FEATURE ARTICLES

Sanat Chattopadhyay — Shaping Merck’s Manufacturing Future
Sanat Chattopadhyay — Shaping Merck’s Manufacturing Future

It’s been a little over a year since Sanat Chattopadhyay was named president of Merck Manufacturing Division (MMD), and this month he gives an exclusive interview on the status of the division’s transformational turnaround.

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ALSO IN THIS MONTH'S ISSUE

  • Rising Out Of Takeda’s Reorganization: New Materials & Innovation
    Rising Out Of Takeda’s Reorganization: New Materials & Innovation

    “You don’t have time to invest in basic research and wait 10 years. You have to go find individuals and companies doing exciting research, engage them, and progress those new technologies through collaborations and funding,” explains Takeda’s Vincent Ling.

  • Alternatives To Funding Lower-Priority Trials
    Alternatives To Funding Lower-Priority Trials

    While some pharma companies struggle to backfill their pipelines, others find the opposite, that they have more development opportunities than they can pursue. While this may seem to be a nice problem to have, it also means that otherwise good drug candidates may be pushed down the list of priorities.

  • How The FDA Views Natural Language Processing
    How The FDA Views Natural Language Processing

    According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.

  • New Hampshire: A Biotech Microhub
    New Hampshire: A Biotech Microhub

    As the biotech sector in the U.S. continues to grow, it is doing so not just in hubs, but in smaller places like New Hampshire — where some of the state’s biopharma entrepreneurs say: “Smaller is better.”

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SPECIAL EDITION: 2017 CRO LEADERSHIP AWARDS

 

Read all the exclusive content — including who our CRO award winners are this year — in the 2017 CRO Leadership Awards Special Edition.

 

 

WEB-EXCLUSIVE EDITORIAL

  • Asset Acquisition Or Business Combination?
    Asset Acquisition Or Business Combination?

    The Financial Accounting Standards Board (FASB) has clarified its definition of a “business” when determining whether an acquisition should be treated as a business combination or an asset purchase for accounting purposes. The guidance is significant for the life sciences industry.

  • Closing The Presubmission Communication Gap Between Drug Developers And The FDA
    Closing The Presubmission Communication Gap Between Drug Developers And The FDA

    Both regulators and sponsors bear responsibility for saying what they mean, and interpreting correctly what’s being said. However, in a dynamic interaction, with so much riding on the outcome, this is not always simple. A solution to a potential impasse in these situations is to adopt a more nuanced approach based on a benefit-risk framework and discussion.

  • Genome Editing & The Future Of Drug Discovery
    Genome Editing & The Future Of Drug Discovery

    The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent.1,2 The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.

  • A Renewed Fight Against The Diseases Of The Poor
    A Renewed Fight Against The Diseases Of The Poor

    The Infectious Disease Research Institute (IDRI) is poised to embark on a bold new step —  it plans to take its early-stage candidates and deploy them in larger, later-stage human clinical trials in a wider range of settings, with the express purpose of having an expanded portfolio of vaccines, adjuvants, and therapeutics to fight the diseases of the poor.

  • HCP Access To Accurate, Evidence-based Information Online Is More Important Than Ever
    HCP Access To Accurate, Evidence-based Information Online Is More Important Than Ever

    There is a lack of awareness about pharmaceutical medical information (MI) services. Approximately 40 percent of health care practitioners are unaware that dedicated MI departments exist and can provide quality information.

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BEYOND THE PRINTED PAGE

  • Coming In September: The Inside Story Of How Allergan Built Its Social Contract

    In the upcoming September issue of Life Science Leader, we will feature an article on how Allergan’s Chairman, President, and CEO, Brent Saunders, conceived and created Allergan’s now-famous social contract. You’ll likely be stunned at the approach that was taken and how quickly it was executed.

    To prepare you for that article, we’ve obtained Allergan’s permission to publish the social contract here in its entirety.   Remember, though, only paid subscribers will be able to access the September issue’s article on Saunders and Allergan, so if you are not yet a subscriber to Life Science Leader magazine, go here to subscribe at a special rate .

  • MMD’s Next Generation Of Leaders

    According to Sanat Chattopadhyay, president of the Merck Manufacturing Division (MMD) and subject of Life Science Leader’s August 2017 feature article, female leaders are going to shape the world in the future.

  • Successful Transformations Require A Post-Period Of Reflection

    While it is a little early in the Merck Manufacturing Division (MMD) transformation to determine what, if anything, he would have done differently, it is likely Sanat Chattopadhyay will explore this exercise in the near future. “Every time I complete an assignment, whether a transformation or consolidation, I reflect on what was done and realize that there are always some missteps,” shares Chattopadhyay, the president of MMD. “For example, when I was in India, I did the transformation from internal to external manufacturing too fast. Sometime I could benefit from right-sizing my own ambition,” he says with a smile.

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LIFE SCIENCE TRAINING INSTITUTE COURSES

How To Establish The Number of Runs Required For Process Validation August 23, 2017
1:00 - 2:00 PM EDT, Online Training
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
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AUGUST 2017 DIGITAL EDITION

2017 CRO AWARDS SPECIAL EDITION

2017 CMO AWARDS SPECIAL EDITION

BLOGS

  • The Solar Eclipse And Other Irrelevancies
    The Solar Eclipse And Other Irrelevancies

    As a trade journalist, I often face the challenge of relevancy. Is what I’m writing about really useful and germane to readers as members of a particular industry?

  • What Do Partnering For Cures And A GSK Plant Tour Have In Common?
    What Do Partnering For Cures And A GSK Plant Tour Have In Common?

    In July I had two interesting opportunities. The first was on July 12, 2017 when I attended the Partnering For Cures (Twitter hashtag #FCP4C) conference in Boston. The second took place on July 19, when I got to tour GSK’s vaccine manufacturing facility in Marietta, PA. And while you might not think that a biopharmaceutical conference and a manufacturing facility would have much in common, in actuality they do, as both are focused on delivering safe and effective, high-quality medicines to patients as quickly and efficient as possible. Here are some highlights from my recent experiences.

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 UPCOMING EVENTS

Outsourced Pharma August 22 - 23, 2017
San Diego, CA
How To Establish The Number of Runs Required For Process Validation August 23, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
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Natalie James September 4, 2017
Paris
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