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.
Friday, January 27, 2012
#DDPEvent 2012: Koska on world heath and Intellictual Property
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:
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 PartnersRobert 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.
Thursday, January 26, 2012
#DDPEvent 2012: Steven Burill & the outlook on Pharma and Emerging Countries
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.
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
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: 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.
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 |
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
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.
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 ServicesThe 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.
Wednesday, January 25, 2012
#DDP 2012: Scouting and Evaluation of Nanocarrier Technologies
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
Formulating for the Geriatric Population: Anticipating Polypharmacy and the Difficulty with Elderly Patient ComplianceDaniel 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.
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