treatments for inflammatory and autoimmune conditions. We offer unparalleled scientific knowledge and experience, integrity, trust, teamwork, and solid Sponsor relationships. Your success is our success! read more…

DMPK: Straightforward or Challenging?

Given the competitive nature of today’s drug development process, it is crucial that the Drug Metabolism and Pharmacokinetic (DMPK) portion of your preclinical research be completed at a facility offering comprehensive DMPK services by talented staff. Otherwise, you may risk a higher rate of clinical failure (and significantly higher development costs) for your drug candidate. Make sure that the CRO you select for DMPK testing can successfully address these six key issues… read more…

The Importance of Failing in DM & PK

Attrition rates as high as 40% due to pharmacokinetics issues are blowing holes in drug development pipelines. That’s tragic for patients and for drug developers. Fortunately, there’s good news: Companies with top quality Drug Metabolism & Pharmacokinetics (DM & PK) programs are cutting clinical failures to as little as 10%.

[1] But what if your organization doesn’t have a solid DM & PK program? You could be staring with one of the worst four-letter words in drug development: FAIL. MPI Research offers the expertise in IND-enabling studies needed for successful IND submissions and clinical PK success. Our expert knowledge in DM & PK covers four distinct data types for your drug… read more…

Challenges with Ocular PK Studies

There are multiple challenges that can be encountered when conducting ocular pharmacokinetic (PK) research. These challenges often involve three areas:

Dissection of Ocular

Consider the situation where a drug is applied to the eye by topical administration. The drug will be distributed to tissues down the concentration gradient from front to back, and from the outside to inside of the anterior chamber as well. Any drug applied in this way reaches the posterior tissues, such as choroid and retina, by moving into and through the conjunctiva, fornix, sclera, and choriocapillaris…read more…

Ocular Tissue and Fluid Processing

Tissue preparation can be problematic with respect to homogenization and extraction efficiency of drug from different matrices. The eye contains significant connective tissue and the homogenization of these tissues, without inadvertent heating of the sample, can be challenging. Important considerations include… read more…

Analytical Sensitivity

Lower Limit Of Quantitation (LLOQ) requirements can be problematic in ocular PK studies due to the small amounts of certain tissues (or fluids) that can be collected from any single animal. For example, the wet weight of rabbit trabecular meshwork (TM) is about 0.25 mg (a volume of 0.25 mL), which is over 100-fold less sample volume than what is usually available for standard quantitative assays of drug in plasma…read more…

By |2017-07-04T10:29:07+00:00September 21st, 2012|News|Comments Off on Directions in Discovery and Development

About the Author:

MPI Research, with global headquarters in Mattawan, Mich., provides safety evaluation, discovery, bioanalytical and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. The company offers comprehensive imaging solutions including preclinical imaging, radiochemistry, and data analysis. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.