News and Publications

Re-thinking Clinical Trials for the World of Crowdsourcing

Tue, 16 Apr 2013 12:00 AM PST

Published online in Xconomy.

"Disruption isn't a word normally associated with clinical drug development, but nevertheless it is coming. We can feel the rumblings of it. New technologies and technology-enabled techniques for productivity in mainstream business applications are slowly making their way into the clinic. There are signals that drug development is starting to catch up with the general trend toward open collaboration and innovation. This trend is enabling tremendous advances in other industries, so why not ours?"

Joint Ventures/Partnerships, Mergers, and Acquisitions

Mon, 08 Apr 2013 12:00 AM PST

Published in The Monitor.

Global pharmaceutical companies often chose to invest in biotech and startup companies in order to drive growth of innovative products developed by these smaller companies as a potential way to keep their pipelines robust and maintain revenue streams, particularly in light of pending expiry of patents for their marketed drugs. Although these large, global companies optimize their strategic investment strategies, executives at small startups are more than willing to be part of the mutually beneficial relationship.

Halloran Principal Consultant, Emily Walsh, Ph.D., Named Mentor of Entrepreneurship Lab NYC Program

Thu, 07 Mar 2013 12:00 AM PST

Halloran Principal Consultant, Emily Walsh, Ph.D., has joined Entrepreneurship Lab NYC as a mentor to its network of aspiring entrepreneurs in New York City. Bio and Health Tech Entrepreneurship Lab NYC is a prestigious 6-month training and mentorship program for aspiring entrepreneurs in New York City's life sciences and healthcare technology community. The Lab provides extensive support to graduate students of science, post-docs, early-career researchers and engineers interested in forming new biotech and health tech ventures.

For more information about the program, please click here.

Risk-Based Monitoring: All Talk And No Action?

Tue, 26 Feb 2013 12:00 AM PST

Published in Life Science Leader.

"Almost two years ago, the FDA issued a draft guidance document "letting us off the hook" from what had been standard practice in most registrational clinical trials: source document verification, the procedure commonly called "100% of 100%", or in layman's terms, a complete verification of every data point for every patient in every clinical trial where data is included to support approval.

Source document verification (SDV) requires significant resources in terms of time and cost. It tends to be the key activity of CRAs or monitors during routine site visits, although there is widespread agreement it should be only part of a monitor's focus to ensure a high performing site. Reducing the practice to a quantitative risk-based model would free up the monitor's time so that s/he may more effectively manage the activities that often cause a research site to veer off track from a regulatory perspective."

Halloran COO, Greg Dombal, featured in Nature Medicine article on FDA's 'breakthrough' designation

Wed, 06 Feb 2013 12:00 AM PST

Halloran Chief Operating Officer, Greg Dombal, has been featured in an article published online by Nature Medicine about FDA's use of the 'breakthrough' designation, which was just awarded for the first time last month. Greg's expertise in regulatory guidelines and submissions lent itself well to the discussion.

First 'breakthrough' drugs designated, but dilution worries linger by Elie Dolgin

As published in Nature Medicine 19, 116–117 (2013).

Please click here to read the article in its entirety online.

Decisions on the Road and on the Project Team: The Mixed Value of "Notions"

Fri, 01 Feb 2013 12:00 AM PST

Published online at BiotechStart.

"After 9 months on the road during a recent sabbatical, I can attest that you learn a lot from your fellow travelers. You learn what food stalls to avoid in the Jamaa El Fnaa square in Marrakesh. You discover the best surf spot for beginners in Nicaragua. You also learn coping skills required for long-term travel: how to diffuse tense situations with a travel partner, how not to get into a street brawl with an aggressive "unofficial" guide, and how to keep a budget without sweating every single financial decision you make. It turns out that these skills are just as apt for the life sciences industry (however the travel partner may be a business partner, the aggressive guide might be a vendor, and the monthly financial close may still be tense). However, one lesson I learned from a fellow traveler named Brie revolutionized the way I think about decisions on project teams."

Halloran to present for second year at Tufts CSDD 40th Annual Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation

Fri, 01 Feb 2013 12:00 AM PST

Laurie Halloran will be among the distinguished faculty presenting at Tufts Center for the Study of Drug Development 40th 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.

Halloran Supports New Life Sciences Angel Group in NYC

Tue, 27 Nov 2012 12:00 AM PST

Halloran is pleased to announce its support of the newly-formed Mid Atlantic Bio Angels group (MABA), an angel investor group focused exclusively on new and emerging life science companies. Formed by three professionals with extensive experience in angel investing, life sciences and early stage companies, MABA seeks to bring together pre-screened, "ready for prime time" start-up life science investment opportunities with knowledgeable and experienced life science angel investors. Halloran will join MABA at their monthly meetings to hear presentations from companies spanning the entire spectrum of life sciences and is looking forward to collaborating with this group.

Click here to learn more about MABA.

Are You Ready for Vendor Oversight Scrutiny?

Tue, 11 Sep 2012 12:00 AM PST

Published in eCliniqua.

"Gone are the days where the highest enrolling site(s) in a pivotal trial could be prepped by the sponsor for a well-timed inspection after submission of a new marketing application (NDA, BLA or PMA). The new 'normal' for sponsors is that they must be ready for a potential inspection at any time during the clinical phases of development, and be prepared that virtually any of the vendors involved in the process are potential inspection targets."

Upcoming Fall Events with Halloran

Fri, 10 Aug 2012 12:00 AM PST

Halloran will host, sponsor, or lead several key events this fall.

On September 13th, the fourth installment of our free Breakfast Series will take place at Infinity Pharmaceuticals in Cambridge. Two weeks later on October 3rd, Laurie Halloran and Elizabeth Schaul will teach a webinar based on their article in ACRP's September 2011 issue of The Monitor, on the topic "Taking Charge of Your Career: Building the Future for Your Real Life". Right after Columbus Day, from October 10-12th, Halloran will host our annual Clinical Operations Retreat for Executives (CORE). Our most-enjoyed Signature Event of the year, CORE features collaborative conversations which encourage debate, dialogue, and mutual learning. Please contact Abbi Baranski at abaranski@hallorancg.com for more details and information on how to register.

On October 24th, Halloran will be speaking at two industry events,...

Don't Get Stuck in a Clinical Trial Rut: Study Challenges, Practical Solutions, and Three Reasons Why You Need to Change

Fri, 01 Jun 2012 12:00 AM PST

Published in PharmaVOICE.

"The entire biopharmaceutical industry is focused like never before. We are looking critically at mega-spending of global development operations and doing more with less. In an international environment of shifting regulatory sands, the goal is to be both effective and efficient, while generating products and producing results.

We are often asked to provide broad industry best practice insights to assist with this effort, so we chose our top findings to encourage self-examination and heighten adoption of best practices. We will touch upon three key areas acknowledged as problematic that we often evaluate to suggest change, and then provide some practical ideas to consider."

From Academic Solos to Industrial Symphonies

Thu, 17 May 2012 12:00 AM PST

Published in Bioentrepreneur.

"Academic researchers often need to stand out to advance, but the corporate world calls for team players. Moving from one world to the other can be a culture shock. Leaping from academia to industry can be vexing, confusing and, to be frank, sometimes irritating. It is not easy to be trained all your life by trusted professors only to be told that some of this training needs to be unlearned to succeed in industry."

Halloran Will Be Speaking at Five Industry Events

Thu, 17 May 2012 12:00 AM PST

Over the next several weeks, Halloran will be speaking at several industry events in the Boston area. On May 18, Simona Cipra will be a panelist at a MassBio event on Outsourcing. Just a few days later, on May 22, Laurie Halloran will moderate a panel hosted by Propel Careers for their Futures in Life Sciences Program. The next day, Laurie will host a webinar with Medidata Solutions on New Approaches to Site Monitoring and Management.

The following week,...

Click here to see more events.

Follow-Up from Halloran on Social Media and Patient Recruitment

Thu, 01 Mar 2012 12:00 AM PST

As part of Our Signature Events series, Halloran facilitated a breakfast on February 23, 2012, covering the topic "Using Social Media for Patient Information and Recruitment".

Jorge Guerra, MD, SVP and Megan Weaver, MPH Director of Biogen Idec, Global Clinical Development Operations, hosted a Halloran-facilitated biotech breakfast on "Using Social Media for Patient Information and Recruitment" on February 23^rd, 2012.

The panel included Troy Morgan, VP of Corporate Compliance, Biogen Idec, Kimberly Basciani, Acurian, Ken Getz, Fellow at the Tufts Center for Drug Development, and Maria Buckley, JD, from Nutter, McClennen and Fish.

For notes and insights from this event, please click here.

Insights from Halloran on Social Media and Patient Recruitment

Thu, 01 Mar 2012 12:00 AM PST

As part of Our Signature Events series, Halloran facilitated a breakfast on February 23, 2012, covering the topic "Using Social Media for Patient Information and Recruitment".

For notes and insights from this event, please click here.

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

Mon, 06 Feb 2012 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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 12:00 AM 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.