“Go-to-Market” in Pharma is defined as a tactical action plan, that outlines the needed steps to succeed in a new market/therapeutic area.

A “Go-to-Market” strategy generally has, as main objectives, to:

  • Ensure a successful product launch defining plan and direction for all functions
  • Reduce time to market
  • Define a Patient journey map
  • Avoid the wrong path reducing costs associated with not adequate assumptions or failed product launches
  • Ensure regulatory implementation and compliance
  • Assess and define pricing strategy
  • Identify marketing tactics
  • Assign budget for product launch and awareness activities
  • Increase ability to adapt to change

In assessing, the most valuable “Go-to-Market” strategy, it’s indeed relevant to assess, at least, the following:

  • Full knowledge and relevant competencies and functions in place.
  • Trends and key facts in the new therapeutic area.
  • Key stakeholders.
  • Patient Journey.
  • Markets assessment and potential.
  • Global pricing analysis and strategy.

Because Medical Affairs is involved in critical decisions – together with R&D functions – for defining,  designing and implementing clinical studies, it’s important for Pharma/Biotech, to have in place adequate Medical Affairs structure for implementing the “Go-to-Market strategy” and in any case, quite a lot of time before any new product enters into the market, therefore, Pharma/Biotech companies must ensure to have Medical Affairs functions in place much sooner than in the past and at least three/four years before the company expects the product to go to market.

Medical Affairs, in fact, plays a pivotal role, especially if engaged in early phases of development strategy. For this reason, Medical Affairs personnel must have, not only deep and complete Medical and Clinical knowledge, but also relevant business understanding and several other cross-functional skills  that should include, in addition of excellent knowledge of therapeutic areas, also a deep knowledge and understanding of healthcare policies and local environment and healthcare scenario.

This, in order to permit a good collaboration within the cross-functional/integrated launch team, particularly with R&D, Market Access/Helath Economics, Regulatory and Commercial functions, being able to understand the market scenario and landscape, recognizing any opportunity or issue, potentially affecting awareness programs and launches to the market in related countries or regions, assessing clinical evidence standards, helping Clinical Development teams in designing clinical trials to ensure that needed standards for efficacy, safety and value will be met for the relevant markets and coordinating with a broader team on the implications of any decision on the clinical program timelines and competitiveness, regulatory pathways, access and pricing issues or constraints.

It’s important indeed that Companies understand and assess key characteristics markets (geographic areas, regions, countries) before preparing the Go-to-Market strategy.

In my personal experience, as Medical Affairs and Clinical Research Director, for a new therapeutic area and new business for the Company, I joined a Company more than 4 years before the new product  entered into the market, being the only Medical Affairs resource in a cluster of countries – working within Region Europe Medical Leadership Team – starting from scratch and preparing the market for a new molecule, working with many different stakeholders, Key Opinion Leaders, Principal Investigators, Patients, Pharmacologists, Payors, External Vendors, working internationally with Global and within Regional cross-functional Team and building all the awareness activities (huge number of different and diversified activities for different stakeholders, to increase disease awareness, fix unmet medical and patient needs and many other topics) assessing the most relevant topics about the “Go-to Market” strategy, including Market Access potential issues and constraints, having benchmark with similar companies (company and country size/therapeutic areas/marketed/pipeline products) for building the proper teams (Medical, Marketing, HE) in the affiliates, building and maintaining strong and solid partnership with Scientific Societies and Patient Association Groups, speaking at the most relevant Congresses about Company R&D, pipeline and scientific data.

The early involvement of Medical Affairs, should indeed help the Company to develop a multifunctional extended Medical/Regulatory/Access strategy.

Another activity to not underestimate, whereas Medical Affairs can provide a relevant contribution in the process, is “Patient Journey”, that indicates the sequence of care events, which a patient follows from the point of entry into the system, triggered by illness, until the patient is discharged from hospital to home, or due to worsening or death.

In a typical patient journey, for example, is important to identify and address: patient population (according epidemiological data and/or available disease registries), seeking treatment, consulting physicians, approaches to physicians and therapies, diagnosis, treatment, barriers and bottlenecks (for diagnosis, treatment, access to therapy), brand differentiation. In the patient journey several info should be obtained as, patient flow, percentage of patients remained at each step, which are major influence factors, which obstacles and constraints.

It’s also important to understand and address, in a pre-launch and post-launch period, any barrier, as “lack of gain access to treatment”.

In a patient journey, the customers (i.e.: physician/pharmacist/patients) are important stakeholders to consider in the analysis, to understand which are their needs, constraints, treatment and approaches.

For all of the above reasons, the recommendation should be, to have Medical Affairs professionals (with a level of business skills, as well as expertise in communicating with multidisciplinary stakeholders), involved as early as possible, in order to think and assess with Clinical Development team, which end points should be  needed, to develop clinical/pivotal studies to successfully implement Clinical Programs, deepening their value by capturing any insight across the scientific landscape, bringing these back to the Go-to-Market/Launch team.

In fact, Medical Affairs knows, working closely with Clinical Research and Access colleagues, about any clinical evidence needed to establish value as for the regulatory expectations and for this, is needed a strong knowledge of a specific therapeutic area, competitors and different mechanism of action, therapeutic algorithms including Regional and Country clinical guidelines and recommendations.

Lastly – together with Commercial and Market Access teams – a segmentation of stakeholders, would be developed, to assess and determine whose engagement should be driven exclusively by Medical Affairs or should remain within the scope of Commercial or Market Access plans and activities.