Where innovation meets obstacles and the cost of drug development skyrockets, the key to unlocking success of groundbreaking products in the biopharma industry will rely heavily on strategic collaborations that pave the way from lab to market.
As the introduction of biopharma products swells in the coming years they promise both opportunities for developers and manufacturers as well as pitfalls along the path to commercialization.
The stakes have never been higher with the average cost of developing a new drug soaring 15% in 2023 to approximately $2.3 billion, according to a Deloitte study that focused on the top 20 global biopharmas.1
Even among promising new product development ideas in preclinical stages there is a less than 4% chance of getting first approvals and reaching successful placement in the market.
Still, the biologics industry is experiencing robust growth with new modalities, including antibody-drug conjugates (ADCs), bispecific proteins, and cell and gene therapies, that accounted for about one-third of approvals in 2023. Most of the top-selling drugs in 2022 were biologics, and it’s expected that in the next few years as more than 30 molecules go off patent—many of them orphan drugs—they will face competition from biosimilars.2
Leveraging the possible against the pitfalls during the journey from development to commercialization and beyond to the patient will require having experienced partners who emphasize collaboration, efficient resource allocation, commercial planning, market access considerations, shaping channel strategy, global distribution, and extensive knowledge of the unique challenges of cell and gene therapies.
Planning your work, working your plan
“You have to have a good plan as well as strategies to adopt to be successful,” Kirsten Jacobs, Chief Service Strategy Officer for Global Consulting Services at Cencora (formerly AmerisourceBergen), said. “It sounds quite easy, but to do a good plan involves very cross functional activity that includes supply chain, marketing and other processes that need to be in place.”
Early pitfalls to avoid in clinical development can be over enthusiasm regarding a scientific idea, requesting too broad a label for data, generating data with different objectives—what marketing may want to see may be completely different from what clinics and regulators want—and identifying the wrong patient groups or clinics.
“Thinking ahead of what you want and why you want it and then putting all the relevant expertise, processes and cross-functional teams in place will ensure you get it,” Jacobs said.
Among the ways to overcome early missteps, she said implementing the correct modeling and statistical analysis, developing a target product profile as early as possible, designing quality guidelines (GxP) and vendor qualification, and developing a global clinical and regulatory rollout strategy before completing Phase III.
“We like to come in as you are transitioning from Phase II—is treatment effective—to Phase III—is it better than current, standard treatment,” said Tommy Bramley, Senior Vice President, Market Access and Healthcare Consulting at Cencora.
Connecting all the stakeholders
In terms of target product profile (TPP), Cencora likes to show that information to payors to get their early reaction and feedback that might highlight early evidence gaps that can be corrected or created in preparation for a launch.
“As you get that feedback that will help you shape your value proposition,” Bramley said. “Also, key, early economic modeling can give you insight into your pricing corridor and what you might be able to achieve in value-based markets.”
Bramley also pointed out additional considerations from a market access perspective such as the global value dossier (GVD). It provides pharmaceutical companies and other stakeholders with evidence that supports the product’s value proposition when making pricing, reimbursement and formulary placement by payors.
In 2022, the Pre Approval Information Exchange (PIE) was signed into law in the U.S., allowing manufacturers to raise awareness and share information about new products and new indications prior to FDA approval. Cencora’s FormularyDecisions tool provides an exchange of information and allows payors to get information for PIE.
“It’s a good information exchange because you can see the information they are pulling in for their decisions to their respective Pharmacy-and-Therapeutics (P&T) committees,” Bramley said. “It’s a very powerful way to shape the markets, specifically those healthcare decision makers that are so valuable in making sure patients can get access.”
Developing an early commercialization plan that accounts for pricing, optimizing revenue and supply chain considerations across numerous global markets is also key to success.
Manufacturers should focus on a strategic approach geared toward the market in which they want to launch that accounts for things like: are they commercializing a product on their own or with a partner; is there commercial infrastructure in place; is it a global or local launch, and is there a master launch plan; what is the timing of the launch.
Other considerations include alignment on reimbursement and understanding global regulatory requirements and timelines, which can all be tracked in Cencora’s Commercialization Blueprint tool.
Having the right navigator on the journey
“At the end of the day it’s about planning early but also working internally, and our team is there to help navigate,” Sandra Anderson, Senior Vice President of International Commercialization at Cencora said. “We spend a lot of time understanding all the implications of the landscape, the different health policies in countries, compliance and then map out launch plans for our customers.”
Cencora has been strengthening its global product distribution and specialty logistics in recent years with the addition of Alliance Healthcare, one of the largest pharmaceutical wholesalers in Europe. Additionally, World Courier operates in more than 50 countries and recently added a location in Denver and is expanding its cold storage capabilities in Indianapolis. Alloga and ICS are Cencora’s global third-party logistics providers that specialize in custom solutions for specialty products.
“Ultimately, you really want to bring it back to the patients and understand what they are looking for and what obstacles they face,” Lung-I Cheng, Vice President of Cell and Gene Therapy at Cencora, said. “If we can all think about that then we’re going to solve a lot of challenges and bring more access to product.”
By leveraging expertise and addressing key aspects at each stage of development, manufacturers can avoid the pitfalls and enhance their chances for success in the biopharma industry through collaborative partnerships. For more information on how to navigate the commercialization journey go to https://www.cencora.com/.
Cencora's Tania Attanasio sits down with Willis Chandler, President of Global Pharma Services, and John Arena, Senior Vice President of Enterprise Strategy & Solutions, to discuss strategic partnerships, Cencora's transformations shaping future collaborations, and the vast potential of the global biopharma pipeline impacting healthcare worldwide.
1Deloitte, “Pharma R&D return on investment falls in post-pandemic market”, (Deloitte, 2023), https://www2.deloitte.com/uk/en/pages/press-releases/articles/pharma-r-d-return-on-investment-falls-in-post-pandemic-market.html
2Amy Brown, Edwin Elmhirst and Joanne Fagg, “Evaluate Vantage 2023 Preview”, (Evaluate Vantage, 2022), https://info.evaluate.com/rs/607-YGS-364/images/Vantage%20Preview%20Report%202023.pdf