EXECUTIVE INTERVIEWS

Regeneron: A Biotech With Commercial Confidence From The First Compound

In 2001, members of a small biotech from the New York City area traveled to the state capital, Albany, to discuss accessing the state’s new Biotechnology Industry Growth Fund. An economic development official responsible for a portion of that fund met with them but came away skeptical.

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THE CURRENT ISSUE

  • Looming Cadillac Tax And ACOs Distort Healthcare System
    Looming Cadillac Tax And ACOs Distort Healthcare System

    By the time this article goes to press, the Supreme Court may have ruled on the constitutionality of subsidies for health insurance flowing through the federal exchange. But other distortions caused by Obamacare are rippling through the healthcare system. Two clear examples are the looming “Cadillac Tax” on generous health plans and unfolding theatrics regarding accountable care organizations (ACOs).

  • Eat Or Be Eaten: Controlling Your Fate In The Specialty Pharma M&A Feeding Frenzy
    Eat Or Be Eaten: Controlling Your Fate In The Specialty Pharma M&A Feeding Frenzy

    You can’t blame specialty pharma companies for looking over their shoulders lately. For the smaller fish in the specialty pharma pond, a shadow circling overhead may turn out to be a Big Pharma at the top of the food chain seeking a rich source of R&D innovations or a growing revenue stream to supplement its business.

  • The Evolution Of CRO Reimbursement: Shifting From Task-Driven Units To Desired Outputs
    The Evolution Of CRO Reimbursement: Shifting From Task-Driven Units To Desired Outputs

    Over the years, pharma and biotech companies have looked to create better models to speed drug development and make it quicker, more efficient, and more effective, and this includes using the specialist expertise in clinical research organizations to carry out clinical development.

  • Value & Pricing: Moving Past The Rhetoric In Biopharma
    Value & Pricing: Moving Past The Rhetoric In Biopharma

    Today we bear witness to a “golden age” for biopharmaceuticals. With all of the exciting/ innovative science, growing scripts, increase in drug approvals, and record revenue, it’s difficult to call it anything else.

  • Outsourcing Increasing To CROs And CMOs Known For Quality And Cost-Effectiveness
    Outsourcing Increasing To CROs And CMOs Known For Quality And Cost-Effectiveness

    With cost and regulatory pressures on drug manufacturers continuing to increase, it is not surprising that growth of the global CRO and CMO markets is healthy (9 percent and 6.4 percent CAGR, respectively). According to market research firm TechNavio, today’s greater demand for CRO services is due in large part to the increase in outsourcing of biopharmaceutical drugs and R&D activities by both pharmaceutical and biopharmaceutical companies.

  • The Importance Of Having Partners You Can Count On
    The Importance Of Having Partners You Can Count On

    June provided a significant number of educational opportunities for life science executives. If you have any interest in oncology, you could probably be found at Chicago’s McCormick Place attending the American Society of Clinical Oncology’s (ASCO) annual meeting (May 29 to June 2).

  • Biosimilar mAbs: Expanding The Global Biosimilar Market
    Biosimilar mAbs: Expanding The Global Biosimilar Market

    After almost a decade of debate, there is now a generally agreed upon definition for biosimilar molecules: a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference product) that demonstrates similarity to the reference product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise.

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FROM THE CUTTING ROOM FLOOR

  • Celgene's M&A Dealer - “The Best Career Decision I Ever Made.”

    For George Golumbeski, the key to becoming good at BD is learning by doing. “I was once asked, ‘What books can one read to learn about negotiations?’” he says. “Forget it. You’ve got to get in there. Hopefully you have somebody who can show you the ropes. And, you are probably going to mess up a few times.” 

  • How Does Being A Scientist Help With Biopharmaceutical Business Development?

    Celgene’s SVP of business development, George Golumbeski, completed his undergraduate degree in biology, a Ph.D. in genetics, and a post doc in molecular biology. So what makes him qualified to run the business development unit for one of the hottest biopharmaceutical companies?

  • Want To Know What Deal Celgene’s George Golumbeski Is Most Proud Of?

    George Golumbeski, Celgene’s SVP of business development, has been listed as one of the most influential folks in all of biotech, the result of the company’s consistent deal-making success, which is his primary role. When I asked him if he had a deal he was most proud of, he replied...

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 UPCOMING TRAINING COURSES

Monitoring Electronic Health Records (EHRs): Frequently Asked Questions

September 9, 2015
1pm-2:30pm EDT, Online Training

Root Cause Analysis for GCP – A Risk Action Plan Guide

September 22, 2015
1pm-3pm EDT, Online Training

CRO Oversight: Risk Assessment & Action Planning

October 6, 2015
1pm-2:30pm EDT, Online Training
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July 2015

 

2015 CRO LEADERSHIP AWARDS - SUPPLEMENT

2015 CRO Leadership Awards

 

 UPCOMING EVENTS

The Vendor GMP Qualification Audit: Ensure Your Vendors Meet Your Compliance Standard

July 29, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Quality Assurance and Quality Control - Differences in FDA vs. EU Regulations

July 30, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!

New Pharma Compliant Google Ad Formats – Implementation Tips For Success

August 4, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!

Project Management: Best Practices for Validation & Regulatory Projects

August 5, 2015
1pm-2:30pm EDT, Online Training
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Medical Device Complaint Handling and MDR Reporting

August 11, 2015
1pm-2:30pm EDT, Online Training
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