Upfront

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PharmaVOICE Staff

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Acorda Rallies Parkinson’s Community

Acorda Therapeutics has launched the “Live Well. Do Tell.” initiative for the Parkinson’s disease community. Its goal is to encourage the community to improve conversations about Parkinson’s symptoms among the circle of care, including people with Parkinson’s, care partners, advocacy, and healthcare professionals. The first output of the initiative — the Statement of Need — was developed based on learnings and insights from a multi-disciplinary steering committee of leaders in the Parkinson’s community who collaborated to discuss unmet needs in understanding Parkinson’s symptoms.

Push for Standards

Six contract research organizations (CROs) — ICON, Medpace, PPD, PRA Health Sciences, Syneos Health, and UBC — and Veeva Systems have formed Align Clinical CRO, a new industry standards group dedicated to making it easier for sponsors and CROs to work together during clinical trials. With input from across the industry, the plan is to create open technology standards to improve trial execution and collaboration with life-sciences companies.

Align Clinical CRO is creating open technology standards to help increase sponsor and CRO productivity, reduce operational costs, and run trials faster. The group’s first standard is anticipated to be an Operational Data Exchange standard to facilitate seamless information sharing between sponsors and CROs.

“There is tremendous potential to enhance clinical trial execution with common technology standards that benefit the entire industry,” says Henry Levy, president of Align Clinical CRO.

Trends That will Drive 2018 Commercial Strategies

Syneos Health’s inaugural Commercial Trends Forecast identifies important trends in biopharmaceutical commercialization — from the frontlines of drug development to patient engagement and next-generation care — expressing the biggest drivers of change.

These include:
The Influencers Are Changing: Today, integrated delivery networks (IDNs) own more than 60% of physician group practices. Those delivery networks play a part in a greater shift centered on how value is defined, delivered, and measured in the current healthcare environment.
New Voices are Being Heard: Pharmaceutical medical teams, sales teams, key opinion leaders, advocacy partners, and other critical affiliates pool capabilities in finding new ways to engage and co-create nearly every aspect of the health experience.
Points of Influence are Rapidly Evolving: The average patient journey diagram once outlined four or five predictable steps representing a real-life journey. In 2018, the patient experience map is being radically updated to reflect new points of interaction.
The Commercial Outlook is Shifting: In 2018, commercial teams are involved far earlier in the drug development cycle, hyper focused and crisis ready. Pharmaceutical innovators are increasingly breaking down the silos that have long divided the clinical and commercial disciplines.

Biopharma Companies Launch Scholarship Programs

Sarepta Therapeutics, a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, has launched Route 79, The Duchenne Scholarship Program, an annual scholarship for students diagnosed with Duchenne muscular dystrophy. Scholarships of up to $10,000 will be awarded to 10 individuals.

AbbVie, a global research and development-based biopharmaceutical company, is accepting applications for the 2018 AbbVie CF Scholarship program for those with cystic fibrosis. The company will award $3,000 to 40 students, and two will receive a total of $25,000 each.

AstraZeneca and Lucy Cavendish College Establish Mentoring Program

AstraZeneca and Lucy Cavendish College, University of Cambridge, have established a strategic collaboration to support their common goals of advancing women in science and business leadership. The Women in Science and Leadership mentoring initiative forms part of the AstraZeneca Exchange program, supporting innovation and collaboration among diverse stakeholders in life-sciences clusters around the company’s three global strategic R&D hubs.

Innovation Index

AstraZeneca tops the list of IDEA Pharma’s Innovation Index for the first time. The company was ranked No. 15 on last year’s index. A series of strategic decisions helped the company generate a substantial amount of robust positive data for their pipeline, which began to stem the company’s downward trend since the loss of several product exclusivities between 2011 and 2017. The index measures, scores and celebrates a company’s ability to deliver innovation to patients.

1. AstraZeneca
2. Gilead
3. Johnson & Johnson
3. Novartis
5. AbbVie
6. Bristol-Myers Squibb
7. Merck & Co.
8. Roche
9. Pfizer
10. Biogen

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Awards

ERT Recognized for Supporting Heart Health in Children

ERT, a global data and technology company, has been recognized by Simon’s Fund with a Big Heart Award. Simon’s Fund is a Philadelphia-based nonprofit organization dedicated to raising awareness about the warning signs and conditions that lead to sudden cardiac arrest and death in children. ERT and its Chief Medical Officer Robert Kleiman, M.D., are being honored for their contributions to the success of Simon’s Fund.

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In Memoriam

Rachel Minnick
Rachel Minnick, senior manager of marketing at the Center for Information and Study on Clinical Research Participation (CISCRP), has passed away. Her battle with cancer was hard fought, and through it all Ms. Minnick brought her usual positive outlook and optimism; compassion for the patient community; and constant support and encouragement for her staff and colleagues, and courage.

Dan Diaz
Dan Diaz, 54, passed away after a two-year battle with ALS, more commonly known as Lou Gehrig’s disease.
Throughout the clinical development world, Mr. Diaz was well-known for his generousity of spirit, well-respected for his vast knowledge and ability to bring people together around new ideas, and well-liked for his sense of humor and congenial manner.

He is recognized as being an innovator and change agent. Among his many credits, Mr. Diaz was among the first to support the rare and orphan drug arena; he was instrumental in implementing site-based portals; he was one of the first members of the Diversity Alliance for Science; he was also influential in establishing niche CRO global partnerships. He tirelessly championed initiatives intended to make the clinical trial experience for patients easier.

Mr. Diaz was recognized for his lasting impact and inspiration to the industry as a PharmaVOICE 100 honoree in 2015.

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Harbingers of Healthcare Transformation

FDA to guide the use of real-world evidence (RWE) to support regulation of medicines: In 2018, FDA will issue its first framework addressing the potential for RWE to support regulatory submissions and drug safety monitoring.

Niche biotherapeutics move toward mainstream: From 2018 through 2022, between five to eight new therapies will launch each year within a new generation of cell-based therapies, gene therapies and regenerative medicines.

Mobile health apps will be added to treatment guidelines: Treatment guidelines from major clinical organizations will adopt and recommend the use of mobile health apps this year.

Use of telehealth will expand: Nearly every privately insured patient in the U.S. will have some form of access to telehealth this year, though few will use it. In 2018, telehealth visits will account for 3% to 3.5% of visits.
Spending on branded medicines will dip:

In 2018, net brand spending will decline in developed markets by 1% to 3%.
Specialty brands will drive growth in developed markets: In 2018, the $318 billion specialty medicines market will represent 41% of developed market spending, up from $172 billion in 2013.
Slower growth across pharmerging markets: Growth in pharmerging markets will slow to 7% to 8% in 2018.
U.S. net per capita spending will stabilize: Real net per capita spending on medicines in the U.S. will decline in 2018 and continue almost unchanged at roughly $800 per person through 2022.
Outcomes-based contracts will play limited role: The basic framework for an outcomes-based contract contains a payment schedule based on how well a drug does or doesn’t deliver results.
New wave of biosimilar competition: In 2018, $19 billion of current biotech spending in developed markets will have competition for the first time.

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NEW: Healthy Opinions:

Patients as Partners: Imagining the Future of Rare Disease Therapies

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