In clinical trials, for-profit review boards are taking over for hospitals. Should they?

http://bit.ly/29hCoA8

http://www.onclive.com/web-exclusives/emerging-immunotherapy-target-in-spotlight-at-wistar

http://www.onclive.com/web-exclusives/emerging-immunotherapy-target-in-spotlight-at-wistar

Pasadena CR2 9:00 AM Wednesday 5/4

case starts at 2:05:14

New Scientist Jobs
Associate Director, Medi 4736


Employer AstraZeneca US
Location USA
Posted Sep 15, 2015
Closes Oct 13, 2015
Ref 15-ADIMMUNO
Result Type Jobs
Discipline Operations, Marketing
Position Type Permanent
Hours Full Time
Share
Apply
Role Description:
The Brand Strategy Associate Director, Medi-4736 will be accountable for leading the definition, design, execution and measurement of US brand strategy across both HCP & Patient segments for Medi-4736, AZ's first biologics launch in oncology. The role will require strong collaboration across brand and portfolio peers within the Lung Cancer Franchise team as well as Sales, Commercial Operations, Managed Markets, Diagnostics, and Alliance and Advocacy teams in order to deliver an integrated product launch plan. This position will report directly into the Brand Strategy Director, I-O Portfolio.

This position is based at our Gaithersburg, MD campus, headquarters for our US Oncology and other Specialty Care businesses as well as the US Commercial Center for multiple Therapeutic Areas of our Global Product and Portfolio Strategy businesses.

Major Responsibilities:
* Responsible for leading the following key work: marketing strategies (PSP), brand positioning, core messaging and campaign, sales integration, and ROI analysis
* Partners with the Brand Insight Director on the planning of all insight work (primary and secondary research, database management, ROI measurements, etc.)
* Works closely with portfolio marketing team to ensure successful implementation of Medi-4736 product strategy and achievement of channel goals
* Primary daily lead with sales teams to monitor performance, ensure message pull through and uncover opportunities and issues in execution.
* Partners with Managed Markets to produce a value story and pricing model.
* Collaborate with other functional areas to ensure promotional planning is consistent with legal/regulatory compliance
* Participates in development of training for field/customer service personnel on brand information
* Lead partnership efforts with Global Brand Team to share learning's, initiatives and also incorporate insights from other marketing companies and global initiatives

Requirements
THIS REQ IS FOR FUTURE OPENINGS ONLY

Minimum Requirements:
Bachelor's Degree in relevant field
7 years of pharmaceutical or Healthcare; preferrably related experience
3 years Brand Management experience
Experience in working collaboratively, thinking strategically, complex project management
Experience developing a strategy and executing on that strategy
Preferred Requirements:
MBA in relevant field
Experience in other commercial roles such as Managed Markets, Market Research, and Sales
Pharmaceuticals launch experience
Oncology and/or specialty care biologics experience

06/22/2015 MINUTES OF Motion Hearing held before Judge Jesus G. Bernal RE: MOTION for Partial Summary Judgment as to the First Amended Complaint 82 . For the reasons stated above, the Court GRANTS Defendant CSMs second Motion for Partial Summary Judgment. (See document for specifics.) Court Reporter: Adele C. Frazier. (iva)

http://www.news-medical.net/news/20150530/Inhibitors-BGB324-and-BGB10C9-show-promise-in-multiple-murine-models-of-pancreatic-cancer.aspx

Use of Autoantigen-Loaded Phosphatidylserine-Liposomes to Arrest Autoimmunity in Type 1 Diabetes. http://www.ncbi.nlm.nih.gov/pubmed/26039878?dopt=Abstract

Imaging and Therapy of Pancreatic Cancer with Phosphatidylserine-Targeted Nanovesicles. http://www.ncbi.nlm.nih.gov/pubmed/26055177?dopt=Abstract

Necrotic Cells Actively Attract Phagocytes through the Collaborative Action of Two Distinct PS-Exposure Mechanisms. http://www.ncbi.nlm.nih.gov/pubmed/26061275?dopt=Abstract

Unquenchable Surface Potential Dramatically Enhances Cu(2+) Binding to Phosphatidylserine Lipids. http://www.ncbi.nlm.nih.gov/pubmed/26065920?dopt=Abstract

FDA Approves First Immunotherapy for Children With Cancer

http://blog.aacr.org/fda-approval-dinutuximab/

Non-small cell lung cancer (NSCLC) is characterized by dramatic changes in phospholipid profiles.

Marien E1, Meister M, Muley T, Fieuws S, Bordel S, Derua R, Spraggins J, Van de Plas R, Dehairs J, Wouters J, Bagadi M, Dienemann H, Thomas M, Schnabel PA, Caprioli RM, Waelkens E, Swinnen JV.



Author information



Abstract

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death globally. In order to develop better diagnostics and more effective treatments, research in the past decades has focused on identification of molecular changes in the genome, transcriptome, proteome, and more recently also the metabolome. Phospholipids, which nevertheless play a central role in cell functioning, remain poorly explored. Here, using a mass spectrometry (MS)-based phospholipidomics approach, we profiled 179 phospholipid species in malignant and matched non-malignant lung tissue of 162 NSCLC patients (73 in a discovery cohort and 89 in a validation cohort). We identified 91 phospholipid species that were differentially expressed in cancer versus non-malignant tissues. Most prominent changes included a decrease in sphingomyelins (SMs) and an increase in specific phosphatidylinositols (PIs). Also a decrease in multiple phosphatidylserines (PSs) was observed, along with an increase in several phosphatidylethanolamine (PE) and phosphatidylcholine (PC) species, particularly those with 40 or 42 carbon atoms in both fatty acyl chains together. 2D-imaging MS of the most differentially expressed phospholipids confirmed their differential abundance in cancer cells. We identified lipid markers that can discriminate tumor versus normal tissue and different NSCLC subtypes with an AUC (area under the ROC curve) of 0.999 and 0.885, respectively. In conclusion, using both shotgun and 2D-imaging lipidomics analysis, we uncovered a hitherto unrecognized alteration in phospholipid profiles in NSCLC. These changes may have important biological implications and may have significant potential for biomarker development.

Curis will be developing small-molecule compounds that can be administered via a pill, rather than nearly all other immune-oncology drugs, which typically must be injected or infused.


http://m.bizjournals.com/boston/blog/bioflash/2015/01/curis-aims-for-anti-cancer-drugs-that-use-the.html?r=full

This board was started to advance discussions regarding company's developing therapies in the immuno space.
this board will serve as a place for exchanging thoughts, ideas and information as seen through the eyes of an honest ambassador. Company vitals good and bad- Science good and incomplete, both positive and skeptical are real discussions, but constant attacks of any company will not be deemed relative.
as most of you will notice, this board was not categorized under Bio for the simple reason of keeping the community hidden. lets keep this a peaceful and painfully honest community.

Enjoy

calico

http://www.utsouthwestern.edu/newsroom/index.html

sugarcone biotech

http://www.slideshare.net/PaulDRennert/rennert-immunotherapy-and-immunomodulatory-2014

If the belief is that Larry's story will increase awareness of bavi, (in the same way PP attempted in March) then perhaps the power of exclusion lies here: (if of course there is a power)
http://www.cancerresearch.org/about/scientific-leadership
You'll find virtually every company ever accused of suppressing PP on these pages,

What could possibly be the gain for PP to pull Larry after announcing Rolf in a banner at PP.com?

I agree--at what level of not understanding do you need to achieve to understanding that commenting that you don't understand is unnecessary!

to support bidrite's notion- within 1 minute of that 100 share $1.81 transaction, there were 44 additional transactions!? the 181 shows as an avgprice transaction- really-?

lmao--someone moved their 5k bid from $1.6 to $1.65-one born every minute!

I looked at the book again later in the day yesterday and saw only a small change- someone cancelled 4 or 5K@1.70, but still 20k+@1.50, 20k+@1.60, 100k@1.70
low limit orders can certainly have value, but what pphm needs as much as anything today is the credibility associated with additional analyst coverage and that will only come after sustaining certain pps thresholds.
penny wise-pound foolish!

glta

morning sales log shows that almost every 'market' order is being filled at a fraction below ask. this is primarily due to the nations best average bid being sucked down by old and possibly forgotten low 'limit' orders on the order book. right now there are limit orders for over 100K@1.70- these 'bids' are factored in to nations best average bid and subsequently adversely effecting the upward trend of the share price.
in-short - CANCEL YOUR LOW LIMIT ORDERS

PVCT- halted @8:22- released this statement yet remains halted.

Provectus says FDA declines request for breakthrough destination for PV-10
Provectus Biopharmaceuticals announced it has received notification from the Food and Drug Administration that the data upon which the company based its request for designation of PV-10, the company’s novel investigational drug for solid tumors, as a Breakthrough Therapy for the treatment of patients with locally advanced cutaneous melanoma was insufficient to demonstrate substantial improvement over existing therapies. As a result, the FDA has declined to designate PV-10 as a Breakthrough Therapy at this time. Further data may cause the Agency to revisit this decision at a later date. In the notification letter the FDA stated, “We have reviewed your request and while we have determined that treatment of ‘locally advanced cutaneous melanoma’ meets the criteria for a serious or life-threatening disease or condition, the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Therefore, designation as a Breakthrough Therapy cannot be granted at this time.” Provectus CEO Craig Dees said, “We are carefully weighing the advice of the Agency and will provide an outline of the path forward for melanoma in our poster presentation June 2nd at ASCO. We continue to enroll our currently active protocols examining the effect of PV-10 on tumors of the liver; providing expanded access treatment of cutaneous and subcutaneous tumors; and probing the immunologic mechanism of action resulting from tumor ablation with PV-10. With adequate available capital we are in a strong position to execute the necessary steps to bring PV-10 to market for solid tumors and continue development of PH-10 for dermatologic indications...Given that only about one third of requests are granted, and no intralesional drugs have received designation, we fully understand the regulatory challenges these types of drugs face. This effort, while not initially successful, will benefit the company in pursuing available approaches for approval of PV-10." The management of Provectus Biopharmaceuticals will host a conference call today at 4 pm Eastern today.

BlackRock Institutional Trust Company, N.A.

http://www.sec.gov/Archives/edgar/data/913414/000108636414002323/xslForm13F_X01/form13fInfoTable.xml

mornings numbers show blackrock ownership spread across 7 accounts @11.6M or 6.6%
institutional+dart=20.8%

http://tickerreport.com/banking-finance/189971/peregrine-pharmaceuticals-rating-increased-to-outperform-at-zacks-pphm/

Utsw commercial running on CBS

http://www.utswmedicine.org/

New UTSW Commercial just ran during Blue Bloods

http://www.utswmedicine.org/

Enjoy

OT- but think you'll enjoy

http://www.businessinsider.com/whiskey-taxonomy-poster-2014-4

http://wallstreetpr.com/peregrine-pharmaceuticals-nasdaqpphm-up-with-their-inventions-18977

is it possible that PP is 'modifying' the art and that the current application is serving as a 'time stamp' and will be either modified/broadened and/or abandoned in lieu of additional discovery.

pardon the intrusion, but do you have PAIR access?

would it change your buying habits or strategy if:
any company selling at the market shares of stock will have their ticker symbol displayed in blue

So in a nut shell- einhorn is accumulating micron based on a document he received from a book runner that pertained inside information regarding micron, however an outsider got wind of the inside transaction and exposed the inside accumulation to all outsiders prior to the completion of the inside accumulation, therefore negating the potential gains sought by the original accumulator, thus creating a level playing field, whereby it is wholly illogical to expect einhorn to complete his desired accumulation goals as the pps has increased by way of outsiders acting on the very information he received- and that’s just NOT FAIR!

The MLV e-mail from Randy Billhardt that surfaced soliciting the preferred shares also stated as a bullet point that 2 institutional investors were in the final stages of due diligence.

is there a copy of this email posted? if not could you post it

thanks

your mind never stops- good for you!

if the logistics of feeding mayonnaise to the tuna seem insurmountable, switch gears and think Monsanto.

And hang on to your rumor mill---dd tweeted-

Roy Friedman ?@DewDiligence 48m
@matthewherper @adamfeuerstein @MarkSchoenebaum $GILD has enough cash to buy $PPHM at a nice premium and become the leader in IO

here's your daily parody

https://twitter.com/SpaceX/status/443479853845590017/photo/1

and yes its a falcon

this tweet'll give you an idea of 'cliché boys' depth- this is his brilliant stock tip

David Aferiat ?@TradeIdeas 22m
"Single Lane Traffic" http://stks.co/cG0e Look for stocks in a tight channel & pick off the ones who break above or below the consolidation

Racing against calico

http://ieet.org/index.php/IEET/more/konovalenko20140305

http://www.xconomy.com/seattle/2014/03/07/genentech-joins-whats-hot-in-cancer-immunotherapy-apr-22/