GLG News by Video Game Software and Hardware Experts (North America)

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Abilify is Go to Drug for Adjunctive treatment for Depression

August 9, 2007

ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder | www.pipelinereview.com

1) Because of its excellent safety profile, enhanced side effect profile (e.g, weight gain, carbohydrate metabolism abnormalities) compared to other atypical antipsychotics such as risperdol, zyprexa and seroquel, this is an exciting 'go-to' medication 2) Best for augmentation, and one of our go-to medications for patients with both unipolar/major depression and bipolar disorder 3) Low dose augmentation is typically best which further enhances treatment response without problematic side effects

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Key Determinant which treatment works best for which particular patient

July 24, 2007

Studies Track Treatment Outcomes for Kids With ADHD | www.forbes.com

1. These are landmark studies helping us better understand the long-term outcome of children with ADHD 2. Recognize that even with treatment the symptoms do not go away 3. Have to take a medical approach analogous to other medical conditions, e.g, diabetes where biologic intervention (e.g, insulin) and psychosocial intervention (diet and excercise)

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

More questions than answers raised by this report

July 24, 2007

UK Regulator: 1 Person in 10 on Acomplia Experiences Psychiatric Side Effects | www.acompliareport.com

1. These type of reports can be concerning but are countered by rates of 'psychiatric events/reactions' in the general community. 2. There are key questions, e.g, how many dieters had diagnosed (or undiagnosed) psychiatric conditions? 3. Tougher warnings can be good if it warns physicians and patients that medications are never magic bullets and there can be side effects with any medication

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Very exciting new lead in ADHD research

July 12, 2007

Shire Receives Approvable Letter from FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD | www.pipelinereview.com

1. While 70% of ADHD patients respond to stimulants and Strattera, 30% do not; thus, a large population who need new treatment approaches 2. Extended release preparation offers significant advantages 3. This medication has shown some efficacy in controlled study with tics/tourettes-often comorbid with ADHD and has safety profile far superior to clonidine

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

More of the same with a twist

July 12, 2007

INVEGA(TM) Receives Marketing Authorization In European Union For Treatment Of Schizophrenia | www.pipelinereview.com

1. Need for active comparator clinical trials, e.g, comparing medication not just to placebo but to risperidone and olanzapine acutely and short-term 2. Advantages of extended release preparations include less daily fluctuation in in drug concentration (peak to trough) so patients may spend more time every day above the minimal therapeutic effective concentration 3. Extended release had favorable side effect profile and may allow in more chronic treatment for better tolerability and ability to increase dose; however, acutely, may not offer advantage over risperidone (active trials needed)

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Alzheimer's Drug Patch Important Advance

July 12, 2007

UPDATE: Novartis Wins FDA OK For Alzheimer's Drug Patch | money.cnn.com

1. Will faciltiate compliance and administration of medication 2. May have fewer drug-drug interactions 3. History for other conditions, e.g, hypertension (clonidine), ADHD (Daytrona) suggests value

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Once daily Welbutrin XL represents a significant advance

July 12, 2007

Once-daily Wellbutrin XL | www.ncbi.nlm.nih.gov

1. XL preparation better tolerated  2. Facilitates better compliance and adherence to treatment than twice daily medication 3. Able to give higher dose early, better compliance likely result in fewer side effects, more rapid onset of antidepressant effect

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Vyvanse-an important new medication but not the holy grail for ADHD

June 28, 2007

Shire showcases new drug Vyvanse to wary doctors | investing.reuters.co.uk

1.  While 70% of patients respond to available ADHD treatments, 30% do not so need for new treatments important 2. Lowering risk of abuse very important and attractive 3. Since same category of drugs as other stimulants not likely to appeal to clinicians who prefer prescribing non-stimulant, FDA-approved medications such as Strattera which is far easier to prescribe/can call in prescriptions, etc. 4. Not FDA approved for use in adults with ADHD which is the largest growing population being treated by Concerta/other stimulant medications

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Nuvigil may have major advantages compared to Provigil

June 21, 2007

Cephalon Receives FDA Approval of NUVIGIL(TM) for the Treatment of Excessive Sleepiness Associated with Three Disorders | www.pipelinereview.com

1. Nuvigil may have fewer side effects than Provigil 2. Nuvigil may have more rapid onset than Provigil 3. May have broader clinical applications, e.g, depression, anxiety, bipolar disorder, ADHD (adult and child), schizophrenia, etc

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN 
          What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

New biomarkers for psychiatric disorders

June 11, 2007

Aspect Medical Systems' psych treatment | biotech.seekingalpha.com

This is new era of biological psychiatry Modern technology including EEG, MRI, pharmacogenetics can help us not only better diagnose subtypes of mental illness but have potential to help predict treatment response (or lack, thereof) Having relevant biomarkers predictive of treatment response (or lack thereof) is critical in psychiatry At present, all are research tools and none equivalent or as good as good comprehensive psychiatric clinical assessment

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