Wednesday, September 25, 2024 - Day Two - ET (Eastern Time, GMT-05:00)
Wednesday, September 25, 2024 - Day Two - ET (Eastern Time, GMT-05:00)
- Mark Cobbold - Senior Vice President Discovery and Head of Oncology Cell Therapy - Oncology R&D, AstraZeneca
Congenital heart defects occur in 1 in 100 live births in the United States each year. The structural nature of these defects has, to date, limited improvements in treatment to improved surgical approaches and management of secondary co-morbidities, while still ultimately leading to cardiac transplant as the only option. Development of novel therapies focused on improving cardiac output has been limited, and research funding is not on par with that of childhood cancer. Our team has leveraged impact philanthropy to de-risk product development in this rare disease population.
While regenerative therapies to re-muscularize the heart are now in the clinic, they are still years from becoming the standard of care. Allogeneic products are more cost-effective from a manufacturing standpoint, and are more readily available in acute settings, but require immunosuppression which adds both financial cost and significant side effects. An autologous approach minimizes the need for immunosuppression and allows subjects to participate while minimizing the likelihood of allo-immunization which could reduce transplant options later in treatment.
- Timothy Nelson, MD, PhD - Founder & CEO, HeartWorks
- Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
- Kenneth Green, PhD - Snr Dir MSAT, Vertex
- Sylvain Roy - CTO, ImmPACT Bio
- Brandon Haigh - Associate Director, Process Development, Cell Therapy, WuXi Advanced Therapies
- Tam Nguyen - Scientist, BioNTech US / Massachusetts Institute of Technology
- Larry Forman - CEO, CHO PLUS
With the RoSS.FILL CGT system, Single Use Support delivers unprecedented filling accuracy for aseptic aliquoting of advanced therapies into single-use bags. Dive into state-of-the-art, scalable ATMP fluid management with 21 CFR Part 11 reproducible accuracy.
- Attracting, recruiting and retaining experienced staff remains a key priority for companies.
- Recruitment strategies: Actively seeking out talent from diverse backgrounds and ensuring that recruitment practices are free from bias.
- Mentorship programs: Pairing young professionals with seasoned executives to ensure the next generation of leadership is as diverse as the populations they serve.
- Early talent and how to invest and engage early to ensure we don’t leave people out of this potential pipeline.
- Consortiums and Associations - Investing in early career programmes to create employment pathways.
- Finding talent to fuel innovation - Increasingly seeking talent with AI and data skills in order to remain competitive as digital technology drives innovations
- How can pharma companies support early career scientists through non-traditional pathways into the industry?
- The impact of digitalisation: What skills will give new hires an edge?
- Industry growth and its implications for career development
- Jared Auclair, PhD - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
- Joseph Chalifoux - Founder & CEO, Athergen
- Martin Williams - Founder and CEO, SYTE.bio
- Dmitry Fradkin - Director of Automation Systems Development, Kite Pharma
- Rae Stephenson - Senior Research Associate - Cell Therapy Drug Product, Sanofi
- Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical
- Paetra Brailsford - Engineer III, Technical Development, Biogen
This presentation delves into the critical aspects of late-stage characterization for antibody-drug conjugates (ADCs) and their role in a robust analytical control strategy essential for successful marketing applications. Starting with an explanation of product characterization and its necessity, we outline its integration into the control strategy, highlighting its role from preclinical development through to commercial production.
Key topics include:
1. Product Characterization: Importance, steps, and impact on safety, efficacy, stability, and performance.
2. Control Strategy Integration: How characterization supports the Quality Target Product Profile (QTPP) and defines critical quality attributes (CQAs).
3. Case Study: An ADC characterization project at KBI Biopharma, showcasing methodologies, challenges, and data analysis.
- What contributes to fostering a truly inclusive work environment?
- Building and sustaining a truly inclusive workplace
- Why is there more focus on DE&I- what is contributing?
- Adopting employee-focused innovative initiatives
- While multinational pharma companies like these are devoting more resources to diversity and inclusion initiatives internally, what impact will this have more widely?
- Why diversity in pharma leadership matters
- What is driving DE&I for talent today?
- Continual education: Regular training sessions on unconscious bias, cultural sensitivity, and the importance of D&I for all employees.
- Embracing D&I will not only lead to a more inclusive industry but also a more prosperous and innovative one.
- Eris Jordan - Global Vice President, Clinical and Medical Affairs, Aurion Biotech
- Dethardt Müller - Chief Technology Officer - CMC, Abalos Therapeutics GmbH
- How can early-stage/research professionals best prepare for GMP
- Critical aspects to keep in mind transitioning from early-stage development into more commercial manufacturing.
- Examples from experiences and lessons learnt
- Cross-team collaboration and pre-emptively preventing down the road bottlenecks
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
- Jared Auclair, PhD - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
- Tushar Patel - Director, Analytical CMC Strategy, Vertex Pharmaceuticals
- How can early-stage/research professionals best prepare for GMP
- Critical aspects to keep in mind transitioning from early-stage development into more commercial manufacturing.
- Examples from experiences and lessons learnt
- Cross-team collaboration and pre-emptively preventing down the road bottlenecks
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
- Jared Auclair, PhD - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
- Tushar Patel - Director, Analytical CMC Strategy, Vertex Pharmaceuticals
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors