Halloran is heading to the World Orphan Drug Congress USA 2024

Visit us at Booth #424

About Halloran

Halloran Consulting Group is a life science consulting firm that provides strategic regulatory, quality, clinical, technology, and organizational support to industry leaders and startup visionaries in the pharmaceutical, biotechnology, and medical device sectors. Our consultants are subject matter experts who deliver a tailored approach to each engagement, propelling our clients to their next inflection point. We connect clients with our trusted industry partners to drive operational excellence and innovation throughout their organizations. We aim to support our clients and the patients they serve.

Meet the Halloran WODC Team

Mike Fusakio
Jen Burke
Mamta Puri-Lechner
Niki Gallo
Hema Balasubramanian
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Sheila Gwizdak Head of Consulting (3)

Speaker Highlight

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Mike Fusakio, Regulatory Affairs Consultant, Halloran Consulting Group  
&
Samantha Zappia, MS, RAC, Principal Consultant, SK Regulatory Solutions, LLC

Rare but Not Forgotten: Challenges and Opportunities for Rare Disease Drugs

Fireside Chat | April 24 | 3:20pm

Join Mike Fusakio and Sam Zappia as they explore the challenges and opportunities for developing rare disease drugs. During this 20-minute fireside chat, you will hear personal stories and lessons learned applicable to new or experienced developers on their path to getting their rare disease drug developed and on the market.

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Rare Disease Day

Preparing Now for FDA’s START Program for Rare Disease Drug Developers

The FDA recently launched a pilot program, Support for Clinical Trials Advancing Rare Disease Therapeutics (START), to enable more frequent communication with the agency to address clinical development issues as they arise.

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Advanced Therapy Medicinal Products: Recent US Approvals, Upcoming Guidance

ATMPs offer new and curative opportunities for the treatment of disease or injury, but the tactical, procedural, and logistic considerations for their development are complex. New guidances have been released to foster development, but harmonization is still needed.

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Critical Considerations to Advance Gene Therapy Products for Rare Diseases

Learn current themes reflecting the agency’s thinking as discussed during recent town halls for the development of gene therapy products for rare diseases.

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Strategies for Maximizing Patient Engagement in Rare and Orphan Disease Clinical Trials

Clinical trials for rare and orphan disease groups are challenging for patient recruitment, but the biggest hurdle lies in retaining those patients. Learn how to target the right patients, especially when they’re under or non-diagnosed.

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