What are the critical areas of focus for commercial planning to successfully launch biopharma products in today’s environment? What are the best practices in commercialization? How to maximize brand value at launch and during its life cycle? Learn about RxC International’s approach and how we are supporting commercialization efforts in biopharma.
Every company contemplates how best to maximize an asset value even in the early stages of clinical development process. The commercial plans must be solidified as soon as the product demonstrates proof-of-concept and the plans must be operationalized during the late stage development process to lay the right platform for a successful launch. In some cases, the commercialization timelines tend to be rather fluid due to accelerated development pathways and early approvals in therapeutic areas where there is the highest unmet need.
Depending on whether the product is expected to be “novel or existing MOA”, “first-to-market or late entrant”, “differentiated or me too”, “first-in-class or best-in-class”, “seeks broader label or limited label”, “gains broader access or limited access”, “has broader awareness or limited awareness”, etc., companies must develop the appropriate commercial strategy to maximize brand value. Based on our experiences in several specialty markets, we believe that there are five key areas of the commercialization process that companies must focus on to maximize the value of the brand.
Product Profile and Target Claims
Market Planning & Conditioning
Patient-Centric Positioning (PCP)
Market Access Platform (MAP)
Commercial Excellence Platform (CEP)
The commercialization process usually starts with the evaluation of the commercial opportunity in target markets and understanding what it takes to capitalize on it. Next step is to design and build the commercial organization (structure, competencies, and governance) to effectively plan and execute pre-/peri-/post-launch activities across regions and globally. Once the commercial organization is established, it’s important to ensure that the commercial planning accounts for the following best practices in each of the five major areas.
1. Product Profile and Target Claims
Clinical Development Plan must reflect the strategies to achieve the globally aligned Target Value Profile (TVP) which should set the tone for all commercial planning activities
Target Value Profile must drive the product claims and various scenarios to address potential positioning considerations in each region based on treatment paradigms
Filing and registration strategy must address regulators needs to gain appropriate claims on the label in each region and global launch sequencing efforts
2. Market Planning & Conditioning
Build relationships with thought leaders in the scientific community and professional organizations to sensitize the market to the new agent
Establish scientific platform to raise disease awareness among thought leaders early if the MoA is relatively new and awareness levels are non-existent or low
Begin INN / trademark development process to account for global and local requirements along with any special considerations with co-marketing partners
3. Patient-Centric Positioning
Differentiate product around two or three key attributes (efficacy, tolerability, dosing, etc.) and clearly articulate how it creates value for patients, providers, and payers (note that differentiation is becoming increasingly challenging in most competitive disease areas)
Develop positioning and aligned messaging platform to ensure that the core messages are customized for each of the stakeholders to communicate value effectively
Develop patient-centric solutions (beyond-the-brand) early with the intent of engaging patients better and to ensure treatment adherence as part of treatment optimization
4. Market Access Platform (MAP)
Develop MAP using payer input and with clear focus on “product value” and what it means to different stakeholders (public / private payers and financial intermediaries)
Ensure that HEOR data needs are prospectively incorporated into Ph 2/3 trials—continue HEOR data generation efforts as part of continuous value profile enhancement efforts
Develop value-based pricing and reimbursement models for payers given the budget constraints and burden of proof required to clear formulary hurdles
5. Commercial Excellence Platform (CEP)
Leverage launch archetypes and prepare launch readiness platform to flawlessly execute activities and communications
Focus on promotional mix (personal and non-personal) and develop the best ‘formula’ using prescriber base, patients, disease, and competitive environment
Ensure accountability for each activity and institute performance management mechanisms to monitor key performance indicators (KPIs) during pre-/peri-/post phases of launch
Ensure cross-functional collaboration to drive innovation and alignment across all commercialization activities
The RxC International team believes that cross-functional collaboration across regulatory, medical, tech ops, and commercial teams as well as global-regional alignment are imperatives for achieving commercial excellence. Long-term success of the brand is further dictated by life cycle planning efforts that a company must pursue throughout the product development and commercialization life cycle.
Subbarao Jayanthi, Managing Partner
Jose De Leon, Executive Partner
About RxC International
RxC International is a premier life sciences management consulting firm. RxC collaborates with clients to identify and develop growth opportunities. The firm leverages consulting partners and advisers to combine strategic and operational expertise to bring multiple perspectives to every engagement. The firm has deep expertise in corporate strategy, new product strategy, and commercial excellence. www.RxCinternational.com
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