scholarly journals Career Transition Points in Toxicologic Pathology: Management and Consulting

2017 ◽  
Vol 45 (7) ◽  
pp. 1012-1021
Author(s):  
Shambhunath Choudhary ◽  
Tanasa Osborne ◽  
Rick R. Adler ◽  
Kevin S. McDorman ◽  
John E. Dillberger ◽  
...  
Keyword(s):  
Career Development ◽  
Career Transition ◽  
Pharmaceutical Companies ◽  
Career Transitions ◽  
Annual Symposium ◽  
Career Changes ◽  
Contract Research ◽  
Strategic Approach ◽  
Research Organizations ◽  
Transition Points

In the constantly evolving field of toxicologic pathology, a pathologist’s career is often characterized by multiple career transitions. However, these transitions can be challenging and/or overwhelming and may require a shift in focus, strategic approach, and acquisition of new skills and expertise. In order to provide a forum to discuss challenges associated with career transitions and skill set/competencies required to navigate career changes effectively and successfully, the Career Development and Outreach Committee of the Society of Toxicologic Pathology (STP) sponsored a career development workshop entitled “Transitions in a Pathologist’s Career” in conjunction with the STP 36th annual symposium. The presentations at this workshop provided perspectives of managers from pharmaceutical companies and Contract Research Organizations as well as consultants. This article is designed to provide brief summaries of their talks in this well-received career development workshop.

scholarly journals The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promises

2018 ◽  
Vol 46 (8) ◽  
pp. 1006-1012 ◽  
Author(s):  
Shambhunath Choudhary ◽  
Audrey Walker ◽  
Kathleen Funk ◽  
Charlotte Keenan ◽  
Imran Khan ◽  
...  
Keyword(s):  
Career Development ◽  
Review Process ◽  
Panel Discussion ◽  
Study Data ◽  
New Drugs ◽  
Information Technology Professionals ◽  
Pharmaceutical Companies ◽  
Annual Symposium ◽  
Fda Approval ◽  
Research Organizations

The Standard for the Exchange of Nonclinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies that enables the U.S. Food and Drug Administration (FDA) to modernize and streamline the review process. As a result, patients may benefit from speedier approval of new drugs. However, SEND implementation and compliance can be challenging and require effective cooperation between pharmaceutical companies and contract research organizations. In order to improve Society of Toxicologic Pathology (STP) members’ awareness about SEND, including the steps, obstacles, and mistakes to avoid in its implementation while applying for FDA approval, the Career Development and Outreach Committee of the STP sponsored a career development lunchtime series panel discussion entitled “The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promise” in conjunction with the STP 37th Annual Symposium. The presentations and discussion at this workshop provided perspectives of experts including pathologists and information technology professionals familiar with the SEND submission process and FDA reviewers. This article is designed to provide brief summaries of their talks as well as the questions asked during this well-received panel discussion.

scholarly journals Contract Research Organization (CRO): An Important Partner to Biotechnological and Pharmaceutical Companies

2019 ◽  
Vol 9 (4-A) ◽  
pp. 759-761
Author(s):  
Rada Santosh Kumar ◽  
Sangbit Paul
Keyword(s):  
Research And Development ◽  
Pharmaceutical Companies ◽  
Contract Research Organization ◽  
Contract Research ◽  
Drug Registration ◽  
Research Organizations ◽  
Drying Up ◽  
Pharmaceutical Industries ◽  
The Cost ◽  
New Compounds

With the ever increasing Research and Development cost for the pharmaceutical industries, the cost of bringing a drug to market was increasing drastically. The funds for drug development was drying up and thus to maintain a healthy profit margin , the pharmaceutical companies have adopted to frame out research and development (R&D) to Contract Research Organizations (CRO’s). The CRO’s have become an important partner to biotechnological and pharmaceutical companies, in the development of new compounds and at the same time in drug registration also it has extended its hands. Out of 20, 19 pharmaceutical companies have invested in emerging markets like China, India, Russia and Latin America since clinical research is accessible to these markets due to adoption of ICH and GCPs guidelines. The traditional nature of CRO’s have changed and they will develop into a formidable industry in near future.

scholarly journals Practical Strategies for Navigating Toxicologic Pathology in One’s Early Career…and Beyond!

2018 ◽  
Vol 46 (8) ◽  
pp. 1037-1048
Author(s):  
Vinicius Carreira ◽  
Gopinath Palanisamy ◽  
Erin Quist ◽  
Keith Nelson ◽  
Stacey Fossey ◽  
...  
Keyword(s):  
Career Development ◽  
Safety Assessment ◽  
Clinical Pathology ◽  
Vital Role ◽  
Early Career ◽  
Career Preparation ◽  
Annual Symposium ◽  
Research Organizations ◽  
Good Laboratory ◽  
Veterinary Pathologist

The toxicologic pathologist plays a vital role in the scientific community, using their unique blend of diagnostic and investigative skills to advance biomedical research, public health, drug discovery, or regulatory practices. But what exactly do toxicologic pathologists contribute? Where do these specialized professionals work? How can toxicologic pathologists maximize their efficiency and potential? To enlighten students and trainees, as well as early- or mid-career toxicologic pathologists, or even those approaching retirement, the Career Development and Outreach Committee of the Society of Toxicologic Pathology (STP) sponsored a career development workshop entitled “Practical Strategies for Navigating Toxicologic Pathology in One’s Early Career…and Beyond!” in conjunction with the STP 37th annual symposium. The workshop featured toxicologic pathologists from contract research organizations and the pharmaceutical industry, who provided their perspectives on career preparation, evolving veterinary pathologist roles within various sectors of toxicologic pathology, the fundamentals of safety assessment, logistics of projects involving good laboratory practices, tools for effective interpretation and communication of anatomic and clinical pathology results, and a recap of scientific resources available to support the toxicologic pathologist in his or her journey. This article provides brief summaries of the talks presented during this career development workshop.

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