“Better science will not speed up a drug launch if the portfolio head doesn’t know which resources are committed, which programs are competing for the same regulatory window, and what a go/kill decision on one compound means for every other. That is not a science problem. That is a sight problem.“
Blog Highlights
- Portfolio management software enables portfolio heads to get real time insight into the progress of programs, their resource utilization, financial investment, regulatory issues and the portfolio risk.
- The decision to Go/Kill in Pharma has implications at the portfolio level, not only at the program level. A robust PPM solution will expose how Go/Kill decisions can impact common resources, CRO agreements, regulatory timelines and the overall drug pipeline.
- Your ideal pharma PPM software will offer stage-gate management, go-kill decision capabilities, resource management, and forecasting as well as monitoring of regulatory requirements, and risk management with a strong reliance on data and information.
- Kytes allows Pharma teams to transform their portfolio visibility into a competitive portfolio advantage by bridging program delivery, resource management, financials, compliance records, and dashboards on a single platform.
- Kytes AI gives pharma portfolio teams the early awareness to recognize the timeline risks, the resource constraints, and the drivers of cost variation before they impact their ability to meet regulatory targets, and their timelines.
The Sight Problem That Science Cannot Solve
A pipeline decision is never about one compound. A go/kill decision on a Phase II compound at a pharma generics company that had a portfolio of twelve drug programs in three therapeutic areas resulted in… “3 of the CRO shared resources were redeployed. 2 regulatory submissions were moved out with new timelines. The most skilled bioanalytical scientist on one Phase III program was pulled out for 6 weeks. ” ppm software told you that this compound was killed.
It did not translate that into a portfolio impact.
All the data was in the platform. The platform did not understand it. This is the pharma portfolio problem. Pharma programs don’t often fail due to bad science – they fail due to the dashboard not showing you the correlation between a kill decision in one program and the impact to another program.
Project portfolio management for pharma is software that does just that – and it does it long before you need it.
Why Every Go/Kill Decision Is Riskier Than Your Platform Shows
A go/kill decision isn’t just a program decision – it’s a portfolio decision. If a Phase II compound is stopped, that impacts the shared resources it holds, the CRO agreements it holds, the regulatory team time it occupies. Most pharma PPM platforms will show the compound that has been stopped. What that compound stopping means for the other molecules in the pipeline is typically not shown.
A budget shift in one phase cascades down the financial forecast for every downstream program.
Traditional portfolio management tools look at each program individually. There’s no visibility into how a shift in one compound impacts the resource availability, cost profile or regulatory timing of others. Portfolio leadership knows how each individual program stands. They don’t know what the risk looks like to the entire portfolio.
Connecting projects across the pharma pipeline isn’t a data problem. The data is there; stages are reported, time is captured, risks are logged. The real challenge lies in translating all that data into real-time insights so a portfolio head can make timely, data-driven decisions with significant impact.
Take resource planning for example. The bioanalytical scientist with the required expertise is required for the upcoming Phase II trial, but she’s already tied up in Phase I, which is running six months behind schedule. The portfolio management software won’t indicate this until the program lead discovers it in the weekly team meeting, four weeks after the decision could have been made. Pharma companies lose roughly $1.3 billion per day a blockbuster drug launch is postponed – and disconnected data leading to suboptimal decisions contribute to this financial drain.
These decisions don’t happen in isolation. The ripple effect through the pipeline can be significant. A delay of one week in the Phase II trial can cause a delay of four weeks for the start of the Phase III trial if the same regulatory group is tasked with first finalizing the Phase II submission. That four-week Phase III delay could lead to missing a regulatory window, and thus add several months to the market timing for a blockbuster product-none of which would be visible with a system focused on tracking each individual project.
What Pharma Project Portfolio Management Software Must Deliver
Stage-gate management with connected impact
Each stage gate needs to flow into the next-from candidate selection to Phase I, II, III, and submission and beyond. When a program does not make it through a stage gate, the platform needs to flag (i.e., automatically alert) all the implications on other programs for cost, regulatory status, and resource utilization.
Go/kill decision support
A go/kill decision involves more than a program status. It involves the ability to see the impact to the common resource pool, contracted CRO agreements and regulatory deadlines if the program is shut down. All of this should be readily available on the platform pre- decision – and not a static spreadsheet after the meeting.
Resource management across CRO, CDMO, and internal teams
Real time visibility on allocation and usage and forecasts on future demand for resources are key. Pharma portfolio teams have the obligation to maximize use of its internal scientists, along with the use of external partners (CROs, CDMOs).
Project portfolio visibility across the full pipeline
You should be able to see how every program, in your portfolio is tracking, what the risk and cost is, and where the project sits against the schedule. In a single view, Red/amber/green. Who’s on track, who is off track. This must not involve creating a report.
Financial forecasting tied to program milestones
Pharma programs are project based – costs are per program, not per person. There are no fixed costs. They move and grow and shrink based on program stage, timelines, CRO contracts change, or a new, more costly, phase begins. The forecast needs to move and change with the program, automatically.
Regulatory compliance tracking
Each program should have a compliance record of the submissions, audits, dossier updates and approvals; these must be linked to the program plan, not kept on a separate system that you’ll then need to reconcile separately.
Data driven risk management
The risk in pharma does not have to wait till the quarterly review. If there is a risk to a particular milestone, the programme team as well as portfolio heads must be notified as soon as it becomes evident.
How Kytes Turns Portfolio Visibility into Portfolio Decisions
The Kytes platform provides program delivery, resource management, financial management, compliance tracking and a single dashboard view for the portfolio in one integrated platform. No reconciliation between multiple tools, no more weekly report construction, just open and view the portfolio overview in the head of portfolio view.
Stage-Gate Process Management
Kytes maps the NPD process via stage gates to guide programs. A stage gate outlines the tasks that need to be completed, along with how these will be assessed and who has final sign off to continue. At gate transition, subsequent stages are automatically initiated with appropriately sequenced tasks and assigned resources and timelines. Kytes supports pharma resource managers to effectively utilize and allocate resources at all stages of the process and, when programs get stuck at a stage gate, identifies how shared resources and timelines are affected.
Resource Management Across Internal and External Teams
Kytes addresses demand and allocation of resources to scientists internally, CRO partners, CDMOs and shared service teams. Heatmaps highlight who is overloaded, who is competing for the same resources, and where the bottlenecks will be – weeks in advance of becoming a delivery issue.
Go/Kill Decision Support
When considering a go/kill decision, Kytes displays the impact to the portfolio prior to final approval of the go/kill decision. It indicates what resources will be freed up, which programmes will benefit and the financial implications on the existing portfolio. The Portfolio Manager receives this information fully informed, rather than through disparate program information.
AI Project Management Software Capabilities
Kytes AI looks for portfolio-wide patterns that you’d never find through manual review: • Identifies projects at risk of missing delivery date – based on prior stage completion rates. • Detects the emergence of resource constraints across the portfolio. • Reveals trends in cost variance prior to a breach. This is AI project management, for the portfolio.
Project Portfolio Visibility Software Built for Pharma
Kytes provides the right view for everyone involved. The view that the program manager has about the status of tasks and milestones; the one for portfolio executives about program health and the overall pipeline; that for the finance department regarding actuals versus budget and projections; that for regulatory professionals on compliance and submissions – all based on one shared and up-to-the-minute data set.
Dossier and Document Management
All regulatory documents, approval records, and audit trails reside in Kytes alongside the program plan. Dossier submissions include version control, assigned reviewer tracking and approval workflows within the system.
Risk Management That Does Not Wait for the Quarterly Review
Kytes builds risk management at the portfolio layer. Each program is tied to a program-specific risk register linked to the program’s milestone plan. When a risk is realized the platform will highlight its impact to the program and the portfolio. Program teams will mitigate the risks at the source, while the portfolio manager will see their aggregate portfolio risk.
The platform tracks and highlights risks by type – timeline risk, regulatory risk, resource risk, and financial risk – in real-time on live portfolio dashboards. A newly identified Phase II program risk would be visible at the portfolio manager’s level alongside the current program’s budget, resources and stage-gate status. They have a holistic view, and can act.
This is data-driven risk management at the portfolio layer. It doesn’t occur on a quarterly basis or a weekly status meeting; it happens continuously on the platform where the work resides.
When the Portfolio View Becomes the Business Decision
Kytes ensures this linkage by providing an view that connects program performance to business objectives. This allows the portfolio head to know which programs are on track, which programs are demanding excessive resources, and which programs should be prioritized higher.
Kytes puts this visibility into effect instantly. Portfolio dashboard views provide instant access to program performance, resources, financial data, compliance status, and-most important-their relationship to business objectives. Portfolio heads know which parts of the portfolio are doing well, which are at risk, and where the pipeline can benefit from reallocating resources.
The scientific work required at this level-linking progress toward discovery to the commercial enterprise-demands clarity of alignment with business goals. Kytes highlights this link not quarterly but on a day-to-day basis. This is what differentiates the true project portfolio management, PPM, tool from a project management tracker: It not only tells what’s going on, but what it means for the business, and what the team should do about it.
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