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Agenda 2023
TBC
0830 - 0930 REGISTRATION AND MORNING REFRESHMENTS
0930 - 0940 OPENING ADDRESS
0940 - 1010 RESERVED PRESENTATION
1010 - 1040 PROMETHEUS DOSE-ADJUSTABLE GENE THERAPY PLATFORM FOR SUBCUTANEOUS DELIVERY
- Introducing Prometheus, a single-injection dose-adjustable gene therapy platform technology
- Understand the potential to optimize safety, efficacy, and treatment pharmacokinetics
- A novel approach for the delivery of a broad range of recombinant proteins and peptides
Alex Goraltchouk
Remedium Bio
Remedium Bio
1040 - 1100 MORNING COFFEE BREAK IN THE EXHIBIT AREA
1100 - 1130 VIRCAD: AN HPC/AI-CAPABLE BIOCAD PLATFORM FOR BIOENGINEERING
- Learn why gene therapy pipelines are limited, leaving many rare diseases untreated
- Know the hardware and software tools necessary for the design and testing of novel biologics
- Introducing virtual prototyping of biologics
Stefan Lukianov
Salve Therapeutics
Salve Therapeutics
1130 - 1200 FLAWLESS CONDUCT OF BIOLOGICS RESEARCH THROUGH DIGITAL PROTOCOL AUTOMATION
- Learn about the hidden complexities of conducting biologics research
- Know more about digital protocol automation
- Evaluate and remove guesswork and errors from derailing your trial
Joseph Kim
ProofPilot
ProofPilot
1200 - 1330 NETWORKING LUNCH & VISIT THE BIOSIMILARS & BIOLOGICS EXHIBITION
1330 - 1400 CLINICAL TRIALS OF BIOSIMILARS – BUILDING OPERATIONAL & SCIENTIFIC EFFICIENCY
- Evolution of the Biosimilar Regulatory Framework – past & future
- Understanding Phase 3 Trial Designs
- Biosimilar to biosimilar switching – rationale & current experience
- Streamlining regulatory approvals of biosimilars
Deepa Arora
CLINEXEL Life Sciences
CLINEXEL Life Sciences
1400 - 1430 RESERVED PRESENTATION
1430 - 1500 AFTERNOON COFFEE BREAK IN THE EXHIBIT AREA
1500 - 1530 ENGINEERING ANTIBODIES TO ACHIEVE PRECISION SOLID TISSUE PENETRATION
- Understand therapeutic targeting and efficacy while facilitating drug toxicities
- Introducing proteomic delivery target discovery platform
- Learn how dual precision antibodies achieve unprecedented therapeutic targeting and efficacy
Jan Schnitzer
PRISM
PRISM
1530 - 1600 BIOSIMILARS IN COMMUNITY ONCOLOGY (2018 TO NOW): A SNAPSHOT IN TIME
- Looking at the original project on biosimilar adoption from 2018-2020
- Look into the role of the payer in adoption and formulary management
- An overview of the state and federal biosim legislation over the last few years
Kathy Oubre
Pontchartrain Cancer Center
Pontchartrain Cancer Center
1600 - 1615 CLOSING REMARKS
1615 - 1700 NETWORKING DRINKS RECEPTION
TBC
0900 - 0930 MORNING REFRESHMENTS
0930 - 0940 OPENING ADDRESS
0940 - 1010 DISCLOSURE IN BIOLOGICS PATENTS AND IMPLICATIONS FOR PATENT PROCUREMENT
- Learn why courts have tightened the degree of disclosure required to support patent claims
- Case studies, the Supreme Court is expected to decide the Amgen vs. Sanofi case in June 2023
- Looking at the legal landscape for patent procurement
Ryan Hagglund
Loeb & Loeb
Loeb & Loeb
1010 - 1040 PATENT LITIGATION TRENDS AND LESSONS LEARNED FOR BIOSIMILARS
- Understand BPCIA (“patent dance”) litigation, non-BPCIA litigation, and IPR/PGR challenges
- Use of IPRs/PGRs: co-pending w/ litigation, success rates, strategies
- Update on patent enablement for biologic products from Amgen v. Sanofi at Supreme Court
Whitney Howard
Venable
Venable
1040 - 1100 MORNING COFFEE BREAK IN THE EXHIBIT AREA
1100 - 1130 SELF-REMOVING AFFINITY TAG PLATFORM FOR THE MANUFACTURE OF BIOSIMILARS
- Understanding self-removing tag provides exceptional purity of the native protein
- Introducing highly reusable resin, compatible with simple buffers
- Case studies on filgrastim, EPO, IFN, and others
David Wood
The Ohio State University
The Ohio State University
1130 - 1200 POSTMARKETING PHARMACOVIGILANCE CHALLENGES OF BIOSIMILARS IN ASIA-PACIFIC
- Challenges in managing and elucidating the safety profile to the potential risks of biologics
- Learn more about unique naming, batch-to-batch variability, and traceability
- Know how pharmacovigilance and biosimilarity lead to a unique combination of challenges
Shubhadeep Sinha
Hetero
Hetero
1200 - 1215 FEEDBACK & RAFFLE DRAW
1215 - 1330 NETWORKING LUNCH
Key topics for 2023:
- Emerging trends in developing biosimilars and biologic therapeutics
Understand how the development of biosimilars improves access to therapeutic interventions and enhances healthcare affordability. - The role of biosimilars design in the development of new drug modalities
Achieve a deeper understanding of biosimilars as novel drug modalities beyond traditional small molecules, including RNA, complex peptides, proteins, glycoproteins, and antibodies. - Exploring new technological advances for the enhanced production of biosimilars
Learn how the latest research in upstream technology for enhanced production enabled biosimilar drugs as well-established therapeutic interventions. - Latest research in bioavailability and bioequivalence assessment of biologic drugs
Gain insights into statistical considerations in the design, bioavailability, safety, immunogenicity, and bioequivalence of biosimilars products. - Regulatory and IP strategies for new-to-market biosimilar-based therapeutics
Learn the key regulatory approaches and IP strategies for approval of biologics-based therapeutics to manage chronic disease in the emerging biosimilars market. - Case studies, clinical trials, and pharmacometrics analysis for biosimilars development
Hear from leading manufacturers and implement strategies that others in the industry use to ensure successful product development and challenges in bringing new therapies to market.
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