Posts Tagged ‘Lead Optimization in Drug Discovery’

How to Conserve Test Article, Time and Money with Telemetry

Posted by CorDynamics on March 11th, 2014

Here’s a familiar dilemma. Your research team detects unanticipated cardiovascular activity in your lead candidate but there is limited test article for follow-up discovery and safety studies.

In these cases, we often suggest either conscious telemetry or an anesthetized preparation in the guinea pig as an effective model for cardiovascular testing, when appropriate. Since they are smaller in size, guinea pigs can serve as a viable species when compound supply is limited.

In some cases, the guinea pig can use five times less compound to conduct studies than amounts needed for their larger counterparts, such as rabbits.

The Conscious Model

Using telemetry to deliver quasi beat-to-beat data, this guinea pig model generates ultra high fidelity QT interval correction. View Conscious Validation Data

The Anesthetized Model

In this preparation, we employ a well-characterized anesthetized method to screen for cardiovascular effects early. Cardiovascular parameters such as blood pressure, heart rate, as well as ECG are measured and cardiac functional assessments can also be provided. View Anesthetized Validation Data

While a plus in terms of compound conservation, the guinea pig’s small size and inherent anatomical obstacles do pose potential roadblocks. This is especially true in the hands of less experienced technical personnel. Guinea pigs have rather obscure vascular access due to the lack of a tail and their orogastric structure can make orally dosing somewhat challenging.

Although the guinea pig is not appropriate for every situation, with careful planning and expert execution, this species does indeed play a valuable role in the successful de-risking funnels employed by a number of our biopharmaceutical clients.

Filed under: Drug Discovery Services, Drug Safety Services, Telemetry | No Comments

CorDynamics Sets Drug Discovery and Development 2013 Trade Show Calendar

Posted by Theresa Gralinski, Marketing Director at CorDynamics on December 19th, 2012

The CorDynamics team is saying goodbye to a great 2012 and looking forward to more research and collaboration with colleagues in 2013. Closing one calendar and turning to a new one, some of the first dates to fill in are our trade show exhibitions.

As we continue to grow the early-stage drug discovery side of our business, we will again be visiting the Experimental Biology meeting in Boston, April 20-24. I look forward to attending this event and meeting with colleagues focused on linking drug discovery to development.

In addition to EB, we’ll also be exhibiting at SOT, SPS and ACT.

  • Society of Toxicology 52nd Annual Meeting

San Antonio, Texas March 10-14

  • 2013 Safety Pharmacology Society Annual Meeting

Rotterdam, The Netherlands September 16-19

  • American College of Toxicology 34th Annual Meeting

San Antonio, Texas November 3-6

If you’re going to be at any of these meetings, please put us on your calendar.

Wishing you a very Healthy and Happy New Year.

Theresa Gralinski, Marketing Director

Filed under: Drug Safety Services | No Comments

Expanding Telemetry Widens the Drug Development Picture

Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on November 02nd, 2012

Highlighting our growing telemetry capabilities will be on our docket in booth #300 at the American College of Toxicology meeting in Orlando.

Cardiovascular Telemetry Drug Development

In an on-going effort to provide our clients with quality data addressing their specific scientific questions, we continue to expand our telemetry technology and our customized study designs.

Leverage GLP Studies and non-GLP Screening

It’s imperative to determine which lead compounds to put finite R&D dollars behind. Understanding this, our team has taken the telemetry models we use for GLP examinations of test articles and transformed the concept to create physiologically relevant screening models for lead compounds early in preclinical development.

Typical GLP canine or non-human primate telemetry studies average around six to eight subjects per interrogation and include a full protocol and report. Clients go back to their project teams with high fidelity assessments of effects on blood pressure, heart rate, ECG (including QT interval) and other parameters.

At the point of lead compound selection, however, project teams are trying to identify the most promising compound for advancement—thus we often compare one compound to another by rank order.

As a result, it’s often not necessary to invest in eight subjects on a screening study, nor have a full protocol or report.

Conserve Time and Money with Dual Capabilities

Simultaneously gathering data on two pressure measurements or analyzing two organ systems, helps project teams operating under tight budget constraints and ambitious timelines meet their regulatory requirements.

With dual pressure telemetry  we can now surgically instrument rats to measure systemic blood pressure AND either pulmonary artery pressure or left ventricular pressure —simultaneously. In addition, we can also provide ECG readings. Previously, this level of in vivo telemetry instrumentation was only available in large animal models.

Likewise with our respiratory telemetry capabilities, we can now analyze two organ systems—cardiovascular and respiratory—with one large species study.

In addition, these models are designed with the 3R’s in mind. Collecting multiple variables from the same subject reduces the need for redundant groups.

 

Filed under: Anesthetized Models, Drug Discovery Services, Drug Safety Services, Hemodynamics, Telemetry | No Comments

Telemetry Leads Lead Optimization

Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on February 13th, 2012

Eeny Meeny Miney Mo…Where Should My R&D Dollars Go?

Do you have compounds with promise, but not enough resources to investigate all of them? I know I did when I managed projects teams and it’s a daily concern for our current clients.

This is why lead optimization screening in drug discovery and safety assessment became a cornerstone of the CorDynamics services and capabilities offerings when we started the company 10 years ago.


GLP Telemetry Vs. Lead Optimization Telemetry

Determining which lead compounds to put your R&D dollars behind is even more imperative in today’s environment. Based on this premise, our team has taken the telemetry models we use for GLP examinations of test articles and transformed the concept to create physiologically relevant screening models for lead compounds early in preclinical development.

 

GLP

Typical GLP dog or non-human primate telemetry studies average around six to eight subjects per interrogation and include a full protocol and report. Clients go back to their project teams with high fidelity assessments of effects on blood pressure, heart rate, ECG (including QT interval) and other parameters.

 

Lead Optimization

At the point of lead compound selection, however, project teams are trying to identify the most promising compound for advancement—thus we often compare one compound to another by rank order.

As a result, it’s often not necessary to invest in eight subjects on a screening study, nor have a full protocol or report. With lead optimization in mind, we design customized telemetry studies:

>> Generates data detecting subtle changes in CV parameters (such as QT interval) for screening purposes.

>> Leveraged in five species: dog, non-human primate, rabbit, rat and guinea pig telemetry.

>> Requires fewer animal subjects.

>> Efficient results with minimal paperwork.

The Bottomline

Telemetry screening allows clients to save money, use less test article and get results back to their colleagues in few days.

We’ve always known that time is money. But I believe our industry is also learning that good science decisions help us make better business decisions.

Filed under: Telemetry | No Comments

Outsourcing Drug Development Research: Should We Be Afraid?

Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on November 09th, 2011

In Phoenix, at the American College of Toxicology annual meetings, we spoke with a number of industry decision-makers.

This year, the topic on everyone’s mind was—outsourcing. Pharma and biotech colleagues tell us of plans to outsource in almost every area of R&D including those that pertain to CorDynamics.

• Lead Optimization in Drug Discovery
• Safety Pharmacology
• Preclinical Toxicology
• Nonclinical Consulting

Some are wary at the speed and scope of predicted reliance on outsourcing. We get it. Before starting CorDynamics, my business partner Peter Senese and I were in their shoes, looking for quality contract research organizations to serve our R&D needs while still maintaining control of our projects, budgets and timelines.

Take an anesthetized study for instance. As a rule, these studies are conducted to obtain a complete cardiovascular assessment over escalating doses in the same animal – using multiple replicates. These results need to be turned around quickly, and oftentimes generated with limited compound supply. No problem, we get it – and have done it many times.

To us, “out” sourcing is a bit of misnomer as we think it insinuates clients are taken “out” of the loop. This couldn’t be farther than the truth. We have our technology and communication processes set up to ensure our clients feel they can access “their” data and, if need be, change course quickly. Our consulting services enable us to provide lead optimization strategies, regulatory compliance advice and FDA risk assessments.

Our philosophy has always been: We may be off-site, but we are always within reach.

It’s a model that works and one I’m excited to see the industry embrace.

Filed under: Anesthetized Models, Drug Discovery Services, Drug Safety Services, Preclinical Consulting Services | No Comments

Guinea Pigs Require Expertise; Provide Effective Model

Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on February 01st, 2011

At recent scientific conferences I’ve noticed a continued interest in using the guinea pig to screen for unanticipated cardiovascular activity of lead candidates.

At CorDynamics, we have used the guinea pig as an effective model for cardiovascular testing, when appropriate. Since they are smaller in size, guinea pigs can serve as viable species when compound supply is limited. In some cases, the guinea pig can use five times less compound to conduct studies than amounts needed for their larger non-rodent counterparts, such as rabbits.

While a plus in terms of compound conservation, their small size and inherent anatomical obstacles do pose potential roadblocks. This is especially true in the hands of less experienced technical personnel. Guinea pigs have rather obscure vascular access due to the lack of a tail and their orogastric structure can make orally dosing somewhat challenging.

Our team has worked extensively with the guinea pig to develop an expertise to overcome these inherent challenges. With this know-how at our disposal, we’ve been able to conduct isolated heart, anesthetized and conscious/telemetry guinea pig studies for a wide variety of clients. One of our latest developments is the validation of an ultra high fidelity QT interval correction in this species using a quasi beat-to-beat approach via telemetry.

Certainly, the guinea pig is not appropriate for every situation that may typically use a smaller animal such as the rat. However, with careful planning and expert execution, this species does indeed play a valuable role in the successful de-risking funnels employed by a number of our biopharmaceutical clients.

 

Filed under: Anesthetized Models, Langendorff Heart, Telemetry | No Comments

Leveraging Lead Optimization: Telemetry and Isolated Heart Models are a Natural Fit in Tough Economic Climate

Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on April 24th, 2009

We’ve recently returned from the 2009 Society of Toxicology meeting in Baltimore. As usual, it was refreshing to catch up with friends, reconnect with previous co-workers, and get the current pulse of our clients.

Other than the scientific topics at hand, the buzz of the convention hall was focused on the current global economic state and the ramifications of continuing job losses and shrinking budgets throughout R&D. Not exactly the catalyst of uplifting discussion. Although difficult to quantify, I did feel some improvement in the attitude and outlook of the people who stopped by compared to our last major trade show in November 2008.

One of our Southern California clients, who attended both meetings, captured it perfectly during a discussion at the CorDynamics booth. She noted, “The end of last year (2008) felt dour and somber.” We both agreed that things seemed to have calmed since then, but the universal feeling was that the current year will be a volatile one.

In addition to this uncertainty, we heard of 2009 R&D budgets that are either flat or have been cut versus previous years. At past meetings attendees’ inquiries were focused on timelines and deliverables, while this year the talk was on maximizing their outsourcing budgets.

At CorDynamics, our inherently affordable cardiovascular models – from the isolated heart to anesthetized and conscious telemetry in a variety of paradigms — provide unparalleled value at precisely the right time. Now, perhaps more than ever, it’s vital to select the right compounds to move forward.

Over the last six months, we’ve seen an increase in our earlier de-risking studies, namely isolated heart and screening telemetry assessments. While meeting deadlines is a critical part of our business (for example, in March we started multiple non-human primate telemetry studies with just three weeks lead time), getting feedback from our clients such as ‘your pricing was by far the best I’ve gotten’ [Outsourcing Manager, Mid-US client] remains just as important, especially in 2009.

The meeting ended on a high note for the CorDynamics team. We look forward to our upcoming exhibitions in September at Strasbourg, France (2009 Safety Pharmacology Society) and in November at Palm Springs, USA (2009 American College of Toxicology).

Filed under: Langendorff Heart, Telemetry | No Comments