New technology product launch

A product launch is intended to solve an identified problem. The product’s technology is essentially the enabler. Preparing for the launch of a new therapeutic is no simple or small task. But, if your therapeutic is also a disruptive new technology, the approach is even more complex.  The novel technology, your product enabler, must have a starring role in your commercial plan.

A historic game changer

There have been pharmaceutical category-makers in the past, one notable the discovery and introduction of statins (HMG-CoA reductase inhibitors). Before the introduction of lovastatin in the late 1980s, lipid lowering was limited to dietary changes, bile acid squestrants, nicotinic acid and fibrates. Mortality was high while therapeutic interventions remained elusive. The launch of a new approach and class—statins—were indeed market disrupters that significantly advanced the treatment of coronary heart disease. Despite the global adoption of statins, cardiovascular disease remains a worldwide health epidemic with dyslipidemia as the number one risk factor. Advances in this field continue with new approaches including RNA based therapeutics and gene therapy; however, even with this established health risk, known therapeutic unmet need, and specialists experienced in introducing breakthrough therapeutics, manufacturers launching new approaches will need to carefully consider and clearly position their bold new technology.

Gene therapy—the ultimate game changer

In the consumer goods world, technology can provide incremental value or be truly disruptive. In life sciences, the commercialization of gene therapies is enormously disruptive for numerous reasons including the potential to be one-time curative interventions. Spark Therapeutics’ Luxturna® (voretigene neparvovec) for RPE65 mutation-induced blindness and Novartis’ Kymriah® (tisagenlecleucel), a chimeric antigen receptor T cell therapy, were the first FDA approved and commercialized gene therapies. Since then, a few others have received approval including Alnylam‘s Onpattro® (patisiran) and Novartis’ Zolgensma® (onasemnogene abeparvovec-xioi) with a significant number of clinical-stage gene therapy products in development. Gene therapy is an exciting and rapidly evolving field that remains in its commercial infancy and without a clearly established class.

Ensuring there is an O in KOL

In this field, gene therapy and gene editing exist as broad categories with countless variations across mechanism, routes of administration, and known safety and efficacy across the long list of therapies in development. It is difficult enough for patients and caregivers to understand this ever-evolving space, let alone the physicians who will ultimately prescribe these interventions. A 2020 survey of over 1,400 healthcare providers in the US, sponsored by NORD and published in Neurology News, identified a major gene therapy education gap among providers across multiple specialties. Despite these practitioners having relatively common exposure to patients with rare genetic diseases, fewer than one-quarter feel comfortable explaining gene mutations to patients and caregivers. They pointed to a lack of knowledge of approved therapies and limited understanding of the mechanisms by which gene therapy corrects faulty genes. These findings highlight a clear need and opportunity for institutions and industry to fill this this education gap with the healthcare leaders who are meant to understand, advise and adopt this new technology.

Clarity in communication is key

A commercial leader must also choose the right level of amplification needed for their technology with careful consideration to the amount of detail stakeholders require. A physician leader at a pharma company in charge of business development for their gene therapy portfolio, recently confided that even he could not fully understand some of the content describing a technology portfolio in corporate presentations he reviews. If you are losing the experts, it is hard to imagine how a mother would have the right information and understanding about a new technology to make a decision about enrolling her child in a clinical trial. Taking the time to understand all of your stakeholders’ sentiments and working at ways to achieve clarity is critical to your planning.

Several ways to incorporate novel technology in your commercial planning

How we can help

A new technology demands extra attention to your pre-launch planning. Our propriety approaches, technologies, and experience can help you define these aspects of your business and provide you a platform to begin developing the critical strategies to drive your success.

Contact us to learn how we can help you define your market, product, and corporate brand—and build value across your organization.


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