The Unsung Influencer: Why Your CDMO BD Contact Matters More Than You Think
By Louis Garguilo, Chief Editor, Outsourced Pharma
You say you want the best shot at a successful CDMO selection, and subsequent relationship – one that thrives during the good times, and survives the stress of development and manufacturing challenges?
Your CDMO’s business development professional (BD) may be a good place to focus.
So says George Hlass, co-founder, Pharma Expanse, and veteran biopharma professional.
“There's a whole checklist for evaluating a CDMO,” he says, including regulatory and compliance history, technical fit, and pricing.
- Is the CDMO’s team accustomed to creative problem solving?
- Do they have the right amount of resources – including analytical – and the requisite equipment and capacity?
“It's a competitive CDMO market,” says Hlass, and considering a 'BD metric' can be helpful. “If you send out 5 or 10 RFPs, you're usually reaching out to a few CDMOs that check all the boxes.”
Pricing, for example, might be within a 5% or 10% delta. Each CDMO being considered could have a good regulatory history, and capable of taking on the project.
“You may go down the lists checking the boxes and find two CDMOs are similar across many factors,” Hlass says.
When you do have multiple CDMOs with little differentiation, look at what might be considered “the next level of determining factors” to aid your decision-making for selecting among those CDMOs.
“Among those, the BD’s role could add important insight.”
Why Focus On Your BD Contact?
Outsourced projects can be long in duration, even require multiple years. There will always be challenges along the way that arise between the sponsor and the CDMO.
When issues do arise, you’ll want a BD to be a voice for the customer’s position, but also someone who has earned credibility within their organization.
They also need to be adept at articulating the challenges and limitations to the customer that their CDMO may face.
Therefore, drug sponsors must work to understand where their BD contact fits within the CDMO.
- How are they treated internally? What kind of actual influence do they have?
- Do they have relationships with their senior management? How about with the site heads, or the project managers?
“You need to assess whether these internal relationships translate into actual influence on decisions or positions the CDMO might take,” adds Hlass.
The last thing you want from an external partner is a muddled message.
The main point for Hlass here is that an effective BD can understand and articulate the challenges for both sides.
Judging The BD’s Influence
With that said, how can you determine the extent of the internal relationships and influence your BD contact has with the CDMO that you’re evaluating?
Hlass says there are at least three signposts.
1. Responses Come Quickly
First off, note during the initial RFP process – when questions and some negotiating arises – if that BD can provide quick and coherent responses. If you send over a CDA or draft supply agreement, are they able to work within their organization to have these agreements prioritized?
2. Takes Part in Discussions
You can evaluate how the BD interacts when you're in the meetings and discussions with senior management, project teams, and other technical or scientific members of the CDMO.
- Do they actively participate in discussions?
- How do their team members react to the BD’s statements or questions?
- Are they generally trying to understand if the project is a good fit with the site’s experience and capabilities?
“It's something that you can actively evaluate during the process,” says Hlass. “Watch the interactions between all sides, whether it's in the beginning for an RFP clarification call or a monthly project meeting."
3. Participates In Site Visits
Is the BD present and an active member when you make your site and facility visits?
If they are there and active, it’s a clear indication they are tightly integrated and valued internally.
“I recognize it isn’t always possible to attend,” says Hlass, so some leeway is warranted, “but if it's an important onsite meeting, then the BD should be joining, or at minimum dialing in for key discussions.”
What Are The Internal Challenges?
In many CDMOs, says Hlass, “there can be a natural conflict between operations and the business development team.”
At some companies, decision-making regarding whether to bring in a project remains with the BD to a larger extent, while at others it sits squarely with the technical or site teams.
Hlass offers an example.
"Thinking back on an experience at the beginning of my career, I moved into a business unit in a CDMO where operations clearly had the lead – they made the final calls on accepting or declining projects.
“When I began, I brought in a project that I thought checked all the boxes – a perfect project for the site. I organized a site visit that went great, and the customer was onsite for a detailed discussion. They left the meeting thinking we were the CDMO of choice for many reasons.
“However, our operations abruptly declined the project.
“It was a shock. The only reason given was we were ‘at capacity,’ and a brief message was sent to the customer. However, if that were the case, we shouldn't have had the prospective customer travel to the site and engage in all the detailed discussion.
“I thought I had a good understanding it was a project that operations wanted. However, I failed to ask questions that fully revealed their interest level, or if there were any factors causing some reluctance..."
That experience steered Hlass to rethink his approach.
He needed to get more integrated with internal operations, and ensure all involved were on board by identifying and addressing concerns throughout the process.
"The operations team appreciated my change in approach; we worked collaboratively on all future opportunities," he says.
Hlass knows now if partner evaluations are approached collaboratively between BD and operations, keeping in mind the CDMOs and the customer’s best interests, then a CDMO will land on an agreed approach for the majority of opportunities.
This will end up benefitting the (potential) clients. That includes In some instances having potential opportunities declined, but in other cases lead to creative solutions to overcome specific challenges.
Seventeen years past the above experience, Hlass, recently co-founded Pharma Expanse – a BD-outsourcing organization for CDMOs and Pharma/Biotechs.
You may be scratching your head over that brief company description. You'll want to learn the details in part two.