Blogs Contributing Editors
Contributing Editors' Blogs
Pharma Faces Reality at the R&D Leadership Summit
Written by Wayne KobersteinAt the R&D Leadership Summit by The Conference Forum, candid conversations, sober analyses, and a widening awareness of the outside world inform a uniquely private confab, where R&D leaders confront the industry’s innovation gap.
When the opening speaker quotes Bob Dylan and Ronald Reagan in the same breath, you know the times really are a’changin’ — but you wonder whether it’s enough. To be fair, I heard Dylan’s famous refrain several times during the R&D Leadership Summit (February 10 - 12), so the message of change predominated the discussion. The climate was dramatically different from the one I witnessed, now 35 years ago, where I first met Fred Hassan, who chaired this year’s Summit. At what was then the annual PMA (now PhRMA) Meeting, Fred was about the only breath of fresh air in the generally older, Ivy League, blue-blazered crowd of CEOs. That year, he was a “baby CEO,” heading Sandoz US, as I was a “baby Editor.” He spoke to me at length about industry change; mainly, how much changes were needed and inevitable. But unlike most of that old crowd, he welcomed them. He handled his Summit duties in the same way, heralding, even invoking, the next industry transformation.
In Flux: Technology, Humanity, And Viscosity
Written by Wayne KobersteinPeople seem to like old war stories, as long as, being fascinating in their own right, they are relevant to today. I believe this one qualifies for telling, or retelling, for its ongoing relevance. First, my memory was sparked by an isolated comment by a speaker in one of the sessions at the AAPS National Biotech Conference: “We still can’t measure viscosity directly.”
Well, more than 25 years ago, visiting Roche headquarters in Basel, Switzerland for a related article, I was given a tour of the company’s “Black Box” vitamin-C plant some miles out of town. Looking every inch like a Borg cube out of Star Trek sitting in a field, the facility operated from one end to the other without any workers present, other than a few engineers in a central control room near the huge cooking vats at the terminus.
Can You Believe This New Pfizer? A Semi-Personal View
Written by Wayne KobersteinYou will have to guess the year I first visited Pfizer from the following account. It will likely date me anyway just to describe the long-gone players in that long-ago entity. Pfizer was then the fact and symbol of the monolithic pharmaceutical corporation, housing nearly all of its management, marketing, and research functions in a single mid-Manhattan skyscraper. Then-CEO Bill Steere hosted me in his office suite along with his entire management team for a three-hour interview. Later, when he caught wind that my report would describe a past company struggle with the FDA over its main product, Feldene, Steere called to persuade me to delete all mention of the “negative” incident, even though Pfizer had prevailed and it was already public knowledge, saying he would “withdraw the interview” if I refused. Let’s just say he, I, and his staff had a prolonged but polite discussion. Fast forward to the end — I published the report as written, the company experienced a generally positive reaction, and Mr. Steere invited me back for several more visits in subsequent years. He was gracious in making what was a fundamental transition from the old pharma model of public invisibility to one of increasing media relations.
This is extra content from the blog "3 Companies To Watch - Part 3."
Excerpts from an interview with M. Timothy Cooke, Ph.D., CEO of Novadigm Therapeutics
COOKE: Our mission is to bring this antigen forward, out of the academic setting into clinical trials. So last year we had our first Phase 1 trial, in 40 subjects. It was safe and well-tolerated. We also had very rapid and broad immune responses after a single dose, because almost everyone has been exposed to Candida or Staph aureus at some point in their life. When we expose people to the antigen, they get a booster response; even though it’s the first dose, because of the previous exposure, they get a strong immune memory response. Within seven days, we see huge increases in antibodies. At day 14, we had a 100% seroconversion, which means 100% of the people got four-fold or higher increase in their antibody levels. You don’t see that with a typical single-dose vaccine if you’re just priming the person for the first time. That’s actually really important because one of the ways that the vaccine against staph and Candida could be used is in the hospital setting where patients are at near-term risk of serious infections.
This is extra content related to the blog "3 Companies To Watch - Part 2."
Excerpts from an interview with Phil Ralston, CEO, MacuCLEAR.
SUCCESSFUL DRUGS FOR AGE-RELATED MACULAR DEGENERATION (AMD) TREAT WET AMD. DRY AMD IS MUCH SLOWER PROGRESSING AND HAS FEWER OBVIOUS SYMPTOMS. WHAT IS THE NEED FOR A DRY AMD TREATMENT?
Our CSO Dr. Chiou realized that the best way to treat AMD overall was at the dry stage. It is a progressive disease. Everyone who gets wet AMD had dry AMD to begin with, if only for a short time. Though typically dry AMD progresses very slowly, there is no treatment to this day and the opportunity was great. So he said, “What can I do to prevent the progression of the disease?”
The following is extra content related to the blog "3 Companies To Watch."
Excerpts from an interview with Jason Rhodes, EVP and chief business officer, Epizyme
WHAT ARE THE CENTRAL ELEMENTS OF YOUR DEVELOPMENT STRATEGY?
We’ll use a companion diagnostic to identify the relevant patients. And we’ll actually orient our clinical development plans and strategy around those patient populations from the very first trial. But rather than going to the broad general populations and hoping that we’ve powered trials well enough to pick out effects that are probably only occurring in certain patients, we have a very specific hypothesis around the target, an HMT with a translocation or point mutation or other genetic lesion. We determine whether the given HMT is actually disease causing — not just associated with the disease, but truly the driver of the disease in those patient populations. That begins very early in clinical development to give us Go and No-Go information at that stage. Assuming that our target hypotheses are correct and are borne out, the compound will also have a very short path to registration.
This blog will present capsules of information, knowledge, and lessons drawn from selected entrepreneurial companies embarked on the path of product development. See Part 1 of this blog here. See Part 2 of this blog here.
Novadigm Therapeutics: Fighting Two Microbes with One Vaccine, a David Engages the Goliaths
VITAL FACTS
• Employees: 10; Headquarters: Grand Forks, North Dakota
• Series A round ($18M)
• Research funding: Government grants (Total $17M), incl. U.S. Department of Defense grant ($12M)
• Partnerships: No major partners; technology licensed from LA BioMed
This blog will present capsules of information, knowledge, and lessons drawn from selected entrepreneurial companies embarked on the path of product development. See Part 1 here.
MacuCLEAR
Leading the Charge against Dry Age-Related Macular Degeneration
VITAL FACTS
• Employees: 1FTE, 3PTE Headquarters: Plano, TX
• Funding:
- $1.7M from the Texas Emerging Technology Fund (TETF) for development of MC-1101 (January 2009). Raised additional $500K in new money to meet the TETF Qualifying Funding Transaction (October 2010).
- IRS/HHS Qualifying Therapeutic Development Project grant of $245K (non-dilutive, tax-free) for 2009 clinical development costs.
Part 1 of 3
Snapshot analyses of selected companies developing new life science products and technologies.
This blog will present capsules of information, knowledge, and lessons drawn from selected entrepreneurial companies embarked on the path of product development. In addition to key facts and figures, each capsule offers reasons to watch the company in its basic history and strategy, proprietary technology, and so on — along with unique challenges to its business model. A brief, exclusive interview with a top company executive is also included for an inside look at each company.
I am a natural skeptic. But this is a blog, and I am allowed that bias, as long as I allow others to counter my views, or perhaps support them. Anyone can observe the tremendous failure rates in the life sciences industry and either take them, as I do, as reason to be incredulous of attractive paradigms or, as many others, to believe in miracles before they happen. (I do believe miracles happen, just not that often, and when pressed to name one, I often resort to the polio vaccine.) From the past I have also learned that a thousand failures lead to the doorway of success — that no miracle occurs before many paths are explored, abandoned, and mined for knowledge essential for reaching the final goal. That is cold comfort for any one of the thousands of start-ups stymied or even still-born before reaching their dream, but it is also the source of invaluable lessons for the ones that live on.
A Conversation with James Mullen, CEO of Patheon
Written by Wayne KobersteinDuring the recent JP Morgan Healthcare Conference, I spent a half hour speaking with Patheon’s relatively new CEO, biopharma veteran Jim Mullen. Patheon is a contract manufacturing and process-development organization that devotes an ever-increasing portion of its business to bioprocessing. In this brief interview, Mullen discusses his business and the future of biopharma manufacturing, especially for small companies.
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