Princeton, New Jersey

Department Page

Development

Pre-Clinical and Clinical Trial Design and Conduct

Department Chair

Name
[Company / Consultancy / Service Provider] 
[Title]

[Several sentences description of qualifications]
[Relevant professional association memberships]

[Link to LinkedIn/ Organization] 
[V-Card]

Advisors

Name
[Company / Consultancy / Service Provider]

[Title]

[Link to LinkedIn profile or Organization 

[V-Card]

Name
[Company / Consultancy / Service Provider]

[Title]
[Link to LinkedIn / Organization]

[V-Card]

Write your awesome label here.

Introduction to the Department

Courses

Pre-Clinical

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[Instructor photo]
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[Title and Employer]

Toxicology

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Clinical

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[_________]

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[Example of resources from Intellectual Property Department Page]:

Invention Disclosure Form

Your company or institution should have an approved version of the form, which you should, of course, use.  However, you should be aware of what is on it and ensure that it and the process for documenting patentable ideas are known in the organization.

Invention Questionnaire

While the Invention Disclosure Form is important to capture ideas as they emerge, it is really just the trigger for a more in-depth discussion.  It can also be useful for all managers to understand the nature of such discussions, and the questionnaire can help get you ther.e.

Patent Timeline Template

Having a clear understanding of the life cycle of your company's current products, those in development, and those being looked at by Business Development is critical.  Use the template not only for your understanding, but also to communicate about the products.

Presentation Template

Use this template if you would like to teach all or part of the Patent Term course in your own organization. 


 

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Checklist / SOP / Field Manual Section

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RFP for patient support services

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Sample budget for department

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Org chart samples with commentary 

Clinical Trial Registries

Clinicaltrials.gov

Publications and Websites

Concepts in Pharmaceutical Biotechnology and Drug Development - Springer Nature - 

<a href="https://www.benthamscience.com/journal/adctra">Applied Drug Research, Clinical Trials and Regulatory Affairs | Bentham Science</a>

Country specific IP issues and resources

Valentina Jaramillo DVM is co-founder of Investigacion Clinica Latam. She is also founder and moderator of the twitter hashtag #hcsmla. She can be contacted at vale.jaramillo@gmail.com.






In the U.S. about 200,000 patents are issued each year.

In the U.S. about 350,000 patent applications are filed each year.

There are about 8,000 patent examiners in the USPTO

USPTO Technology Center 1600 handles drug and biologic therapies and diagnostics Most patent examiners are attorneys

Patent examiners are divided among nine centers, each with a different technology focus.

The average amount of time a USPTO examiner spends with a patent is 19 hours.

Most patents have no, or very limited, commercial value.

About 3% of patents have a Patent Trials and Appeals Board hearing or litigation

Article 1, Clause 8 of the U.S. Constitution provides for a patent and trademark system

Length of time a patent lasts is 20 years plus extensions

Internal POA Notes for this page





Bioagylytix

Science Note
   In vitro
   In vivo
   In silico





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