Cell Therapies: Commercializing a New Class of Biopharmaceuticals

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Over the past six months I have been honored and pleased to have seen and been part of an increasing focus and attention being paid to the unique manufacturing and bioproduction issues related to cell therapy.


Certainly it is the Cell Therapy Group's view, that this is both timely and much-needed as more cell therapies reach later-stage. Issues related to larger scale production and lowering the costs associated with it will be critical to successful commercialization of these products. It is encouraging to see both content-providers and and companies involved in potentially bringing solutions to these issues now bringing their focused energies to this sector.

This focus has come from a number of different sources including conferences focused solely on the topic, companies engaging stakeholders in identifying potential bottlenecks they might be positioned to solve, more conference sessions dedicated to these issues, and now a commitment by one of the leading publications in bioprocessing to engage both the cell therapy industry and the traditional bioprocessing community in stepping up the level of two-way education, dialog, and problem-solving that will be critical to commercializing these products.

In March/April 2011, watch for a special issue of BioProcess International entitled "Cell Therapies: Commercializing a New Class of Biopharmaceuticals".

BioProcess International is a publishing leader of cutting edge technologies, improved processes and breakthrough sciences. With this cell therapy focused issue, in partnership with ISCT and others, BPI is launching what we hope will be a regular supplement and increased focus on the unique bioproduction issues related to cell-based therapies.

BioProcess International aims to accomplish three main objectives with this supplement:
  • Educate the bioprocess and cell therapy market (suppliers and end-users) on the similarities and differences between the two processes;
  • Educate and encourage the investor community to keep increasing their interest and investment;
  • Expedite the commercialization process.

Distribution will include:

  • BPI's 30,010 qualified readers;
  • Delegates attending ISCT's 2011 Annual Meeting (included in all delegate bags)
  • Delegates attending ESACT 2011 (Chair drop at the Cell Therapy Plenary Session)
  • INTERPHEX 2011 Cell Therapy Roundtable (VIP Invitations, 200 attendees, produced by BPI)
  • BIO 2011 International Convention (BioProcess Theatre - Cell Therapy track)

If you are interested in advertising, click here for more info.

While the content for this issue is now being finalized, it you are interested in contributing something to BPI, we are looking for more cell therapy related content. As the cell therapy representative on BPI's advisory board I would be happy to champion it through submission.

Cheers.

--Lee

Biotech tax credit appears perfectly designed for cell therapy companies to recoup research dollars spent in 2009-10

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Stewart Lyman of Lyman BioPharma Consulting posted a great article in today's Xconomy summarizing some key points and links to more information about the rules governing the Therapeutic Discovery Project Credit which have now been released by the US Treasury Department. Today, a detailed fact sheet was released about the tax credit program and it seems almost perfectly designed for most cell therapy companies.

Lyman points out a few important details about the application schedule including:

1. The Formal IRS applications (Form 8942) will not be available until June 21st or thereabouts.

2. The application period opens on June 21 and ends on July 21. The postmark on the application is deemed to be the date of delivery. Preliminary review of the applications is to be completed by Sept. 30; this is to ensure that applicants are eligible taxpayers and that their applications are complete. Applicants will receive determinations as to whether or not they qualify for credits and/or grants, and how much they will receive, by Oct. 29.

By way of a little more background, the following is excerpted from a March Forbes.com article by Dean Zerbe:

What does the credit cover?

The credit/grant covers research in tax years beginning in 2009 and 2010. The taxpayer is provided a 50% credit/grant for qualified investments in "qualifying therapeutic discovery projects." What expenses count as qualified investments? The aggregate amount of costs paid or incurred in the taxable year for expenses necessary for and directly related to the conduct of a qualifying discovery project. What doesn't count? The pay of employees covered by 162(m)(3) of the tax code--think CEOs--doesn't count. Other excluded items: interest expenses; facility maintenance expenses (e.g. mortgage or rent payments, insurance, utility and maintenance and costs of employment of maintenance personnel); and certain indirect costs (basically general and administrative costs) as defined in the Treasury Regulations at 1.263A-1(e)(4).

What is a qualifying therapeutic discovery project?

According to the legislation, it's a project designed to do one of three things:

--Treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials and clinical studies, or carrying out research protocols for the purpose of securing federal government approval by the FDA.

--Diagnose diseases or conditions or to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions.

--Develop a product, process or technology to further the delivery or administration of therapeutics.

Finally, to qualify, a venture may not have more than 250 employees in all businesses of the taxpayer--meaning a small biotech project at a big company wouldn't qualify.

Which biotech companies might benefit?

Those that are investing significant resources in pre-clinical or clinical studies, which may take years to come to fruition to ultimately satisfy FDA requirements, could now recoup a significant portion of their expenses. Additionally, biotech start-ups focusing on the development of diagnostic assays or applications to advance therapeutics and treatments can also benefit. Finally, companies currently engaged in basic or applied research which may ultimately contribute to curing caner within the next 30 years may also be excellent candidates. Along these lines, companies studying signal transduction pathways, gene therapy and stem cell research seem like prime candidates.

The Cell Therapy Group will be collecting more information about the tax credit and service providers who might be recommended to assist in the application if needed. Contact CTG for more details or watch here for more information.

Google to Invest in Regenerative Medicine

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While the US government prints money to shore up failing and broken business models which no one likes but are considered simply too big (not too important or significant or even useful) to fail, Google is making money and investing it in start ups who expect nothing less than to create "disruptive, even world-changing technologies".

No suggestion here that GOOG is being altruistic, just that this is the way the new entrepreneur and investor class thinks. Opportunity and money are to be found in technologies that improve the way we live, work, play, eat, and think... and perhaps even improve the world.

To Google Ventures this has already meant wind farms, carbon emission reduction systems, green vehicles, and medical cures. To former Microsoft chief scientist Nathan Myhrvold and his high-level think tank, Intellectual Ventures, this means creating TerraPower - a company intending to revolutionize the nuclear power by developing reactors run on waste uranium - and also actively looking at regenerative medicine technologies.

Having formed the fund a little over a year ago, Google is only now starting to make a splash with the fund. Officially the fund has no specific industry focus saying on the Google Ventures website FAQ:

We are interested in a wide range of industries, including (but not limited to) consumer Internet, software, hardware, clean-tech, biotech, health care and others. First and foremost, we're looking for entrepreneurs who are tackling problems in creative and innovative ways, with the potential for significant financial return.

Unofficially and yet not so quietly, Google has named a few broad areas of interest. An article in Monday's New York Times quoted Google Ventures' managing partner, Bill Maris as saying that while they were not going to name particular investment themes, a few broad ares of interest include:

regenerative medicine, bioinformatics, cloud storage, companies that use large data sets, online monetization and mobile.

There it is. Regenerative medicine right there front and center.

In typical Google tradition, Maris, who looks all of 30 years old on the website, has a successfull and multidisciplinary track record. He was involved in founding Web hosting pioneer Burlee.com (now part of Web.com), where he built much of the key computing, network and technological infrastructure.Prior to that, Bill was a biotechnology and healthcare portfolio manager for Stockholm, Sweden-based Investor AB. Bill’s background also includes research at the Duke University Medical Center, Department of Neurobiology.

Google Ventures is said to be aiming at investing about $100 million a year. Any portion of that for regenerative medicine is more than welcome.

While traditional VC money remains reticent to back RM in any signifant way, Google's move confirms a trend we've been seeing and talking about at the Cell Therapy Group for the past 12 months or so. The multinational lifescience, biopharmaceutical, and healthcare companies along with strategic investors all now have regenerative medicine on their radar. They are all quietly and not-so quietly developing internal and external regenerative medicine strategies.

Please join us in welcoming regenerative medicine to the radar screen. It's bound to be an exciting ride ahead.

Autism-Topic Overview – WebMD

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What is autism?

Autism is a brain disorder that often makes it hard to communicate with and relate to others. With autism, the different areas of the brain fail to work together.

Most people with autism will always have some trouble relating to others. But early diagnosis and treatment have helped more and more people who have autism to reach their full potential.

Autism tends to run in families, so experts think it may be something that you inherit. Scientists are trying to find out exactly which genes may be responsible for passing down autism in families.

Other studies are looking at whether autism can be caused by other medical problems or by something in your child's surroundings.

False claims in the news have made some parents concerned about a link between autism and vaccines. But studies have found no link between vaccines and autism. It's important to make sure that your child gets all childhood vaccines. They help keep your child from getting serious diseases that can cause harm or even death.

Symptoms almost always start before a child is 3 years old. Usually, parents first notice that their toddler has not started talking yet and is not acting like other children the same age. But it is not unusual for a child with autism to start to talk at the same time as other children the same age, then lose his or her language skills.

Symptoms of autism include:

There is no "typical" person with autism. People can have many different kinds of behaviors, from mild to severe. Parents often say that their child with autism prefers to play alone and does not make eye contact with other people.

Autism may also include other problems:

There are guidelines your doctor will use to see if your child has symptoms of autism. The guidelines put symptoms into categories such as:

Your child may also have a hearing test and some other tests to make sure that problems are not caused by some other condition.

Treatment for autism involves special behavioral training. Behavioral training rewards appropriate behavior (positive reinforcement) to teach children social skills and to teach them how to communicate and how to help themselves as they grow older.

With early treatment, most children with autism learn to relate better to others. They learn to communicate and to help themselves as they grow older.

Depending on the child, treatment may also include such things as speech therapy or physical therapy. Medicine is sometimes used to treat problems such as depression or obsessive-compulsive behaviors.

Exactly what type of treatment your child needs depends on the symptoms, which are different for each child and may change over time. Because people with autism are so different, something that helps one person may not help another. So be sure to work with everyone involved in your child's education and care to find the best way to manage symptoms.

An important part of your child's treatment plan is making sure that other family members get training about autism and how to manage symptoms. Training can reduce family stress and help your child function better. Some families need more help than others.

Take advantage of every kind of help you can find. Talk to your doctor about what help is available where you live. Family, friends, public agencies, and autism organizations are all possible resources.

Remember these tips:

Raising a child with autism is hard work. But with support and training, your family can learn how to cope.

WebMD Medical Reference from Healthwise

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Autism-Topic Overview - WebMD

Signs of Autism – National Autism Association

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Autism is a neurodevelopmental disorder characterized by:

Because Autism is a spectrum disorder, it can range from very mild to very severe and occur in all ethnic, socioeconomic and age groups. Males are four times more likely to have autism than females. Some children with autism appear normal before age 1 or 2 and then suddenly regress and lose language or social skills they had previously gained. This is called the regressive type of autism.

Early Signs:

A person with ASD might:

People with autism may also:

Other Symptoms:

M-CHAT-RTM General Information

The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F; Robins, Fein, & Barton, 2009) is a 2-stage parent-report screening tool to assess risk for Autism Spectrum Disorder (ASD). The M-CHAT-R/F is an autism screening tool designed to identify children 16 to 30 months of age who should receive a more thorough assessment for possible early signs of autism spectrum disorder (ASD) or developmental delay.

The American Academy of Pediatrics (AAP) recommends that all children receive autism-specific screening at 18 and 24 months of age, in addition to broad developmental screening at 9, 18, and 24 months. The M-CHAT-R/F, one of the AAP recommended tools, can be administered at these well-child visits.

If you and your physician agree that further screening is needed, you can request a free developmental assessment through your State Department of Health.

For more information on M-CHAT-R, visit http://m-chat.org.

Source: http://m-chat.org.

Developmental Screening

Developmental screening is a short test to tell if children are learning basic skills when they should, or if they might have delays. During developmental screening the doctor might ask the parent some questions or talk and play with the child during an exam to see how she learns, speaks, behaves, and moves. A delay in any of these areas could be a sign of a problem.

All children should be screened for developmental delays and disabilities during regular well-child doctor visits at:

Additional screening might be needed if a child is at high risk for developmental problems due to preterm birth, low birth weight or other reasons. In addition, all children should be screened specifically for ASDs during regular well-child doctor visits at:

Additional screening might be needed if a child is at high risk for ASDs (e.g., having a sister, brother or other family member with an ASD) or if behaviors sometimes associated with ASDs are present.

It is important for doctors to screen all children for developmental delays, but especially to monitor those who are at a higher risk for developmental problems due to preterm birth, low birth weight, or having a brother or sister with an ASD.

If your childs doctor does not routinely check your child with this type of developmental screening test, ask that it be done. If the doctor sees any signs of a problem, a comprehensive diagnostic evaluation is needed.

Comprehensive Diagnostic Evaluation

The second step of diagnosis is a comprehensive evaluation. This thorough review may include looking at the childs behavior and development and interviewing the parents. It may also include a hearing and vision screening, genetic testing, neurological testing, and other medical testing.

In some cases, the primary care doctor might choose to refer the child and family to a specialist for further assessment and diagnosis. Specialists who can do this type of evaluation include:

Source: http://www.cdc.gov/ncbddd/autism/screening.html

If your child is young and you suspect there might be something wrong, immediately seek early intervention services for your child. Click here for more information on Early Intervention.

Originally posted here:
Signs of Autism - National Autism Association

Kentucky Autism Services and Supports

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Find providers in your area

The demands of caring for an individual with autism are great, and families frequently experience high levels of stress.

Often, the lack of appropriate services adds to the frustration of families.

To increase the awareness of currently available resources, the Kentucky Autism Training Center is gathering information about services to create an Kentucky Autism Supports and Services Directory.

The goal of the Kentucky Autism Services and Supports Directory is to include all providers who serve individuals with disabilities in Kentucky.

To be added to the Kentucky Autism Services and Supports Directory submit your organization application online. If you have any questions you can contact us at katc@louisville.edu or (502) 852-4631.

Please be aware that there is no implied endorsement of the listed programs in the Kentucky Autism Supports and Services Directory by the KATC. The purpose of the Kentucky Autism Services and Supports Directory is to help parents and professionals share information. It is recommended that parents speak to a representative of the program before enrolling their children, to ensure that the interests, skills, talents and needs of each child can be met in the program.

More here:
Kentucky Autism Services and Supports

Autism – KidsHealth

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You've probably heard about autism. You may know someone who is on what doctors call the "autism spectrum." It could be someone in your family or a kid at school. But what is autism? How does someone get it? And can it be treated?

Autism is a word that refers to a wide range of developmental disorders that some people are born with or develop early in life. This group of disorders makes up what doctors call the autism spectrum. Someone whose condition falls within the spectrum has autism spectrum disorder (ASD).

Autism affects the brain and makes communicating and interacting with other people (chatting, playing, hanging out, or socializing with others) more difficult.

People on the autism spectrum often have trouble talking and understanding language from an early age. It can be hard for them to play games and understand the rules when they are kids. As they become teens, people on the autism spectrum might have trouble understanding what clothes are cool to wear, or how to play sports, or how to just hang out and talk.

Not everybody with autism spectrum disorder has the same difficulties. Some people may have autism that is mild. Others may have autism that is more severe. Two people with autism spectrum disorder may not act alike or have the same skills. Some people with autism are especially good at music or computers or art just like other teens. Others may have trouble with speech and balance and coordination (just like other people!).

About 40% of people with autism spectrum disorder have average or above-average intelligence. The other 60% have intellectual disabilities that range from mild to severe.

Right now, doctors and researchers don't fully understand what causes autism. Scientists believe it has something to do with genes and

Some studies suggest that something in the environment could make kids more likely to develop a spectrum disorder, but so far scientists haven't identified what that thing might be. Other studies have suggested that autism could be caused by viruses, allergies, or vaccines. But none of these theories have been scientifically proven. Most of the scientific studies on vaccines have found no link between vaccines and autism.

Figuring out what causes autism is hard because of how complicated the human brain is. Current research focuses on genetic causes, but since there are so many genes in the human body, it could be a long time before researchers know exactly which ones are involved.

Autism is usually diagnosed when a child is between 18 months and 4 years old. The earlier kids are diagnosed with a spectrum disorder, the sooner they can start getting help with their language and learning skills. There are no medical tests for autism, but doctors may do certain tests to rule out other possible problems, including hearing loss and difficulties with learning and paying attention.

Diagnosing autism can involve lots of health care professionals such as psychologists, neurologists, speech therapists, psychiatrists, and developmental pediatricians. To decide whether a child has autism spectrum disorder, doctors and other professionals compare the child's levels of development and behavior with those of other kids the same age.

Teens on the autism spectrum might have more problems with learning or making friends. Some can be like other teens much of the time but might have differences in the way they learn or in their interests. Some people on the spectrum have special gifts and talents.

Some kids with autism spectrum disorder can go to school just like their peers. People with moderate or severe autism spectrum disorder usually don't take part in regular classes typically, they have more trouble talking, and some might not talk at all.

Sometimes it can seem as if kids and teens with autism want to be left alone because they have trouble looking at, talking to, or hanging out with people. Sometimes they can seem rude or act like they're not interested in others.

Because of the way their brains work, it can be hard for some teens with autism to look at people while they talk. They also may have trouble understanding jokes or sarcasm. And since they've been taught by other people how to talk, teens on the spectrum might imitate what they have learned and their voices might sound flat or boring.

People with spectrum disorders often do things that seem unusual or repetitive, like saying the same word over and over or moving a body part in a certain way. When they do this, it's almost as if their brains have a case of the hiccups. They know they're doing it, but often have a hard time controlling it.

Sometimes people with autism may seem insensitive or look unemotional, but often they just don't know how to express how they're feeling. It doesn't mean they don't have feelings it can just be more difficult for them to show those feelings or understand the feelings of others.

There is no cure for autism, but treatment can make a big difference by helping people with autism spectrum disorder have fewer issues related to their conditions. Therapy can help kids with autism learn language and life skills, and ways to develop socially and behaviorally so they can enjoy their lives like other kids.

The brains of kids under 5 years old often adapt more easily. That's why it's best to start treatment for autism as early as possible. A treatment program might include:

Many other types of therapy (including diet, music, and art therapies) can help people with autism spectrum disorder. Teens with autism who don't attend regular classes in middle school and high school can also benefit from going to special-education classes or separate schools for students with disabilities.

You're bound to meet someone with autism spectrum disorder at some point. If you know someone who is on the autism spectrum, try to be understanding and patient. Don't expect the person to view the world the same way you do.

Sometimes it can be hard for teens with autism to interact with other people. For them, learning to communicate and express emotions can be like learning a foreign language. When even a casual conversation requires so much effort, and when hanging out or talking to a classmate becomes stressful and frustrating, it can be hard for people on the autism spectrum to make friends.

Even though people on the autism spectrum see the world in a different way, there's plenty to connect on, like playing video games. If you know someone on the autism spectrum, you can help just by including him or her or where possible or hanging out one-on-one. Watching how you interact with other people can help the person learn rules for friendships and make it easier to make other friends.

Reviewed by: Raphael Bernier, PhDDate reviewed: January 2014

Original post:
Autism - KidsHealth

Autism-Symptoms – WebMD

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Core symptoms

The severity of symptoms varies greatly, but all people with autism have some core symptoms in the areas of:

Symptoms of autism are usually noticed first by parents and other caregivers sometime during the child's first 3 years. Although autism is present at birth (congenital), signs of the disorder can be difficult to identify or diagnose during infancy. Parents often become concerned when their toddler does not like to be held; does not seem interested in playing certain games, such as peekaboo; and does not begin to talk. Sometimes, a child with autism will start to talk at the same time as other children the same age, then lose his or her language skills. Parents also may be confused about their child's hearing abilities. It often seems that a child with autism does not hear, yet at other times, he or she may appear to hear a distant background noise, such as the whistle of a train.

With early and intensive treatment, most children improve their ability to relate to others, communicate, and help themselves as they grow older. Contrary to popular myths about children with autism, very few are completely socially isolated or "live in a world of their own."

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Autism-Symptoms - WebMD

Autism Spectrum: Get Facts on the Disorders

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Autism Autism Overview

Autism is a complex developmental disorder that has the following three defining core features:

A number of other associated symptoms frequently coexist with autism. Most people with autism have problems using language, forming relationships, and appropriately interpreting and responding to the external world around them.

Autism is a behaviorally defined developmental disorder that begins in early childhood. Although the diagnosis of autism may not be made until a child reaches preschool or school age, the signs and symptoms of autism may be apparent by the time the child is aged 12-18 months, and the behavioral characteristics of autism are almost always evident by the time the child is aged 3 years. Language delay in the preschool years (younger than 5 years) is typically the presenting problem for more severely affected children with autism. Higher functioning children with autism are generally identified with behavioral problems when they are aged approximately 4-5 years or with social problems later in childhood. Autism disorder persists throughout the person's lifetime, although many people are able to learn to control and modify their behavior to some extent.

As of May 2013, autism, along with what were formally described as Asperger's syndrome and pervasive developmental disorders were classified by the American Psychiatric Association as autism spectrum disorders (ASDs).

All of these disorders are characterized by varying degrees of problems with communication, social interaction, and atypical, repetitive behaviors.

There is a wide range of symptoms, severity, and other manifestations of these disorders. The expression of autism spectrum disorders varies widely among affected individuals. A child with significant impairment in all three of the core functioning areas (socialization, communication, and atypical, repetitive behaviors) may have a lower level-functioning autism spectrum disorder, while a child with similar problems but without delays in language development may have a higher level-functioning autism spectrum disorder.

Some people are affected with fairly mild symptoms and signs of autism. Many of these individuals learn to live independent lives. Others are more severely affected and require lifelong care and supervision.

As the following statistics indicate, autism is a common developmental disorder.

There is no cure for autism; however, there is good news.

Medically Reviewed by a Doctor on 7/18/2014

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Autism Spectrum: Get Facts on the Disorders

Autism – Autism Spectrum Disorders

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What is autism?

Autism is a developmental disability. Children with autism, also known as autism spectrum disorder or ASD, have social, communication and language problems. They also have restricted and repetitive patterns of behavior, interests, or activities, such as flipping objects, echolalia, or excessive smelling or touching of objects. Autism may be mild or severe. All children with autism don't have the exact same problems. Children with autism may have the following social and communication skills and common behaviors:

Social Skills

Your child may have problems using social skills to connect with other people. He may seem to be in his own world. It may be hard for him to

Communication Skills

Your child may have trouble with communication skills like understanding, talking with others, reading or writing. Sometimes, she might lose words or other skills that she's used before. Your child may have problems

Your child also may

Common Behaviors

A childwith autism may

It is important to have your child evaluated by professionals who know about autism. Speech-language pathologists (SLPs), typically as part of a team, may diagnose autism. The team might include pediatricians, neurologists, occupational therapists, physical therapists, and developmental specialists, among others. SLPs play a key role because problems with social skills and communication are often the first symptoms of autism. SLPs should be consulted early in the evaluation process. There are a number of tests and observational checklists available to evaluate children with developmental problems. The most important information, however, comes from parents and caregivers who know the child best and can tell the SLP and others all about the child's behavior.

Problems with social uses of language may be a social communication disorder, sometimes called a pragmatic language disorder. All children with autism have social communication problems. Children with other disorders also may have social communication problems. Sometimes a child just has a social communication disorder. Children with social communication problems also may have other language disorders. These may include problems with vocabulary, grammar, reading, or writing.

A social communication disorder may lead to behavior problems. Children may be frustrated because of their communication problems. They may not be able to share their wants or needs.

Children who have social communication problems without restricted or repetitive patterns of behavior, interests, or activities may be diagnosed as having a Social (Pragmatic) Communication Disorder rather than an Autism Spectrum Disorder.

There is no known cure for autism. In some cases, medications and dietary restrictions may help control symptoms. Intervention should begin when the child is young. Early intervention and preschool programs are very important. An evaluation by an SLP should be completed to determine social skill, communication, language, and behavior needs. An appropriate treatment plan that meets the needs of the child and family can then be established. Treatment may include any combination of traditional speech and language approaches, augmentative and alternative communication, and behavioral interventions. It is also important to have the child's hearing evaluated to rule out hearing loss.

Read more in this guide from the Agency for Healthcare Research and Quality (AHRQ), Therapies for Children with Autism Spectrum Disorders: A Review of the Research for Parents and Caregivers.

Autism is a lifelong problem with a number of possible causes, including but not limited to:

An SLP may work with your child at home, in the classroom, or in an office. Your child might work on some goals alone or in small groups. Small groups allow your child to practice skills with other children.

An SLP will help your child understand, talk, read, and write. SLPs work with children on social skills too. They also work with children who don't talk at all. An SLP may help your child:

An SLP will help your child understand and use words. Your child may learn to

SLPs also work on reading and writing. Your child may learn to

An SLP may use augmentative and alternative communication (AAC) with your child. AAC should be used at home and when you go out. It's not just for school.AAC includes

Many children with autism can benefit from AAC. AAC may even help children learn to talk.

Children with autism may to like the way foods look, taste, or smell. They may not like how some foods feel in their mouth. Your child may

An SLP can help your child accept new foods.

ASHA developed some resources about autism for clinicians who work with autism spectrum disorders.

Additional Resources

This list is not exhaustive and inclusion does not imply endorsement of the organization or the content of the website by ASHA.

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Autism - Autism Spectrum Disorders

Autism Spectrum Disorder: Get Facts on Tests and Treatment

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Autism Symptoms and Screening

Medical Author: David Perlstein, MD FAAP Medical Editor: William C. Shiel, Jr., MD, FACP, FACR

It is commonplace to have a family member or close friend with a child diagnosed with one of the autism spectrum disorders (ASDs, including autistic disorder, Asperger disorder, pervasive developmental disorder). These are a set of neurodevelopmental disabilities affecting young children and adults, which are currently not considered "curable". The goals of management include minimizing the symptoms and maximizing both independent function and quality of life. These are not uncommon disorders. Their prevalence has been estimated as approximately 6.5 per 1000 children, or 1 in every 150 children. Many believe that there is an "Autism Epidemic." However, as with many diseases and disorders, there are many reasons for this high prevalence.

Fortunately, significant media coverage and increased research have resulted in a better educated public and more vigilant healthcare practitioners. It is clear that early diagnosis and intervention are associated with better outcomes.

The American Academy of Pediatrics (AAP) published an updated guide for the "Management of Children with Autism Spectrum Disorders." In this publication, both background information and management choices are reviewed. In addition the AAP's approved "Surveillance and Screening Algorithm: Autism Spectrum Disorders (ASDs)" is introduced. Currently this translates into the following: All children should be screened for autism at 18 months and again at 2 years of age, and at any time a parent raises a concern about autism spectrum disorders (even if they have no signs of developmental delay). Although many health care practitioners were already screening, the process has been formalized and I expect that even more children will be referred, resulting in earlier diagnosis and intervention.

The rest is here:
Autism Spectrum Disorder: Get Facts on Tests and Treatment

Autism Treatment Myrtle Beach SC – Autism Support Network

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Before Wendy Radcliff agreed to marry Scott Finn, she made it clear they would have to live in her home state of West Virginia.

Politically active, Radcliff loved West Virginia and wanted to spend her life there, helping to make it a better place. The couple married, had a son, Max, and built their life together in Radcliff's hometown of Charleston.

Then, just before his second birthday, Max was diagnosed with autism.

Radcliff had insurance -- good insurance, she says -- through West Virginia's Public Employees Insurance Agency, which she received through her work for the state. But although PEIA paid for the autism diagnosis, it would not pay for the prescribed treatment -- applied behavior analysis, or ABA. There are a similar models that go by different names, but ABA is by far the best-known.

ABA is typically administered one on one, in a program that is customized to the individual. It involves breaking down learning tasks into small steps, and teaching them over and over in a reinforcing way until they are mastered.

It is the best-researched and most effective current treatment for autism, experts say.

By the time Max was 4, Radcliff and Finn were spending $750 to $1,000 a week to treat Max.

"Our credit cards were being used to pay for things that they shouldn't be paying for, like groceries and utility bills, because we were spending any cash we had on our therapists," says Radcliff.

And even then, they struggled to get the right therapy, Radcliff says.

"In West Virginia, because insurance will not cover ABA, it's very difficult to find people that know and are trained in how to do ABA -- they're just not available and around because of that," says Radcliff.

They cobbled together a few hours a week of basic ABA therapy, sometimes administered by inexperienced, overwhelmed or noncertified therapists. At one point, desperate for help, Radcliff even had her brother trained to administer a few hours a week of basic ABA therapy, she says.

"We only knew of a couple of ABA therapists even in the Kanawha Valley where we lived. And [they] were being overused by people -- they just didn't have enough hours in the day."

Research suggests any child with autism, regardless of severity, has an equal chance at "best outcome" if the child completes an ABA program (average is three years to completion) that starts before the age of 3 1/2, says Kristi Oldham, program director for the Lovaas Institute Midwest Headquarters in Minneapolis, Minnesota, which provides early intervention services for kids with autism.

Sixty-seven percent of such children can expect a "best outcome," which Lovaas defines as a child who is mainstreamed in a classroom without additional support, has no diagnoses on the autism spectrum and has a typical IQ, Oldham says.

And yet PEIA, like many insurance companies across the nation, does not cover the treatment for kids diagnosed with autism.

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Autism spectrum disorder – Mayo Clinic

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Autism spectrum disorder is a serious neurodevelopmental disorder that impairs a child's ability to communicate and interact with others. It also includes restricted repetitive behaviors, interests and activities. These issues cause significant impairment in social, occupational and other areas of functioning.

Autism spectrum disorder (ASD) is now defined by the American Psychiatric Association's Diagnosis and Statistical Manual of Mental Disorders (DSM-5) as a single disorder that includes disorders that were previously considered separate autism, Asperger's syndrome, childhood disintegrative disorder and pervasive developmental disorder not otherwise specified.

The term "spectrum" in autism spectrum disorder refers to the wide range of symptoms and severity. Although the term "Asperger's syndrome" is no longer in the DSM, some people still use the term, which is generally thought to be at the mild end of autism spectrum disorder.

The number of children diagnosed with autism spectrum disorder is rising. It's not clear whether this is due to better detection and reporting or a real increase in the number of cases, or both.

While there is no cure for autism spectrum disorder, intensive, early treatment can make a big difference in the lives of many children.

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Autism spectrum disorder - Mayo Clinic

Autism spectrum disorder: MedlinePlus Medical Encyclopedia

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At this time, there is no cure for ASD. An early, intensive, appropriate treatment program will greatly improve the outlook for most young children with ASD. Most programs build on the interests of the child in a highly structured schedule of constructive activities.

The best treatment plan may use a combination of techniques, including:

APPLIED BEHAVIORAL ANALYSIS (ABA)

This program is for younger children. It can be effective in some cases. ABA uses one-on-one teaching that reinforces the practice of various skills. The goal is to get the child close to normal developmental functioning.

ABA programs are usually done in a child's home under the supervision of a behavioral psychologist. These programs can be very expensive and have not been widely adopted by school systems. Parents often must seek funding and staffing from other sources, which can be hard to find in many communities.

TEACCH

Another program is called the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH). TEACCH was developed as a statewide program in North Carolina. It uses picture schedules and other visual cues that help the child work independently and organize and structure their environments.

Though TEACCH tries to improve a child's adaptation and skills, it also accepts the problems associated with ASD. Unlike ABA programs, TEACCH programs do not expect children to achieve typical development with treatment.

MEDICINE

There is no medicine that treats ASD itself. But medicines are often used to treat behavior or emotional problems that people withASD may have, including:

Currently, only risperidone is approved to treat children ages 5through 16 for the irritability and aggression that can occur with ASD. Other medicines that may also be used include mood stabilizers and stimulants.

DIET

Some children withASD appear to respond to a gluten-free or casein-free diet. Gluten is found in foods containing wheat, rye, and barley. Casein is found in milk, cheese, and other dairy products. Not all experts agree that dietary changes will make a difference, and not all studies of this method have shown positive results.

If you are considering these or other dietary changes, talk to both a doctor who specializes in the digestive system (gastroenterologist) and a registered dietitian. You want to be sure that the child is still receiving enough calories, nutrients, and a balanced diet.

OTHER APPROACHES

Beware that there are widely publicized treatments forASD that do not have scientific support, and reports of miracle cures that do not live up to expectations. If your child has ASD, it may be helpful to talk with other parents of children withASD andASD specialists. Follow the progress of research in this area, which is rapidly developing.

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Autism spectrum disorder: MedlinePlus Medical Encyclopedia

About Autism | Autism Society

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Autism spectrum disorder (ASD) is a complex developmental disability; signs typically appear during early childhood and affect a persons ability to communicate, and interact with others. ASD is defined by a certain set of behaviors and is a spectrum condition that affects individuals differently and to varying degrees. There is no known single cause of autism, but increased awareness and early diagnosis/intervention and access to appropriate services/supports lead to significantly improved outcomes. Some of the behaviors associated with autism include delayed learning of language; difficulty making eye contact or holding a conversation; difficulty with executive functioning, which relates to reasoning and planning; narrow, intense interests; poor motor skills and sensory sensitivities. Again, a person on the spectrum might follow many of these behaviors or just a few, or many others besides. The diagnosis of autism spectrum disorder is applied based on analysis of all behaviors and their severity.

In March 2014, the Centers for Disease Control and Prevention issued their ADDM autism prevalence report.The report concluded that the prevalence of autism had risen to 1 in every 68 births in the United States nearly twice as great as the 2004 rate of 1 in 125 and almost 1 in 54 boys.The spotlight shining on autism as a result has opened opportunities for the nation to consider how to serve families facing a lifetime of supports for their children. In June 2014, researchers estimated the lifetime cost of caring for a child with autism is as great as $2.4 million. The Autism Society estimates that the United States is facing almost $90 billion annually in costs for autism. (This figure includes research, insurance costs and non-covered expenses, Medicaid waivers for autism, educational spending, housing, transportation, employment, related therapeutic services and caregiver costs.)

Autism is treatable. Children do not outgrow autism, but studies show that early diagnosis and intervention lead to significantly improved outcomes. For more information on developmental milestones,visit the CDCs Know the Signs. Act Early site.

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What Is Autism? | | Autism Speaks

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What Is Autism? What is Autism Spectrum Disorder?

Autism spectrum disorder (ASD) and autism are both general terms for a group of complex disorders of brain development. These disorders are characterized, in varying degrees, by difficulties in social interaction, verbal and nonverbal communication and repetitive behaviors. With the May 2013 publication of the DSM-5 diagnostic manual, all autism disorders were merged into one umbrella diagnosis of ASD. Previously, they were recognized as distinct subtypes, including autistic disorder, childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified (PDD-NOS) and Asperger syndrome.

ASD can be associated with intellectual disability, difficulties in motor coordination and attention and physical health issues such as sleep and gastrointestinal disturbances. Some persons with ASD excel in visual skills, music, math and art.

Autism appears to have its roots in very early brain development. However, the most obvious signs of autism and symptoms of autism tend to emerge between 2 and 3 years of age. Autism Speaks continues to fund research on effective methods for earlier diagnosis, as early intervention with proven behavioral therapies can improve outcomes. Increasing autism awareness is a key aspect of this work and one in which our families and volunteers play an invaluable role. Learn more

Autism statistics from the U.S. Centers for Disease Control and Prevention (CDC) identify around 1 in 68 American children as on the autism spectruma ten-fold increase in prevalence in 40 years. Careful research shows that this increase is only partly explained by improved diagnosis and awareness. Studies also show that autism is four to five times more common among boys than girls. An estimated 1 out of 42 boys and 1 in 189 girls are diagnosed with autism in the United States.

ASD affects over 3 million individuals in the U.S. and tens of millions worldwide. Moreover, government autism statistics suggest that prevalence rates have increased 10 to 17 percent annually in recent years. There is no established explanation for this continuing increase, although improved diagnosis and environmental influences are two reasons often considered. Learn more

Not long ago, the answer to this question would have been we have no idea. Research is now delivering the answers. First and foremost, we now know that there is no one cause of autism just as there is no one type of autism. Over the last five years, scientists have identified a number of rare gene changes, or mutations, associated with autism. A small number of these are sufficient to cause autism by themselves. Most cases of autism, however, appear to be caused by a combination of autism risk genes and environmental factors influencing early brain development.

In the presence of a genetic predisposition to autism, a number of nongenetic, or environmental, stresses appear to further increase a childs risk. The clearest evidence of these autism risk factors involves events before and during birth. They include advanced parental age at time of conception (both mom and dad), maternal illness during pregnancy and certain difficulties during birth, particularly those involving periods of oxygen deprivation to the babys brain. It is important to keep in mind that these factors, by themselves, do not cause autism. Rather, in combination with genetic risk factors, they appear to modestly increase risk.

A growing body of research suggests that a woman can reduce her risk of having a child with autism by taking prenatal vitamins containing folic acid and/or eating a diet rich in folic acid (at least 600 mcg a day) during the months before and after conception.

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Autism, Autistic Spectrum Disorders (ASD) and Pervasive …

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What are the autistic spectrum disorders (ASD)? Autism spectrum disorders, or ASD, are also called pervasive developmental disorders (PDD) because they involve delay in many areas of development. PDD or ASD is a category that includes five different disorders of development, each with differing severities and patterns:

For more information on ASD and PDD:

What is autism or autistic disorder? Autism is the most common autism spectrum disorder. People with autism have differences in the development of their thinking, language, behavior and social skills. The differences appear before age three, and can be diagnosed by 18 months. For a diagnosis of autism, a child must have a specified number of symptoms in these areas:

If you think your child may have these traits, talk to your health care provider and find out how to have your child evaluated.

What is Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS)? PDD-NOS, also called atypical autism or mild autism, means having differences in some of the same areas as in autism, only not to such a great extent. A child with PDD-NOS does not meet the criteria for any other specific PDD/ASD.

What is Asperger syndrome? See YourChild: Asperger syndrome.

What is Childhood Disintegrative Disorder (CDD)? See these resources:

How common are the autism spectrum disorders? The Center for Disease Control and Preventions (CDC) Autism and Developmental Disabilities Monitoring (ADDM) Network released data in 2007 that found about 1 in 150 8-year-old children in the areas of the United States they monitor had an ASD1 For more on the numbers: Prevalence of ASDs, from the CDC.

Autism occurs throughout the world in families of all racial, ethnic and social backgrounds. Boys are four times more likely to have autism than girls2.

The MIND Institute in California found that the number of cases of autism is on the rise. This is probably a national trend.

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Autism, Autistic Spectrum Disorders (ASD) and Pervasive ...

NIMH Autism Spectrum Disorder

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What Is Autism Spectrum Disorder?

Autism spectrum disorder (ASD) is characterized by:

The term spectrum refers to the wide range of symptoms, skills, and levels of impairment or disability that children with ASD can have. Some children are mildly impaired by their symptoms, while others are severely disabled. The latest edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) no longer includes Aspergers syndrome; the characteristics of Aspergers syndrome are included within the broader category of ASD.

Information on ASD can also be found on the Eunice Kennedy Shriver National Institute of Child Health and Human Development website and the Centers for Disease Control and Prevention website.

Scientists don't know the exact causes of autism spectrum disorder (ASD), but research suggests that both genes and environment play important roles.

Genetic factors

In identical twins who share the exact same genetic code, if one has ASD, the other twin also has ASD in nearly 9 out of 10 cases. If one sibling has ASD, the other siblings have 35 times the normal risk of also developing the disorder. Researchers are starting to identify particular genes that may increase the risk for ASD.

Still, scientists have only had some success in finding exactly which genes are involved. For more information about such cases, see the information below about Fragile X syndrome and tuberous sclerosis.

Most people who develop ASD have no reported family history of autism, suggesting that random, rare, and possibly many gene mutations are likely to affect a person's risk. Any change to normal genetic information is called a mutation. Mutations can be inherited, but some arise for no reason. Mutations can be helpful, harmful, or have no effect.

Having increased genetic risk does not mean a child will definitely develop ASD. Many researchers are focusing on how various genes interact with each other and environmental factors to better understand how they increase the risk of this disorder.

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NIMH Autism Spectrum Disorder

Autism spectrum – Wikipedia, the free encyclopedia

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The autism spectrum or autistic spectrum describes a range of conditions classified as neurodevelopmental disorders in the fifth revision of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5). The DSM-5, published in 2013, redefined the autism spectrum to encompass the previous (DSM-IV-TR) diagnoses of autism, Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), and childhood disintegrative disorder.[1] These disorders are characterized by social deficits and communication difficulties, stereotyped or repetitive behaviors and interests, sensory issues, and in some cases, cognitive delays.

A revision to autism spectrum disorder (ASD) was proposed in the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5), released May 2013.[2] The new diagnosis encompasses previous diagnoses of autistic disorder, Asperger's disorder, childhood disintegrative disorder, and PDD-NOS. Rather than categorizing these diagnoses, the DSM-5 will adopt a dimensional approach to diagnosing disorders that fall underneath the autism spectrum umbrella. It is thought that individuals with ASDs are best represented as a single diagnostic category because they demonstrate similar types of symptoms and are better differentiated by clinical specifiers (i.e., dimensions of severity) and associated features (i.e., known genetic disorders, epilepsy and intellectual disability). An additional change to the DSM includes collapsing social and communication deficits into one domain. Thus, an individual with an ASD diagnosis will be described in terms of severity of social communication symptoms, severity of fixated or restricted behaviors or interests and associated features. The restriction of onset age has also been loosened from 3 years of age to "early developmental period", with a note that symptoms may manifest later when demands exceed capabilities.

Autism forms the core of the autism spectrum disorders. Asperger syndrome is closest to autism in signs and likely causes;[3] unlike autism, people with Asperger syndrome have no significant delay in language development.[4] PDD-NOS is diagnosed when the criteria are not met for a more specific disorder. Some sources also include Rett syndrome and childhood disintegrative disorder, which share several signs with autism but may have unrelated causes; other sources differentiate them from ASD, but group all of the above conditions into the pervasive developmental disorders.[3][5]

Autism, Asperger syndrome, and PDD-NOS are sometimes called the autistic disorders instead of ASD,[6] whereas autism itself is often called autistic disorder, childhood autism, or infantile autism.[7] Although the older term pervasive developmental disorder and the newer term autism spectrum disorder largely or entirely overlap,[5] the former was intended to describe a specific set of diagnostic labels, whereas the latter refers to a postulated spectrum disorder linking various conditions.[8] ASD, in turn, is a subset of the broader autism phenotype (BAP), which describes individuals who may not have ASD but do have autistic-like traits, such as avoiding eye contact.[7]

Under the DSM-5, autism is characterized by persistent deficits in social communication and interaction across multiple contexts, as well as restricted, repetitive patterns of behavior, interests, or activities. These deficits are present in early childhood, and lead to clinically significant functional impairment.[9] There is also a unique form of autism called autistic savantism, where a child can display outstanding skills in music, art, and numbers with no practice.[10]

Asperger syndrome was distinguished from autism in the DSM-IV by the lack of delay or deviance in early language development.[11] Additionally, individuals diagnosed with Asperger syndrome did not have significant cognitive delays.[12]PDD-NOS was considered "subthreshold autism" and "atypical autism" because it was often characterized by milder symptoms of autism or symptoms in only one domain (such as social difficulties).[13] In the DSM-5, both of these diagnoses have been subsumed into autism spectrum disorder.[9]

Although autism spectrum disorders are thought to follow two possible developmental courses, most parents report that symptom onset occurred within the first year of life.[14][15] One course of development follows a gradual course of onset in which parents report concerns in development over the first two years of life and diagnosis is made around 34 years of age. Some of the early signs of ASDs in this course include decreased looking at faces, failure to turn when name is called, failure to show interests by showing or pointing, and delayed pretend play.[16] A second course of development is characterized by normal or near-normal development followed by loss of skills or regression in the first 23 years. Regression may occur in a variety of domains, including communication, social, cognitive, and self-help skills; however, the most common regression is loss of language.[17][18] There continues to be a debate over the differential outcomes based on these two developmental courses. Some studies suggest that regression is associated with poorer outcomes and others report no differences between those with early gradual onset and those who experience a regression period.[19] Overall, the prognosis is poor for persons with classical (Kanner-type) autism with respect to academic achievement and poor to below-average for persons across the autism spectrum with respect to independent living abilities; in each case, a lack of early intervention exacerbates the odds against success.[19] However, many individuals show improvements as they grow older. The two best predictors of favorable outcome in autism are the absence of intellectual disability and the development of some communicative speech prior to five years of age.[medical citation needed] Overall, the literature stresses the importance of early intervention in achieving positive longitudinal outcomes.[20]

While a specific cause or specific causes of autism spectrum disorders has yet to be found, many risk factors have been identified in the research literature that may contribute to the development of an ASD. These risk factors include genetics, prenatal and perinatal factors, neuroanatomical abnormalities, and environmental factors. It is possible to identify general risk factors, but much more difficult to pinpoint specific factors. In the current state of knowledge, prediction can only be of a global nature and therefore requires the use of general markers.[21]

The results of family and twin studies suggest that genetic factors play a role in the etiology of autism and other pervasive developmental disorders.[22] Studies have consistently found that the prevalence of autism in siblings of autistic children is approximately 15 to 30 times greater than the rate in the general population.[23] In addition, research suggests that there is a much higher concordance rate among monozygotic twins compared to dizygotic twins.[24] It appears that there is no single gene that can account for autism. Instead, there seem to be multiple genes involved, each of which is a risk factor for part of the autism syndrome through various groups.[25][26][27]

A number of prenatal and perinatal complications have been reported as possible risk factors for autism. These risk factors include maternal gestational diabetes, maternal and paternal age over 30, bleeding after first trimester, use of prescription medication (e.g. valproate
) during pregnancy, and meconium in the amniotic fluid. While research is not conclusive on the relation of these factors to autism, each of these factors has been identified more frequently in autistic children compared to their non-autistic siblings and other normally developing youth.[30]

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Autism spectrum - Wikipedia, the free encyclopedia

Autism Fact Sheet: National Institute of Neurological …

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Autism spectrum disorder (ASD) is a range of complex neurodevelopment disorders, characterized by social impairments, communication difficulties, and restricted, repetitive, and stereotyped patterns of behavior. Autistic disorder, sometimes called autism or classical ASD, is the most severe form of ASD, while other conditions along the spectrum include a milder form known as Asperger syndrome, and childhood disintegrative disorder and pervasive developmental disorder not otherwise specified (usually referred to as PDD-NOS). Although ASD varies significantly in character and severity, it occurs in all ethnic and socioeconomic groups and affects every age group. Experts estimate that 1 out of 88 children age 8 will have an ASD (Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report, March 30, 2012). Males are four times more likely to have an ASD than females.

The hallmark feature of ASD is impaired social interaction. As early as infancy, a baby with ASD may be unresponsive to people or focus intently on one item to the exclusion of others for long periods of time. A child with ASD may appear to develop normally and then withdraw and become indifferent to social engagement.

Children with an ASD may fail to respond to their names and often avoid eye contact with other people. They have difficulty interpreting what others are thinking or feeling because they cant understand social cues, such as tone of voice or facial expressions, and dont watch other peoples faces for clues about appropriate behavior. They may lack empathy.

Many children with an ASD engage in repetitive movements such as rocking and twirling, or in self-abusive behavior such as biting or head-banging. They also tend to start speaking later than other children and may refer to themselves by name instead of I or me. Children with an ASD dont know how to play interactively with other children. Some speak in a sing-song voice about a narrow range of favorite topics, with little regard for the interests of the person to whom they are speaking.

Children with characteristics of an ASD may have co-occurring conditions, including Fragile X syndrome (which causes intellectual disability), tuberous sclerosis, epileptic seizures, Tourette syndrome, learning disabilities, and attention deficit disorder. About 20 to 30 percent of children with an ASD develop epilepsy by the time they reach adulthood..

ASD varies widely in severity and symptoms and may go unrecognized, especially in mildly affected children or when it is masked by more debilitating handicaps. Very early indicators that require evaluation by an expert include:

Later indicators include:

Health care providers will often use a questionnaire or other screening instrument to gather information about a childs development and behavior. Some screening instruments rely solely on parent observations, while others rely on a combination of parent and doctor observations. If screening instruments indicate the possibility of an ASD, a more comprehensive evaluation is usually indicated.

A comprehensive evaluation requires a multidisciplinary team, including a psychologist, neurologist, psychiatrist, speech therapist, and other professionals who diagnose children with ASDs. The team members will conduct a thorough neurological assessment and in-depth cognitive and language testing. Because hearing problems can cause behaviors that could be mistaken for an ASD, children with delayed speech development should also have their hearing tested.

Children with some symptoms of an ASD but not enough to be diagnosed with classical autism are often diagnosed with PDD-NOS. Children with autistic behaviors but well-developed language skills are often diagnosed with Asperger syndrome. Much rarer are children who may be diagnosed with childhood disintegrative disorder, in which they develop normally and then suddenly deteriorate between the ages of 3 to 10 years and show marked autistic behaviors.

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Autism Fact Sheet: National Institute of Neurological ...