Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.
Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.
This podcast is for you if:
- You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What you will learn:
CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling and manufacturing economics, continuous manufacturing and Industry 4.0 in biopharma, biologics modalities including mAbs, ADCs, and cell and gene therapies.
Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.
New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.
Next Steps:
Book a free assessment to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/assessment
Fast-track bioprocess development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
226: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 2
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Hard-to-treat cancers like pancreatic ductal adenocarcinoma (PDAC) have long defied conventional therapies. Radiopharmaceuticals, combining targeted therapy with diagnostic power, are creating new opportunities in precision oncology.
Host David Brühlmann speaks with Bryan Miller of Crown Bioscience, who explains how Crown's strategic partnerships, rigorous quality standards, and adaptive study design are shaping radiopharmaceutical development—delivering speed, safety, and real clinical impact.
In this episode, you'll learn:
- The promise and practical implications of theranostics—agents used for both diagnosis and treatment (02:44)
- Definitions and distinctions between CDX (cell line-derived xenograft) and PDX (patient-derived xenograft) models, and why PDX models better recapitulate tumor heterogeneity (05:11)
- Strategies for building more predictive, clinically relevant research models (06:09)
- Balancing rapid innovation with rigorous quality standards—why robust QC systems enable speed without compromising safety (08:01)
- Key advice for scientists entering radiopharmaceutical development, including how to choose the right research partners (09:53)
- Why effective collaboration between biotech companies and CROs is akin to a well-chosen partnership (10:50)
- The future outlook for radiopharmaceuticals and their impact on hard-to-treat cancers (12:21)
Strategic insight:
Focusing on theranostic radiopharmaceuticals—agents that combine diagnostics and therapy—offers a high-impact strategy for hard-to-treat cancers like PDAC. By enabling simultaneous patient stratification and targeted treatment, theranostics can accelerate development, improve clinical outcomes, and create a competitive advantage in areas where traditional therapies are limited.
Where do you see radiopharmaceuticals and advanced preclinical models making the biggest impact in oncology or beyond?
Explore the full conversation to learn how Bryan Miller and Crown Bioscience are scaling innovation for the next generation of cancer therapies.
Connect with Bryan Miller:
LinkedIn: www.linkedin.com/in/bryan-miller-148344aa
Crown Bioscience: www.crownbio.com
Next step:
Need fast CMC guidance? → Get rapid CMC decision support here