With increased pressures to shorten time to market, more biopharmas are engaging outside consultants, CROs and CMOs, to fill their manufacturing or research needs. Ahead of our annual CRO/CMO Symposium, we spoke with Colin Minchom, who advises, project manages, and executes on CMC formulation & drug delivery strategy and development for companies of all sizes, on what biopharmas should consider when partnering with a CRO or CMO.
As an advisor to biopharmas, what’s your advice when deciding to engage an outside CRO/CMO?
When engaging a CRO/CMO there are a many boxes to be ticked before making a decision. The first boxes that need to be ticked are whether they have appropriate capabilities, expertise, facilities, and systems (e.g. project management, reporting, quality). Second but equally important are the softer boxes on how they behave as an organization. More projects are delayed or fail due to bad relationships and poor communications than for technical reasons. I recommend a Request for Proposal (RFP) process for obtaining proposals for a body of work unless you already know the capabilities and dynamics of the CRO/CMO. This requires putting a Non-Disclosure Agreement in place – how easy or painful was that? How the organization responds to the RFP is telling e.g., speed and quality of response, did they encourage a call or meeting and if so how did you feel about that communication? During that communication, did their SMEs make recommendations beyond that which you wrote or did they merely reflect back the details of the RFP?
Once the CRO/CMOs have been rank ordered, then visits to the top one or two are critical. The visit will involve inspection of facilities, systems, and should provide a deeper understanding of the dynamics of the organization. This is my eyeball test; look the SME(s) and project manager in the eye while asking questions and decide whether you trust them to deliver on your program with a quality outcome in a timely manner. Lastly, try to understand their issue management process. Something will go wrong during execution of the project. How do they deal with this? Asking will normally get a stock positive answer – references from industry colleagues who have used that organization are invaluable. These don't need to be formal documents – simply a phone call.
All the above is a risk management exercise – there are no guarantees.
Can you share any lessons learned?
I have contracted with many CMOs. Here are two examples of communications one handled well, the other badly.
In the case handled well, a clinical packaging company identified empty containers in a batch of injectables transferred from a manufacturing company. The manufacturing company acknowledged their responsibility and assigned an experienced quality assurance investigator to the issue. I had many communications with this individual and the PM over the course of a week. The QA investigator really put out to resolve the issue including working long hours. This is nothing less than would have been expected of a QA investigator in a large pharma with a deviation of this significance. The deviation needed to be resolved with my client's QA contractors who were asking all the right tough questions. The manufacturing company identified the data & information to write the report to answer all the questions posed and negate patient risk. This deviation only cost a one week delay which was made up later.
In the case handled badly, a regulator asked a question, requiring a response within a fixed time window to enable the start of a clinical study to schedule. Answering the query required a small amount of analytical work at a CMO. A telecom was quickly pulled together, the protocol was agreed and the analyst committed to the data being available on a specific date. This date was communicated within my client's company including to the executive level. No information was delivered on the agreed date. Calls were made, and it transpired that the analyst had meant that she would have finished the practical work generating the data on the agreed date. The data would then need computational analysis (half a day) and quality review (standard timings 3-5 days). It took several communications to the CMO, including to the CMO's executive to be able to receive the data one and a half days later. A lesson from this is to always have a relationship with an executive in the CMO to be able to escalate urgently. This was a case of mis-managed expectations.
Are there any major shifts in the CRO/CMO landscape that MassBio members should be aware of?
M&A within providers seems to be accelerating, which has its benefits. Customers can access a greater breadth of offerings/technologies in a single organization, providing greater choice in single contractors when looking for the needs for your program.
However, there are significant potential negative repercussions from such activities with ongoing programs; uncertainty leading to demotivation of the CRO/CMO staff has impact on timeliness of delivery, shuttering of sites leading to transfer of programs, loss of relationships at the company with the reassignments or the departure of staffs. To mitigate these negative impacts, it's important for biopharmas to react to news of M&A at your vendor and to use your relationships to ensure continued delivery of services with little or no interruption, along with maintenance of quality.
To learn more about the benefits of partnering with a CRO or CMO and to meet directly with qualified vendors, register for MassBio's annual CRO/CMO Symposium on September 6th in conjunction with Biotech Week Boston.
About Colin Minchom, PhD, FRPharmS
Colin Minchom, Principal, Cordack CMC Consulting, advises, project manages, and executes on CMC formulation & drug delivery strategy and development for companies of all sizes.
Previously at Shire Colin led CMC small molecule due diligence and two priority programs. Prior to Shire Colin worked in contract services attaining executive leadership positions at Patheon & Hovione, and has worked in other pharmas including Eli Lilly and also a startup.
Trained as a pharmacist in the UK he received a PhD in Pharmaceutics from the University of Wales. Colin chaired the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting Programming Committee in Chicago, was a member of the MassBio Annual Meeting Steering Committee for 2018, and sits on the USP General Chapters Expert Committee for Dosage Forms. He is a Fellow of the Royal Pharmaceutical Society of Great Britain and over his career has contributed to the development & successful launch of more than ten pharmaceutical products.