Examining the dynamic progress in targeted oncology, the episode delves into the shift from single-mutation therapies to broad pathway targeting, highlighting advances in EGFR, KRAS, and the MAPK axis. Recorded prior to the recent release of Revolution Medicine’s impressive Phase 3 data for daraxonrasib in pancreatic cancer, Mavra Nasir interviews Peter Bak for an in-depth exploration of the commercial, clinical, and investment trends influencing major pharma, biotech, and investors, showcasing why validated biology and platform innovations continue to drive both deal-making and patient impact.

Key clinical challenges such as resistance, CNS coverage, and durable efficacy are unpacked, alongside the ongoing appetite for early-stage platforms and the evolution of M&A strategy in the sector.

You can find our paper on the targeted oncology here: https://www.bblsa.com/analyst-reports/a-map-to-the-future-of-targeted-oncology

As ovarian cancer research enters a pivotal new era, Back Bay Life Science Advisors' Dr. Pete Bak is joined by Director Mavra Nasir and Consultant Trent Gordon for a deep dive into one of oncology's most active and rapidly evolving therapeutic landscapes.

Despite ranking as one of the top causes of cancer death among women worldwide—with a five-year survival rate still hovering around 50%—ovarian cancer has historically suffered from a sparse treatment pipeline. That is changing fast. This episode traces the field's major inflection points, from the landmark approvals of bevacizumab and PARP inhibitors in 2014, to the game-changing 2022 ADC approval of Elahere, to the recent Keytruda approval in high PD-L1 expressors—and looks ahead to a wave of innovation that could fundamentally reshape how patients are treated.

Pete, Mavra, and Trent break down the competitive ADC landscape, discuss next-generation entrants targeting folate receptor alpha and beyond, and examine what a crowded pipeline means for clinical development strategy in a space where the standard of care is moving fast.

Podcast topics include:

• The ovarian cancer patient landscape: why late-stage diagnosis remains the norm and what that means for treatment
• Key historical milestones in ovarian cancer drug development and why the pace of innovation is now accelerating
• Elahere's approval, efficacy profile, and the real-world challenges of ocular toxicity and patient eligibility
• Next-generation folate receptor alpha ADCs from Genmab, Lilly, and AstraZeneca—and how they may differentiate on payload, ORR, and sequencing
• Emerging targets beyond folate receptor alpha: B7H3, B7H4, NAPI2B, and CDH6
• The role of ADC stacking and sequencing as the platinum-resistant setting becomes increasingly crowded
• Bispecific antibodies and the potential to convert immunologically "cold" ovarian tumors into candidates for immunotherapy
• AbbVie's strategy to expand Elahere into earlier lines of therapy
• How clinical trial sponsors can future-proof development programs against an evolving standard of care—adaptive protocols, investigator's choice comparator arms, pre-specified amendment triggers, and FDA alignment strategies
• The importance of competitive intelligence, NCCN/ESMO guideline tracking, and reimbursement analysis for drugs in development

Thank you for listening. You can find previous episodes of the podcast on our website.
We’d love to hear from you—questions and feedback are always welcome.

As the life sciences industry turns the page to 2026, Back Bay Life Science Advisors’ Dr. Pete Bak and Dr. Mavra Nasir take a detailed look back at FDA drug approvals in 2025, a year marked by regulatory turbulence, shifting policy signals, and several category-defining product launches.

Despite a dip in the total number of approvals compared to prior years, 2025 delivered meaningful innovation across oncology, rare disease, pain, infectious disease, and beyond. In this episode, Pete and Mavra break down the key approval trends at both CDER and CBER, highlight standout commercial launches, and discuss what last year’s data may signal for drug development and regulatory strategy going forward.

The conversation spans blockbuster forecasts, novel modalities, and evolving FDA expectations—from compressed review timelines to the potential phase-out of animal toxicology studies—offering listeners both a retrospective and a forward-looking view of the regulatory landscape.

Podcast topics include:

• Key FDA drug approval trends from 2025 and how they compare to prior years
• CDER approvals and standout launches, including Insmed’s brensocatib in non-CF bronchiectasis
• Vertex’s non-opioid pain drug Journavx and the commercial realities of first-in-class pain therapies
• The continued rise of antibody-drug conjugates, with a focus on Daiichi Sankyo’s TROP2 ADC
• A wave of innovation in hereditary angioedema, including RNA therapies and oral acute treatments
• New approvals in antibiotics, women’s health, and pulmonary fibrosis
• CBER approvals, including gene therapies, vaccines, and nonprofit-led commercialization models
• What a slowdown in cell and gene therapy approvals may indicate
• FDA policy developments to watch in 2026, including priority vouchers, streamlined pivotal trials, and alternative preclinical requirements
• A prediction (and friendly wager) on whether 2026 will surpass 2025 in total approvals

Thank you for listening. You can find previous episodes of the podcast on our website.
We’d love to hear from you—questions and feedback are always welcome.