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16sepallday19alldayFeaturedDiscovery on Target
Event Details
The event brings forth current and emerging “hot” targets, technologies and validation strategies for the development of novel small molecules and biologics.
Event Details
The event brings forth current and emerging “hot” targets, technologies and validation strategies for the development of novel small molecules and biologics.
Time
september 16 (Monday) - 19 (Thursday)
Location
Sheraton Boston Hotel
39 Dalton Street Boston MA 02199
17sepallday19alldayWorld Bispecific Summit
Event Details
World Bispecific is the Only End-to-End Meeting Dedicated Solely to Enhancing the Development of Bispecific Therapeutics In
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Event Details
World Bispecific is the Only End-to-End Meeting Dedicated Solely to Enhancing the Development of Bispecific Therapeutics
In the context of unprecedented clinical progress, World Bispecific will deliver a greater breadth and depth of technical content than any other conference.
Returning for the tenth year, the reimagined agenda will devote specific tracks to the unique discovery, translational and manufacturing challenges encountered in the bispecific space, ensuring that whatever your role in the field, you will leave with tangible actions to implement into your strategy and pipeline to translate the promise of bispecific therapeutics into a reality for patients.
Download the event guide for more information.
Time
september 17 (Tuesday) - 19 (Thursday)
19sepalldayallday3rd Extractables and Leachables Symposium for Drugs and Devices
Time
All Day (Thursday)
19sep5:00 pm7:00 pmOktoberfest w/ J.P. Morgan @ M2D2
Event Details
Join us on September 19th as we kick off Oktoberfest with authentic German food and beer! Raise a glass of Märzenbier with the J.P. Morgan Life Sciences team
Event Details
Join us on September 19th as we kick off Oktoberfest with authentic German food and beer!
Raise a glass of Märzenbier with the J.P. Morgan Life Sciences team as we usher in the world’s most celebrated beer festival, Oktoberfest! Sample traditional German delicacies from Bronwyn, along with a variety of authentic brew straight from Bavaria. This happy hour event is free and open to the M2D2 community. Prost!
Time
(Thursday) 5:00 pm - 7:00 pm
20sep12:00 pm1:00 pmLeveraging FDA’s Expedited Programs to Accelerate Product DevelopmentWebinar
Event Details
Accelerating the development of therapeutic products intended to treat serious conditions has been an interest of the public, legislators, and the scientific community for many years. Responding to this interest, the
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Event Details
Accelerating the development of therapeutic products intended to treat serious conditions has been an interest of the public, legislators, and the scientific community for many years.
Responding to this interest, the United States government has passed a number of laws intended to encourage the development of products for these indications, including the Prescription Drug User Fee Act of 1992 (PDUFA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and most recently, the 21st Century Cures Act of 2016. Responding to these directives from Congress, FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies.
This webcast will highlight the requirements, benefits, and procedures for Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. We will also discuss two newer programs, Regenerative Medicine Advanced Therapy (FDA guidance, Feb 2019) and Qualified Infectious Disease Program (FDA guidance, Jan 2018). This webcast will also describe the importance of establishing a therapeutic area as a serious condition with unmet medical need for each of these programs and provide examples for this.
Webinar Overview:
Title: Leveraging FDA’s Expedited Programs to Accelerate Product Development
Date: Friday, September 20, 2019
Time: 12:00-1:00 M Eastern Daylight Time
Register for this Complimentary Webinar Now (you will be brought to the Xtalks website for registration)
Time
(Friday) 12:00 pm - 1:00 pm
23sepallday24alldayFeaturedCharles River 3rd Annual World Congress
Event Details
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Event Details
Join us this year as we explore novel approaches to drug development that effectively reduce program timelines and accelerate delivery to the clinic. Using a variety of case studies, our speakers will illustrate methods that successfully cut time to market and highlight how artificial intelligence and genomics are expediting target discovery and drug development. In an agenda that includes presentations, panel discussions, and short technology demonstrations, you will learn how the latest science and regulatory strategies are helping us get drugs to patients faster than ever.
Time
september 23 (Monday) - 24 (Tuesday)
Location
Kimpton Marlowe
25 Edwin H. Land Boulevard
23sepallday24alldayFeaturedStability Testing SummitDiscount code “Big4BioVIP” for 15% off
Event Details
Come to the Stability Testing Summit on September 23-24,2019 at the Hyatt Regency Boston Harbor. The time has never been more critical for companies to evaluate their stability testing programs
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Event Details
Come to the Stability Testing Summit on September 23-24,2019 at the Hyatt Regency Boston Harbor. The time has never been more critical for companies to evaluate their stability testing programs and learn new, innovative approaches to product validation. As organizations look to streamline operating costs and reduce time to market, we invite executives in this field to gain insight into how real-life conditions can impact their supply chain, testing facilities, operating costs, formulations, manufacturing processes, packaging, and analytical methods.
Recognizing the demand for a one-stop shop for essentials, future-looking stability testing information, this is the only conference in North America to truly take a full-scope view of the business and scientific advancements essential to ensuring patient safety and the desired clinical outcomes. Participants will leave knowing how to save resources and improve the likelihood of regulatory approval of stability protocols. For more information please visit Stability Testing Summit. Reserve a seat and use discount code “Big4BioVIP” for 15% off.
Time
september 23 (Monday) - 24 (Tuesday)
Event Details
Join us for the 6th Technology Transfer for Biologics Conference taking place September 23-24 at the Hyatt Regency Boston Harbor. This is the only educational gathering in the U.S. to
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Event Details
Join us for the 6th Technology Transfer for Biologics Conference taking place September 23-24 at the Hyatt Regency Boston Harbor. This is the only educational gathering in the U.S. to focus on the project, facility, and partnership management skills needed to maintain biologics quality at every step of process transfer.
This conference provides attendees with an unequaled opportunity to study and improve fundamental, day-to-day management techniques. Our unmatched speaking faculty helps you to minimize variation between biologic runs at all production scales, maximize biologics quality and predictability, and accelerate commercialization.
Click the link to learn more about the event and save 15% with the discount code B4BVIP today!
Time
september 23 (Monday) - 24 (Tuesday)
Event Details
The 9th CMO Quality Oversight & Risk Management Summit taking place September 23–24, 2019 in Boston, MA, will optimize the collaboration between sponsors and vendors by addressing the most
Event Details
The 9th CMO Quality Oversight & Risk Management Summit taking place September 23–24, 2019 in Boston, MA, will optimize the collaboration between sponsors and vendors by addressing the most pressing topics including data integrity, quality systems, relationship management, risk management and more. Download the brochure to view the full agenda.
Reserve your seat today and be sure to mention Discount Code 786919B4B to save 15% off the standard rate!
Time
september 23 (Monday) - 24 (Tuesday)
23sepallday25alldayThe MedTech Conference 2019
Event Details
From September 23–25, 2019, more than 3,000 of the world’s top medtech executives will gather in Boston, MA, for the leading event in our industry — The MedTech Conference. Featuring world‑class
Event Details
From September 23–25, 2019, more than 3,000 of the world’s top medtech executives will gather in Boston, MA, for the leading event in our industry — The MedTech Conference.
Featuring world‑class plenary speakers, cross‑cutting educational programming, valuable networking and business development opportunities, The MedTech Conference is a must‑attend event for the industry’s prominent and most promising companies.
Time
september 23 (Monday) - 25 (Wednesday)
24sep4:30 pm7:30 pmBiomedical Informatics Entrepreneurs Salon: Andy Coravos, Elektra Labs
Event Details
Hosted by
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Event Details
Hosted by Harvard Office of Technology Development and Harvard Medical School\’s Department of Biomedical Informatics.
A monthly conversation about medicine, biology, computers, entrepreneurship, and pizza. Open to all.
Stay in touch! To join the mailing list (to receive invitations to future events), sign up here.
Featured speaker
Andy Coravos
Co-founder and CEO, Elektra Labs
Andy Coravos (@andreacoravos) is the CEO/co-founder of Elektra Labs, building a digital medicine platform with an initial focus on digital biomarkers for decentralized clinical trials, and a Member of the Harvard-MIT Center for Regulatory Sciences
Time
(Tuesday) 4:30 pm - 7:30 pm
25sepallday26alldayCell Therapies for Diabetes
Time
september 25 (Wednesday) - 26 (Thursday)
26sepallday27allday2019 The 9th U.S.-China Health Summit
Time
september 26 (Thursday) - 27 (Friday)
September 23-24
6th Technology Transfer for Biologics Conference
September 23-24
9th CMO Quality Oversight & Risk Management Summit
September 23–24
FierceBiotech’s Drug Development Forum
October 28-29
Launch Readiness for Medical Affairs and Communications Teams Summit
December 2-3
4th New Product Planning Summit
December 2-3
Multi-Stakeholder Commercial Model Summit
December 2-3