drug development


Headline of the Month, Maybe the Year . . .

Journalists and politicians have been hitting pharma companies pretty hard and heavy these days over high drug prices.  But we think a recent headline at STAT news about drug effectiveness might be going too far.  

The following appeared in my email inbox:

Opinion:  Drug effectiveness should influence what doctors prescribe.

Is the Future of Biology a Return to Chemistry? Carolyn Bertozzi, Stanford

Classes for the school year begin this week at Stanford University. New to the faculty is Carolyn Bertozzi, an American chemist who made her name across the bay at Berkeley and was wooed to Stanford by a chance to do research and teach chemistry in a new interdisciplinary institute known as ChEM-H. The institute will bring chemists, engineers, biologists and medical doctors together to understand life at a chemical level. We’ve often heard of biology and engineering institutes, or bringing bio and IT. This institute ups the ante and includes chemistry and medicine.

Carolyn is an outspoken scientist who feels that chemistry gets short shrift in a time when biology is considered the queen of the sciences. She points out that the National Insittues of Health tend to be lead and run by biologists. We usually call it biomedical research, not chemical-biomedical research. And yet, she argues, it is chemistry that will give us the answers going forward.

“This is a bit of semantics, but I’d say that what we don’t understand about biology is what happens at the level of molecules. What we don’t understand about biology is the chemistry of it. It is hard to see. You need a different set of tools and technology to see what happens at the molecular scale. And that is the chemistry,” says Carolyn in today’s interview.

Does Carolyn think there’s too much hype around genomics? Would she like to see a revival of chemistry?

As the editor-in-chief of a new open access journal, ACS Central Science, Carolyn will be publishing much more on the topic, making louder and prouder the voice of the chemist.

Returning to Old Biotech Model, OncoMed Boasts of Seven Drugs in Clinical Trials by Mid 2015

For many years, the trend in biotech was for drug development companies to pursue one or maybe two drug candidates, or assets, as they’re called in industry parlance. Go lean and attract the attention of big pharma or investors in the late stage trials. But today’s guest says there is more innovation when the biotech organization invests in a technology platform that produces multiple drug candidates. Paul Hastings is the CEO of OncoMed, a company developing drugs that target cancer stem cells. He’s built OncoMed in what he says was the old model. By mid-2015, the company will have seven drug candidates in the clinic.

"There was a period of time when investors were only interested in late stage products that they could put their arms around and measure,” he says. "But I think investors woke up. . . .They realized that the innovation part of what we were doing before was suffering from this model.”

OncoMed was one of the first IPOs of the current bull market. Has Paul changed his management style since going public? Does he buy into the virtual drug development model? And what does he see for the industry in 2015?

'A Good Year' with John LaMattina

Guest:

John LaMattina, Senior Partner, Pure Tech Ventures Bio and Contact Info

Listen (6:27) Comparing drug approvals: 2014 with 1996

Listen (7:10) More rational drug development?

Listen (1:58) Did public image of big pharma improve last year?

Listen (7:00) The Peter Bach argument

Listen (5:16) Who is winning the debate?

John LaMattina, the former president of Pfizer Global Research, is spending his semi-retirement cultivating the brand of public defender of pharma. As a contributor to Forbes, he showcases some of the great stories of drug development and offers counter punches to pharma’s detractors.

His recent column: FDA Approvals 1996 vs. 2014: The Two Most Prolific Years, But Stark Differences provides the context for today’s interview.

After a look at what is now seen as a banner year for drug development, LaMattina comments on highlights from last week’s JP Morgan Healthcare Conference in San Francisco. He's excited not only about all the business deals, but the new science as well.

The interview ends with a discussion about the debate over drug pricing, and who John thinks is winning it.

Janet Woodcock, FDA, on Biomarker Development and the Future of Clinical Trials

Guest:

Janet, Woodcock, MD, Director, CDER, FDA
Bio and Contact Info

Listen (4:41) No agency charged with better translational outcomes

Listen (2:46) How will recent FDA move on LDTs impact biomarker development?

Listen (4:45) Lung Map and the future of clinical trials

Listen (3:07) What about trials of one?

Listen (4:12) Translation not just about getting to Phase I

Listen (1:49) How important are biosampling issues?

Listen (2:50) Diagnosis the foundation of medicine

Listen (2:25) Thoughts on drug pricing debate

Since becoming the Director of the Center for Drug Evaluation and Research at the FDA, Janet Woodcock has been a strong advocate for better science. But the FDA’s job as regulator is to protect and promote health, not particularly to focus on improving the process of drug development. In fact, Janet points out, there is no agency “charged” with better translational outcomes.

For this reason, Janet worked to set up the Critical Path Initiative some years back. This would be a program to bring together a consortia of different organizations to primarily focus on better biomarker development as well as to modernize clinical trials.

Today we ask Janet for an update on the program. Are we getting better biomarkers? And what do the clinical trials of the future look like?

“In the future, we’ll be setting up trials around patients and disease rather than setting up a trial around a drug,” she says in today’s interview. “We have too many questions to answer about treating disease than can be done by serial trials, each one one only addressing a question about a single investigational drug.”

She’s particularly excited about a new Lung Map trial being run by the NCI. This trial is about finding a second line treatment for patients with squamous cell lung cancer. Patients are enrolled into one of five different strata based on the biomarkers of their tumors. This is a trial that can go on and on, where if a patient doesn’t respond to one treatment, this patient can be moved to a different therapy. This type of trial is known as an adaptive trial and has strong support from the FDA.

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What are Janet’s thoughts about "trials of one," where the health of the patient in the trial is more important than some future unknown patients as advocated by former guest on the program, Marty Tenenbaum?

And what does Janet think about the translational work of physician scientists who are enrolling their own patients in clinical trials based on those patients' biomarkers?

We explore with Janet the question of why diagnostics are valued so much lower than therapeutics in our culture. And at the end of the interview she offers some brave, if limited, comments about the current debate over drug pricing.

Podcast brought to you by: National Biomarker Development Alliance - Collaboratively creating standards for end-to-end systems-based biomarker development—to advance precision medicine

Biotech’s Gentleman Lawyer: Alan Mendelson

Guest: Alan Mendelson, Partner, Latham & Watkins

Bio and Contact Info

Alan Mendelson, a partner at Latham & Watkins, is the first service provider--as opposed to a scientist, entrepreneur, or venture capitalist--to receive one of BayBio’s prestigious Pantheon Lifetime Achievement Awards. We talk to him a month before the awards ceremony which will be held in San Francisco on December 11th, 2014.

Alan’s career took off back in the early 80’s when he incorporated one of the few new biotech companies coming on to the scene. The company: Amgen. Alan gives a great deal of credit to his “mentor”, George Rathman, the legendary first CEO of Amgen who inspired a generation of biotech entrepreneurs.

In the early 2000’s, Alan was one of the first to see signs of the Silicon Valley dot com bust which led to him leave his long time firm, Cooley and Associates, to join Latham & Watkins. In today's wide ranging interview, he shares this and other stories from his career as well as his thoughts on the current biotech marketplace.

“The award means a lot to me,” he says, "it’s been thirty-four years since I first incorporated Amgen. Working with biotech and life science companies, I can’t tell you how satisfying it is to feel that in a small way, I've helped improve the human condition. I’ve had cancer patients tell me that I saved their lives because I worked with Amgen. . . and this is, frankly, why I don’t want to retire.”

Chapters: (Advance the marker)

1:17 The “gentleman lawyer”

5:20 If they’re passing out cookies, take one

10:25 Importance of the Jobs Act

16:12 The Cooley “divorce”

25:34 What does this award mean to you?

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Sponsor: Today’s show is brought to you by the 11th Annual BayBio Pantheon Ceremony, presenting the 2014 DiNA Awards on December 5 in San Francisco. The Pantheon Awards Ceremony is a celebration of the contributions and achievements of the Bay Area, a moment to pause and reflect on the industry’s legacy over three decades.

The Basic Biology Lab Goes into the Cloud: Brian Frezza, Emerald Therapeutics

Guest: Brian Frezza, Co-Founder, Co-CEO, Emerald Therapeutics

Bio and Contact Info

Chapters: (Advance the marker)

0:50 What is the Emerald Cloud Lab?

4:16 Does this impact the scientific method?

10:00 Pulling the labor, not the scientist out

14:20 Much more data detail

19:52 A chance to improve reproducibility

24:06 The tools are slowing us down

We knew it was coming. Everything else has been going that direction--that virtual realm that offers humanity such hope, affectionately referred to as The Cloud.

Brian Frezza is a young entrepreneur quite fresh out of grad school. Brian and his co-founder, D.J. Kleinbaum, went to Carnegie Mellon and Stanford. They liked to think about the big picture when they were in school. What could we do, what product, what company could we work on that would drastically--not just incrementally--change the world of drug and diagnostic discovery? they'd ask themselves.

Four years into their commercial adventure, they've released what they think will make that big change--to use the popular term, be a disruption.

"The Emerald Cloud Lab--think of it as a remote laboratory that you're controlling via the internet, as if you were standing in front of the instruments themselves when you run your experiments," says Brian at the outset of today's interview.

Brian carries on with a cool evenness, but this is quite a mouthful. What? A scientist can have access to a full laboratory to run one of about forty experiments without having to invest in the equipment, space, and labor?

Brian says the biggest challenge to putting a lab in the cloud, no doubt, was in coding the language for the automation. This is automation on a scale we've never seen before.

Presenting The Emerald Cloud Lab.

Editor's note to our audience: As a scientist what is your view of this? Is this the best thing ever, or is it too giant a step? Does this degrade the scientific method or better enable it? Please give your feedback in the comment section below.

Podcast brought to you by: Chempetitive Group - "We love science. We love marketing. We love the idea of combining the two to make great things happen for your marketing communications."

A Year Later: Indie Scientist, Ethan Perlstein

Social media sites are all the fad.  But how much are they really impacting life science?

Ask Ethan Perlstein that question, and he’ll tell you “a lot.”  

Raising the Standards of Biomarker Development - A New Series

We talk a lot on this show about the potential of personalized medicine. Never before have we learned at such breakneck speed just how our bodies function. The pace of biological research staggers the mind and hints at a time when we will “crack the code” of the system that is homo sapiens, going from picking the low hanging fruit to a more rational approach. The high tech world has put at the fingertips of biologists just the tools to do it. There is plenty of compute, plenty of storage available to untangle, or decipher the human body. Yet still, we talk of potential.

Remembering Dr. Zaffaroni

On March 1 2014, at age 91, Dr. Alejandro Zaffaroni passed away. His inventions impact many lives, yet how he worked directly with people was equally compelling. Mario Rosati once mentioned to me that Dr. Zaffaroni was the best he had seen in a board room. When I first became an entrepreneur, the one person whom I especially wanted to work with was Dr. Alejandro Zaffaroni. I was blessed to have some unique experiences working with him that I thought would be worth sharing.



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