{"id":8783,"date":"2022-01-05T17:47:01","date_gmt":"2022-01-05T17:47:01","guid":{"rendered":"https:\/\/amarintech.com\/?p=8783"},"modified":"2026-05-29T12:02:02","modified_gmt":"2026-05-29T12:02:02","slug":"transdermal-cdmo-small-company-competitive-advantage","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/transdermal-cdmo-small-company-competitive-advantage\/","title":{"rendered":"Sergio Lucero: \"Amarin se diferencia por siempre respetar las reglas y ser flexible en los negocios\""},"content":{"rendered":"\t\t
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In transdermal pharmaceutical development, the initial instinct of many business development managers is to default to the largest available CDMO, the assumption being that scale correlates with capability, and that a recognized name reduces risk. Sergio Lucero, Director and CEO of Amarin Technologies, has spent 38 years in the pharmaceutical industry examining that assumption from the other side of the table, and his conclusion is direct: the competitive advantages of a small, specialized transdermal CDMO are not compromises relative to larger alternatives. They are structural features that a large organization cannot replicate.<\/span><\/p>

Amarin Technologies is, by Lucero’s own account, the smallest company operating in the major leagues of the global transdermal industry, with a team of 36 people. It is also, by any objective measure, competing successfully: products marketed in Latin America, the United States, and Europe; a 30% strategic shareholding from Helm AG of Hamburg; GMP certification from European health authorities; and a pipeline of development projects in progress for partners across MENA, South Korea, and the Philippines.<\/span><\/p>

What makes that position possible? Lucero identifies four operational characteristics that define Amarin’s competitive differentiation, and that are, in structural terms, inversely correlated with company size.<\/span><\/p>

1. Professionalism at International Standards \u2014 Without the Corporate Overhead<\/b><\/h2>

‘Amarin is proudly part of this group [of major transdermal companies] and, I believe, the smallest player,’ Lucero says. His team ‘holds discussions with first-world companies on an equal footing.’ This is not a claim about aspiration, it is the operational reality that makes it possible for Amarin to maintain commercial relationships with European and US partners who conduct full facility audits and apply their own regulatory standards to what Amarin delivers.<\/span><\/p>

The professional capability Lucero describes is not generic competence. It is highly specialized knowledge: transdermal formulation, adhesive systems, permeation enhancer chemistry, bioequivalence study design, and GMP manufacturing for controlled substances. Building this knowledge in a team of 36 requires a different approach than building it in a team of 360, one where depth of individual expertise compensates for the absence of division-level redundancy.<\/span><\/p>

‘The only thing I might envy these companies is the economic resources they have,’ Lucero notes. The distinction matters: Amarin’s constraint is capital, not competence. For partners who are evaluating technical capability, rather than buying brand reassurance, that distinction changes the evaluation calculus.<\/span><\/p>

2. Flexibility as a Structural Feature, Not a Sales Pitch<\/b><\/h2>

Large CDMOs operate on standardized processes and pre-established client schemes. This is rational from their perspective: it enables volume throughput and reduces organizational complexity. It also means that clients are, to varying degrees, expected to fit into the CDMO’s operational model rather than the other way around.<\/span><\/p>

Lucero describes Amarin’s approach differently: ‘What I always say is that we have to have a scheme for each client. Because each client is different. Large companies work with pre-established schemes and models. Amarin offers a plus by telling the client: I offer you the same service, but tell me what you need, because we can talk about it.’<\/span><\/p>

In transdermal development partnerships, where project scope, molecule-specific challenges, regulatory targets, and partner capabilities vary considerably, this flexibility is not a nice-to-have. It is operationally material. A partner evaluating a 505(b)(2) development program in Europe has different requirements than one seeking generic ANDA manufacturing for the US market, which is different again from one building a regional Latin American supply chain. The ability to genuinely adapt to these different configurations, rather than accommodating superficial variations within a fixed service model, is a competitive differentiator that scales inversely with organizational size.<\/span><\/p>

3. Commitment and Transparency as Operational Policies<\/b><\/h2>

Lucero’s description of Amarin’s commitment and transparency standards is concrete enough to function as a service-level specification:<\/span><\/p>

  • 48-hour query response: ‘We have an internal policy that obliges us to answer any query in less than 48 hours, and if we don’t have the answer, we reply saying that and we commit a specific time to provide it.’ The rationale is explicit: ‘If someone asks us something it is because he needs that answer and answering immediately is part of our respect for our client.’<\/span><\/li>
  • Honest capability scoping: ‘We never take on development or task without knowing that we can commit to fulfilling it.’ And more unusually: ‘If there is something the client needs and we cannot do it, we give him the advice so that he knows who can do what we cannot. Because we would be very wrong to commit ourselves to something we can’t do.’ In an industry where CDMOs sometimes overpromise capabilities to close deals, this policy functions as a risk management tool for partners.<\/span><\/li>
  • Long-term relationship orientation: ‘Transparency is essential in our convictions, in our actions, in our capabilities and in all aspects of our professional life. Nothing can be built based on the convenience of a single party or on deceit.’ The Fentanyl patch development timeline is the most concrete illustration: Amarin began working on it in 1999 (then within Laboratorios Beta), made its first European export in 2007, and that product is still being supplied today, nearly 25 years of continuous engagement with a single product and its associated partners.<\/span><\/li><\/ul>

    4. A Vision for Strategic Partnership at Scale<\/b><\/h2>

    Lucero is transparent about where Amarin’s current manufacturing capacity sits relative to its ambitions: ‘With our plant we can supply Latin America and even a small product in a large market.’ The commercial ceiling imposed by a single manufacturing facility in Argentina is a real constraint, and he does not minimize it.<\/span><\/p>

    His medium- and long-term response to that constraint is instructive for partners evaluating Amarin’s trajectory:<\/span><\/p>

    • Medium-term (6-7 years): 4-5 development projects in active progress, all at early investment stage, with expected commercial outcomes timed accordingly. Pharmaceutical development timelines are long. ‘We started working on Fentanyl in 1999 and the first export was in 2007, and Amarin’s planning horizon reflects that reality.<\/span><\/li>
    • Long-term vision: ‘I have a great objective which does not depend 100% on me: just as I have a strategic commercial partnership with Helm AG, I have the ambition of establishing a strategic partnership of Development and Production with a company that is in patches, that already exists in the United States or Europe \u2014 that we can make a synergy between the development capacity that exists here, with a company that has a greater production capacity than us. We can be the product developers and our partners can implement the manufacturing, and we both win.’<\/span><\/li><\/ul>

      This framing, Amarin as development engine, partner as commercial-scale manufacturing and distribution platform, identifies exactly the competitive advantage proposition that a small transdermal CDMO can credibly offer to a larger player: IP, formulation expertise, regulatory packages, and clinical data that the partner can then scale commercially through its own infrastructure.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

      In transdermal pharmaceutical development, the initial instinct of many business development managers is to default to the largest available CDMO, the assumption being that scale correlates with capability, and that a recognized name reduces risk. <\/p>","protected":false},"author":21,"featured_media":11327,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51,20],"tags":[],"class_list":["post-8783","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-and-society","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts\/8783","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/users\/21"}],"replies":[{"embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/comments?post=8783"}],"version-history":[{"count":7,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts\/8783\/revisions"}],"predecessor-version":[{"id":11333,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/posts\/8783\/revisions\/11333"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/media\/11327"}],"wp:attachment":[{"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/media?parent=8783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/categories?post=8783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/amarintech.com\/es\/wp-json\/wp\/v2\/tags?post=8783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}