Authors


BY Tanvi Kachhy, CareMetx

Latest:

Precision medicine and the importance of data

Patient-support Hub services are a vital repository of the patient journey


Jon Weisberg, SAFE-BioPharma Association

Latest:

Data security for Pharma

Cloud computing opens a new array of benefits--and challenges--to data-sharing


Nancy Dreyer, MPH, PhD, Quintiles Outcome

Latest:

Ensuring the quality of comparative effectiveness research

As payers seek higher-quality data from real-world treatment settings, the importance of reliable measures becomes critical


Tom Noto, Covance Periapproval Services

Latest:

Economic Considerations For REMS

Drug sponsors have options in both how the new FDA risk programs are structured and how to execute them



Andy Studna

Latest:

FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.



Fran DeGrazio, West Pharmaceutical Services

Latest:

How Packaging and Delivery Technologies Influence the Commercialization of Injectable Drugs

Often mistakenly considered an afterthought, today’s packaging and delivery systems can powerfully affect the safety, efficacy and commercial success of injectables


Gary Tyson

Latest:

Preparing the Market for a New Drug with an Effective 'Medical Affairs Launch'

The Medical Affairs function can play a vital role in today’s product launch process



Steve Tallant, Systech

Latest:

Serialization and Beyond

Leveraging your Mandated Investment to Truly Protect Your Brand






Ron Krawczyk, Jennifer Hamilton, Jason Bogroff, Blue Fin Group

Latest:

Specialty drugs are generating a new paradigm: Commercial Innovation

Specialty drug market success requires patient-focused and therapy-specific channel and services strategies



Dyana Boutwell, MBA, Halloran Consulting Group

Latest:

Get better at managing clinical trial financials

Control of costs and accounting during clinical trials is a well-known challenge to sponsors. Tools are available


David Weiss, IntegriChain

Latest:

Use data analytics to monitor 340B discount drug pricing

Discerning how and where products are discounted is an expensive headache for manufacturers



Tanielle D. Henriques, Esq., Waller Lansden Dortch & Davis LLP

Latest:

Regulatory Focus on Off-Label Promotion Is Rising

While FDA guidance on appropriate medical communication has evolved, US Dept. of Justice attention the practice is intensifying


By Jason Shafrin, PhD, Precision Health Economics

Latest:

Value frameworks are here: What to do about them?

A host of evaluation methodologies are defining ‘value’ in drug prices





Adam Millinger, LCSW

Latest:

What Makes a Pharmaceutical Industry Leader?

Personality assessments identify the traits that enable some pharma researchers to ascend to leadership roles in industry


Manny Tzavlakis, Joe Morrell

Latest:

Getting ready for Sunshine Act public data

How to prepare for reporting and utilizing published data for business and compliance purposes


Steve Wood, Covectra

Latest:

Alleviating go-to market challenges faced by small virtual pharma companies

These organizations are encouraged to consider all alternatives when planning their packaging, serialization and validation strategies


Lena Anthony

Latest:

Grappling with the long-term care market

The geriatric-dominated LTC market is growing, but has unique constraints


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