Biopharma Milestones—the Markers of Our Industry

By Sue Nemetz

Don’t you love when a word means what it sounds like it means?

A milestone, according to Google AI: “originates from the practice of ancient Romans who placed stone markers, called miliarium in Latin, along their roads at mile intervals, essentially marking the distance traveled; mile meaning a mile and stone referring to the physical marker made of stone.”

In our personal lives, a milestone birthday tends to be one with a five or zero at the end of it. Of course, there are other meaningful and celebratory milestones like the birth of a baby, a graduation, a wedding, a divorce, a retirement, and an unending list of other notable markers in our lives.

In the biopharma industry, we mark critical research, clinical, and regulatory milestones in developing our novel therapies. As commercialization leaders, we must understand these milestones before we can even begin to hope to track future market or revenue milestones that fall under the commercial domain after a launch.

Once a product goes into clinical trials, the path to clinical development and regulatory approval follows—at a high level—the same general steps. However, there may be significant variability in clinical study design, size, and regulatory strategy based on the therapeutic area, prevalence of the disease, type of asset, and option for accelerated vs full regulatory approval, etc.

• Phase 1 – Tests the safety and preliminary tolerable dose in healthy volunteers, usually 20-100.
• Phase 2- Tests the drug in actual patients with a specific disease (typically involving 100-200 participants, depending on the disease) while also refining the dosage range and treatment approach to ensure effectiveness in that condition.
• Phase 3 – Typically involves two randomized controlled trials conducted at multiple centers across the U.S. or globally. These trials are time-intensive and provide critical data for the future package insert, detailing the drug's efficacy, safety, and tolerability for a specific indication. They also serve to confirm (or adjust) the recommended dosing.
• Approval - If the NDA or BLA meets all the requirements, the product is cleared for market introduction
  
  

"Commercialization is a mindset or ethos that pervades all aspects of development and preparing to bring a product to market, ultimately optimizing value for patients and the company. Successful market introduction is directly linked to appropriate commercialization planning ideally starting early in product development."

—from Commercialization vs Launch: What You Need to Know

Why is it important for commercialization leaders including new product planning, marketing, market access, medical affairs, supply chain, sales, and operations to understand these phases? The clinical and regulatory pathways are the backbone of our industry and are highly regulated, so understanding these phases and recognizing the corresponding inputs ensures that we all make the wisest decisions to get our novel therapies to patients. The other reason, however, is that there are many critical commercialization activities along that continuum that if not anticipated or completed in a thoughtful, comprehensive manner, the obstacles to successful launch and the barriers to reaching patients increase. We are all in this to ultimately serve patients so tending to the important milestones along the way is critical. 

As you start exploring how commercialization planning aligns with development milestones, you may find yourself considering the following points.

• Are you aware of all the steps of commercialization planning?
• If not, where do you turn?
• Do you trust that resource to have the right lens to see and understand your situation?
• Do you know how much each step costs, the effort required, and who should be responsible?

A few examples of commercialization activities at each of those milestones include:

Phase 1:

• Market assessment
• Competitive intelligence
• Target Product Profile (TPP)
• Clinical trial awareness
• Patient journey
• Stakeholder communication plan
• And more...

Phase 2:

• Preliminary lexicon
• KOL engagement strategy
• Commercialization map and budget
• Strategic brand plan
• Forecast
• Congress plan
• And more...

Phase 3:

• Product positioning
• Tactical marketing priorities
• Value and access plans
• Patient registry and more
• Launch planning
• And more...

Tracking these pre-launch activities to clinical and development milestones ensures the work is right-sized and informs decisions for the next phase. Strategically linking prelaunch activities to key milestones ensures that investments are made at the right time. This approach helps manage and mitigate risk by preventing premature spending on activities that might need to be repeated due to data or fundraising uncertainties. This avoids getting ahead of themselves. At the same time, it ensures that critical activities necessary for a successful launch are prioritized, so companies stay on track and avoid falling behind. Additional milestones after the drug is on the market include Phase 4 trials, publications of key data, competitive milestones, market share, and many more.

In an age where speed and managing integrated cross-functional plans are critical for success, biopharma leaders need to understand where technology can help do the heavy lifting so that they can make crucial decisions along the way.

The Corval Solution was built by experts in biopharma for biopharma leaders. It is pre-populated with all the critical commercialization activities, interdependencies, and costs. Most importantly, this essential multi-faceted information is tied to your milestones so that when timelines change in either direction, you can make a simple adjustment and remain current with your plan. Milestones also provide a shared language that aligns your internal team and external consultants or domain experts. Having a common language and lexicon is essential in our current fast-paced industry.

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Corval dramatically reduces the time, effort, and resources it takes to chart a clear path from clinic to market. Learn more at How It Works.