CALVERT Laboratories

Calvert Laboratories, Inc. recently distributed three employee awards for exemplary merit in 2008.  These awards are based upon recommendations by the Calvert staff, and each recipient is selected from these nominations.

The winners for 2008 are:

Study Director of the Year – Jay Pennell, Study Director, Toxicology

Technician of the Year – Carrie Olechna, Research Associate, Toxicology

Support Person of the Year – Dennis Roe, Team Leader, LAR

Calvert congratulates these employees and wishes them the best in their continued career.

I hear news daily about companies in our industry shutting down operations or making headcount cutbacks due to loss of revenue and profits. It’s sad to read that people who have devoted their professional careers contributing to advancements of health related technologies are losing their jobs in favor of a culture where financial profitability rules the way. I wonder why or on what strategic basis executives of those companies, especially ones in our sector of the drug development business, managed their operations to the point where cutbacks, layoffs or even shutdowns are required. I guess somewhere in the mix, customers of these companies — many facing cutbacks in funding or reduced budgets themselves — don’t see value in the services being offered. Price, not necessarily quality and professional attention to the customer, dictates who and where business is placed.

Calvert Labs is not immune to the realities of global economics. But we see a great opportunity ahead to showcase our services, our company and the way we conduct our business. We have been in the service business for many years and we have always maintained that the biggest differences between Calvert Laboratories and our colleagues in the non-clinical development business are the professionals we employ, the selective services we offer and a healthy competitive attitude. We cannot be everything to everybody, but we can mean a great deal to some. We pride ourselves on our total attention to the needs of our customers. We do not take quality for granted, nor do we try to do studies or projects that do not draw heavily on our top skills. We run an efficient and affordable operation and we will be around to service our customers long after the resizing of the industry is complete. In short, we like the way we do our business, we like our size, we like the type of people who want to work with us, and especially, we like ourselves. Give us a call; we’d be happy to pay you a visit.

Russ McLauchlan
CEO, Calvert Holdings, Inc.
(Parent company of Calvert Labs)

Cesar Mujer, PhD, a study director in Calvert Laboratories toxicology department, recently collaborated with Dr. Vito DelVecchio on a chapter for the book, “Mass Spectrometry: Instrumentation, Interpretation, and Applications.” Dr. Mujer’s work can be found in Chapter 12 of the book and speaks of bioterrorism.  As defined in this portion of the book, bioterrorism is the intentional use of pathogenic microorganisms or toxins to cause disease or death in plants, animals and humans.

The chapter deals with a short historical account of bioterrorism, the Geneva protocol of 1925, and the biological weapons convention of 1972.  It also touches on the categories of biothreat agents and the use of mass spectrometry (e.g., MALDI-TOF MS, LC-MS/MS, SELDI-TOF-MS) in proteomics particularly in the rapid and accurate identification of biological threat agents.  Identification of these threat agents using mass spectrometry is essential in confirming that a bioterrorism event has occurred and will determine appropriate countermeasures to protect public health.

Also discussed are the challenges in using biomarker proteins for bacterial strain identification, diagnosis, vaccine development, and therapeutic agent development. One specific area of interest is expression profiling of biological samples such as serum or plasma which can be used for early detection of infection. For instance, serum proteomics profiling assay has been used to distinguish patients with acute SARS from patients with fever and influenza with 100% accuracy.

The book, “Mass Spectrometry: Instrumentation, Interpretation and Applications” is currently available for purchase on Amazon.com as well as a number of other outlets. It was published this year (2009) by John Wiley and Sons, Inc., Hoboken, N.J. as part of Wiley-Interscience Series on Mass Spectrometry.  The book was edited by Rolf Ekman, Jerzy Silberring, Ann M. Westman-Brinkmalm and Agnieszka Kraj.

Several members of the Calvert Laboratories staff recently authored a poster titled “A Percutaneous Intrasalivary Gland Dosing Technique in Rats”, and their work was presented November 9-13, 2008 at the 59th American Association for Laboratory Animal Science National Meeting in Indianapolis, IN.  Employees who assisted with this authorship were Jaclyn G. Tontini, DVM, Laurie M. Serfilippi, VMD, DACLAM, Danielle R. Pallman, BS, LVT, Cesar V. Mujer, Ph.D., Charles B. Spainhour, VMD, Ph.D., DABT.  Dr.Laurie Serfilippi had the honor of  presenting the poster at the meeting.

This technique was developed as a result of one of Calvert Labs’ client requests to developing a non-invasive and consistently repeatable dosing technique to deliver test article to the submandibular salivary glands of rats. Since the company strives to personalize and optimizing client service, the Calvert team went to work to address this challenge and develop an appropriate technique.

The first consideration in the quest to solve this puzzle was to use surgery and ultrasound to aid us in locating and localizing the glands for injection.  However, due to equipment costs, invasiveness, and the need to dose multiple times, everyone decided to look into other options.  During the process, the team found that if they anesthetized Sprague Dawley rats, placed them in dorsal recumbency, and extended their necks (which were shaved and prepared with alcohol), the glands would be better visualized under the skin. The technicians could then use tissue forceps to isolate each individual submandibular salivary gland, and then they could easily inject test article percutaneously into the gland’s parenchyma.

To insure that this theory was something of value, the staff initially tried the procedure on training animals using Evan’s Blue dye to ensure that the glands themselves were actually being injecting.  The success rate during the initial training process was around 90% but as the technicians became more proficient, the rate grew to around 95%.

To further study the effects of this dosing procedure, staff members dosed a couple of studies using the technique. The study animals did well post-injection and showed no obvious adverse effects to the injections or anesthesia. The staff members further confirmed that the test article injections were placed in the proper location through findings on histopathology. As a result, the members of Calvert Labs now feel reasonably confident that this technique could be considered along with surgical exposure or ultrasound guidance as another option to deliver test article to the salivary glands in the rat model.

Click here to download a PDF of the poster.

Olyphant, Pennsylvania — January 27, 2009
Calvert Labs, a Calvert Holdings company, announced today the hiring of Mr. Terry Ladd as Vice President of Business Development.  Mr. Ladd had worked at Calvert Labs from 1994-2003 as Executive Director, Business Development and Marketing.

Mr. Ladd will be responsible for the sales and marketing of preclinical services in North America.  With his many years of experience in the drug development/contract research organization field, he brings significant wisdom and experience to the table to help clients attain their goals in drug development in a timely and proper manner.

In addition to earning an MBA from McGill University and an MA from the University of Sherbrooke, Mr. Ladd’s well-rounded background includes experience managing the sales, marketing, business development, finance, and administration functions for a wide variety of companies including IMS Health, Guillevin International, Supertel Video Productions and General Electric.

Allan Reiss, President and COO of Calvert Holdings, Inc. remarked: “Although given opportunities to continue a successful career within larger pharma organizations, Mr. Ladd chose to return to a younger, innovative company that has a proven track record within the industry. We are honored that he has chosen to return.” Mr. Ladd responded: “I am glad to be back with my former colleagues and look forward to the challenges and successes ahead.”

About Calvert Labs
Regarded by many as the premier IND-enabling contract research organization, Calvert Laboratories has been providing contract nonclinical services for almost four decades.  As a global service provider, Calvert Labs’ core offerings include Calvert Laboratories offers comprehensive preclinical services in Toxicology (Acute, Subchronic, Chronic, Carcinogenicity, Developmental, Reproductive, Multi-Generation), Pharmacology (General, Discovery, Safety) Immunology, Pharmacokinetics/Toxicokinetics & ADME. Located in northeastern Pennsylvania and easily accessible by major airlines, Calvert Labs provides services to companies in the biotechnology, pharmaceutical, and chemical industrial sectors.

About Calvert Holdings
Formed in 1996, Calvert Holdings (www.calvertholdings.com) is a privately-held company consisting of a diverse portfolio of companies including the following: Calvert Labs, Calvert Research, Calvert BioCapital, Calvert Creative, and Calvert Café.

Calvert Holdings is a company of people who are passionately engaged in contributing to the future well being of the planet we live on. By analyzing how emerging discoveries and current trends will affect future global needs, we position resources and apply our skills to meet them.

A Trusted Ally
The roots of Calvert Labs began on the basis of personal and individual relationships, and our focus is on the growth and success of our customers business. We have seen that the best solution cannot be found in outsourcing, but rather in a dependable, long-term relationship based on offering outstanding science, operational excellence, stellar personalized service, and regulatory assuredness.

Quality
For nearly 40 years, Calvert Laboratories has provided quality contract scientific services to the pharmaceutical and biotechnology industries. The Calvert relationship is based on delivering quality service to our customers, and we honor our commitment to you through our regulatory standards, commitments, and deadlines.

Experience
Employing an impressive team of highly qualified industry experts and staff, Calvert Labs provides their customers with years of unprecedented real world experience in the pharmaceutical and biotechnology fields.

Accessibility
Communication is the cornerstone of the Calvert business relationship. In order to deliver the quality service that our customers need and deserve, we make it a priority to provide you with the most timely and relevant communications focused on your business. We make it a point to keep you involved in the process every step of the way, and help you understand the laboratory policies and procedures relevant to your business.