Archive for the ‘Uncategorized’ Category

Iotron Industries USA Announces Strategic New Hire

April 25, 2017

 

PRESS RELEASE:

Mon, 24 Apr 2017, 07:59:30 EST

COLUMBIA CITY, Indiana, Apr. 24, 2017 – Iotron Industries USA is carefully adhering to its strategic growth plan in the area of geographic expansion of its electron beam processing services. This week it announced a new hire, Brandon Glock, Business Development Manager for the Columbia City, IN location.

Brandon brings with him experience in project management and technical marketing as it applies to the medical device manufacturing community. Prior to joining Iotron, he was account manager at a Warsaw, IN based orthopedics manufacturing firm.

In his new role at Iotron, he will work to build upon the foundation of customer partnerships developed within the region, and begin to lay the groundwork for new opportunities in the medical
device industry as demand continues to increase for Iotron’s contract sterilization and radiation crosslinking services.

“Brandon shares the same passion and values for the medical device industry as Iotron when it comes to market development and customer service,” says Aaron Starkey, Commercial Director of Iotron Industries CANADA/USA. “Customer service is paramount in our work. Brandon’s knowledge in med device and his methodic approach to brand promotion will be key to executing our strategic growth plan in Indiana and throughout North America.”

Iotron Industries provides sterilization, bio-reduction and materials modification services for the orthopedic, medical device, and specialty plastics markets. Iotron offers a team of dedicated experts to facilitate material processing requirements utilizing Electron Beam irradiation technology. For over 25 years, Iotron’s highly experienced staff has been providing a knowledgeable approach to the development of unique processes associated with a broad array of products and materials, earning Iotron recognition as a global leader in radiation processing.

About Glock:
Brandon Glock brings to Iotron a diverse background in the medical device and orthopedics industries, with previous roles in Project Management and Sales & Marketing at both Instrumedical Technologies (Warsaw, IN) and Zimmer-Biomet (Warsaw, IN). He holds a Bachelor’s Degree from Grace College with a Double Major in Communications and Sports Management.

4394 East Park 30 Drive, Columbia City, IN 46725 USA Tel: 260 338-0046 Fax: 260 338-0448
Web Site: www.iotron.com email: iotron@iotron.com

March 2017 Life Sciences Lunch – How Secure Are Your Patents?

April 12, 2017

LSL Banner

The last run at patent reform fell flat in the fall of 2015. With no real legislative appetite to tackle the reform process, you might think that things would have calmed down but in this age of uncertainty, nothing stays quiet for long. Whether it is regulatory reform coming from the Patent Office and Congress, addressing the continued issues of inter partes review (IPR) and managing patent trolls, or exploring potential changes in patent protection due to the renegotiation of trade agreements, it is important to plan ahead and be aware of where there may be future disruptions. Please join us as our panel discusses the current patent landscape for life sciences products, delves into the key players and constituencies shaping the process, and see what it might mean for protection of your intellectual property.

PANELISTS
Deborah Pollack-Milgate, Partner, Barnes & Thornburg LLP
Angela Freeman, Associate, Barnes & Thornburg LLP
Jennifer Finefield, Senior Technology Manager, Indiana University Research and Technology Corporation
MODERATOR
Chris Felts, Partner, Barnes & Thornburg LLP

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

February 2017 Lunch – “One Health – It’s All Connected”

March 22, 2017

“One Health – It’s All Connected”

The One Health concept recognizes that the health of people is connected to the health of animals and the environment. The goal of One Health is to encourage the collaborative efforts of multiple disciplines-working locally, nationally, and globally-to achieve the best health for people, animals, and our environment.  Sixty percent of infectious diseases in people are spread from animals and the interactions between the points of this triad are changing more rapidly and dynamically than ever before.  Our panel will discuss how looking at the bigger picture will shape drug development and impact innovation and research efforts going forward.

Panelists:

Josh Johnson

 General Manager

Benchmark Biolabs

Reza J. Rasoulpour, Ph.D.

 Global Predictive Safety Center LeaderRegulatory Sciences, R&D

Dow AgroSciences, LLC

 Kristin Bloink

Senior Director

 Global Research and External Innovation 

 Elanco Animal Health

Moderator:


Deborah Pollack-Milgate 

Partner

Barnes & Thornburg LLP

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

 

AdvaMed Statement on House Reconciliation Legislation

March 7, 2017

FOR IMMEDIATE RELEASE                                                                                                                   March 7, 2017

 

AdvaMed Statement on House Reconciliation Legislation

 

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after introduction of reconciliation legislation in the U.S. House of Representatives:

 

“AdvaMed commends the House Ways and Means Committee for moving forward with legislation that will permanently repeal the medical device excise tax. Bipartisan majorities in both the House and Senate are on record in support of repeal of this onerous tax, which has been associated with a significant loss of American jobs. Recent data from the U.S. Commerce Department showed that the medical technology industry experienced a decline of nearly 29,000 U.S. jobs while the tax was in effect. Conversely, an analysis by the American Action Forum demonstrated that permanent repeal of the tax could result in excess of 53,000 additional industry jobs, compared to what would occur if the tax remains in effect. Repealing the tax will provide medical technology innovators with the long-term certainty necessary to support future job growth and sustainable, cutting-edge R&D that will ultimately lead to the next generation of breakthroughs in patient care and treatment. We urge the House and Senate to act expeditiously to pass this important legislation.”

 

# # #

 

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

 

 

 

Drug Cost Facts: Your comprehensive guide to the drug cost ecosystem

March 6, 2017

March 3, 2017

BIO Logo Horizontal RGB

The Biotechnology Innovation Organization (BIO) today launched DrugCostFacts.org, a new interactive web tool designed to help healthcare stakeholders gain a better understanding of the true facts surrounding drug costs, spending and value.

 

The site features a series of commonly asked questions—ranging from “Why are some drugs expensive?” to “What role do PBMs, insurance companies and wholesalers play in determining what patients pay for their drugs?”—and then answers these questions using infographics, videos and interactive tools. The site also has additional research and reading materials for those who want to dive deeper into these issues. The tool is mobile responsive, allowing users to access information on their phones and tablets.

 

The goal of the site is to provide information—drawn from independent studies, news articles and outside research—that policymakers, the media and the public can rely on when writing or engaging in discussions about issues relating to drug costs and spending. The site also features a “Follow the Debate” section, where users can get more information on topics ranging from drug importation to government negotiations in Medicare that are making headlines and that are part of the current policy and public debate.

 

Below are highlights of some of the elements of the site:

 

(Note: The interactive tools were developed based on publically-available data and each tool includes an explanation of how the calculations were determined.)

 

Understanding Your Drug Costs: Follow the Pill

 

Understanding Your Drug Costs: Follow the Pill is designed to give users a better understanding of how prescription drug costs are really determined and where the pharmaceutical dollar actually goes. The whiteboard video begins with a typical transaction at your local pharmacy. It then traces that purchase back through a series of complex transactions that occur throughout the pharmaceutical distribution and insurance chain. The video breaks down the differences between the list price and the net price of a medicine, explains how the various actors (e.g., pharmacy benefit managers (PBMs), wholesalers, insurance companies, etc.) in the health care ecosystem operate to deliver medicines to patients and at what cost, and demonstrates why it is that a biopharmaceutical company has very little power to determine what a patient ultimately pays for his or her medicine.

Insurance Calculator

The Insurance Calculator is an interactive tool that allows you to explore how changes on the front end of insurance benefit design (e.g., to your deductible or required cost-sharing for drugs) ultimately impact what you pay each month for premiums and other out-of-pocket costs.

 

The calculator allows you to get a better understanding of how insurance design impacts patient out-of-pocket costs. The tool starts you off with two pre-set plans (i.e., an Affordable Care Act Silver Family Plan and a Large Corporate Individual Plan) to give you examples of what common deductible and co-payment amounts can be. Once you gain more familiarity with how to use the tool, choose the “customize” option to explore all of the various elements of a plan benefit. Users are encouraged to experiment with the different parameters, keeping a close eye on “Total Monthly Out-Of-Pocket Costs” on the left-hand side to see just what elements of your insurance plan’s structure impact the costs you bear the most.

 

For example, increasing deductibles may not have as much of an impact on your premiums as you may think. In addition, you’ll see that increasing brand drug cost-sharing by patients does little to lower your premium, but has a major impact on your out-of-pocket costs.

 

Like the tool discussed below, this insurance calculator is not meant to provide exact data on your individual plan or an individual patient’s costs—instead, it uses real-world data to map the relationship between insurance benefit design of a plan like yours and out-of-pocket costs to demonstrate the effect that one has on the other.

 

How Much Does the Cost of an Innovative New Drug Impact Overall Health Care Costs?

 

When an innovative new medicine becomes available on the market, insurance companies often raise concerns that covering the drug will put upward pressure on health care costs. To take a deeper look at this issue, BIO developed an interactive tool that simulates the impact of adding a new innovative drug on average health care costs across a hypothetical insurance market. The site allows you to enter the monthly cost of a new medicine and the number of people who would take the drug to determine what an approximate monthly impact would be on health care costs if the cost were distributed equally nationwide. What you will see is that, even in the case of more expensive drugs, the incremental cost across all insured individuals is modest. This is important information to know when the alternative is restricting access to these new medicines, and in turn, restricting the potential benefits they would have for patients.

 

Here are a few scenarios you can try: Take your typical statin, which would cost about $10 per month. The population taking this drug would be about two million people. As the calculator shows, the incremental impact on each individual’s health care costs would be about $0.11 a month. Remember, these numbers are not meant to be exact for any particular plan or individual, but instead to demonstrate the magnitude of the impact of covering medicines on health care costs.

 

Another scenario would be a novel therapy costing $1,000 per month and taken by 100,000 patients, which could be the case for a new medicine that treats a certain type of cancer or a specific form of cardiovascular disease. Ensuring coverage of this drug for all patients that need it would have a monthly impact of just $0.56. Or, for example, if a more expensive rare disease drug cost $25,000 per month, and is utilized by 2,000 patients, the monthly impact would be $0.28.

 

Try it out yourself to see how both common and rarer medicines impact the insurance system. We think you’ll quickly see how easy it is for insurance plans to provide robust drug coverage for patients who need new medicines without fear of significant cost increases.

 

Additional Tools

 

In addition to these tools, the site includes an animated video that follows a molecule from the lab through the drug development process, and it features a range of downloadable infographics on topics – from where new drugs are being developed to the role of private sector R&D in drug development.

 

With this resource, BIO has created a one-stop shop for factual information and answers to some of the most hotly debated questions regarding the role of drugs in our nation’s health care system.

January 2017 -Understanding 21st Century Cures for Drugs and Devices

February 1, 2017

This month we’ll discuss the 21st Century Cures Act – a $6.3 billion, nearly 1,000-page, comprehensive legislation package that passed the U.S. House and Senate in late December 2016. 21st Century Cures overhauls the way drugs and devices will be coming to market; the legislation offers grant funding to states to help fight the opioid epidemic and addresses mental health laws and resources. It also places a big emphasis on research funding – especially for cancer and neurodegenerative diseases – and patient rights. All of these factors are expected to change the research-to-commercialization pathway. Please join us as we learn more about the act and its impact on patients, regulators, and large and small companies.

Presenters:

Jeanne Haggerty, Senior Vice President, Federal Government Relations
BIO

Lynn Tyler, Partner
Barnes & Thornburg LLP

Moderator:

Kristin Jones
Indiana Health Industry Forum

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

For more information on upcoming programs, please visit www.ihif.org/pages/lifescience

Follow us on Twitter @IHIF1 #LifeScienceLunch @BTLawNews

SEP expands with the opening of a new software product design studio

January 6, 2017

PRESS RELEASE – FOR IMMEDIATE RELEASE

Media Contacts:

Raquel Bahamonde, 317-319-6875,Raquel@bahamondecommunications.com

Kelly Wilson, 317-413-0943, kmwilson@sep.com

SEP expands with the opening of a new software product design studio

CARMEL, Ind. (January 5, 2017) ─ Software Engineering Professionals (SEP) is expanding its Carmel, Ind. operations with the opening of the new SEP Product Design Studio. The new space is an immersive, collaborative environment to assist in the development of software products and information systems for businesses.

Whether it is helping a race car engine manufacturer design aerodynamic modeling software, developing software for a new generation of tractors, or assisting a medical device company in creating a diabetes management mobile application, the new SEP Product Design Studio will help companies build better products for their customers.

“The market is changing. Product design and development is being disrupted by technology advancements and cultural changes,” Chris Shinkle, director of innovation for SEP, said. “We are seeing big companies wanting to be more like startups. They are looking for ways to innovate and move faster. SEP has always provided research, design, development and user experience testing. For the first time, the new studio puts all of that in one place for a cohesive client experience.”

The SEP Product Design Studio provides companies with a space that is designed to work alongside the people who are actually building the product or trying to solve a business problem. The new space will give companies a dedicated place for discovery sessions all the way to testing of the product.

The studio is equipped with technology that includes stations for wearables and mobile device usability testing so companies can see what the end user is naturally doing when using a device. This enables SEP to validate a product as it’s being developed so it can iterate on the outcome very rapidly. This approach to product development reduces the risk of testing delays and the high cost of learning about a problem too late.

“Design isn’t a ‘make it pretty’ sort of discipline anymore,” Noelle Webster-Milam, lead experience architect for SEP, said. “Design is about intention and understanding the context of the product you’re building. Great design happens when a company is invested in design thinking from the start and is engaged in the investigation, study and understanding of the problem they are really trying to solve,” she added.

SEP started in 1988 by four Rose-Hulman Institute of Technology graduates as a place where engineers love to work and today has grown to more than 100 employee-owners.

“Engineering has always been at our core,” Raman Ohri, president of SEP, said. “Over time, we and the industry at large have realized the importance of building the right product, in addition to building the product right. Our team has developed exceptional capabilities to help customers determine what to make.”

SEP is a software product and design company that builds products for global, midsize and small companies.

“This space is a physical manifestation of our commitment to this essential work in building great software,” said Ohri. “We are eager to get people in this space and drive innovation.”

About Software Engineering Professionals (SEP)

Started in 1988 and headquartered in Carmel, Ind., Software Engineering Professionals (SEP) was created by four Rose-Hulman Institute of Technology graduates. SEP is one of Indiana’s largest software development firms with more than 100 employees. SEP partners with companies to develop software products and information systems that solve complex problems and building products that impact people’s lives. SEP serves Fortune and Global 1000 clients as well as midsized and startup companies. The company is 100% employee-owned through an Employee Stock Ownership Plan (ESOP) and has made the Indiana Chamber of Commerce’s Best Places to Work list for seven consecutive years (2010 ranked #1). To learn more, visit www.sep.com.

 

2015 Advocacy Efforts

November 30, 2016

 

October 2015

Moderated afternoon session of Rep. Susan W. Brooks, “Connecting Classrooms and Careers” program.

September 2015

Signed on to a joint letter to the President urging him to focus on ag biotech issues in his upcoming meetings with President Xi Jinping of China.

August 2015

Participated with IMDMC in Legislative Roundtable, Indianapolis

July 2015

Participated in Hoosiers Work for Health/We Work for Health PhRMA Partnership Fly-In to Washington D.C.

June 2015

Requested Indiana Congressional Delegation to sign-on to bi-partisan letter encouraging fair and balanced patent reform consideration in HR 9.

Met with Rep. Susan W. Brooks at BIO Convention in Philadelphia, provided tour of Indiana booth in the conference exhibit hall

May 2015

Awarded Rep. Susan W. Brooks IHIF’s Legislator of the Year Award for outstanding service to Indiana’s health science sector

Signed on to joint-association letter supporting H.R. 1078, the FDA Safety Over Sequestration (SOS) Act

Participated in Hoosiers Work for Health Award to Rep. Susan W. Brooks

Signed on to Healthcare Leadership Forum letter to repeal IPAB

April 2015

Participated in the BIO Fly-In to Washington, D.C. – met with nine of Indiana’s eleven offices.

March 2015

Signed on to the Declaration Supporting Incentives for Medical Innovation in Trade Agreements organized by the Global Colon Cancer Association and the Information Technology and Innovation Foundation

February 2015

Indiana Expanding Exports and Creating Jobs – Fact Sheet with information on TTIP and TPA impacts on state.

Signed on to National Osteoporosis Foundation letter to Congress supporting Medicare Part D.

January 2015

IHF signed on to a letter to the Administration emphasizing the importance of strong IP and data protections for medicines.  Letter was initiated by the Global Colon Cancer Association and the Information Technology and Innovation Foundation.

IHIF co-hosted our 4th Annual Legislative Breakfast Briefing (agenda) on January 28th.  Co-Hosts include IMDMC and Hoosiers Work for Health/PhRMA

IHIF shared concerns over Senator Elizabeth Warren’s “Medical Innovation Act”.

IHIF provided informational testimony on HB 1065 – Use of investigational drugs, biologics, and devices.  Also expressed concern over SB 66.

IHIF signs on to letter encouraging US legislators to proceed with caution when considering making changes to patent legislation

IHIF signs on to letter to US legislators highlighting the success of Medicare Part D and urging Congress to reject any proposals that would undermine the current program’s success in holding down premiums and taxpayer costs, while still producing high satisfaction rates among enrollees.

2016 Advocacy Efforts

November 30, 2016

Recent Activities

October 2016

Signed on to letter  sponsored by the Healthcare Leadership Council in support of repeal of IPAB.

August 2016

Signed on to letter supporting intellectual property protections in current UN negotiations.

Signed on to BIO letter to SEC supporting re-examination of the definition of ‘Smaller Reporting Companies”.

June 2016

IHIF supports HWFH and opposition to Medicare Part B Demo

May 2016 

IHIF joins BIO and other state bioscience groups in supporting the Fostering Innovation Act – allowing growing bioscience companies to focus on R&D.  Read BIO’s statement on passage of the Act here

IHIF announces Legislators of the Year at 2016 Annual Meeting – Honoring Rep. Larry Bucshon, M.D. and Senator Patricia Miller

April 2016

IHIF attends BIO Fly-In to meet with entire Indiana federal delegation in Washington, D.C. – continuing focus on Medicare Part B reimbursement changes.

March 2016

Provided Letter of Support for HB 3320 – A Bill to Establish a Smart Card Pilot Program Under Medicare

Participated in Lilly 2016 Vendor Conference

Signed on to letter opposing CMS proposed changes to Medicare Part B

January 2016

IHIF testified in favor of HB 1176 – creating a Diabetes Incidence Study and Action Plan through IDOH.  The bill was held and DOH was requested to provide a study update to stakeholders within six months.

IHIF Legislative Breakfast featuring remarks by Rep. Ed Clere and Lt. Governor Sue Ellspermann.

Activity Archive

 

Moonshot for Pediatric Pharmacology

August 30, 2016

By: Peter T. Kissinger

*Published in August 2016 issue of Drug Discovery News and Op/Ed section of the Indianapolis Business Journal Aug. 29 edition     

Fire up the rocket. This month I hope to stimulate debate in favor of an underrepresented group in clinical pharmacology research.  Two decades ago women were underrepresented, including even female rats.   We’ve made real progress. The same is true for the elderly and racial minorities, although that challenge continues, as reflected in the FDA declaring 2016 the Year of Diversity in Clinical Trials.

 

Children remain a group neglected by the pharmaceutical industry.  They are a vulnerable and inconvenient population for medical research, especially outside the developed economies.  This is a demographic which demands an individualized approach to therapy that is even more compelling than for adults.  Many children die of infectious diseases and malnutrition while others are permanently damaged.  Others have inborn metabolic errors which respond well when caught early. Children, of course, contract cancer.  Physicians often must guess on drug choice and dose, because there is limited supporting data and often no suitable formulation.  Mixing portions of drugs with compatible (or not) “baby food” is common for parents and not well controlled.  Adult formulations are often unsuitable for children in physical size, dose, and excipients. Special pediatric formulations, such as liquids, require extensive regulatory review, including oral syringes for parents to use, which are then medical devices.

Self-administered protein-based drugs become more popular for adults, for example, using pumps.  In children this presents costly regulatory issues with labeling, instructions and compatibility with little hands and physical play.

There is opportunity, step-by-step to now reduce the art and increase the science.  Pharmacophenomic progress can be made today, without any speculative drug discovery.  Most approved drugs compatible with pediatric disease are generic, but few have been thoroughly studied in children as N=1 individuals.   The goal of individualized, data-based dosing for children also has implications for adults. The current government precision medicine initiative is largely genetics focused and does not explicitly deal with the phenotypic reality of individuals. The likelihood of genomics solving many diagnostics challenges is very small.  It is only one dimension of a multifactorial problem for which we have many new tools.

 

Why are children not the focus of clinical pharmacology?

 

  1. Children are not small adults.  Their phenotype changes very rapidly from birth to their early 20s. This is inconvenient for scientists and statisticians alike.
  2. Children are generally healthy and thus represent a small market for new drugs. This is inconvenient for CFOs.
  3. The ethical challenges of clinical trials with children are daunting to some. Informed consent is for parents/guardians. We do not do drug trials on healthy children as we typically do for adults (Phase I).  On the other hand, adult trials will have been done first. Recruiting sufficient numbers of patients for statistical power is tough, but with better measurements you need fewer subjects.
  4. The rate of change in children confounds clinical trials of any length. For example, newborns vary biochemically month to month.  Age is NOT a good metric for measured phenotype. The equivalent of a three year trial for patients in their 40s is impossible in patients who will double in age over 3 years.
  5. While Congress and the FDA have provided incentives (extended market exclusivity) to pharmaceutical companies who add a pediatric component to trials for new drugs, the incentive is not often sufficiently compelling. There are many generic drugs that are useful in children, but most have not yet been studied in children using modern protocols before patents have expired.
  6. Young children are small. Neonates are tiny.  This makes both physical and chemical measurements more difficult than for adults. Small blood volumes is one challenge. Children also do not have the mobility to get to a clinic on their own and most can’t describe their feelings with any precision to a caregiver as researcher.
  7. Because of the “tyranny of averages” from clinical trials and the significant variations in the rate of ontogeny person-to-person, children are especially subject to medical errors of drug choice and dose. Dosing in units of mg/kg of body weight is done because it is better than nothing, not because it optimizes a satisfactory result.  It does not!

 

 

There are good things to say about pediatric research.

 

  1. The return on investment in children’s health promises to be much higher than the return on investment in the health of elderly professors like me. Preventive medicine means a lot.
  2. Children as a rule have avoided some of the bad habits that make studies in adults inconvenient (smoking, alcoholism, drug addiction, French fries,…) and have not experienced the degenerative diseases of aging.
  3. Children are less subject to polypharmacy and thus have fewer drug-drug interactions or drug induced enzymes.

 

To facilitate research, we are moving step-by-step from accumulated “art” to evidence-based medicine (decisions by averages from randomized trials) and on now to individualized medicine based on N=1 data.  While physics plays a role, chemistry is more specific in health care research.  My own team has developed means of automatically sampling exquisitely small blood volumes in a preprogrammed painless way that eliminates labor and reduces infection risk.  This is especially important with respect to recruiting children for trials where parental approval is crucial.  Colleagues have further developed measurement technologies that are compatible with much smaller sample volumes than even a decade ago. These include several ambient ionization mass spectrometry schemes, among others.   Today the required sample volumes and concentrations for quality measurements are both reduced by up to a million-fold compared to 1980.   Expertise in modelling and predicting, much of it developed from industrial engineering, is now coming into play.  Health care is a process that is largely “out of control” because of inadequate process monitoring along the way.  Proper decisions by health care providers are thus inhibited.  Imagine operating a chemical, electronics or auto plant with such haphazard in-process monitoring.

 

Nutrition matters because food-effects matter and the microbiome also impacts circulating drug concentrations.  Today these are not adequately measured in children.  Some data will improve decision making.  Better, faster, cheaper data will improve decision making more.  A malnourished child in Africa will not react to a drug the way a plump over-nourished child in Indiana will.

 

Collaborative Opportunities:

 

There are several networks of Children’s Hospitals, many of which have a research component. The NIH (NICHD) has organized a pediatric trials network (PTN) and a neonatal research network (NRN) among children’s hospitals that share experiences and data. [Taken from the NICHD website: “Formed in 1986, the NICHD Neonatal Research Network (NRN) is a collaborative network of neonatal intensive care units across the United States. The NRN comprises 18 clinical centers.”  “The main objective of the PTN is to provide an environment and an appropriate infrastructure for conducting safe and effective pediatric clinical trials for the Best Pharmaceuticals for Children Act (BPCA) drug development program and for performing ancillary activities in support of these trials. The network will conduct pediatric clinical drug trials in a variety of therapeutic areas, including but not limited to cardiovascular diseases, cancer, infectious diseases, gastroenterology, respiratory diseases, neonatology, and medical devices.”]  I encourage those working in drug discovery to consider pediatric applications early and often. Please also recall that many drugs used in this population were approved before the new tools became available.  When you consider estate planning, consider pediatric pharmacology. After all, government contribution to R/D is far below traditions in % of the federal budget and as a % of GDP.  The kids will be unaware of this until they are 30.  Let’s lend them a hand now to reduce the cost of the downstream consequences of inadequate care.

 

[Note:  On July 14, The Research to Accelerate Cures and Equity (RACE) for Children Act was introduced to Congress requiring compliance with the Pediatric Research Equity Act (PREA) of 2003.  This no doubt will be debated for quite some time. Alert readers will note that the word compliance almost always implies longer R/D cycles, higher drug prices and less venture investing in research.  Of course, RACE would not stimulate the optimization of generic drug use in children as described above.]