Industry Leader

Industry Leader articles are written by executives at biopharma companies, consultancies, research firms, and companies that provide services or products to sponsors. The topics are nonpromotional and focused on industrywide business issues.

  • How Patients Will Revolutionize Next-Generation Clinical Research
    How Patients Will Revolutionize Next-Generation Clinical Research

    Often when we think about inefficiencies in the clinical trial process, we focus on the role of the sponsor or CRO, a particular aspect of the value chain, or new technologies that promote data sharing and faster decision making. While these are critical aspects that drive day-to-day operations, there is another aspect of the value chain that we may be neglecting: the patient side.

  • Considerations For The Use Of Wearables In Clinical Trials
    Considerations For The Use Of Wearables In Clinical Trials

    With wearables, we now have the means to innovate the “where” and the “how” of patient data capture, creating a 24-hour digital map of physical behaviors.

  • How To Increase Productivity Via Unconventional Hiring
    How To Increase Productivity Via Unconventional Hiring

    One of the most vexing and common problems HR professionals face is acquiring and training talent for specific skilled positions, only to see that talent, and the time and money invested in them, walk out the door too soon.

  • Meeting The Unknown Need In Pharma Labs
    Meeting The Unknown Need In Pharma Labs

    The very nature of many scientific processes creates habitual behaviors. Often these habits are effectively passed from senior lab generations to younger ones. Old habits can be hard to break, especially in a time-pressured lab environment.

  • Active Targeting: A New Wave In Drug Delivery
    Active Targeting: A New Wave In Drug Delivery

    Although the history of drug development contains many stories of serendipitous discovery, critical advances often emerge by setting out to address specific challenges. Today, many challenges associated with older drugs are being solved with new delivery technologies.

  • The Space Squeeze: One Challenge In Building A Biopharm Lab
    The Space Squeeze: One Challenge In Building A Biopharm Lab

    Any biotech or life sciences company in Boston — early-stage or mature — is no stranger to Kendall Square’s lab space squeeze. As the top-performing lab market in the U.S., Kendall Square is especially sought after by life sciences companies — ranging from emerging startups to Big Pharma.

  • Great Expectations For Personalized Medicine Outside Oncology
    Great Expectations For Personalized Medicine Outside Oncology

    Oncology has always been the front runner in personalized medicine, so this is where targeted therapies and diagnostics have, for the most part, been focused. However, there is new activity outside this area where biomarker and targeted approaches are proving successful.

  • Life Sciences Companies Have Reason For Optimism In 2016
    Life Sciences Companies Have Reason For Optimism In 2016

    Even though the U.S. economy continued to strengthen in 2015, many public investors sat on the sidelines grappling with global economic and political concerns and uncertainty surrounding the Fed’s policy concerning interest rates. Because of these and other factors, middle-market IPO transaction activity (IPOs completed by companies with market caps between $10 million and $2 billion) in 2015 decreased versus the previous year. Contributing to the downward pressure on IPO activity was the availability of capital and high valuations from private financial and strategic investors.

  • 3 Keys To Successful Industry-Academic Collaborations
    3 Keys To Successful Industry-Academic Collaborations

    Industry-academic collaborations are becoming more popular as pharmaceutical and biotechnology companies seek to harness the innovation and human capital within life sciences institutions.

  • How Lab Improvements Can Drive Productivity
    How Lab Improvements Can Drive Productivity

    Today’s laboratory managers are facing significant budget cuts while simultaneously being challenged to obtain faster results. These pressures have created an increased focus on identifying potential areas of lab productivity improvement.

  • Strategic Financing Alternatives For Later-Stage Companies
    Strategic Financing Alternatives For Later-Stage Companies

    With the exception of several mega-financings for blue chip management teams in companies such as Juno and Denali from syndicates of well-heeled venture funds such as ARCH Ventures and Flagship Ventures, venture financing for startup life science companies has been relatively lean for the last several years.

  • Should Your Executives Help You Recruit?
    Should Your Executives Help You Recruit?

    No industry is more competitive than the life sciences for leadership talent. And we all know there are obvious advantages to asking one’s own leaders to help recruit, but allow me to offer a few words of caution if this is your strategy.

  • How Much Transparency Is Too Much With Clinical Trials?
    How Much Transparency Is Too Much With Clinical Trials?

    There is a growing movement by some researchers and regulators to increase disclosure of clinical trial results.

  • A Life Science Manufacturing Executive’s Role In Establishing A Quality Culture
    A Life Science Manufacturing Executive’s Role In Establishing A Quality Culture

    Creating the appropriate quality culture is arguably the most important element of being a manufacturing leader in the life sciences industry. Yet, reflecting back on my long career, I have not seen a single recipe for doing this, and I don’t profess to have a well-documented approach myself. But, boy, do I have some stories.

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Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
5th Euro-Global Summit on Aquaculture & Fisheries March 30 - 31, 2017
Madrid, NV
Clinical Trial Collaborations April 3 - 4, 2017
Renaissance Boston Waterfront Hotel, Boston, MA
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You April 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made April 5, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
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4th Middle East Pharma Cold Chain Congress April 10 - 12, 2017
Dubai
Qualifying Your Trainers – What Do They Need For Your Training To Be Effective? April 11, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Designing GxP Onboarding Programs for the Life Sciences: Ensuring Employee Success April 12, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Change Management Plan Development for Risk-Based Clinical Studies: From Site Monitoring to Vendor Management and Beyond April 13, 2017
1pm-2:30pm EDT, Online Training
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Best Practices in CMC Dossier Preparation – Facing Tough Challenges April 24, 2017
1pm-2:30pm EDT, Online Training
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Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof Processes April 25, 2017
1pm-2:30pm EDT, Online Training
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Cleaning Validation – Health Based Limits and Beyond: Answers to Current Industry Gaps April 26, 2017
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Cleanroom Microbiology – A Foundational Introduction April 27, 2017
1pm-2:30pm EDT, Online Training
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Price:  $299 - Includes Bonus Handouts!
Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls May 2, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response May 9, 2017
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Price:  $299 - Includes Bonus Handouts!