Drug Delivery Blog

Intranasal Drug Delivery Developments

noreply@blogger.com (Kate) — Fri, 18 May 2012 21:15:00 +0000

This allergy season, keep an eye on new developments in the intranasal drug delivery world that are rapidly changing, from the drugs offered to how its administered. Researches are saying that drugs administered the intranasal route are not only efficient, but also highly effective. Empirical studies reveal adequate pain relief when drugs are administered intranasally. Several intranasal pain management drugs have been developed fortreating postoperative pain, chronic and acute pains (arthritis), andmigraines.

In addition to treating common ailments, such as nasal congestion, application of intranasal drug administration is expanding to include treatment of allergies,osteoporosis, pain management, vitamin B12 deficiency, smoking cessation,migraines, and nocturnal enuresis. Some are also saying that Bi-directional drug delivery is perhaps the most efficient way to deliver a drug. Bi-directional nasal device offers two major advantages,namely restricting the entry of smaller particles into the lungs, and enabling easy airflow inside the nose. With nasal sprays and inhalers, often times air can either escape or allow unwanted particles in. Bi-directional delivery would help avoid that problem. What do you think about the use of intranasal drug delivery for non-allergy related medication?

Want to learn more about Drug Delivery? The Drug Delivery Partnerships conference will take place February 6-8, 2013 in San Diego, Ca. o view the recap on the 2012 Executive Summary, download it here.

Download the 2012 Drug Delivery Partnerships Executive Summary

noreply@blogger.com (Jennifer) — Tue, 15 May 2012 18:11:00 +0000

Over 350 attendees from 20 different countries descended upon Caesar's Palace in Las Vegas for the 16th Annual Drug Delivery Partnerships to network, learn new partnering strategies and discover novel drug delivery technologies for their drug products. As a valued reader of our blog, we’d like to share with you what happened at the event.

We invite you to download the 2012 DDP Executive Summary.

This summer, we are launching the 2012 DDP Summer Video Series featuring in depth interviews and presentations from today’s drug delivery leaders. Visit www.DrugDeliveryTV.com for a sneak peak!

Save the Date! 17th Annual Drug Delivery Partnerships, February 6-8 in San Diego, California. Be sure to register online to lock in 2012 rates when mentioning code XP1878BLOG! If you have any questions about DDP, feel free to email me at jpereira@iirusa.com.

We look forward to welcoming you to next year's event!

13th Annual Business of Biosimilars and Generic Drugs agenda now available

noreply@blogger.com (Jennifer) — Tue, 08 May 2012 16:37:00 +0000

After years of waiting, in which your business came ever closer to the “patent cliff,” the FDA has released its long-awaited user fee structure and draft guidelines for the development and regulatory approval of biosimilars in the United States.

The 13th Annual Business of Biosimilars and Generic Drugs event is designed to help you focus on the most significant new points in these guidelines and further accelerate what indeed promises to be a significantly abbreviated path to approval for your follow-on biologics.

No other event focuses so sharply on eliminating the obstacles you face in the commercialization of your next biosimilar candidate. This year we are particularly proud to feature time-sensitive updates on the biggest news now facing the industry!

What is featured in this year’s Business of Biosimilars and Generic Drugs event?
- FDA REGULATORY UPDATES
- STRATEGIC PARTNERSHIPS
- LEARNING THE RIGHT MARKET LESSONS FROM GENERIC DRUGS

For the complete program, download the 2012 agenda.

13th Annual Business of Biosimilars and Generic Drugs will take place September 10-12, 2012 in Boston, MA. As a reader of The Drug Delivery Blog, you receive an exclusive discount of 25% off of the standard rate when you register to join us. Simply use priority code XP1786BLOG. Have any questions about the event? Feel free to email Jennifer Pereira.

LyoGo's Latest Drug Delivery Development

noreply@blogger.com (Kate) — Fri, 20 Apr 2012 21:10:00 +0000

LyoGo, a company formed by three graduate student at Purdue University and winner of last year’s 10xelerator, is changing the way injectable medication is being administered. Their new technology will allow patients to give themselves injectable medication, minimizing the number of doctors’ visits, and ultimately decreasing their healthcare costs.

The issue with self-administering medication before always came down to the possible error in mixing and injecting it, however Lyogo says that they have simplified this process. And with an investment from an investor, they will have the opportunity to refine the device. Greco says “LyoGo is gathering test data which the pharmaceutical companies can use to assess the compatibility of our device with their drugs. We expect to be working soon with a pharmaceutical company to pair their drug with our device so that it may improve patients’ lives. How do you think this will effect lyophilized drugs in the future?

Want to learn more about Drug Delivery? The Drug Delivery Partnerships conference will take place February 6-8, 2013 in San Diego, CA. To view the recap on the 2012 Executive Summary, download it here.

Fierce’s Top 5 Drug Delivery Companies To Watch

noreply@blogger.com (Kate) — Fri, 13 Apr 2012 20:00:00 +0000

Whether its insurance issues, expiring drug patents, or constitutional acts, it’s evident that healthcare is a topic of conversation. Another subject to keep your eye on for the next coming months? Drug delivery companies. Below are Fierce’s top 5 Drug Delivery Companies to watch:

QLT - (Vancouver) The company is now in PHASE II of their glaucoma trial for the punctual plug delivery system. For years eye treatment has been a concern but this low maintenance, one time office visit device might change that forever.

Bend Research – (Oregon) This company is best known for their controlled-release and inhalation technology. They recently signed with major drug companies to provide services including drug formulation, analysis, engineering and manufacturing.

Bind Biosciences – (Cambridge) Bind's Accurins technology blends polymers with existing drugs to create an enhanced, controlled-release compound that hits a precise target with its payload. Last fall Bind received $47.25 million dollars from Russia’s government fund, RusNano for further research and development.

Endocyte – (Indianapolis) Known for developing drugs that are absorbed rapidly by the target and then removed from the body just as fast, to minimize side effects. There have also been talks of their compound, EC145 (used to treat ovarian cancer and other forms of cancer) heading in the Phase III direction.

Polymer Factor – (Stockholm) The company's technology is based on polyester dendrimers and monodisperse polymers (like proteins) for which it owns the intellectual property. Also a contract research company, Polymer Factory uses its drug delivery materials to support research and development in the pharmaceutical industry, among other sectors.

Would you add/amend any of these companies? Who do you think will have the greatest impact on the drug delivery industry in years to come?

Zogenix and Battelle to Collaborate on Advanced Drug Delivery Technology

noreply@blogger.com (Jennifer) — Tue, 31 Jan 2012 14:00:00 +0000

Includes Option for Joint Development of Expanded DosePro(R) Drug Delivery Platform

SAN DIEGO and COLUMBUS, Ohio, Jan. 25, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and Battelle, the world's largest independent research and development organization, today announced a unique collaboration with the objective of advancing the development and commercialization of Zogenix's DosePro drug delivery technology outside Zogenix's core therapeutic focus areas.

The companies have signed a Letter of Intent to enter into an exclusive co-marketing and technology development option agreement to utilize Zogenix's DosePro® needle-free drug delivery technology for new commercial out-licensing opportunities. DosePro technology enables needle-free medication delivery under the skin. Instead of a needle injection, DosePro technology uses a small amount of compressed gas to deliver a liquid formulation through the skin as a thin jet of medication. DosePro is the world's only commercially available, single-use, disposable, needle-free, subcutaneous delivery technology.

In the joint marketing arrangement, Zogenix and Battelle intend to offer Zogenix's novel DosePro technology to pharmaceutical and biotechnology firms to develop and commercialize innovative drug delivery products for development pipelines and for life cycle management of marketed prescription drugs and biologics, subject to Zogenix and Battelle executing a definitive agreement on the terms contemplated by the non-binding Letter of Intent. In addition, the Letter of Intent contemplates that upon successful out-licensing of DosePro, Battelle will have the option to participate directly in further development of the DosePro technology. This work, for which Zogenix has completed prototype design, is intended to broaden the capability of the technology to deliver larger dose volumes required for high-dose biological products. The arrangement is intended to fulfill the needs of biopharmaceutical companies that want to offer more customizable platform technologies resulting in differentiated products that can potentially increase efficacy, patient compliance and market share.

Zogenix's DosePro has received regulatory approvals in the United States and Europe, and is covered by more than 46 international issued patents extending through 2026. Zogenix has shipped in excess of 1.5 million DosePro units of the Company's approved migraine therapy, SUMAVEL® DosePro®, and patient experience has demonstrated that they will switch from oral to injectable formulations when provided the option of using DosePro.1

John Turanin, Vice President and General Manager, DosePro Technology, of Zogenix, said, "We recognize that DosePro can provide sustainable competitive advantages for many injectable drugs, especially biologics. With Battelle's expertise in product development and strong relationships with biopharmaceutical companies, we can now match DosePro technology to drug candidates in a more efficient manner by providing customizable drug delivery solutions that can effectively deliver biologics, vaccines and other critical drugs. We believe this arrangement will accelerate entry into licensing agreements with major pharmaceutical companies."

Barbara Kunz, President of Battelle Health and Life Sciences Global Business, said the collaboration is a strategic way for Battelle to advance its leading-edge health care science and technology offering to new and existing customers.

"We believe DosePro features market-leading technology for the safe and effective delivery of biologics, especially high viscosity formulations, which is critically important to our customers," Kunz said. "This collaboration will enhance our ability to extend our leadership in drug delivery technology development to create innovative solutions for the pharmaceutical industry."

About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro™ (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

About Battelle
As the world's largest independent research and development organization, Battelle provides innovative solutions to the world's most pressing needs through its four global businesses: Laboratory Management; National Security; Health and Life Sciences; and Energy, Environment and Material Sciences. It advances scientific discovery and application by conducting $6.5 billion in global R&D annually through contract research, laboratory management and technology commercialization. Headquartered in Columbus, Ohio, Battelle oversees 22,000 employees in more than 130 locations worldwide, including seven national laboratories which Battelle manages or co-manages for the U.S. Department of Energy and the U.S. Department of Homeland Security and a nuclear energy lab in the United Kingdom.

Battelle also is one of the nation's leading charitable trusts focusing on societal and economic impact and actively supporting and promoting science, technology, engineering and mathematics (STEM) education.

Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding the negotiation and execution of the definitive agreements establishing the co-marketing arrangement, the ability to successfully out-license the DosePro technology, and the expected duration of patent protection for the DosePro technology. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the scope, validity and duration of patent protection and other intellectual property rights for DosePro; difficulties in identifying, negotiating and carrying out strategic transactions relating to DosePro and obtaining regulatory approval for other DosePro products; risks associated with the development of a larger volume, second generation version of the DosePro technology to accommodate drug formulation volumes greater than 0.5 mL; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

1Hibbard, J and Turanin, J. (2011), Will Patients Accept and Adopt a Subcutaneous Self-injection Dosage Form When Alternative Oral or Nasal Dosage Forms Are Available? A Case Study in Needle-free Subcutaneous Delivery of Triptans for Migraine Headache; Poster Presentation, PDA Universe of Prefilled Syringes and Injection Devices, Basel, Switzerland. J. Hibbard and J. Turanin are employees of Zogenix, which sponsored the article.

#DDPEvent 2012: OTC brands and CEOs Perspectives

noreply@blogger.com (Jennifer) — Fri, 27 Jan 2012 21:21:00 +0000

The New IP Landscape: Less is More
Philip C. Strassburger, Purdue Pharma L.P

What’s the most important issue on IP Protection at this time? He believes ownership is the most important issue at this time. It is important that you can document the fact that the ownership has completely transferred from the inventor to the company.

Review employee and consulting agreements to confirm ownership obligations
-Conduct regular audits on chain of title on important IP
-When buying or licensiging IP: Due diligence on chain of title, structure deal in a manner that details business needs and objectives

Capitalize on Novel Drug Delivery to Build OTC Brand Franchises
Bob Nissen, Nissen , Consulting
Dennis Nelson, Chattem, Inc., a Sanofi Compan

Nissen: An OTC is a medicine that can be purchased without a prescription. There are some of the key segments: pain, cough/cold/allergy, nutritional, dermatological. This accounted for $100 billion in annual sales. The biggest brand worldwide is Tylenol. A consumers main goal is to feel better faster. How does drug delivery make OTCs better? A good place to find out more about OTCs for the United States: www.chpa-info.org.

Nelson: Companies in the OTC space like to develop a brand franchise so they develop: line extensions, new brands and Rx to OTC switches. Emerging challenges in the OTC Market: innovation, differentiation, speed, regulatory, and compliance. In order to achieve innovation for development of new OTC products, it’s critical to have a product concept, technology and consumer need. What to consider: new dosage forms, new packaging, new combinations of drugs, pediatric products and senior friendly products.

Drug Delivery Technology Company C-Suite Panel
Lee Shorter, GlaxoSmithKline
Sesha Neervannan, Allergan
James Ingebrand, 3M Drug Delivery Systems

How will drug delivery be involved over the next few years:
Ingebrand Serving the Pharma segment. What 3M sees is big shifts within Pharma, which will change the way they do things. At Allergan, drug delivery is an integral part of what they do. It’s not an add on or a part that succeeds, but hey think of drug delivery right from the start.

What’s on the cusp of making a breakthrough in the drug delivery industry? Ingebrand believes that the micro technology is points to breakthrough. It’s early but could be the breakthrough. Shorter thinks that the developing world and the possibilities for vaccinations, not only the success that could come with needles.

#DDPEvent 2012: Koska on world heath and Intellictual Property

noreply@blogger.com (Jennifer) — Fri, 27 Jan 2012 18:55:00 +0000

KEYNOTE: See a Need and Fill it: Innovative Ways to Uncover the Next Best Technology
Marc Koska, Inventor and Award Winning Humanitarian

There are 23 million cases of hepatitis and over 3 million doses of HIV delivered through dirty needles in the developing world. In India, 62% of injections are unsafe. In Pakistan, 70% of injections are unsafe and 90% are unnecessary. The reuse of syringes costs the world $119 Billion to the world.

Recycled syringes are worth money those operating in the market. Children make money from reselling the syringes on the market through repackaging, frequently for more money than they can be purchased form the pharmacy. Koska challenges the developed world to find a way to protect those who don't know any better. He spent three years researching the whole process of syringes – production to use to government standards to learn everything he needed to know. His solution – a valve at the top of the syringe to automatically lock and break it after it's first use. The cost of the syringe is $.05, and the cost of a Coca Cola is $.50. Those purchasing syringes can afford it, should be educated to make the right decision.

His organizations world wide, which can be seen here, are working to educate those around the world about this practice. He began this education in India. They made a short film and promoted it over five days in India. Through the five days, there were 720 million exposures. This worked, and in his meeting with the Heath Head of India, he mandated auto-disabled syringes throughout Public Healthcare in India.

CASE STUDY: Manage the IP from Early Stage to Commercial
David Azad, Galen Partners
Robert Jones, Acura Pharmaceuticals
Chris Halliday, Morgan Lewis

Five Points from the Panel:

Halliday: IP is very critical to everything any employee does for their company. The space of IP protection is so deep and technical, investors will find technical experts to confirm what they think. You can tell a lot about an investor by how deeply and intellectually they answer your questions. When it comes to budgets, IP is not an area where drug delivery companies want to cut corners.
Jones – Taking an idea to an innovation then add value to that idea. They also use IPs to assess the competitive landscape. Who is working in the space, and who has IP that may be a threat/useful to the company? In just thinking of new ways of doing business, they send it over to their lawyers to create that protection.
Azad: If your patent is covered, that’s your right to do something. It doesn’t necessarily protect you from someone getting to the same endpoint.
Halliday: Form an IP prospective, it’s important for a Pharma to be able to speak with them (the investors) on their level.
Jones: He suggests to find your company a good patent councilor. The guidance and expertise is invaluable. They get involved in the R&D Process, to improve and solidifying the IP. They give you the competitive assessment, They also expose possible vulnerabilities and possible solutions to solidify patent position and add value.

#DDPEvent 2012: Steven Burill & the outlook on Pharma and Emerging Countries

noreply@blogger.com (Jennifer) — Fri, 27 Jan 2012 02:39:00 +0000

KEYNOTE: The Globalization of the Pharmaceutical and Biotechnology Industry: What Does it Mean for Your Bottom Line?
G. Steven Burrill, Burrill & Company

Pharma will no longer be an industry driven by multibillion dollar drugs, instead, it will be focused on personalized medicine. Big and small companies are focusing, one section of this will be in stem cells. The Pharma companies want new return opportunities.

What is the good news coming for the Pharma industry? Pharma will continue to succeed in the world of personalized medicine. Defining desease differently is a big part of the success of the personalized medicine. Burrill places emphasis on the fact that the FDA has approved more drugs this year than over the past few years. The healthcare needs of a place like China are huge, as they have 300 billion in their population and essentially an entire United States of the older generation.

Pharma will loose most of their revenue with patent expirations, this leads to massive generic competition. Over 70% of prescriptions written today are generic drugs. Drug development costs continue to increase. Used to be 7 years for $200 million to get a drug to market, it could be 15 years and cost over $1.6 billion. Big Pharma is getting out of the R&D Businesss, from 2009-201, Pfizer dropped their R&D Budget 9.2%.

What does Pharma do best? They are an industry that excels at sales and distribution. Personalized medicine a pro-health industry being lead by digital. The iPhone is leading the industry, changing the care for diabetes and hard disease among other things. It’s turning into a functional wellness care system.

Emerging Markets: Eastern Europe, Asia and Latin America are very different emerging markets. Many companies have partnered in order to reach deeper into the market – most frequently in biologics and biosimilars.

The world around us is flat, single, interconnected borderless marketplace. Most places around the world are trying to protect local industry, while the United States is doing the exact opposite. Everything healthare has done to take care of all of the acute problems has been done, so not as many people die as in the beginning.

Featured Panel Discussion: Emerging Markets: What are the Current Market Opportunities and How Do We Make them Profitable?
Moderator: Ronald L. Smith, Merck
Panelists:
G. Steven Burrill, Burrill & Company
Christopher Seaton, Bayer Pharmaceuticals
Uros Urleb, Sandoz

Burrill: One of the ways we will succeed in emerging markets is through innovation. Innovativeness is the competitive advantage of the United States, we will have to continue to be that way in terms of new product development and delivery so we can provide value to emerging markets.

Seaton doesn’t agree: We don’t know what will happen in the next 5-6 years. The US Market over the next 3-5 years, it’s flat, but that is driven by the loss of exclusivity. As a Pharma industry, we’ve been terrible about thinking outside a box. He sees little innovation in big Pharma. Burrill believes that in most countries, they are different because they don’t have as much consumer driven advertising. Urleb believes it’s the time for generics.

Packaging in Pharma is very important. Marketing is one part, but so is technical. Seaton then wonders what the packaging will do: help differentiate his product is safety, efficacy or cost. Without a holistic approach, the companies can’t predict the packaging. Would this be a partnership opportunity or what? Burrill believes we think of healthcare in a dysfunctional sick care system, but when we actually know what’s wrong with them, we can treat them that way.

Technology today will change the way the industry works. Pharma by and large today is actually disconnected with the customer. Seaton: we don’t have nearly enough data about our products about the people who actually take Pharma’s products. If Pharma can get access to data like this, like genome sequencing works against medicine, the insights would be huge.

#DDPEvent 2012: Investing and IP Protection for Drug Delivery Companies

noreply@blogger.com (Jennifer) — Thu, 26 Jan 2012 23:32:00 +0000

Take on the 505b2 Monster and Develop an Optimized Strategy to Ensure Regulatory ApprovalDanchen Gao, Abbott Laboratories
Jeffrey A. Wolfson, Haynes & Boone, LL

What does it take to start a 505b(2) Company?
-Make sure you know how to access your market, have physician detailing and how much payors will pay for reimbursement.

IP Considerations – Rights needs to be protected beyond FDA. Intellectual property is more than just patents – trademarks register with patients.

Challenges with patent system for 505b(2):
-Narrow patent protection – new indications, combination products and broad formulations are ways to reach patent protection. Patent extensions are only valid once per product.

FIRESIDE CHAT: Walk Down Wall Street—Analyze the Economy's Effects on Pharma and Drug Delivery and Predict Future Trends
Moderator: Alex Zisson, Thomas McNerney & Partners
Brett Zbar, Aisling Capital
Scott Henry, Roth Capital Partners

Alex Zisson, Thomas McNerney & Partners

Alex Zisson: What have drug delivery companies done to get the attention of Wall Street? Among other things, they’ve focused on macromolecules, mostly biologics. Macromolecules typically pose tons of risk when it comes to developing them. The numbers show that it is much easier to fully integrate your product and delivery in order to reach their target revenue. Zisson encourages small companies to think outside the box, and provide a very big value added proposition when it comes to their technologies.

Scott Henry: There are four variables to covering a company according to investors: relationship, credibility, business model, investment appeal. What can a company do to increase their coverage chances? In order to get on the radar screen of the investors. Companies should get to know analysts and bankers and develop relationships, gain credibility, business model should not be highly risky and investment appeal by telling the story when times are good.

Zbar: What do investors look at when looking to invest? Team technology products (focus on commercial potential), focus on products (clinical development and regulatory) , IP review, and exit strategies. They also examine where the technology is already being used, as a way to leverage the power of the product. Investors focus has been on the reimbursement environment. Investors do like drug delivery companies

Small companies spend a lot of time trying to find a contact to make connections to Wall Street types. These Wall Street Professionals encourage these companies to make the time to have a meeting to discuss the opportunity, because everyone is a potential client. They also want to see some early stage data on the performance of the new potential drug delivery method.

#DDPEvent 2012: A morning of change, personal medicine and regulation

noreply@blogger.com (Jennifer) — Thu, 26 Jan 2012 19:35:00 +0000

To kick off DDP 2012, Chairperson,Lee Shorter, Director, GlaxoSmithKline, looked at a few things that are going to impact the Drug Delivery World in the next few years:

The industry, in light of new challenges, are looking into new therapeutic areas that make financial sense, such as cancer. Biologics are the future, as well as the human genome. Big Pharma is looking at new delivery systems for emerging markets. Drug delivery technologies need to add value when they are to be used by the patients and insurances.

Adapt to the New Rules for Profitability— The New Role of Drug Delivery in the Changing Drug Development Paradigm
John Baldoni, GlaxoSmithKline

Baldoni believes knowledge is becoming more and more of a commodity, and it will be transformational in human health. Electrons will be a key part in the future of medicine. What are the key healthcare stakeholders? The six key groups who have interest in healthcare are patients, physicians, payers, pharma, politicians, and policy makers. In order to make their best investments possible, they are differing investment until the last possible moment in order to make the best decisions. GSK won’t invest with anyone unless they have presented their proof of the hypothesis, thus only investing in highly probable ventures.

Why is Pharma a key part to the world? Baldoni believes that the professionals take ideas that their employees have and translate them into meaningful medicines that help people feel better and live longer. The focus is on the better life of the human.

At GSK, to reinforce this, they have a patient visit each month to share about their disease. The patients that come bring their inspiring stories to those who are developing the drugs to make those lives better. Some of the best developments through this industry has been to the in targeting the lung, liver, absorption of medicine into in the gut and more. Better molecules are entering the pipeline and that will directly impact drug delivery partnerships. Where are the proteins that you see in a disease eliminated by the drug? This is one of the ways these better molecules are being developed for the drug delivery process. The capitalization cost is hindering drug development – is there an opportunity for drug companies to work together to share these?

Will it Help or Hurt? The Impact of Healthcare Reform on Drug Delivery Innovation, Reimbursement, and Patient Compliance
Mark McClellan, Engelberg Center for Healthcare Reform, Brookings Institute, Centers for Medicare and Medicaid Services

The healthcare world is anxiously awaiting the the decision from the Supreme Court as to whether or not the ACA is legal. McClellan believes that some of the Act will be overturned, but not the whole thing. No matter the individual mandate to buy healthcare insurance will be delayed or repealed entirely. A lot of the other aspects are directly impacted by the 2012 Election. Since it is unpopular, Congress will delay the implementation. McClellan believes that this whole process will take longer and won’t be implemented on schedule in 2014. What won’t change? The insurance market will change, and those with chronic conditions will be covered. Republicans can’t repeal the whole law should they win the 2012 Election. The challenge is how to figure out how to cover more and more people who aren’t covered by insurance.

Rising healthcare costs that are coupled with a lot of rules to restrict spending means it will be very difficult to find a way balance the budget.
As for FDA Drug Approvals, they are up. This includes more personalized treatments. The process of developing new treatments is very long and uncertain. So success rates are still running around 11-13% for approval. Pharma is moving towards targeting therapies and innovative develop methods require new ways for the FDA to approve them.

Quick approval methods currently from the FDA: Fast track, Priority review, Accelerated approval. There were 8 drugs over the past few years approved this way. It’s hard to set up post approval success measures to get the drugs approved as well.

In the future, McClellan believes that there will be an evidentiary standard (Progressive approval), Targeting , better regulatory guidance and premarket development science

McClellan believes that personalized medicine will have a huge impact on health care in the future, but only if the reimbursement structure is changed from its current structure.

#DDP 2012: Scouting and Evaluation of Nanocarrier Technologies

noreply@blogger.com (Jennifer) — Thu, 26 Jan 2012 00:09:00 +0000

Tomas Landh, Novo Nordisk

Why use nanoparticles? What can they do?

-Overcome solubility
-Stability issues
-Limitations on route of administration
-Biocompartementalization
-Side effects of generalization drug administration

The size offers tremendous opportunities in chemistry. It is critical to realize how enormously small these nanoparticles are. You can build nanoparticle by aggregating them into macroparticles.

What is forgotten when it comes to nano-particles? Among other things, often the shape, specifically the forms of the particle and topology. Topology, to this point, is a field that is largely unexplored. Some examples of nanocarriers are micelles, vesicles, nanocapules, nanosphere, and dendrimers. They are all spherical in shape. When looking to dive deeper in the field, Landh suggests meeting and conversing with the universities known for that study. On place to do this is through science forums. Surprisingly, China is one of the countries most interested in nanoparticles and on the forefront of the technology.

What is one of the biggest challenges for manufactures of the nanoparticles? Human resources. Often times, the best minds choose to go into other fields such as electornics. If you build your particles from bottom up by self-assembly, you’ll do very little harm to your API.

Mahesh Chaubal, Baxter Healthcare

Nanotechnology’s definition has been debated for a while. The usual definition of a nano particle is any that are <1 micron. Interestingly, for the most part, Pharma’s products don’t fit in the nano definition. The benefit of nanotechnology is the ability to target places that can otherwise not be reached.

#DDPEvent 2012: Developing Products for Pediatrics

noreply@blogger.com (Jennifer) — Wed, 25 Jan 2012 19:45:00 +0000

Formulating for the Geriatric Population: Anticipating Polypharmacy and the Difficulty with Elderly Patient Compliance
Daniel Bar-Shalom, University of Copenhagen

It is critical to know how chemical entities will react with each other before you mix them. The combination of e two products that are not compatible – micro-capsulate them. Is it possible to make a combo product where we can put the drugs together in one formulation?

In order to gelling granulate, the following things are critical: micro-encapsulate, dispensing machine, a syringe (container), software can lead to the product in the future. It is important to find out the specification and then the question is whether or not we need to develop it or adapt it. How can you check the behavior of the drug particles in a gel?

Challenges in Pediatric Medication
Patrick Crowley

In terms of drug delivery to children, the problems are mainly focused in the fields of diverse/requirements of the amount of drugs. Children are not small adults when it comes to medication, scaled down doses for adults won’t properly treat their ailments. Some medications have been found to be more toxic in children than adults. 50% of drugs used in the EU have not been rigorously tested for children. Where is R&D Going in Developed countries? For the most part, into genetic clinical conditions like asthma and cancer. he developing world it’s environmental effects – nutrition and infectious diseases.

When looking formulating an adult medication to a pediatric medication, something to be considered include: solid to liquid forms, what the liquid vehicles would be, developing it so it has a good taste, and how self administration makes drug delivery a major issue for children as well as portability if dosage has to be frequent.

How does a company cope with poorly tasting drugs? It’s important to consider the bitterness threshold.The reduction of the level of drug in solution such that is below the bitterness threshold, it can then be formulated without bitterness. Then it is important to choose a soluble form to formulate by buffering a new liquid.

Forms that are key to pediatric drug delivery:

- Needle free delivery – Parental dosage is a major concern with respect to Type 1 Diabetics. Looking for better delivery forms – like needle free delivery. Is it acceptable for children?
- Transdermal delivery – it has become more prominent and successful way for delivery. Drug: low dose, hydrophelicic, small molecule, reasonable solubility in water Advantages: silent administration, infrequent dosing, sooth plasma profile, dosing can be terminated and patch can be adjusted to vary dose.

A New Approach to Developing Drugs for Pediatric and Geriatric Markets
Peter R Joiner, CEO, Maderia Therapeutics

Adult medications do not fit children. New diseases like hypertension and making their way into the pediatric arena. Drugs intended for pediatrics and geriatrics are niche drugs and they need to be focused for use.

When working with children in clinical trials, three three people as opposed to one– the child and the parents. In the US, only 2/3rds of medication fail to have advice on child dosing. They previously didn’t run pediatric drug trials. New law “If a drug has a potential use in children, you must run a pediatric trial at the same time.” When it comes to drugs and dosing, the us is not treating our younger and older populations appropriately with respect to drug use in the US. Taste masking and stability for 24 months are critical for a liquid medication.

Look Who is Attending the 16th Annual Drug Delivery Partnerships!

noreply@blogger.com (Jennifer) — Tue, 17 Jan 2012 22:23:00 +0000

We call our event Drug Delivery Partnerships for a reason. The networking and partnering opportunities found here every year are unmatched. That’s why companies keep coming back, and new ones join us every year.

In Las Vegas next week, from January 25-27, you will have the opportunity to network with hundreds of companies involved in drug delivery. If you'd like to join these companies, register today and use code XP1778BLOG to receive 25% off the standard rate!

Here is a full list of all the companies attending:

3M Pharmaceuticals * Abbott Laboratories * Accredo Health Incorporation* Activaero * Acura Pharmaceuticals * Aisling Capital * Alkermes Inc * Allergan Incorporation * Amcor Rigid Plastics * Amgen Incorporation * Aparna Biosciences Corporation * Aprecia Pharmaceuticals * Apricus Bio/NexMed USA * Aptalis Pharma Tech Incorporation * Aptar Pharma * Aradigm Corporation * Arecor * ARx LLC * ASLAN Pharmaceuticals * Astellas Pharma US Incorporation * AstraZeneca * Aveva Drug Delivery Systems Incorporation * Banner Pharmacaps Inc * Battelle Product Development Group * Bausch + Stroebel * Baxter Healthcare Corporation * Bayer Healthcare Pharmaceuticals Incorporation * BD Biosciences * Becton Dickinson & Company * Bespak * Biochemics Incorporation * Biocodex Incorporation * Boehringer Ingelheim * Bristol Myers Squibb * Buehler Motor Incorporation * Burrill & Company * Cambrex Corporation * Cambridge Consultants * Camurus AB * Carticept * Catalent Pharma Solutions * Chattem Incorporation * CIMA Labs * Columbia Analytical Services * Corium International Incorporation * Credit Agricole * Critical Pharmaceuticals * CSIRO * CSL Behring * Delpor Inc * Deutsche Bank * Dharma Therapeutics * Dow Corning Corporation * DSM Pharmaceuticals * Durect Corporation * Eisai Incorporation * Elcam Medical * Eli Lilly & Company * EMD Millipore Corp * Emergent Technologies Incorporation * Encompass Pharmaceutical Services Incorporation * Endo Pharmaceuticals Incorporation * Ethypharm USA * Evonik Degussa * Flamel Technologies * Flextronics Medical * Flugen * Galen Partners * Galenix Innovations * Gattefosse * Genentech Incorporationorporated * Genisphere Incorporation * GlaxoSmithKline Pharmaceuticals * Glide Pharma * Grunenthal * Haselmeier * Haynes & Boone Llp * Henkel Corporation * Hospira Incorporation * ICP Consulting * Inhalation * Insulet Corporation * Intec Pharma * Ipsen * Jaleva Pharmaceuticals * Janssen * Jazz Pharmaceuticals Incorporation * Johnson & Johnson * JRX Biotech * KAI Pharmaceuticals Incorporation * Kimberly Clark Corporation * Laboratoires Plasto Sante * Ligand Pharmaceuticals Incorporation * Lipocine Inc * Lux Research * Madeira Therapeutics * Mayne Pharma International * Medimetrics * MedImmune * Medpro Safety Products * Merck & Company Incorporation * Merial * Mikron * Millennium Pharmaceuticals Incorporation * MonoSol Rx * Morgan Lewis & Bockius LLP * NanoSmart Pharmaceuticals * NexMed Inc * Next Breath LLC * Nissen Consulting Group, LLC * Novaliq GmbH * Novartis * Noven Pharmaceuticals * Novo Nordisk * Novozymes Biopharma UK * OctoPlus * Ompi of America * Onconova Therapeutics Incorporation * OraPharma Incorporation * Owen Mumford * P/L Biomedical * Pacira Pharmaceuticals Incorporation * Pantec Solutions * Pantheon Pharmaceutical Service * Par Pharmaceutical Incorporation * Particle Sciences * PCCA * Pfizer * Pierre Fabre Medicament * PII * PL Developments * Plasto Technologies * PLD * PolyPeptide Laboratories Inc * PPI * Precision NanoSystems * Prime Therapeutics * PTM Consulting * Purdue Pharma LP * Q Chip *Ranbaxy Labs * Ratio Incorporation * Roth Capital Partners * Safety Syringes Incorporation * Sandoz Incorporation * SCD PharmaConsulting * SciDose LLC * Senfile Medical * SNBL Europe * Solubest * South University * SPI PHARMA * SteadyMed * Stevanato Group SPA * Supernus Pharmaceuticals Incorporation * Takeda Pharmaceuticals North America Incorporation * Tapemark Medical Products * Taris Biomedical * Teamtechnik Corporation * Technology Catalysts Corporation * Teicos Pharma Incorporation * Teikoku Seiyaku Company * Teva Pharmaceuticals * The Safepoint Trust * Thomas McNerney & Partners * TRL & MTS Business Development * Unigene Laboratories Incorporation * Unilife * University of Coimbra and LaserLeap Tech * University of Colorado * University of Copenhagen * University of Utah * Unomedical AS * UPM Pharmaceuticals * Upsher Smith Laboratories * Valeo Partners * Velocity Consulting * Vetter Pharma International USA * Washington Speakers Bureau * Watson Pharmaceuticals * West Pharmaceutical Services * Wilmington Pharmaceuticals * Wolfe Tory Med Inc * WR Grace * Z Cube SRL * Zogenix * Zydus Noveltech Incorporation

Could poweder liquid based proteins encourage better patient complaince?

noreply@blogger.com (Jennifer) — Mon, 16 Jan 2012 21:59:00 +0000

The scientists at Engineered BioPharmaceuticals believe so. According to Go Dan River, The new company in Virginia is working on creating powder dried versions of liquid based proteins for easier storage of drugs such as vaccines that often have to be handled with extreme care. This new company is working to find a way to make the molecules similar to those in the body so they are more effective in the drug. The company also believes it could help vaccinations become a bigger possibility for the rest of the world, as they could ship easier. It would also give the government an opportunity to stock pile vaccines.

Next week at Drug Delivery Partnerships, Riccardo Panicucci, Global Head,Chemical and Pharmaceutical Profiling, Novartis will be on hand to present "Overcome the Adoption Hurdle to Develop a Product that Will Enjoy Robust Patient Compliance" which will address how companies can look at how different delivery formats can be developed, much like Engineered BioPharmaceuticals is doing for these liquid proteins. For more information on this session and the rest of the event, download the brochure here. We also encourage you to join us next week in Las Vegas for Drug Delivery Partnerships. As a reader of this blog, when you register and mention code XP1786BLOG, you save 25% off the standard rate.

What opportunities do you see with developing a method were liquid based proteins are freeze dried for easier delivery?

Silk microneedles present new opportunities for vaccine delivery

noreply@blogger.com (Jennifer) — Wed, 11 Jan 2012 16:22:00 +0000

In the past, biodegradable microneedles have not been an option for drug delivery due to the lack of biomaterials that can properly deliver these types of drugs. However, researchers in the United States have discovered that using a protein in silk called fibron can be used to deliver a wide range of compounds that also don't have to be refrigerated when stored.

According to InPharam: In contrast, fibroin microneedles can be made with relative ease at normal temperature and pressure, which allows sensitive drugs such as antibiotics and enzymes to be delivered via the technology. Furthermore, the rate of drug release can be fine-tuned by adjusting the processing and drying of the silk protein.

At the 16th Annual Drug Delivery Partnerships, a track focused on Novel Drug Delivery Technology and Partnering Case Studies examines many of the partnerships that are taking place in order to develop and delivery drugs via patches. Join these professionals January 25-27 in Las Vegas, NV. For more information on the program, visit the webpage. Also, as a reader of this blog, you receive 25% off the standard rate when you register and mention code XP1778BLOG!

The Solutions to Your Drug Delivery Challenges are in Las Vegas

noreply@blogger.com (Jennifer) — Mon, 09 Jan 2012 17:33:00 +0000

Almost every pharmaceutical success story includes a successful partnership, and in drug delivery, that partnership is the cornerstone to improving drug effectiveness and patient compliance. As the industry evolves, new challenges arise in fostering and developing those relationships, but at the 16th Annual Drug Delivery Partnerships, you will learn how to overcome these challenges and develop relationships that will bring your drug to the forefront of commercial viability.

Four tracks identify key areas where challenges arise, and sessions highlight specific strategies to surmount those obstacles:

The New Partnering Landscape: Using Co-Development, Novel IP Strategies, and Emerging Markets for Growth & Sustainability
Make Life Cycle Management and Risk Sharing Work for More Effective Commercialization
Incorporate Formulation into the Delivery Strategy for Optimal Partnering Opportunities
Novel Drug Delivery Technology and Partnering Case Studies

For more information on these tracks and the sessions they include, visit the webpage to download the brochure.

As a reader of this blog, you receive an exclusive discount of 25% off the standard rate when you mention code XP1778LINK. The event is taking place January 25-27, 2012, in Las Vegas. If you have any questions about the agenda or event, please email Jennifer Pereira at or visit our webpage.

Can fear really impact individual's behavior for better health?

noreply@blogger.com (Jennifer) — Thu, 05 Jan 2012 14:00:00 +0000

DDP TV now switches focuses to the affects the future of the US population with the consideration for healthcare they have right now. In this segment, Marc Dresner interviews Thomas Goetz, Author, “The Decision Tree: Taking Control of Your Health in The New Era of Personalized Medicine” Executive Editor, Wired Magazine.

How much impact does fear have on the changing of individuals behavior? Goetz believes relatively little. What to focus on, in fact, happens to be the amount of willingness that individual has to change their behavior. Could that be the key to having someone change their actions for better health?

Watch Part 3 here:

Drug Delivery Partnerships 2012 will be taking place January 25-27, 2012 in Las Vegas. For more information on the program, download the brochure here. Don't forget, as a DDP Blog reader, when you register for DDP 2012 and mention code XP1778Blog, you receive a discount of 25% off the standard rate!

Drug delivery will help nanotechnology

noreply@blogger.com (Jennifer) — Wed, 04 Jan 2012 16:04:00 +0000

Howard Lovy of PJ Media sees drug delivery as the one place nanotechnology will stand up to it's hype. Side effects are one of the most publicized occurrences when it comes to drugs, however, the technology and microdelivery that is included in nanodelivery can solve the majority of these problems:

In many cases, the drug breaks down, but then tend to clump together. The body generally sees these clumps as alien invaders and works like crazy to get them out. So, one of the major problems facing the pharmaceutical industry today is the poor solubility of drugs. The result is that drugmakers tack on compounds to make the drugs soluble.

So what does nanotechnology do: Improves solubility, targets tumors better and has a better effect to control the release of the drugs.

At Drug Delivery Partnerships 2012, Novo Nordisk, Baxter Healthcare, Emergent Technologies will be presenting a symposium entitled Nanotechnology and RNAi Use for Drug Formulation and Delivery: How Do We Move Closer to Success? that will look at how technologies like this are impacting the drug delivery sector Register to join us in Las Vegas and don't forget to mention code XP1778BLOG to receive 25% off the standard rate.

What are the other benefits you see nanotechnology bringing to drug delivery?

Twas the Night Before DDP

noreply@blogger.com (Jennifer) — Fri, 23 Dec 2011 17:09:00 +0000

Twas the night before DDP, and all through the office

Not a creature was stirring, not even a delivery novice.

The out of offices were set in Outlook with care,

Knowing that anyone important would really be there.

"Now Pfizer! Now, Baxter! Now, Astra and Janssen!

On, Catalent! On, Elan! On Pacira and 3M!

To the top of the list! To the front of the hall!

Now Register! Register! Register All!

They sprang to their laptops, to theirs teams gave approval,

And away they all flew like the down of a thistle.

But I heard them exclaim, ‘ere they drove out of sight,

"Happy Partnerships to all, and to all a good-night!"

We thank you for your continued support of the Drug Delivery Partnerships Event & Online Communities, and remind you of your exclusive discount code XP1778BLOG, with which you receive 25% off the standard rate when you register to join us next month. The Event is taking place January 25-27, 2012, in Las Vegas. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com or visit our webpage.

Breakthrough in Q-Dot technology to locate drug delivery

noreply@blogger.com (Jennifer) — Tue, 20 Dec 2011 16:24:00 +0000

At the University of Central Florida, researchers have made a breakthrough with electronic quantum dot technology that allows them to see exactly where and how much of a drug has been administered to a cancer cell.

According to Florida Biotechnology News, when the quantum cell attaches and delivers the drug, through a microscope, researchers can identify the location of the delivery thanks to the reddish light the q-dot emits. The researchers can see the number of cells light up as well as the size of the tumor to judge the effectiveness of the treatment. The full report on this breakthrough in the Q-Dot technology is in the new volume of Biomaterials.

At Drug Delivery Partnerships 2012, Novo Nordisk, Baxter Healthcare, Emergent Technologies will be presenting a symposium entitled Nanotechnology and RNAi Use for Drug Formulation and Delivery: How Do We Move Closer to Success? further examining cases like the breakthroughs in Q-Dot technology. Register to join us in Las Vegas and don't forget to mention code XP1778BLOG to receive 25% off the standard rate.

What can a breakthrough like this in nanotechnology do for the advancement of cancer treatment?

Drug Delivery Partnerships TV: An Interview with Thomas Goetz Part Three

noreply@blogger.com (Jennifer) — Wed, 14 Dec 2011 18:32:00 +0000

DDP TV now switches focuses to the affects the future of the US population with the consideration for healthcare they have right now. In this segment, Marc Dresner interviews Thomas Goetz, Author, “The Decision Tree: Taking Control of Your Health in The New Era of Personalized Medicine” Executive Editor, Wired Magazine.

There are many uneducated individuals when it comes to personal health. Goetz spotlights how many in California are against western education. While this is a bienefit to society, it hasn't be communicated properly how this medicine does indeed work. Goetz suggests we find a way to constructively use data to communicate that with these users.

Watch Part 3 here:

Drug Delivery Partnerships 2012 will be taking place January 25-27, 2012 in Las Vegas. For more information on the program, download the brochure here. Don't forget, as a DDP Blog reader, when you register for DDP 2012 and mention code XP1778Blog, you receive a discount of 25% off the standard rate!

If you'd like to get a taste of this year's keynote presenations, 2012 Keynote Steven Burrill will be presenting "Drug Delivery: A Look Forward" on Tuesday, December 20 at 1:30PM. Sign up for this complimentary web seminar here. Use priority code XP1778W1BLOG.

New for DDP 2012 - Speakers, Companies, Tracks and Topics Never Heard Before!

noreply@blogger.com (Jennifer) — Fri, 09 Dec 2011 17:12:00 +0000

Are you tired of hearing the same old speakers talk about new innovations that are arguably not new, nor innovative? At DDP this year you’ll hear over 80 speakers divulge of-the-moment strategies, brand new case studies, and lessons learned that will help you move your drug delivery programs forward because we know nothing is more valuable than hearing pharmaceutical executives share how they utilize drug delivery to improve effectiveness and patient compliance.

At DDP, over 50% of our speakers are new to the event. Never before at DDP have you heard from:

• Christopher Seaton, Senior Vice President, Global Licensing, Bayer Pharmaceuticals
• John Baldoni, Senior Vice President, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals R&D
• Uros Urleb, Chief Scientific Officer, Sandoz International GmbH
• Ronald Smith, PhD, Executive Director and Head Product Value Enhancements, Merck & Co
• Paul Gellert, Senior Principal Scientist, Astrazeneca
• Michael Kaufman, Vice President, Pharmaceutical Sciences, Millennium Pharmaceuticals
• Joel Richard, Vice President, Drug Product Development, Ipsen

For more information on these new speakers to 2012 and the rest of the program, download the brochure.

Drug Delivery Partnerships is taking place January 25-27, 2012. As a member of the Drug Delivery Partnerships International LinkedIn Group, you get a 25% discount off the standard rate when using code XP1778BLOG. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com or visit our webpage.

Batteries could be the next trigger for Drug Delivery

noreply@blogger.com (Jennifer) — Thu, 08 Dec 2011 19:51:00 +0000

In a new innovative, yet simple procedure, researchers at Standford University have developed a drug delivery method where nanoparticles are triggered by the jolt of energy from the battery. Instead of the traditional methods, which often include electronic chips or surgery, according to Fierce Drug Delivery.

According to the article the system works like:
[Researchers] loaded a chemotherapy drug and fluorescent dye into conductive-polymer nanoparticles, and placed them into a temperature-sensitive solution that becomes a gel after it is injected into the body. In the lab, a light electrical jolt generated by an AA battery caused the nanoparticles to release the drugs, and different levels and durations of the electricity controlled dosage level and duration.

This method can control the level and dosage according to how long the batters are charged.

At DDP 2012, Marc Koska, Inventor and Award Winning Humanitarian, who has capatalized on simple innovation will be presenting, "See a Need and Fill it: Innovative Ways to Uncover the Next Best Technology." For more information on the event, download the brochure here. Don't forget, as a reader of the DDP Blog, when you register and mention code XP1778Blog you receive 25% off the standard rate!

What can a boarding pass do for a blood test report? Thomas Goetz answers

noreply@blogger.com (Jennifer) — Wed, 07 Dec 2011 18:33:00 +0000

This week in DDP TV, we continue with Marc Dresner interview with Thomas Goetz, Author, “The Decision Tree: Taking Control of Your Health in The New Era of Personalized Medicine” Executive Editor, Wired Magazine.

In this segment, Goetz examines how health system can improve simply by listening to patient feedback. Things in the healthcare industry have moved at a slow pace, but simply listening and discussing tasks with patients can help many of the patients in the industry understand more about their healthcare. Can you read your blood test? Goetz gives a suggestion as to how the information can be presented.

Watch Part 2 here:

Drug Delivery Partnerships 2012 will be taking place January 25-27, 2012 in Las Vegas. For more information on the program, download the brochure here. Don't forget, as a DDP Blog reader, when you register for DDP 2012 and mention code XP1778Blog, you receive a discount of 25% off the standard rate!