Noble Life Sciences and QIAGEN "Analyzing CAR-T Biodistribution with Digital PCR (dPCR): Enhancing Preclinical Research Precision" Webinar

? Mark Your Calendars! Noble Life Sciences Inc in partnership with QIAGEN will present an insightful webinar "Analyzing CAR-T Biodistribution with Digital PCR (dPCR): Enhancing Preclinical Research Precision."

Join us as we introduce a tailored dPCR workflow designed for evaluating the biodistribution of human CAR-T therapy and leukemia cell lines in rodents. This innovative approach underscores the potential of our #dPCR workflow to enhance precision and reliability, establishing a new standard for the preclinical assessment of investigational cell therapies.

? Date: Tuesday, February 20
? Time: 10:00AM ET
? Register for Meeting Link: https://ow.ly/cuQY50QuF2F

Don't miss this chance to explore a new benchmark for the preclinical assessment of investigational cell therapies and ask your questions directly to a leading authority in the field!

Learn more and secure your spot: https://ow.ly/cuQY50QuF2F

EIR Feedback Day, Febuary 21

This free 1:1 virtual session is an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices.

If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To request a feedback session, please send a non-confidential pitch deck, and a short description of the input you’re seeking from the EIRs, to Jon Nelson: jnelson@biohealthinnovation.org  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. Thank you!

FDA/CDER – AAPS Public Workshop: Therapeutic Drug Monitoring of Biologics – Current Practice, Challenges and Opportunities

https://www.aaps.org/education-and-research/workshops/biologics

This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. TDM of some small molecules is commonly performed to sustain target drug levels for efficacy and to minimize safety issues. TDM of large molecule biologics has been reported to improve clinical outcomes in some inflammatory diseases,  by ensuring sustained therapeutic levels and reducing the probability of immunogenicity.  The potential benefits, limitations, and future considerations for TDM of  large molecule therapeutics will be discussed. 

Conference Objectives:

• Discuss the impact of TDM on patient outcomes in inflammatory and other diseases
• Discuss the challenges and enabling factors and best practices in the implementation of TDM for biologics as an end-to-end  process from evidence generation to point-of-care implementation and evaluation (pre-analytical, analytical, clinical, regulatory, and health-economic considerations)
• Explore possible ways all stakeholders could work collaboratively to address these challenges and actualize identified opportunities

Programming Committee 

Yow-Ming Wang, Ph.D., US FDA, Office of Translational Sciences, Office of
Clinical Pharmacology (Chair)
Tara Altepeter, M.D., US FDA, Office of New Drugs, Division of Gastroenterology
Daphne Guinn, Ph.D., US FDA, Office of Translational Sciences, Office of Clinical Pharmacology
Mohsen Rajabi, Ph.D.,  US FDA, Office of Translational Sciences, Office of Clinical Pharmacology
Sophie Shubow, Ph.D., US FDA, Office of Translational Sciences, Office of Clinical Pharmacology
Michele Gunsior, Ph.D., Astria Therapeutics (co-chair)
Michael Partridge, Ph.D., Regeneron (co-chair)
Amy Rosenberg, M.D., EpiVax (co-chair)

Children's National: Navigating from Research to Market Approval: The AGAMREE Journey

Join Children’s National Hospital for an enlightening symposium that shines a spotlight on the remarkable journey from academia to successful FDA and European Commission approvals of the drug AGAMREE® for the treatment of DMD in children. This symposium is dedicated to recognizing the importance of academic entrepreneurship in advancing breakthroughs for rare diseases and how collaboration with small businesses and the industry played a crucial role in the process.

Agenda

3:00 – 3:25 PM - Registration and Networking

3:25 – 3:30 PM – Welcome remarks by Dr. Mark Batshaw

3:30-3:45 PM - Overview of the Vamorolone drug development program by Dr. Eric Hoffman

3:45-4:25 PM. The regulatory path of Vamorolone: Insights and innovations from parallel FDA and EMA approvals.

Panel Chair: Daniela Drago

Panelists:

Jesse Damsker, Eric Hoffman, John McCall, Kanneboyina Nagaraju, John van den Anker [ReveraGen],

Paula Clemens (University of Pittsburgh), Lauren Morgenroth (CEO TRiNDS LLC)

Topics:

- Role of pre-clinical efficacy studies

- Pediatric first-in-patient studies (4 to <7 years); choice of stage of disease

- Clinical trial design (dose ranging n=48; double-blind placebo and prednisone-controlled n=121)

- Effective and rapid pivot during COVID to remote assessments

- Choice of novel primary outcome (time to stand from supine)

- Effective leveraging of International Academic Clinical Trial Consortium (CINRG)

- Discordant discussions with the FDA and EMA

- EMA PIP - enabling a broad age label at initial approval (FDA 2 years and older)

- Joint FDA-EMA inspection of Sponsor

- Contrasts of the FDA and EMA labels for Vamorolone

- Hand-off to marketing partner at NDA (Santhera)

4:25-4:35 PM Coffee break

4:35-5:20 PM. The venture philanthropy business model: Shared risk, shared benefit, and giving back to the non-profit sector.

Panel Chair: Sharon Hesterlee, Muscular Dystrophy Association

Panelists: Eric Hoffman, Jesse Damsker, John McCall [ReveraGen], Paula Clemens (University of Pittsburgh)

Topics:

- Definition of venture philanthropy model; MDA's experience

- ReveraGen venture philanthropy model: where the $75M of non-dilutive funding came from

- The importance of 'de-risking' as a component of the model

- The importance of NIH NCATS TRND in early-stage de-risking

- The importance of federal sources of support (NIH, DoD, EU)

- Paying forward to the international non-profit research community (2/3rd of ReveraGen proceeds to non-profits)

- While this clearly worked, can it be done again?

5:20 – 5:50 PM Fireside Chat | Dr. Batshaw + Dr. Hoffman

5:50 -7:30 PM | Networking reception

CVILLE BIOHUB Speaker Series: From Molecule to Market: Innovations in Gene and Cell Therapy

From Molecule to Market: Innovations in Gene and Cell Therapy

Preserving U.S. Leadership in Biopharmaceutical Innovation

U.S. leadership in advanced technology industries is never guaranteed. It takes ongoing stewardship from policymakers to ensure America provides the most globally competitive environment to support cutting-edge innovation. Unfortunately, policy lapses in recent decades have contributed to America losing its global competitiveness, market share, and high-skilled, high-value-added employment across a wide range of advanced technology industries, including semiconductors, telecommunications equipment, televisions, solar panels, and chemicals. Now we are at risk of compromising U.S. biopharmaceutical leadership, which has become increasingly imperiled by policies imposing price controls and weakening intellectual property rights (IPR), with measures such as COVID-19 waivers and proposals to expand Bayh-Dole march-in rights.

Please join ITIF in the U.S. Capitol Visitor Center for an expert briefing on a new report examining why the United States lost its lead in other advanced technology industries, and how policymakers can avoid repeating the same mistakes in the biopharmaceutical sector.

Lunch will be served for in-person attendees.

Questions for the speakers? Ask on Slido.

https://itif.org/events/2024/03/05/preserving-us-leadership-in-biopharmaceutical-innovation/

NCI Webinar: Adjuvanted Mucosal Subunit Vaccine for Preventing SARS-CoV-2 Transmission and Infection

Register to attend a free NCI webinar. Attendees will learn about a new adjuvanted subunit mucosal Covid-19 vaccine. Study results show that this new vaccine prevents SARS-CoV-2 transmission and infection. Most SARS-CoV-2 vaccines focus on delivering immunization through an intramuscular injection. This new technology combines an initial intramuscular injection with subsequent intranasal boost administration of a novel, molecular adjuvant nanoparticle formulation.

5th Annual IVI Methods Summit - The Future of Patient-Centered Health Technology Assessment

Join us at the 5th Annual IVI Methods Summit as we delve into the forefront of patient-centered health technology assessment (HTA) to explore its future direction.

The Summit aims to bridge the gap between theory and practice by exploring actionable steps that stakeholders can take to implement patient-centered HTA effectively. Attendees will have the opportunity to engage in thought-provoking discussions, explore patient-focused methodologies, network with thought leaders, and contribute to shaping the future landscape of HTA.

Don’t miss this unique opportunity to be at the forefront of patient-centered health technology assessment and play a vital role in advancing research, policy, and practice. Join us and be part of the conversation that is transforming the future of healthcare.

In-Person and Live Stream - https://thevalueinitiative.org/2024-methods-summit/

UpRise Masterclass: An Exclusive Fireside Panel with Exited Founders!

? Unlock the Secrets to Entrepreneurial Success: An Exclusive Fireside Panel with Exited Founders!

Join us for a captivating evening as we delve into the intricate world of entrepreneurship with a panel of seasoned founders who have not only navigated the treacherous waters but have emerged triumphantly.

Who are the panelists? ?

• ? Dr. Ethel Rubin: Leads NIH SEED life sciences, delivers value, connects 200+ companies annually, guides assets from development.

• ? Alex J.: Switz Advisory CEO, Switz Capital Angel Investor, drives startups, offers strategic funding and guidance.

• ? Luke Cooper: Latimer Ventures' Founding Partner, focuses on Black & Hispanic Founders, successfully exited enterprise founder.

• ? Christopher (Chris) Brandt: Audacious Ventures Capital Founder, socially conscious investments, led Audacious Inquiry's growth, impactful acquisitions, exceptional returns.

? Why You Should RSVP:

• Hear firsthand experiences on navigating the exit process, from the initial spark to sealing the deal.

• Uncover the key factors that paved the way for a successful exit strategy.

• Discover the battle scars of entrepreneurship – the most significant challenges faced and the invaluable lessons learned.

• Get insights into specific mistakes that turned into stepping stones towards success.

• Gain wisdom on building and scaling a dream team. Learn the secrets of hiring and retaining top talent.

Parking Instructions:

Paid visitor parking is available on Jenkins lot at that time. Parking on Charles Street and Coldspring is NOT permitted between 4 – 6 and they do ticket and tow. Otherwise, shuttle service is available from the Cathedral (same details as below).

The conference room is College Center 114, located behind Starbucks. Go down the ramp or few steps next to the Starbucks pick-up counter and the room is on the right.

Don't miss this opportunity to connect, learn, and be inspired by the remarkable journeys of these successful founders. Secure your spot now, and let's ignite the spark of success in Baltimore together! ?? #ThisIsEquitech #BaltimoreTech #UpRise #UpRiseMasterclass #SuccessfulExit #Founders #Startups

https://www.eventbrite.com/e/uprise-masterclass-an-exclusive-fireside-panel-with-exited-founders-tickets-857054572297?aff=oddtdtcreator

BioBoost: The Future of Bio/Life Science Funding in 2024

Join Rockville Economic Development, Inc. (REDI) for the first BioBoost, a series of expert-led discussions designed to ignite your bio/life science venture.

Dive deep into the DMV’s trends, navigate emerging challenges and unlock opportunities to propel your success.

Network with industry leaders, glean funding insights, and gain the edge you need to thrive.

Discussion:
? Overview of Investments in 2023
? Outlook of 2024: Macro-headwinds and Tailwinds

Moderator:
? Justin Yang - CEO, DMV Bio

Speakers:
? Zeshan Muhammed - Co-Founder, MBX Capital
? Barbara White - Founder, The Avoka Group

https://lp.constantcontactpages.com/ev/reg/m3xbxgk/lp/d6396847-951f-4bac-a5aa-324ff7458aad