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Gene Therapy: Spark Charts A Course From Science To Payer And Patient Satisfaction

Gene therapy’s promise depends on the ecosystem now being built to deliver real product to patients – safely and at quantities that match the soaring expectations fed by the curative potential of the science. To assess the state of play, In Vivo talks to the man who leads the team responsible for bringing forward the first US-approved gene therapy to treat an incurable, inherited genetic condition: John Furey, chief operating officer of Spark Therapeutics

C-Suite Speaks Leadership Strategy

Microbiome Drug Development: An Investigation Into Challenges And Innovative Pipeline Approaches

The discovery and deep investigation of the microbiome has been one of the most cutting-edge advances in biomedical research of recent times, but as the science moves forward new hurdles are emerging for microbiome therapies.

Innovation Gastrointestinal Clinical Trials

Drug Delivery Outsourcing In A World Of Pharma’s Shifting Sands

The contract drug delivery industry is facing disruptive influences from an evolving client base, the increase in biologics manufacturing and specialty pharma needs. In Vivo speaks to Catalent’s vice president of strategy, Cornell Stamoran, about the evolution of the industry and the continuous search for efficiency.

C-Suite Speaks Leadership Manufacturing

Aptar's Focus On Digital Connectivity Presents New Drug Delivery Opportunities

Digital connectivity is the future of drug delivery, according to Aptar Pharma, which recently deepened its partnering commitment with digital therapeutics software developer Propeller Health. But it stresses that value is the key, and not connectivity for its own sake.

Growth Respiratory Combination Products
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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‘Going Digital’ Is Changing Pharma’s Processes, People And Culture

Digital must become a core capability for pharma if it is to remain competitive. New technologies bring faster innovation cycles, but demand new kinds of expertise and partnerships that threaten traditional hierarchies and mindsets. The rewards, for pharma, are most likely to come from improved efficiency and stronger relationships with stakeholders, rather than from digital end-products.

Digital Health Artificial Intelligence

Vericel: Rebooting A Failing Business With Unloved Assets

Following the acquisition of cell therapy assets from Sanofi, which Sanofi had secured in its purchase of Genzyme, Aastrom Biosciences changed its name to Vericel, doubled down in cell therapy and relocated to Massachusetts. Since then it has seen its revenues grow 12% per year from just under $43 million in 2013 to just under $64 million in 2017. The target for 2020: drive revenues north of $100 million.

Business Strategies Growth

Record Breaking First Half For Start-Ups Raising Cash In Europe

The first half of 2018 appeared promising for the European biopharma sector, with multiple large investment funds promising cash to young, innovative companies in the region – a turnaround after years of life science firms suffering from a funding drought across Europe.

Growth Financing

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Drug Delivery Trends Across The Biopharma Pipeline

Exploring route of administration, mode of action, clinical trial, and therapy area trends across the biopharma pipeline.

Innovation Research and Development Strategies

TRD Societal Cost Can Sway US Payer On VNS Coverage Decision

LivaNova is counting on CMS paying more than lip service to the value-based agenda as it assesses coverage decisions for Vagus Nerve Stimulation (VNS) for the treatment of resistant depression over the coming months. In many ways it is a test for both parties.

Innovation Reimbursement

True Innovation In Women’s Health Hindered Because Conditions Are Not Fatal

Drug developers and financiers discuss the biggest challenges delaying novel R&D in diseases effecting only women and how poor awareness of the debilitating symptoms that come with some conditions has led to a lack of emphasis on innovative research.

Clinical Trials Innovation

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Bringing The Clinician's Rationale Into The Heart Of Strategic Decision-Making At Boston Scientific

Boston Scientific Corp. has been back on the M&A trail in a big way in 2018, with a succession of strategic additions of various sizes that all have potential patient and shareholder impact across – and beyond – its established divisions. Chief medical officer of 18 months Ian Meredith explains the thought processes driving this policy, and the added dimension a CMO can bring to the overall question of strategy.

Leadership M & A

Broader Capabilities Keep Consort On Top At Device End Of Drug Delivery

Drug delivery technology specialist Consort Medical has capitalized on device respiratory expertise for 50 years, but a renewed focus on strategic expansion has seen it make an IP play, move into the pharma side and target other delivery formats for global pharma industry customers. Its enhanced capabilities will keep rivals on their toes.

Business Strategies Leadership

Moving Medical Affairs To The Pharma Forefront

Straddling the R&D and commercial sides of a typical pharma organization means medical affairs is naturally positioned to play an expanded role along the full pharma value chain. The combination of exploding data from internal and external sources, and a stronger focus on value and outcomes, has reshaped the requirements and expectations for drug development and commercialization businesses.

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Spark Therapeutics: Calculating The Price Of A Cure

John Furey, chief operating officer of Spark Therapeutics, discusses how the company has created a value framework for the first US-approved gene therapy to treat an incurable, inherited genetic condition: Luxturna  (voretegene neparvovec-ryzl).  He also highlights the remaining access and reimbursement challenges for this novel gene therapy, which is approved specifically for treatment of inherited retinal blindness from a rare RPE65 gene mutation. 
Market Access Strategy

Solving Reimbursement Puzzle Can Unlock Potential Of Digital Health For Medtech Innovators

Investment in digital health is at an all-time high having reached $1.6 billion in the first quarter of 2018, representing a total of 77 digital health deals and growing 44% over the first quarter of 2017. But what can the medtech market learn from early successes in other industries to seize its opportunity in digital health?

Market Access Strategy

Regenerative Medicine Is Here: New Payment Models Key To Patient Access

Potentially curative regenerative medicine therapies are no longer theoretical, but instead have become reality. As more and more gene, cell and tissue-based therapies reach the market, the need for payment solutions is becoming more pressing. The Alliance for Regenerative Medicine has consulted with payers and other stakeholders to consider the barriers to alternative payment models and look at possible solutions.

Regenerative Medicine Personalized Medicine

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Biopharma Quarterly Dealmaking Statistics, Q2 2018

Biopharma financing for the second quarter totaled $12.4 billion, a 25% decrease from Q1 2018. Meanwhile Q2 merger and acquisition deal value reached $101 billion, three-quarters of which came from Takeda's $79 billion takeover of major European player Shire. Alliances – totaling $13.8 billion (a significant decline from the previous quarter's $30.7 billion) – featured large partnerships in the antibody space, the biotechnology industry sector with the highest dollar volume.

Deals Market Intelligence

You May Be Making These Drug Forecasting Mistakes

What are the top 10 most common drug forecasting errors, and how can these be avoided? Life sciences consulting firm, Trinity Partners, explores the ins and outs of forecasting. 

Market Intelligence Strategy

Consort Targets Complete Drug Delivery Service, But Rivals Keep Heat On

Industry activity in the drug delivery device sector is characterized more by stability than speed. Consort Medical's recent strategic moves have been both deliberate and decisive. For these players, deals with pharma can be several years in the making.

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