Upfront

CSL Behring Sponsors Biotech-Themed Mural

CSL Behring’s sponsorship helped to bring about The Promise of Biotechnology, a mural that explores the promise of life sciences in Philadelphia, a city that boasts world-leading universities, research hospitals, and private industry. Part of the Philadelphia’s Mural Arts program, this project was a three-year initiative to tap into the power of adding art to STEM education in Philadelphia’s schools. The initiative creates collaborative public art inspired by science and math, engages students in project-based learning, and helps them envision a future for themselves in biotechnology and other scientific fields. Philadelphia’s iconic murals number in the thousands and represent 35 years of creating public art.

Growth in Rare Disease R&D Challenges Development Strategy

Rare disease drug development, which now accounts for nearly one-third of all drugs in active R&D worldwide, presents scientific and operational challenges that will accelerate the adoption of new development strategies and operating models, according to a recently completed analysis from the Tufts Center for the Study of Drug Development.

“Our research on rare disease development programs suggests that sponsor companies are encountering unprecedented operating challenges in this area," says Ken Getz, associate professor and director of sponsored research at Tufts CSDD.

Other findings:
The share of new drug approvals worldwide for rare diseases doubled from 29% of all approvals in 2010 to 58% in 2018

Clinical through approval phase durations for rare disease drug development on average take four years longer than those for non-rare diseases.

Phase I clinical trials for rare diseases, on average, engaged six times the number of investigative sites to recruit a quarter of the number of patients, compared with those for non-rare diseases.

Merck Foundation Launches Programs in Malawi

The Merck Foundation has partnered with the First Lady of Malawi and Ministries of Health, Information, Education and Gender to train Malawian doctors in the fields of cancer, diabetes, and fertility care to improve access to equitable and quality healthcare in the country.

Additionally, the Merck Foundation together with The First Lady of Malawi and Ministry of Education and Ministry of Information launched an inspiring children’s story of Limbani and Takondwa crafted to strengthen family values of love and respect.

Oncology Trends

The IQVIA Institute for Human Data Science found in its latest report, Global Oncology Trends 2019: Therapeutics, Clinical Development and Health System Implications, that in 2018 a record-setting 15 new active substance (NAS) oncology treatments with 17 indications, including one tissue-agnostic therapy, launched in the United States. Those 2018 products bring the total number of new oncology therapeutics launched since 2013 to 57 covering 89 approved indications for 23 different tumor types.

Within the clinical pipeline, activity is most intense for the nearly 450 immunotherapies currently in development, which are identified with more than 60 different mechanisms of action (MOA). At the same time there are more than 100 next-generation biotherapeutics — defined as cell, gene, and nucleotide therapies — in clinical trials focusing on 18 different MOAs.

“Within oncology therapeutic development, the notable successes and failures in recent years have furthered our understanding of the underlying causes of certain cancers, disease progression, and the potential for novel treatments," says Murray Aitken, IQVIA senior VP and executive director of the IQVIA Institute for Human Data Science.

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Awards…

LaVoieHealthScience Honored with Bell Ringer Awards
LaVoieHealthScience, an integrated public and investor relations agency focused on advancing health and science innovations, has received two 2019 Bell Ringer Awards. The agency was awarded a Bronze Bell for Investor/Financial Relations Campaign for its work with client Newron Pharmaceuticals and a Merit Award for its Executive Thought Leadership Campaign for client Xontogeny. The Bell Ringer Awards are held annually by the PR Club of New England and celebrate the outstanding achievements of the region’s public relations and marketing professionals.

Novartis and Sandoz Honored with Power of Partnership Award
Americares, in partnership with the Healthcare Distribution Alliance (HDA), has presented its annual Power of Partnership Award to Novartis and its Sandoz division, in recognition of their outstanding commitment to increasing access to healthcare around the world. The award recognizes pharmaceutical manufacturing and distribution organizations that have shown exceptional dedication to expanding access to healthcare for disadvantaged populations.

PMSA Lifetime Achievement Award Presented to Michel Denarié
The 2019 PMSA Lifetime Achievement Award was presented at the annual PMSA Annual Conference in San Diego to Michel Denarié for his contributions to PMSA and the pharma analytics industry. Mr. Denarié is a senior principal with IQVIA’s strategic drug development team, a group that helps sponsors with their early clinical development strategy. Mr. Denarié’s experience in the pharmaceutical industry spans three decades and encompasses roles in sales, marketing, and offering development, both on the pharma and vendor side of the industry.

TauRx Recognized as a Technology Innovation Leader
TauRx, a leader in neurodegenerative disease research, is the recipient of Frost & Sullivan’s 2019 Asia Pacific Neurodegenerative Disease Management Technology Innovation Award. The award, part of ongoing research and independent analysis by Frost & Sullivan to identify companies pursuing new technologies, recognizes TauRx for its visionary innovation in developing novel treatments for neurodegenerative disease and the impact that the company’s low-cost therapeutic and diagnostic solutions will have on Alzheimer’s disease.

VirTrial Honored with Awards
VirTrial has been awarded Best New Technology Solution in the 2019 MedTech Breakthrough awards program in the drug development category. The company was also named winner of three Gold Stevie Awards in the Health & Pharmaceuticals – Service, Cloud Application/Service, and Healthcare Technology Solution categories in the 2019 American Business Awards. In addition, VirTrial won the People’s Choice Stevie Award in the Health & Pharmaceuticals category.

Weber Shandwick Honored at 2019 PRWeek Global Awards and SABRE Awards
Weber Shandwick, one of the world’s leading global communications and marketing solutions firms, received six awards at the 2019 PRWeek Global Awards in London, including four in partnership with clients: Best Campaign in Asia-Pacific, Corporate and Social Responsibility, Global Citizenship and Issues and Crisis.

Weber Shandwick was also recognized with Diamond and Gold SABRE awards across eight categories at The Holmes Report’s 2019 North America SABRE Awards in New York.

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Editor’s Take Videos
Recorded at the 2019 Annual
DIA Conference in San Diego.
Videos can be viewed at:
www.pharmavoice.com/videos

Advanced Clinical
Jason Casarella, executive VP, business development and marketing, talks about why it’s important for companies to embrace E6 (R2), which provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

ArcheMedX
Joel Selzer, co-founder and CEO, discusses his company’s unique approach to measuring and analyzing behavioral insights from clinicians based on their interactions with educational and training content.

Axiom Real-Time Metrics
Andrew Schachter, CEO and founder, explains how sponsors can use technology to achieve trial objectives more quickly and easily even as clinical research becomes increasingly complex and as FDA regulations demand more accountability.

Bioforum
Tanya du Plessis, VP, data strategies and solutions, discusses why the increased adoption of new solutions, including medical and consumer-grade technologies, changed data collection and management processes and the role of data managers.

Celerion and VitaLink Research
Dr. Marc Hoffman, chief medical officer, Celerion, and Steve Clemons, founder and chief commercial officer, VitaLink Research, discuss the prevalence of COPD as the third-leading cause of death and how their two companies are collaborating to bring new biomarkers to sponsors and CROs to address this health crisis.

Cognizant
Larissa Comis, product lead, shared investigator platform, discusses how Cognizant’s Shared Investigator Platform is reducing the administrative burden on sites and why organizational change management is so important for success.

eClinical Solutions
Raj Indupuri, CEO, talks about why companies need to transform their current processes and adopt digital clinical capabilities and how to overcome current obstacles to achieve better outcomes.

endpoint Clinical
Cat Hall, VP, product strategy, discusses the next priorities for technology advancement in helping to manage clinical trials and what future customer needs will need to be met.

ERT
Karin Beckstrom, senior product manager, discusses the opportunities that virtual trials can bring to the clinical trial ecosystem and to patients as well.

Flex Databases and Avance Clinical
Evgenia Mikhalchuk, director, business development and marketing, Flex Databases, and Yvonne Lungershausen, CEO of Avance Clinical, discuss the best practices for selecting the right clinical software provider and the benefits a solid partnership provides to both entities.

IQVIA
Dr. MaryAnne Rizk, senior VP, digital R&D strategy, discusses one of the hottest topics of the moment: the digital transformation of research & development. Dr. Rizk explains how an end-to-end patient-centric cloud platform can provide the needed orchestration for sponsors’ R&D organizations.

IQVIA
Josh Rose, VP, strategic planning, discusses the coming of age of virtual trials and what sponsors need to know as they strategically evaluate this clinical model.

Medable
Dr. Michelle Longmire, CEO, talks about the value eCOA brings to the table and why it’s important to integrate data to improve the patient experience as part of participating in a clinical trial.

Oracle
Bruce Palsulich, global VP of product strategy, discusses the impact AI will have on pharmacovigilance as well as other aspects of clinical trials and the industry at large.

Saama
Joe Ehrline, VP of sales, talks about the opportunities and benefits that life-sciences companies can gain by effectively employing data analytics as part of a comprehensive strategy to accelerate drug development.

Signant Health
Mike Nolte, CEO, talks about Signant’s new brand and the importance of bringing empathy into clinical trials.

Syneos Health
Eleanor Doyle, executive VP, FSP 360, talks about the evolution of FSP (functional service outsourcing) and how Syneos Health’s FSP 360 model is driving speed, quality, and efficiencies for customers.

UBC
Wenda Brennan, VP, global safety, discusses the important areas in adverse event reporting, and trends in pharmacovigilance.

WIRB-Copernicus Group
Dr. Donald Deieso, executive chairman and CEO, WCG, and Mary Elizabeth Williams, author of A Series of Catastrophes & Miracles, discuss patient centricity in clinical development and ways to improve the patient experience.

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PV100 News

Jeff Berg Named President of AbelsonTaylor
AbelsonTaylor, a health and wellness advertising agency, has a new president. Founder Dale Taylor has named Jeff Berg, formerly executive VP and director of client services, as president. A 17-year veteran of AbelsonTaylor, Mr. Berg says helping map the agency’s path into the future is an exciting next step.

Mr. Berg is a PharmaVOICE 100 — 2014.
Mr. Taylor is a PharmaVOICE 100 — 2005.

Bhaskar Sambasivan leads Patient Services at Eversana
Bhaskar Sambasivan has been appointed president, patient services and chief strategy officer, at Eversana. He brings a commitment to best-in-class patient services and expertise leading digital transformation.
Previously, he was senior VP and global head, life sciences at Cognizant.

Mr. Sambasivan is a PharmaVOICE 100 — 2018 and 2017.
Dr. Steven Shak Honored by the Personalized Medicine Coalition
In recognition of his visionary scientific research underpinning two flagship personalized medicine products — a therapy and a diagnostic — that have revolutionized cancer care, Dr. Steven Shak, co-founder, chief scientific officer, Genomic Health, has been awarded the 15th Annual Leadership in Personalized Medicine Award from the Personalized Medicine Coalition.

Dr. Shak is a PharmaVOICE 100 — 2017.

Evidera to Acquire Medimix
Evidera, a business unit of PPD, and a provider of evidence-based solutions, has entered into an agreement to acquire Medimix International, a global technology company providing real-world evidence insights and information.

“Our ambition is to bridge the gap between real-world data used for research and commercial purposes, and to offer a wide range of new solutions," says Henry Gazay, CEO of Medimix. “By joining forces with Evidera, we will better support our clients with extended resources and geographic footprint."

Mr. Gazay is a PharmaVOICE 100 — 2011.

Saama Technologies Acquires Comprehend Systems
Saama Technologies has agreed to acquire Comprehend Systems.

“Our combined forces create an exciting, enhanced suite of complementary capabilities to empower life-sciences companies to further accelerate clinical development," says Suresh Katta, founder and chairman of Saama.

“The Comprehend-Saama transaction creates a data analytics powerhouse with a singular vision of improving human health through the application of AI-powered solutions," says Rick Morrison, founder and chairman of Comprehend.

Mr. Katta is a PharmaVOICE 100 — 2018.

Mr. Morrison is a PharmaVOICE 100 — 2012.

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Podcasts:
Behavioral Science — The Compass to Improve Patient Outcomes
Sponsored by: Micromass Communications

Precision Medicine Trials in Oncology
Sponsored by: Parexel

Contributed Articles:
The Future of Drug Development: The Implementation of Precision Medicine for Successful Oncology Drug Development
Provided by: Parexel

Reimagining Content Supply Chain for a Next-Gen Customer Experience in Pharma
Provided by: PharmaFuture Digital Council

eBook:
How to Achieve a Patient-centric Clinical Trial
Provided by: Firma Clinical Research

Webinars:
Save Time and Reduce Costs in Procurement and Outsourcing Using Breakthrough Technology
Sponsored by: Life Science Marketplace

Promotional Review Best Practices: Mitigating Risks, Maximizing Success
Sponsored by: Manatt, Phelps& Phillips LLP

RWE in an Evolving Regulatory Landscape: Using Real-world Evidence to Support Novel Product Development Pathways
Sponsored by: Parexel

White Papers:
Inspiring Healthcare Professionals to Action: Changing Behaviors through Medical Storytelling
Provided by: Avant Healthcare