Serving women’s health in the specialty pharma sector
Mark Nawacki gives insights into starting a specialty pharma business, therapeutics for women’s health, and the shift to more personalized medicines in healthcare. (Issue #328, 1,030 words, 5 minutes)
Good morning, and welcome to the NPC Healthbiz Weekly e-newsletter from the National Pharmaceutical Congress and Chronicle Companies.
The pharmaceutical industry has undergone significant transformation over recent decades, evolving from a mass-market, blockbuster-driven model to a landscape where specialized, targeted therapies and personalized medicine are increasingly prominent. This shift has opened the door for smaller, agile companies to thrive by addressing unmet needs that larger multinationals may overlook. As the pharmaceutical industry continues to evolve toward more targeted, patient-centric treatments, experienced leaders have helped steer the shift. During an episode of the NPC Podcast, Mark Nawacki, President and CEO of Searchlight Pharma, emphasized the importance of finding and developing underappreciated opportunities in niche markets. “Specialty pharma plays an important part in filling the gaps where the big multinationals don’t want to play or choose not to play,” he said.
Nawacki [pictured below] co-founded Searchlight in 2015 following his departure from a prior specialty pharma firm. Initially considering leaving the industry altogether, he was drawn back in by opportunities he saw in licensing and partnership models. His objective was to build something from the ground up, driven by a focus on unmet medical needs and collaborative business development. “I wanted to challenge myself with that opportunity to build something from the beginning and do it differently,” he noted. “There’s always that question of whether we can apply what we’ve learned along the way, and I wanted to put that to the test.” That mindset shaped the company’s name and direction, which Nawacki described as centred on a search for overlooked assets and a commitment to constructive partnerships.
Nawacki’s international experience, particularly in South Africa and Latin America, has shaped his approach to business strategy. He emphasized bridging cultural differences and understanding diverse business practices, especially when sourcing innovations globally. “Canada is just one market within a global market, and being able to bridge cultural differences and business practices opens your eyes,” he said. “You need to communicate clearly across distances, especially when you can’t just walk down the hall to speak to someone.” Nawacki said he learned to adapt and communicate effectively, skills he brought back to help shape Searchlight’s reputation as a capable and reliable partner within Canada and beyond.
The transition toward more personalized medicine is a major theme in his perspective on industry change. He noted he entered the industry during the height of the blockbuster drug model, where a single drug could dominate the market with massive sales forces behind it. According to him, that model has given way to a more fragmented and personalized approach, where smaller-scale drugs targeting specific conditions, such as rare diseases, can succeed with leaner infrastructure. However, this shift has also introduced new challenges, particularly in physician access and the complexities of reimbursement. “Reimbursement is probably the biggest risk to any business plan,” he said. “Whether or not you can count on getting your product reimbursed can make or break everything.”
Regarding therapy, Nawacki points to women’s health and migraine relief as central to his business activities. “Searchlight has built a strong women’s health business, which remains a core focus for us,” he said. “Our key product in that portfolio is Nextstellis, a new combined oral contraceptive. We also have a significant presence in the pain space, particularly migraines, which ties closely to our women’s health strategy.” He added that dermatology and central nervous system drugs are also areas of active development, with plans to expand further, particularly in collaboration with larger partners.
THIS WEEK 04/22/25
The U.S. FDA has approved Biocon Biologics’ bevacizumab-nwgd (Jobevne), a biosimilar of Avastin, for the treatment of several different types of cancer, including metastatic colorectal cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and more.
The U.S. FDA has granted accelerated approval to Novartis’ atrasentan (Vanrafia), a selective endothelin A receptor antagonist, for the reduction of preducingults with primary immunoglobulin A nephropathy at risk of rapid disease progression.
GSK today announced that Health Canada has approved dostarlimab for injection (Jemperli) in combination with chemotherapy (carboplatin and paclitaxel) for the treatment of adult patients with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy. This approval expands the previous indication for Jemperli in combination with carboplatin and paclitaxel to include patients with mismatch repair proficient/microsatellite stable tumours.
The Australian Therapeutic Goods Administration has approved Norgine’s registration of eflornithine (Ifinwil) for the treatment of adult and pediatric patients with high-risk neuroblastoma who have responded to prior multiagent, multimodality therapy.
NOW, LISTEN UP: HERE’S PAUL LEVESQUE OF THERATECHNOLOGIES
In season 13 of the NPC Podcast, Paul Levesque, President and CEO of Theratechnologies Inc., gives insights into biopharma innovation, tariffs' effects on the supply chain and pharma manufacturing, and cross-border business development. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. You can listen to the podcast here.
Rodrigo Reis
General Manager
UCB Pharma
Season 13, episode 02
Listen to this episode here
What bold predictions do you have for the life sciences industry during the coming 12 or 24 months?
I think we’ll continue to see significant macroeconomic pressures—rising inflation, geopolitical instability, and other global challenges—impacting every industry, including pharmaceuticals. These pressures create real constraints, particularly around pricing, as we see with the IRA even in Western markets.
These challenges won’t be resolved quickly; they’re likely to they will likely ars ahead. At the same time, we’re seeing promising developments with AI, machine learning, and other advanced technologies becoming more integrated across the pharmaceutical landscape—not just in R&D to accelerate drug discovery and development, but also in areas like regulatory review, where there’s growing interest in collaborating with agencies.
We’ve focused on that in our work throughout 2024, and I expect to see more collaboration between pharma and the public sector going forward. What were once considered pilot or 'pet' projects are now becoming key partnerships with public institutions across countries, all aimed at improving patient outcomes, speeding up diagnosis, and ultimately delivering better care. That’s a trend I believe will continue to grow in the years to come..
NEXT WEEK
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