Wearable Devices Provide a New Look for the Modern Clinical Trial

Posted by Premdharan Meyyan on Oct 24, 2017 10:34:40 AM

Clinical development has historically been a laborious and expensive process, driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs, across different therapeutic areas. Additionally, a complex and dynamic regulatory framework has made it difficult to introduce new technologies to facilitate the development process. 

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Topics: Market Analysis, Medical Devices, Life Sciences

Upcoming Event: Ken Sawka Speaking at BU Questrom Health & Life Sciences Conference October 14th

Posted by Fuld + Company on Oct 12, 2016 1:40:45 PM

On Friday, October 14th, Fuld + Company CEO, Ken Sawka, is speaking at the Boston University Questrom School of Business's fourth annual Health & Life Sciences Conference. 

The Health & Life Sciences Conference is an annual, student-organized event that brings together a diverse audience of more than 350 students and professionals across all sectors of the US healthcare industry for valuable networking and comprehensive programming spanning from healthcare delivery and hospitals to pharmaceuticals and medical devices.

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Topics: Events, Healthcare, Life Sciences

Medication-Induced Syndromes Offer Growth Opportunity

Posted by Kyle Nicholson on Aug 15, 2016 1:40:17 PM

Opioid-induced constipation, tardive dyskinesia, and other medication-induced syndromes present worthwhile revenue opportunities for pharmaceutical R&D.

In the 1960s, researchers discovered that the loss of motor control from Parkinson’s disease (PD) was tied to a deficiency of dopamine in a part of the brain involved in the coordination of movement.

Evidence soon established that administration of levodopa, a dopamine precursor molecule, dramatically improved PD symptoms. Here’s the catch: relief of symptoms was accompanied by severe nausea and vomiting. Levodopa was not only being converted to dopamine in the brain but also in the bloodstream, activating dopamine receptors in the peripheral nervous system and causing the adverse side effects.

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Topics: Pharma, Life Sciences, Product Positioning, Competitive Strategy

Teva Membership in PhRMA Benefits Brand-Name Pharma

Posted by Steve Ames on Jul 12, 2016 10:53:02 AM

Teva, the world’s largest producer of generic medications, recently requested membership into Pharmaceutical Research and Manufacturers of America (PhRMA), the powerful US trade association of brand-name medicine manufacturers.

PhRMA is a lobby powerhouse, largely due to representation from most of the biggest players in the pharmaceutical industry. As detailed in the New York Times, Teva’s request ruffled the feathers of some PhRMA members who see Teva (and other generics companies) as a threat to the success of branded medicine. Brand-name and generic drug companies are no strangers to court battles against each other, typically around brand patent validity and timelines for generic entrance.

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Topics: Innovation, Pharma, Life Sciences, Competitive Strategy

Defending Market Share in Pharma

Posted by Fuld + Company on Mar 18, 2016 9:49:49 AM

Pharmaceutical firms frequently need to defend their market position against rivals’ competitive strategy. Threats to leading therapies can come in many forms:

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Topics: Competitive Intelligence, Fuld + Company, Pharma, Healthcare, Life Cycle Management, Life Sciences, Competitive Strategy

Upcoming Event: Fuld + Co. at Pharma CI Europe 2016 Conference & Exhibition

Posted by Fuld + Company on Feb 1, 2016 10:17:25 AM

Join us this month at Pharma CI Europe Conference & Exhibition taking place February 18-19th at the Charles de Gaulle Airport Marriott Hotel in Paris, France.

The Pharma CI Conference & Exhibition is the largest assembly of senior level pharma, biotech, and device professionals seeking the latest news and the chance to network with all the industry’s luminaries. 

Members of our Life Sciences team will be at our booth to find out how we can address your competitive intelligence and strategy development needs in the pharmaceutical, biotech, medical device, and diagnostics industries. David Staknis, Ph.D., Principal, Global Life Sciences Practice Head will be giving a talk on Protecting Institutional CI Memory on Friday, February 19th (details after the jump). 

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Topics: Competitive Intelligence, Events, Fuld + Company, Life Sciences, Competitive Strategy

Medical Education and the Affordable Care Act

Posted by Fuld + Company on Jan 28, 2016 10:32:17 AM

Ken Sawka   | Jacob Golbitz 

Perhaps it was inevitable. Kaiser Permanente, the California-based health system that integrates health insurance with its own hospitals and clinics, last month announced that it would open its own medical school in the state in 2019. 

The move underscores two factors that have bedeviled healthcare reform in the United States before and after the passage of the Affordable Care Act in 2010 – a forecasted shortage of physicians in the United States, and the failure of traditional medical education to keep pace with the training required to enable physicians to provide healthcare in an integrated, risk-based system.

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Topics: Competitive Intelligence, Innovation, Market Analysis, Healthcare, Life Sciences

Filgotinib: Still Early to Pop the Champagne

Posted by Adi Reske on Dec 24, 2015 12:38:39 PM

Recently, Galapagos NV and Gilead entered a partnership, potentially worth more than $2 billion, to develop Galapagos’s oral JAK1 inhibitor, filgotinib, for inflammatory diseases.

Earlier in December 2015, Galapagos announced positive interim Phase II Crohn’s disease results for filgotinib. Based on the data presented, 48% of moderate to severe CD patient treated with filgotinib achieved clinical remission at 10 weeks compared to 23% placebo (p=0.0067); clinical response (CDAI decrease of 100 points or more) as well improvement in patients’ quality of life were also met in the study. According to the company’s CEO, results from the Phase II trial merit moving the drug into a Phase III Crohn's program “as soon as possible”.

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Topics: Brand Insights, Pharma, Life Sciences, Product Positioning

New Video! Building a Life Sciences CI Team

Posted by Fuld + Company on Dec 15, 2015 9:50:08 AM

Finding the right talent to fill CI needs at a Life Sciences company can be challenging. From companion diagnostics to biosimilars, it's a complex marketplace that requires highly skilled CI practitioners.

David Staknis, Principal, Practice Head Global Life Sciences, and Ken Sawka, CEO + President, discuss necessary industry experience and academic qualifications for inclusion in a CI team, as well as team dynamics within Fuld + Company's own Life Sciences practice.

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Topics: Competitive Intelligence, Fuld + Company, Pharma, Healthcare, Life Sciences

New Video! Companion Diagnostics

Posted by Fuld + Company on Dec 11, 2015 8:00:00 AM

Companion diagnostic (CDx) devices are in vitro and imaging tools that are paired with specific drug therapies. Part of a larger trend towards personalized medicine, they are used to identify patients most likely to benefit from a specific therapeutic agent or to determine appropriate dosage. 

While questions remain about who should bear the cost for companion diagnostics, the promise of greater safety and efficacy and the potential for faster regulatory approval have made this an area of growth for both pharmaceutical and molecular diagnostics clients.

David Staknis, Principal, Practice Head Global Life Sciences, and Ken Sawka, CEO + President, discuss increased requests for monitoring development and expansion of CDx platforms, earlier coordination by pharmaceutical and diagnostics firms, and the benefits of CI for optimizing R&D spending.

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Topics: Competitive Intelligence, Early Warning Monitoring, Medical Devices, Pharma, Healthcare, Life Sciences

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