FIERCE Pharma Webinar – Compliant TMF Migration & Management in 2024
For small & mid-size Clinical teams, the TMF struggle is real.
- Maybe you’re using your CRO’s eTMF for now – but what happens after study completion?
- Or maybe you’re trying to save money by using file-sharing tools – but creating extra work and compliance risk along the way?
It’s 2024. There are better options. And compliant systems to help.
Fierce Pharma will bring together Sponsor, Services, and Software perspectives on how to plan and manage the evolution of your eTMF – from active studies to completion and migration from a CRO. Designed for Clinical Operations and IT professionals at small to medium-sized sponsors, this webinar will feature:
- A case study from Elevar Therapeutics, who migrated 19 studies from disparate systems into a compliant, cost-effective solution
- Industry best practices and TMF trends from the Halloran Consulting Group
- Data standards and migration considerations from DMS and eTMF provider, Kivo
Mike Lynch, Senior Specialist at Halloran Consulting Group will speak to the importance of the TMF, challenges/patterns he has seen, and how migration is a critical operation.
He will be joined by Matt Webb, Executive Director, Information Technology at Elevar Therapeutics, and Toban Zolman, CEO at Kivo. Kevin Tate, Chief Revenue Officer at Kivo will moderate this informative webinar.
ASGCT 27TH ANNUAL MEETING
We are looking forward to ASGCT 27th Annual Meeting in Baltimore, MD this May! Be sure to visit our experts in the exhibit hall at Booth # 638.
The American Society of Gene and Cell Therapy’s (ASGCT) Annual Meeting is the premier event for professionals in gene and cell therapy. The meeting is the best place for people in the field to learn from the latest scientific research, stay up to date on new technologies, and make career-advancing connections with peers.
Originally designed as a venue for academic researchers to share their work, the Annual Meeting has grown to serve a wide community encompassing clinicians, bio-industry development, regulatory agencies, equipment manufacturers, patient advocates, and more.
MedExec Women 2024
Halloran will be participating at this year’s MedExec Women 2024 in Boston, MA, with Kanchana Iyer, Senior Consultant, Regulatory Affairs, serving as a Subject Matter Expert (SME) on the panel discussing “Bridging Regulatory & Reimbursement Strategies for Success.”
About this panel: Regulatory and reimbursement strategies are changing to provide great benefit to the medtech world. How can we find innovative solutions to navigate the complex regulatory and reimbursement landscape and create streamlined approaches for faster market access? The panel will address: What are emerging trends or future regulatory changes and how should companies prepare to adapt to these changes proactively? How to leverage regulatory intelligence and predictive insights to anticipate changes, proactively navigate complex regulatory landscapes, and optimize reimbursement strategies? How does regulatory support AI in the development of innovative products? What are best practices in collaboration and networking with regulatory bodies, reimbursement experts and other stakeholders to successfully navigate successful market adoption?
MedExecWomen is a registered 501(c)3 non-profit organization that empowers female executives to accelerate the positive impact of medical devices, diagnostics, drug delivery, and digital healthcare around the world.
Convergence Forum 2024
Meet the Halloran team at Convergence 2024 in Cape Cod, MA, where our Chief Innovation Officer, Katie McCarthy will lead a lunch panel discussion on (Not So) Failure to Launch: How to Successfully Move from Development to Commercialization.
Abstract: Drug discovery and development is a long, costly, and high-risk journey that takes 10-15 years with an average cost of over $1-2B for each new drug to be approved. While many emerging biotech and pharmaceutical companies successfully navigate the early transition from research to development, 90% of clinical drug development fails even backed by the best of strategies. For developers and investors, this risk is all too common. While turning great science into a product starts with impeccable strategy, that is just one part of the equation. Join us for an interactive luncheon panel to move beyond risk and into possibility, learn common obstacles and pitfalls, and gather best practices to implement on the path to commercialization.
Convergence exists to explore those questions (and many others), with a high-level audience interested in what’s happening in the rapidly-converging worlds of biotech, pharma, healthcare, medical devices, and the Internet.
The Convergence Forum fosters real debate and discussion among audiences that are every bit as high-level as the speakers. The programs provide an opportunity for participants to make important new contacts, do business, explore important new directions in research, delve deeply into what it takes to maintain competitive advantage in a fast-changing world, and leave feeling recharged
World Orphan Drug Congress 2024
Meet the Halloran team at World Orphan Drug in Boston, MA where our experts will be available to engage with you at our booth.
The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies.
SCOPE Summit 2024
We are looking forward to SCOPE Summit 2024 in Orlando, FL this February! Be sure to visit our experts in the exhibit hall at Booth # 202 and join us for a luncheon presentation on Monday, February 12 @12:55 p.m. on the Quality & Monitoring Track.
Speaker: Sheila Gwizdak, Head of Consulting
Title: Excellence Unveiled: Elevating Clinical Trials through Cutting-Edge Quality and Monitoring Strategies
Abstract: This session explores the dynamic landscape of clinical trials, focusing on innovative quality assurance and monitoring techniques. Attendees will learn their pivotal role in enhancing trial efficiency, reliability, and participant safety. The session will highlight the synergies between quality strategies, and monitoring protocols using evolving methodologies, technologies, and regulatory frameworks. By leveraging analytics and real-time tools, we will navigate their transformative potential to advance the pursuit of excellence in clinical trials.
Clinical trials and clinical research are essential for advancing medical knowledge, improving patient care, and developing new treatments and therapies for the patients who need them. Execution of this vital work requires collaboration, innovation, and strategic decision-making. Now in its 15th year of fostering these joint efforts to advance medical knowledge inclusive of all stakeholders, SCOPE Summit 2024 offers over four stimulating days of in-depth discussions and networking in 29 different conferences, a bustling exhibit hall with 200 companies, 3 plenary keynote sessions, the 8th annual Participant Engagement Awards, the inaugural Site Innovation Award, special cross-department panels, the 3rd annual Master of Clinical Research golf tournament, a Big Game Tailgate Party, and a boutique investor conference, the programming focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management, operations, and investment. SCOPE welcomes more than 3,500 attendees, 850 different organizations, from 27 countries, in clinical operations, clinical trials, innovation, and research.
Halloran 25th Anniversary Celebration in San Diego
We’re celebrating 25 years of life science excellence
Please join the Halloran team at our San Diego Open House for an evening of drinks and light refreshments, as we celebrate, connect, and express our gratitude to the California life sciences community. We look forward to seeing our valued clients, friends, and colleagues, as well as making new acquaintances with like-minded industry colleagues.
Tuesday, December 5th | 4 – 7 pm
3040 Science Park Road Suite 1300
San Diego, CA 92121
Halloran ClinOps Brunch Series: Implications of the New Guidance on Informed Consent
Please join Halloran for a discussion on “Implications of the New Guidance on Informed Consent.” During our webinar, we will review the principles and requirements of informed consent, share common challenges and recommendations in the landscape of increasingly complex clinical studies, and unpack FDA’s final guidance on informed consent (August 2023).
We’ll discuss strategies and tactics around the sponsor’s role in the informed consent process, including:
- Implications of FDA’s final guidance on informed consent
- ICF format and delivery best practices
- Proactive considerations for patient comprehension beyond the written ICF
- Communicating new risks, benefits, or changes during an ongoing study
- Adapting consent approach to the target population, particularly vulnerable populations
- Communicating trial role and expectations with compassion and honesty
- Karen Travers, Associate Principal Consultant, Halloran – Moderator
- Laura Gilliam, Specialist Consultant, Halloran
- Meghan Patterson, Senior Consultant, Halloran
- Krista Tibbs, Principal Consultant, Halloran
BIOCOM CEO Networking Reception 2023
Biocom California invites you to mix and mingle with your fellow CEOs within the life sciences industry over hosted hors d’oeuvres and cocktails at the Grande Colonial Hotel, located in the picturesque village of La Jolla. These informal receptions are designed for CEOs of life science companies to network with one another on a peer‐to‐peer level and provide a venue for CEOs to discuss pertinent, informative issues, as well as learn from each other.
Registration + Attendance
Please Note: Registration for this event is only open to CEOs from Biocom California industry member companies. Registrations by non-members of Biocom California will be canceled so that we may provide the spot for members. To learn how you can gain access to our exclusive networking events, please contact Biocom’s membership team here.
Advancing Drug Development Forum 2023
ABOUT THE 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 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.
The program will include two keynote presentations, the first presentation of the day is an interview with a biotech CEO who has seen their company change dramatically within the last year. The second keynote is from an Academic that is bringing future innovations to the industry. At the end of the day, a fireside chat is moderated by two inspiring individuals from our industry.
Throughout the program, there are several provocative and focused panel discussions and plenty of opportunity for inactive dialogue between faculty and attendees. It is imperative that everyone comes open-minded, ready to explore and share various approaches so that together we can find better ways to break down barriers and improve past standard methods for developing complex and challenging drug formulation and manufacturing methods.
Within our scope, we will learn better ways for biotech and pharma executives, consultants, CROs, and CDMOs to learn to communicate, form strong relationships. and work seamlessly together. Discuss together how critical it is to invest one’s resources with the right partners to break down the barriers, and meet the demands and expectations to develop high quality.
Together, we will push each other to explore better ways to face new challenges that still lie ahead while searching for better solutions and begin to be more entrepreneurial, and more efficient and incorporate technologies in development.