#SpeakPharma with Eurofins CDMO
This week, SpeakPharma interviews Frédéric Gaussens, Vice President, Business Development and Strategy at Eurofins CDMO Europe which provides high-quality, customized drug development solutions for chemical and biologicals drug candidates in the earliest phases of their development pathway (from API to clinical packaging). Gaussens tells us how CDMOs, CMOs, CROs and third-party laboratories that may have been competitors in the pre-Covid world have come together to fight the unknown virus by providing unbridled support to its clients. CDMOs like Eurofins are shuffling their schedules to support clients who are holding clinical trials on treatments for the novel coronavirus. Gaussens also talks about some of the challenges the pharma industry is likely to face in the near future, while specifying the crucial role being played by regulatory bodies across the world. Excerpts:
We are facing a challenge that none of us were prepared for. The sudden outbreak of the virus has impacted the molecule pipeline, R&D and the pharmaceutical supply chains across the world.
The pandemic has sent shockwaves across the pharmaceutical industry. But I think we have shown more resilience than most other sectors, and we owe that, in large part, to the outsourcing partners within the drug industry.
CDMOs, CMOs, CROs and other third-party laboratories who generally compete with each other, have made fighting the unknown virus their common cause.
We have seen a huge number of partnerships being announced, some of them built under incredibly short notice. We have seen small biotech getting associated with the Big Pharma. The virus has brought CDMOs, CROs, institutional and public partners, big and small pharmaceutical companies together.
Over the last few months, we have seen production lines of cosmetic and retail companies getting reshaped to produce millions of liters of hydro-alcoholic gel.
Overall, we have seen a fantastic surge of solidarity across many industries. In fact, the human race has come together, and workers around the world have shown a lot of determination in fighting the pandemic.
The regulatory bodies, such as the EMA, ANSM and FDA, have played a crucial role . They have worked hard to further reduce the timelines for validating protocols or for authorizing the launch of new clinical studies. They displayed both flexibility and speed. This was truly unprecedented.
Despite being affected by a resource shortfall due to the lockdown and delays in payment from our clients, we succeeded in implementing our crisis management plan to handle increasing demands from our customers. We met their needs within the framework of our quality standards.
Within the outsourcing industry, the situation today is quite intense. The response strategies of CDMOs are driven by two factors. First is to safeguard ongoing clinical trials for the current molecule pipeline (for oncology, infectious diseases, CNS or any other pathologies) that is in various stages of development. Those molecules cannot be put aside if we want to save millions of lives. The second strategy is to be flexible and to take on new projects, triggered by the rally against Covid-19, at a very short notice and under tight timelines for execution.
Our response strategy has been a mix of both these factors.
For instance, we implemented new services like “Direct-To-Patient” in order to ensure the continuity of ongoing clinical trials. This service took care of the fear of catching the novel coronavirus amongst patients who had to visit hospitals in order to be a part of these trials. Our service ensured that the study remained active, as we delivered the medication directly to the homes of patients who were participating in the trial.
We also ensured manufacturing slots to all our repeat clients, albeit by juggling our own planning in order to respect their production deadlines.
We took on such clients on high priority. We shuffled our already busy schedule to support clients on developing the clinical phases of their product against Covid.
While showing such flexibility, we also did not apply a rush fee or inflate our rates. We considered it our duty to take up their work on priority. We also increased production to provide hospitals with our pyrogen-free, ready-to-use products, such as our Pyrofree® vials.
We hope our approach will help saving lives. In our view, being associated with such initiatives is an accomplishment on our part.
The industry is likely to face several challenges in the near term, such as those pertaining to finances, capacities, meeting environmental norms and challenges pertaining to technology.
By our industry, I mean pharma/biotech, outsourcing partners, suppliers of equipment and consumables.
Some of these challenges are not easy to handle, especially when they exist in combination with others.
In the near future, many biotech firms may face cash shortages, and may not be supported by their investors. Some investors may re-assign the financing round or may postpone investments.
There are also challenges pertaining to a significant lack of facilities or capacities to produce new innovative drugs or vaccines. This challenge could get worsened with postponement of capital expenditure by the investor.
The rush against Covid-19 also has an unanticipated collateral impact. There is a risk on supply chain disruption for consumables or other types of materials such as vials. We are already feeling some tension on the timelines for delivery at clinical stage development. You can well imagine what will be the bottleneck if a vaccine is found and needs to be produced in large scale.
While the Western world may have resolved to reduce its high dependence on countries like China for APIs, masks, respirators or testing kits, it will be difficult for them to achieve this as the demand for these things are at its peak at the moment, and may continue to be high for sometimes.
The other challenge the industry is likely to face is in the management of the ‘Green vision’ of the world, if it wants to reduce its dependence on China. Whether we like it or not, the production of APIs causes pollution. This is one of the reasons why production was outsourced to China, where “green” standards are far lower than the West.
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