ACT

SEPTEMBER 10/2019


news roundup

PPD's AES Acquires Bioclinica's Site Business

Accelerated Enrollment Solutions, a business unit of PPD, has acquired the clinical research site business of Bioclinica, which expands the AES global footprint across five continents, 20 countries, and over 180 research sites.


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Launching Medical Devices in the Japanese Market - How to navigate regulatory and reimbursement approval
Thursday, October 31, 2019 at 11am EDT
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Tufts CSDD: Oncology Development Up, Regulatory Approval Time Down

According to the latest analysis from Tufts CSDD, oncology drugs account for 27% of all new drug approvals in the United States since 2010, an increase from the 4% share in the 1980s. Other highlights include clinical development time for cancer drug approvals during 1999-2018 was 9% longer compared to non-cancer drugs and regulatory approval phase time for cancer approvals in the same time frame was 48% shorter on average vs. non-cancer approvals.


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Begin with the End in Mind: The Strategic Benefit of Coordinating Site Budgeting, Contracting, & Payments
Wednesday, October 2, 2019 at 11am EDT
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Advarra to Acquire Forte

Advarra, a provider of IRB, IBC, and research quality and compliance consulting services, will acquire Forte and its integrated suite of solutions for CTMS, CDM and research administration.


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Successful Early Phase Drug Development of mAb Drugs
Europe: Thursday, September 26, 2019 at 3pm BST | 4pm CEST
North America: Thursday, October 3, 2019 at 11am EDT | 10am CDT | 8am PDT
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Articles

Prostate Cancer Month: A Time to Highlight Treatment Options

Over the last 15 years, the addition of novel therapies for prostate cancer have made a significant positive impact for patients. Essentially all the agents detailed in this article have demonstrated an improvement in overall survival, progression free survival, or both. Also included are promising areas for novel therapeutics such as immunotherapy and agents that target the prostate-specific membrane antigen.

In this edition

Patient Centricity is Good for Business
Labeling Challenges from EU's Annex VI
Novartis Data Manipulation Hints at Wider FDA Concerns

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Labeling Challenges from EU's Annex VI

EU regulations around clinical supply compliance are set to be in effect early 2020. This article details the regulation, its mandate of the inclusion of 'period of use' dates on both immediate and outer packaging, removing the option for companies to reference the information centrally via IRT or RTSM systems and offers steps for companies to consider in compliance.


Blog Posts

Novartis Data Manipulation Hints at Wider FDA Concerns

Washington correspondent Jill Wechsler writes: "In a harsh statement issued in early August, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), emphasized the importance of FDA having confidence in all tests and data submitted by sponsors, particularly to support the rapid development and approval of innovative therapies that benefit from accelerated pathways."


Zeroing in on Real Patient-Centric Metrics

Some very compelling research on the business case supporting patient-centric clinical trial designs is a welcome development for patient-centric leaders.


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Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
TBaker@mmhgroup.com