Biotech leadership promote their companies on the ability to assess/manage risk and to minimize expense to the next milestone. They are also frequently progressing complex formulation programs to demanding timelines with minimal internal CMC expertise. One can understand the perceived gap in provider performance given the expectations here.
Pharma business units have increased the pressure on their internal CMC/biologics R&D organizations to excel technically and operationally. They hold the purse strings and are highly influential in major organizational change decisions. They seek maximum visibility and transparency into risk assessment and mitigation for delivery, quality, cost and timelines. They expect technical excellence and highly efficient project management and communications. The CMC organizations have responded during the last five years by designing and implementing fit-for-purpose suites of customer facing processes while also significantly increasing the outsourcing of all categories of work. Internal surveys of business unit clients have validated that these processes are improving on the “black-box” reputation of CMC R&D.
Leverage Investment in Customer-Facing Processes
Pharma CMC has invested significant effort and resources to optimize operations, project management and customer service. These have evolved from initial approaches that were compartmentalized and manual to current systems that are highly integrated. Hand in hand with the systems approaches have been cultural changes with regard to communications, transparency and relationship management. Pharma CMC is highly motivated to be the partner of choice to their internal business units. CMC organizations are listening to their customers and committed to continuous improvement in all aspects of the services they provide.
CRO/CMO organizations can benefit by understanding these approaches and adapting them to their individual needs in a fit for purpose manner. None of the approaches are groundbreaking in themselves but they have been reduced to practice for CMC. These processes have been “automated” in some cases and CMC providers are applying suites of them to meet business unit needs and demonstrate real improvements in how they are perceived. These processes include:
- General customer facing agreements: communications, change-control, quality/regulatory issues, outsourcing, etc.,
- MS Project plans, Gannt’s etc. These may include required resources: people, money, facilities, etc.,
- Short, monthly project summary updates. Can include next milestones, deliverables at risk, etc. Can be electronically mined to produce monthly dashboards of all project risks, all upcoming milestones,
- Development plans that span the R&D and commercial manufacturing timelines,
- Risk assessment processes and tools. Can be electronically mined for monthly project summaries. Monthly dashboards are a cornerstone of provider-client transparency,
- Development alerts that flag technology scale-up challenges (new facilities required, etc.) to client leadership,
- Budget tracking systems (both people and money) that show committed spends plus commitment dates and amounts for future spends. Shows the sponsor mid- and long-range resource expectations,
- Lessons learned processes triggered by completion of discrete modules, e.g., formulation scale-up,
- Internal CMC/manufacturing assessment of change in risk. Processes to provide one accurate message to the customer in a timely manner.
DMAIC Process Improvement Approach
A DMAIC data-driven improvement cycle is a useful approach for CRO/CMOs to adopt to help close gaps in their customers perceptions. DMAIC is an abbreviation of five improvement steps: Define, Measure, Analyze, Improve and Control. Each organization may approach the Measure phase somewhat differently. Online surveys are an easy means of obtaining baseline metrics on key performance parameters from stakeholders. The Analyze phase identifies the most important causes driving the metrics of interest. In a multifaceted case study which I led with external consultants, structural complexity, project & resource management and decision making were identified as the priority improvement areas. (see Fig. 1 for an outline of the process).
Figure 1: Outline of process-improvement case study
Another way of approaching this is to review each of the systems/processes listed earlier against your company’s desired improvement areas. In doing this you should be able to identify worthwhile benefits for several of the systems. No doubt, you may also be somewhat discouraged by the potential proliferation of new systems and attendant resources required to maintain them. Accordingly, you will want to select carefully what you elect to implement to achieve maximum improvement. You can also merge systems as part of this.
A special case to consider is where a CRO/CMO has one or more mega-projects. These will likely need to be managed by “heavyweight” teams. This can require full-time team leadership, closer integration with client working groups and specific alliance structures and governances. Fig. 2 is a perspective on close vs. arms-length integration from the automotive industry, applied to a CMC project.
Figure 2: Close or arms-length integration vs. project complexity and size
Overall, where the improvement areas are a priority for the CRO/CMO, a well-executed DMAIC, or equivalent process, is a good investment and should move the dial on client satisfaction.
The “Softer” Skills
It’s not all about systems of course, but without effective value-added systems the relationship skills can ring hollow to customers. One key area that spans both is speaking with one organizational voice to the client. This is particularly true around significant increases in risk for technical, timeline, quality or cost deliverables. At my former employer, we learned by experience to facilitate this through governance. In recent years we limited small molecule CMC technical governance (for R&D through early launch) to a single global body drawn from CMC and manufacturing. This team met monthly and was always available to project teams and technical lines to review major changes in risk, to endorse risk mitigation and to agree and help craft the messaging to business unit leaders. With this set-up, multiple levels within the organization could confidently communicate the same message to clients without fear of contradiction or mixed messaging by CMC/manufacturing leadership.
Another area where we married systems approaches with relationship skills was project updates and transparency to business clients. Our project summary system (monthly one-page update) was made available, live, online, to internal clients. This also included deliverables at risk (red, yellow, green status), which the client’s project management staff could access at any time. Initially, this was considered risky, letting the client see some of the nuts and bolts in real time. Once in place, it prompted good questions from project managers and served as a clear demonstration that we did not want to stay in the “black box.”
Ideally, a CRO/CMO should strive for a relationship where its liaison can call up the client and give a heads-up on a possible, emerging issue which might be very manageable but could represent a significant risk if upcoming data is not as expected. The CRO/CMO would also communicate when the relevant data would be available and talk about possible next steps. In this scenario if the relationship is strong and the client is mature, the potential risk will be communicated in a balanced manner to the client leadership. If not, the client leadership will be told that the sky is falling and damage control will be required. To achieve the desired outcome here you need mature, skillful communicators on both sides and that a significant foundation of trust has already been established.
Corporate culture, staff development and recruitment play a key role in continuous improvement of customer relations. The ideal is a mutually beneficial setup between hard technical/business deliverables and the relationship-building processes. You know you are winning when you install a significant system (e.g., on-line project summaries) and your own internal technical management find it highly valuable in running your business. One of my best days was hearing a senior technical director comment, “You know, this really helps me locate up-to-date information when I need it!”
Large pharma experience indicates (and I’m sure CROs and CMOs agree) that when the toughest technical issues arise you bring the technical experts face to face with the client. These issues include stability failures, non-robust formulation technology, new impurities at the wrong time, etc. These can be difficult discussions. Many times they will involve data or findings that could not have reasonably been predicted. Occasionally the cause might be human error. Regardless, the client CMC and business leaders will want to hear the detailed, straight story from the technical expert. If the expertise is clear and the story well articulated, the outcomes should be positive both for the client and the CRO. This is particularly true if you already have a proven reputation of transparency and reliability built on performance and effective systems. Many of the tools discussed in this article are designed to build this reputation and trust. They provide the client confidence that they are always hearing the straight story (risk or resource) in real time.
- Pharmaceutical Technology, Aug 2012, “CROs and CMOs have cause to celebrate” by Jim Miller.
Joe Taylor is a CMC consultant in project and portfolio delivery and previously served as senior director Pharmaceutical Sciences at Pfizer R&D. With Pfizer, he chaired the global R&D and manufacturing portfolio governance. He also was Pharm Sci Portfolio head at the Specialty Care business unit. Dr. Taylor gratefully acknowledges that much of the CMC improvement content referenced in this paper is based on the expert work of former Pfizer colleagues. He can be reached at firstname.lastname@example.org