PHARMAnetwork has asked the CEOs of major CDMOs in Europe and the US to give their reactions to this crisis and its (first) consequences for the strategy of their groups. Their testimonies are full of ideas for the future and, as such, exciting. Read all the interviews here.

When a CDMO is faced with VUCA!

by Alain Sainsot, President of GTP Bioways

 

A young, recently created (2019) CDMO that is still under construction has been facing unprecedented times since day one… and responding with all its strengths!

The Covid-19 pandemic, war in Ukraine, the predicted recession…. two years ago, we could not have imagined such a crash test to try out our strategies! Yet, even with such upheavals, the fundamentals of strategy for a biological CDMO have not changed at all. How can a young company like GTP Bioways approach their response to such a challenge?

Biotherapeutics complexity is constantly growing, demanding answers

Proteins are increasingly complex, difficult to formulate, and unstable. Formulation services require greater integration of these kinds of expertise. In this area, the provider’s track record is an essential asset, and the collection of case studies is a true well of potential solutions. The “Quality by Design” approach now includes component availability parameters to a far more detailed degree than in the past.

Combine the D of development with the M of manufacturing

Never has the term continuum been so appropriate as in a process that strings together stages from the sequence of interest to fill & finish, including testing development. This is even more the case in the biological sector. This kind of continuum puts a definitive end to any compartmentalization of operations and prevents any kind of closing or sectioning off. Planning for pharmaceutical regulatory reference documents upstream of development is once again essential.

Uncertainty is disrupting each stage of development

Availability of components, postponed deliveries, delayed service providers, etc. The solution requires organizations to be flexible, capable of replacing one program with another. For example, a Fill & Finish line like the one installed at GTP Bioways – hyperflexible, equipped with robotic arms that manage ready-to-use nests and using single-use isolators – is perfectly adapted to last-minute schedule changes.

By their nature, the results of a clinical study remain uncertain, so renewing projects is very important for a CDMO like GTP Bioways.

Ambiguity

There are many molecule profiles, calling for very high-level expertise. Two examples demonstrate this kind of situation:

• Is an ADC a biological or chemical product? Both, of course, it’s ambiguous! Moreover, it’s a “highly potent” chemical product. When chemists work with biologists: characterization, process, conjugation, technical environments, regulatory approach, increased number of professions, etc.
• An “armed” cell, another lovely example of a cell (e.g. an NK cell) equipped with antibodies. Or when the cell is combined with a protein to become a medication!

Volatility

Biotech companies are entering an even more delicate funding context. While this has never been an easy topic, the tensions from the international financial context are now even higher…. and therefore, the selection of candidates is tougher.

Consequence: projects are more volatile, starting without having secured all their funding, in the aim of keeping to the timeline at least until proof-of-concept. The likelihood of stopping a program midway through is higher than before.

It is no longer unusual for a CDMO to help a biotech company enter into contact with potential investors, through its network. The logical next steps of such an approach would likely be for investors to become more interested in the service providers of their investments, in the aim of optimizing the overall project approach… to be investigated! The question is, what will be the preferred areas for financiers post-recession (medtech, energy, AI, etc.).

This discerning strategic marketing approach is a key component of the CDMOs of the future. Market-access approaches are developing, particularly from a health economics perspective, with industrial cost prices and access costs for the patient. In this context, the recombinant protein and antibody segment is almost considered mature, though it is relatively recent. Will genetic and cell therapies (and their variations) follow the same trajectory, in fast-forward? The increasing number of therapeutic approaches requires very detailed analysis of expertise, equipment, technical environments and regulatory reference documents.

Based on these observations, how should a small CDMO and a young company like GTP Bioways react?

First of all, remain extremely solid on the fundamentals (back to basics!):

• Be strong in both D (strong areas of expertise mastered in advance) and M (little m for the size of clinical batches, big M for a constant, uncompromising foundation in international pharmaceutical GMP reference documents);
• Work at the service of innovation (embodied by our project leaders) without being innovative yourself, by first of all responding with robustness, availability and the proximity of our (experienced, trained, qualified and robust) teams;
• Have confidence in the project itself and the quality of your teams;
• Rely on a group of stakeholders and a board that themselves are constant, loyal and reliable in all circumstances;
• Commit to a medium-term process, which is best for integrating a value chain;
• Plan investments and/or external growth programs without making huge gambles solely based on intuition or enthusiasm, and staying strictly within your means;
• Have sound cash flow to be able to weather storms.

Complex projects require solid, strategic alliances in place

Increase the number of all forms of alliances with other CDMO actors. The idea is to be able to extend our range, complete our services, and bolster our expertise through partnerships that do not necessarily involve integration and acquisition processes. GTP Bioways has already adopted this purely marketing and sales approach, with two major companies:

• Fareva, through a strategic partnership that allowed GTP Bioways to transfer its process development work and analytical development to the GMP antibody and ADC production platform in Saint-Julien-en-Genevois.
• CEA-Leti, also through a strategic partnership that allowed GTP Bioways to draw on LETI’s nanoformulation development expertise, by sharing a cutting-edge laboratory at the CEA Tech structure in Toulouse.

Other partnerships are already planned in the near future. This approach undeniably strengthens the range and its credibility, while simplifying the overall approach for the client.

Renewing contact with strategic providers

GTP Bioways is a young, small CDMO, sharing the sector with several (huge!) suppliers, in terms of culture media, available components, filters, purification resins, etc., in a context of extremely high tension on supply. This area still needs to be developed, or initiated for small structures like ours, which are not the target of “key accounts” approaches. GTP Bioways has structured its purchasing with the priority objective being to connect with actors in its supply chain and strengthen relationships with them.

Don’t hesitate to refine your deployment strategy

Another decision related to the context described was to tighten the GTP Bioways development strategy for recombinant proteins, antibodies, ADCs and injectable nanoformulations. The choice to invest in two GMP production platforms (350L microbial and 20L cellular) is a direct result of this strategic reflection.

Never forgetting our teams!

The most important and decisive factor in this situation is first and foremost the social factor. No need to list the studies and articles that illustrate this point: teams finish their days anxious, worried, disrupted and full of questions in this “VUCA world”!

Never has the desire for work/life balance been so strong, never has the relationship to work been so challenged, calling for new methods, new tools and better support. Similarly, never (in any case not for many years) have we been subject to such shortages in qualified staff, in all sectors. These questions are pushing us to reconsider our organizational structures, likely reinternalize certain roles that struggle to meet our specifications, and reinvent good management practices!

Once again, we are heading back to basics: working closely together, sharing and making ourselves available, with empathy, high standards, rigor, respect, teamwork, exemplariness and lastly, giving meaning to the company’s operations.

New operational rules must not mask these base expectations that GTP Bioways wishes to profoundly develop and redevelop in the coming months (we are still a very young company), not only to improve the wellbeing of its teams but also to strengthen its attractiveness. Our responsibility is undoubtedly to contribute to our employees’ sense of balance, modestly, with elegance and without pressure, by including this relationship to work in a holistic approach.

Remembering the planet we live on

It is time to focus on Earth, which has been so mistreated by the systems that we had the unfortunate genius to create: the world of factories, globalization, fabless manufacturing, and other sins. Joining the movement to respect environmental norms systematically is no longer a necessity, it is now a question of long-term survival!

Have we finally become what the “New Man” should be, a concept stretching back to the philosophers of the Enlightenment? Certainly not, we are simply joining in a process of change that requires us to be adaptable and creative, without being restricted to naive optimism, not to mention 19th-century idealism.

For public health stakeholders working to serve patients and innovation in a context accelerating Volatility, Uncertainty, Complexity and Ambiguity, only the smartest and most resilient will survive… and GTP Bioways will be one of them!