Barriers to successful biopharmaceutical commercialisation

Mike Ackermann, Vice President of Global Commercial Strategy and Alliance at Quintiles, illuminates the significant barriers to successful biopharmaceutical commercialisation.

The biopharmaceutical industry increasingly finds itself facing a host of challenges – from declining productivity, increasing costs, a dwindling pipeline, lower earnings and an enormous patent cliff – what must the industry focus its efforts on to develop drugs successfully?

Mike Ackermann. Most importantly, the industry must fully realise that the blockbuster model is gone. The days of launching a product en masse, with significant resources allocated to detailing primary care physicians, are over. Biopharmaceutical companies can no longer look to one product to carry the organisation and fund future R&D. This mindset has to change.

The environment of the New Health now demands manufacturers to demonstrate clear value to multiple stakeholders compared to therapies that are already available for a specific patient population. And by value, I mean more than just cost. Value needs to be re-defined to include real-world patient outcomes and an accurate benefit/risk profile, among other things. Payers – both private insurers in the US and national health systems in Europe and elsewhere – are demanding more evidence of a product’s overall contribution to healthcare. Safety and efficacy benchmarks still apply, of course, but simply obtaining regulatory approval isn’t enough to ensure that a new product will be reimbursed.

The most critical notion that biopharmaceutical companies must understand is that they need to develop medicines that are a demonstrable improvement from existing therapies and will therefore be paid for.

Is the pharmaceutical industry currently structured in a manner to accommodate this overall shift?

MA. The silo structure of most large biopharmaceutical companies is not at all conducive to a convergent approach to drug development. By and large, drug development is still compartmentalised into clinical development and commercial preparation; with each function basing success on different measures. In today’s environment, the knowledge and expertise of how a drug might be used in the real world, by whom and at what cost, needs to be understood and incorporated early into the clinical development plan.

The end goal is to identify and to unlock the latent value of the product in the early phases of development, so when it actually launches, you have much better insights into how it will perform from both a clinical and outcomes perspective. The industry as a whole might certainly recognise this need – and our research indicates that 77 percent of biopharmaceutical executives say the convergence of clinical development and commercial operations will affect the success of their firm positively – but most companies are not yet structured to develop products in this manner.

In addition to pressure from payers, will an increasing level of patient empowerment play a role in how, and which, drugs are developed?

MA. Patients are now being asked to directly carry a larger share of their overall healthcare costs, so they’re naturally demanding a greater voice in their treatment. Commercialising a new product is no longer about detailing physicians; biopharma companies must gain a much better understanding of the decision process of patients and develop a new model for commercialisation that recognises a patient as a key stakeholder. Once recognised, the challenge is then to apply a patient-centric model to deliver the necessary information that demonstrates a product’s value and to help patients ‘experience’ that value in a real world setting.

Could this same type of information be used to demonstrate a product’s value to payers?

MA. It might consist of a different set of data with different analytics applied, but the concept of stressing patient outcomes still applies. For example, commercialising a product in Europe is first and foremost about working with national and regional paying bodies to ensure that the drug will be covered. In the US, biopharma must work with the large private insurers in a similar capacity. On a global level, many emerging markets are maturing and offer enormous potential for revenue growth, so understanding the market access complexities of each region is vital.

The bottom line is that payers everywhere are simply demanding more evidence of a product’s differentiation, and most biopharmaceutical companies are not equipped internally to properly address market access. As such, partnering with an ally with knowledge and experience of the potential market, as well as the therapeutic area, could be tremendously valuable to help identify, promote and prove the product’s worth.

What are some of the key elements to a successful commercialisation partnership?

MA. Biopharma companies must choose a partner that has both a track record of developing comprehensive commercial solutions for numerous product launches and an understanding of the complexities involved in successfully entering a market. That partner should also possess core capabilities to support the commercial model, including market intelligence, analytics, regulatory strategy, pharmacovigilance, as well as patient-centered solutions and observational studies.

As for structure, any commercialisation partnership must be tailored to the needs of the specific brand, the specific market and the specific partner in order to unlock the value of the product. All of these functions then need to work in concert to support an overall brand solution that can identify, define and communicate value in a way that resonates with stakeholders. However, before entering into any strategic alliance, both parties should conduct a thorough examination of the product, the patient, the market, key players, the competition and the pipeline to fully maximise the brand’s commercialisation potential.

Aside from unloading the burden of having to devote internal resources, what other tangible benefits can be had in developing a commercialisation partnership in support of a new product?

MA. The benefits are numerous, but primarily, a strategic partnership to support a new brand gives biopharmaceutical companies the opportunity to manage its core business in a more focused and flexible way as they use their partner’s capabilities to expand their resources. These resources could fulfill a therapeutic need or a geographic need. For example, should a company be looking to optimise a wide portfolio of products, but retain their internal focus on core strategic areas, a partner with deep therapeutic expertise could embrace assets that fall outside the company’s main priorities but which still have additional market potential. Quite simply, an effective commercialisation partnership can support a brand in ways that are more effective and efficient than most companies have the ability to do internally.

Partners can also help in the convergence of clinical and commercial insights into earlier phases of product development. Biopharmaceutical companies need to understand that in order to create and demonstrate value, they must begin to embrace the needs of the New Health stakeholders – payers, providers and patients. Doing so would enable the creation of a ‘value track’ – focused on commercialisation requirements – to run in parallel to the traditional conventional regulatory-driven clinical development needs. This would ensure having the right data available to achieve optimal market access upon approval.

The realities of today’s marketplace dictate that biopharmaceutical companies need to be both flexible and discerning in choosing the right criteria to determine which products to move forward and how and where to market them. It’s confusing and convoluted, but sharing responsibilities with capable partners can minimise risk, expand shots on goal and gain critical flexibility in the deployment of their internal resources to develop tomorrow’s innovative medicines.

Biography

Michael Ackermann, PhD, serves as the Senior Vice President of Global Commercial Strategy and Alliance, Global Commercial Solutions at Quintiles. Prior to joining Quintiles, Dr. Ackermann founded and acted as President of Laurus, LLC; a business accelerator for start-up life sciences companies. Ackermann also spent 18 years at Eli Lilly where he held numerous executive positions as a Business Unit Leader, executive sales leadership positions as well as corporate strategic pricing and market research.