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BioMarin Supports the Hemophilia Community with Theater Program

BioMarin Pharmaceutical has entered into a partnership with Believe Limited to produce the Breaking Through! musical theater intensive.

The first-of-its-kind program is a three-day music workshop for members of the bleeding disorders community and is designed to provide young adults with powerful educational messages on the healing and therapeutic power of the arts and self-expression.

The musical workshop, directed by hemophilia advocate and Believe Limited CEO Patrick James Lynch, will be held from Nov. 9 — Nov. 12, 2018, in New York and will culminate in a Broadway-style performance for local bleeding disorder community members, family, and friends.

Innovations Positively Impact Clinical Trial Timelines

New innovations in drug development have a positive impact on clinical trial timelines, likelihood of market launch, and inclusion on selected payer formularies, according to a new report by the Economist Intelligence Unit (EIU) and commissioned by Parexel International.

The research program evaluated adaptive, patient-centric, precision and real-world data trials and found that the innovations had a consistently positive impact on these critical success factors for the industry, yet demonstrated low adoption rates.

Trial efficiency demonstrated improvement through the adoption of innovative trial types, with patient recruitment time reduced by at least 37% for all the selected therapy areas studied; Drugs developed using innovations were more likely to be launched, with the chances increasing by upwards of 21%; and Drugs developed using innovations were also more likely to be added to payer formularies or other national approved-drug lists, with the greatest differences found in US Medicare formularies and some publicly funded European lists.

“The most striking finding was that the adoption rates for these four innovations — all of which can have a measurable impact on trial efficiency, likelihood of launch and inclusion in formularies — were surprisingly low,” says Alberto Grignolo, Ph.D., corporate VP, Parexel.

Amgen Launches Science Education Platform

The Amgen Foundation and Harvard University have teamed up to launch a free online science education platform uniquely designed to level the playing field for aspiring scientists. The LabXchange platform, which will launch with a focus in biology, will offer digital instruction and virtual lab experiences to high school and college students, enabling them to gain meaningful exposure to the scientific process. It will also include online networking focused on collaboration and mentoring. As the founding sponsor, the Amgen Foundation has awarded $6.5 million in grant funding to Harvard University to develop, launch and grow the LabXchange platform for teachers and students globally. LabXchange will be building prototypes and testing them with potential users beginning in the summer of 2018, and is expected to launch globally in 2019.

Bristol-Myers Squibb and Biogen Are Most Trusted by Doctors

Doctors surveyed for Taking the Pulse U.S., the longest-running U.S. study of online physician attitudes and multichannel behaviors, rated Bristol-Myers Squibb and Biogen as the most trusted partners based on recent digital interactions.

Of 2,724 U.S. physicians surveyed by DRG Digital | Manhattan Research, 91% of those that had recently interacted online with Bristol-Myers Squibb rated it a trusted partner, while 90% said the same of Biogen and 82% said they trusted Celgene.

PharmaVOICE 100 News

Bill Hinshaw Appointed CEO of Axcella
Axcella Health, a biotechnology company pioneering a new class of products to rebalance patients’ metabolic state to address serious unmet medical needs, has appointed William (Bill) Hinshaw as president and CEO. Mr. Hinshaw was most recently executive VP and head of U.S. oncology at Novartis.
Mr. Hinshaw is a PharmaVOICE 100 — 2017.

J&J’s Alex Gorksy Named Top CEO
Glassdoor has named Johnson & Johnson’s Alex Gorsky a 2018 Top CEO. The J&J chairman and CEO has now appeared on the Glassdoor list for five years running. Glassdoor, one of the world’s largest jobs and recruiting sites, compiles its annual list of best CEOs throughout North America and parts of Europe based solely on employee reviews submitted through its platform — and 95% of staffers who reviewed Johnson & Johnson for the 2018 rankings said they approved of Mr. Gorsky’s leadership.

Mr. Gorsky is a PharmaVOICE Red Jacket — 2015.

NY Academy of Medicine Honors Dr. Freda Lewis-Hall
The New York Academy of Medicine has honored Freda C. Lewis-Hall, M.D., executive VP and chief medical officer of Pfizer, for her visionary leadership and partnership in the journey to health equity. A champion for empowering patients through access to research-based medical information, she defines what it means to be a voice for change in today’s rapidly changing healthcare industry.

Dr. Lewis-Hall is a PharmaVOICE Red Jacket — 2015.

Outcome Health Appoints Matt McNally as CEO
Outcome Health, which provides health education at the moment of care, has named veteran advertising executive Matt McNally as CEO. Mr. McNally was selected to oversee the company’s ongoing transformation based on his proven record of success and leadership. He previously served as chief media officer at Publicis Health and president of Digitas Health North America.

Mr. McNally is a PharmaVOICE Red Jacket — 2017.

Editor’s Take Videos
Recorded at the 2018 Annual DIA Conference in Boston
Videos can be viewed at:

ACM Global Laboratories
Azhar Kalim, Chief Commercial Officer, ACM Global Laboratories, discusses the company’s two major acquisitions, its Smarter Testing for Oncology services, the ACM rebranding, and what they looked for at DIA this year.

Advanced Clinical
Jason Casarella, Executive VP, Advanced Clinical, discusses why large clinical development service providers are slow to adapt to changes in technology, the impact of ICH E6(R2), optimal strategies for talent acquisition, and studies for oncology and rare diseases.

Cardinal Health
Todd Phillips, Pharm.D., Director, Global Regulatory Affairs, Cardinal Health, talks about the importance of patient-reported outcomes (PROs), therapeutic areas using PROs, FDA guidances on PROs, and how pharma companies can incorporate PROs into their development programs.

Bruce Morimoto, Ph.D., VP, Scientific Affairs, Celerion, discusses scientific breakthroughs and their impact on drug development efforts, expertise in vaccine research, and using biomarkers in clinical research.

Jason Monteleone, CEO, Clinipace, discusses challenges CROs face working with sponsors, the importance of focusing on regulatory and strategic development issues, opportunities for small/midsized CROs, critical aspects of a good partnership, and understanding the dynamic changes in technology.

Beenu Kapoor, Senior Director, Consulting, Life Sciences, Cognizant, talks about the company’s Shared Investigator Platform, how it ties in with TransCelerate’s members, the qualitative and quantitative benefits of sponsors and sites using the platform, and interesting trends at DIA.

DrugDev, an IQVIA Company
Brett Kleger, Chief Commercial Officer, DrugDev, an IQVIA company, discusses alleviating the technology burden on clinical trial sites, the future of clinical trials, and technology trends and strategies for clinical research.

Dr. Qi Li, Physician Executive, InterSystems, talks about supporting the life-sciences industry, the clinical trials ecosystem, and leveraging real- world data in clinical research.

Cynthia Verst, President, R&D Design and Delivery Innovation, IQVIA, discusses how the company addresses pain points in clinical research, using real-world data, advanced analytics, and machine learning, how technology enables collaboration, and how rare disease is driving productivity in clinical trials.

Kevin Duffy, Global OVP, Life Sciences, KellyOCG, discusses trending skills in the life-sciences industry, the gig economy, and attracting the best and brightest employees.

Eric Hayashi, President and CEO, LabConnect (pictured), and Jeff Mayhew, Chief Development Officer, LabConnect, discuss the company’s collaboration with Symphony Clinical Research, hot topics at DIA, technology as an industry connector, as well as trends and issues related to PBMC isolation within clinical trials.

Medical Research Network
Todd McGrath, VP of U.S. Operations, Medical Research Network, discusses the company’s growth in the industry due to a patient-centric approach to recruitment and retention, the emergence of virtual clinical trials, the
inherent challenges of patient recruitment, and the company’s partnership with Patient Primary to provide a patient travel support service.

Jackie Kent, Senior VP, Head of Product, Medidata, discusses the role technology plays in the life-sciences industry, employing patient-centric clinical trials, and mentoring women in the life-sciences industry.

Andy Alasso, Global VP, Product Management, Oracle, discusses the biggest challenges for sponsors and CROs in exploiting new technology in clinical research, enhancing the patient experience, the impact of technology on clinical trials in the next three to five years, and the biggest trend seen at DIA.

Saama Technologies
Karim Damji, Senior VP, Product Management and Marketing, Saama Technologies, discusses trends in clinical trials, how AI and natural language understanding will impact drug development, and optimizing the clinical journey using validated cloud-based solutions.

Lisa Dilworth, VP, Rare and Orphan Diseases, Synteract, discusses the key trends and challenges in operationalizing rare disease trials and what drives her to work in the rare disease space.

Dr. Annette Stemhagen, Senior VP and Chief Science Officer of Safety, Epidemiology, Registries & Risk Management, UBC, discusses using a RWE strategy in clinical development, the practical applications of RWE, and the long-term results of RWE.

WIRB-Copernicus Group
Donald Deieso, Chairman and CEO, WIRB-Copernicus Group (WCG) and Jill Johnston, President, Site Activation, WIRB-Copernicus Group (WCG), discuss how precision medicine is impacting clinical trials, the opportunities provided by precision medicine, WCG’s partnership with Informed DNA, and the evolution of the Center for Genetics and Precision Medicine in Clinical Trials.

Worldwide Clinical Trials
Peter Benton, President and COO, Worldwide Clinical Trials, discusses the evolution of the CRO industry, the sustainability of the current M&A model, what sponsors should look for in a CRO partner, and his vision for the future.



Astellas Included in Forbes Best Midsize Employers List
Astellas was named one of America’s top workplaces by Forbes Magazine for the fourth consecutive year. Astellas appeared among the top 200 best midsize companies in the U.S. from 2,300 employers assessed. Astellas also ranked eighth out of the top pharmaceutical companies, up from the 25th spot previously.

Flexion Therapeutics one of Boston Business Journal’s Best Places to Work

Flexion Therapeutics has been named as one of the Boston Business Journal’s Best Places to Work for the second year in a row. Flexion was ranked among the top 15 companies in the medium business category (100 to 249 employees). The Best Places to Work program recognizes companies where voices are heard, cultures are thriving, and employees are engaged. Flexion more than doubled its workforce following the U.S. approval of its first drug product in October 2017, an extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain.

Klick Health wins two Cannes Lions Health Awards
Klick Health has won a pair of Cannes Lions Health Awards at the 2018 Cannes Lions International Festival of Creativity. Klick received two of the 23 awards, bestowed to the world’s most outstanding creative communications in the healthcare industry (out of almost 400 entries), for its client campaigns in the Education and Social Media categories.

The Wrestler, the unbranded Direct to Consumer (DTC) campaign Klick created with a client to raise awareness about carcinoid syndrome won a Cannes Lions Health statue.

In the Social Media category, Klick also won a Cannes Lion Health award with an agency partner for their work on Lighter Blue, a client’s educational initiative that uses light-hearted humor and a spokescharacter named “Blue” to open dialogue about major depressive disorder symptoms and let patients know they are not alone.

Additionally, Klick has been named to the 2018 List of Best Workplaces in Professional Services by Great Place to Work.

J&J’s Seema Kumar Recognized
Seema Kumar, VP of innovation, global health and science policy communication for Johnson & Johnson, was named recipient of the Biotechnology Institute’s newly launched 2018 Woman of the Year Award. The award, part of the institute’s new Bi♀GENEius Innovators women-in-science mentoring initiative, recognizes a woman in science who exemplifies the goals of the institute’s mission to engage, excite, and educate future young innovators. Drawing from the institute’s historic 50% participation by young women in the BioGENEius program, Bi♀GENEius Innovators brings together Biotechnology Institute alumni and experienced women professionals for two days of formal and informal exchange.

Reviva Awarded Red Herring Top 100
Reviva Pharmaceuticals, a clinical stage pharmaceutical company, has been selected as a winner of the 2018 Red Herring Top 100 North America award, which recognizes the continent’s most exciting and innovative private technology companies.

“We are proud that our hard work and commitment for the development of innovative medicines for the treatment of patients with unmet medical needs have been recognized through this award,” says Laxminarayan Bhat, Ph.D., founder, president and CEO of Reviva.

Ajay Singh wins EY’s Entrepreneur Of The Year
Slayback Pharma’s Founder and CEO, Ajay Singh, has won the 32nd Ernst and Young’s Entrepreneur Of The Year 2018 Award in the life-sciences category. Slayback is a NJ-based pharmaceutical company focused on the development of complex generic and specialty pharmaceutical products.

Vertex’s Senior VP Awarded the Warren Alpert Foundation Prize
Vertex Pharmaceuticals Senior VP Paul Negulescu has been named one of the winners of this year’s Warren Alpert Foundation

Prize for transformative discoveries in the fields of genetics, physiology, pulmonology, and pharmacology that led to the development of life-altering precision-targeted treatments for the devastating multi-organ disease cystic fibrosis (CF). Dr. Negulescu is one of five awardees.

The Warren Alpert Foundation Prize is awarded annually to individuals whose scientific achievements have led to the prevention, cure or treatment of human diseases or disorders, and/or whose research constitutes a seminal scientific finding that holds great promise of ultimately changing our understanding of/or ability to treat disease.

Parexel Receives Multiple Industry Recognitions
Parexel has been named to the Forbes America’s Best Management Consulting Firms list recognizing the top consulting companies across all industries. The company was named the winner of the Silver Stevie Award in the Company of the Year – Pharmaceuticals – Large category in the 16th Annual American Business Awards. Parexel also achieved second place in the first-ever Association of Clinical Research Professionals (ACRP)-Avoca Group CRO Quality Awards, determined by survey ratings from investigational sites.

Additionally, Josef von Rickenbach, Parexel co-founder and chairman, is the recipient of a 2018 Ellis Island Medal of Honor from the Ellis Island Honors Society (EIHS), which is presented annually to a select group of individuals whose accomplishments in their field and inspired service to our nation are cause for celebration.

Retrophin Recognized for Workplace Excellence
Retrophin has been awarded the Peter Barron Stark Companies (PBS) Award for Workplace Excellence, which recognizes top-tier organizations committed to a culture of workplace excellence based upon employee feedback from the PBS Employee Opinion Survey. Retrophin’s survey results exceeded PBS’ Best of the Best Benchmark, which represents the top 25% of companies participating in the survey nationwide.


Case Study
Implementing a Study Design Change Late in a Trial for Breast Cancer Indication
Provided by: Parexel

Unlocking the Potential of Online Communities – Looking Beyond the Surface
Sponsored by: Health Union

The Future of Work is Now. Are you Ready?
Sponsored by: KellyOCG

Addressing Unmet Needs of Patients and Providers in Rare and Complex Disease
Sponsored by: VMS BioMarketing

White Papers
Launch Excellence: Once in a Life Cycle Opportunity
Provided by: Health Advances

Enhance Precision Oncology Trial Success
Provided by: Medidata

Understanding Patient Health Engagement
Provided by: S3 Connected Health

Enhanced Methods to Maximize Your KOL/Influencer Identification and Activation
Provided by: W2O Group

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