Archive for the ‘Global Partnering & Biotech Investment’ Category

JP Morgan Healthcare Conference: Highlights for Day Three and Day Four

Reporter: Aviva Lev-Ari, PhD, RN


JP Morgan Healthcare Day Three: Foundation Med; Cepheid; BD; Invitae; GenMark; Berry Genomics

Jan 14, 2016

Ed Winnick

Monica Heger 

  • Berry Genomics
  • GenMark Diagnostics
  • Invitae
  • Becton Dickinson
  • Cepheid
  • Foundation Medicine

The company’s liquid biopsy assay, FoundationAct, will genomically profile circulating tumor DNA from patients for whom a tissue biopsy cannot be obtained. Pellini stressed that the assay was designed to help guide oncologists’ treatment decisions. But the company is also developing an assay that could be used to monitor patients’ disease burden and response to treatment.

Pellini added that the company is taking a “new approach to companion diagnostics” in work it is doing to develop a universal companion diagnostic that will be a regulated product used with any targeted agent or immunotherapy.



JP Morgan Healthcare Conference Day Four: Luminex, Exact Sciences, T2 Biosystems, Singulex

Jan 15, 2016

a GenomeWeb staff reporter



Luminex received US Food and Drug Administration clearance for the Aries system and Aries Herpes Simplex Virus (HSV) 1&2 Assay last October. The firm launched the real-time PCR-based sample-to-answer system in the fourth quarter of 2015 and is targeting 100 placements by the end of this year, Shamir said.


Exact Sciences

Exact Sciences reported earlier this week that it had sold 38,000 of its Cologuard tests, below its expected 42,000 tests. Conroy attributed the lower sales to a higher-than-expected dropoff in orders around the holidays.


T2 Biosystems

In his presentation, T2 Biosystems President and CEO John McDonough provided an update on the uptake of the company’s T2Dx magnetic resonance-based rapid diagnostic platform and its first test, T2 Candida, a US Food and Drug Administration-cleared assay for the detection of sepsis-causing Candida infections. He also provided attendees with an update on the company’s assay pipeline.

The assay, which was FDA cleared in September 2014, can directly detect Candida species from a patient blood sample without prior culturing in three to five hours and with better sensitivity.

McDonough said that the company has been targeting the top 450 hospitals in the US with the platform and assay and that adoption “has been going at a very nice rate.”


Singulex’s CEO Guido Baechler said that the company will launch its CE-IVD marked single-molecule counting platform, Singulex Clarity, in Europe this year. The first two systems will be installed in Barcelona and London in May and he expects approval for the machine by September.

Baechler added that the company is also looking to bring the platform through US Food and Drug Administration 510(k) clearance with an assay that rules out acute myocardial infarction in patients.




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J.P. Morgan 34th Annual Healthcare Conference & Biotech Showcase™ January 11 – 15, 2016 in San Francisco

Reporter: Aviva Lev-Ari, PhD, RN

J.P. Morgan 34th Annual Healthcare Conference


January 11, 2016 – January 14, 2016 (all-day)


San Francisco, CA, USA

Conference AGENDA 


UPDATED on 1/10/2016

The definitive guide to the J.P. Morgan Healthcare Conference


[Image courtesy of Flickr user Ryan McDonald]


MAJOR BioTech Conferences in San Francisco –

The CAPITAL of BioTech for 2nd week in January 2016


  • Festival Start up Health

  • Biotech Showcase 2016

  • JP Morgan HealthCare Conference



  • The 9th Annual OneMedForum, San Francisco 2016 – A Private Investment Conference for OneMed Research Clients


  • RESI@JPM — Redefining Early Stage Investments – Life Science Nation (LSN)


Venture Valkyrie (and capitalist) Lisa Suennen rightly pointed out that JPM is typically a male-dominated affair, which is why she’s written “JP Morgan: Where the Boys are… And not the Girls.”

In a field where women hold many senior positions in actual US healthcare corporations, they are drowned out at this conference by the advancing horde of finance guys in red ties and the CEOs that love them.

Signal Podcast on STAT

Listen to Episode 5: By LUKE TIMMERMANandMEG TIRRELL

San Francisco 2016

Union Square: Maps & Resources by MacDougall Biomedical Communications.

Biotech Showcase™ 2016 Program Overview

Sunday, January 10, 2016
1:00–5:00 pm
Additional Program
Biotech Showcase™ pre-event

This workshop is focused on delivering results and securing funding at All Levels: Boards, Angels, VCs, Corporate Partners and Other Sources of Funds, with four hours of intensive and interactive discussion, on-your-feet sessions, war stories and insights aimed at folks looking for financing. It is designed to accelerate your funding activities and eliminate unnecessary noise.

Preregistration is required, more information can be found here.

3:00–6:00 pm
Level 4, Cyril Magnin Foyer

All Biotech Showcase attendees are invited to pick up name badges prior to the beginning of the conference on Monday.

Monday, January 11, 2016
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–8:55 am
8:00 am–6:00 pm
One-to-one Meetings ►

Hilton Union Square
333 O’Farrell Street
Level 2, Ballroom

8:00–9:50 am

Regenerative Medicine and Advanced Therapies State of the Industry Briefing

8:00 am–12:00 pm

Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm

Lunch Plenary

1:45–5:30 pm

Company Presentations ►

Private Biotech
Public Biotech

Tuesday, January 12, 2016
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–8:55 am
8:00 am–6:00 pm
One-to-one Meetings ►

Hilton Union Square
333 O’Farrell Street
Level 2, Ballroom

8:00–9:15 am

Medtech Showcase State of the Industry Report

8:00 am–12:00 pm

Company Presentations ►

Private Biotech
Public Biotech

12:00–1:30 pm

Lunch Plenary

1:45–5:30 pm

Company Presentations ►

Private Biotech
Public Biotech

4:30–5:30 pm

Medtech Showcase Workshop


Wednesday, January 13, 2016
7:00 am
Level 4, Cyril Magnin Foyer
Registration Opens and Continental Breakfast
8:00–8:55 am

8:00 am–5:00 pm
One-to-one Meetings ►

Hilton Union Square
333 O’Farrell Street
Level 2, Ballroom

8:00–9:00 am

Digital Health Showcase State of the Industry Report

8:00 am–12:00 pm

Company Presentations ►

Private Biotech
Public Biotech

10:00–11:00 am

Digital Health Showcase Workshop

11:00–11:45 am

11:45 am–12:15 pm

Digital Health Showcase Discussion

12:00–1:30 pm

Lunch Plenary

1:00–1:45 pm

Digital Health Showcase Workshop

4:00–5:00 pm

Digital Health Showcase Workshop

1:45–5:00 pm

Company Presentations ►

Private Biotech
Public Biotech

5:00–6:00 pm

Level 4, Cyril Magnin Foyer
Closing Reception



About Biotech Showcase™ 2016

Previous conferences ►

Biotech Showcase™ 2016
January 11–13, 2016, San Francisco

Biotech Showcase™ 2015 Highlights

  • 232 company presentations
  • 2,100 attendees
  • 1,276 companies
  • 37 countries represented
  • 4,277 one-to-one meetings
  • 14 workshops and panels

Photos of Biotech Showcase 2015 ►

Biotech Showcase™ is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and potential strategics in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week which is widely viewed as setting the tone for the coming year.

Now in its eighth year, this rapidly growing conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings.

Biotech Showcase delegates include investors in private and public companies, sector analysts, bankers and industry professionals, as well as biopharmaceutical and life science company executives.

Biotech Showcase is produced by Demy Colton Life Science Advisors and EBD Group. Both organizations have a long history of producing high quality programs that support the biotechnology and broader life sciences industry.

Biotech Showcase™ 2016 Press Releases

J.P. Morgan 34th Annual Healthcare Conference


January 11, 2016 – January 14, 2016 (all-day)


San Francisco, CA, USA

Conference AGENDA 




Whether you’re a conference veteran or a rookie, we hope this light-hearted guide helps you survive the week of life science mayhem in San Fransisco. At Chempetitive Group, we have a deep passion for everything life science—its people, its processes and its promise for the future. As life science marketers, this passion takes us to the industry’s biggest events every year, including the J.P. Morgan Healthcare Conference and related conferences each January. Over the years, we’ve learned our way around San Francisco’s Union Square—places we like to frequent.


January 11-14 San Francisco RAMP UP

Over 12,000 attendees

Over 15,000 meetings

Over 1,500 companies presenting

Over 40 countries represented Projected value of this year’s deals: unlimited

Surviving the J.P. Morgan Healthcare Conference [Plus Insider’s Guide]


Each January, the J.P. Morgan Healthcare Conference – perhaps the life science industry’s largest and most frenzied conference of the year – reliably draws thousands of investors and executives across the healthcare sector to San Francisco’s Union Square neighborhood as hundreds of companies present their latest innovations and dreams in an attempt to pique the interest of venture capitalists and potential partners. In addition to J.P. Morgan, parallel events Biotech Showcase, OneMedForum and RESI Conference ensure that there is a high density of biotech brainpower and capital in the City by the Bay.

The conference week is a mix of long days of presentations and lively evenings of cocktail parties and networking events. With more than 50 networking receptions, days of sessions, and still a volume of work to manage while away from the office, you might need some guidance on where to take your client or potential partner for a meeting, where to refuel or caffeinate, or simply where to hide from the chaos. For these reasons, we decided to let you into our world by creating this simple guide to surviving the 2016 J.P. Morgan Healthcare Conference week.

Download it and, if you happen to find yourself in one of our favorite spots, let us know with a direct message on Twitter at @chempetitive. Safe travels, have fun, and get some deals done.

JP Morgan 2016 Healthcare Conference Participants

The following organizations have released announcements of their participation in the 34th Annual JP Morgan Healthcare Conference:



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TSUNAMI in HealthCare under the New Name

Curator: Aviva Lev-Ari, PhD, RN


UPDATED on 6/8/2016

The Tricorder project was announced only 3 months after Google entered the life sciences field, according to the report, and came from the same incubator which rolled out the company’s self-driving car and recently cancelled Google Glass.

Verily CEO Andrew Conrad said the scientific basis for the device was proven upon unveiling in 2014, but experts have presented conflicting views on the reality of such a device, STAT Newsreports.

“What (Verily is) really good at is physical measurements — things like temperature, pulse rate, activity level. They are not particularly good at … the chemical and the biological stuff,” Walt toldSTAT news.

Four former Verily employees said the Tricorder “has been seen internally more as a way to generate buzz than as a viable project,” according to the report.



UPDATED on 4/16/2016


Verily, Alphabet’s medical business, is profitable, Sergey Brin tells Googlers


Verily | YouTube


Publicly, Alphabet has said very little about its assortment of companies not named Google.

But internally, Alphabet is a little more forthcoming.

As we reported earlier, Nest CEO Tony Fadell appeared before Google’s all-hands meeting two weeks ago to address recent criticism of his company. During that meeting, Google co-founder and Alphabet exec Sergey Brin also defended another company under the holding conglomerate: Verily, the medical tech unit previously called Google Life Sciences.

Lumped together, Alphabet’s moonshots aren’t making money yet — but Verily is, Brin said.

Verily was the target of a scathing article — in Stat, a medical publication from the Boston Globe — scrutinizing its CEO, Andy Conrad. Several former employees told Stat that Verily suffered a talent exodus due to “derisive and impulsive” leadership by Conrad.

Here’s what Brin said in response at Google’s TGIF meeting:

I have seen a smattering of articles. And, you know, it’s actually sad to see sometimes where it appeared that … former employees or soon-to-be former employees talked to the press. But, anyhow, I can tell you what’s going on with these companies, fortunately. So in Verily’s case, despite a handful of examples, their attrition rate is below Google’s and Alphabet’s as a whole. And also, there are articles that have generally said we are blowing a lot of money and so forth. It’s true that, you know, as whole our Other Bets are not yet profitable, but some of them are, including Verily on a cash basis and increasingly so. So we’re pretty excited about these efforts.

Verily makes money through

  • partnerships with pharmaceutical companies — such as Novartis, which is licensing and planning to sell Verily’s smart contact lens — and
  • medical institutions.

It is one of three units contributing to the Other Bets total revenue ($448 million) in 2015, along with

  • Google Fiber and
  • Nest.

As we reported earlier, Nest likely brought in around $340 million of that and Fiber pulled close to $100 million, meaning that Verily’s sales were somewhere around $10 million. During the year, all the moonshot units combined reported operating losses of $3.6 billion.

Note Brin’s stipulation that Verily’s profit comes on a “cash basis.” That probably means that it’s not making profit on the normal basis, meaning when you take into account total sales minus total costs. But “cash positive” suggests they’re booking sales faster than they’re spending money, which is a positive sign. Companies normally report financials accounting for all costs. And that’s how Alphabet will next week, when it shares first-quarter results for Google and the Other Bets — although we almost certainly won’t see figures on Verily’s profitability.

We reached out to Alphabet and Verily reps for more clarity, but didn’t get any.



Original Curation dated 12/14/2015

  1. Part 1: Verily in Action
  2. Part II: Innovations at a Different Scale: GDE Enterprises – A Case in Point of Healthcare in Focus – Work-in-Progress

12/31/2015 – All time

  1. Following this Journal by e-mail subscription: along with X other amazing people
  4. Top Post and Pages
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Part 1: Verily in Action

They write @

When Google[x] embarked on a project in 2012 to put computing inside a contact lens — an immensely challenging technical problem with an important application to health — we could not have imagined where it would lead us. As a life sciences team within Google[x], we were able to combine the best of our technology heritage with expertise from across many fields. Now, as an independent company, Verily is focused on using technology to better understand health, as well as prevent, detect, and manage disease.

Andy Conrad, Ph.D.

Chief Executive OfficerFormerly the chief scientific officer of LabCorp, Andy is a cell biologist with a doctorate from UCLA. He has always been passionate about early detection and prevention of disease: Andy co-founded the National Genetics Institute, which developed the first cost-effective test to screen for HIV in blood supply.

Brian Otis, Ph.D.

Chief Technical OfficerBrian’s team focuses on end-to-end innovation ranging from integrated circuits to biocompatible materials to sensors. He joined Google[x] as founder of the smart contact lens project and now leads our efforts across all hardware and device projects, including wearables, implanted devices, and technology like Liftware.

Jessica Mega, M.D., MPH

Chief Medical OfficerJessica leads the clinical strategy and research team at Verily. She is a board-certified cardiologist who trained and practiced at Massachusetts General Hospital and Brigham and Women’s Hospital. As a faculty member at Harvard Medical School and a senior investigator with the TIMI Study Group, Jessica directed large, international trials evaluating novel cardiovascular therapies.

Linus Upson

Head of EngineeringA long-time Google software engineer, Linus has been a team lead in developing products that now help billions of people worldwide find the information they need on the Internet, including Chrome and Chrome OS. He now oversees our engineering teams.

Tom Stanis

Head of SoftwareTom spent nine years working on core Google products before joining Google[x] in 2014 to work on the Baseline Study. He now leads all our Software projects, including the development of machine learning algorithms for applications ranging from robotic-assisted surgery to diabetes management.

Vikram (Vik) Bajaj, Ph.D.

Chief Scientific OfficerVik’s broad research interests in industry and as a former academic principal investigator have included structural and systems biology, molecular imaging, nanoscience, and bioinformatics. Vik now leads the Science team in research directions related to our mission.

What are the Dimensions of the Tsumani in Healthcare?

  • prevention,
  • detection,
  • management of disease



  • contact lens with an embedded glucose sensor for measuring the glucose in human tears.


  • multiple sclerosis, for example, combines wearable sensors with traditional clinical tests
  • signals that could lead to new knowledge about the disease and why it progresses differently among individuals.


  • Constituencies industry, hospitals, government, academic centers, medical societies, and patient advocacy groups
  • The Baseline Study is one of these dedicated efforts, a multi-year initiative that aims to identify the traits of a healthy human by closely observing the transition to disease.


  • Understand processes that lead to conditions like cancer, heart disease, and diabetes
  • computational systems biology platforms and life sciences tools
  • bio-molecular nanotechnology for precision diagnostics and therapeutic delivery
  • advanced imaging methods for applications ranging from early diagnosis to surgical robotics.


FOLLOW the LEADER of Parish in the Tsunami


Google[x] searches for ways to boost cancer immunotherapy | Science/AAAS | News


Google Life Sciences and American Heart Association commit $50M to study heart disease | VentureBeat


Google Life Sciences Division Is Now Called… Verily?


WIRED: Google’s Verily Is Spinning Off ‘Verb,’ a Secretive Robot-Surgery Startup

Alphabet’s Verily, née Google Life Sciences, has announced its first spinoff, a brand new robot-assisted surgery company.


Google Life Sciences Rebrands as Verily under Alphabet – Fortune

Vik Bajaj, CSO

Verily, I Swear, Google Life Sciences debuts a New Name



Why biomedical superstars are signing on with Google Tech firm’s ambitious goals and abundant resources attract life scientists.

Erika Check Hayden 21 October 2015






Google Reveals Health-Tracking Wristband

Caroline Chen and Brian Womack

June 23, 2015 — 9:30 AM EDT


Google Moves to the Operating Room in Robotics Deal With J&J



Google, Biogen Seek Reasons for Advance of Multiple Sclerosis

Caroline Chen

January 27, 2015 — 9:00 AM EST


Google’s Newest Search: Cancer Cells

Google X Team Hopes to Develop Nanoparticles to Provide Early Detection of Cancer, Other Diseases


Updated Oct. 29, 2014 11:17 a.m. ET


A Spoon That Shakes To Counteract Hand Tremors

Updated May 14, 201411:43 AM ET



Google’s New Moonshot Project: the Human Body

Baseline Study to Try to Create Picture From the Project’s Findings


Updated July 27, 2014 7:24 p.m. ET


Novartis Joins With Google to Develop Contact Lens That Monitors Blood Sugar



Google[x] searches for ways to boost cancer immunotherapy

Jon Cohen

15 January 2015 6:25 am



Part II: Innovations at a Different Scale: GDE Enterprises

A Case in Point of Healthcare in Focus –




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Transparency in Clinical Trials

Curator: Larry H. Bernstein, MD, FCAP



Does Pharma Really Want Transparency In Clinical Trials?

Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @outsourcedpharm


My recent article on transparency in clinical trials, featuring Dr. Brad Thompson, CEO of Oncolytics, solicited a good number of comments and emails from readers. While most readers agree that more transparency would be good for patients and the industry, there seems to be a lot of disagreement over how it can be achieved, and if it can actually be achieved at all.

To recap, Thompson believes we still have a long way to go, and questioned whether true transparency would ever be achieved. His primary argument noted researchers who want to be published will not put much focus on neutral or negative trials, and even the press releases put out by sponsors include a limited amount of information.

One reader that works for a CRO made the following comment: “Dr. Thompson from Oncolytics made some very interesting comments about investigators holding back information. An investigator will enter patient data into an EDC system that is then verified by monitors. And that is just one of a number of sites. These investigators will generally know when a drug is working and when it is not. As a CRO, I often saw statistical outputs on blinded studies where you could see where the data was trending. Even data guys can tell if a drug is working by the data results and improvements in patients.”

If physicians and researchers are able to see clear results even when the data is still in the process of being collected, then what is the problem with being more transparent? One possible explanation is that once physicians know a drug will not work, they will no longer continue to place patients at risk by having them participate in the trial. This could be done for purely ethical reasons.

But there may also be reluctance to greater transparency on the part of the pharma company. “No drug company truly wants transparency because it leaves the results and outcomes more open to interpretation, mainly by Kaiser, Blue Cross and other groups,” noted another reader.  “Pharma companies could cost themselves a lot of money in sales if they do not have the time to target and position.”

Investors Are A Consideration

There is still another consideration at play. If a study is not going well, would it be to the benefit of the executives of a company to share those results? Let’s play devil’s advocate for a moment and assume you are the CEO of a biotech company. You’re making $500,000 a year with good benefits. You have several investors who have dumped millions of dollars into your company and your product. The study is targeted for four years, but within the first year you see results that indicate your drug is not going to produce the intended results.

“In that scenario, how prone would you be to ending the trial, saving the investors their remaining money, and losing your job?” notes one reader. “Are companies prone or pressured to locate new targets for therapy or identifying reasons to extend the trials, sometimes for a few years or longer?”

All of us have heard discussions about the possibility of electronic medical records (EMRs) someday replacing electronic data capture (EDC). According to one email I received, this will never happen because of the physician issue mentioned above. After all, if patient results were posted in the EMR and every doctor on the network has access to the information, everyone would know if I drug was not having the desired effect. As soon as that happens, promises of riches being delivered to investors will fall by the wayside, and executives will be out of jobs.

“Within big pharma, this is called job preservation,” noted another reader. “If funding for the trial is cut, I am out of a job. At the same time, trial results are not getting any better for patients. Years ago about one in three trials resulted in a successful outcome. Then it went to one in four. Today that success rate is around 15 percent with R&D commitment at about 12% (down from approximately 28%). It appears that the industry is run by money and managed by guys who know how to play the system.  If patients are the primary concern, the industry would target physicians who have the right patients, get enrollment done faster, and quickly identify if the product works as advertised.”

Limit Procedures And Additional Fields

Going back to Thompson’s comments, the problem is not always investigators wanting to get published. One reader noted oftentimes it is the in-house pharma and biotech doctors as well as researchers in academia who are anxious to get their names into publications. “Unfortunately, these are often the same people who include numerous unnecessary procedures in protocols. They will also ask for additional data fields to be included in EDC systems after study launch, which can delay database activity for two months. The reason is they see a hint of something and decide they want to dig deeper, even if the activity has nothing to do with the study results and the overall goal of the trial.”

The obvious fix to this would be executive leadership and study teams standing up and challenging the reason for inclusion of the additional data fields, which cost the industry both time and money. A large number of procedures should be challenged as well, especially if they are not standard of care.

“If a researcher sees a hint of something that seems to be interesting but has nothing to do with the study, they should engage one of the thought leaders to conduct an IIR program to see if the hypothesis is valid,” notes the reader. “They can do this while keeping the clinical program on track to closure without delay, and still appease their interests.”

Clearly, there are no easy solutions. Many pharma companies are certainly making a concerted effort to put the patient first, and I believe those efforts are sincere. But there is no question they must also be focused on funding and trial results – the industry has gone from one focused on a patient to one driven by investors, and that trend is unfortunate. Physicians and researchers will always have their own goals and aspirations, and placing additional burdens upon them could have the unintended consequence of driving them away from trial participation – poor sponsor/CRO pay practices and poorly written/detailed protocols have already moved many physician practices away from clinical trial participation. Coming up with a solution will likely involve bringing together all stakeholders for a more in-depth discussion on the topic, which unfortunately I don’t see happening anytime soon.


Transparency In Clinical Trials: Will It Ever Be Achieved?
Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @outsourcedpharm


A lot has been made recently about transparency in clinical trials. In the EU a new regulation is about to address the issue, and CISCRPrecently sent a petition letter to the FDA asking it to pass a similar regulation in this country. The petition, signed by hundreds of patients, hopes to make trials results more accessible to patients.

It’s also not hard to understand why a patient participating in a trial would want to know the results of the study, and whether or not they received the active drug or a placebo. But while changes might help companies with patient recruitment and retention issues, will true trial transparency ever be possible?

Dr. Brad Thompson, CEO of biotech firm Oncolytics, believes we still have a very long way to go, and that perhaps pharma companies are not the ones that should be blamed. “I think a lot of people, patients especially, believe that companies are the roadblock in keeping the results of clinical studies from becoming public,” he says. “But personally, I believe it is a much wider issue than that, especially when it comes to finding out the results of unsuccessful trials.”

For example, Thompson looks at clinical investigators. He notes many of these individuals would like for their academic careers to progress. For these folks, the reporting of trial results, especially those that are negative or neutral, does nothing to advance their goals. It is not a deliberate action to conceal information, but the lack of an incentive to do so can often result in delays, provided the results are reported at all.

“If you are conducting a trial at 50 or 60 locations, it doesn’t take too many of them not reporting information to significantly slow down the ability of a sponsor to report on what is going on with the study,” notes Thompson. “And the more time that goes by, the more people will lose interest in doing so. Add to that the fact that there are no journals or annual meetings that are focused on reporting negative results. This is due to space and time limitations. If there are 100 speaking opportunities at the ASCO show in June, those spots will be given to people reporting exciting new results in cancer therapies. There is no time for, nor interest in, anyone reporting on therapies that didn’t work.”

From the standpoint of a public sponsor company, they will typically report negative trial results, but that will generally be via a press release, where there is very little detail. It’s also unlikely that a patient participating in a trial will be on the company’s PR distribution list. As a result, there is an entire system set up with no positive incentives to go into more detail about trials that did not go as planned.  That in itself is unfortunate, since we often learn as much from things that don’t work as we do from things that do.

“In many ways, knowing what didn’t work, or what caused a safety problem, can be more important than knowing what did work and knowing there were no safety problems,” adds Thompson. “Knowing of negative results will allow you to improve your own trials and continue to work to try and find something that does work. I think this is a bigger issue than people realize and it is not something that will be easy to address.”

All Requirements Fall On Sponsors

Of course in this entire daisy-chain of events, there is only one party involved that has a legal obligation to disclose positive or negative information on the trial. That is the sponsor company, which by law is required to disclose information about the trial. Failure to report something could result in a criminal offense. If an investigator doesn’t disclose something, they do not face the same negative repercussions.

“If you talk to an attorney from any sponsor company, they will tell you how important it is to disclose, disclose, disclose,” says Thompson. “They fully understand the importance of doing that. The situation might be slightly different in privately-held companies, because public companies have an obligation to their investors. But even then they have a duty of disclosure under the investment terms. More often than not the investors are sitting on your board of directors and would be privy to the information anyway.”

On a positive note, Thompson is quick to note that most companies, investigators, and researchers he knows want to disclose as much as they possibly can.  There are just a number of soft reasons that might end up keeping them from getting into more detail than they do. For example, there is generally the same amount of content going into a press release regardless of whether or not the trial was successful. He notes no one on the planet is going to put out a 30-page press release covering the detail of a clinical study, whether it was good or bad.

For that reason, most of the press releases that go out are seldom more than two pages, with just a few sentences on the results and the safety aspects. While that will meet the disclosure standards, it certainly does not disclose much detail to the investigators or others who wish to know the details.

“When you look closely at this situation, what you see is a system that is almost accidentally set up to inhibit full disclosure,” states Thompson. “The industry might feel it is good to publish negative results, but where would we publish them? Who is going to pay for it? Who is going to read it? It’s a difficult issue. You can try to induce people to do things, but if an investigator has a failed study, his academic career will not be helped by spending the weeks it would take to write a paper to be published. Especially if they can spend that time writing a paper on a study that did work. There is not a conspiracy of silence. It is just natural for people to want to focus on things that will help them out with their careers.”

More Information Benefits Patients

There are other reasons for reporting as much information as possible. Patients appreciate the information, but from the sponsor perspective, more information might mean coming up with better versions of existing medicines. Thompson likes to use bone marrow studies as an example of how more information can be helpful to patients. When physicians first started using radiation to kill off bone marrow for certain types of leukemia patients, that marrow had to be replaced. It was discovered that bone marrow transferred from people who did not match the patient’s tissue type caused them to perform better…but only for a period of time. After that, the patients began to die quicker. Still, researches published the complete findings.

“They could have reported that non-matching bone marrow works really well for six months and left it at that,” says Thompson. “But they opted to include the downside of the study as well. That led physicians to decide it would be used for emergency use only until a better match could be found. That knowledge ended up making these transplants better for the patients and better for the industry. I think in that case we were lucky that there was a positive effect to report along with the negative. If there was only the negative effect, I don’t know that it would have ever been published.”

Is There A Fix?

I wish I could report that there is an easy fix to this transparency issue. Unfortunately, there is not. According to Thompson, there are not a couple of adjustments that can be made to correct the problem.  After all, you cannot force a researcher to publish an article on a failed study if they have more important needs to attend to. You can’t force a company to produce or publish a 30-page press release or, if they did, force anyone to read it. Unfortunately, that is a reality of the industry.

“We need to come up with a mechanism where the end result is of benefit to the industry, such as people having access to needed information and disseminating it without the process being burdensome,” notes Thompson. “I honestly don’t know how you do that.”

There are so many pieces to this problem…the sponsor companies, the FDA, the investigators, the research sites. It is difficult to fix a problem when the players involved in it are so varied. Still, if this is an issue that is too complicated to tackle with all players at once, perhaps the best approach would be to take it one step at a time. If we put sponsors, patients, and investigators in a room together, all would likely be clamoring for the same end result.

“We would not see pockets of stakeholders fighting this,” adds Thompson. “A solution to this transparency problem would make everyone better off. It’s frustrating because everyone knows this is an issue, and that we have to do better. People who are a lot smarter than I am have spent time on this and were not able to come up with an answer.  But the fact that this is a complicated issue doesn’t mean we should throw our hands in the air and give up. Eventually we will have to produce a solution.”


Taking The “Risk” Out Of Risk-Based Monitoring

The clinical trial landscape is continually evolving and with it, efforts in the improvement of participant safety and data integrity. CROs are beginning to transition from on-site monitoring, with 100% point-to-point source data verification, toward a risk-based monitoring (RBM) approach that utilizes source data review and more centralized monitoring techniques better adapted for mitigating risk.

While RBM has gained considerable attention in recent years, reluctance still remains around the approach—from uncertainty arising from the use of “risk” employed in its name to sponsors being wary of potential implications on data quality and regulatory inspection outcomes.

Despite these concerns, there is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% source data verification to ensure subject protection, data integrity, and overall study quality.


Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial



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Huge Data Network Bites into Cancer Genomics

Larry H. Bernstein, MD, FCAP, Curator



Closer to a Cure for Gastrointestinal Cancer

Suzanne Tracy, Editor-in-Chief, Scientific Computing and HPC Source

In order to streamline workflows and keep pace with data-intensive discovery demands, CCS integrated its HPC environment with data capture and analytics capabilities, allowing data to move transparently between research steps, and driving discoveries such as a link between certain viruses and gastrointestinal cancers.


SANTA CLARA, CA — At the University of Miami’s Center for Computational Science (CCS), more than 2,000 internal researchers and a dozen expert collaborators across academic and industry sectors worldwide are working together in workflow management, data management, data mining, decision support, visualization and cloud computing. CCS maintains one of the largest centralized academic cyberinfrastructures in the country, which fuels vital and critical discoveries in Alzheimer’s, Parkinson’s, gastrointestinal cancer, paralysis and climate modeling, as well as marine and atmospheric science research.

In order to streamline workflows and keep pace with data-intensive discovery demands, CCS integrated its high performance computing (HPC) environment with data capture and analytics capabilities, allowing data to move transparently between research steps. To speed scientific discoveries and boost collaboration with researchers around the world, the center deployed high-performance DataDirect Networks (DDN) GS12K scale-out file storage. CCS now relies on GS12K storage to handle bandwidth-driven workloads while serving very high IOPS demand resulting from intense user interaction, which simplifies data capture and analysis. As a result, the center is able to capture, store and distribute massive amounts of data generated from multiple scientific models running different simulations on 15 Illumina HiSeq sequencers simultaneously on DDN storage. Moreover, number-crunching time for genome mapping and SNP calling has been reduced from 72 to 17 hours.

“DDN enabled us to analyze thousands of samples for the Cancer Genome Atlas, which amounts to nearly a petabyte of data,” explained Dr. Nicholas Tsinoremas, director of the Center for Computational Sciences at the University of Miami. “Having a robust storage platform like DDN is essential to driving discoveries, such as our recent study that revealed a link between certain viruses and gastrointestinal cancers. Previously, we couldn’t have done that level of computation.”

In addition to providing significant storage processing power to meet both high I/O and interactive processing requirements, CCS needed a flexible file system that could support large parallel and short serial jobs. The center also needed to address “data in flight” challenges that result from major data surges during analysis, and which often cause a 10x spike in storage. The system’s performance for genomics assembly, alignment and mapping is enabling CCS to support all its application needs, including the use of BWA and Bowtie for initial mapping, as well as SamTools and GATK for variant analysis and SNP calling.

“Our arrangement is to share data or make it available to anyone asking, anywhere in the world,” added Tsinoremas. “Now, we have the storage versatility to attract researchers from both within and outside the HPC community … we’re well-positioned to generate, analyze and integrate all types of research data to drive major scientific discoveries and breakthroughs.”

About DDN

DataDirect Networks is a big data storage supplier to data-intensive, global organizations. For more than 15 years, the company has designed, developed, deployed and optimized systems, software and solutions that enable enterprises, service providers, universities and government agencies to generate more value and to accelerate time to insight from their data and information, on premise and in the cloud. Organizations leverage DDN technology and the technical expertise of its team to capture, store, process, analyze, collaborate and distribute data, information and content at largest scale in the most efficient, reliable and cost effective manner. DDN customers include financial services firms and banks, healthcare and life science organizations, manufacturing and energy companies, government and research facilities, and web and cloud service providers.


“Where DDN really stood out is in the ability to adapt to whatever we would need. We have both IOPS-centric storage and the deep, slower I/O pool at full bandwidth. No one else could do that.”

Joel P. Zysman

Director of High Performance Computing

Center for Computational Science at the University of Miami

The University of Miami maintains one of the largest centralized, academic, cyber infrastructures in the US, which is integral to addressing and solving major scientific challenges. At its Center for Computational Science (CCS), more than 2,000 researchers, faculty, staff and students across multiple disciplines collaborate on diverse and interdisciplinary projects requiring HPC resources.

With 50% of the center’s users come from University of Miami’s Miller School of Medicine with ongoing projects at the Hussman Institute for Human Genomics, the explosion of next-generation sequencing has had a major impact on compute and storage demands. At CCS, the heavy I/O required to create four billion reads from one genome in a couple of days only intensifies when the data from the reads needs to be managed and analyzed

Aside from providing sufficient storage power to meet both high I/O and interactive processing demands, CCS needed a powerful file system that was flexible enough to handle very large parallel jobs as well as smaller, shorter serial jobs. CCS also needed to address as much as 10X spikes in storage, so it was critical to scale and support petabytes of machine-generated data without adding a layer of complexity or creating inefficiencies.

Read their success story to learn how high-performance DDN® Storage I/O has helped the University of Miami:

  • Establish links between certain viruses and gastrointestinal cancers discovered with computation that were not possible before
  • Reduce genomics compute and analysis time from 72 to 17 hours

  • Diverse, interdisciplinary research projects required massive compute and storage power as well as integrated data lifecycle movement and management
  • Highly demanding I/O and heavy interactivity requirements from next-gen sequencing intensified data generation, analysis and management
  • Handle large parallel jobs and smaller, shorter serial jobs
  • Data surges during analysis created “data-in-flight” challenges


An end-to-end, high performance DDN GRIDScaler® solution featuring a GS12K™ scale-out appliance with an embedded IBM® GPFS™ parallel file system


  • Centralized storage with an embedded file system makes it easy to add storage where needed—in the high-performance, high-transaction or slower storage pools—and then manage it all through a single pane of glass
  • DDN’s transparent data movement enables using one platform for data capture, download, analysis and retention
  • The ability to maintain an active archive of storage lets the center accommodate different types of analytics with varied I/O needs

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Point of Care Diagnostics

Larry H. Bernstein, MD, FCAP, Curator



Point-of-Care Diagnostics—An Expanding Field Driven by Technology Development 

Impact of Various Disease Classes on the Development of POC Diagnostics

Gary Oosta, Ph.D.Enal Razvi, Ph.D.

Point-of-Care Diagnostics—An Expanding Field Driven by Technology Development

Figure 1. POC diagnostics word cloud

  • There is growing interest in the point-of-care (POC) diagnostics field as the space is expanding and evolving from pure technology development to applications development in various settings. We sought to understand the dynamics of the point-of-care diagnostics field by examining the entire ensemble of publications in this space and analyzing trends from the bottom-up.

  • Click Image To Enlarge +
    Figure 2. POC diagnostics is a global field.

    We harvested and analyzed 14,046 publications from the academic literature where the search terms were “point-of-care” in the titles and/or abstracts of the publications.  Figure 1 presents a word cloud that shows a pictorial representation of the abundance of various terms within this space as a means to illustrate the dataset which we harvested.  Most of the data was collected in 2015 and therefore it represents the current scenario of the field.

    We subsequently sought to understand the nature of the POC diagnostics field by examining the geographic source of these publications—is this a concentrated marketplace or is it truly global in nature, vis-à-vis research and publications in this field.  Figure 2 presents the geographic breakout and this clearly shows that POC diagnostics is a global field.

  • Click Image To Enlarge +
    Figure 3. Growth of publications in the POC diagnostics space.

    The U.S. dominates publications in this space with 39% of total but it’s important to note the breakout is truly global in nature and attests to the fragmented nature of research in this field.

    We also sought to understand the pace of growth of this field—if the hypothesis is that the POC diagnostics field is expanding we should observe a steep climb in the growth of publications—Figure 3 presents this data, which shows a clear expanding space and this begs the question as to where the growth in the field is coming from. To address this question, we examined the compound annual growth rates (CAGRs) of the various segments of the broader POC diagnostics space and this data (not presented in this article) suggest that specific segments of the POC space are outperforming the growth of the broader POC diagnostics space and there are opportunities for applications development in these particular spaces.

  • Click Image To Enlarge +
    Figure 4. Cardiovascular disease classes are an important component of the POC space.

    Infectious diseases are a strong theme in the overall POC diagnostics field and estimates suggest that infectious diseases account for 70% of the overall POC diagnostics marketplace.  Our industry research however also suggests that the oncology space is experiencing growth in the POC diagnostics arena and this suggests to us that the technology development taking place in POC diagnostics is starting to branch out and impact other market segments.  Another space we investigated as part of our industry analyses was the impact of POC diagnostics into the cardiovascular diseases space.  Figure 4 presents the publications landscape of POC diagnostics impacting various cardiovascular disease classes.

  • Click Image To Enlarge +
    Figure 5. In POC, specific biomarkers are an almost unexplored space.

    Even though POC diagnostics seeks to interrogate biological marker[s], the specific biomarker[s] that are implicated in POC diagnostics are generally not well characterized and indeed studies of biomarkers do not crossover into POC diagnostics.  We interpret this data to mean that the majority of the efforts in the POC diagnostics field are focused on technology development, approaches for deployment into the point-of-need setting rather than the molecular characterization of the biomarkers that are the underlying molecular entities associating the readout with the biological phenotype studied. This is especially true in the cancer biomarkers space where there is an extensive body of literature where specific biomarkers or signatures thereof are associated either as prognostic or diagnostic biomarkers with specific pathological states—such levels of association are not observed in the POC diagnostics field.  This will evolve over time and such molecular associations of the lesions will be described.  Figure 5 presents the publications landscape of specific biomarkers that have been described thus far in the POC diagnostics space.

  • Click Image To Enlarge +
    Figure 6a. In the POC space, the penetrance of cancer is growing, albeit small currently.

    POC diagnostics are suited ideally for high-impact diseases for which quick time to diagnosis and treatments are crucial, cardiovascular diseases for example as well as infectious disease where time to diagnosis is a key determinant of the therapeutic regimen that is deployed.  The broader cancer space impact on POC diagnostics is small at the present time, but growing.  We believe that the impact of minimally invasive diagnostics such as biofluid/liquid biopsies will increase the penetrance and impact of POC diagnostics into the cancer diagnostics space.

    The impact of molecular diagnostics tools onto the POC diagnostics space is expanding, and we believe that this trend will drive the interrogation of specific molecular species [biomarkers] in the POC context.  In this vein, we have noted that the penetrance of PCR amplification in POC diagnostics is growing suggesting the potential move of molecular testing, MDx, precision medicine into the POC diagnostics space.  We will continue to monitor this trend closely as the impact of nucleic acid analyses into POC diagnostics is an important theme and will enable precision medicine at the molecular level in the point-of-need setting.

    Earlier in this article, we alluded to the observation that in the point-of-care diagnostics setting cancer is currently a small contributor but is a growing space—Figure 6a illustrates this trend.

  • Click Image To Enlarge +
    Figure 6b. Segmentation of cancer classes by penetrance by POC diagnostics.

    We have further characterized this market segment and found that specific cancers are represented to various degrees—breast cancer is the most penetrant.  Figure 6bbreaks-down the various cancer classes vis-à-vis their penetrance into the POC diagnostics space and the trends observed are very interesting as they reflect on clinical practices in cancer screening as well as early diagnostics testing.  We seek to analyze this trend over the coming year to observe shifts in cancer POC diagnostics with the mounting interest in the liquid biopsy space—liquid biopsy can be viewed as a POC diagnostic since it is minimally invasive and can be performed in out-patient settings—a hallmark of the POC diagnostics space.

  • In summary, we have framed the current landscape of POC diagnostics, seeking to bring together various disease classes and describing their impact on the overall POC diagnostics field.  We continue to monitor this space as it evolves and is impacted by other fields, such as liquid biopsies, which will affect the character and dynamics of this space. We believe that not only will new technologies (such as microfluidics) drive the POC diagnostics field forward in resource-rich and resource-limited settings but also the impact of new biomarkers and biomarker classes will drive the field forward as more precise tailored-medicine becomes the norm in clinical practice.  Therefore even though currently POC diagnostics is deployed for high-impact diseases, the trend is moving toward its utilization in many niches of clinical unmet need.

  • Click Image To Enlarge +

    At the 2nd Annual Biofluid Biopsies and High Value Diagnostics 2015 conference Select Biosciences brings together academic researchers, industry researchers, as well as biotechnology and pharmaceutical companies to explore the expanding and evolving field whereby Circulating Biomarkers of various classes are being evaluated for their potential to be developed into diagnostics for cancer as well as other disease classes.



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The Pharmaceutical Consulting Consortium International (PCCI) June Meeting: Envisage-Wistar Partnership and Immunacel LLC

An early stage healthcare venture creation and management firm

Presenter: Vic Subbu, COO of Immunacel & Managing Partner of Envisage and Heather Steinman, VP of Business Development & Executive Director Tech Transfer Wistar Institute

Monday, June 8, 2015

Embassy Suites, Chesterbrook, Pennsylvania (directions)

Announcement from the PCCI website:

Much has been said lately about how to improve the tech transfer situation. Wistar is meeting this challenge. Immunacel is the first of a series of developmental challenges and the Envisage-Wistar partnership solution becomes the meat of the evening’s discussion.

The Wistar Institute is the nation’s first independent institution devoted to medical research and training. The Wistar Institute has evolved from its beginnings as an anatomical teaching museum to its present-day status as an international leader in basic biomedical research.

Envisage LLC is an early stage healthcare venture creation and management firm. By focusing on key healthcare segments, Envisage aims to identify and advance promising healthcare innovations into value-add ventures.

IMMUNACCEL LLC is a Wistar Institute spin-out focused on accelerating the development of immune-mediated treatments for cancer and other unmet medical needs:

MMUNACCEL’s 3-D cancer-immune cell organotypic culture system is a physiologically relevant culture system utilizing primary human cancer cells and cytotoxic T cells (CTL) generated from patient T-cells, amongst fibroblasts and collagen assembled in a 3-D organotypic model.

Other related articles on PCCI and Philadelphia Biotech were published in this Open Access Online Scientific Journal, include the following:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy

The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC

The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC

The Bioscience Crowdfunding Environment: The Bigger Better VC?

R&D Alliances between Big Pharma and Academic Research Centers: Pharma’s Realization that Internal R&D Groups alone aren’t enough

BIO Partnering: Intersection of Academic and Industry: BIO INTERNATIONAL CONVENTION June 23-26, 2014 | San Diego, CA

Diagnostics and Biomarkers: Novel Genomics Industry Trends vs Present Market Conditions and Historical Scientific Leaders Memoirs

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