Unlock the Key to Advancing Immuno-Oncology

As innovations and discoveries in cancer immunotherapies progress at lightning speed, it is critical to understand the successes and challenges with current immunotherapies to separate the hype from the real opportunities. IBC's Immuno-Oncology event develops tactics for improving the efficacy and response rates with first generation immunotherapies and builds a strategy for utilizing combination therapies, t-cell therapies, and checkpoint inhibitors to propel the next wave of cancer immunotherapies.

Download the Immuno-Oncology brochure now to create your pathway for an answer to cancer: http://bit.ly/1O6tbIZ

Immuno-Oncology

Advancing the Next Generation of Cancer Immunotherapies

September 30 – October 1, 2015

Hilton Alexandria Mark Center, Alexandria, VA

Register today and explore the latest advances in Immuno-Oncology to:

Develop next generation immunotherapies by understanding recent advances made with CAR-T and T-Cell therapies, checkpoint inhibitors, cancer vaccines, and agnostic antibodies

Create a successful combination therapy strategy by gaining insights from global leaders on effective combinations

Optimize the discovery and development of your promising immunotherapies by hearing best practices and lessons learned from the first wave of cancer immunotherapies

Download the brochure for full program details: http://bit.ly/1O6tbIZ

Reserve your seat now. Use code IMMUNO15BL to get $100 off the current rate. Register today: http://bit.ly/1O6tbIZ

Best,

The Immuno-Oncology Team 2015

@ibcusa

#Immuno15

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This Week in BioPharma: 7/5-7/10 - $80 million dollars in pharma packaging and more

Med device manufacturers are being pushed toward taking partial responsibilities for faulty products alongside with insurers and U.S. hospitals. In the competitive environment, often pressed by insufficient demand, suppliers slowly move toward taking a risk and providing additional guaranties to gain an edge on the marketplace. Reuters, UK reports that in recent years there were billions of dollars paid to settle court claims of unsatisfied and at times unable to covers additional costs of treatment customers. The emerging trend is pushing medical device makers to not just cover the cost of broken or defective parts but to become accountable for health outcomes.

Vaccine products are said to reach $40 billion in sales by 2020. According to a recent report by the Tufts Center for the Study of Drug Development this number has tripled comparing to 2005. Research and development of vaccine products are on the rise. It is explained by many factors include the healthcare system and reluctance of healthcare providers to deliver long-term care for patients as well as continuous advances in cancer treatment research. The "Vaccine products in the R&D pipeline have more than tripled since 2005" report also suggests that while vaccine product makers are in the development phase at full speed, one of the obstacles they may face is distrust that consumers express toward vaccination as a general trend.

The packaging market in pharmaceutical industry in projected to reach $80 million dollars in value by 2020. Packaging of pharma products aims to protect the products from external influence, extend it shelf-life as well as cover all legal aspects. The pharmaceutical packaging market is rapidly growing due to steady progress in drug and vaccine development, and therefore the need of appropriate up-to-date packaging that responds to ever-changing demands of capricious consumers persists.

Not true they say, that biotech industry belongs to the West Coast - a biotech company from NY (Albany) was awarded more than $1 million in grants from the National Institutes of Health and the National Science Foundation. HocusLocus is focusing its attention on developing a cure against HIV and Ebola through the "switchable" mechanism that allows to switch from one gene to another one potentially killing cancer cells and viruses.


About the author: Ksenia Newton, a Digital Marketing Assistant at IIR USA, Pharma Division, who works on various aspects of the industry including social media, marketing analysis and media. She can be reached at knewton@iirusa.com

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This Week in BioPharma: 6/22-6/26

Here is the top news from the biopharmaceutical industry this week:

Organic Industry Wants Biotechnology Regulated By Process, Not Product: About 40 activist organizations that usually can be counted upon to rally with the organic industry against genetically engineered (GE) plants and animals weighed in with a letter to USDA’s Animal and Plant Health Inspection Service (APHIS) for the federal regulation of biotechnology products. Monday’s letter, which included some food company signatures as well as those from organizations, called for APHIS to “regulate biotechnology based process, not product.” The letter also called for adding noxious weeds to biotechnology regulations, which the signers want regulated to the “fullest extent.”

Saudi Engineer Invents Unique Biotechnology: Saudi engineer and inventor Ibrahim Alalim has 

come up with a new biotechnology to break down the composition of any animal fat, crude oil or any petrochemical product. “This biotechnology involves a liquid extract from vegetables that could be instrumental in coming up with products that will be useful in cleaning utensils, floors and marble,” Alalim said.

These are the Fortune 500's Fastest-Growing Pharma Companies: The pharmaceutical industry has been rocked in recent years by a confluence of patent expirations of blockbuster drugs, increasing competition from generics and new governmental and industry efforts to control costs the world over. That’s made growth prospects for many pharma companies a risky and uncertain proposition. 

The Importance of Real-World Data to the Pharma Industry: For years, randomized controlled trials (RCTs) were considered the gold standard for generating clinical data on efficacy and safety to support product registration and subsequent prescribing. Recently, analysts and academics have discussed the promise of real-world data (RWD), signalling its potential to contribute to improved health outcomes. Data's role in normal clinical practices, or in settings that reflect the reality of healthcare delivery, is likely to become increasingly important in ensuring that medicines are accepted by national policymakers and are adopted into practice.

Is the FDA Too Tough on Medical Device Makers?: In a new paper, “Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices,” Wharton health care management professors Matthew Grennan and Robert Town shed light on the question: Are the FDA’s medical device regulations too hard, too soft, or just right? Town recently sat down with Knowledge@Wharton to discuss their findings.

House Ignores Veto Threat and Backs Repeal of Medical Device Tax: The House on Thursday easily backed repeal of a tax on the medical device industry. But President Obama has threatened to veto the bill, which would add more than $24 billion to the deficit over the next 10 years. With not all House members voting Thursday, that chamber's 280-140 vote fell one vote shy of a veto-proof majority to repeal the tax, which helps pay for the expansion of health insurance under the 2010 Affordable Care Act.

Short Sellers Become More Focused on Big Pharma: The short interest data has been released for the June 15 settlement date. Pharmaceutical companies are usually involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside.

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This Week in BioPharma: 6/8-6/12

Top news from the biopharmaceutical industry this week:

In the future, treatments tailored to patients: Cambridge biotechs such as Genzyme Corp. and Alnylam Pharmaceuticals Inc. are developing personalized treatments for rare genetic disorders like Gaucher and Fabry disease. Vertex Pharmaceuticals Inc. of Boston is turning out a portfolio of medicines that attack the life-threatening lung disease cystic fibrosis by targeting specific genetic mutations.

Getting to the red zone in biopharma R&D: For some time after the FDA put its new breakthrough therapy designation together for the industry, there was a good deal of back and forth among industry analysts over whether the BTD would make much of a difference. You don't hear much of that kind of carping much these days, and a new report from EP Vantage illustrates why.

Study: biopharma innovation outpaces tech overall: Innovation in the biotech and pharmaceutical industries outpaced the combined activity of 12 technology sectors between 2009 and last year, according to a report released today by Thomson Reuters.

The 25 most influential people in biopharma in 2015: A lot of people make news in the biopharma business. Few of them are influential. Influence, simply put, is the ability to make your mark in such a way as to get other prominent people in this business to rethink the way they do business.

Alder Biopharmaceuticals' new drug promises migraine relief:  Shares of clinical-stage biopharmaceutical company Alder Biopharmaceuticals Inc. are up more than 100 percent from the lows they made in late April this year and are currently trading near their all-time highs.One of the main reasons for this surge has been the promising data released by company last month for its migraine treatment drug.

Cancer clinical trials expert to assist Regen BioPharma, Inc. in addressing FDA questions: The goals  of the collaboration is to  address  questions  posed by the FDA regarding  Regn BioPharma, Inc.'s planned  Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer and to modify the existing Investigational New Drug application in order to maximize the probability  of clinical trial success.

Merck Millipore develops compaction technology for biopharma: Merck Millipore, the life science business of Germany-based Merck, has developed a new technology that compacts dry powder cell culture media into granules, accelerating solubility and improving flowability and handling. The compacted media are, therefore, more convenient to use, allowing biopharmaceutical manufacturers to further optimize their upstream processes.

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Last Chance to Save Up To $550 off Immuno-Oncology

As research in cancer immunotherapies continues to rapidly evolve, it is critical to separate the real opportunities from the hype. There has been great progress with checkpoint inhibitors, CAR-T and T-Cell therapies, cancer vaccines, agnostic antibodies, and combination therapies.

IBC's Immuno-Oncology provides the critical insights and strategies you need to improve response rates, efficacy, and get closer to a cure!

Download the full agenda for complete session and speaker information here:

Immuno-Oncology

Advancing the Next Generation of Cancer Immunotherapies

September 30 – October 1, 2015

Hilton Alexandria Mark Center, Alexandria, VA

Visit the website for more details: http://bit.ly/1A4NPY2

Don't miss out on maximum savings for IBC's Immuno-Oncology!

Register by May 15 to Save up to $550 off the standard rates: http://bit.ly/1A4NPY2

Register today and explore the latest advances in Immuno-Oncology to:

-          Design next generation immunotherapies by understanding recent advances made with CAR-T and T-Cell therapies, checkpoint inhibitors, cancer vaccines, and agnostic antibodies

-          Develop a successful combination therapy strategy by gaining insights from global leaders on effective combinations

-          Improve the discovery and development of your promising immunotherapies by hearing best practices and lessons learned from the first wave of cancer immunotherapies

Best,

The Immuno-Oncology Team 2015

@ibcusa

facebook.com/ibclifesciences

www.ibclifesciences.com/ImmunoOncology

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Should the FDA be sharing more about clinical trials?

According to the LA Times, the FDA could be providing more information about approved drugs with doctors and the public. While most of the information doctors use to prescribe medicine and information patients use to learn about the medicine, there's a lot of information that is left out about the drugs. The article points out a few cases in which the FDA doesn't share some of the road bumps that occurred in Phase III clinical trials, such as the drug being ineffective in some of the population.

What do you think? I think that the FDA should share all of the information they possibly can on a drug, and how the drug was accepted by different people's systems. If a drug barley passed the FDA approval, they should be required to share that too, as it could help doctors when prescribing it to individuals. Read the full article here.

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How to rescue a clinical trial

At ClinPage, they recently posted an article about the keys to resuming a clinical trial if you've taken over it midway through the process. So what should you do if you're asked to resume a project after everything's been started?

They suggest:
1) Assess and plan
2) No rushing
3) Create trust
4) Initial Visits
5) Ongoing oversight

For an in-depth look at the steps, read the article here.

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