After your biopharmaceutical company creates a new drug or gene therapy, you need to get strategic. How will you bring this drug to market and distribute it to the right patients? How will you monitor its efficacy? As you know well, biopharmaceuticals require specific strategies for commercialization, distribution, and beyond.
Here are four ways to make sure your new biopharma drug is successful. These steps have all appeared as individual blog posts on McKesson.com.
1. Consider your biopharma drug’s unique commercialization needs
Your groundbreaking orphan drug or gene therapy can only change lives if you get it to market. But biopharma drugs can pose unique commercialization challenges for your company. As we touched on in “How Biopharmaceutical Manufacturers Can Commercialize New Gene Therapies,” there are several factors you need to consider when creating a commercialization action plan.
- Temperature and storage requirements. How will you maintain the quality of your product in specific conditions? Many cell and gene therapies must be maintained at cryogenic temperatures to work.
- Patient access and assistance. Biopharma drugs are expensive. How can you ensure patients can easily obtain the drugs they need and keep costs down for them?
- Physicians who can help drive awareness. Physicians who have used your drugs in clinical trials can become the champions of your new gene therapies. They can help drive awareness among their peers and offer education to peers and patients alike.
2. Set up a thorough distribution plan
Next, you need a distribution plan. As Kevin Kissling explains in “Prescribe Robust Distribution for Your New Orphan Drug,” your groundbreaking new medicine won’t land in the hands of those who need it by itself. You need to ask some thorough questions first. As the VP of 3PL Operations for McKesson Specialty Health, Kissling recommends you ask yourself the following questions before distribution.
- How many patients will use this drug?
- Where will they receive care? In a hospital setting? A clinic? At home?
- How can you safely deliver their drugs to them?
- How much of this drug should you manufacture?
- How will you accept and fill orders?
You’ll also need to consider services that add value to your distribution model. You can offer patient and provider education programs. You can develop patient assistance programs to make the drug more affordable. Getting your drug to the right people is about understanding who will use the drug and what they need to use it safely and effectively.
3. Choose the right distribution partner
It pays to be selective when it comes to choosing a distribution partner for your biopharma drug. In “How Biopharmaceutical Manufacturers Can Support CAR-T Therapy Patients,” Layne Martin suggests finding a distribution partner who has experience handling complex therapies like your own. “Given the cost and clinical stakes,” Martin explains, “your biopharma company, patients and providers all have a huge interest in making sure your distribution partner is up to the job.”
Martin is the VPGM of Specialty Distribution Solutions for McKesson Specialty Health. He outlines several things to look for when selecting a distribution partner. Your distribution partner should be able to:
- Store and transport your product at the right temperature range
- Provide storage logistics during your product’s entire lifecycle
- Help you maintain product viability from thawing to infusion
- Educate receiving providers about your product
Because of the complexity of your product, look for an ally that understands its unique distribution needs.
4. Collect real-world evidence to improve drug performance
Once your biopharma drug is available, it’s not enough to sit back and wait for clinical trials to collect information. In “Using Real-World Evidence to Improve Biopharmaceutical Drug Outcomes,” Sarah Alwardt describes why using Health Economics and Outcomes Research (HEOR) to collect real-world evidence (RWE) is important to enhance your drug. Alwardt is the VP of Health Informatics and HEOR for McKesson Specialty Health. She believes that using HEOR to gather RWE closes the knowledge gap between clinical trial and real-world outcomes.
“During a clinical trial,” Alwardt explains, “patients meet very specific and narrow clinical demographic criteria to participate. The pool of patents is fairly homogenous.” In other words, it doesn’t always reflect the patients who are taking your drug in the real world.
Plus, patients don’t engage with biopharma drugs during clinical trials like they would in real life. Clinical trial participants don’t usually have to pay for the drug, and they’re reminded to take the drug by someone who records their adherence. Because of this, medication adherence and patient outcomes may be different in a clinical trial than they might be in the real world.
When you collect RWE through HEOR, you get more relevant data that can inform your strategy. A primary way of using HEOR to collect RWE is through analyzing electronic health records. You can see the efficacy of the drug when a patient takes it properly. You can also determine who it helps the most.
Collecting RWE can also:
- Demonstrate the value of your drug to payers and prescribers
- Expand the possible market for your drug
- Improve use, adherence, and outcomes
- Make future clinical trials more efficient
- Improve the efficacy of the drug and patient outcomes
As these four blog posts show, creating a biopharmaceutical is just the beginning of a long process. Biopharma manufacturers have a lot of steps—and stakeholders—to consider before their products can reach patients. But with careful planning and a thorough strategy, these products can offer life-changing hope to people who need it most.
Related: Learn more about McKesson’s specialty drug distribution services for pharmaceutical manufacturers