Imvax tackles solid tumours head-on with faster document reviews
Imvax, Inc. has a rich history of innovation when it comes to battling tumours with personalized immunotherapies
In-house experts draw on many decades of experience in biopharma development, which they bring to bear on their strategy to deliver a portfolio of therapies targeting solid tumours.
They wanted document owners to spend less time chasing contributions, collating feedback and documenting changes, with a goal of ultimately delivering on its mission to get its transformational tumour therapies approved and into the hands of patients faster.
We spoke to the Former Head of Program Management, Imvax with 20+ years of global specialty pharmaceutical experience in rare disease and diverse therapeutic areas, with a concentration in GI. Previously holding senior roles at Radius Health, Idera Pharmaceuticals, Shire Pharmaceuticals, Otsuka Maryland Research Inst, and ICON.
Supporting Imvax’s mission in the past, now and in the future
According to Imvax’s Former Head of Program Management, Ideagen was essential in supporting Imvax to achieve its objectives in 2022, which were considerable for a small company.
“Imvax recently made a filing to the FDA and the number of documents we had in review was substantial, with each one requiring multiple review cycles.”
The filing was ultimately successful and Imvax has credited Ideagen PleaseReview with helping to achieve this goal.
“It helped us efficiently get through each review in a timely manner.
We could ensure all comments were collated, reconciled and adjudicated within a specified timeframe.
“The tool has definitely improved our ability to ensure consistency across documents. It also allows us to ensure that we have the appropriate individuals reviewing each document and that we conduct our reviews in a timely and
disciplined manner.
She says that “it greatly organised how we reviewed documents; it allowed us to be disciplined in our review process.
Additionally, we’ve used Ideagen PleaseReview extensively for collaboration on documents across a number of different functional areas throughout the company.”
Supporting Imvax’s mission in the past, now and in the future
According to Imvax’s Former Head of Program Management, Ideagen was essential in supporting Imvax to achieve its objectives in 2022, which were considerable for a small company.
“Imvax recently made a filing to the FDA and the number of documents we had in review was substantial, with each one requiring multiple review cycles.”
The filing was ultimately successful and Imvax has credited Ideagen PleaseReview with helping to achieve this goal.
“It helped us efficiently get through each review in a timely manner.
We could ensure all comments were collated, reconciled and adjudicated within a specified timeframe.
“The tool has definitely improved our ability to ensure consistency across documents. It also allows us to ensure that we have the appropriate individuals reviewing each document and that we conduct our reviews in a timely and
disciplined manner.
She says that “it greatly organised how we reviewed documents; it allowed us to be disciplined in our review process.
Additionally, we’ve used Ideagen PleaseReview extensively for collaboration on documents across a number of different functional areas throughout the company.”
Imvax recently made a filing to the FDA and the number of documents we had in review was substantial. […] Having Ideagen PleaseReview helped us efficiently get through each review in a timely manner.
Imvax’s main challenges
The Head of Program Management is responsible for ensuring that all of Imvax’s teams are aligned.
Previously, Imvax was using its document repository system to facilitate its internal document reviews.
However, it was noted that “It was difficult to control the review process when multiple parties were involved.
People could change things and forget to track their changes; version control became a significant issue; and there was limited visibility to who had reviewed and changed a document.
Ultimately, these issues became a source of growing frustration within the organization.”
Imvax’s main challenges
The Head of Program Management is responsible for ensuring that all of Imvax’s teams are aligned.
Previously, Imvax was using its document repository system to facilitate its internal document reviews.
However, it was noted that “It was difficult to control the review process when multiple parties were involved.
People could change things and forget to track their changes; version control became a significant issue; and there was limited visibility to who had reviewed and changed a document.
Ultimately, these issues became a source of growing frustration within the organization.”
The main challenges
Not hitting timelines
Deadlines missed due to lengthy and inefficient review process
Lack of version history
Difficult to keep track of changes to the document. Some reviewers’ work would be overwritten and lost
Unstable review platform
Needed a stable review environment that would accommodate vast documents without slowing down or crashing
Limited control of review cycle
Difficult to manage deadlines. No clearly defined start and end points for the review cycle and no ability to track progress against deadlines
External collaboration
Difficult to collaborate securely in the document with external partners
Large, cross-functional review teams
All document reviews at Imvax are cross-functional and simultaneous review is often necessary
Administrative burden
It was difficult for the document owner to consolidate comments from multiple different versions of a document
Formatting Issues
Issues with document formatting being maintained across versions
Accelerating document reviews
The Former Head of Program Management knew they could quickly and easily resolve the problems their colleagues at Imvax were facing.
“I had previous experience using Ideagen PleaseReview and knew it was an effective review platform that would facilitate us maintaining definitive, disciplined review cycles.
We can assign the document—even portions of the document—to specific reviewers.
The review tool details page and activity tracing, which helps to keep reviewers accountable.”
Additionally, for Imvax, the ability to have real-time conversations in the document with colleagues across different functions was invaluable.
“All of our reviews are cross-functional. Everyone can work on the document simultaneously and see what other reviewers are saying.
If you have a question for a specific team member, you can easily highlight what you need them to answer.
“The ability to see, and resolve, issues in real-time saves us a lot of time.”
Results
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Create higher quality documents with a full audit trail of document activity
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Streamline review cycle by 65% and increase efficiency
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Create culture of transparency and reduce costs
Ideagen PleaseReview provides a more stable and disciplined environment for document reviews. It’s a much more viable tool to use when you’re trying to get things done and stick to timelines.
Discover Ideagen PleaseReview
Are you ready to discover how Ideagen PleaseReview could save you 65 hours for every 100 hours spent on a document review? Request a quick demo today to discover how others in your industry have achieved this.