In this Hangout, we will discuss when a small business should contact the FDA, and what formal and informal mechanisms exist for device, drug, biologic, and diagnostic developers to obtain early advice from the FDA.
Mobile devices are revolutionizing the health care system for patients and medical providers. Using this new technology wisely and securely is the goal of the health information technology experts who talked about trends in the field during a Health IT Forum at the Johns Hopkins University Montgomery County Campus.
The Health IT Forum series, held four times a year, is a community partnership co-sponsored by Montgomery County Department of Economic Development, the TechCouncil of Maryland and the Montgomery County Chamber of Commerce. The May forum, titled “mHealth: Bring Your Own Device,” attracted dozens of IT experts from the region.
After a lengthy and somewhat contentious markup, the House Science, Space and Technology Committee approved the Frontiers in Innovation, Research, Science, and Technology (FIRST) Act (H.R. 4186) by a vote of 20-16 on May 28th. As discussed in previous editions of Capitol Update, the bill reauthorizes and prioritizes federal investments at the National Science Foundation (NSF) and the National Institute of Standards and Technology (NIST) by funding research and development (R&D) to address national needs. The bill also sets priorities to drive the nation’s investments in science, technology, engineering and math (STEM) education programs.
The FIRST Act would require that the NSF publish a justification of each grant’s scientific merits and relevance to the broad national interest in order to meet minimum standards of public accountability and transparency in its grant funding decisions. The FIRST Act does not change NSF’s peer review process. Provisions of the FIRST Act also broadens the definition of STEM education to include computer science and supports student participation in nonprofit competitions, out-of-school activities and field experiences related to STEM.
More than a decade has passed since scientists completed the Human Genome Project, a worldwide effort to decode our DNA. That DNA sequence contains instructions for making all of the proteins that our bodies need to function.
Now researchers have cataloged the vast majority of those proteins, creating a dynamic map of the human body called the proteome.
Before coming into the program I would highly stress putting together a comprehensive product roadmap for the duration of the program as well as 2 months after. Start by splitting the upcoming 3 months into individual weeks & writing out goals both for the tech side (development, design, ux etc.) of the company as well as the business side (sales, fund raising, partnerships etc.). If possible have them written on a huge calendar for everyone in the company to see & be aware of.
Then go more granular and translate those weekly goals into individual tasks using any project management software, here I’d recommend Trello since its very intuitive, has great array of browser plugins to support different styles of task management & it’s totally free.
Qiagen announced a collaboration with Eli Lilly and Co. to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types. The agreement includes the development of tests that will be based on Qiagen’s multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and biomarkers in a single test.
GlaxoSmithKline ($GSK) has already made some moves to sell off some of its older meds. But now, it’s making more that could end up much, much bigger.
As Sky News reports, the pharma giant has solicited bids from a handful of private equity firms–Advent International, Blackstone and KKR included–for some or all of the 50 or so drugs in its established products portfolio, worth up to £7.5 billion ($12.6 billion). A spokesman for GSK told Sky the company is currently evaluating its options.
The University of Maryland’s commitment to expanding science opportunities on campus could not be any more clear having now acquired a five-year, $1.2 million grant to further undergraduate science education from the Howard Hughes Medical Institute.
The College Park institution plans to use the grant to develop a new living-learning program for students enrolled in the biological and chemical sciences. It will include a residence hall with integrated support mentoring programs, community-building activities, co-enrollment in introductory science courses and advanced access to stellar hands-on research opportunities.
Once a year, all of the tech world stops to listen to what influential analyst Mary Meeker has to say. According to Meeker, current trends show a slight dip in internet user growth but she highlights that emerging markets are showing the fastest growth in terms of internet usage. This growth can be seen more rapidly in what she calls “difficult to monetise developing markets” like India, Indonesia and Nigeria.
Meeker, a partner at VC company Kleiner Perkins Caufield Byers (KPCB), unveiled her annual trends report at the Code Conference this week. The report highlights the disruption that is underway in areas like media consumption, education, healthcare, commerce, security, mobile and consumer apps. We have picked some key trends that we thought were worth highlighting.
GlaxoSmithKline (GSK.L) has invited private equity firms to consider making offers for a range of its older drugs sold in Western markets, according to three people with direct knowledge of the matter.
The move is part of a reshaping of the drugmaker’s business, which also involves a major asset swap deal struck last month with Novartis (NOVN.VX).