Velocity The Key Metric For External Manufacturing

“We talk a lot about resilience, quality, and cost in external manufacturing. We live every day managing CDMO relationships, navigating tech transfers, chasing batch dispositions across time zones. These fundamentals matter.

However, I've come to believe the capability that most separates high-performing external manufacturing networks from struggling ones is velocity – the speed at which problems are seen, decisions are made, knowledge moves, and outcomes are delivered across the sponsor-CDMO interface.”

     --- Ratna Shekhar, Managing Principal of Sila Lee LLC ---

After a yearslong interlude, this spring I caught up with Shekhar at the Outsourced Pharma CDMO Leadership Awards in Manhattan. He had not changed; he’s unabashedly enthusiastic about drug development and manufacturing.

His focus today is on this theme of supply-chain velocity.

“The payoff is tangible,” he says, and immediately presents three examples. These may not be exactly new insights, but the emphasis is heightened:

• tech transfer that completes in six instead of eighteen months means first-in-human dosing a year earlier — in a GLP-1 or ADC race, that's the difference between market leadership and irrelevance
• deviations closed in days instead of months means the next campaign starts on schedule
• development/manufacturing lessons that reach a second production site before the same failures occur there saves millions of dollars in lost batches, and valuable time

“Across a portfolio,” Shekhar says, “velocity becomes the single largest driver of time-to-patient, capital efficiency, and competitive positioning.”

Velocity In The Research

A 30-year biopharma veteran, Shekhar has filled supply-chain positions in organizations such as Novartis, Pfizer, and Takeda. His thoughts solidified earlier this decade when he took on an assignment at a CDMO; they crystalized more recently as a fractional executive for biopharma site turnarounds and greenfield startups, CMC-program delivery ,and CDMO governance.  

Even with that background, Shekhar likes to look outside our industry to sharpen his thinking.

He references Steven Spear’s 2010 book, The High-Velocity Edge: How Market Leaders Leverage Operational Excellence to Beat the Competition, which explains how market leaders achieve sustained competitive advantage through operational excellence focusing on four key capabilities: dynamic discovery, problem-solving, knowledge sharing, and continuous innovation.

Shekhar says we can learn from the case studies in the book of organizations with high velocity that develop Spear’s capabilities framework:

• Toyota did not dominate by building the biggest factories – it designed systems that surfaced problems in seconds, solved them immediately, and spread fixes across every plant
• Alcoa under Paul O'Neill demanded every injury be reported within 24 hours with root cause and corrective action; that urgency transformed every operational dimension, doubling revenue.
• The U.S. Navy's Nuclear Power Program has logged over 5,700 reactor-years without a single radiation casualty, in large part because junior engineers are expected to challenge senior officers when something looks askew.

“Different industries; the same four capabilities,” says Shekhar. “They map directly onto our biopharmaceutical outsourcing world.”

Safely Speeding Up Supply Chains

Unfortunately, we have a way to go in our industry to reach peak velocity.

Shekhar suggests sponsors:

• recognize and try to deal with problems as they occur, but often don't get CDMO process data until weeks after a batch completes
• coordinate at the interfaces, but problems at the sponsor-CDMO handoff get escalated through separate hierarchies instead of solved by the right people together
• circulate knowledge across the network, but we still witness the same failure repeating across programs – learnings may never leave one team's share drive.
• look to build capabilities, but the instinct is to rush than invest in right-first-time discipline and then pay for it in rework and missed timelines.

In our increasingly CDMO-sponsor-centric model, these “buts” are detrimental.

Ironically, they point out challenges that today should be easily measurable and addressed. Rectifying them, says Shekhar, will “progressively evolve the entire outsourcing model.”

Which begs the question:

Why have our otherwise experienced and erudite professionals not more effectively dealt with these outsourcing drawbacks – or raise them as strident supply-chain operating and CDMO relationship barriers?

Again, Shekhar points to recent research for answers.

He starts with a book by Amy C. Edmondson (2018), Novartis Professor of Leadership & Management at Harvard Business School, The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth.

Her foundational finding is the best teams don't report fewer errors – they report more, because people feel safe raising problems early.

Quiet teams aren’t error-free; they are error-silent. This is not squishy psychology; it is, though, a derogative aimed at leadership and management positions.

An outsourcing best practice we put to too little practice is senior leadership and project management creating a “safe environment” for speaking up.

Secure relationships that move fastest are the ones where all parties build what Edmondson calls a learning zone – “high standards paired with high psychological safety,” as Shekhar interprets it.

Again, in our advancing CDMO-sponsor intertwining, the creation of this work situation is measurable.

Measurable, and today aided by the adoption of artificial intelligence tools. Shekhar points to metrics such as:

• days from anomaly discovered to escalation
• weeks from deviation to root cause
• time to implement corrective and preventive actions (CAPA)
• months from lessons learned to network-wide adoption

“Every one of these velocity metrics is longer when professionals on either side of the sponsor-CDMO relationship hesitate to flag a trend, challenge a timeline, or deliver unwelcome news,” says Shekhar.

AI won’t disseminate as such. Our goal as an industry should be to grease the wheels of decision and action however we can.

We can accomplish that by building a culture and outsourcing ecosystem enabling fluid and open communication, and the best use of technology.

In practice on the human level, concludes Shekhar, it may be as simple as “a CDMO quality lead contacting their sponsor counterpart at 7 a.m. to flag a questionable trend before it becomes a deviation, and knowing the sponsor response will be equally accelerated, and include collaboration strategies rather than the threat of an audit.”

Safe communication at a high velocity. We should already be there, but better late than never.