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Life-changing Launch


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Manufacturer perspectives on maximizing success for orphan drug commercialization.

Published in: Healthcare
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Life-changing Launch

  1. 1. Life-changing LAUNCHManufacturer perspectives on maximizing success for orphan drug commercialization
  2. 2. LIFE-CHANGING LAUNCH You’re a manufacturer of orphan drugs, which means the new product you’ve spent years developing has an established patient population that’s desperate to receive it the moment it’s first available.
  3. 3. LIFE-CHANGING LAUNCH How do you ensure a successful launch … one where patient financial hurdles are swiftly overcome, supply chain and order management works smoothly and product arrives safely to global locations?
  4. 4. To address all those questions, we'll take a look at the brief story of Manufacturer M, which met each challenge head-on ... and saw success demonstrated directly in the life of a patient.
  5. 5. LIFE-CHANGING LAUNCH A little background on Manufacturer M: • 20+ years of successful innovation • Focused exclusively on serious and rare conditions • Passionate about patients—instilled in every decision made
  6. 6. LIFE-CHANGING LAUNCH A manufacturer like this has decisions to make: build out all the capabilities it needs to support product commercialization in-house, or embrace a model that relies more heavily on partners.
  7. 7. In this case, the manufacturer chose a partner-based approach— and at virtually every key stage of product development and commercialization … LIFE-CHANGING LAUNCH
  8. 8. … from clinical trial logistics, to secure storage and shipment, to commercial logistics and business process outsourcing, to reimbursement support. LIFE-CHANGING LAUNCH
  9. 9. We want to bring our products to market ourselves, but at the same time, we don’t want to build massive infrastructure. We want to keep it lean and funnel capital back into drug discovery. VP, Supply Chain for Manufacturer M Here’s what the manufacturer had to say about the decision to trust an external partner with so much of its core operations: LIFE-CHANGING LAUNCH
  10. 10. However you approach in-house vs. partner-provided solutions for commercialization, make the decision intentionally. Manufacturer M sees success with its model because its leaders view outsourced services not as an expense, but as an investment and a platform for strategic growth. The lesson here for other manufacturers: Doug Cook, President, Global Specialty Logistics, AmerisourceBergen LIFE-CHANGING LAUNCH
  11. 11. Turn good ideas into great results
  12. 12. LIFE-CHANGING LAUNCH This is not to say that the work to support Manufacturer M was without challenges. In fact, onboarding and operationalizing support for Manufacturer M’s new product required AmerisourceBergen to address some tricky questions.
  13. 13. LIFE-CHANGING LAUNCH What’s the best way to move high-value, time- and temperature-sensitive products on a global basis?
  14. 14. How quickly can providers and patients gain access to the product after launch? LIFE-CHANGING LAUNCH
  15. 15. LIFE-CHANGING LAUNCH Can financial hurdles be cleared effectively and with enough speed to meet goals for patient initiations?
  16. 16. In each instance, Manufacturer M saw results that affirmed its partner-reliant strategy.
  17. 17. LIFE-CHANGING LAUNCH Clinical trial product and samples were transported effectively across more than a dozen countries, including the U.S., Italy, Portugal, Spain, the U.K. and Germany.
  18. 18. LIFE-CHANGING LAUNCH Within six hours of product availability on the day of launch,AmerisourceBergen’s 3PL services had already shipped enough orders to fill Manufacturer M’s specialty pharmacy channel — typically a process that might take up to 48 hours.
  19. 19. LIFE-CHANGING LAUNCH Through the first quarter post-launch, Manufacturer M saw patient initiations for its new product top 101% of planned expectations.And Manufacturer M’s partner-reliant approach gave it the ability to scale patient support quickly to accommodate dynamic product demand.
  20. 20. LIFE-CHANGING LAUNCH We need partners who know how to do things we can’t do ourselves and that will also work with us to come up with a solution that isn’t focused on liability or cost, but instead on a high quality result for our patients. VP, Supply Chain for Manufacturer M
  21. 21. LIFE-CHANGING LAUNCH In the best situations, that line between manufacturers and solution providers disappears entirely. We're one team working toward shared success. Doug Cook, President, Global Specialty Logistics, AmerisourceBergen The second lesson other orphan drug manufacturers can glean from Manufacturer M’s experience:
  22. 22. Balancing purpose & passion alongside profits
  23. 23. LIFE-CHANGING LAUNCH Manufacturer M views success as more than financial returns. The global company takes extreme pride in demonstrating a philosophy of "every patient matters."
  24. 24. LIFE-CHANGING LAUNCH AmerisourceBergen adopted the same mindset in its work with Manufacturer M, ensuring all roadblocks were cleared to get the life-changing medication to those most in need.
  25. 25. LIFE-CHANGING LAUNCH The extra efforts paid off most significantly with one particular patient, a young man who almost had to make the decision between taking a once-in-a-lifetime trip or receiving life-extending therapy.
  26. 26. LIFE-CHANGING LAUNCH Fortunately, he didn’t have to choose. Manufacturer M worked with AmerisourceBergen to ensure product delivery on the first day of availability, and the patient received treatment within one hour of his flight’s departure.
  27. 27. LIFE-CHANGING LAUNCH The best part of the experience was that we did the right thing—and by we,I mean Manufacturer M and AmerisourceBergen.We got the drug out as fast as possible, knowing that every hour mattered. And AmerisourceBergen was integral in that, lending flexibility and willingness to understand and work with us on something that wasn’t a huge dollar value to them, but critical to patients.” VP, Supply Chain for Manufacturer M
  28. 28. LIFE-CHANGING LAUNCH Cultural alignment matters tremendously with partnerships between manufacturers and solution providers. We’re on the operational side of our manufacturer clients’ business, but it’s as much about the patient for us as it is for the manufacturers we serve. That’s the only way to achieve our highest goals. Pete Belden, President, ICS, an AmerisourceBergen company The final lesson to be learned is about shared purpose and values:
  29. 29. Contact us to learn more and share your own thoughts on effective commercialization of orphan drugs. LIFE-CHANGING LAUNCH Doug Cook President, Global Specialty Logistics Pete Belden President, ICS Or to gain more information on how AmerisourceBergen can create a tailored and patient-centric approach to your product's commercialization strategy, visit