ARTICLES BY WAYNE KOBERSTEIN

• Back In Action — At and After ASCO 2015

  6/11/2015

  At ASCO (American Society of Clinical Oncology) most of the experts are leading researchers in the immunotherapy field with whom I spoke at last year’s ASCO meeting. This time, I essentially collected their views on how cancer immunotherapy has progressed during the past year.

• Boehringer Ingelheim Ups The Ante In Treating Lung Disorders

  7/31/2014

  Tunde Otulana, M.D., heads Boehringer Ingelheim’s clinical development and medical affairs group. He is a former FDA reviewer who studied, learned, and finally got the chance to apply his knowledge of clinical trials when he stepped over into industry in 1997. As a pulmonologist who previously worked for about seven years in the FDA’s pulmonary division, Otulana subsequently led related R&D efforts at several companies before coming to BI in 2011. He now plays a key role in the U.S. in preserving the company’s position as a pioneer and leader in respiratory therapy, mainly in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

• Millennium Carries On With The Takeda Oncology Expansion

  6/30/2014

  Since I’ve been writing about the pharma industry for many years, I often find it impossible to walk in any direction without bumping into a connection from the past. It seems like a thousand years ago that I interviewed Millennium’s founder, Mark Levin, soon after the launch of its hallmark cancer drug. Certainly enough has transpired since then.

• Life Science Partnerships With Patient Foundations: Best Practices - Part 1

  6/2/2014

  One by one, life sciences companies and patientadvocacy groups have been getting together, bound by a common purpose — to ensure development of new treatments for unconquered diseases. Not always an easy marriage, these unions have grown and benefitted from experience.

• Eli Lilly Navigates The Realities Of Innovation

  6/2/2014

  You have seen the headlines, reading like obituaries for the about-to-be departed. You know the drill: repeated failures in Phase 3, nothing to replace the big earners with vanishing patents, mental images of a ship lost at sea. So why is Eli Lilly & Company still here — sailing the same course, undiverted, undiluted, and seemingly undeterred as the uniquely independent Midwestern-based company it has always been?

• Janet Woodcock's Quality Agenda At CDER

  2/2/2014

  New mandates, new user fees, and new uncertainties occupy the FDA’s drug center in 2014.

• Companies To Watch: Proteon Therapeutics

  12/2/2013

  Proteon Therapeutics has the singular purpose of treating the bane of nearly all kidney dialysis patients – stenosis and failure of the surgically placed vascular access for hemodialysis.

• A Bullish Season At The Time BIO Investors Forum

  11/27/2013

  The BIO Investor Forum had a unique mood with a shift in content from previous years with less focus on the downside of VC funding and IPO action and more focus on partnering, noncancer conditions, and new cancer treatment modes.

• Companies To Watch: Vivaldi Biosciences

  11/1/2013

  Vivaldi biosciences is aiming to parlay its new vaccine target a live-cell approach to accomplish an unprecedented level of protection against the flu, using live attenuated influenza vaccines (LAIVs) to stimulate multiple arms of the immune systems: antibodies, T-cells, and interferon.

• Companies To Watch: Inovio

  10/2/2013

  Inovio is developing DNA-based vaccines and its Cellectra Electroporation Delivery Technology platform are providing positive results from animal studies for HIV, malaria, tumors and influenza.

• AstraZeneca Translates 'Winning With Science' From Words To Action

  8/29/2013

  An exclusive interview with Menelas Pangalos, executive VP of innovative medicines at AstraZeneca, one of the three direct-to-CEO reports, responsible for small-molecule discovery and early-stage (through Phase 2) development.

• Esperion Therapeutics, Does Their Cholesterol-Reduction Drug Have “Blockbuster Potential”?

  8/29/2013

  Esperion CEO, Tim Mayleben says “Success for Esperion will be if ETC-1002 completes clinical development, is approved, and is prescribed by physicians for the millions of patients who can’t tolerate statins or can’t get to their LDL-C goal”. As one of the relative few mid-stage developers of new drugs with blockbuster potential, Esperion could be headed for membership of that elite club.

• Companies To Watch: Soligenix

  7/1/2013

  Strong federal support and a unique model centered on biodefense therapeutics and vaccines drive this company — and our interest in it.

• Companies To Watch: Cempra

  6/3/2013

  Cempra is one of a rare but expanding breed of companies answering the call for new antibiotics.

• Companies To Watch: Aeras

  11/1/2012

  Aeras, not-for-profit enterprise, is the only player solely organized around a TB vaccine goal with integrated development and manufacturing in a single organization.