“Skyepharma: the specialized CDMO growing in double digits”
This week, SpeakPharma interviews David Lescuyer, CEO, and Benoit Mougeot, CFO, of Skyepharma, a fully integrated French CDMO for complex oral solid dosage forms. Over the last six years, Skyepharma has transformed itself from a basic contract manufacturing organization (CMO) to an agile, expert, and differentiated contract development and manufacturing organization (CDMO). Continuous, proactive and major capital investments and a strong people-based unique expertise have generated double-digit growth for Skyepharma over the past five years. Skyepharma is now actively working on building stronger partnerships to constantly improve the supply chain of the health industry and the lives of many patients.Excerpts:Over the last six years, Skyepharma has truly transformed itself from a CMO to an agile CDMO. Can you briefly take us through this journey?Lescuyer: Yes, the last few years have been quite eventful. We initiated this journey in 2016, to establish a first-in-class expert CDMO. In 2021, further to the successful completion of a MBO (short for management buyout), Skyepharma became a 100 percent French-owned independent CDMO, owned by its management team, which has more than 150 years of cumulative experience in the pharmaceutical business and a proven expertise in the CDMO business. Over the last two years, we have emerged as a key player in the development of oral solid drugs and the delivery of oral complex technologies. We are experiencing double-digit growth.Such a transformation could not have been easy. Can you tell us what were some of the things Skyepharma relied on to bring about this change?Mougeot: Our transformation and growth have leaned on two strong pillars.The first is the development of our people. The company has invested a lot in skilling up our people and establishing a strong and specific organizational culture. As a result, we are offering a recognized customer experience to our partners, where agility, reduced time-to-market and breakthrough innovation are key differentiators.The second pillar is our capital investment strategy. We deployed an investment to the tune of €40 million (US$ 42 million) between 2016 and 2023. This investment is being used not only to revamp our manufacturing and development suites but also to upgrade our FDA-approved facility and to tremendously expand our development and production capabilities with, for instance, the design and building of two new, state-of-the-art areas fully-dedicated to highly potent molecules, including oncology. This way, we will keep offering more support to our partners for their high-value projects.You said Skyepharma has been growing in double digits. Did Covid-19 impact your growth?Mougeot: We have been successful in building a resilient model that was able to withstand the Covid years.Given the macroeconomic context, we have been leaning on a strong operational organization and leadership team, resulting in a continuous premium service level that was kept high during the pandemic.This is what we mean by customer experience!Lescuyer: Our approach is to be a “PDMO”, wherein “P” stands for partner, that focuses on long-term partnerships. Anticipating the unmet needs of our partners throughout the supply chain and early in their development programs, there’s now a world of opportunities for innovative and reliable companies in the CDMO marketplace.Our organic growth strategy relies on our expertise for complex and hard-to-make drugs and in our ability to keep investing in science and added-value capabilities, such as high-potency drugs. Innovative initiatives such as our proprietary Skyehub model, the expansion of our proprietary technologies’ portfolio and related IP (intellectual property), and academic partnerships are just some of the ways in which we are differentiating ourselves from other CDMOs.What is the Skyehub model? Can you elaborate on this initiative?Lescuyer: Skyehub is part of our strategic opportunities for adjacencies. France and Europe are dramatically missing large-scale clinical and commercial capacities for bioproduction. We have decided to allocate 10,000 square meters of our real estate close to Lyon to build and run dedicated facilities for biotech companies looking for such capacity. We take care of the construction and certification of the related buildings. The resident companies will benefit from our industrial expertise, from our quality systems, while also allowing them the opportunity to run their production with their own staff.In February 2022, we entered into a partnership with MaaT Pharma to establish the first cGMP manufacturing facility dedicated to microbiome ecosystem therapies in France, the largest such facility in Europe. Through this partnership, we will provide MaaT Pharma with a dedicated 1,700+ square meter biotech plant, with the potential to double if needed. This will support the clinical and commercial development of MaaT’s most advanced assets – MaaT013 and MaaT033. It will also support the expansion of R&D manufacturing capacities for the development of its new drug (MaaT03x).Other partnerships will be signed, focusing on microbiome-based therapies or other innovative biotechnologies.More than just bioproduction capacity, our proprietary Skyehub model is clearly a value accelerator for our partners.Where does Skyepharma go from here? Tell us about your future plans.With our highly skilled team, experienced in transforming sites into centers of excellence, we have been able to build strong partnerships and extensive collaborations with our existing clients, while also taking on new partners. We offer seamless and adapted solutions support for the most demanding projects from our partners by utilizing our capacity, services and expertise, focusing on reducing time to market.Skyepharma is now the preferred supplier for quite a few pharma companies, ranging from virtual pharmaceutical companies (VPCs) to Big Pharma. Having invested twice our yearly revenue over the past five years, Skyepharma will now continue to leverage its differentiators to keep growing and remain the solution provider for pharma companies facing strong supply and technical challenges in complex oral solid dosage (OSD) and biotech spaces. 

Impressions: 2118

https://www.pharmacompass.com/speak-pharma/a-differentiated-expert-and-agile-cdmo-player-in-the-osd-market

#SpeakPharma with Skyepharma
18 Jan 2023
“Through our technological knowhow, we are able to reduce time to market for our clients”
This week, Speakpharma interviews David Lescuyer, President of Skyepharma, near Lyon in France, an oral solutions business unit of the British drug company Vectura Group Plc. Skyepharma is today a fully integrated CDMO serving the global pharmaceutical, biotech and consumer health industries. Lescuyer talks about the company’s technological competencies, its technology transfer process, its efficient ‘quality by design’ procedure and a strong organizational culture with its team spirit approach that is giving Skyepharma an edge over competition. — Can you briefly tell us about the origins of Skyepharma? Skyepharma is a part of Vectura Group Plc, a British pharmaceutical company. Three years ago, Skyepharma embarked on a transformation journey from being just a drug delivery platform to a fully integrated, expert and agile CDMO (contract development and manufacturing organization), with a strong “D”, serving the global pharmaceutical, biotech, and consumer health industries. With expertise in early stage formulation and analytical development, we are able to offer full services from development up to commercialization of oral solid dosage forms: powders, pellets, beads, granules, monolayer tablets, but also complex ones (multi-layer and tab in tab / press coated tablets). We have several years of experience in the development and manufacture of complex oral dosage forms. We build strong and long term relationship with our clients, big pharma, virtual or startup companies. The outcomes of this effort are the 10 different oral products being currently marketed by multinational pharmaceutical companies in numerous countries worldwide. — In a crowded CDMO market, how does Skyepharma differentiate itself? Over the past three years, in addition to creating a strong early stage development and technological platform, professional expertise and state-of-the-art equipment, we have also made significant evolution as an organization with regard to our corporate culture. We have also instilled lean management practices across the company. As a result, we have nurtured a strong culture that is based on respect, trust, performance, transparency and team values. The goal has been to establish an integrated organization where discussion and exchange are encouraged in daily operations. Everyone’s involvement is required in developing a strong organizational culture. In particular, it calls for true leadership and empathy from the senior managers. One of the keys to success is to adopt a ‘team sport’ approach, where we all have our different jobs to do and our success lies in our ability to ensure our processes flow properly between all the players. We have no stars in our team. We are all serving the team and our common goals. — What are some of Skyepharma’s key technological capabilities? We have embedded QbD (quality by design) into our early stage pharmaceutical product development process so that quality is built from the beginning. This reduces our reliance on testing of the final product to establish quality, and enhances the CDMO experience of our clients. We leverage three of our patented technologies — Geomatrix®, Geoclock® and Soctec® — that create a strong differentiation for us, as compared to our competitors. These platforms allow us to build controlled release formulations to adapt to patient dosing schedules or adjust API intake that help in managing side effects.  These competencies also help reduce the time to market, which is what our clients are also seeking. Thanks to our innovative compression simulator and our efficient QbD procedure, the Skyepharma technology transfer process can be carried out in six months, instead of 10 months on average. — How do Skyepharma’s manufacturing capabilities give it an edge over competition? Our 65,000 square meter state-of-the-art facility near Lyon in France has an advanced manufacturing facility of 22,000 square meters. We have high-tech equipment that includes two integrated granulation lines of 600 liters and 1,200 liters, wet granulation and fluid bed drying, a micro fluidization line with high-pressure homogenizer equipment, and more. Our facility has eight compression suites that are able to manufacture single, two-layer, three-layer tablets, press-coated tablets and hard capsules. Our manufacturing site is approved by European Medicines Agency (EMA), US Food and Drug Administration (FDA), ANVISA of Brazil and the Korean FDA. We have a global supply chain and currently Skyepharma is selling its pharma proprietary technologies in the US, Europe, Brazil and Asia. All these factors allow us to offer the fastest time to market for our partners. This way, we are also able to offer flexibility on minimum order quantities. — What about customer services? Are there any customer service initiatives you have undertaken? Absolutely! An equally important facet in our transformation has been the creation of a customer service department, focused on better anticipating our clients’ needs. Clients want to be heard, they want to be able to ask for advice and share ideas. They seek a long-term partner to reflect with them on their projects.  We have created alliance teams that ensure the right understanding of the key objectives and the strategy of our clients. — What are some of the new initiatives underway at Skyepharma? Although there are several large players in the CDMO sector, we see several small to mid-size CMOs/CROs growing and there is room for expansion, in particular for an agile CDMO like Skyepharma. The CDMO space is very fragmented and it is important that we continue to differentiate ourselves in order to stay ahead of the competition on the complex solid forms segment. We have created a center of excellence for classic and complex oral solid dosage forms using our technologies. We are also developing new technologies for new formulations, that should benefit patients.  

Impressions: 1796

https://www.pharmacompass.com/speak-pharma/through-our-technological-knowhow-we-are-able-to-reduce-time-to-market-for-our-clients

#SpeakPharma with Skyepharma
14 Oct 2019