Understanding What Happens Before the RFP Lands on Your Desk (1/7)
You receive an RFP with a two-week deadline, a protocol to review, a budget target that feels aggressive, and maybe a few background slides about the indication. But here's what that RFP doesn't tell you: you're seeing just the tip of an enormous iceberg.
What you don't get with that RFP is the context of everything that happened before it reached your desk: the years of discovery work, the tens of millions of dollars already invested, the strategic decisions debated at the highest levels of the organisation, and the career-defining pressure your Sponsor is carrying right now.
You don't need all those details to execute your project successfully. But understanding what came before the RFP fundamentally changes how you interpret what might otherwise seem like difficult Sponsor behaviours.
Why This Matters to You as a CRO PM
Many PM/PDs treat each project as if it starts when they receive the RFP. They see Sponsor pushback on budget as being cheap. They see timeline urgency as unreasonable pressure. They see protocol rigidity as inflexibility. They see frequent status requests as micromanagement.
Having worked both on the pharma side and the CRO side, I can see what CRO PM/PDs who've never had pharma experience are missing and how much that missing context costs them in client relationships.
When you've only worked on the CRO side, you naturally interpret Sponsor behaviour through an operational lens. But when you've seen the pharma side, you understand the context behind those behaviours: the years of investment before the RFP, the stakeholder pressures driving decisions, the strategic constraints shaping requests. That understanding completely changes how you respond to clients, position recommendations, and build partnerships.
The PM/PDs who understand the pre-RFP journey (whether through direct pharma experience or through intentional learning) see something completely different than their peers. They see budget consciousness as financial stewardship of a massive investment. They see timeline urgency as protecting precious patent life. They see protocol rigidity as the result of months of strategic alignment. They see status requests as a Sponsor managing multiple stakeholders you can't see.
That perspective shift (from transactional to partnership) is what separates good PM/PDs from exceptional ones. It's the foundation of the strategic partnership approach that wins more work, builds stronger client relationships, and makes you invaluable to both your CRO and your Sponsors.
You don't need pharma experience to gain this perspective. But you do need to actively seek to understand the world your Sponsors are navigating.
The Moment Everything Changes: The Go/No-Go Decision to Phase I
Your Sponsor's journey to Phase I readiness varies dramatically depending on their business model and strategy. Understanding these different paths helps you appreciate the context behind their decision-making and urgency.
Path 1: Internal Discovery (The "Home-Grown" Asset)
This is the classic drug discovery path that most people envision (figures are just example):
Target Identification (Year 0-2): Scientists identify a biological target. Perhaps a protein that's overexpressed in certain cancers, or a receptor that's malfunctioning in a neurological disease. This phase involves extensive literature review, computational modelling, and preliminary validation studies.
Hit-to-Lead Optimisation (Year 2-4): Once they have a promising target, medicinal chemists screen thousands or millions of compounds looking for "hits" (molecules that show some activity against the target). Then comes the painstaking work of optimising those hits into "leads" (compounds with better potency, selectivity, and drug-like properties). During this phase, companies might synthesise and test hundreds of chemical variants, each one hoping to improve on the last. They're optimizing for multiple parameters simultaneously: Does it work against the target? Can it get to the right place in the body? Will it be safe? Can we make it at scale? Can we patent it?
Lead Selection and IND-Enabling Studies (Year 4-5): Eventually, they select one (or sometimes a few) lead compound(s) to take forward. This is when serious money starts flowingβthey're committed to this molecule now, and the preclinical safety and efficacy studies required for an IND (Investigational New Drug) application begin in earnest.
By the time they're ready to file the IND and start thinking about Phase I, this Sponsor has invested:
5-10 years of work
Several million to tens of millions of dollars
Multiple scientists' careers (some researchers spend their entire professional lives on one program)
Significant organisational credibility (internally, leadership has been watching this program's progress closely)
Path 2: In-Licensing (The "Strategic Acquisition")
Not every asset comes from internal discovery. Many companies, particularly mid-size biotechs, build their pipelines through in-licensing:
A biotech identifies a promising molecule being developed elsewhere (maybe an academic institution, maybe another company that's decided it doesn't fit their strategic focus). After extensive due diligenceβreviewing all the preclinical data, assessing the patent landscape, evaluating the competitive environmentβthey negotiate a licensing deal.
These deals are complex. The biotech might pay:
Upfront licensing fees: Often millions of dollars just for the right to develop the asset
Milestone payments: Additional payments as the program hits development milestones (IND filing, Phase I completion, Phase II start, etc.)
Royalties: Percentage of future sales if the drug makes it to market
When this Sponsor comes to you with an in-licensed asset, they've already written a substantial check before any clinical work begins. They're now betting their company's resources and reputation that they can succeed where others haven't yet, or that they can develop the asset more effectively than the original owner.
Path 3: Acquisition (The "All-In" Bet)
Sometimes a company doesn't just license an asset. They acquire the entire company that owns it. This is the highest-risk, highest-stakes entry point into Phase I.
Imagine a mid-size pharma company acquires a smaller biotech for $500 million. The crown jewel of that acquisition is a single molecule that's Phase I-ready. The acquiring company's board, shareholders, and leadership are all watching this program intensely. The integration teams are working to merge the two organisations. The press releases have gone out announcing the strategic rationale.
When that Sponsor comes to you for the Phase I study, they're not just executing a clinical trial. They're validating a half-billion-dollar acquisition decision. The pressure they're under is extraordinary.
What This Means for the RFP You Just Received
Regardless of which path brought your Sponsor to Phase I readiness, by the time that RFP lands on your desk:
They've already invested massive resources:
If it's internal discovery: 5-10 years and $10-50M+
If it's in-licensed: Immediate upfront fees ($5-50M+) plus milestone commitments
If it's an acquisition: Potentially hundreds of millions to billions of dollars
They're under enormous pressure from stakeholders:
Investors watching for progress and return on investment
Board members who approved the program and expect results
Internal leadership whose strategic credibility is tied to this program
Scientists whose life's work is now moving to human testing
Regulatory teams who need to demonstrate the company's development capability
The timeline isn't arbitrary:
Patent clocks are ticking (typically 20 years from initial filing, and years have already passed)
Competitive intelligence reports other companies working on similar targets
Financial models project revenue based on specific launch dates
Investor presentations promised certain development milestones
The budget isn't just about saving money:
Every dollar spent on Phase I is a dollar not available for Phase II or Phase III
Financial analysts and investors are watching the burn rate
The company may be managing limited cash reserves carefully
Budget overruns can trigger difficult board conversations
The Pressure Compounds: What Happens During Phase I
Once Phase I begins, the pressure doesn't decrease. It intensifies. Here's what your Sponsor is managing that you rarely see:
Regular Board Updates: Quarterly (or more frequent) reports on program progress. Timeline slips aren't just operational issues. They're board-level conversations that can affect leadership careers.
Investor Relations: For publicly-traded companies, Phase I progress gets discussed in earnings calls. Their stock market analysts are tracking enrolment rates and timeline adherence. Stock prices can move based on clinical trial updates.
Internal Competition for Resources: That budget you're executing isn't unlimited. It's competing internally with other programs, other priorities, and other needs. When your project goes over budget, it's not just your Sponsor's problem. It's a resource allocation issue that affects other programs.
Scientific Publication Timing: Many Sponsors plan to present Phase I data at major medical conferences (ASCO, ASH, etc.). These presentation slots are prestigious and competitive. They're scheduled months in advance. If your study isn't ready to read out when promised, they lose that opportunity and the visibility that comes with it.
Partnership Discussions: Often, Sponsors are conducting partnership discussions (with larger pharmas, for instance) based on planned Phase I timelines and data. Delays can derail these discussions.
Practical Application: Before Your Next Kick-Off Meeting
Before your next project kick-off, invest 30-60 minutes researching your Sponsor's journey (or ask them directly about it):
About Their Company:
Is this a small biotech with a single asset or a diversified portfolio company?
What's their funding situation? (Recent raises? Public vs. private?)
What have they publicly announced about this program?
What's their organisational experience with clinical development?
About This Asset:
How long has it been in development?
Is it internal discovery, in-licensed, or part of an acquisition?
What therapeutic area? What's the competitive landscape?
What's the mechanism of action? (This affects the complexity they've already navigated)
About Their Constraints:
What's driving their timeline urgency?
What's behind their budget constraints?
Who are they reporting to?
What metrics are they being measured on?
Create a one-page "Sponsor Context Brief". Document these insights before kick-off. This becomes your reference for every strategic decision throughout the project.
You don't need to know everything. But having this context helps you (and your team) ask better questions, make smarter decisions, and position your recommendations in terms that resonate with their reality.
Note: Understanding how to gather and apply this context strategically is exactly what we develop in clinical research project management mentoring. Moving PMs from task execution to strategic partnership.
The Mindset Shift
When you receive your next RFP, pause before jumping into the operational details. Ask yourself: What journey did this Sponsor take to get here? What's at stake for them that I can't see? How can I position myself as a partner who protects their investment rather than just a vendor executing a scope of work?
That mindset shift, from "What does this difficult Sponsor want from me now?" to "How can I help this partner succeed?", is what separates good PMs from exceptional ones.
And it all starts with understanding the landscape they traveled before you even entered the picture.
In the next post, we'll explore the preclinical journey in detail. The years of work, the specific studies, and the regulatory milestones that must happen before any Sponsor can even think about dosing the first human. Understanding this technical journey will give you even deeper appreciation for why your Sponsor behaves the way they do when things don't go according to plan.
