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Biopharma global barriers
Tear Down These Walls — Overcoming Global Barriers To BioPharma Access
People from every region of Earth work, travel, mix, and mingle with each other, more or less harmoniously, all joined in the industry’s common identity and purpose. Our motivations may be as diverse as our geographies — some seeking fortune, others fidelity to humanitarian ideals, and the rest all shades in between — but we all gain something immensely valuable from the sum of our parts.  Continue Reading..
c-path coalition against major disease
Clinical Trial Upgrades — A Critical Path to Innovative Consortia
At the 2014 BIO International Convention in June, I spoke with Martha Brumfield, President and CEO of the Critical Path Institute (C-Path), and Diane Stephenson, Executive Director of C-Path’s Coalition Against Major Diseases. C-Path is a non-profit organization working with the FDA and the EMA in forming government-industry consortia that create new universal biomarkers and clinical-trial simulation software tools to improve the speed and...  Continue Reading..
A Tale of Two Confabs
I returned from the ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago, I headed for the annual BIO International Convention in San Diego. But at BIO, ASCO was still on my mind, for it was among the most extraordinary of events I, and surely many others, have ever attended.   Continue Reading..
pharmaceutical risk-taking innovation
Pfizer and AZ — A Question of Loyalties
My overall take from the beginning of the Pfizer/AstraZeneca affair has been “nothing good will come of this.” But up until Pfizer finally pulled the plug on its merger offers, for now, I still believed the merger might happen because of the signals the British Prime Minister and AZ CEO Pascal Soirot kept putting out, implying they would support the sale at the right price and conditions.   Continue Reading..
pharma changes in quality manufactiong - cracked mirror
The Mirror Cracks — Pharma Must Face Its Future
Despite great changes in the corporate landscape, the pharma industry clings to an old, broken business model, especially in manufacturing.  Continue Reading..
DCAT: Drug, Chemical & Associated Technologies in Life Sciences
My DCAT Week Diary
Like the annual JP Morgan Healthcare Conference, DCAT is a gathering where most of the action is invisible to conference attendees. But DCAT also resembles a big market or bazaar, bringing people together to do business the best way it can be done — face to face — which no amount of social media, telecommunications, or remote sensing can replace.  Continue Reading..
Duchenne Muscular Dystrophy (DMD) an advocate mother's view and eteplirsen
Is the FDA Getting It Right with Accelerated Review? The Advocate’s View
An advocate mother’s view of Duchenne Muscular Dystrophy (DMD), the concerns she shares with other DMD patient advocates and experts, and the ticking clock as she watches her own son progress and pushes for a new drug now forestalled by the FDA’s refusal late last year to grant it accelerated review.  Continue Reading..
following bio conference via twitter
Covered In Snow, Covering Bio By Twitter
This week I’ve been working on editing a roundtable discussion we held at this year’s JP Morgan Healthcare Conference in San Francisco. The article is about how small biotech companies establish their valuations and market caps. But what I, like so many people, have been thinking about most is the weather. Whether or not we helped cause it, this winter’s extreme weather has united us in a way political unions cannot.  Continue Reading..
A Q&A With MacuCLEAR
This is extra content related to the blog "3 Companies To Watch - Part 2." Excerpts from an interview with Phil Ralston, CEO, MacuCLEAR.  Continue Reading..
A Q&A With Novadigm
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...  Continue Reading..
wayne koberstein

Wayne Koberstein

Wayne Koberstein is a 30-year veteran of the publishing industry, with extensive experience in publishing, communications, and business development. Wayne has interviewed and profiled more than 300 top executives in pharmaceutical companies, as well as major regulatory and health care leaders, around the world. He has also created special media projects and conferences, in addition to serving widely as speaker, moderator, and advisor for industry meetings.