Case Studies

Filtered by Client: Biotech

An NDA and IPO Tied Together Situation: A small biotech company licensed a compound approved in Japan.  The compound had previously been subject of clinical and pre-clinical development in the United States and Europe over a period of nearly 10 years.   The client's internal resources were ... Biotech Meets Big Pharma Situation: A biotech company licensed their product currently midstream in development to a big pharma company. The two groups had very different approaches and decision and action speeds in product development.   Solutions: Halloran worked as an intermediary ... Clinical Monitoring Oversight ToolKit Situation: A biotech company elected to outsource their clinical study monitoring.  As a result, the company needed a toolkit for internal use to evaluate and monitor the quality of the outsourced monitoring effort.  Solutions:Halloran developed a Clinical Monitoring ... Clinical Operations Best Practices Situation: Established biotech company with a small pipeline of novel products was at a key juncture and wanted to position itself for actionable reflection on its clinical operations using an independent assessment. Solutions: Halloran conducted a gap analysis on ... Clinical Project Management Situation: An innovative life science company with a focus on improving fertility outcomes for women through a modified IVF procedure required expertise and guidance to initiate their first clinical program.  The venture included designing, implementing, and managing the ... Critical Outsourced Program Has Skill Gaps Situation: Risks were identified around quality of data and cost/timeline management by the management of an early stage vaccine company. Their in-house team did not have the capabilities to adequately manage outsourced programs. Solutions: Halloran created and delivered a ... CRO Management Situation: Start up biotech with novel oncology pipeline, built on proprietary animal models thought to be predictive of certain cancers, were in need of rapid completion of a Phase 1 study to secure additional venture funding. Solutions: Halloran established a working ... Development Strategy Used for Fundraising Situation: Small virtual biotech start-up with stem-cell therapy treatment for HIV.  Strong scientific expertise but limited experience in moving research phase work into early clinical (pre-IND) development.  No experience in regulatory affairs to understand the ... Due Diligence Saves Dollars Situation: A commercial stage antibiotics company needed to expand its pipeline, and was conducting due diligence on a distressed asset. The team needed validation on the quality of data and analysis of resources required to get the product to a marketing ... Due Diligence Support Needed Situation: Cancer therapeutics discovery and development company needed clinical development expertise during their due diligence of a potential acquisition. Solutions: Led due diligence activities and facilitated all communication between the two organizations, ensuring ... Electrical Impedance Myography Trial Situation: A virtual operating company in partnership with a patient association focused on a rare pediatric disease identified a promising technology for use in measuring muscle health. The organization wanted to run a clinical trial to compare the technology to standard ... Expanded Access Program Quality Process Situation: Established medium sized biotech company with orphan disease pipeline was in need of a streamlined, harmonized process for the global Early Access Programs.  The existing flow of information to the supply chain lacked visibility across line functions and varied ... Expanding Business: Starting up a Life Science Division Situation: Mature, global animal health care company wanted to expand into human health care.  The company was unsure whether their lead product was ready to advance to IND-enabling activities.  The company also lacked expertise in human clinical product ... Gaps in Senior Leadership Situation: Halloran was asked to conduct a Gap Analysis on a Phase 3 clinical study for a biotech company.  The trial was 12 months old and already running six months behind schedule on site activation and patient recruitment.  Solutions: Halloran utilized a team ... Global Growth Brings Compliance Challenges Situation: A recently acquired vaccine company with a very robust pipeline had several pivotal programs ongoing. Numerous quality issues were identified and associated with gaps in knowledge and skills. Additionally, integration of this subsidiary's operations with the parent ... IND-Readiness Situation: Small virtual biotech start-up with well-funded stem-cell therapy treatment for vascular repair, but no experience in product development.  Research had been ongoing for five years and was supported through government grants.  Strong scientific expertise, ... Industrializing an IND in Virtual Development Situation: A virtual company was in the process of acquiring an IP and an active IND from a well -known academic hospital. The IND was on clinical hold for a variety of issues.  The investment by the venture capital syndicate was dependent upon the ability of the virtual ... Interim Project Management Support and Clinical Quality System Gap Analysis Situation: A small biotech company, with a novel technology to develop, produce, and commercialize therapeutic proteins, was embarking on a global Phase 2-3 clinical program and was in need of a strong project manager for three global clinical trials, including vendor selection ... Multi-Year On-Demand Clinical Development Expertise Situation: An emerging specialty biopharma company in rapid acquisition mode had skill gaps at several levels over a multi-year period, including senior clinical leadership, outcomes research, and clinical quality assurance positions. Solutions: Interim leadership of ... NDA Readiness Situation: Small virtual biotech company was completing a four-year, global Phase 3 study in diabetes.  The study was conducted through a series of outsourced providers and this, along with several internal management transitions, led to limited internal clinical and ... On-Demand Clinical Operations Expertise Situation: Biopharmaceutical company developing a revolutionary class of drugs using novel technologies was transitioning their lead compound from research to development and needed clinical leadership to drive program development, planning, and ... On-Demand Development Team Situation: Small virtual biotech with transdermal delivery system and no experience in the drug development process. Solutions: Gap analysis revealed no experience in drug development and approval and limited understanding of expectations . No vendor management competency ... Part Of The Team Situation: Lean biopharma led by expert industry executives with a promising discovery pipeline was in need of a critical path to rapidly select a development candidate in a neurological indication. Solutions: Halloran provided interim project management to help both with ... Preemptive Training to Mitigate Compliance Risks Situation: A global pharmaceutical company acquired a small biotech company with a novel product for seriously ill liquid tumor patients. Upon post-acquisition due diligence, the compliance issues identified in the mid-stream proof of concept trials were alarming, and the ... Program Launch and Phase 1 Management Situation: An innovative biotechnology company that uses stem cell science needed regulatory and clinical operations guidance for launching their first Phase 1 program. Solutions: Halloran developed immediate and long term regulatory strategy plans for product ... Starting Off On the Right Foot Situation: Venture capital seeded start-up biotech with novel therapeutic modality sought to identify possible first targets based on scientific and clinical development criteria. Solutions: Halloran attended launch meetings with the entrepreneurs and investors to flesh out ... TMF Inspection Readiness Strategy Needed for Pivotal Clinical Trials Situation: A large biopharmaceutical company with pivotal clinical trials underway required strategic support and a unified approach to ensure trial master file (TMF) quality while safeguarding inspection readiness of pivotal trial documentation. Solutions: Halloran conducted a ... Training the Whole Team Situation: A growing global specialty biotechnology company needed external expertise to enhance corporate training initiatives for employees on all aspects of product development. Solutions: Over a multi-year period, short courses were developed and delivered on a regular ... Transition From Research to Development During Acquisition Situation:  A small, emerging biologics company was starting their first Phase 2/3 program with limited resources and systems in place. The company had just been acquired by an EU-based quasi-government conglomerate. Solutions: A gap analysis identified clinical and ... Vendor Audit Consistency Over the Years Situation: Mid-size biotech company outsources many aspects of clinical study execution.  As part of their vendor oversight activities, the company wanted consistent, high-quality vendor audits. Solutions: Halloran established a standardized vendor audit process to ... Virtual Quality Control Service: Data Integrity Review Situation: The clinical group of a small combination product company had recently lost its quality control department as a result of an organizational restructuring and needed a data integrity review of key clinical and regulatory documents for an IND ...