Posts Tagged ‘American College of Toxicology’

New Model Measures Time Course of Pulmonary Artery Pressure Increases

Posted by CorDynamics on November 20th, 2013

November is pulmonary hypertension month, shedding needed attention on the rare disease.

Pulmonary arterial hypertension is an orphan disease, characterized by increased blood pressure in the arteries of lungs, causing dizziness, shortness of breath and can lead to heart failure.

CorDynamics has developed several discovery research models for PAH.

We recently published a poster at ACT 2013 sharing our findings: PAH Induced by Semaxanib and Low Oxygen Environment: Time Course Pulmonary Artery Pressure Increases Measured by Telemetry.

The study built on our previous data set which showed a robust increase in pulmonary arterial pressure (PAP) between Day 1 and Day 42 in untreated rats. In our latest study, we conducted additional validation of the model by evaluating the daily progressive increase in pulmonary artery pressures using telemetry.

In this investigation, instead of only interrogating PAP at the end of study, in the current assessment we used telemetry to provide daily readings of PAP. The data demonstrate a linear increase in PAP between Day 1 (~35 mm Hg) to approximately Day 28 (~120 mm Hg). After this time, PAP increases tended to plateau when examined out to Day 42.

This data was intriguing for a number of reasons.

  • It suggested that an optimal interval for intervention exists, as opposed to prevention mode when we start dosing on Day 1. In our labs we recommend considering to initiate treatment between Days 10 and 14 to reverse or mitigate further PAP increases.
  • Starting reversal therapy later than that has diminishing returns, as PAP levels become very high toward Day 21.
  • There were no substantive increases in PAP between Days 28 and 42.

This suggests a nominal difference between 4 and 6 weeks of treatment – saving test article and getting efficacy issues resolved quicker.

Conclusions
Oral administration of sildenafil reduces PAH induced by semaxanib and a low oxygen environment. The increase in pulmonary artery pressure reaches a plateau after approximately 4 weeks. Putative reversal therapy should be started between two and three weeks after initiation of PAH.

Filed under: Drug Discovery Services, Pulmonary Arterial Hypertension | 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

5 Signs Drug Development Outsourcing is In

Posted by Theresa Gralinski, Marketing Director at CorDynamics on November 14th, 2012

I spent most of last week at the American College of Toxicology meeting in Orlando taking the industry’s proverbial temperature.

Over the last four years this meeting’s attendees seemed concerned about feverishly downsizing, feverishly cutting budgets or feverishly outsourcing. People just didn’t feel well. This year attendees seemed to be “feeling” healthy and more optimistic.

Preclinical CRO Drug Development Outsourcing

I saw five clear signs that industry outsourcing is officially IN.

1. Back to Business—With mass waves of downsizing behind a number of our colleagues, clients and competitors, the focus of discussions turned to current programs and upcoming projects.

2. Changing Roles—Longtime  friends were embracing new positions, translating their pharma drug safety and drug discovery experience into success at virtual biotechs or contract research organizations.

3. New CROs and Consultants Join the Ranks—We welcomed new CROs to the “club” and I met with quite a few toxicologists who have decided to work as consultants to share their expertise to meet the anticipated demand.

4. Buzzwords—Collaboration. Customized. Experience. Responsive. Did I say collaboration?

5. Social Media…Really?—Admittedly the industry is still skeptical of the idea in a regulated industry. However with more drug developers looking for external services, vendors and CROs want to be easily found. (Shameless examples: cardiovascular CRO, prolonged QT interval, cardiovascular pharmacology.) Social media is a good way to get the message out.

I polled attendees on their comfort levels with the top social media platforms. Results: LinkedIn=Great; Blogging=Good; Twitter=So-So; Facebook=No Thanks.

Did you get a different temperature reading from the meeting? Or, did you sense a healthier optimism as well? Feel free to comment here or you can find me on Linkedin.

 

Filed under: Drug Discovery Services, Drug Safety Services, Preclinical Consulting 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

CorDynamics Sets Fall Conference Calendar: Safety Pharmacology Society and American Colllege of Toxicology

Posted by Theresa Gralinski, Marketing Director at CorDynamics on September 06th, 2012

With a great summer behind us, the CorDynamics team is looking ahead to a productive fall season and two upcoming trade shows.

2012 Safety Pharmacology 51st Annual Meeting in Phoenix (October 1-4)
With all the recent FDA decisions surrounding cardiovascular safety in everything from weight-loss compounds to hepatitis C therapies, this meeting will be the ideal place to discuss our cardiovascular safety pharmacology expertise with clients and colleagues.

2012 American College of Toxicology 33rd Annual Meeting in Orlando (November 4-7)
We will showcase our safety studies as well as our discovery models to demonstrate our ability to help clients translate preclinical data into greater pipeline predictability.

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

If not, feel free to contact us–we’re always available to collaborate on your most pressing projects.

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

CorDynamics Sets 2012 Trade Show Calendar

Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on December 15th, 2011

The CorDynamics team is closing out a successful year and setting the stage for 2012. Closing one calendar and turning to a new one, some of the first dates to fill in are our trade show exhibitions.

For the first time, we’ll take our booth to the Experimental Biology meeting in San Diego April 21-25. As we continue to grow the drug discovery side of our business, I look forward to attending this event and meeting with colleagues focused on this exciting and important side of drug discovery.

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

  • Society of Toxicology 51st Annual Meeting

San Francisco, March 11-15

  • 2012 Safety Pharmacology Society Annual Meeting

Phoenix, October 1-4

  • American College of Toxicology 33rd Annual Meeting

Orlando, November 4-7

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

Best Regards and Happy New Year.

 

Filed under: About Us, Events | 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