Global Role Players: Launching Pharma Products in Different Regions

Alliance managers not only need to connect the dots at the corporate level, they need to do so for all of the internal functions that are often operating within their own regional silos, as well. Leslie Meltzer, PhD, chief medical officer at Orchard Therapeutics, gave the example of the medical affairs group developing clinical messaging for research that will ultimately be published. Even if this activity is intended for local or national healthcare audiences, “these things inherently have global implications,” she said. “There are so many moments in my career where I wished medical affairs had a relationship with alliance management.”

Other functions will impact and be impacted by business ventures in new areas of the globe. Meltzer ticked off sales, patient advocacy, patient services, and marketing teams as audiences that will need to be involved in global initiatives. Re: the latter, she mentioned that post-marketing data generation has global implications and that all parties must fully understand the “data generated in one universe and how that will apply to the potential commercialization strategy in a different part of the world.”  

“I’d be remiss as a tech ops person in the past to say manufacturing, supply chain, those things all get impacted by how you are thinking about launching a product and getting it to patients across the globe. Alliance managers can be a great internal connector,” added Christine Carberry, CSAP, principal of Carberry Consulting and moderator of the panel. 

Adam Kornetsky, principal at Vantage Partners, noted that it works both ways; alliance managers can bring learnings to the internal functions from their worldly travels. When they are “listening for how the team is thinking about different challenges they are running into” they can “be that much more equipped to help connect to the other regional partners once they get there.”

Patients Without Borders

A global presence comes with new challenges, broad and narrow. Svahnqvist spoke of the increased level of competition putting pressure on pharma companies in a variety of countries and therapeutic areas.  

“If one is not able to create a truly global brand, the message becomes fragmented. Patients and physicians don’t really have borders,” she said.  

Another area newly global companies often need to iron out with partners: global congresses. Svahnqvist said it’s “a huge benefit” when partners are brought into tactical planning for these events. “You can create a much stronger voice.”  

Meltzer told a story about an alliance in a new region, in which the partners disagreed on the target market for the joint product. She and her alliance manager counterpart facilitated a joint market research project designed by both parties to assess fundamental issues about payors, patients, advocates, and healthcare providers in the region. 

“Through the generation of that shared set of facts, it changed the dynamic of the discussion. It allowed it to become much more about the shared information more so than the perspective of the individuals,” she recalled.  

Staying Grounded When Everything Is Up in the Air 

There’s a somewhat steep learning curve when companies start to figure out how to work with regional partners, and the current geopolitical environment, with wars in the Ukraine and the Middle East and continuing post-pandemic supply chain–related fallout, might make it steeper. It all adds up to more due diligence required of alliance managers, according to Kornetsky.

“I know those environments are always changing,” he said. “Making sure that we are getting more and more familiar with what those regional implications might be will help us better set the team up for success early on before we ultimately find those partners.” 

Regulators, too, are constantly evolving, according to Meltzer. 

“It can be challenging designing a program to meet needs locally today and also meeting the needs of other regulators that may not be as familiar to you, and then trying to think ahead of how those needs may be evolving over the timeline once you’re developing a product,” she said, before sharing some potential good news on the horizon: some countries are discussing “global harmonization” of their regulatory processes. “[This] would be great because then you only have to worry about evolution in one direction rather than five or six different directions at the same time.”

For any type of region-specific initiative, Meltzer recommended applying a “bottoms-up” versus a “top-down” approach “to meet the needs of the stakeholders and the geographies where you’re actually commercializing the product.” After all, brand strategies are pulled through by the people on the ground. She added that companies can always partner to bring that local expertise if they don’t have local branch offices in those locales. 

Please keep checking back with this blog for more recaps of ASAP BioPharma Conference sessions throughout the month of November.