"You have to have a dip in spirit, right? Of course. And then I guess leadership is being active, grouping people, keep spirits high, listen to people in the first place, and then you get through it and you'll be further successful."
In this episode, I talked with Dr. Tobias Kampfenkel, Vice President of Early Clinical Development and Translational Research at Miltenyi Biomedicine. Tobias spent nearly a decade at Janssen building the daratumumab story from the German launch and HTA negotiations through global pivotal trials and regulatory submissions — and then did it again with two bispecific antibodies in multiple myeloma. In early 2025, he made a deliberate move to Miltenyi Biomedicine, stepping into an executive committee role to lead a CAR-T program now being tested in autoimmune diseases — one of the most fascinating and fast-moving intersections in drug development right now.
We go deep on what it actually feels like when a late-stage program doesn't land, how to hold a team together after a major setback, and the real tension between hiring for hard skills versus hiring for cultural fit. We also explore what the CAR-T revolution in autoimmune disease could mean for patients who have been on lifelong immunosuppression — and why some people are beginning, very carefully, to use the word "cure." Outside the office, Tobias is a racket sports enthusiast, a recreational runner, an avid reader, and an occasional piano player — and someone who will happily trade a busy schedule for a quiet weekend on a small Dutch island with no traffic and nothing to do.
Here's What You're In For
- What it means to spend a decade attached to a drug — and why it's more about people than the product
- What really happens to a team when a major readout doesn't go the way you planned
- Why leadership during failure is about being active, not assuming everyone is okay
- The unique strengths Miltenyi Biomedicine brings to CAR-T — and the blind spots that come with it
- Why some hard skills in drug development can only be built through repetition, not reading
- How to think about the balance between modality experience, disease expertise, and cultural fit when building a team
- What it's like to move intentionally from Big Pharma to a smaller, more entrepreneurial company
- How CAR-T moved from hematology to autoimmune disease — and what the first case in 2021 showed the world
- Why the potential of a one-time treatment for autoimmune diseases is something unprecedented in medicine
- What in vivo CAR-T is, and why it could be the next major evolution in cell and gene therapy
Timestamps
03:39 – Whether his MHBA at Erlangen-Nürnberg was coincidence or connected to the CASEL trial
04:54 – A decade with daratumumab and what deep team ownership really feels like
07:13 – When a major readout doesn't land and what that does to a team
12:49 – Miltenyi's core strengths in CAR-T manufacturing and the blind spots of a multi-business organization
15:55 – Bridging oncology and autoimmunity across zamtocell and zorpocell
19:59 – Balancing modality expertise, disease experience, seniority, and culture when building a team
23:44 – What moving deliberately from J&J to a smaller company actually teaches you
27:32 – Tobias's first time in autoimmune drug development and the learning curve that came with it
29:39 – The first ever CAR-T treatment in a patient with systemic lupus in 2021
32:52 – What early safety data from CAR-T in autoimmune patients is starting to show
34:13 – In vivo CAR-T, solid tumors, and where cell and gene therapy is heading in the next 10 years
38:19 – Why this is one of the most exciting times to be working in this space
Full episode here:
- Spotify: https://open.spotify.com/episode/1YEj5ENOWlB6BbcJ7ULJyW?si=2c0895e7c9f4407f
- Apple Podcast: https://podcasts.apple.com/us/podcast/tobias-kampfenkel-md-mhba-vice-president-of-early/id1736051162?i=1000772829910
About Tobias
Tobias Kampfenkel, MD, MHBA, is the Vice President of Early Clinical Development and Translational Research at Miltenyi Biomedicine, and a member of the company's executive committee. A board-certified internist and hematologist/oncologist, Tobias spent nearly a decade at Johnson & Johnson (Janssen), where he led clinical development across multiple myeloma programs including daratumumab (Darzalex) and bispecific antibodies teclistamab and talquetamab — spanning the German launch and HTA negotiations through to global pivotal trials and regulatory submissions. In early 2025, he joined Miltenyi Biomedicine to lead their CAR-T programs in autoimmune diseases, including studies in systemic lupus and systemic sclerosis. He also holds a Master's in Health Business Administration from the University of Erlangen-Nürnberg.
Outside the office, Tobias is a racket sports enthusiast — tennis and badminton both — a recreational runner, an avid reader, and an occasional piano player. Above all, he values time with family and friends, which keeps him grounded amid a demanding professional life. Welcome, Tobias.
Connect with Tobias
- LinkedIn: https://www.linkedin.com/in/tobias-kampfenkel-m-d-mhba-026b54b9/
- Miltenyi Biomedicine: https://www.miltenyi-biomedicine.com/
About Charles
My name is Charles Spence and I lead Discera. After many years working in the life-science recruitment world, I decided to work for myself. Before doing recruitment I graduated with a biomedical degree, have worked in hospitals (including translation work in Seoul, South Korea), and also spent a year working in diabetes research in Stockholm. After doing research and travel, a career in business and science felt the most appropriate.
In 2023, I decided to launch my firm - Discera Search. A firm committed to solving the biggest talent needs of early clinical stage SME biotechs on the East Coast and DACH.
Connect with me:
- LinkedIn: https://www.linkedin.com/in/charles-spence-clinical/
- Website: https://www.discera-search.com/
Opinions and comments expressed by the guest do not represent the company and are fully their own.
