Recomendados
Recomendados
Más contenido relacionado
La actualidad más candente
La actualidad más candente (20)
Similar a PharmaPendium - An introduction June 2012
Similar a PharmaPendium - An introduction June 2012 (20)
Más de Ann-Marie Roche
Más de Ann-Marie Roche (20)
Último
Último (20)
PharmaPendium - An introduction June 2012
- 1. Welcome to our PharmaPendium Webinar! An introduction PharmaPendium, for informed drug development decisions Your host: Dianne Baunbaek Your presenter: Pooja Jain
- 2. About us
- 3. Need to know Webinar control panel: ‘chat’ or ‘ask a question’ for questions and comments Option for full screen view Q&A after presentation
- 4. Today’s Agenda What is PharmaPendium? How do the documents appear in PharmaPendium? What is the Pharmacokinetic Module? Poll Live Demo Q&A 4
- 6. What is PharmaPendium? First product to offer both searchable FDA approval packages and EMA EPARs • 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938), • Searchable EMA EPAR content (from 1995) 6
- 7. What is PharmaPendium? First product to offer both searchable FDA approval packages and EMA EPARs • 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938), • Searchable EMA EPAR content (from 1995) Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs 7
- 8. What is PharmaPendium? First product to offer both searchable FDA approval packages and EMA EPARs • 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938), • Searchable EMA EPAR content (from 1995) Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs AERS (post-marketing events) 8
- 9. What is PharmaPendium? First product to offer both searchable FDA approval packages and EMA EPARs • 1.9M newly-searchable pages covering all of FDA history, over 70 years (from 1938), • Searchable EMA EPAR content (from 1995) Used primarily for Preclinical assessment (Safety, PK, Efficacy) and Regulatory Affairs AERS (post-marketing events) Unique Content 9
- 10. What is PharmaPendium? First product to bring together preclinical, clinical & post marketing data •Normalized terminology on searches, extracted data •Which experimental data translates, why or why not? 10
- 11. What is PharmaPendium? First product to bring together preclinical, clinical & post marketing data •Normalized terminology on searches, extracted data •Which experimental data translates, why or why not? Over 1,100,000 extracted drug safety observations •Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry 11
- 12. What is PharmaPendium? First product to bring together preclinical, clinical & post marketing data •Normalized terminology on searches, extracted data •Which experimental data translates, why or why not? Over 1,100,000 extracted drug safety observations •Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry Over 1,300,000 extracted PK parameter data, preclinical and clinical. Normalized and related the same way (structure, class, target) 12
- 13. What is PharmaPendium? First product to bring together preclinical, clinical & post marketing data •Normalized terminology on searches, extracted data •Which experimental data translates, why or why not? Over 1,100,000 extracted drug safety observations •Normalized AE/Tox terminology mapped to Class, Target, Structural Chemistry Over 1,300,000 extracted PK parameter data, preclinical and clinical. Normalized and related the same way (structure, class, target) Extracted Data 13
- 14. How do the documents appear in PharmaPendium?
- 15. FDA Approval Packages: Examples of original documents 15
- 16. FDA Approval Package Search result 16
- 17. What is the Pharmacokinetic Module?
- 18. Pharmacokinetic Module Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents.
- 19. Pharmacokinetic Module Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents. • preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions:
- 20. Pharmacokinetic Module Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents. • preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions: • Concomitant drugs, disease states, demographic differences, etc.
- 21. Pharmacokinetic Module Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents. • preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions: • Concomitant drugs, disease states, demographic differences, etc. • The level of PK data to be contained in this database is almost never published (competitive reasons) at this level of detail.
- 22. Pharmacokinetic Module Unprecedented access to Preclinical and Clinical exposure data extracted from FDA packages (current & historic) and EMEA documents. • preclinical and clinical exposure data at multiple parameters and usually under various experimental conditions: • Concomitant drugs, disease states, demographic differences, etc. • The level of PK data to be contained in this database is almost never published (competitive reasons) at this level of detail. Pharmacokinetics, preclinical and clinical, & Drug Safety databases browsable within the same platform.
- 23. POLL The poll should appear on your screen shortly…. 23
- 24. Let’s take a look at PharmaPendium ….by going to www.pharmapendium.com 24
- 26. Q&A will be sent to you by e-mail. For more information and questions please contact bdtraining@elsevier.com The next PharmaPendium webinar will on the 29th of May and will focus on Pharmacokinetics. Go to www.trainingdesk.elsevier.com/pharmapendium for all training related materials. Please fill out the survey that appears on your screen after leaving the webinar.
Notas del editor
- What do we do besides webinars and Reaxys/Embase/PharmaPendium – a broader perspective
- What can attendees expect from todays’ session?
- Hello everyone! My name is Pooja Jain and I am the Sales Development Manager of PharmaPendium. A bit about me. My experience stems from working in academia, a start-up pharma, and also a large pharmaceutical company, Eli Lilly, which all together has resulted in over 10 years of experience. And I am excited to talk about PharmaPendium today. Today’s agenda will cover an introduction as to what is Pharmapendium, how do the documents appear in PP, and what is the pharmacokinetic module in PP. We will then switch to a live demo where we will go through some examples of how you can use PP. That will be followed by a poll question where we would like to understand what kind of example you would like to see us do live based on what you would have seen thus far and then the session will be followed by a Q&A.
- So let’s now describe the first part of the webinar which is “what is pharmapendium”
- PharmaPendium is the first product to offer both searchable FDA approval packages and european packages in a searchable format. We have scanned over 1.9 million pages covering all of the FDA history since 1938 as well as the european approval documents since 1995.
- Our product is used primarily for preclinical assessment of safety, efficacy, and pharmacokinetic parameters as well as for regulatory affairs purposes when looking at the criteria necessary for making a successful application.
- And we also have AERS data which is easily searchable as well.
- Overall, we have unique content in the sense that we are the only one on the market that offers such a product due to our unpredented access to data from the FDA.
- So lets kind of go a little more at the granular level and take a closer look at PP. PP is the first product to bring together preclinical, clinical, and post marketing data together in one platform and it basically allows you to answer questions such as “which experimental data translates, why or why not?”
- We have over 1.1 million extracted drug safety observations which contains normalized adverse event and tox terminology mapped to drug class, target, and structural chemistry as examples.
- In addition, we also have over 1.3 million extracted PK parameter data in both preclinical and clinical studies.
- And the take home message here is that a lot of this data is actually manually extracted data so a lot of the data that is presented is actually a collection of data from many different documents, hence within a matter of minutes you can get access to critical data that help you make go or no-go decisions.
- Now how do the regulatory documents appear in PP?
- Here is an example of an original document. You can see that these documents can contain some really interesting data. Here we have an example of how there can be some really interesting toxicokinetic data here. So how does an original document look in PP?
- Once you conduct a search in PP and click on one of the query results, you will see the document displayed in this manner where it will take you directly to the page that is of interest to you. You can tell that the documents have not been manipulated in any manner because of the marks that you see on the page. In fact, the FDA requested that we keep these original marks in order to retain the document in its original form. Highlighted in blue, you can see an example of a term which is highlighted and indexed from the original document. You will get a better idea of looking at these documents more when we go into the live demo.
- Now let’s look at the Pharmacokinetic module. This is an add-on module to the PP platform that we have described up till now.
- The pharmacokinetic module allows you to have unprecedented access to preclinical and clinical exposure data extracted from FDA packages (both current and historic) and european documents. And by current and historic we are actually making a distinction between the documents which are offered in the PP platform versus what is offered in an additional module called the classic collection. Essentially the current platform offers all FDA documents from 1992 till present whereas the classic module offers all documents from 1938 till 1991 inclusive.
- The extracted data allows you to gain access to pharmacokinetic data at multiple parameters usually under various experimental conditions
- And you can get information on concomitant drugs, disease states, demographic differences etc.
- Now it is important to keep in mind that the level of PK data that you get access to is almost never published at the level of detail that we offer. So you get access to data that is exclusively found in PP.
- And all of the data is browsable within the same platform as the drug safety databases.
- And just to give you an idea of what kind of value PP can offer to you, let’s now go to a live demo so that I can demonstrate some examples.