MEHRAN BHATTI, CEng, CPSM
I increase the valuation of ATMP and advanced therapy organisations through supply chain and external manufacturing strategy. Cost reduction, supply continuity, and on-time launch.
If you are a Commercial Biotech
Is your commercial supply chain losing margin on cost while reliability is under pressure, while your pipeline is making decisions that will lock in the next set of supply chain problems?
If you are a Pre-Commercial Biotech
Are you 18 to 24 months from launch without a supply chain function in place?
You need the function built correctly before your permanent head steps into it, or someone who can act as that head while you hire. Either way, the window to make the right decisions is closing.
If you are a CDMO
CDMO sites contribute to up to 40% of CMC-related CRLs. Are your supply chain gaps contributing to sponsor attrition and lost mandates?
This is not a one-off problem. It is a structural one.
Supply chain decisions in biotech and ATMP get locked in years before a dedicated supply chain function exists. CDMO selections, BOM choices, and supplier governance happen without commercial supply chain input. By the time the consequences surface, they are expensive to undo.
74% of FDA Complete Response Letters between 2020 and 2024 cite quality or manufacturing deficiencies. Up to 40% of those trace to CDMO sites. The decisions that drive those outcomes were made years earlier.
Whether you are managing a commercial product, building your first supply chain function, or trying to become the CDMO sponsors trust, the root cause is the same: supply chain thinking arrives too late, and nobody closes that gap on purpose.
How the gap gets closed
1.
Baseline diagnostic
What is locked, what is at risk, and what can still be changed
2.
Therapy-specific capability mapping
A supply chain model built for your therapy, stage, and CDMO setup
3.
Pre-lock supply chain integration
Decisions made with supply chain input before they become irreversible
Already know this is your problem? Let us talk.
Outcomes
PUBLISHED ANALYSIS
The 9 Year Supply Chain Gap in Drug Development
74% of FDA Complete Response Letters cite quality or manufacturing deficiencies. The decisions that drive those outcomes were made years earlier, without supply chain input.
Selected Mandates
Johnson & Johnson · Advanced Therapies
Advanced Therapies Supply Chain & External Manufacturing — CARVYKTI
CARVYKTI is the first CAR-T approved in multiple myeloma. I led the supply chain through Phase 2 to on-time commercial launch during COVID, across a $40M+ supply base and 10+ CDMOs. Zero critical supply failures at launch. Governance model designed and embedded across Quality, Procurement, and Manufacturing, with clean regulatory filings across FDA, EMA, PMDA, and SwissMedic.
Accenture · Advanced Therapies
CDMO Go-to-Market Strategy for an Automated Cell Therapy Platform
A platform technology company with an automated Level 3 cell therapy manufacturing process needed to enter the CDMO market with no established positioning or partner framework. I conducted structured interviews and surveys with pharma companies and CDMOs, then synthesised the findings into a CDMO-pharma partnership value framework covering barriers, enablers, and what each party looks for in a strategic partner. This delivered market entry positioning and a thought-leadership framework used to guide commercial strategy and partner conversations.
Johnson & Johnson · Advanced Therapies
Supply Chain Integration into Process Design
Supply chain and procurement had no visibility into pipeline process design decisions. BOM choices, material specifications, and supplier selections were being made by R&D without commercial input. I led a pilot to integrate procurement upstream, reviewing the BOM alongside the process design team before specifications were locked. Material substitutions were identified and implemented, reducing single-source dependency and improving the supply network cost position.
Accenture · Life Sciences
Supply Chain Operating Model Design and Transition
A major pharma organisation redesigning its global supply chain function needed two workstreams consolidated into a single global hub. I owned the end-to-end workstream design, transition planning, governance structure, and cut-over sequencing for both functions. Over 100 people affected. Both workstreams successfully transitioned with governance embedded and hub operations running at handover.
If the problem is real, it is worth a conversation.
Tell me where the pain is and what you are trying to avoid. I will tell you directly whether I can help.