41st Annual Quality Conference BOSCON2023
BOSCON is an eagerly anticipated gathering that brings together the brightest minds and leading experts in quality. Over the course of two days, attendees will have the unique opportunity to engage in a rich program comprising keynote speeches, interactive workshops, panel discussions, paper presentations, and networking sessions.
At BOSCON, we believe in the power of collaboration and cross-pollination of ideas. The event offers a vibrant and inclusive environment that encourages participants to share their knowledge, expertise, and insights. We aim to spark innovation and drive progress in our field by facilitating meaningful interactions and fostering interdisciplinary conversations.
Whether you are an academic, researcher, industry professional, or an aspiring student, BOSCON offers a platform to connect, learn, and thrive. Join us as we collectively shape the future of quality and create lasting impacts on a global scale.
We look forward to your active participation and the valuable contributions you will bring to this exciting conference experience.
CONFERENCE TRACKS:
- Technology/Innovations
- Quality for Lifesciences
- Quality Tools and Continuous Improvement
- Reliability, Maintenance & Managing Risk
Implications of the IRA
Halloran’s Katie McCarthy will be featured on a panel hosted by Boston Biotech Forum on the Implications of the Inflation Reduction Act.
Note – This is an invitation-only event
biodiversity Summit 2023
Join Halloran’s, Rashida Challenger, and Sheri Jacobsen at the 2nd annual Biodiversity Summit – a gathering of the biotech and STEM education ecosystem around actionable areas of DEI critical to innovation expansion, enhanced community engagement, equitable career opportunities, and inclusive workplace best practices.
CBSA Innosphere Ventures Workshop 2023
Halloran’s, Carolina Ahrendt co-leading workshops on a deep dive into the intricate fabric of having a robust clinical and economic strategy, exploring fundamentals and mandates associated with regulatory and clinical data and utility.
Colorado BioScience Association (CBSA) is proud to partner with Innosphere Ventures, a leading incubator with a 25-year track record of success supporting high-tech startups, on a new program designed for Colorado’s early-stage life sciences companies, the CBSA and Innosphere Ventures Workshop: Strategizing Clinical Excellence.
The program is designed to help companies identify and plan for key regulatory milestones required to commercialize new health innovations. It was originally developed for companies selected for the Colorado Life Sciences Incubation Program, offered through a partnership with Innosphere Ventures, CBSA, and Colorado BioScience Institute and partially funded by an Advanced Industries Business Accelerator Grant from Colorado’s Office of Economic Development and International Trade (OEDIT).
Because of the workshop’s impact for participants in the Colorado Life Sciences Incubation program, we are proud to offer it to all startups in our state’s life sciences community.
Join us at Fitzsimons Innovation Community in Aurora, across the street from the University of Colorado Anschutz Medical Campus, for an insightful workshop focused on successful clinical strategies and networking with leaders and founders of early-stage life sciences companies.
Why Participate?
Embarking on the right path from the onset not only ensures that you’re advancing in the correct direction but also significantly enhances your narrative when appealing to potential investors and partners. It’s about communicating that you’re not just aiming for success, but you’re equipped to achieve it.
Key Objectives
- Delve deep into the intricate fabric of a robust clinical and economic strategy, exploring its fundamentals and mandates.
- Decode the chronology of crucial milestones, discerning their timeframes and event implications.
- Equip yourself with a tailored framework to meticulously sculpt your company’s strategy blueprint.
Workshop Topics
Regulatory Strategy
- Charting the Pathway: Identifying the most efficient route through the regulatory maze.
- Harnessing Expertise: Determining the caliber of regulatory acumen your journey requires.
- Status Check: Ascertaining requisite regulatory nods and mapping the quest to achieve them.
Clinical Validity and Utility
- Grasping the bedrock: Identifying the scientific and clinical pillars upholding your product or service.
- Navigating Clinical Data: Pinpointing the exact clinical evidence required to fortify your product’s standing.
- Understanding Validation: Demystifying clinical validation and its nuances.
- Benchmarking with Standard Care: Is your product at par, or does it surpass existing standards in efficacy, safety, and cost?
- Evaluating Clinical Utility: Determining and showcasing the tangible benefits your product brings to healthcare.
SPARK BootCamp 2023
Halloran’s, Shawn Roach will lead a session on regulatory considerations for startup pharma and biotech companies. This event is hosted by the University of Colorado Denver.
BIOCOM CEO Summit 2023
This prestigious conference, created by San Diego life science industry CEOs, exclusively for San Diego life science industry CEOs, provides the opportunity for our community’s industry leaders to share, interact, and learn from each other and thought leaders on a peer-to-peer level. The San Diego summit aims to provide our member CEOs a unique opportunity to connect with each other, develop stronger relationships and support an ecosystem where they can build upon each other’s successes and challenges.
Want to connect with Halloran at the event? Contact Us.
Halloran Virtual Town Hall: How the Inflation Reduction Act is Impacting Product Development Programs
The Inflation Reduction Act (IRA) contains $500 billion in new spending and tax breaks aimed at reducing healthcare costs, boost clean energy, and increase tax revenues. Since signed into law on August 16, 2022, the life science industry continues to mull its impacts to the healthcare ecosystem.
While the IRA seeks to lower prescription drug costs by allowing Medicare to negotiate prices with product development companies, place an inflation cap on drug prices, and lower out-of-pocket expenses for Medicare recipients, product developers are already noticing significant impacts and juggling tradeoffs. Conversely, many developers remain unaware that the IRA may impact their programs.
Please join us for a virtual Town Hall – How the Inflation Reduction Act is Impacting Product Development Programs – led by Katie McCarthy, Halloran’s Chief Innovation Officer, in collaboration with industry colleagues:
- Kendalle Burlin O’Connell, President & CEO, MassBio
- Tamar Thompson, Head of Global Corporate Affairs & DEI Lead, Alexion Pharmaceuticals
- Neil Di Spirito, Partner, Brown Rudnick
- John Stanford, Managing Partner, Prism Group
Prepare to learn:
- IRA basics and fundamentals
- Overview of life science industry response
- Examples of how the IRA is impacting product development programs
- Suggestions and strategic considerations to navigate IRA implications
As we navigate this new legislation together, now is the time to collectively share examples, suggestions, and considerations for success.
Upon registration, you will receive a calendar invite with Zoom info.
Please feel free to distribute this event and any questions, contact townhall@hallorancg.com.
Colorado Life Sciences Innovation Forum 2023
CBSA’s Colorado Life Sciences Innovation Forum brings together the big thinkers and bold leaders from our state who work on the leading edge of health innovation. C-level leaders, innovators, and researchers from our community connect and collaborate at this highly anticipated conference and trade show. At the conference, our community will discuss the revolutionary technologies in development by Colorado companies, share insights on emerging trends, and dig into the issues impacting our industry.
Conference activities include:
- Morning and afternoon keynote sessions
- Presentations from thought leaders
- Panel discussions featuring innovators from our ecosystem
- Trade show booths with technology demonstrations
- Innovation Showcase featuring three emerging companies who will pitch for a cash prize
- Networking breaks throughout the day
Biocom California Let’s Talk About Series 2023
Join Halloran’s April Purcell on the panel “How Does the FDA View AI” in partnership with Biocom California.
BIOMEDevice Boston 2023
BIOMEDevice Boston brings engineers, business leaders, disruptive companies, and innovative thinkers from the region’s top start-ups and medical device OEMs together to inspire the next life-changing medical device.
Join Halloran’s Katie McCarthy as she hosts a panel “Strategy: The First Step in Your Product Lifecycle Journey”.
In the midst of an evolving regulatory landscape, the increasing influence of Artificial Intelligence (AI), and the drive for more personalized healthcare, this is an exciting time for the medical device industry from an economic and innovation perspective. Yet, many medical device leaders face an uncertain landscape. To balance opportunity and risk, medical device companies must establish their corporate strategy, align on milestones, assess potential partnering strategy, and chart their regulatory roadmap early on.
Often, many struggle with these components in the early phases and continue to experience challenges as they move throughout later phases of development. Despite these challenges, leaders have a powerful opportunity to refine their approach and establish resiliency and competitive advantage by working through the following:
- What does it mean to move from research to development, and what is required in the shift?
- What are common challenges many medical device companies, regardless of size, experience as they move throughout their entire product lifecycle?
- How do you decide on your regulatory pathway strategies, and at what point in the development is it critical to have an established plan?
- What are the considerations in aligning the regulatory and product development strategies with the business strategy?
- When evaluating a partnership with biopharma and medical device companies, what are key strategic considerations for a beneficial partnership?
- How is the development and regulatory pathway for a Software as a Medical Device (SaMD) similar or different to more traditional medical devices? Is this pathway any different when AI or Machine Learning (ML) is involved?
- In the early development phase, how do you account for future changes when a device will use AI/ML to improve over time?
- What are some common pitfalls that may be avoided when developing products with a software component?