Why Leen Kawas Believes the Future of Drug Development Starts with Patients

About nine in ten experimental medicines that enter clinical trials never reach the people they were designed to help The mostcited analysis of the failure problem published in Acta Pharmaceutica Sinica B attributes 4037 to 5037 of those failures to a single root cause lack of clinical efficacy The drugs work in cells in animals sometimes even in healthy volunteers Then they meet actual patients and fall apartFor Leen Kawas cofounder and managing general partner at Propel Bio Partners that statistic is the strongest argument she knows for inverting the way drug development gets sequenced The Los Angeles biotech investor cofounded Propel Bio Partners in 2022 to back companies that begin with patient questions and work their way back to the lab rather than the other way aroundHow patientcentric drug development changes the equationThe traditional sequence in biopharma is familiar a researcher identifies a molecular target designs a candidate tests it in animals then runs through three phases of human trials before submitting to regulators The patient enters the picture late often as a recruitment statisticThat model has been shifting since at least 2012 when the FDA began formalizing what it calls patientfocused drug development or PFDD The agency has since released a fourpart guidance series describing how sponsors should collect and submit patient experience data for regulatory decisions A 2024 policy brief in Frontiers in Medicine argues PFDD is now an integral piece of the development paradigm though its full potential remains underrealizedKawas frames the same idea less procedurally Her view drawn from a recent Enterprise Radio conversation is that drug development as currently practiced contains too many redundancies and too few feedback loops with the people its meant to serve Theres a lot of redundancies in our industry she told the show Ways of things that people are used to doing things which most of the time is expensive and capital intensive Her prescription is to treat those inefficiencies as openings for entrepreneurs willing to design programs that center patient outcomes from the first protocol forwardHow Propel Bio Partners weighs patient signals at the diligence stageThe diligence framework Leen Kawas has described publicly runs along two parallel tracks The first is the conventional one science and business fundamentals The second less common in standard biotech investing is whether a candidate company has built a credible path to reaching underserved populations rather than defaulting to the easiest commercial markets firstThe second track is where patientexperience signals enter the model Kawas has been explicit that money on its own cant carry a biotech program from early science to durable impact Propel Bio Partners pairs every investment with what she has called an ecosystem of strategic and operational support The point of that ecosystem is to help portfolio companies move programs forward faster and with fewer latestage failuresWhat that posture means in the questions she asks of founders becomes clearer when you listen to her describe what she values She has talked openly about the importance of building an advisory board early with the right clinical voices in the room She has emphasized identifying inefficiencies in drug development as a strategic opportunity rather than a tolerated friction And she has consistently returned to the criterion that a therapy should be able to reach more than the easiest commercial cohortDrugdevelopment efficiency in her framing is an underexploited investing edge A startup that has interrogated which clinical workflows add value and which exist out of habit is a betterpriced asset than one selling pure target novelty The patientfirst lens sharpens that judgment It tells you which workflow steps actually serve the people the therapy is meant to reachWhat patientfirst investing looks like in practicePropel Bio Partners offers a working example of how that thesis translates into capital allocation Two of its higherprofile portfolio bets both on company boards Kawas serves illustrate the patternThe first is Persephone Biosciences a San Diego microbiome company whose My Baby Biome study is one of the largest investigations of infant gut health undertaken in the United States Its initial findings published in June 2025 in Communications Biology a Nature portfolio journal showed 7637 of US infants carry deficient levels of Bifidobacterium a foundational gut microbe linked to immune development A quarter of the babies had none at all Persephones product pipeline is being designed around what the patient population in this case the very youngest patients actually needs to thriveThe second is Inherent Biosciences where an epigenetic test for male infertility addresses a gap in reproductive medicine that historically left women bearing most of the diagnostic and treatment burden Inherents diagnostic begins with a clinical reality patients had been describing for decades that unexplained infertility is often not unexplained at all and works backward to the scienceKawas tends to describe the operational logic in plain terms Her stated goal at Propel Bio Partners is to support founders building companies that improve human health on a broad scale which in her construction means therapies designed to reach more people not fewer That orientation traces back to her decisionmaking at LeonaBio the neurosciencefocused biotech she previously cofounded and led to a 2020 IPO that raised more than 400 millionWhy the failure economics support a patientfirst thesisTheres a financial argument layered into the philosophical one The Tufts Center for the Study of Drug Development whose periodic RampD cost analyses have become an industry benchmark has estimated the full cost of bringing a single new prescription medicine to market in the billions of dollars when capitalized over development time When 9037 of candidates fail and the dominant failure mode is misalignment with what real patients experience the math starts pointing in a particular directionThat direction also overlaps with where regulators are pushing the industry The FDAs June 2024 draft guidance on Diversity Action Plans requires sponsors of many latestage trials to submit enrollment goals broken down by demographics including sex age race and ethnicity The agencys premise is straightforward drugs studied in narrow populations dont always work as advertised in everyone else A separate 2024 STAT News report on a Health and Human Services inspector general review found that NIHfunded trials still routinely enrolled fewer Black patients and other underrepresented groups than they had planned forFor an investor like Leen Kawas the inference is that startups designing for representative populations from day one have a structural advantage over those retrofitting diversity at the regulatory stageWhat founders should take from the patientfirst modelLeen Kawas tends to give scientistfounders the same handful of pieces of advice when they ask how to build durable biotech businesses She tells them to know what they dont know and hire accordingly She tells them to network for advice not just capital And she tells them that a fresh outlook is a competitive asset especially in an industry as set in its conventions as this oneUnderneath that practical guidance is the deeper thesis that the entrepreneurs most likely to clear the failure cliff are the ones who treat patient experience as the input to discovery rather than its endpoint The future of drug development in the framing Kawas keeps returning to will be defined by companies that figured out earlier than their competitors how to listen to the people their science is supposed to helpIts a quieter argument than the moonshot rhetoric that dominates much of the biotech press Its also given what the failure data shows harder to dismiss

Why Leen Kawas Believes the Future of Drug Development Starts with Patients

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Why Leen Kawas Believes the Future of Drug Development Starts with Patients

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