Newsletter | May 21, 2024

05.21.24 -- Business Of Biotech Newsletter

In the business of the FDA, Immunity Bio, Orna Therapeutics, Tome Biosciences, and more!
Business of Biotech Newsletter

The past few weeks have produced some of our best work, and that’s a direct reflection of the incredible guests we’ve hosted. I’m not just talking about their credentials and experience, either. I’m talking about their incredible displays of humanity.


If we had more people like Tome Biosciences’ Rahul Kakkar, M.D. (episode 198) leading this industry, I trust we wouldn’t have the black eye that Allan Shaw and I regretfully address on episode 201. Dr. Kakkar’s truths, that novel science is simply uninteresting without clear patient benefit and that holding clear patient benefit for ransom is a crime, promise to offend plenty of pharmaceutical academicians and capitalists. He doesn’t care, and he’s awesome for it.


If we had more leaders like Immunity Bio’s Bobby Reddy, M.D. (episode 197), I trust that cancer patients like my dad, whose story I share on that episode, would suffer less. Congratulations to Dr. Reddy and his team on the approval of ANKTIVA, which came on the heels of his Business of Biotech appearance.

Coincidence? There’s no SI cover curse here, my friends. Thank you, Dr. Reddy, for your perseverance.


What’s next, you ask? More amazing specimens of humanity. CTMC's Jason Bock, Ph.D. and KSQ's Thomas Leitch are on deck to tell us why they’re working with MD Anderson to do things that have never before been done in clinical-stage TIL therapy. Daiichi Sankyo President & CEO Ken Keller will follow them up with a story about building a startup within a giant Japanese enterprise. It didn’t take the full hour of my time with him to realize why he’s the right guy for the job. Dementia Discovery Fund’s Jonathan Behr will pop the hood on the value of mission-driven investing. Arcellx’s Rami Elghandour will draw direct lines between his rabid commitment to diversity and inclusion and the company’s stellar market and clinical performance. Stay tuned, Business of Biotechers. May’s lineup is coming in hot!


Now, here are some top stories from the Life Science Connect community. Enjoy!


 Matt Pillar, Business of Biotech host and chief editor, Bioprocess Online 

Biotech Beat

May 21, 2024

Does This Look Like A Nice Guy To You?


 Clinical Leader’s Dan Schell coaxed former FDA inspector Patrick Stone to dish on what to expect from a clinical site audit. Dan brought the goods with this resulting column, in which Stone admits he’s a “bear” when he sees compromises in patient safety, and that the tears of research coordinators were shed on more than one occasion during his auditing days. It’s not just a good read, but an important one, because clinical missteps can cost biotechs a lot more than site-level embarrassment.


Are LNPs RNA's One Trick Pony?


Michael Koeris, Ph.D. has a warning for the RNA therapeutics space, and he shared it with Advancing RNA’s Anna Rose Welch here. “We can’t just bet on one horse [said ‘horse’ being LNP delivery mechanisms]. In the world of soccer, kicking one good free kick doesn’t mean that you’re going to win the World Cup … our industry, and its RNA delivery approach, has to be multidisciplinary.”


Cutting Out The Medicine Middleman


Direct-to-patient drug distribution models factored heavily into our conversation with Allan Shaw about fixing the gluttonous PBM model (episode 201). Where appropriate, the direct model offers some inherent advantages—closer monitoring of patient adherence and a cleaner money trail among them. But there are risks, too. In this exclusive for Life Science Leader, PA Consulting’s Jenna Phillips offers three fundamental questions to consider.


Cell Therapy’s Year To Climb


It’s shaping up to be a banger of a year for cell therapy, and few have a better read on why that is than our own Erin Harris at Cell & Gene. The three upward-trending storylines in cell therapy are in blood cancer, solid tumors, and autoimmune diseases. Erin offers evidence of progress in all three via interviews with biotech builders Kristin Yarema, Ph.D., Orca Bio CMO Scott McClellan, M.D., Triumvira CEO Paul Lammers, M.D., and Carl June, M.D. himself. Read the article here and subscribe to Erin’s Cell & Gene: The Podcast here.


Quotes Of The Month

“The mistake a lot of companies make is to say, ‘we're gonna do it all.’ But how many products does it take to make a successful biotech company? It's just one.”

― Tom Barnes, Ph.D., CEO, Orna Therapeutics, Episode 199 

“You are using your pipeline as the way to advance your platform, and using your platform as the way to advance your pipeline.”

― Yochi Slonim, CEO, Anima Biotech, Episode 200 

“Novel technology, with all due respect to academic scientists, is not important. It really isn't. Unless it underlies and underwrites a drug that will help a patient in a way that they cannot be helped with any existing technology.”

― Rahul Kakkar, M.D., President & CEO, Tome Biosciences, Episode 198 

Created exclusively for the leaders of new and emerging biopharma firms, the Business of Biotech podcast tackles organizational, funding, HR, regulatory, production and CMC considerations with insight from peer founders who have taken biologic therapies from an idea to clinical success. Check out our episode archive.

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