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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
The US is in the
midst of yet another, or perhaps the most, polarizing Presidential election.
The two candidates have highly divergent personas, records, visions and views.
That gets reflected in their starkly different visions for the healthcare
system.Healthcare is the
second most important issue for voters in the 2024 US elections, with only the
economy ranking higher, according to the Pew Research Center.In this week’s PharmaFlow, we look at the past approaches of both the contenders — Democratic presidential nominee Kamala Harris and Republican contender Donald Trump — towards healthcare, and what the two presidencies could mean for the US healthcare industry.Both Harris and
Trump have a rare point of agreement — that the US government should act on reducing high drug prices. But have they spelt out how they will make healthcare more accessible? Our analysis should give you some answers.Abortion remains a pivotal issue, may shape
broader discussions on healthcareTrump takes pride in the fact that he played an important role in overturning Roe v. Wade, a ruling that protected the abortion rights of women across America. Trump did that by selecting Supreme Court justices who were instrumental in overturning it. Two and a half years after Roe v. Wade was overturned, Trump faces an electorate that largely seems to favor abortion rights — according to Pew Research, 63 percent respondents say abortion should
be legal in all or most cases, while 36 percent say it should be illegal in all
or most cases.Candidates’ stances on
abortion access, including the regulation on medications like mifepristone, are being scrutinized by both supporters and
opponents of abortion rights. In June this year, the US Supreme Court had
unanimously rejected a case to restrict access to the abortion drug
mifepristone. The demand for its ban had been raised by an anti-abortion group
in Texas.Of late, there
have been reports of Republicans trying to distance themselves from aggressive anti-abortion ideas coming from its party men and allies. Aiming to carve-out a political middle ground, Trump has said that abortion policy should be made by the states. Despite Trump’s softening of stance, abortion rights is likely to not only affect voter turnout, but also shape broader discussions on healthcare and women’s rights.Affordable Care Act: Harris to strengthen it,
Trump has ‘concepts of a
plan’ to replace itHarris has been
all for expanding and strengthening the Affordable Care Act (ACA). She has promised
to “make affordable healthcare a
right, not a privilege.”Trump, on the other hand, had made attempts during his presidency to repeal and replace the ACA, arguing that it provided “lousy healthcare.” While those efforts ultimately failed in the Senate, Trump succeeded in weakening the ACA by eliminating the individual mandate penalty through the 2017 Tax Cuts and Jobs Act.In a potential
second term, Trump might renew efforts to dismantle or significantly alter the
ACA. Although he has not presented a comprehensive replacement plan, he said
during the Presidential debate held on September 9 that he has “concepts of a plan.”Drug prices: Harris to accelerate Medicare price
cuts; Trump to focus on genericsHarris has had an
aggressive stance on reducing prescription drug costs. Her tie-breaking vote on the Inflation Reduction Act gave Medicare the power to negotiate
lower drug prices with pharmaceutical companies.Harris has
pledged to accelerate those negotiations, once she becomes President, to cover
more drugs and further lower prices for Americans. She also intends to extend
the US$ 35 cap on insulin and the US$ 2,000 cap on out-of-pocket spending for
seniors to all Americans, not just those on Medicare.Harris plans to
make permanent the Biden-Harris tax credit enhancements that have already
lowered healthcare premiums by an average of about US$ 800 a year for millions
of Americans. This move would ensure continued accessibility to health
insurance for a broader segment of the population.However, her stance on insurance companies and Big Pharma, including her support for “march-in” rights, might face resistance from pharmaceutical companies concerned about maintaining incentives for innovation.On the issue of drug pricing, Trump’s record is mixed. While he took credit for some decreases in prescription drug prices during his presidency, his administration’s most significant regulatory changes often favored pharmaceutical companies.Trump did issue a
rule setting up a path to import drugs from Canada and other countries, but
this initiative has faced significant hurdles, including pushback from Canadian
authorities.Trump’s stance on drug pricing for a potential second term appears to focus on increasing generic and biosimilar competition, importing drugs made in the US but sold overseas back to the US, and capping out-of-pocket insulin costs. While he has criticized Big Pharma for putting profits above people, his administration’s policies had often aligned with industry interests.Harris appears committed to drug control; Trump
had cut public health fundsMental health and
substance abuse are the other areas where Harris has shown strong commitment.
Having prosecuted drug traffickers, she has demonstrated her commitment to curbing the opioid epidemic.In the White House, she helped direct more than US$ 150 billion to disrupt the flow of illicit drugs and delivered billions of dollars in investments to states to fund lifesaving programs. Under a Harris
administration, we might see increased funding for addiction treatment programs
and continued efforts to make overdose-reversal drugs like naloxone more
accessible.During his presidency, Trump had significantly reduced funding for public health programs. His administration had suggested budget cuts to the Centers for Disease Control and Prevention (CDC) and other public health agencies, justifying them as measures for fiscal responsibility.Our viewGiven her record, a Harris presidency could lead to increased insurance coverage. However, it might also come with increased regulation and price controls. More aggressive drug price negotiations could pressure pharmaceutical companies’ profit margins, potentially affecting R&D budgets. Stricter vigilance on the pharmaceutical industry could lead to more litigation and regulatory challenges for drug companies. But in the long run, this might also improve public trust in drug companies and in the healthcare systems.Under a second Trump term, reduced public health funding could create challenges for community health providers and public health initiatives. An emphasis on generic competition could pressure brand-name drug manufacturers, but create opportunities for generic drug makers.