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Essential Guide to the Drug Commercialization Process

Developing a new drug and bringing it to market is cost-, time-, and risk-intensive. According to studies, it’s estimated that launching a new drug can take a decade and cost between $314 million to $2.8 billion in R&D costs. Even after all that work and investment to develop a quality product and get it approved for distribution, there’s still no guarantee that it’ll be a long-term success.

To survive this competitive space, pharmaceutical companies must engage a well-planned drug commercialization strategy that helps them enter the market, enhances patient access and education, prepares the supply chain, informs marketing activities, and drives revenue.

But what does the ideal pharmaceutical drug commercialization process look like? Let’s review the best strategies for ensuring the success of a new drug product.

How does a drug get made?

The genesis of a new pharmaceutical therapy typically begins with a long-standing medical issue that requires novel treatment along with a patient population and payment mechanisms capable of supporting its development costs and some return on investment. Once that issue has been identified, the development process will typically follow three key stages before they’re ready to hit the market.

1. Research & discovery – According to the International Journal of Innovation, Management and Technology, the research and discovery phase consists of three components: (1) identification of genes connected to the disease, (2) identification and authentication of proteins that result in disease, and (3) identification of new molecules that prevent disease. Once this initial groundwork has been laid, a pharmaceutical company is prepared to start developing the actual product using promising compounds discovered in this early-stage testing, including clinical trials and case studies.

2. Development – The pharmaceutical development process encompasses both the preclinical and clinical testing stages. Preclinical tests are first conducted on animals, and then an Investigational New Drug Application (INDA2) is filed to enter into the clinical, human testing phase. If granted accelerated approval, clinical testing is divided into three stages:

Phase I:
20 to 100 volunteers are tested for several months to ascertain the optimal safety and dosage.

Phase II:
Several hundred people with the disease or condition are tested for up to 24 months to identify the drug’s efficacy and side effects.

Phase III:
Several hundred to several thousand people with the disease or condition are tested for up to 48 months to determine the efficacy and monitor potential adverse reactions.

For this stage, deploying an insights management platform could significantly enhance the entire clinical testing process by helping you understand the market, connect and collaborate with HCPs, payers, and patients, and leverage data-driven insights to move your strategy forward.

3. FDA drug review – After phase 3 is finished, the company will file a New Drug Application (NDA), including all related information from preclinical data to Phase 3 trial data. If the FDA finds that the data conclusively shows that the drug is safe and effective for intended use, they’ll begin working with the application to develop prescribing information via the labeling process.

Having survived this gauntlet, a new drug is finally ready for commercialization.

productive MSL meetings

02: What is commercialization?

The final stage of drug development is commercialization and product lifecycle management.

While the intended population, associated labeling and marketing and payment mechanisms have been considered earlier in the development process, commercialization typically begins at the end of clinical tests.

At its essence, commercialization is the process by which companies find commercial methods for producing a product and then bringing that product to the market. It encompasses the various marketing and sales strategies a pharmaceutical company must deploy to make their product a sales success. This may cover a wide array of concerns, ranging from product launch planning, logistical and operational readiness, and payer influence.

As with any new product, to achieve success, you must have a coherent strategy for educating and targeting medical providers, caregivers, and patients. To accomplish this in the medical space, you must be intimately familiar with your managed market customers. This can be public (government) or private (commercial) entities that play an essential role in drug reimbursement and access, while exerting influence over prescriber and patient drug choices in an era of constant pressure on drug companies to lower cost or substantially validate a therapy’s value.

But that’s just the start.

Along the long journey to launch, a pharmaceutical company will have to wrestle with several industry pressures, including regulatory requirements, industry uncertainty, and technical and commercial risks.

How can we help you?
challenges in oncology drug development

03: Drug Commercialization Process Timeline

Although it may vary for each drug maker, the drug development and commercialization process will typically follow a binary process: pre-launch and post-launch.

PRE-LAUNCH

At this stage, your primary task is achieving market access. Having received the green light from the FDA, manufacturers must then consider their branding and messaging strategies by identifying the product’s unique value propositions. This stage typically takes a year or two and will involve collaboration between an array of perspectives from different stakeholders. Naturally, a brand will need to develop different strategies to reach payers, providers, and patients. According to Deloitte:

“Pre-launch activities need to have a stronger customer focus, including early engagement with customers to co-develop the product value proposition (aligning R&D and Commercial) while capturing insights to inform the commercialization and access strategy. Furthermore, a critical success factor is to identify the three to four key questions that make each drug launch unique.”

Although it may vary for each drug maker, the drug development and commercialization process will typically follow a binary process: pre-launch and post-launch.

Related: What is “launch excellence?” In the pharmaceutical industry, launch excellence combines sound clinical data, a comprehensive marketing plan, accurate sales forecasts, and no small amount of luck. In other words, launch excellence is another term for operational excellence, in which all parts of a launch team are in sync and working toward a common goal.

How are life science organizations building more successful launches? Read on.

PRE-LAUNCH CHECKLIST

If you’re gearing up for a product launch, here are some questions you should ask in order to foster public acceptance and adoption:

  1. Who is the target population for the product?
  2. Who will be the entity responsible for dispensing the product?
  3. Is the product going to be administered at site of care or is it self-use?
  4. How can I satisfy regulatory compliance requirements?
  5. What are the data requirements for market transparency?
  6. How do we ensure that the product is accessible and affordable?

Finding the proper answers to these questions can help you establish the proper partnerships and technology investments necessary to thrive post-launch.

POST-LAUNCH 

After the product is launched, awareness is key.

The work that started with patient support programs must continue with ongoing provider and patient education and marketing campaigns. And these are far more effective for drug companies that are able to assemble a cross-functional team of essential stakeholders. Today, much of this is centered upon digital methods. Most pharmaceutical companies are moving towards a digital-first approach towards a new drug launch – one that leverages the valuable data-based insights to make the best decisions possible.

That said, launch events are now back on the menu. A well-planned event creates further opportunities to establish and grow relationships with field representatives, who can also provide important insights about your messaging strategies.

POST-LAUNCH CHECKLIST

So how can you measure the success of your new launch? There are several KPIs you should actively monitor, including:

Launch KPI – These measure the buzz surrounding the new product launch, such as:

Leads generated

News coverage

Website traffic

Page views

Product adoption KPI – These metrics tell you whether the new drug is meeting market needs. They include:

Customer usage

User retention

Product trials

Qualitative feedback (internal and external)

Product adoption KPI – These measure the market penetration and sales impact of the launch. To that end, common KPIs include:

Revenue

Market share

Competitive win rate

An insights management platform can help you monitor and gauge your campaign’s launch performance according to many of these variables.

04: 3 Challenges of Drug Commercialization

While there are dozens of pressing concerns for any new drug launch, three, in particular, could interfere with a successful launch:

1. Misguided communication and communication silos – Establishing clear lines of communication is vital for pre- and post-launch processes. And yet, many initiatives come up short because they lack the communication cadence—the clear, consistent messaging—necessary to motivate, educate, and foster product commitment.

Just 11% of respondents to a recent Impatient Health and Within3 webinar poll indicated insights change strategy with any meaningful depth and frequency in their organizations. How can we surface insights more quickly and with greater frequency to accelerate drug commercialization?

Breaking down barriers in organizational and data silos is one way. The same group indicated the most significant bottleneck to insights generation is siloed data (39%).

Communicating the value of insights with impact up through the chain of command to senior leadership is another. “Understanding by senior management the value insights can bring should be something we invest in to become world class. It can be the difference between therapies achieving their targets or not,” said Lance Hill, CEO of Within3.

2. Missing USPs and value propositions – Far too often, the messaging surrounding a new drug launch fails to adequately convey the drug’s most important value props, which is usually the result of poor patient and stakeholder engagement. Put simply, patients, doctors, and other key stakeholders must be engaged throughout all stages of drug development to better understand:

  1. Their specific condition
  2. How they respond to messaging
  3. Common challenges they face

For this stage, deploying an insights management platform could significantly enhance the entire clinical testing process by helping you understand the market, connect and collaborate with HCPs, payers, and patients, and leverage data-driven insights to move your strategy forward.

3. FDA drug review – After phase 3 is finished, the company will file a New Drug Application (NDA), including all related information from preclinical data to Phase 3 trial data. If the FDA finds that the data conclusively shows that the drug is safe and effective for intended use, they’ll begin working with the application to develop prescribing information via the labeling process.

Having survived this gauntlet, a new drug is finally ready for commercialization.

Focusing on stakeholder engagement, especially with the help of insights management technology, makes it easier for developers to engage with patients throughout every stage of the commercialization process.

3. Inability to accurately compare competitors – Competitor and market research can play critical roles in developing a commercialization strategy. You can learn from their success and mistakes to refine your own process. But many pharma companies fail to implement the technologies capable of accurately gauging competitor behavior and activity.

05: Identifying Actionable Insights with and Integrated Platform