Sébastien Poncet is charged with enhancing the portfolio of proprietary processes and seizing opportunities in new therapies.
January 27, 2022 – The Health Chemistry division of the Minafin Group today welcomes Sébastien Poncet as managing director of the Minakem Generics and New Therapies business unit. He is also an executive member of the division.
Sébastien is a graduate of the Montpellier School of Chemistry Engineering (ENSCM) and holds a master's degree in business: B2B strategy
and marketing from EM Lyon and participated in several international management programs from IMD Lausanne and from INSEAD. Over the past 20 years, he has held numerous sales positions at Solvay, Clariant (now Curia), Johnson Matthey, and Minafin. Sébastien is returning to the Minafin Group following an eight-year tenure at Fareva, where for the last two years he was a member of the executive committee.
Frédéric Gauchet, chairman of the Minafin Group, said: "Sébastien’s appointment reflects our desire to enhance our portfolio of proprietary processes for manufacturing generic active ingredients in support of the efforts authorities are taking to secure a European drug supply. Minafin has the advanced know-how in fine chemistry required to enable the development of innovative therapies. But in order to remain at the cutting-edge of ‘new technologies,’ we may consider potential acquisitions in high value-added chemistry or biotechnology."
Sébastien will focus on developing the business of active pharmaceutical ingredients that are within the public domain and seizing commercial opportunities generated by emerging therapies such as Messenger RNAs.
“I am very pleased to start working again with the world-class teams at Minakem. They are globally recognized for their capacity to design innovative chemical routes, to scale them up successfully and their proven track record agility in the field of active ingredients. And I look forward to collaborating with them on the generic API product portfolio that I see has significant growth potential,” said Sébastien “As for new therapies, the sanitary crisis we are going through has demonstrated their importance in the therapeutic arsenal against COVID-19, for example, messenger RNA vaccines. These new technologies developed with high value-added chemistry are where Minakem’s Research & Development know-how can really make a difference in the years to come.”
About the Minafin Group
Health Chemistry Division
The Health Chemistry division develops and manufactures active
ingredients for the pharmaceutical industry through its two business units: Minakem
CDMO and Minakem Generics & New Therapies. Minakem is the leader
in Europe. It offers a wide range of cutting-edge technologies and
pharmaceutical services to ensure that its customers have a seamless supply of
high-quality products. The company provides its expertise for the development
of exclusive manufacturing processes and to produce active pharmaceutical
ingredients following cGMP conditions. Patients' needs being at the heart of
its activities, the Healthcare Chemistry division ensures that the drugs it
manufactures meet the strictest health and environmental safety standards.
Minakem CDMO focuses on proprietary custom synthesis while Minakem Generics
& New Therapies develops proprietary manufacturing processes for generic
active ingredients and innovative therapies.
The three production sites of the Healthcare Chemistry division, approved by the FDA, are located in Louvain-la-Neuve (BE), Dunkirk (FR) and Beuvry-la-Forêt (FR). Created in 2004, Minafin's Health Chemistry division employs 550 people.
About the Minafin Group
The Minafin Group is a leading process developer and manufacturer of fine chemicals with three main areas of expertise: health chemistry, green chemistry, and challenging chemistry. Minafin operates six industrial manufacturing sites across Europe and North America. They provide customers in pharmaceuticals, life-science ingredients and added-value chemicals for high-tech application, with a range of proprietary processes, custom manufacturing, R&D, analytical and regulatory services, as well as formulations. Minafin invests significantly in R&D to create value for customers by specializing in innovations and eco-friendly solutions that bring a competitive edge and sustainability. Its strong industrial capabilities are consolidated through nine business units: Minakem CDMO, Minakem Generics, Blendamix, Pennakem, Minasolve, Minagro, EcoXtract, Minascent and Pressure Chemicals, which generated over €243M (approx. $280M) in revenue in 2020. Founded in 2004 as a privately held industrial company, Minafin is headquartered in Belgium and employs 900+ staff.
Press contact: Sylvie Boone –Press Relations Minafin Group –Sylvie.firstname.lastname@example.org –32/497.540.945
In a panel discussion on custom synthesis and contract manufacturing, panelist Stéphanie Roullé, VP Sales & Marketing - Minakem, spoke about the company’s markets in terms of their size, segments, and trends. She further commented on key market success factors, the effects of Covid-19 on the market, forecasts in terms of market demands, and how to be prepared to cope with demands amidst the possibility of a second outbreak. Excerpts:
What are your company’s target markets? Can you please describe these
markets in terms of their market size, segments, and trends?
Minakem is a fully integrated development partner and manufacturer of APIs, HPAPIs, key intermediates, and building blocks supplying the clinical as well as commercial needs of biotech and pharmaceutical companies globally.
Technically, we can serve all clients who develop and produce medicine based on small molecules, whether it is in therapeutic areas like respiratory, CNS, or cardiovascular diseases, or even in orphan drug applications.
Given our core competence in manufacturing highly-potent
APIs (HPAPI) requiring specialized containment, one central
area we focus on is oncology, which represents the primary
driver in the growth of HPAPI holding a 20-25% market share in
highly-potent drug applications. Oncology is also the
area with the highest forecasted expenditure in clinical
development, unsurprisingly leading to a soaring forecasted
number of FDA approvals of any therapy area. The global
oncology market is supposed to reach $ 200 billion in sales by
2022 (av. annual growth of 10-13%). Approximately 60% of the
oncology pipeline is HPAPI. Apart from conventional cancer
treatments, there is a fast-growing number of novel oncology
drugs coming from discovery and being clinically tested,
including new therapeutic classes such as antibody-drug
conjugates or RNA-targeting small molecule drugs. Due to
stringent regulatory requirements and high cost of production,
innovators in pharma are looking for HPAPI experts from
the early phase onwards (50-70% is being outsourced), and ideally, a company that can provide both, HPAPI
development and manufacturing services, such as Minakem.
Which are the most relevant key success factors in these markets, and how did the key success factors ange in these markets over the last decade?
On top of a proven quality track record, full regulatory
compliance, and lean manufacturing, clear communication
towards our clients combined with the ability to anticipate
and to preventively address quality or process performance
issues are certain key success factors.
Over the last decade, we have seen more and more
pharmaceutical companies that were sourcing their
intermediates or APIs from low-cost manufacturers in the Far East
now coming back to Western CDMOs. One reason is that the
Chinese government, for instance, has raised their environmental,
health, and safety standards closer to those applied in Western
countries, resulting in a less signifi cant difference in COGS.
Moreover, many Chinese plants even have been closed
down due to environmental or safety issues, leading to
a shortage in supply of goods and overall supply chain
uncertainties. In India, on the other hand, the concern is more
related to quality and compliance (e.g., violating cGMP
standards, warning letters) as some pharmaceutical
companies have experienced it.
When it comes to overall performance and future viability
of a CDMO; we believe that companies striving to update their
technological expertise routinely, cultivating a clear
communication style across cultural barriers and monitoring the
dynamics in the development departments of their customers;
will stand out from the competition and set themselves up for
future success. More than ever, today’s focus is to understand
our customer’s development products and future commercial
requirements: What are the unmet patient’s needs? What
therapeutic areas do our clients target? How do novel drug
applications work? What does it mean for a company like
Minakem in terms of our client’s future needs?
Did the coronavirus
outbreak affect your supply chains and target markets, and if so, in what way? Where do you see lasting
effects and lessons from the covid-19 lockdown?
Covid19 has been a game-changer all over the world, and the
biggest reality check for all of us is how vulnerable our supply
chain is, and how critical it is to protect it.
However, while fi rst and foremost focussing on the protection
and safety of our employees working at our sites, we implemented from the beginning of this crisis, measures to
ensure the sustainability of our supply chains and to guarantee
business continuity for our pharma customers and their patients.
It has been a success, thanks to the collective work achieved.
For each of our development and manufacturing sites, we
have worked out business continuity plans taking into
account local specifi cs, and having production facilities all
located in Europe is clearly a countless advantage.
At the end of this crisis, we will not only need to ask ourselves
what can be done to better leverage the collective wisdom
within the pharmaceutical industry and academia to
accelerate the development of life-saving vaccines safely
and in quantities needed for global use. We also need to
address the issue of maintaining a resilient supply chain during
such outbreaks, to manufacture and to transport pharma
goods quickly and safely to patients in need.
What is your forecast in
terms of market demand to the end of the year and beyond? How are you preparing to cope with the future
demand and possible setbacks should a second outbreak occur?
Everybody points to pharma when it comes to curing diseases
and supplying drugs, especially in times like these, when we run
at full steam to fi nd a cure for Covid19. Yet behind the big
pharma brands is a complex universe of suppliers, distributors,
academic institutions, and technology providers. Pharma
simply doesn’t have all the required capacity, so they are
heavily dependent on companies like Minakem to supply them
with their needs for APIs or key building blocks needed in the
assembly of new, promising drugs to fi ght this outbreak.
Furthermore, in conjunction with the virus outbreak, we are also
dealing with other medical problems when Covid19 patients
catch a bacterial infection, for instance, or require pain
relievers or even anesthesia. Last but not least, people still suffer
from CNS, cardiovascular or metabolic diseases. With a signifi
cant portion of the manufacturing capacity in pharma now
taken by drugs to treat Covid19 or diseases resulting from it,
CDMOs like Minakem are standing by to secure drug supply
chains and provide to patient’s needs. I, therefore, do rather
see an increase in demand for manufacturing capacity over
the coming 12-24 months. Minakem is currently in the process
of expanding its technical asset bases to meet those demands.
We also optimize capacity utilization by constantly reassessing
our product portfolio: what has priority for 2020 and what
production can safely be moved to a later point in time to
meet more urgent patient’s needs. We are also in the lucky
position to have multiple GMP-compliant and audited
production sites where capacity can be reallocated to some
extent to make room for unplanned, time-critical requests.
Thierry van Nieuwenhove, CEO of the End Market Division at Minafin Group, discusses the challenges faced by the company and the changes performed to meet them. He talks about possible investments in the near future, technologies supporting Minakem’s development, patient-centric strategies, and the importance of analytical management in the pharmaceutical development and manufacturing value chain.
Mr Van Nieuwenhove, you joined minafin group as CEO of the End Market Division three years ago. What new challenges did you bring to the group, and what are the changes performed to meet them?
In only three years we have worked as a team to :
Develop Minakem as a recognized brand on the CMO market; Minakem has a lot of services and technologies ( some very unique) that can help our customers to be fast and efﬁcient to the market. We ensured the service a Customer receives from any of our sites remains identical and in line with the expected standard.
Ensure our existing and future customers are placed in the center of our focus. Whatever your position in the company, one must remember that the customer should be in the center of our attention. Eventually, we must all acknowledge that a Customer- centric organization in our industry means that we pay attention to the patient that will ultimately be at the end of the chain! As such words like quality, efﬁciency, the security of supply, mean a lot to us.
Roll out OE (Operational Excellence) to the entire organization. The focus was to ensure that we continuously improve ourselves, we deliver and improve efﬁciency and involve all our teams in this success. It is a long term journey, but which today has already given successes in our daily life.
The pharma business unit represents 70 percent of the group’s revenues, but the cosmetic and agri-food businesses are undoubtedly essential niches markets as well. Are you planning to invest in these businesses in the near future?
Yes, in three years, we have transformed Minasolve (Cosmetics) from a mono-product business to a full catalog company. Minasolve, under the “Green Solving Attitude” spirit, is now able to offer the Cosmetic Industry a fully integrated green alternative to cosmetics ingredients and preservatives. The “sustainable beauty” represents, within Minasolve, a deﬁnite meaning of giving every customer a green option for their products, with a service on top!. We have recently launched Minagro. Minagro is the green solving option for the agro-industry. Our focus is to ensure that sustainable agro-industry also means using eco-friendly products that ultimately will be used in our ﬁelds.
Concerning the pharma business division (minakem), are there any new technologies that have supported its development?
There are technologies, e.g., ﬂow chemistry,
enzyme-catalysis, or RC1 proﬁling, that simply improve the process economy or safety aspects of pharma manufacturing. Minakem is undoubtedly looking into those and has already taken steps towards implementing such technologies on a routine basis. When it comes to new, enabling technologies, it is crucial not only to analyze the development pipelines of our customers in the pharmaceutical industry but also to analyze what new therapeutic concepts are currently are under investigation. The trends in innovative medicine also pretty much determine what technologies a CMO needs to apply to address those needs. Here, we can see a good part of the early-stage pharmaceutical pipelines changing to what we call “new modalities,” chemical APIs that look more structurally complex or different, in nature, versus their predecessors. There are new, semi-synthetic conjugates, hybrid-molecules, complex heterocycles or multifunctional molecules that are engineered to hijack cellular processes, such as translational regulation or degradation mechanisms. The challenge for a company like Minakem, who is in the small molecule business, is, how can those trends be translated into chemical solutions, and what tool-box do we need to make it happen? For a good part, maybe even for the majority, we do not need a completely different technical set-up. We just need a highly ﬂexible and easy adjustable manufacturing conﬁguration that can handle even more highly diverse chemical processes in parallel, not just high volume blockbuster drugs: new catalytic systems that can also be run in continuous ﬂow and at deep temperatures; a semi-synthetic process involving enzymes an aqueous-organic media; sophisticated monitoring devices that allow us to process sensitive coupling reactions, especially in conjugations smoothly–just to name a few. Minakem is continuously learning how to upgrade its technological basis and how to attract the right talents who can help us to move to the next level of innovation.
Pharma business has become patient-centric, and the tagline of the company “chemistry for life” summarises perfectly the core mission of minakem. How can a company (cdmo) like minakem contribute to better human health? How can the safety of the supply chain be improved? How can quality be assured? How can time to market be accelerated without an increase in costs?
Companies like Minakem, who are providing custom manufacturing services to the pharmaceutical industry, are essential for patients’ needs and the entire society. Everybody points to pharma when it comes to curing diseases and adequately supplying drugs and medical devices. Yet behind the big pharma brands is a complex universe of suppliers, distributors, academic institutions, think tanks, and technology providers. Facing the current Coronavirus sanitary crisis, the biggest reality check is how vulnerable our supply chains are, and how critical it is to protect them. To re-design and diversify them might be an essential consequence after we have overcome this crisis. And this is were companies like Minakem play a key role. The ﬁnal pill package is just the tip of the iceberg. We all depend heavily on every step of the way from the original idea in the lab to the ﬁnal pill going smoothly. Having the right partners with companies like Minakem within this complex and interdependent supply chain is not only essential – it saves lives. Our customers in the pharmaceutical industry rely on the collective wisdom, capacity and commitment of everybody involved in making the transition from the bench to the patients’ bedsides happen.
Furthermore, our responsibility doesn’t just stop at providing products and services to our customers under the highest quality standards, where we get routinely audited and certiﬁed, we also need to make sure medicine becomes affordable for all patients in need. Here, we do not only optimize our existing supply chains and production facilities to assure smooth and cost-efﬁcient processes, this is also where science and technology comes in. To ﬁnd the best synthetic pathway to a chemical API using novel technologies in order to reduce cumbersome multi-step processes and to eliminate waste is always in our focus to stay lean and cost-effective, which ultimately translates into affordable prices for medical treatments. For instance, there are examples where the manufacturing cost of an API could be cut in half by employing a speciﬁcally designed catalyst system to eliminate costly protection/deprotection steps in chemical processing. It is also the reason why we closely monitor our customer’s product pipelines so we can prepare ourselves for lean manufacturing of their products by employing innovative technical solutions.
What are, according to you, the issues impacting the pharmaceutical development and manufacturing value chain? How are you going to face them?
ANALYTICS. Today all pharma companies are looking at speed
to market and ﬁrst-time-right quality whether we speak about new or existing
Analytics has become a vital element of the development of new products, and authorities are getting more and more focus on the quality of the product as impurities are being tracked at levels that were never thought about less than ﬁve years ago. Realizing today that Analytical Management is as crucial as operation, R&D,… is a gap that all companies have not yet been able to make and certainly to implement.
We have taken that path for three years!A word with Thierry van Nieuwenhove – CEO End Market – Minafin Group