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Carolyn E. Green Scholarship Award Reception

The Carolyn E. Green Scholarship Committee is extremely excited to award scholarships to four recipients in honor of Carolyn E. Green. The recipients consist of both women who are emerging in leadership roles, and those that are firmly established leaders, distinguished by their common goals to build leadership skills and advance their careers as executives in the life sciences. 

To celebrate the transformative power of scholarship, The Carolyn E. Green Life Science Foundation and Halloran are proud to host the Carolyn E. Green Scholarship Award Reception on Tuesday, October 4th beginning at 5:30 p.m. at Halloran’s Boston Headquarters. The reception will unite the scholarship recipients and generous donors, peers, friends, and family. 

The Carolyn E. Green Scholarship was established in memory of Carolyn Green’s leading voice in the life science communities in Pittsburgh, Boston, and beyond. Carolyn was not only an inspiration and a force – but an incredibly loving and talented woman who created waves in the life sciences universe. A mentor, Carolyn taught young women to push limits, have confidence in their contributions, and courage to ask for what they deserve.

Carolyn was a staunch advocate for women’s rights, as well as women in leadership and STEM (Science, Technology, Engineering and Math). Carolyn was Executive Director, Strategic Investments for Pfizer’s Worldwide Research and Development, where she was responsible for a strategic venture capital fund dedicated to investing in early-state biotechnology companies that align closely with Pfizer’s R&D strategy.

Spanning more than 20 years of operating and investment experience, much of Carolyn’s career was devoted to translating emerging scientific ideas to novel therapies that addressed unmet medical need.

We hope you’ll join us on October 4th to celebrate Carolyn’s pioneering contributions – and to inspire our life sciences leaders of the future.

Location: Halloran Consulting Group Headquarters, 22 Thomson Place, Boston, MA 02210

Parking: Necco Street Garage, 10 Necco St, Boston, MA 02210

NOTE: This is an invite-only event. To request an invite, please click the more details link to email Halloran’s Event Manager.

Fierce Clinical Collective

On October 24-26 in Philadelphia, Fierce Pharmaceuticals will host its Clinical Collective event, which features a Clinical Quality Oversight Forum and a Decentralized Clinical Trials Summit. Halloran Consulting Group is proud to serve as a sponsor for the event, as well as speak at two programs on Wednesday, October 26th.

As part of the Clinical Quality Oversight Forum(CQOF), Lyn Agostinelli, Principal Consultant in Clinical Operations, will moderate the panel “How to Establish Effective Escalation and Communication Plans and Procedures for Timely Notification and Resolution of Identified Issues.” The panel will cover the following:

As part of the Decentralized Clinical Trials (DCT) Summit, Consultant Nikki Cammarata will moderate the panel “A Look into the Future of Clinical Trials: DCT Today and Beyond.” The panel will cover the following:

The CMO Roundtable | In Partnership with Anthos Therapeutics: Integrating Regulatory Strategy and Operations in Your Development Programs

If you’re a CMO at a small-to-mid sized biopharma organization, there’s a good chance your organization isn’t supported by an internal regulatory science and operations team to develop tools, standards, and approaches to assess the safety, efficacy, quality, and performance of your programs. Those regulatory considerations are critical to success – both from a regulatory science and operations perspective – especially as more complexity is added as a program moves through the later stages of a clinical trial.

As a CMO, you’re at the heart of the science, and may not have a regulatory mindset or expertise. If that gap exists in your organization, how do you assess options for building capabilities in-house or acquiring external help to enable better odds of program success?

In the spirit of sharing insights to advance regulatory science, please join Halloran Consulting Group on Thursday, September 15th from 12-1 pm ET for a virtual CMO Roundtable on “Integrating Regulatory Strategy and Operations in Your Development Programs.” The Halloran team will be joined by experts from Anthos Therapeutics who know a few things about building this internal function.

Your hosts:

Roundtable Discussion Points:

Mark your calendars! We hope to see you soon.

NOTE: This is an invite-only event. To request an invite, please click the more details link to email Halloran’s Event Manager.

DPHARM: Disruptive Innovation US

On September 13-14 in Boston, The Conference Forum will host the 12th Annual DPHARM: Disruptive Innovations to Modernize Clinical Research conference, and Halloran Consulting Group is proud to be a sponsor and speaker. In a session focused on “Making DCTs a Realistic Option for More Patients,” Lyn Agostinelli, Prinicipal Consultant, will present on “Three Key Tactics to Designing a Patient-Centric DCT.”

Halloran Town Hall | Lessons Learned from the Current State of Clinical Trials Impacted by the War in Ukraine

The military conflict in Ukraine and Eastern Europe is a rapidly evolving humanitarian crisis with vast geopolitical implications and continuous accounts of human suffering. Beyond the immediate humanitarian and geopolitical concerns, areas impacted by the conflict are also seeing extreme disruption to the local health care ecosystem. Clinical trials throughout Ukraine and nearby parts of Eastern Europe continue to be in peril.

Our team recently put together an article on “The Current State of Clinical Trials Impacted by the War in Ukraine,” and now we invite you to join us for a virtual Town Hall on Friday, September 9th from 11 am -12 pm ET where our team will be building on their insights and welcome colleagues from Jounce Therapeutics and CSL Behring to share their experience, challenges, and recommendations in navigating the complex regulatory and operational challenges of clinical trials impacted by the war in Ukraine.

Our panelists will share the following:

Meet the Panel:

Mobile Tech in Clinical Trials

On September 12 in Boston, The Conference Forum will host the 9th Annual Mobile Tech in Clinical Trials conference, and Halloran Consulting Group is proud to be a sponsor and speaker. Karen Travers, Associate Prinicipal Consultant, will serve as a panelist for the session “Scalability and Sustainability: How to Manage the Explosion of Digital Technology Features and Point Solutions and Consolidating Connected Ecosystems in Clinical Trials.”

ABOUT THE SESSION: As a result of the pandemic, there has been a rapid acceleration with digital technologies, in particular point solutions or technology features that can connect into other mobile solutions. With all these different technologies, there’s going to be a need to consolidate many of these connected environments and systems that are capturing such data points, and delivering care locations, whether in trials or the health setting. This session will provide suggestions for:

Halloran Clinical Operations Executive Brunch In Partnership with Neurocrine Biosciences | Accelerating RBM Adoption: Harnessing Momentum, Clearing Hurdles, and Planning for Implementation

Risk-based quality management (RBQM) is both a mindset as well as a critical system for managing data quality and ensuring patient safety throughout a clinical trial. It’s comprised of different components, each of which plays an important role in ensuring that risks are identified, mitigated, and, if possible, eliminated, through the entire study execution process. However, RBQM has not been widely or consistently adopted despite the availability of the guidelines developed by the International Council for Harmonisation (ICH).

The implementation of risk-based monitoring (RBM), a key component of RBQM, has lagged in the clinical trial industry. To better understand the state of RBM implementation across the industry, the Association of Clinical Research Organizations (ACRO) recently conducted a landscape survey among its member companies across 6,500+ trials. The implementation rates for the individual RBM components ranged from 8-19% with the most frequently implemented component being centralized monitoring and the least frequently implemented component being source document review (SDR).

When the COVID-19 pandemic emerged in early 2020, by necessity, many clinical trial sponsors moved to remote monitoring (another component of RBQM) with, as it currently appears, little or no reduction in monitoring effectiveness. Despite the proven benefits to reducing costs and shortening timelines without sacrificing trial integrity or patient safety, why haven’t many trial sponsors made the RBM leap? Why are many sponsors still evaluating when and how to implement some or all RBM components?

Please join executives from Neurocrine Biosciences during our virtual Clinical Operations Executive Brunch on Thursday, August 25th from 11:30 am – 1:00 pm ET on “Accelerating RBM Adoption: Harnessing Momentum, Clearing Hurdles, and Planning for Implementation.” The team at Neurocrine understands the importance and value of implementing RBM and will share their experiences – successes, hurdles, and “pull out your hair moments” – and the following points:

Our Virtual Brunch will be hosted by:

NOTE: This is an invite-only event. To request an invite, please click the more details link to email Halloran’s Event Manager.

In-Person Interactive Roundtable Discussion | Long-Term Follow-Up for Gene Editing Workshop: How to Implement the FDA Guidance

In January 2020, the FDA issued a guidance on long-term follow-up after administration of human gene therapy products because of the potential long-term safety concerns with gene editing. Many gene editing biotechs are still left with questions and concerns on how to implement the draft guidance. Examples, aside from overall logistics and feasibility considerations, include but are not limited to, how to select the most appropriate study format, data points to capture, where to host the data, how to contextualize the observations, and how to embark upon such a long-term engagement with the study centers and CRO partners.

There are multiple ways to obtain the data and no one way that may work for all development companies. So, how do we as an industry, find common ground on this expectation and work through solutions and best practices together? We can start by talking it out.

Please join Halloran Consulting Group, experts from Editas Medicine, Intellia Therapeutics, and other local gene editing biotech organizations for an interactive roundtable workshop on August 24th from 9 -10:30 am ET on “Long-Term Follow-Up for Gene Editing Workshop: How to Implement the FDA Guidance.”

This small roundtable style event will be led by:

The conversation will be centered around the following:

We look forward to working through these questions with you, hearing your feedback, and aligning on best practices together since there is a great deal emerging with gene editing technology and study operations of such technology.

Location:

Editas Medicine

One Main Street, Cambridge, MA 02141

Coffee and breakfast will be served.

NOTE: This is an invite-only event. To request an invite, please click the more details link to email Halloran’s Event Manager.

Women Leadership in Biotech Summer Webinar Series | How to be Proactive as a Networker

This August, Halloran will once again join The Conference Forum to conclude their four-part “Women Leadership in Biotech Summer Webinar Series” where women leaders will speak about their career journeys and offer advice around the challenges and opportunities in navigating a biotech career. This free webinar series is designed primarily for women leaders at all levels, but all are welcome. 

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We all know that networking is essential in building a community, ideas and actions. Networking can at times require a strategic and creative approach. It can also require planning and most certainly stepping outside one’s comfort zone. In this webinar, our group of experienced biotech executives share best practices on how to be a more effective networker and how to maximize networking opportunities. In addition, we also address: 

The fourth and final installment of this webinar series will be moderated by Edith A Perez, MDCMO of Bolt Biotherapeutics, and will feature Halloran’s President & CEO Laurie Halloran as a panelist.

Other panelists include:

There is no fee to attend, but registration is required. Please visit The Conference Forum’s website to register if interested.

Global Regulatory Affairs CMC Conference

Attaining Positive CMC Responses through a Comprehensive Understanding of Regulatory Requirements in the Global Marketplace, Best Practices for Swift Post Approval Submission Acceptance & Lifecycle Management Strategies

On July 28-29 in Philadelphia, Q1 Productions will host the 8th annual Global Regulatory Affairs CMC: Chemistry, Manufacturing, and Controls conference, and the Halloran team will proudly sponsor and speak at the event. Shawn Roach, Lead Consultant, Regulatory CMC and Ros Hafen, Senior Consultant, Regulatory CMC will present “Perspectives on CMC Impact of Accelerated Approvals and EUAs” on Day 2 of the conference.

ABOUT THE SESSION: The utilization of accelerated regulatory review pathways has always been a complex, but potentially rewarding, approval process for manufacturers, but the tightened timelines to ensure product safety and compliance has been a complex hurdle, especially for CMC teams. Throughout the pandemic, from diagnostic testing products to vaccine therapies, accelerated review processes were continually and successfully traversed. From understanding the expedited development timelines, a plethora of tool deployment and overall data requirements, manufacturers can be better aware of how to successfully navigate this tightened approval opportunity.