From Big Pharma to Biotech: Lessons in Patient-Centered Drug Development with Dr. David Krause

What does it take to lead successful drug development—whether at a global pharma giant or a small biotech start-up?In this episode of SNiPs, Dr. David Krause joins Bracken CEO Dr. Colin Miller to reflect on three decades of experience spanning large organizations like GSK to fast-moving start-ups. From aligning clinical development with medical affairs to serving “many masters” in drug development, patients, regulators, providers, and marketers, Dr. Krause shares insights on how to keep the patient at the center while driving innovation forward.Topics include:Lessons learned moving from big pharma to start-upsThe evolving relationship between medical affairs and clinical developmentBalancing regulatory, commercial, and patient prioritiesWhy knowing what you don’t know is key to success in smaller companiesListen to this episode of Fractals: Life Science Conversations wherever you get your podcasts—and connect with Bracken to learn how we support drug development from concept to approval.

With more than 30 years of experience spanning global pharma, emerging biotech, and the evolving field of personalized medicine, Bracken Senior Partner Dr. David Krause has helped shape the clinical and regulatory landscape across therapeutic areas—from vaccines and anti-infectives to neuropsychiatry and oncology.As a physician, former Chief Medical Officer, and trusted development advisor, David brings a uniquely humanist and interdisciplinary lens to the science and strategy of drug development.In this episode of Fractals: Life Science Conversations, David and host Colin Miller explore:How leadership style must evolve from large pharma to small biotech—and why succession planning matters more than you think.The future of personalized medicine in CNS and oncology—and how AI, genetics, and neuroplasticity are reshaping treatment paradigms.What pharma can learn from infectious disease: why psychiatry is just now catching up to decades-old precision strategies in anti-infectives.Reflections on partnering with the FDA, lessons learned from vaccine development, and the clinical promise of psychedelics.Listen to Fractals on your favorite podcast platform, and contact Bracken to learn how our cross-functional teams can support your clinical, medical, and regulatory strategy.

Can AI help radiologists see what humans can’t—and speed up drug development in the process?In this episode of SNiPs, Dr. Ben Larimer joins Bracken CEO Dr. Colin Miller to explore how artificial intelligence and machine learning are redefining what’s possible in molecular imaging. From interpreting complex PET scans to designing radiopharmaceuticals faster than ever, the future of diagnostics is being shaped by intelligent tools.Dr. Larimer shares real-world examples of how AI is already shaping radiopharmaceutical innovation and clinical trial design—and why the era of data-driven diagnostics is just getting started.Topics include:PET imaging and tumor heterogeneityAI-assisted radiologyAccelerating development of imaging agentsThe promise of radiomics and multimodal dataTune in now and explore how intelligent tools are reshaping life sciences from pixel to patient.

As a scientist, innovator, and CEO of CytoSite BioPharma, Dr. Ben Larimer has reshaped how we think about imaging immune response in cancer. His work on Granzyme B PET imaging is unlocking unprecedented insights into whether—and where—immunotherapies are working inside the body.In this episode of Fractals, Ben joins host Colin Miller to discuss:The origins of Granzyme B imaging and what makes it a uniquely powerful imaging agent.How CytoSite’s imaging agent revealed success in preclinical models—and sparked a new clinical path forward.The balance between scientific innovation and real-world biotech execution.Why PET imaging’s future depends on AI, cost reduction, and deeper diagnostic precision.Tune into Fractals: Life Science Conversations wherever you get your podcasts—and contact Bracken to learn how we help imaging agents move from molecule to market.

With more than two decades of experience at the intersection of biostatistics and biomedical imaging, Bracken Senior Partner Dr. David Raunig has been a driving force in biomarker development, validation, and regulatory strategy. From leading FDA biomarker qualification review teams to co-inventing imaging advancements and setting industry-wide standards through QIBA, David has played a pivotal role in defining how we measure—and trust—biological data in clinical trials.In this episode of Fractals: Life Science Conversations, David and host Colin Miller explore:What truly defines a biomarker—and how clinical outcome assessments differ from biological markers.Why the FDA’s "context of use" is key to biomarker qualification and how to demonstrate that a biomarker measures what it’s meant to.How the evolution of imaging—from WHO criteria to RECIST to AI-assisted reads—could transform how we assess tumor burden and therapeutic response.Statistical strategies for trial design and endpoint validation, and why QIBA’s standardized imaging protocols are essential tools for trial sponsors.Tune in to Fractals on your favorite podcast platform, and connect with Bracken to learn how David and our experts can support your clinical trial strategy from biomarker planning to regulatory approval.

In drug development, the right biomarker can mean the difference between success and a missed opportunity. In this episode of SNiPs, Bracken Senior Partner David Raunig, PhD explores how imaging biomarkers—like DXA and the fracture risk score—are being used in new ways to assess efficacy in clinical trials, especially for rare and complex diseases. David breaks down the evolving landscape of FDA qualification, highlighting a flexible path that allows sponsors to leverage novel endpoints without requiring tens of thousands of patients. From muscle mass in aging populations to trial-specific biomarker strategies, he shares valuable insight into what’s possible today—and what’s coming next.

Scientist, entrepreneur, and investor—three small words to describe the way Hatch BioFund Managing Partner Dr. Lorenzo Pellegrini has devoted his career to translating the cutting-edge into impactful solutions. From founding six biotech companies to driving investments in industry-shaping firms like Elevation Pharmaceuticals and Anacor, Lorenzo has consistently championed the necessity of fusion between innovation and practicality in the life sciences. In this episode of Fractals: Life Science Conversations, Lorenzo and host Colin Miller take a wide-ranging deep dive on:The rapid evolution of biotech within the last few decades, from small molecules to biologics, and its impact on drug evolution, supply, demand, and adaptation.Balancing financial success with societal impact in life sciences venture capital decisions—and why 80% of these decisions hinge not upon the science, but on the management team executing it.The role of fractional support in scaling startups and avoiding costly over-hiring mistakes.The importance of exploring global markets beyond the US to diversify pricing and reimbursement strategies.Tune in to Fractals on your preferred podcast platform, and contact Bracken to learn more about how we can support biotech companies in navigating complex M&A decisions.

What does it take to balance bold innovation with prudent decision-making in biotech? Lorenzo Pellegrini, PhD, Managing Partner at Hatch BioFund, shares his perspective and experience on the strategic choices that define success—and survival—in the industry.From securing $20M to $200M in funding, to grappling with the complexities of portfolio diversification, Lorenzo unpacks the critical factors biotech companies must consider. He discusses the nuances of resource allocation, the power of clear go-no-go decisions, and the trade-offs between focusing on a single asset or building a broader pipeline.Lorenzo’s insights on navigating the high-stakes world of biotech will apply to founders, investors, and industry professionals alike—in 5 minutes or less.Catch SNiPs on your favorite podcast platform, and connect with Bracken to explore how we can help drive your company’s M&A success.

With career highlights including the launch of Ivermectin and NuvaRing, along with expertise spanning microbiome therapeutics, M&A, regulatory affairs, and clinical and non-clinical development, it’s no surprise that Bracken Senior Partner Dr. Graham Lumsden is striving to shift our approach to healthcare. Holding a doctorate in veterinary medicine, Graham takes an integrated approach that bridges the various facets of life sciences. He advocates for preventative medicine and strategic partnerships to drive meaningful changes in the biotech and pharmaceutical industries. With years of experience, Dr. Lumsden recognizes that the future of medicine is not just about treatment—it’s about prevention, accessibility, and aligning scientific progress with market needs.In this episode of Fractals: Life Science Conversations, Graham and host Colin Miller discuss:Why accessible medicine is a smart investment for both patients and payers, shifting the cost burden from reactive to proactive care, and revolutionizing healthcare delivery.The power of strategic partnerships and mutual benefits, particularly for small biotech companies seeking to launch successful products.The innovative "Label As Driver" (LAD) approach that ensures early product development aligns with market demands and long-term goals.How go-to-market and commercialization strategies must adapt to regional differences, prioritizing each market’s unmet needs, effective communication, and connecting treatments to the right audience.Listen to Fractals: Life Science Conversations on your favorite podcast platform, and contact us today to learn more about working with Graham and Bracken’s team of expert consultants.

In the biopharmaceutical industry, groundbreaking discoveries may start in the lab—but to reach the market, they require more than just great science.In this SNiP, life sciences veteran Dr. Graham Lumsden highlights an essential yet often overlooked step: identifying unmet medical needs before developing a solution. Drawing from decades of experience, Graham shares the value and necessity of a market-first approach, where science and business strategy align to drive commercial success. Especially relevant for researchers and investors seeking to bridge the gap between discovery and market adoption, Graham discusses the importance of anticipating customer needs and ensuring a clear path to profitability—a critical foundation that turns innovative research into impactful, sustainable products. Tune in for Graham’s practical approach and subscribe to Fractals today to be the first to hear the full-length conversation!