Transcript - Demo Video
“We find that although there is a lot of information available in the Pharma industry, the information is quite fragmented and it takes a great deal of time to sift through it.”
“The purpose of Pharma Hub is to provide a single, reliable source of consolidated information that can be used to make strategic business decisions and improve a company’s likelihood of success.”
“Pharma Hub efficiently integrates known and reliable data sources so that companies can research complex scenarios and assess a wide variety of business opportunities in a matter of minutes.”
“After all, speed and direction are only valuable if you have confidence in the quality of your information.”
“At Pharma Hub, you will find the answers to your high-level strategic questions and ultimately be able to drill down into the significant details that you need to plan your next move.”
“Experience less research; More execution; And greater return with Pharma Hub.”
(pause)
“In this demo, we will walk through a couple of examples of how Pharma Hub works.”
“But before we jump into the first example, let’s take a look at the website.”
“Across the top of the site there is a navigation bar that outlines the various sections of our site.”
“Each section allows you to search a different set of criteria.”
“The ‘Product’ section is where you will spend a lot of time, so let’s jump into our first example there.”
“What if you want to know which products have no more than 3 DMF holders…?”
; “Have no more than 5 generic suppliers…?”
; “And are injectables?”
“This seems like a straightforward question; however, anyone that has done the research required to answer this question knows that it can involve searching through several information sources and spending a lot of time on digging through them, only to find that the information is not always accurate.”
“At Pharma Hub, our goal is to not only answer these types of questions, but to do so in a swift and precise manner.”
“You will see that with a few keystrokes, you can not only answer this question, but also create a query that can be saved so that you can run the query again once a month…”
; “Once a week…”
; “Or even every single day, depending on what timeframe is important to you.”
“Let’s get started by clicking on the product tab in the navigation bar and selecting ‘comprehensive report’ from the drop-down list.”
“Next, click the ‘Add Product Filter’ tab, and you will see a pop-up that gives you various input options for product criteria.”
“To address our product filter for this example, select API criteria, and then select DMF holders.”
“You will see 3 boxes appear.”
“The first box is the criteria you have selected.”
“The second box provides search options.”
“In this case select Less than or equal to.”
“The third box allows you to enter a value for your search option.”
“In this case you will either type the number 3 or select it from the dropdown.”
“This has established a search criterion of less than or equal to 3 DMF holders.”
“Now, let’s add our second product filter by clicking the ‘product filter tab’ again”
“You will then select ANDA slash NDA Criteria on the left”
“Once selected, on the right-hand side you will see various options related to ANDA slash NDA filers.”
“In this case select Count of ANDA Holders.”
“When the three boxes appear again, click on the middle box and select the filter option ‘Less than or equal to’ and enter ‘five’ into the third box.”
“This has added the search criteria of less than or equal to 5 ANDA holders to go along with our initial criteria of less than or equal to 3 DMF holders.”
“Finally, we will add our last product filter and then review the results.”
“Click the ‘add product filter’ tab one more time.”
“Then select finished dose criteria on the left and dosage form on the right”
“In the middle box choose ‘equals,’ and then in the right-hand box type I-N-J.”
“You will see injectables appear in the search results.”
“Select injectables.”
“Now click ‘search’ to run the query.”
“The table that appears shows a list of all products that have less than 3 DMF holders…”
; “Less than 5 ANDA holders…”
; “And are injectable products.”
“You will notice on the bottom left hand side of the screen that there is a box that allows you to increase the number of entries displayed on each page of the table.”
“Additionally, all the columns can be sorted by clicking the double arrow.”
“Anything that is underlined in the table is an active link and can be clicked for more detailed information, such as this.”
“You are also able to add or remove columns from the search results by selecting the ‘Add slash Remove Columns’ tab”
“Once you click ‘Add slash Remove Columns,’ you will see all the criteria options.”
“Within each one, you can uncheck any undesired columns and they will be removed from the table below.”
“For example, if you click on ‘Other Criteria’ and uncheck the box for ‘Pharma Class’… and ‘Reference Product Label Link’… those columns will disappear in the table below.”
“If you re-check them, they will be added back to the table.”
“You can then hit ‘Close’ to save the current table.”
“At the top right of the screen you will see three icons.”
“The first allows you to hide filters.”
; “The second allows you to save your search.”
; “And the third allows you to download the table.”
“Saving the search allows you to run this search again in the future without having to go through the process of inputting each criterion.”
“The download feature converts the table into a CSV file and allows you to download it onto your desktop.”
“You can select the ‘Clear Filters’ tab at any time, and it will clear all the filters you had previously selected.”
“You are now ready for your next query.”
“What if you want to know which products have ‘Orange Book Exclusivities’ expiring between July first 2022 and July first 2024?”
“Additionally, of those products, you want to know which ones have less than or equal to 5 ‘Orange Book’ patents.”
“Finally, you're only interested in products where the total number of DMF holders is less than or equal to 5.”
“In this example, let’s say your company is targeting a PIV product to develop and file.”
“Let’s assume you need two years to develop and file the product, and let’s also assume you expect a thirty month stay from the innovator and want to launch the product shortly after that.”
“Given this scenario, we are likely targeting a product where the exclusivity expires anywhere from 2 to 4 years from today.”
“Although this seems like a complicated request, as you start to refine the criteria that are important to you, these are the types of searches you can run quickly and easily.”
“We will start by clicking on the ‘Add Product Filter’ tab.”
“We will then select ‘Orange book Criteria’ on the left, and ‘Expiration of earliest Exclusivity’ on the right”
“In the middle box, select ‘between,’ and on the right-hand side you will see a calendar tool that allows you to easily choose your dates.”
“Use the calendar tool to select July first 2022 as your start date, and July first 2024 as your end date.”
“By making these selections you will only see products whose exclusivities expire between July first, 2022 and July first, 2024.”
“To add our next filter, click the ‘Add Product Filter’ tab again”
“On the left side click ‘Orange book Criteria,’ and on the right select ‘Total number of OB patents.’”
“In the middle box select ‘Less than or equal to,’ and in the right box enter the number ‘5’”
“You have successfully added a criteria for less than or equal to 5 total OB patents”
“Finally, to add our last filter, click the ‘Add Product Filter’ tab again”
“On the left side click ‘API criteria,’ and on the right select ‘count of DMF holders.’”
“In the middle box select ‘Less than or equal to,’ and in the right box enter ‘5’”
“Finally, click ‘search,’ and the answers to our initial question of what products have orange book exclusivities expiring between July first, 2022 and July first, 2024, with less than or equal to 5 patents, and less than or equal to 5 DMF holders, will appear”
“If you click on the number in the OB patents column, additional detail on the patents pops up for reference.”
“What if you want to know who is marketing or selling an ANDA for another company?”
“For example, I want to know which products Breckenridge is promoting, and for which companies?”
“Another significant reality of today’s marketplace is that many companies develop and file drugs, and then license them out to other companies to promote, market and sell.”
“Sometimes it is difficult to keep track of who is the promoter, and who owns the ANDA or NDA.”
“It’s for this reason we created the ‘Product-Marketed-By’ feature.”
“This feature allows you to see who is promoting which product for which company.”
“Let’s explore how this feature works.”
“First, click the ‘Product-Marketed-By’ tab in the navigation bar”
“Next, click the ‘Add Product Filter’ tab, and on the right-hand side select ‘Product Marketer Name’”
“The middle box is already set to ‘Equals,’ so in the right box type ‘B-R-E-C,’ and you will see all the Breckenridge entities that you can choose from pop up.”
“hold the ‘Control Key’ in order to select multiple options, and select both of the Breckenridge listings, and then click ‘Search’”
“A table will appear with multiple columns.”
“You will see a column labeled ‘Product Applicant Name,’ and a column labeled ‘Product Marketer Name.’”
“You will notice that the’ Product Marketer Name’ is listed as Breckenridge for all products”
“However, the ‘Product Applicant Name’ shows who has filed the ANDA application, which in this case is multiple different entities”
“With this feature, you can see which companies are working with each other.”
“Ok, let’s click ‘clear filters’ to prepare for our next query”
“What if you want to know which facilities in America are registered to manufacture injectable drugs?”
“First, you will click ‘FDA Approved Facilities’ in the navigation bar, and from the drop down, select ‘Products by Manufacturing Facilities.’”
“Next, click the ‘Add Product Filter’ tab, and select ‘Dosage Form’ on the right”
“The middle box is already set to ‘equals,’ so we will type in ‘I-N-J’ into the right box”
“You will see the word ‘Injectable’ pop up, go ahead and select that to choose that dosage form for our query”
“To add our next filter, click the ‘Add Product Filter’ tab”
“Select ‘Manufacturing Location’ on the right”
“Again, the middle box is set to’ equals,’ so in the right box type in ‘United States’”
“You will see ‘United States’ pop up as the top search result. Go ahead and click that option to make your selection.”
“Please note that you will see ‘United States’ entered as the search criteria, meaning we are including the entire country in our query.”
“Go ahead and click ‘search’ and you will get a list of all the facilities in the United States which are registered to manufacture the injectable dosage form”
“You will notice that some of the FEI numbers have a red W next to them.”
“This indicates that the facility has a warning letter from the FDA.”
“If you click on the red ‘W’ a screen will pop up providing details about the company… the date the warning letter was issued… the issuing office… and the subject of the warning letter.”
“If you then click the ‘Manufacturer Name’ that is highlighted in blue, a link opens up to the warning letter on the FDA website.”
“What if you want to save your searches so that you can run them as frequently as you want in the future?”
“We understand that efficiency is critical to speed.”
“For that reason, we created a feature that allows you to save your searches, so that you don’t have to reinvent the wheel each time you need to do a search you have previously run”
“Let’s look at how you can do that”
“Let’s say you want to know which companies have a DMF for a product?”
“you can select all the appropriate criteria as we have shown you earlier in this demo”
“and then click the disk icon at the top right of the screen”
“You can name the search whatever you would like.”
“Let’s name this one ‘Injectables USA,’ and click create”
“Any saved searches will appear under ‘My Searches’ in the navigation bar.”
“Searches are sorted by the type of report, and are sorted within the table below”
“This way, if you want to run a report say, every week to see if there is a change or update; all you need to do is find the report you are looking for such as the injectables report we just saved, and click ‘view’”
Outro
“Thank you for taking the time to go through this demo with us. We understand that we have provided you with a lot of information, but we hope this demo was helpful in understanding how the Pharma Hub tool works.”
“we would greatly appreciate any feedback that you might have on the tool, or the demo”
“less research.”
“more execution”
“greater return”
“Pharma Hub”