drug development


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."

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.

Life Scientist Goes Indie

Guest: Ethan Perlstein, Independent Scientist

Bio and Contact Info

Chapters (Move marker to advance)

0:55 A declaration of independence

8:14 Setting up an indie lab to do evolutionary pharmacology

19:07 What are you doing for funding?

28:21 Darwin would be tweeting beak sizes

Ethan Perlstein has a message for his fellow scientists: declare independence. Giving up for now on the traditional career path of seeking positions at research institutions around the country, Ethan has gone rogue. What does this mean? How does one become independent? And the $64 million question: how does an independent scientist get funding? These are the questions this young scientist tackles in his own "declaration of independence."

Podcast brought to you by: Assay Depot - the world's largest cloud-based marketplace for research services. With Assay Depot, you can easily find the perfect research service provider and manage your project from anywhere in the world.

Making a Difference: Janet Woodcock, FDA

Podcast brought to you by: See your company name here. - Promote your organization by aligning it with today's latest trends.

Guest:

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

Listen (6:48) Is the FDA changing their approach?

Listen (4:34) Message to pharma: work together

Listen (5:08) How does a submission get breakthrough status?

Listen (2:29) It's a privilege to work somewhere you can really make a difference

Listen (2:47) What feedback lets you know you're doing a good job?

Recently named one of Fierce's 25 most influential people in biopharma, Janet Woodcock is changing things at the FDA. With her influential position as Director of CDER (Center for Drug Evaluation and Research) she is pushing for the use of more biomarkers and combination therapies. With targeted therapies, "it's easier to see that they work, and they require a smaller number of people in trials to demonstrate they're effective." This is not just talk from Woodcock. Last year the agency approved more drugs than in any of the previous 15 years. Woodcock speaks in the interview about her role as prod to the bio-pharma industry. She regularly urges them to work together and share more of their pre competitive work.

A couple weeks ago, Janet made headlines announcing the FDA's new "Breakthrough Status" program, a process for streamlining submissions with a special potential to make a big difference. In today's show, Janet explains what it take to get this designation, saying that potentially a drug could be approved after a Phase I trial. Woodcock has spent many years at the FDA and talks about the secrets to her success. "I have to use my own individual judgement about what is right for the people who are my customers, the patients."

Clinical Trials Go Open Source with Marc Desgrousilliers, Clinovo

Podcast brought to you by: Assay Depot - the world's largest cloud-based marketplace for research services. With Assay Depot, you can easily find the perfect research service provider and manage your project from anywhere in the world.

Guest:

Marc Desgrousilliers, CTO, Clinovo Bio and Contact Info

Chapters: (Advance the marker)

1:26 Why does open source make sense for clinical trial software?

7:47 What are the objections to adopting open source?

11:12 Will adoption speed up clinical trials?

14:15 Is this the future?

18:16 Do FDA regulations pose special challenges?

22:04 BONUS: Swimming with sharks, literally

We've been tracking the open science movement here at Mendelspod with shows on open access publishing, platforms for collaboration and sharing data, and genome sharing for research. But what about open source software? Does this trend so strong in the IT world translate over to the life sciences. Marc Desgrousilliers, CTO of Clinovo says yes. Marc comes from the world of IT, spending several years at Microsoft where he led the development of Windows' network management. Marc is passionate about open source and the benefits that come from using software that is developed by the larger community. First of all the software has no licensing fees. (Clinovo makes their money on services that go along with the software.) Users are not dependent upon one software vendor. In addition, Marc points out, when software is designed by a large community free of charge, the user/designer volunteers tend to me very passionate about upgrades and development of the software. Are there special issues related to FDA regulation for open source software? Marc tells of his experience with the Clinovo software and of the validation they provide.

A Time Out for the Mice: Szczepan Baran

Podcast brought to you by: BioConference Live's Annual Laboratory Animal Sciences - Coming February 13-14. Register here for free.

Guest:

Szczepan Baran, VMD, President, Veterinary Bioscience Institute Bio and Contact Info

Listen (6:23) A worldwide platform for improving lab animal welfare

Listen (2:40) A PR problem - it's not like the movies

Listen (5:23) A big change in thinking with a little education

Today’s show is about a topic which doesn’t receive much coverage, that of the issues around lab animals. Joining us is Szczepan Baran, president of the Veterinary Bioscience Institute, which provides education for lab animal science. He’s partnering in February with our friends over at BioConference Live for an online conference on the topic. As Szczepan says in the interview, the conference will be focused on the 3 R's: replacement (not using animals when possible), reduction (using less animals), and refinement (alternate, more humane procedures). The Institute is now engaging in a public PR offensive to change attitudes about using animals for research as well as offer custom training courses for those in the lab working with the animals.

Going Behind the Headlines with Luke Timmerman, National Biotech Editor, Xconomy

Podcast brought to you by: Assay Depot - the world's largest cloud-based marketplace for research services. With Assay Depot, you can easily find the perfect research service provider and manage your project from anywhere in the world. Guest:

Luke Timmerman, Biotech Journalist Bio and Contact Info

Listen (4:41) Xconomy - covering the innovation community

Listen (5:58) Biotech, a calling

Listen (4:59) What makes a good story?

Listen (7:26) At your best, a reporter can do what for the industry?

Listen (1:59) A green guy

What makes a good story? What difference can a good reporter make in the industry? These are some of the questions we pursued in a chat with Luke Timmerman, National Biotech Editor at Xconomy. Luke was a finalist this year for the Gerald Loeb Award, what he says is the Oscar for business reporting. It's a great achievement for Luke and for Xconomy, which has been covering the "innovation" community for five years now. Luke is known for his up-to-date reports on everything biotech and his Monday BioBeat column where he pursues tough questions for the industry. Timmerman is always telling others' stories. Today's interview turns the table and provides a rare glimpse into his own story.

Innovation in Big Pharma with Chris Haskell, Bayer

Podcast brought to you by: Assay Depot - the world's largest cloud-based marketplace for research services. With Assay Depot, you can easily find the perfect research service provider and manage your project from anywhere in the world.

Guest:

Chris Haskell, PhD, Head, U.S. Science Hub Bayer HealthCare Pharmaceuticals Bio and Contact Info

Listen (4:00) Head of Bayer Science Hub

Listen (4:48) Grants4Targets and the Collaborator

Listen (2:24) Why is proximity important?

Listen (7:36) Characterize your master agreement with UCSF

Listen (3:35) Bayer is doing well - why the doom and gloom?

Listen (6:46) Personal journey to Bayer Hub

To finish up our special series, Innovation in Pharma, we wanted to bring someone on from Big Pharma to get their point of view. Chris Haskell is the head of the US Science Hub for Bayer Healthcare. The Science Hub sits at the core of Bayer's innovation strategy and Chris is developing innovative partnered research programs between Bayer’s research projects and early programs in academia and biotech. The Hub is located in San Francisco's Mission Bay next to UCSF. We talk with Chris about Bayer's master agreement with UCSF and ask him what benefits come from the close proximity to this top biomedical research university.




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