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 joint program Register today! 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.
Schedule (Part I, May 1)
9.30 – 9.40 am Introductions and Objectives
Nigel Langley, IPEC-Americas and Ron Smith, CRS
9.40 – 10.30 am The Aims of the Subcutaneous Drug Delivery Consortium
Sachin Mittal, Merck
10.30 – 10.50 am Networking Break
10.50 –11.20 am Viscosity Modification of Monoclonal Antibody Formulations Using Derivatives of Amino Acids
Arvind Srivastava, Avantor
11.20 –11.50 am SQore ™ Platform Technology and Excipients for Highly Concentrated mAb Formulations
Yuhong Zeng, Comera Life Sciences
11.50 – 1.00 pm Networking Lunch
1.00 – 1.45 pm Current Combination Product Challenges of Delivering High Concentration Biologics in Subcutaneous Tissue
Jason Choi, Biogen
1.45 – 2.30 pm Polysorbates 20 & 80 and Poloxamer 188 - Preventing Protein Aggregation and Avoiding Enzymatic Hydrolysis
Bjorn Peters, BMS
2.30 – 3.15 pm Novel Surfactant for the Stabilization of Proteins
Joshua Katz, IFF
3.15 – 3.30 pm Networking Break
3.30 – 4.00 pm Novel Excipients FDA Pilot Review Program (PRIME)
Nigel Langley, IPEC-Americas
4.00 – 4.45 pm Panel Discussion
All Speakers
Moderator: Ron Smith, CRS
4.45 – 5.00 pm Wrap Up and Biologics Summit Part 2 Communication
Nigel Langley, IPEC-Americas and Ron Smith, CRS
Nigel Langley, IPEC-Americas and Ron Smith, CRS
9.40 – 10.30 am The Aims of the Subcutaneous Drug Delivery Consortium
Sachin Mittal, Merck
10.30 – 10.50 am Networking Break
10.50 –11.20 am Viscosity Modification of Monoclonal Antibody Formulations Using Derivatives of Amino Acids
Arvind Srivastava, Avantor
11.20 –11.50 am SQore ™ Platform Technology and Excipients for Highly Concentrated mAb Formulations
Yuhong Zeng, Comera Life Sciences
11.50 – 1.00 pm Networking Lunch
1.00 – 1.45 pm Current Combination Product Challenges of Delivering High Concentration Biologics in Subcutaneous Tissue
Jason Choi, Biogen
1.45 – 2.30 pm Polysorbates 20 & 80 and Poloxamer 188 - Preventing Protein Aggregation and Avoiding Enzymatic Hydrolysis
Bjorn Peters, BMS
2.30 – 3.15 pm Novel Surfactant for the Stabilization of Proteins
Joshua Katz, IFF
3.15 – 3.30 pm Networking Break
3.30 – 4.00 pm Novel Excipients FDA Pilot Review Program (PRIME)
Nigel Langley, IPEC-Americas
4.00 – 4.45 pm Panel Discussion
All Speakers
Moderator: Ron Smith, CRS
4.45 – 5.00 pm Wrap Up and Biologics Summit Part 2 Communication
Nigel Langley, IPEC-Americas and Ron Smith, CRS
Register for Biologics Summit Part I, May 1
Co-located with Excipient World Conference & Expo, National Harbor, MD
Biologics 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
Biologics 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.)