10 Jan

Whitepaper: Transforming Deviation Management

http://www.bioprocessintl.com/business/risk-management/transforming-deviation-management-biophorum-operations-group/

Suggested by /u/ghattoy in a previous thread.

Reading this would be like staring directly at the sun for some QA people. Deviations where I work are tracked by initiator, and QA is debating whether to make this tracking public as a way to increase pressure on mfg to increase compliance.

Some people worry that it makes people afraid to surrender bad news quickly. As a compromise, I want to suggest to QA that they display their tracking of only minor deviations and entry errors (spelling, write overs, etc). People in manufacturing only see this tracking as if its an HR type thing to document poor performance. In reality, initiating a deviation is much better than the alternative: deviating but trying to hide or minimize it. Some deviations are inevitable, for example ones that result form a poorly written batch record or SOP. If we are worrying about what HR will think of a deviation, we risk losing sight of what really matters, which is what a patient/ clinician (and after that, regulator/ client) would think of the deviation.

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10 Jan

Duke scientists transform skin cells into functioning human muscle

Researchers have struggled to transform induced pluripotent stem cells-which can be developed into other cell types for potential transplants-into functioning tissue. A team at Duke University has overcome significant hurdles to create the first functioning human muscle from these stem cells.

10 Jan

“A Transformative Year in Medicine”

2017 will be remembered as an exciting year for biopharmaceutical innovation. Not only did we experience some tremendous medical breakthroughs that will improve the lives of patients, we also witnessed policymakers take positive steps to help ensure prescription medicines are accessible and affordable for patients.

In an op-ed published by The Hill, BIO President and CEO Jim Greenwood recounts some of the important achievements that took place last year, both in America’s research labs and the halls of Congress. He also explains why any future action on prescription drugs needs to take a “holistic approach,” one that recognizes the unique roles others play within our health care system, including insurers and hospitals. As Jim notes, “Anything less would be misleading and do little for patients at the pharmacy counter.”

To read the full op-ed by Jim Greenwood, click here.

To learn about the responsible steps policymakers should take on prescription drug costs, click here.

 

10 Jan

Ag Startup Inocucor Adds $9.5M for Microbes that Improve Yields, Soil

A growing number of agtech startups are researching biological products that work with the community of microorganisms in and around plants. Denver-based Inocucor has developed microbes intended to improve plant and soil health and it now has $9.5 million in additional financing to support its efforts to bring these products to crops.

The latest investment adds on to a $29 million financing that Inocucor raised last year, bringing the total for that Series B round to $38.5 million. The company says it will use the cash to ramp up production and marketing of its microbes.

Inocucor has developed and patented a… Read more »

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09 Jan

Stock Indexes Manage Another Day of Gains

Click to view a price quote on FB.

Click to research the Internet industry.

09 Jan

Allergan’s David Melnick Joins Spero Tx as Chief Medical Officer

David Melnick has joined Spero Therapeutics (NASDAQ: SPRO) to become the Cambridge, MA, company’s chief medical officer. Melnick served as vice president of clinical development for anti-infectives at Allergan (NYSE: AGN) since 2015. Spero has two clinical-stage antibiotics that the company hopes can help address the growing problem of drug-resistant bacteria.

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09 Jan

BAMB Stakeholder Network Annual Meeting – 23 January 2018, Brussels, Belgium

[Source: Research & Innovation] The Annual Meeting of the BAMB Stakeholder Network will be held on January 23, 2018 from 10:00-18:00. An exciting program has been put together and the Consortium is looking forward to sharing what’s new with the H2020 BAMB project, as well as illustrating the key functions of BAMB tools through concrete case studies and pilots.
Breakout sessions will allow participants to dive deeper into select topics. In addition, the inaugural exposition of the Reversible Experience Modules pilot project will be on site and available to explore!
The pilot is built up reversibly and showcases products in connection with their Materials Passports, while demonstrating their value for (present) use, recovery and re-use. Visitors are invited to interact with products and to experience hands-on their value propositions related to the circular economy.
The Annual Meeting is open to all registered members of the BAMB Stakeholder Network. Not yet a member? Join today! www.bamb2020.eu/ Upon registration you will recieve your code to reserve a ticket. We hope to see you soon!

09 Jan

Resolve to Focus on What Matters Most About Your Health (It’s Not GMOs)

At this time of year, you see lots of stories about making New Year’s resolutions: losing weight, improving one’s health, and just generally making changes in one’s life.

Whether people can stick with these resolutions is debatable, but one thing that IS true is that there are a lot people putting trendy health claims out there to take advantage of this “New Year, New You” trend that happens every January.

One trend that you DON’T have to worry about is avoiding GMOs. GMOs are just as safe, healthy, and nutritious as any other food that you eat. Sometimes even MORE nutritious!

In a new blog post for GMO Answers, Registered Dietitian Amber Pankonin tells us what you SHOULD focus on, instead of fad diets, scare tactics and just plain woo, in order to have a healthier 2018.

  1. Read the ingredients.
  2. Consider your portion size and cooking method.
  3. Balance your plate.
  4. Know your numbers.

It’s that simple. Follow these steps and you can accomplish those goals.  So, instead of jumping on the latest fad diet or resolving to give up GMOs in 2018, focus on what matters most about your health. We should let science be our guide and not fear-based marketing.

To read Amber’s entire post, please visit the GMO Answers Medium page. And if you have any more questions about GMOs, visit the GMO Answers website to explore and learn the science behind this technology.

09 Jan

BioClin Therapeutics hires Gilead blood cancer R&D exec

Nearly a year after closing a second funding round, cancer biotech BioClin has nabbed Esteban (Steve) Abella, M.D., as its new chief medical officer.