by Stephanie D. Fischer BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below: “On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment […]

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The Department of Justice announced today that the government has joined a civil lawsuit alleging that Lance Armstrong, Johan Bruyneel and Tailwind Sports LLC and Tailwind Sports Corporation submitted or caused the submission of false claims to the U.S. Postal Service in connection with its sponsorship of a professional bicycle racing team by regularly employing banned substances and methods to enhance their performance, in violation of the USPS sponsorship agreements.

More than 30 years ago, LISC was launched in a moment of great challenge – at a time when distressed neighborhoods across the country faced uncertain futures. After decades of rising crime and deteriorating fortunes in parts of America’s most vibrant cities, the Ford Foundation and its allies stepped forward. And they established the Local Initiatives Support Corporation to take what was – at the time – a novel approach to addressing community challenges.

Venture capital is a long investment cycle business, and never before has that been so clear as now in the face of the ongoing COVID pandemic. Even with the unprecedented public equity market volatility, venture investing into private biopharma companies

The post Booming VC-Backed Biopharma: Strong Market Despite Pandemic appeared first on LifeSciVC.

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When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.

What does this have to do with PI oversight?



As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?

We have some suggestions.


Assessing Attention to Detail
Any GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.

This is not sexy stuff. That’s why it’s a good indicator of PI oversight.  A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.

Assessing Commitment to Protocol Compliance
During site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”

The A answer:
“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”

The F answer:
“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)

Just Ask
After reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.

There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out.

Epilogue
After running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”

My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.

I was a child bride.

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The search for murdered policewoman Ashwini Bidre's mortal remains has reached the final stage. Of the nine locations that came up during the search, two, showing strong signals of presence of a metal object, have been zeroed on.

Having a radius of five metres, both locations are covered with mud that's nearly two metres deep. The police will now take a call on how to remove the objects from these locations, as they will need specialised machinery for it. After an initial investigation, the police had procured a gradiometer, an equipment to locate metal objects underwater, from Israel. "During the two-day search operation, experts found nine spots with the help of the equipment; strong signals emanated at two of the spots," said an officer.

These two locations are expected to have objects at a depth of 25 to 40 metres below the water surface. "The depth varies according to tide. Our search also revealed that the objects are covered with one-metre thick mud, which is hard and can't be removed manually," said the officer. These spots also have deep wells, said a source, adding, "Sending divers in these wells can be dangerous to their lives. Hence, we are considering bringing in machines capable of drilling deep underwater."

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Radhika Madan, who played the role of Irrfan Khan's daughter in his last release Angrezi Medium, remembers the actor as a "fighter". "I don't know what to say. My heart aches when I write this. He was one the strongest people I knew, a fighter. And so are (Irrfan's wife) Sutapa ma'am, (his sons) Babil and Ayan," Radhika said.

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In his last days, Irrfan was mourning the loss of his mother. The actor's mother Saeeda Begum breathed her last on Saturday in Jaipur where she used to stay. However, owing to the ongoing lockdown, the actor could not physically attend his mother's last rites and reportedly paid his last respect through video conferencing.

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Attention women! It's time for you to make friends in your office as a study has found that strong friendships among women co-workers, especially in male dominated organisations, are less likely to experience conflicts.

Researchers from the Institute For Operations Research And The Management Sciences suggested that when employers foster an office environment that supports positive, social relationships between women coworkers, especially in primarily male dominated organisations, then they are less likely to experience conflict among women employees.

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Knowing that unique gendered network characteristics such as the gender compositions of an employee's social support at work were associated with negative ties can help organisational leaders anticipate potential trouble spots within their firms where gendered conflict may erupt.

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[Source: Research & Innovation] ‘For Europe to come out stronger after the Corona crisis, we need to already direct our investments towards game-changing innovations that create a sustainable and human centric digital future’, according to the vision statement of the European Innovation Council Advisory Board published today.

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