| General Fiction posted October 25, 2025 | Chapters: |
...25 26 -27- 28... 
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The investigational new drug review
A chapter in the book Beating the Devil
Beating the Devil - Chapter 27
by Jim Wile
| Background A cancer researcher invents an early cancer detection system. |
Recap of Chapter 26: Cedric has to return to New York and makes his final goodbye to Marie in an emotional scene where they replay their standard joke with each other for the last time.
The family members spend their final few days with Marie, who is fading fast as the end approaches. She and Julia express their love for each other as Julia tries to assure Marie that all past troubles have been forgiven. Earl continues to offer his comfort to Marie and stays with her.
When Marie slips into unconsciousness, Earl lets Julia know of her death in the middle of the night.
Chapter 27
January 2034
Four months later
Four months later
The snow was falling, and two inches had accumulated so far. School had been canceled, as was typical in North Carolina for just about any amount of snow, and the kids would likely have at least two or three snow days.
Mal and Bertie managed to make it into work, and Brian was glad because Paul Rieke had made a special trip to Cherryville to discuss the Investigational New Drug application the entire team had been working on for the past week. This included Abby, who had flown down earlier in the week. The team wanted to see if Paul could poke any holes in it.
The IND application would be evaluated by the Center for Drug Evaluation and Research branch of the FDA before they would allow human trials to begin. It contained documentation of the animal studies, the composition of both the nanoparticle pill and the home breathalyzer, and a human trial plan.
To give his lab techs practice, Brian asked them to make a presentation to Paul, with Bertie leading off. She gathered her notes together and stood in front of the group in the small conference room of the lab.
“Brian and Abby have put us on a rather tight schedule, so we developed this IND for the CDER of the FDA PDQ.” She said it with a straight face, and the others cracked up at this alphabet soup of abbreviations.
She began by discussing the chemical makeup of the nanoparticle pill. She then described its primary function—to target cancer tumors and cause a burst of volatile organic compounds or VOCs when the nanoparticles bind to them.
She further discussed the toxicity tests she and Mal had designed and executed. The data showed that 100% of the nanoparticles ended up being excreted by the kidneys within 48 hours, and none of them remained and accumulated in the rats’ bodies.
“One hundred percent,” marveled Paul. “That’s very impressive.”
Mal was next, and he discussed the home breathalyzer’s function, which was to determine the type and amount of VOCs present in the breaths. He talked about its construction and what made this possible.
Abby went last and described how her identification and analysis algorithms were able to determine which combinations of VOCs and in what amounts and proportions indicated the presence of cancer.
Paul said, “This is a really impressive system, folks, and y’all should be commended for the success you’ve achieved with it so far. My main question, though, is: Can your nanoparticle pill target all forms of cancer or only specific ones?”
“That’s a great question, Paul,” said Brian. “Bertie, how about you take a stab at answering this?”
“Sure. The nanoparticles in the pill we tested will only seek out cancer tumors of the pancreas, colon, and liver. I call it the ‘pancoliver’ pill. I’m pretty proud of that name, by the way, but it’s not as good as the one Mal came up with for a pill that would target cancers of the stomach, lung, and esophagus. Tell ‘em, Mal.”
“The ‘stungus’ pill. But Brian and Abby haven’t invented that one yet.”
Everyone laughed and agreed that was a better name.
“There are other combinations as well,” said Brian, “but the point is, why wait years to develop a single pill when we could undoubtedly prevent a huge number of cancers by introducing this one sooner? These cancers account for around 20% of all diagnosed cases worldwide. That’s almost 3.5 million new cases per year. We’ll be taking a phased approach, and this is phase 1.”
“That seems like a reasonable approach,” said Paul. “So, will your ‘stungus’ pill be next?”
“Haven’t decided yet for sure, but probably. They also represent around 20% of all new cancers.”
Paul had a few more questions for the group, but during the course of these, Mal’s phone rang with Tanya’s ringtone, and he excused himself to take the call.
“Hi, baby. What’s up?”
“I told your mother not to, but she don’t listen to me and went outside to shovel the walk. She slipped on a patch of ice and fell hard. She busted her hip, Mal.”
“Oh, no! Where is she now?”
“We’re all at the hospital, including Sammy. No school today. The paramedics came and got your mother. She’s gonna need surgery.”
“Ah, jeez. How bad is it?”
“They said it was a simple fracture, and they wouldn’t have to replace the whole hip. But they said she’d be in the hospital a few days and then a few weeks in a rehab place.”
“Stubborn old woman. Sun probably woulda melted it by this evening.”
“Have some sympathy, Mal.”
“I do. But she can never just sit still. Always has to be doing something, and see what she gets for it? Look, as soon as this meeting is over, I’ll come right there. Is she in any pain?”
“No, they gave her Glyptophan. She’s okay.”
“Alright. This meeting should be over in an hour. I’ll meet you at the hospital.”
When Mal came back to the conference room, Brian noticed his concerned look.
“Anything wrong, Mal?”
“Yeah, my mother fell on the ice and broke her hip. She’s going to have surgery this afternoon.”
“Oh, no. Sorry to hear that. Why don’t you take off now then? You should be with her.”
“Well, I guess if you don’t mind, I will.”
“Please give her our best,” said Abby.
“Thank you, Abby. Alright, y’all. I’ll call later and let you know how it’s going.”
The meeting was soon over. Paul had a few minor suggestions for the new drug application, but his overall impression was very favorable. After Julia served everyone lunch, Paul had to leave. It was a long drive back to Raleigh where he lived, and traffic would be slow on the snowy roads.
Abby had a 4:00 PM flight back to her home in Altoona, Pennsylvania. On the way to the airport, she said, “You’ve done this before, so how long does it take an IND to be approved?”
“Usually about 30 days, but who knows with the FDA?”
“Should we start trying to line up our phase 1 trial subjects, or might that be a waste of our time if it gets rejected?”
“Well, how confident are you in our system?”
“Pretty darn.”
“Me too. I think we should start,” said Brian.
“I don’t really know how to go about it.”
“I did it before for Glyptophan. I’ve got some information I can send you on best practices.”
“So, from what I understand, there’s no control group for the phase 1 trial, correct?”
“That’s right,” said Brian. “No placebo. Everyone gets the real deal.”
“And what happens to those we detect cancer in?”
“That’s where we’ll need some guidance from the FDA. I’m not sure what they’ll recommend. I’m hoping they’ll give the okay for testing by an oncologist.”
Abby thought of a problem with this. “Okay, but presumably, we’ll be detecting cancers well before their methods might. So, what happens when we detect it but they can’t?”
“That’s the $64,000 question.”
 Recognized |
Brian Kendrick: A 43-year-old neuroscientist and cancer researcher
Julia Kendrick: Brian's 43-year-old wife. She is also a world-class violinist.
Johnny Kendrick: Their 8-year-old son
Lindsay Kendrick: Their 6-year-old daughter
Earl Kendrick: The Kendrick's chocolate Labrador Retriever
Dr. Marie Schmidt: Julia's mother
Abby Payne: Brian's partner on the project. She is 67 and a brilliant mathematician.
Malcolm Roberts (Mal): One of Brian's two lab technicians
Tanya Roberts: Mal's wife
Samantha (Sammy) Roberts: Mal's 6-year-old daughter
Letitia Roberts (Lettie): Mal's mother
Larry Posner: One of Brian's two lab technicians
Vivian Delacroix: An oncology professor at Wake Forest University also doing early cancer detection work
Roberta (Bertie) Chen: Brian's new lab technician
Cedric (aka Cecil) Washington: Marie's premier violin student and friend
Maddy McPhail: Owner of Bo
Bo McPhail: Maddy McPhail's cancer-sniffing therapy dog
Dr. Renee Houlihan: Marie's oncologist
Dr. Paul Rieke: Brian's former chemistry professor and mentor, now a good friend
Picture courtesy of GPT-Image-1
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