Early Bird Registration and Hotel Block Available Until
APRIL 10
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Biologics Summit
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NEW THIS YEAR: Biologics Summit
a Controlled Release Society and IPEC-Americas join program 2023 Theme
Subcutaneous Delivery of High Dose mAbs
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Dates/Location
PART I, May 1: Co-located with Excipient World Conference & Expo, National Harbor, MD
PART II, July 24: Co-located with CRS Annual Meeting & Expo, Las Vegas, NV
Subcutaneous (SC) delivery of biologic therapeutics as an alternative to IV infusion is of increasing interest to expand the patient-centric opportunities for self-or caregiver-assisted administration at home or in an office setting. The normally high dose and volumes associated with IV administration of therapeutic proteins present significant challenges to achieving SC delivery, such as, high concentration viscosities, stability/protein aggregation, unpredictable bioavailability, potential immunogenicity, manufacturability and injection device compatibility.
This Biologics Summit, jointly hosted by the Controlled Release Society and IPEC-Americas, will address the current state and prospects for future advancements related to formulation and characterization technologies, functional excipients, predictive bioavailability and device technologies to enable the SC delivery of high dose/volume biologics.
This Biologics Summit, jointly hosted by the Controlled Release Society and IPEC-Americas, will address the current state and prospects for future advancements related to formulation and characterization technologies, functional excipients, predictive bioavailability and device technologies to enable the SC delivery of high dose/volume biologics.
Preliminary Schedule (Part I, May 1)
10.00 – 10.15 am Introductions and Objectives
10.15 – 11.00 am The Aims of the Subcutaneous Drug Delivery Consortium (Sachin Mittal, Merck)
11.00 – 11.30 am Networking Break – Coffee
11.30 am – 12.15 pm Review of the Current Challenges to Deliver Highly Concentrated Biologics, e.g. mAbs – Subcutaneous Injection Techniques (Jason Choi, Biogen)
12.15 – 1.30 pm Networking Break – Lunch
1.30 – 2.00 pm Developing Excipients for Reducing Viscosity of High Concentration Biologic Formulations (Speaker coming soon!)
2.00 – 2.45 pm
> Review of Polysorbates (80 & 20) Including Mode of Action to Prevent Protein Agglomeration and Current Lipolysis Concerns (Dr Bjorn Peters, Bristol Myers Squibb)
> Poloxamer 188 as Surfactant in Biological Formulations – An Alternative to Polysorbate 20/80 (Invited: Patrick Garidel, Boehringer-Ingelheim)
2.45 – 3.00 pm Networking Break – Coffee
3.00 – 3.45 pm Regulatory Considerations in the Subcutaneous Delivery of High-dose/Volume Biologics (Invited: Ashutosh Rao, Office of Biotechnology Products, OPQ, FDA)
3.45 – 4.00 pm Wrap Up and Biologics Summit Part 2 Communication
10.15 – 11.00 am The Aims of the Subcutaneous Drug Delivery Consortium (Sachin Mittal, Merck)
11.00 – 11.30 am Networking Break – Coffee
11.30 am – 12.15 pm Review of the Current Challenges to Deliver Highly Concentrated Biologics, e.g. mAbs – Subcutaneous Injection Techniques (Jason Choi, Biogen)
12.15 – 1.30 pm Networking Break – Lunch
1.30 – 2.00 pm Developing Excipients for Reducing Viscosity of High Concentration Biologic Formulations (Speaker coming soon!)
2.00 – 2.45 pm
> Review of Polysorbates (80 & 20) Including Mode of Action to Prevent Protein Agglomeration and Current Lipolysis Concerns (Dr Bjorn Peters, Bristol Myers Squibb)
> Poloxamer 188 as Surfactant in Biological Formulations – An Alternative to Polysorbate 20/80 (Invited: Patrick Garidel, Boehringer-Ingelheim)
2.45 – 3.00 pm Networking Break – Coffee
3.00 – 3.45 pm Regulatory Considerations in the Subcutaneous Delivery of High-dose/Volume Biologics (Invited: Ashutosh Rao, Office of Biotechnology Products, OPQ, FDA)
3.45 – 4.00 pm Wrap Up and Biologics Summit Part 2 Communication
Register for Biologics Summit Part I, May 1
Co-located with Excipient World Conference & Expo, National Harbor, MD
Biolgics Summit Part I + Excipient World Conference & Expo Registration (May 1-3)
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Biologics Summit Part I only (May 1)
If you plan to attend the Biologics Summit Part I only, without attending Excipient World Conference & Expo, pricing is as follows:
Early Bird Rate (through April 10): $395
Standard Rate (after April 10): $495
Register for Biologics Summit PART II, July 24
Co-located with CRS Annual Meeting & Expo, Las Vegas, NV
Biolgics Summit Part II + CRS Annual Meeting & Expo Registration (July 24 - 28)
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Biologics Summit Part II only (July 24)
If you plan to attend the Biologics Summit Part II only, without attending the CRS 2023 Annual Meeting & Expo, pricing is as follows:
Early Bird Rate (through April 10): $395
Standard Rate (after April 10): $495
Register for Biologics Summit Part I and Part II only (May 1 and July 24)*
If you plan to attend the Biologics Summit Part I and Part II only, without attending Excipient World Conference & Expo or the CRS 2023 Annual Meeting & Expo, pricing is as follows:
Early Bird Rate (through April 10): $651.75
Standard Rate (after April 10): $816.75
*If you attend Part I and Part II of the Biologics Summit, a 35% discount will apply to Part II of the registration. The discount will be applied after IPEC-Americas verification of attending Part I. (NOTE: The discount will apply ONLY to "Biologics Summit Part I and Part II only" registrations.)