Smartphones and biotech are not closely related subjects but Nick Paul Taylor, of fiercebiotechit.com, explains that app centers powered by Google, Microsoft, and Blackberry are closing the gap on Apple’s dominance in the app marketplace. Big Pharma and biotech apps traditionally have been exclusive to Apple devices first and then later released to other app stores. But the high growth of Android devices, especially in emerging markets, has forced these apps to be simultaneously released for both devices. Biotech apps have been growing since 2011, and 2013 has not alluded to any signs of this industry slowing down. For the complete article and list of 2013 biotech apps, click here.
The 2013 Site Solutions Summit features Pearl Pathways’ own Diana Caldwell. She will be involved in the roundtable discussions as a panelist and moderator for topics such as: Investigator Insider: What your site needs to know about your next potential investigator; and Your Circle of Friends: Why social media matters. The Summit focuses on encouraging dialogue and sharing of information to arrive at best site practices. Diana adds to a group of panelists with years of experience and wisdom to share. Below are the two discussions Diana will partake in:
Roundtable Title: Investigator Insider: What your site needs to know about your next potential investigator.
Roundtable Date: Saturday, October 12, 2013
Roundtable Start Time: 1:45
Roundtable Duration: 45 minutes
Roundtable Location: Magnolia E
Roundtable Title: Your Circle of Friends: Why social media matters.
Roundtable Date: Saturday, October 12, 2013
Roundtable Duration: 45 minutes
Roundtable Start Time: 2:45
Roundtable Location: Cumberland E
For more information please refer to the Site Solutions Summit 2013 agenda.
Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients and FDA. On July 25, 2013, Pearl Pathways’ own Gretchen Bowker will lead a webinar on FDA audits discussing the best practices and provide practical tips to prepare for FDA audits, as well as client audits. The webinar will be held through CompliaceOnline.com.
When: July 25, 2013
Duration: 60 minutes
For more information and registration click here.
Biotech companies are starting to accumulate Big Data, consisting of gene expression profiles, biomarker reliability, patient outcomes and numerous other measurable aspects of drug development. The hope is that the mass amount of data can help streamline R&D. During the JP Morgan Healthcare Conference, FierceBiotech Executive Editor Ryan McBride asked a panel of drug development executives about the potential applications and implementation of Big Data in drug development. The bioteh executives discussed the pros and cons of using Big Data to generate hypotheses, and how Big Data can be used to target the right patients for the right drug trial. Another issue discussed was the unstructured, handwritten notes taken by physicians and the challenge of merging and indexing this data with the newly collected high tech data. Nevertheless, the executives agreed at the conference that Big Data is a great source of information for R&D, provided one knows how to use it, and it is just a matter of time before R&D companies do what is necessary to merge all the data into one integrated system. To read the full article on FierceBiotech, click here.
The MWDG of the ASQ Biomedical Division is next meeting to discuss the topic of biocompatibility in regards to medical devices.
When: November 29, 2012 from 5:30-8:00pm
Where: University of Indianapolis, Schwitzer Student Center Building #7, Room 013, Indianapolis IN 46227
Cost: Buffet dinner, $12.50 for members and $15.00 for nonmembers
Click here to register for the upcoming event. This link will be available until 5pm on Monday, November 26th. If you are unable to use the link, contact Ann Stankiewicz at firstname.lastname@example.org
MWDG devision of ASQ Biomedical presents “Human Factors in Medical Device Development” in Indianapolis
The Midwest Discussion Group (MWDG) of the ASQ Biomedical Division presents Human Factors in Medical Device Development on Thursday, October 25, 2012. Jim Kershner from Eli Lilly will share his experience dealing with issues around human factors in medical device development. Kershner will share his extensive knowledge and hands-on experience on human factors investigations. The meeting will be held at the University of Indianapolis. Hot buffet, beverage and dessert will be served at this event.
When: Thursday, October 25, 2012
Where: University of Indianapolis, Schwitzer Student Center Building #7 Room #013 (on lower level)
Time: 5:30p.m. – 8:00p.m.
Cost: $12.50 for members, $15.00 for non-members
For full details of this event, click here.
The Midwest chapter of Biomedical ASQ presents the Process Validation Game!
When: Thursday, May 24th, 2012 from 5:30-8 pm.
Where: University of Indianapolis in the Schwitzer Student Center Building #7 Room #013 Indianapolis, IN 46227
Cost: Buffet dinner $12.50 for members and $15.00 for non-members.
For additional information and to register for this event, click here.
FDA recently issued new final guidance for medical device manufacturers navigating the premarket approval (PMA) and de novo decision pathways. The document, entitled Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications was issued on March 28, 2012 and describes in detail how FDA will weigh the risks and benefits of a device during premarket review—both in the future and for devices currently under review.
Featured in the guidance is a worksheet designed to streamline the risk-benefit analysis of submissions by providing in advance several key features of the device’s potential to do both harm and good, including: the duration, type, and magnitude of risks and benefits; as well as risk likelihood, patient tolerance, reported value to patients, and available alternatives. According to the guidance introduction, “FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.”
For more information about the premarket process or for help with premarket device strategy, planning, and submissions, contact Pearl.
Dr. Bruce Booth, Partner at Atlas Ventures, recently published an article on Forbes outlining the various models (or “worldviews”, as he calls them) of startup and early-stage biotechs, and how those models are perceived and evaluated for investments among the Venture Capital community.
Booth takes us from the more traditional, brick-and-mortar, product-generating platform companies (see Amgen); to the current trend of virtual, single-asset entities built for acquisition (see FerroKin). He outlines 3 critical success factors for each model; though different, the success factors all revolve around a theme of recruiting experienced core management and making effective use of resources and environment (in-house vs. outsourced development, early partnerships with big pharma, etc…).
The article is a great read for Pearl’s biotech clients—or anyone else developing and revising corporate strategy and fundraising campaigns in the biotechnology space. To read the article, click here. Or contact Pearl for more information.
It’s a brave new world when it comes to financing startup and early stage biotechs, and particularly for pharmaceutical development groups. No longer are there hundreds of pharma-focused VC firms able to independently fuel and sustain the growth of drug development programs. These development paths are long-term and extremely risky investments that more often than not fail to generate sufficient returns to back startups.
Plus, it’s been tough for VCs all around since the economic crisis. According to the National Venture Capital Association, the number of VC firms in the last decade has dropped from 1,022 down to just 462; and the biotech sector—with its extended timelines and lower probability of success—was arguably hit hardest by the shrinkage.
But with all that said, new models are emerging that give small and startup drug developers a chance to secure early capital and survive, and more importantly to share more effectively with investors and partners in both the risks and the rewards of the drug development process. And don’t worry—VCs haven’t dropped out of the race (total VC financing is up 34% from Q1 last year, according to BioWorld). Because after all, there are still enormous rewards to be earned; and often the focused effort of a small biotech is the most effective way to reach them.
A FierceBiotech report from VC heavy-hitter Burrill & Co. tracked $2.6B worth of the most recent biotech investing, which revealed several interesting players, partnerships, and trends. What stands out is the dramatically enhanced collaboration, co-investment, and partnership among various players as compared to years past. VCs, for example, are playing more nicely than ever before with governments, big pharma, academia, hospitals, trusts and foundations—and the result is a landscape of shared responsibility that enables biotechs to continue doing business.
Of course, this model won’t allow for the development of the next Amgen—with R&D, manufacturing, packaging, labeling, marketing, and just about everything else under one roof supported by bricks and mortar. But partnerships with major research foundations, governments, and big pharma—and the allocation of resources, responsibilities, and revenue that go along with them—may very well be the way of the future start-up and early-stage biotechs.
For more information, check out an Xconomy article by Luke Timmerman which does a good job identifying and explaining some of the newest trends and models in biotech financing. For regulatory, clinical, or product development support with your biotech, contact Pearl.