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This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules.
🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules
Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years?
We have achieved incredible milestones over the last two years, thanks
to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent
CDMO by building on the 50 years of expertise that we brought with us. In
addition, we expanded our capabilities and applied a more agile approach
available to us as a company singularly focused on life sciences. This has
allowed us to move into our second year with clear and strategic goals for
generating growth in our sites, people, capabilities, and offerings.
Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some
exciting growth milestones of my own. Most recently, we announced an estimated
US$ 30 million investment in our Devens, Massachusetts, site. This expansion
will allow us to build upon existing development and manufacturing capabilities
in ADCs and HPAPIs that will address the growing demand for strong US-based
capacity in these key drug modalities.
We also appointed our Advisory Board, thereby bolstering
Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas.
We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024.
🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board
Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years?
The pharmaceutical pipeline is witnessing an increasing number of
complex and highly potent molecules. This trend is driven by the demand for
more targeted, patient-centric therapeutics and the focus on innovative
modalities such as ADCs and other bioconjugates.
At Veranova, our expertise, world-class facilities, and scientific
excellence enable us to provide our customers with the clarity and solutions
needed to manage this development and manufacturing complexity and ultimately
deliver the required treatments to customers and patients.
Our people are key to this approach. We have an expert team ready to
collaborate with customers at any point, from early development through
large-scale commercial production. Our services include world-leading
crystallization development, process development, and specialized manufacturing
expertise for complex synthetic molecules, including those requiring
chromatography capabilities. In many cases, we can provide all these under one
roof.
Our service offering to our customers is also based on the foundational
element of strong quality and compliance systems. We operate multiple
facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually
focused on ways to strengthen our global quality management system.
Looking ahead, we are focused on continually investing in our facilities
and team to meet growing complexity, as evidenced by our recent announcement of
new investment in our Devens site. This investment signals our commitment to
providing state-of-the-art capacity and capabilities to enable these
next-generation therapies to reach patients. It is a key milestone as we
advance Veranova’s broader growth strategy.
🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems
How is Veranova approaching the challenge of designing and
manufacturing effective linker molecules for ADCs?
As a leader in complex linker-payload synthesis, Veranova is committed
to unlocking the life-changing potential of ADCs without letting their
complexities slow down the development of much-needed cancer therapies.
ADCs are intricate, multi-component molecules that require extensive
expertise and agile collaboration to overcome unique development challenges.
With over a decade of experience in ADC linker-payload systems, we have
developed the ability to anticipate challenges and avoid common pitfalls.
The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic.
We prioritize getting it right the first time, minimizing change orders
and ensuring high-quality results. We have developed a robust phase-appropriate
strategy that is backed by state-of-the-art analytical equipment and regulatory
procedures to ensure our partners can rapidly progress their ADC projects from
pre-clinical to commercialization.
🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects
Can you specify how Veranova is using artificial intelligence (AI) to optimize
manufacturing processes that can reduce costs and environmental footprint as
well as speed up development?
In May 2024, Veranova announced a partnership with Phorum.AI to leverage
AI to optimize pharmaceutical manufacturing processes. This collaboration aims
to enable the rapid development of processes that can drive efficiency and
reduce costs while maximizing environmental sustainability.
Our goal is to combine Veranova’s extensive empirical manufacturing dataset
of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers.
At Veranova, we are constantly looking to employ innovative technologies
and approaches to improve efficiency, accelerate time to market and reduce
environmental footprint. We have the means to work with a variety of partners
who have unique project requirements, without sacrificing time to market.
🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint
Over
the last two years, there has been a significant surge in layoffs by
pharmaceutical and biotech companies. The trend spilled over to 2024. Data
compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs.
Bristol Myers Squibb (BMS) tops the list of
companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816
retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing
over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions,
and Novartis is going ahead with its
multi-year restructuring, and cutting another 770 jobs.
One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development.
The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland).
This
is not to suggest that job cuts are a norm. Certain segments have been
experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)
BMS cuts 2,284 jobs to meet
cost targets, Bayer hands pink slips to 1,816 employees
Several
large drugmakers have announced job cuts this year in order to meet their cost
cutting goals, or as part of their restructuring exercise.
BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled
it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity
initiative”.
In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally.
Bayer is laying off 1,816 employees
worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the
German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026.
Japanese
drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses.
Starting
next month, Genentech, a Roche subsidiary, will lay off 93
employees in San Francisco. Earlier this year, Genentech trimmed roughly 3
percent of its workforce across several departments, impacting 436 employees.
Roche also laid off around 340 employees in its product development
team.
Novartis has been undergoing a
significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce.
This year, it announced an additional 770 job cuts in its product development
organization, separate from the previous reductions. Once again, it was workforces in
Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt.
Tylenol and Band-Aid maker Kenvue,
which spun off from J&J last year, announced plans
to cut 920 jobs, representing about 4 percent of its global workforce.
Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)
Perrigo, Emergent Bio,
Catalent, BioMarin trim workforces amid strategic shifts
Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future.
In
February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which
translates into nearly 550 employees.
CDMO-turned-biopharma Emergent BioSolutions plans to reduce its
workforce by about 300 employees. The Maryland-based
multinational is closing its Baltimore-Bayview drug
substance manufacturing facility and its Rockville drug product facility in the
state.
Rare
disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign
efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash.
Drug-delivery
specialist Catalent has also been significantly
impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of
being acquired by Novo Nordisk’s parent company for US$ 16.5
billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of
2023.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)
Pfizer job cuts continue to
trickle in; Lykos, Lyra downsize after pipeline setbacks
Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to
trickle in, with some estimates putting the number at 1,500 employees
in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated,
near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go.
It
has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75
employees). Its founder, who had spent 38 years working on the therapy, left
the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line.
Similarly,
Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing
late-stage results for its implant to treat chronic rhino-sinusitis. The
retrenchments include its chief technology officer.
View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)
Our view
Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes.
The
employment landscape is certainly evolving. We foresee significant changes in
the skills required for pharmaceutical and biotech careers, with a growing
emphasis on data science and computational biology.