Biocom California’s Global Life Science Partnering & Investor Conference
Join the Halloran team at “the premier partnering event of the year,” the Global Life Science Partnering & Investor Conference, presented by Biocom California. This conference is an exclusive global partnering forum that brings together senior executives, bankers, venture capitalists, and business development professionals from leading pharmaceutical and biotech companies. Join us this month, where industry leaders will debate current trends, companies will showcase their latest technologies and all attendees will have the opportunity to schedule one-on-one meetings with leading deal-makers from around the globe.
Halloran is proud to sponsor this exclusive event, and we hope to see you there. To learn more and register, please click the “More Details” button below.
Halloran Clinical Operations Executive Brunch In Partnership with CSL Behring | Transitioning to a Different Clinical Trial Operating Model: An Insider’s Look
Operating a clinical trial, regardless of the development phase, is reliant upon clinical operations professionals to complete essential tasks, but what if you’re a smaller-sized sponsor and you don’t have those resources in-house? Such sponsors will often outsource their work, design a hybrid model, or work with a Functional Service Provider (FSP) to bring personnel into their organization to move the trial along as development progresses. As a community, we’ve heard all the operating model stories – the good, the bad, and the ugly.
We often hear “we need to change our operating model.” Can you relate? Let’s discuss options and explore opportunities for improvement that are fit for your company.
Please join Halloran and our industry colleagues from CSL Behring on Wednesday, January 25th from 11:00 am – 12:30 pm ET for a discussion on “Transitioning to a Different Clinical Trial Operating Model: An Insider’s Look” to kick off our virtual Halloran-hosted Clinical Operations Brunch series of 2023.
The speakers will share their personal journey, how they arrived at their current decision, issues they experienced during the transition, and lessons learned along the way. Because breakouts will follow this interactive discussion, please bring your questions, ideas, and insights to share with the community.
Our Virtual Brunch will be hosted by:
- Laurie Halloran, CEO, Halloran Consulting Group
- Jason Milovanovic, VP, Clinical Development & Operations, Halloran Consulting Group
- Valerie Reynaert, Head of Global Clinical Operations, CSL Behring
- Ross Watson, Director, Global Clinical Operations, Site Management Head, CSL Behring
NOTE: This is an invite-only event. Clinical Operations Brunches are open to life sciences companies whose employees are actively engaged in clinical operations or clinical leadership work. If you are a service provider or independent contractor, please contact Halloran’s Event Manager, Maria Coakley, by clicking the “more details” link to inquire about participation. To request an invite, please click the “more details” link.
Immuno-Oncology 360° Conference
Join Halloran’s Katie McCarthy, Chief Innovation Officer, at the Immuno-Oncology 360° Conference on February 7-10, 2023 in Brooklyn, NY. Katie will co-moderate a panel on “Navigating Unique Challenges that Female Leaders Face in IO” with Cancer Research Institute’s Dr. Jill O’Donnell-Tormey, CEO & Director, Scientific Affairs, on Wednesday, February 8 (day 2 of the conference).
The session will address topics such as unconscious bias and negotiation skills, and will feature the following as additional panelists:
- Lisa Butterfield, PhD
Adjunct Professor of Microbiology and Immunology, University of California San Francisco (UCSF)
- Priti Hegde, PhD
CSO, Foundation Medicine
- Raluca Verona, PhD
Head, Heme Malignancies, Translational Research, Janssen R&D
Halloran is offering a 20% discount on registration, so please be sure to use the code HALLORAN20 to save. To learn more about the conference and register, please click the “More Details” button below.
Advancing Drug Development Forum
This forum is designed to allow free-flowing dialogue and plenty of time has been woven throughout the day to assure interactive quality networking.
The forum strives to attract and stimulate dialogue with key opinion leaders in biotech and pharma, executive leadership, senior directors, consultants, and a close network of CROs and CDMOs to further explore together novel solutions, promising technology breakthroughs, and hearing how the entrepreneurial industry leaders are introducing and incorporating novel approaches in small molecule drug development, changing timelines and ROIs. Hear for yourself, how you can speed up your timelines and improve your product quality.
Halloran’s Chief Development Officer, Katie McCarthy will speak at 2:30 pm on “Getting Innovation Through the FDA while Making ‘Friends’ with the Agency.”
To learn more about the event or register, please click “more details” below.
Momentum Events: GCP Inspection Readiness Hybrid Event
Leverage Tools, Training, and Technology to Achieve a Confident State of GCP Inspection Readiness.
Achieve confidence that your company is GCP inspection ready by walking through every step of the inspection preparation and execution process. Leave having heard directly from the regulators themselves about inspection trends, what you need to implement to ensure you are prepared, and understand how technology and effective training can be utilized to drive a culture of quality, and a continued state of GCP inspection readiness.
On Monday, December 5th (Day 1 of the conference), Halloran’s Principal Consultant Elizabeth Bodi will present an Inspection Readiness Plan workshop with Susan Greenbowe, Executive Director, Clinical QA of Chinook Therapeutics. The workshop will outline the critical components of an effective inspection readiness plan and do the following:
- Define the purpose of an inspection readiness plan
- Discuss who should be responsible for developing and managing the plan
- Assess inspection risks and identify critical areas of focus
- Develop an inspection readiness plan that effectively addresses identified risk areas
- Identify best practices for execution of the plan and assessing effectiveness
To learn more about this hybrid event and register, please click “more details” below.
Biocom California’s “Let’s Talk About: (Female) Life Science CEOs”
Let’s Talk About: I am a Female Life Science CEO
This past March, 24 female biotech CEOs gathered for a retreat in Arizona to foster relationships and discuss ways to sponsor other women in the life science industry. In an effort to continue this discussion, Biocom California has the privilege of featuring a few of these powerhouse CEOs at this event and connecting them with our members.
Only 23 percent of biotech CEOs identify as women, according to a 2021 Biotechnology Innovation Organization (BIO) report. It’s important that our industry comes together to redefine what authentic leadership means and continue to move the needle on diversity in the pursuit of supporting women in the industry. Join us as we take time to celebrate some of our industry’s top leaders in life science while furthering our allyship and confronting the challenges women face in the workplace.
Sheila Gujrathi, Venture Advisor, OrbiMed
Sabrina Johnson, President and CEO, DARÉ Bioscience
Ciara Kennedy, President & Chief Executive Officer, Sorriso Pharmaceuticals
Laura Shawver, CEO, Capstan Therapeutics
Katie McCarthy, Chief Development Officer, Halloran Consulting Group
Please click “More Details” below for more information or to RSVP. Please RSVP by November 30 2022, 3:00 pm EST. Thank you!
Fierce Diversity, Equity, & Inclusion Forum
Diversity has been an increasingly important topic in every industry, and there is a hunger for companies to create initiatives that bring them closer to a more diverse organization. Pharma and biotech are well behind most other industries for diversity and inclusion initiatives.
Across two days, the Diversity, Equity & Inclusion Forum will provide a wide range of strategies and best practices for pharma and biotech companies looking to improve their diversity efforts across all areas of their business, while also providing a deep dive into key areas and access to leaders across functions.
On Tuesday, November 15th, Halloran’s Rashida Challenger will serve as a panelist on “Increasing Diversity in Clinical Trials to Ensure Better Representation and Improve Health Equity.” In their panel session, Rashida and her fellow industry experts will work to understand the patient perspective and identify obstacles to participation, develop targeted outreach to recruit patients in diverse and underserved populations, and leverage new technology and resources to better engage with and monitor patients.
We hope you’ll join us for this engaging event! This webinar is FREE, but registration is required. For more info and to register, please click the “more details” button below.
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:
- Develop a clear and consistent definition of CAPA and effectively articulate this to all stakeholders
- Outline the communication plan for identified issues and ensure compliance – clear expectations defined for all parties
- Evaluate when issues should be escalated and ensure consistency among all stakeholders
- Establish specific criteria for when a CAPA should be development
- Track the progress of the CAPA and execute effectiveness checks
- Prepare effective documentation of the escalation and CAPA
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:
- Discuss the pros/cons of hybrid versus completely virtual models
- Navigate the effects of DCT on Clinical QA (e.g. Updating QMS to include additional SOPs, enhancing vendor management qualification and oversight process)
- How to be Inspection Ready in a DCT-world
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.
- Dan Bloomfield, CMO of Anthos Therapeutics
- Nikhil Mehta, Head of Regulatory, Quality & Tech Operations, Anthos Therapeutics
- Kim Raymer, Vice President, Regulatory Affairs, Halloran Consulting Group
Roundtable Discussion Points:
- When do you need to consider building regulatory strategy into clinical development?
- What can a regulatory expert offer in the development of clinical development strategy, clinical trials, and reporting data to regulatory agencies?
- What options do you have to build regulatory science and operations capabilities in-house or externally (in Phase 1, 2 or 3 trials)?
- What types of regulatory support are out there and what should you look for based on what you think you need?
- What’s the value of building an internal team and how does it impact the development of your program?
- How do you decide on the best option for your organization?
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.