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September 7, 2015 Issue

The Most Powerful Name In Corporate News and Information

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Drug Discovery Contract Research

 

 

Joe Pesek

CEO & Co-founder

 

Dr. Richard Peterson, PhD

EVP Research and Development,

CSO & Co-founder

 

PreClinOmics, Inc.

www.preclinomics.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – September 7, 2015

 

CEOCFO: Mr. Pesek, would you tell us the concept at PreClinOmics?

Mr. Pesek: 25 years ago my partner Richard Peterson (Pete) and I, confirmed a growing niche market need for a novel rat model that Pete had developed while a professor at the Indiana School of Medicine. This novel model was the ZDF Rat. We started a company, Genetic Models Inc (Gmi) with a business model that focused on acquiring unique animal models that best represented the translational properties of various human diseases in rodents (rats and mice). That business grew, mainly on the merits and market entry timing of the ZDF, a model of type II adult onset diabetes. Gmi was sold 10 years later in 2001. Pete and I then decided we wanted to do a variant of the original business model. We established a new company called PreClinOmics (PCO) with its mission of conducting contract research in testing drugs for efficacy in rats and mice. Additionally, we saw a need and wanted to develop better models -more translational- for metabolic disease and diabetes research. A better rodent model for diabetes drug development then became an important objective for the new company.

 

CEOCFO: What is the new model and what is different in your approach?

Dr. Peterson: The new model is a much more translational than the ZDF and other rodent models that have been developed and currently available. We eventually developed two new models, one being the ZDSD rat, the other FATZO a mouse. ZDSD is obese, has metabolic syndrome and like aging adult humans, develops diabetes as it matures. It is an adult onset diabetic model that is establishing itself as being very translational to the human condition. Most of the other animal models being used have no leptin receptor or a leptin receptor defect that would cause the animal to become obese. This is a very rare human genetic defect. ZDSD rats do not have that defect; instead they have a polygenic obesity which is much more like that found in the human condition. The other model that we have developed is a similar model, the FATZO mouse. It was selectively bred for the purpose of screening candidate compounds in the early stages of developing a new drug. Like ZDSD, the FATZO better mirrors the human condition and requires less compound to produce a response due to its size. Supported by scientific publications, ZDSD and FATZO are more translational to the human condition than those rodent models currently in use for developing drugs that cure or alleviate the symptoms of metabolic syndrome, including obesity, diabetes and their resulting complications.

 

CEOCFO: What goes into developing a rat or mouse with the characteristics you want?

Mr. Pesek: It involves a lot of work, perseverance and a significant financial commitment for a small company. Let’s put it this way, we look for animal models that offer a prospect of taking us toward our objective. In the instance of ZDSD and FATZO we took two models that had the propensities for the diseases we were targeting, but had other characteristics that we did not want in a new model. Then, over a long period of selective inbreeding, we tested and selected offspring for the characteristics that we wanted to be expressed in the target model. The development process also involves the identification of undesirable characteristics and eliminating those animals from the process. It is a long and arduous process with no guarantee of success. For the ZDSD rat, we have been working on that model for about fourteen years and for the FATZO mouse, it is approaching twelve years. We are just now beginning the process of branding and commercialization

 

CEOCFO: Are people coming to you because of the superior models?

Dr. Peterson: Some companies and their drug development teams are. We still have not reached the brand recognition that we would like to have for these novel animal models. Scientific publications by 3rd party scientists are an important part of the model acceptance process. Having to work with limited resources, PCO, along with the acceptance of the animals, has not achieved a high degree market recognition. We are gaining more traction as time goes on. We have a number of clients that are asking specifically for the ZDSD rat in their studies (drug development experiments). We have had a recent influx of a number of orders coming from around the world for the ZDSD. The FATZO mouse is not as advanced in its scientifically published characterization. Consequently, it has not achieved as much brand recognition.

 

CEOCFO: How do you get the attention?

Mr. Pesek: Our efforts to achieve brand recognition have been primarily centered on using electronic media. Being a small company, we do not have an active sales force, which is one of the reasons, if not the main reason that we are not growing faster. We are organically grown, using only income generated from operations to fund operations. Those funds have primarily gone into development of our IP (ZDSD and FATZO). We have been using electronic media and have been using the internet to identify those companies that have therapeutic programs that could benefit from use of our models. We have spent considerable effort identifying target companies using the internet. Our target list of potential users or decision influencers now contains over 5000 contacts. The company has begun issuing blogs/press releases to present the characteristics and the availability of these novel models to the attention of companies on a worldwide basis. In addition to the business development efforts just described, we are seeking to partner with a technologically compatible company that may have, for lack of a more contemporary term, “troops on the ground” that can get our brand more directly and more powerfully delivered.

 

CEOCFO: Are there results you can point to and have you received feedback from people using your new rat version?

Dr. Peterson: One of the examples is that of a major collaborative study that we recently completed. Johnson & Johnson wanted to look at this model in detail. We did this as a shared costs study. This has now been published and the results significantly reflect the translational characteristics of the ZDSD model to the human condition.

 

CEOCFO: How do you ship them and how much of an inventory of rats do you have to maintain?

Dr. Peterson: We ship them with a lot of attention to detail. The models are expensive animals so you want to make sure they get to their location safely and that their condition remains stable during the shipment. We have to engage experienced transporters that can ship animals worldwide and maintain their environmental conditions. We source special boxes that help to insure safe shipment. The boxes are made of hard plastic with filters on the sides so that the animals are also not exposed to potential environmental contamination. Food and water are provided with a margin of safety. If you do let them run out of food or water, you can impair their characteristics. We ship using carriers that minimize time in transit. We have had no significant problems with shipping animals.

 

CEOCFO: Would you give us an example using your model of what someone was able to discover because it was closer to the human?

Mr. Pesek: In using a model or establishing the value of a model such as what we have developed, part of the process is validation. What a company typically will do in validating a rat or mouse model is they would treat the animal with a therapeutic compound. For example, in the case of diabetes the drug might be Metformin. Metformin is often used as a starting point for treating adult onset diabetes and in a “standard of Care” validation study a positive outcome would be the objective. We would also evaluate the performance of other drugs that are already established and in human use. Such protocols are conducted to demonstrate that a model is responsive to a broad spectrum of well-established therapeutic compounds that are used in the clinical environment. This is basically the first step. As for a specific example of a drug that was developed using one of our models, I would call your attention to the ZDF. We brought this model to the marketplace well over twenty years ago. Having delivered thousands of ZDFs to pharmaceutical companies, we believe that the ZDF was the most significant rat model used in developing the thiazolidinediones (TZDs). Many scientists working in the industry will confirm that. There are a number of drugs that have been developed that are in that thiazolidinedione class. One of those is Actos, and there are a number of others that are out there. Troglitazone was the first one that we tested, which was a drug that Pfizer was developing. Troglitazone failed in clinical trials due to toxicity or what was attributed to complications. It was an impressive compound, but unfortunately, it fell into disrepute for a couple of reasons. There were alleged cardiovascular problems with the thiazolidinediones. Also, the weight-gain associated with thiazolidinedione treatment has been viewed as negative.

 

Dr. Peterson: Speaking of the TZD class of compounds and the alleged cardiovascular issues associated with it, one of the exciting traits found in the new ZDSD model is that the model, like in the human condition has a propensity to develop cardiovascular disease symptoms. We believe this translational trait is going to greatly enhance the attractiveness of the ZDSD for developing a new generation of type II diabetic drugs. Our hypothesis is that the model can demonstrate an improvement in or a stabilization of cardiovascular indications for a drug in the early development stage. Another point of differentiation for the ZDSD model is that it also develops a neuropathy that is similar to the human condition. In terms of a brief summary, ZDSD is hypertensive in the metabolic syndrome state, develops the Type II onset diabetes and also expresses co-morbidities of the diabetic state which are neuropathy, impaired wound healing, diabetic nephropathy and diabetic osteoporosis. There is no other model out there now that gives a drug company a model that exhibits these translational characteristics. We are trying to build our brand for this model around “one rat many models” because it develops the full spectrum of what the disease exhibits.

 

CEOCFO: Are you conducting trials and doing other services in addition to making the rodents available or are rodents the focus today?

Dr. Peterson: Rodents are our focus in this company. We do not conduct clinical trials. The people who are working with us and bringing us compounds obviously want to take their compounds to the clinical level. We are currently working with one company who has a series of compounds and we know from some of the earlier studies, with PCO that they are taking some of these to the clinic. The company is a small company with impressive management and technology. They have now gone public. Having raised more working capital with their IPO, they are one of the companies that continues to come to PCO for work and are using of the ZDSD.

 

CEOCFO: What is ahead for PreClinOmics?

Mr. Pesek: We are strategically evaluating where we need to go or vice versa, who might find us to be an attractive M&A candidate. A number of companies should be interested in our models of metabolic diseases and services capabilities to enhance the product and service lines they already have. We want to see the company taken to the next level. The future probably resides in M&A for PCO.

 

CEOCFO: Why pay attention to PreClinOmics?

Dr. Peterson: I think the best answer to your question is that with PreClinOmics’ animal models and service capabilities we can provide valuable tools to produce badly needed answers facing the drug development industry. We can help provide a more assured pathway to successful clinical trials and eventual FDA acceptance of a drug.

 

Mr. Pesek: When we decided to go ahead and try to build a small CRO, we also wanted to create jobs; this was and remains an important part of our motivation. We are very proud of our staff and their accomplishments. Our staff is not large but they do very high-quality work. Our hope is to not only preserve what has been accomplished but to perhaps be part of a drug development legacy that contributed greatly to solving the growing occurrences of the metabolic diseases, especially Type II diabetes.



 

“With PreClinOmics’ animal models and service capabilities we can provide valuable tools to produce badly needed answers facing the drug development industry. We can help provide a more assured pathway to successful clinical trials and eventual FDA acceptance of a drug.” - Dr. Richard Peterson, PhD


 

PreClinOmics, Inc.

www.preclinomics.com



 

 



 

 


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