Cognigen

Senior Pharmacometrician

2012-02-23T14:02:33Z

Work closely with our clients to plan and implement pharmacometric analyses, while considering the strategic implications of modeling and simulation within our clients’ drug development programs. As a member of the scientific team at Cognigen, you will have the opportunity to bring your skills and talents to multiple projects for different clients in diverse therapeutic areas.

Think this job may be for you? Send us your resume and say “hello”.

PK/PD Scientist

2011-11-08T23:54:25Z

Multiple Openings
PK/PD Scientist openings for pharmaceutical data/statistical analysis company located in Williamsville, NY. Requires a Ph.D. degree in Pharmacology, Pharmaceutical Sciences or related field and minimally one year experience developing and executing protocols of preclinical studies, developing and validating clinical pharmacokinetic/pharmacodynamic (PK/PD) models including analyzing and interpreting clinical PK/PD studies, performing PK/PD modeling and simulation, developing, testing and documenting statistical analysis programs for exploratory data analysis, statistical analysis and graphical summarizations of data as well as preparing formal manuscripts of analysis methodologies and results. Send resume to Cognigen Corporation, 395 Youngs Road, Williamsville, NY 14221-5831, Attn: Kathie Mann. Please indicate PK/PDS in subject line. EEO/AA.

MAA Found Math

2012-03-30T17:30:06Z

Each week, the Mathematical Association of America website posts a new math-related photo that was submitted by an MAA member. The photo reposted here is a decorative Venn Diagram on a ceiling light that was featured on May 31, 2011. The photographer was Joy Hsiao of Brooklyn Technical High School. Visit the MAA Found Math gallery to view more of these fascinating photos.

The pluses and minuses of groupthink.

2012-02-28T20:29:00Z

Susan Cain recently wrote about the advantages and limitations of team work versus going it alone in the New York Times Sunday Review.

Cain said that research strongly suggests that people are more creative when they enjoy privacy and freedom from interruption. But solitude is out of fashion. Our companies, our schools, and our culture believe that creativity and achievement come from an oddly gregarious place.

The problems we face in science, economics and many other fields are more complex than ever before, and we’ll need to stand on one another’s shoulders if we can possibly hope to solve them. But even if the problems are different, human nature remains the same. And most humans have two contradictory impulses: we love and need one another, yet we crave privacy and autonomy.

If that knocked your socks off, take a look at our next cool topic, coming soon. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

Cain S. The Rise of the New Groupthink. The New York Times Sunday Review. January 13, 2012. http://www.nytimes.com/2012/01/15/opinion/sunday/the-rise-of-the-new-groupthink.html?_r=2&ref=opinion&pagewanted=all. Accessed February 28, 2012.

Thinking about thinking.

2012-02-13T15:31:22Z

In a podcast called Thinking About Thinking, three eminent scientists discuss the ways humans think. All three have interesting and useful insights. I recommend this podcast to anyone responsible for managing Pharma R&D teams or for anyone looking for new ways to improve team performance, especially in knowledge-intensive research efforts.

The scientists interviewed in the podcast are:

Daniel Kahneman, a Nobel laureate psychologist and author of Thinking, Fast and Slow.
Duncan Watts, a principal research scientist at Yahoo! Research and author of Everything is Obvious: *Once You Know the Answer: How Common Sense Fails Us.
Cathy Davidson, an American scholar and university professor whose most recent book, Now You See It: How the Brain Science of Attention Will Transform the Way We Live, Work, and Learn, was named by Publishers Weekly as one of the top ten science books of the Fall 2011 season.

The podcast was produced by Wisconsin Public Radio and distributed by PRI. It was released on January 15, 2012, as part of the To the Best of Our Knowledge series.

If that knocked your socks off, take a look at our next cool topic, The Pluses and Minuses of Groupthink. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

George Steiner, a certain idea of knowledge.

2012-01-31T14:46:51Z

George Steiner:

Our world is shrinking. Science is becoming inaccessible to us. Who can understand the latest innovations in genetics, astrophysics and biology? Who can explain them to the profane? Knowledge no longer communicates; writers and philosophers in our day are incapable of enabling us to understand science. At the same time, the scope of imagination in science is dazzling. How can we claim to speak of human consciousness if we overlook what is most daring and imaginative? I am concerned by what it means to be literate today. Is it possible to be literate if you do not understand non-linear equations?

What is the mystery that triggers creation? I wrote Grammars of Creation to understand it. But at the end of my life, I still don’t understand.

If that knocked your socks off, take a look at our next cool topic, Thinking About Thinking. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

from: Cerf, Juliette. George Steiner, a certain idea of knowledge. Translated from the French by Mark McGovern. Presseurop 30 Dec 2011. http://www.presseurop.eu/en/content/article/1320071-george-steiner-certain-idea-knowledge. Accessed 31 Jan 2012. Originally published as: Cerf, Juliette. George Steiner: L’Europe est en train de sacrifier ses jeunes. Télérama 12 décembre 2011. http://www.telerama.fr/idees/george-steiner-l-europe-est-en-train-de-sacrifier-ses-jeunes,75871.php.

Steiner G. Grammars of Creation. New Haven, CT: Yale University Press, 2001.

The age of the smart machine.

2012-01-16T15:43:02Z

Frances Fukuyama had some interesting things to say in the current issue of Foreign Affairs about the implications of globalization and technical innovation for our children’s future.*

For example:

But what if the further development of technology and globalization undermines the middle class and makes it impossible for more than a minority of citizens in an advanced society to achieve middle-class status?
Americans may today benefit from cheap cell phones, inexpensive clothing, and Facebook, but they increasingly cannot afford their own homes, or health insurance, or comfortable pensions when they retire.
We are today living in what the scholar Shoshana Zuboff has labeled ‘the age of the smart machine’, in which technology is increasingly able to substitute for more and higher human functions. Every great advance for Silicon Valley likely means a loss of low-skill jobs elsewhere in the economy, a trend that is unlikely to end anytime soon.

Fukuyama points out that solutions to these challenges will require a new narrative regarding the political and economic system in the United States. It will be interesting to see how this narrative develops among those who would seek to lead the US into the future.

If that knocked your socks off, take a look at our next cool topic, George Steiner: a certain idea of knowledge. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

* Fukuyama F. The future of history: can liberal democracy survive the decline of the middle class? Foreign Affairs 2012;91(1). http://www.foreignaffairs.com/articles/136782/francis-fukuyama/the-future-of-history. Accessed January 16, 2012.

ACCP Finalist

2011-10-20T19:06:34Z

Exposure-Response Analysis of Eslicarbazepine Acetate Adjunctive Treatment of Patients with Partial-onset Seizures, a paper and poster based on a collaboration between Sunovion Pharmaceuticals Inc and Cognigen Corporation, was one of 8 finalists in the Best Paper competition at the annual meeting of the American College of Clinical Pharmacy. The meeting was held in Pittsburgh from October 16 to 19, 2011. Jahnavi Kharidia, PhD, of Sunovion presented the paper. Julie Passarell, MA, Elizabeth Ludwig, PharmD, Ted Grasela, PharmD, PhD, and Jill Fiedler-Kelly, MS, of Cognigen contributed to the analysis.

A second poster, Population Pharmacokinetics of Eslicarbazepine Acetate in Patients with Partial-onset Seizures, was presented at the 2011 ACCP Annual Meeting. Qiang Lu, PhD, Elizabeth Ludwig, PharmD, Ted Grasela, PharmD, PhD, and Jill Fiedler-Kelly, MS, of Cognigen contributed to the analysis. The poster was presented by Elizabeth Ludwig.

It’s not gloom and doom if it helps to frame the problem.

2011-10-18T19:11:57Z

I know, I know — you don’t want to read another doom and gloom blog. But, in a recent article in the National Review*, Peter Thiel does an excellent job of linking the desperate necessity of advancements in technology and science with the broader societal crises we are now experiencing. Thiel posits that there is a mistaken, but nearly universal, background assumption about easy progress that underlies our unwillingness to tackle difficult problems.

The challenges in bringing about much needed, but so far elusive, improvements in Pharma research and development productivity are becoming increasingly clear. It should also be clear that success is surely not going to come from more of the same.

Thiel says:

While innovation in medicine and biotechnology has not stalled completely, here too signs of slowed progress and reduced expectations abound. In 1970, Congress promised victory over cancer in 6 years’ time; 4 decades later, we may be 41 years closer, but victory remains elusive and appears much farther away. Today’s politicians would find it much harder to persuade a more skeptical public to start a comparably serious war on Alzheimer’s disease — even though nearly a third of America’s 85-year-olds suffer from some form of dementia. … Looking forward, we see far fewer blockbuster drugs in the pipeline — perhaps because of the intransigence of the FDA, perhaps because of the fecklessness of today’s biological scientists, and perhaps because of the incredible complexity of human biology. In the next 3 years, the large pharmaceutical companies will lose approximately one third of their current revenue stream as patents expire, so, in a perverse yet understandable response, they have begun the wholesale liquidation of the research departments that have borne so little fruit in the last decade and a half.

If that knocked your socks off, take a look at our next cool topic, The age of the smart machine. And if you want to peruse all of the previous sock-knocking blog entries, visit the Knocked My Socks Off archive.

* Theil P. The end of the future. National Review Online. October 4, 2011. http://www.nationalreview.com/articles/print/278758. Accessed October 17, 2011.

Virtual Physiological Human

2011-10-17T16:00:38Z

Cognigen was invited to use its expertise in modeling and simulation to comment on a recently published policy brief called: Policy needs and options for a common approach towards modelling and simulation of human physiology and diseases with a focus on the Virtual Physiological Human.

The policy brief was edited by Marco Viceconti of the Istituto Ortopedico Rizzoli, and Andrew D. McCulloch of the University of California San Diego.

From the Brief:
The European Union and the United States of America are investing substantial research funding in the development of frameworks of computational methods and technologies that make possible an integrative approach to biomedical research and clinical practice.

This approach, which is called “Virtual Physiological Human” (or VPH for short) in Europe, involves laboratory and clinical data collections, information databases, models repositories, as well as simulation, information and communication technologies that make it possible to overcome the “reductionist chaos” produced by the fragmentation and the dispersion of scientific and clinical data, information, and knowledge that together compose what we humans know and understand about the biological mechanisms of life and disease.

The Virtual Physiological Human Institute for Integrative Biomedical Research is an international nonprofit organization that was established to promote the development of the VPH vision

Register for NONMEM Course

2011-10-12T15:15:57Z

Registration is now available for 3 courses to be offered by the University at Buffalo School of Pharmacy and Pharmaceutical Sciences in May 2012.

May 20-23, 2012: Pharmacokinetic-Pharmacodynamic Modeling: Concepts and Applications
The 19th annual 3-day course on PK/PD modeling will feature lectures by WJ Jusko and other faculty members from the University at Buffalo.

May 17-19, 2012: Introductory Workshop in Population PK Data Analysis: A Hands-on Course Using NONMEM
This 3-day course will precede the PK/PD modeling course and will be taught by Jill Fiedler-Kelly and David Jaworowicz of Cognigen Corporation.

May 24-25, 2012: Monoclonal Antibody Pharmacokinetics & Pharmacodynamics: Concepts and Applications
This 2-day course will follow the PK/PD modeling course and will offer state-of-the-art perspectives on the special properties and approaches to PK/PD modeling of therapeutic proteins such as monoclonal antibodies. The course will be presented by Dr. Joseph Balthasar.

All 3 courses will be held at the Conference Center in Niagara Falls, New York. Niagara Falls offers opportunities for additional family activities and sightseeing in both the USA and Canada.

The Department of Pharmaceutical Sciences at UB is considered one of the top departments in the world in pharmacokinetics, pharmacodynamics, and biopharmaceutics.

Drug Development Boot Camp

2011-10-12T14:58:08Z

Cognigen CEO Ted Grasela will lecture on pharmacokinetics at the Drug Development Boot Camp: An Intensive Two Day Course for Biotech and Pharma Company Executives.

The Boot Camp will be held November 9-10, 2011, at the Harvard Club in Boston and will be hosted by the Harvard University Office of Technology Development and Speid Associates, Inc. It will provide a unique opportunity for participants to obtain a hands-on insight into the drug development process from drug discovery (designation of a lead) to registration.

Ted at PoC Conference

2011-10-07T16:29:53Z

Ted Grasela, President and CEO of Cognigen Corporation, presented Pharmacometrics and PoC: Preventative Care for Drug Development on October 4, 2011, at the 3rd Annual Accelerating Proof-of-Concept Conference in Philadelphia. Ted described a strategy for using pharmacometric methods to perform a comprehensive and interdisciplinary synthesis of available data that can play a central role in R&D planning and in the design, analysis, and interpretation of study results.

The conference was organized by Cambridge Healthtech Institute.

Poster at EASD in Lisbon

2011-10-07T15:11:42Z

A poster describing Cognigen analyses was presented at the 47th annual meeting of the European Association for the Study of Diabetes (EASD) held in Lisbon, Portugal, in September 2011. The poster, based on a collaboration between Cognigen and Lilly Research Laboratories, was titled Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Subcutaneous (SC) LY2189102, a Neutralizing IL-1 beta Antibody, in Patients with Type 2 Diabetes Mellitus. Cognigen scientist Sebastien Bihorel, PharmD, PhD, was the primary analyst on this effort, which was presented by Eyas Abu-Raddad, PhD, of Lilly. Jill Fiedler-Kelly, MS, from Cognigen also contributed to the analyses.

Cognigen Posters at ACoP

2011-09-16T18:17:33Z

Two posters describing Cognigen analyses were presented at the 2011 American Conference on Pharmacometrics (ACoP) in April.

The first poster, based on a collaboration between Cognigen and Merck Research Laboratories, was titled A Semi-mechanistic Approach to PK/PD Modeling of Complex Response Data: Bone Turnover Example for Odanacatib, a Cathepsin K Inhibitor. David Jaworowicz, PhD, was the primary analyst on this effort, which was presented by Julie Stone, PhD, of Merck. Julie Passarell, MA, and Jill Fiedler-Kelly, MS, from Cognigen also contributed to the analysis.

In addition, Susan Willavize, PhD, presented a poster called Mixture Modeling as a Data Imputation Method, which described the use of mixture modeling in a population PK analysis to predict drug concentrations for subjects with missing data for a key categorical covariate. The project was a collaboration of Cognigen with Merck & Co. Cognigen scientists Jill Fiedler-Kelly, MS, and Luann Phillips, MS, also contributed to the analysis.