Commercialization

Best Practices in Global Commercialization to Optimize Brand Potential

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.

  1. Product Profile and Target Claims

  2. Market Planning & Conditioning

  3. Patient-Centric Positioning (PCP)

  4. Market Access Platform (MAP)

  5. 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.

 

 

Authors

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

RxC International adheres to the following values.

Pioneering | Collaborative | Principled | Tenacious

Gene Therapies: Pathways for Commercial Success

RxC Gene Therapy Pathways for Commercial Success

Gene therapies are poised to enter the US healthcare system within the next 1-2 years as viable treatment options for a variety of diseases. In response to this burgeoning opportunity, the Institute for Clinical and Economic Review (ICER) convened a policy summit and recently released a report on the potential value and challenges of gene therapy treatments, GENE THERAPY: Understanding the Science, Assessing the Evidence, and Paying for Value.

Developing Pathways for Commercial Success

The pathway to commercial success is just as vital as the pathway to regulatory approval. RxC International has drawn key insights in conversation with ICER’s white paper for the commercial entrance of gene therapies.

Value Assessment for Gene Therapies:  Pricing and innovative payment mechanisms have received much attention as significant concerns for gene therapy stakeholders. A more pressing issue, however, is that gene therapies will not have the robust data generated by clinical trials. The reliance on abbreviated data sets coupled with the fact that gene therapies are not a homogenous group mean that market sizes, target populations and clinical trial evidence will vary greatly.  Thus, the plan for gene therapy commercial success must be integrated with the clinical development strategy. At RxC we have modified the typical Target Product Profile into the Target Value Profile that better reflects the market dynamics of gene therapies.

Identifying partners and alliances for commercialization: Due to the complexity of gene therapy commercialization, persuading providers to use gene therapy treatments may require the resources of a partner with commercial expertise. To assist companies in identifying partners and alliances, RxC has the experience and models for forging the strategic partnerships necessary for commercial success.

RxC International Advantage

RxC International, a premier life sciences consulting firm, has created proprietary, cross-functional frameworks for aiding life sciences companies with commercialization and go-to-market strategies for new treatments.  We have adapted our models to assist clients with navigating the unchartered waters of planning and commercializing gene therapies. If you are interested in keeping abreast of our expert work in the gene therapy market, please follow RxC International on Linkedin for updates.