News and Publications

Halloran will be presenting at Tufts CSDD 39th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation

Mon, 06 Feb 2012 00:00:00 PST

Laurie Halloran will be among the distinguished faculty presenting at Tufts Center for the Study of Drug Development 39th Annual Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation.

The only course that links clinical pharmacology and trial design and the regulatory review of new drugs and biologics - taught by leading experts from industry, the FDA and academia.

For more information and to register, please click here.

A Primer on Vendor Oversight for Clinical Project Managers

Mon, 06 Feb 2012 00:00:00 PST

Published in ACRP Monitor.

This article delves into the newly illustrated focus of regulatory inspectors on the relationship between sponsors and monitors and on recommendations to build quality risk management into the clinical trials process.

Angry at the Genome

Wed, 25 Jan 2012 00:00:00 PST

Published in Xconomy.

"Finding a drug that provides a therapeutic benefit at doses that are much lower than those that cause toxic side effects is probably one of the most challenging jobs on earth. For many years, drug researchers have all been hopeful that the genome would reveal its secrets for some of the tough diseases like MS, and that they'd find drug targets that allowed them to develop precise, targeted, 'heat-seeking missile' type therapies, even if for just a subset of all patients.

So we are left with a key question: How much more data (and what kinds of data) would we need to collect to better differentiate the genomes like mine, which (so far) have proved unaffected, while there are similar risk factors in genomes like that of my cousin, who developed the disease at 28 years old?"

Bringing Business Risk into Sharp Focus

Mon, 16 Jan 2012 00:00:00 PST

Published in Bioentrepreneur.

"Although we tend to blame pressures outside the industry, such as the recent economic crisis, for such failures, in truth, unfavorable business conditions may just accelerate the failure of companies destined to falter anyway. One avoidable reason for failure is that entrepreneurs do not do their homework on the external forces that affect the adoption of breakthrough science in their R&D programs. Instead, they lock onto an idea or technology and become mesmerized by its uniqueness rather than its utility—a trap that snares many."

Halloran and MassBio Education Foundation Announce Collaboration

Thu, 05 Jan 2012 00:00:00 PST

BOSTON, MA – January 5, 2012 – Halloran Consulting Group (Halloran) and the Massachusetts Biotechnology Education Foundation (MassBioEd), today announced their cooperation to offer a six-week training course, facilitated by Halloran personnel, which focuses on effective management and oversight of outsourced clinical programs. This is the latest addition to MassBioEd's Biotech Learning Center, which targets educational offerings towards those already in the industry, and is a first-time collaboration between MassBioEd and Halloran.

Key CMO Attributes

Tue, 18 Oct 2011 00:00:00 PST

Published in Life Science Leader.

"On the surface, it might be easy to conclude that the primary feature of success in the manufacturing sphere was the ability of these companies to establish their own dedicated facilities. In reality, however, the success of the initial products was likely a combination of the manufacturing efforts as part of a larger, fully integrated, and thriving product-development program. In effect, these facilities — with dedicated utilities, unique training programs, and their own engineering and quality staffs — were early CMOs, and they laid the groundwork for identifying the key attributes of a thriving and productive contract manufacturing facility today."

Join Us for Our Annual Clinical Operations Retreat for Executives

Wed, 12 Oct 2011 00:00:00 PST

Please join us for our annual Clinical Operations Retreat for Executives (CORE), which we are hosting in Chatham, MA on October 12th-14th at the renowned Chatham Bars Inn.

CORE sets itself apart from other events with its interactive and intimate setting which allows for deeper discussion between peers.

Please contact Abbi Baranski at abaranski@hallorancg.com for more information.

Taking Charge of Your Career: Building the Future for Your Real Life

Thu, 01 Sep 2011 00:00:00 PST

Published in ACRP Monitor.

This is an article about career planning, taking a practical, clinical research–oriented approach to the topic, with case studies to illustrate some of the key concepts as best practices.

Hitting Leadoff in Biotech

Wed, 13 Jul 2011 00:00:00 PST

Published in Drug Discovery & Development.

Oft heard advice for the entrepreneurial set is: "Be a credible threat." That of course is a tall order. The odds and costs are stark. Historically, only one in 10 lead candidates make it through to approval, and this number is likely to be lower in 2010. If this weren't daunting enough, the failure-inclusive cost of developing that one drug is thought to be a billion dollars. So how will you reduce the risks associated with your technology from five or six to one or two without significant funding? There is one way to derisk your efforts from an experimental and clinical point of view, with very little cash outlay: proper disease indication selection.

Halloran Continues Growth Trend, Broadening its Client Offerings and Strategic Expertise

Wed, 16 Mar 2011 00:00:00 PST

BOSTON--Halloran Consulting Group (Halloran), today announced the addition of Emily Walsh, Ph.D. as a Principal Consultant and Melissa Clark as a Senior Consultant. These are the latest in a recent series of staff additions that have substantially increased Halloran's alliance management, translational program management, and regulatory strategy offerings.

Halloran Consulting Group Appoints New Senior Executives to Bolster Industry Expertise

Tue, 07 Sep 2010 00:00:00 PST

BOSTON – Halloran today announced the addition of Simona Cipra, as a Managing Director, and Bradley A. Yount, as Chief Operating Officer. These additions enhance the Halloran management team and will allow Halloran to continue its rapid growth and to expand its expertise into new areas. HCG is a management consulting firm delivering high-value clinical development strategies and services for emerging and established life sciences companies.

PharmaVOICE Names Laurie Halloran as One of the 100 Most Inspiring People in the Life-Sciences Industry

Tue, 03 Aug 2010 00:00:00 PST

BOSTON – Laurie Halloran, Chief Executive Officer and Managing Partner of Halloran Consulting Group has been named one of the "100 Most Inspiring People in the Life-Sciences Industry" by PharmaVOICE magazine. Halloran Consulting provides both strategic oversight and tactical implementation of clinical, quality, and regulatory services.

Halloran Further Expands Its Biomarker and Clinical Operations Groups

Wed, 10 Mar 2010 00:00:00 PST

BOSTON--Halloran Consulting Group (HCG), a firm that specializes in clinical development strategy and services for established and emerging life sciences companies, today announced the continued expansion of its range of services, with the addition of Claudio Carini, MD, PhD, FRCPath, as a Senior Consultant leading the Biomarker and Translational Medicine efforts.

How Can Clinical Development Be Fixed?

Fri, 01 Jan 2010 00:00:00 PST

Published in Next Generation Pharmaceutical.

What would happen if we all took a step back and, for just a moment, stopped focusing on the race to the finish line of drug development, stopped worrying about costs, timelines and how to maximize efficiencies, and realized that the industry is losing sight of its people?

Virtual Development Models Become Biopharma's Efficiency Initiative

Tue, 18 Aug 2009 00:00:00 PST

Published in Genetic Engineering and Biotechnology News.

Such a strategy allows drug development to be driven by scientific data rather than a company's survival or long-term stability.

Conducting Global Trials in Asia

Wed, 01 Apr 2009 00:00:00 PST

Published in ACRP Monitor.

More trials are now shifting to emerging regions, such as developing countries in Asia, which is perhaps the most diverse continent in terms of cultures, populations, education, healthcare, and drug regulatory policies.

Five R&D Mistakes to Avoid

Thu, 08 Jan 2009 00:00:00 PST

FierceBiotech has previously explored the top 10 mistakes biotechs make, covering a broad range of issues from securing IP to plotting an exit strategy. Now we're taking a closer look at R&D pitfalls that many small companies encounter, and what your company can do to avoid these common mistakes.

Laurie Halloran is the founder of Halloran Consulting, a Massachusetts-based firm that helps biotechs, pharmas and medical device companies use smarter approaches to clinical trial management. The group provides expertise for start-up companies that need help efficiently developing products, saving time and money throughout the clinical trial process. The work has made Halloran an expert on recognizing R&D hazards and helping her clients avoid common development errors. Here are her thoughts.