Drug Commercialization

What is Drug Commercialization and Why Is It Outsourced?
It is widely known that developing new drugs is an incredibly costly, time consuming venture that requires millions of dollars and years of effort, but that is only the beginning of the story.  Innovation and breakthroughs in medical science do not necessarily ensure the success of a drug.  Often that is the beginning of the set of hurdles that begins an extensive effort to bring a new drug from the laboratory to healthcare clinics, pharmacies, healthcare practitioner offices and hospitals.
Drug commercialization involves a strategic complex multi-departmental and even multiorganizational effort in collaboration to gain market access, enhance both patient and healthcare provider access, empower sales force readiness, prepare the supply chain, distribution networks and customer support programs to ensure the successful launch and continued use of a new drug.
To ensure the success of a new drug product, patients need to be educated about, actively engaged with and adherent to the treatment protocols.  At every stage of the patient treatment journey, information must be readily available, digestible and appropriate for all concerned parties.  When dealing with specialty drugs in which treatment protocols mandate multiple touch points and individual involvement with the patient, this is especially critical.
A patient-centric hub provides the means to concentrate all the primary assets that a patient needs in one easy-to-access location for:
  • Education of the patient, healthcare providers and payers
  • Streamlining of claims processing
  • Automation of prior authorization
  • Evaluation and minimization of risk
  • Support and monitoring of patient adherence to the treatment protocols
  • Providing information regarding financial aid and copay
  • Collection and analysis of outcomes data
The bottom line is that patients are consumers.  Period.  Over the past decade, patients have become more educated, empowered and involved in the selection of their own drug therapies.  Today patients have information at their fingertips and can interact with other consumers with similar health concerns, needs and questions.  Engaging with patient communities is essential.  This provides added support for patients and helps in sharing news of the new product launch and the product’s efficacy.

To ensure a successful drug commercialization effort, patients need to be provided with services that are easy to access, use and understand.  These services need to bridge the patient journey from diagnosis to therapy to reimbursement.  Healthcare providers need to also have the tools to prescribe the medication, facilitate insurance reimbursement and ensure communication with patients for proper medication management. 

Healthcare providers need to have the ability to integrate patient support program services into electronic medical record systems. This will eliminate the duplication of work, minimize errors and expedite patients’ access to therapies.  The concept of “eEnablement” coined by Dr. Scott Dulitz, VP of Product Support and Innovation at UBC is now used across the healthcare industry to refer to ways that pharmaceutical companies leverage today’s technologies to communicate with and manage patients, providing them with the needed support services that interface with new operating models.

Pharmaceutical drug commercialization services are now moving beyond simply providing patient care and access to reach new horizons that can readily impact drug development.  By focusing not only on therapeutic efficacy and drug costs but also on the value that the drug product and services can provide to patients, the value proposition of the drug is enhanced.  This helps to provide a powerful, convincing case to patient communities, enhancing engagement, sharing of information and encouraging feedback and involvement in future drug development.

How Outsourcing Drug Commercialization Works

A third-party service provider makes a deal with a pharmaceutical manufacturer to use its internal sales force and business units designed to provide patient hub services and commercial functions including marketing and distribution.  The service provider receives reimbursement for specific costs involved with the drug commercialization and is also paid a percentage of the profits for the respective drug product, often once sales surpass metrics established for administrative, manufacturing and commercialization costs.

The practice of outsourcing drug commercialization efforts is favored by smaller pharmaceutical companies. This provides them with an alternative option to out-licensing or having their company acquired.  Outsourcing pharmaceutical drug commercialization enables smaller drug companies to forego the significant investment needed for a corporate infrastructure, investment in a sales force, distribution and/or third party logistics facilities and other requirements.

Why Outsource Drug Commercialization?

With research and development costs soaring, pharmaceutical companies need to ensure the optimization of revenue generation for their products.  Outsourcing pharmaceutical drug commercialization to third party experts often can make a notable difference in the level of success of a given drug product. 

Effective third-party drug commercialization service providers are able to integrate the infrastructure, personnel and processes to create and maintain a seamless patient experience which results in product loyalty that withstands product loss of exclusivity or introduction of competing drug products.
Outsourcing Drug Commercialization to a Third-Party Service Provider Can
  • Decrease time-to-market
  • Improve the effectiveness and efficiency of drug development
  • Enhance the commercial success of drug products
  • Improve the level of patient adherence to the therapeutic regimen, especially critical with specialty pharmaceuticals
  • Aid in demonstrating value of the drug production within the patient community
  • Extend the pharmaceutical manufacturer’s team with drug commercialization experts
  • Enable the third-party service provider to assume chain of custody of the drug products
  • Effectively manage the payer relationships
  • Strategically handle the distribution efforts needed to address the needs of specific patient populations, channel, network and therapy needs
  • Ensure the proper fulfillment of the pharmaceuticals that are shipped directly to patients

Conclusion

From San Diego to Maine, the pharma industry works hard to overcome the challenges of marketing pharmaceuticals and ensure the commercial success of new drugs.  From biotechnology drugs to gene therapies and even medical devices, commercialization strategies and efforts can be highly complex, costly and cumbersome to execute.

As drug discovery development and commercialization costs have escalated, pharmaceutical companies have sought relief.  From developing drug development and commercialization processes including those for orphan drug commercialization, pharmaceutical companies have learned the value of investing in the patient experience.  Drug commercialization plans involve a build up of infrastructure, staffing and technology, a costly investment in the commercial success of a drug.  Pharmaceutical drug commercialization is a top-heavy engagement, to be sure.

Beyond all the white papers on drug commercialization, the exciting advances provided by leveraging new technologies such as artificial intelligence (AI) and machine learning are the third party service providers that specialize in enhancing the patient experience and health care.  Outsourcing drug commercialization to a third party service provider specializing in drug commercialization helps to ensure maximization of a drug product’s value proposition.  Many third party service providers not only provide patient centric hubs but also specialize in utilizing data science, data analysis, supply chain and health care expertise in combination with well-crafted distribution and marketing strategy to ensure the successful product launch of drug products.

It is a complicated business, no doubt.  To be successful in drug commercialization, a pharmaceutical company’s drug product must be properly positioned and patients, healthcare providers and payers all need to have access to education and communication resources.  It is not enough for a pharmaceutical manufacturer to have an effective drug product development strategy.  The pharma company must ensure an effective strategic partnership between patients taking the drug according to therapeutic guidelines along with the efforts of healthcare providers.  In addition, payers, the insurance companies paying the bills must be involved in this strategic alliance so as to ensure that the funds used to pay for these therapies are well spent, for drugs with high rates of efficacy.

In marketing pharmaceuticals, the third party service providers need to overcome challenges that may include market access, regulatory issues, and challenges of new or competing drug products handled by external stakeholders.  The launch plan geared to ensure commercial success of a new drug needs to take into account patient populations, others in the community with the same health condition.

From the drug launch commercial team to healthcare providers, management consultants, risk management specialists and payers are engaged to help provide patients with support needed involving patient care, proper therapeutic drug use, drug pricing and reimbursement, treatment regimens, financial assistance and much more. At the end of the day, beyond all the rigors of patient hub management, project management of the new drug launch and drug commercialization process is the patient, often a fragile, scared person suffering from a chronic health condition or disease who simply wants to feel better and enjoy life.

All the markets and sales strategy in the world pale in comparison to that, the patient experience. 

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