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Theme 1: Role of Excipients in Formulation & Drug Product Development
Excipients play an important role in the development of the final drug product. While generally considered pharmacologically inert, excipients affect a wide range of performance characteristics ranging from manufacturing robustness to stability and even bioavailability. This theme will explore the role of excipients in formulation and drug product development for both chemical and biomolecules.
Chemical entities topics may include: impact of excipients on bioperformance (i.e., role of polymers, to maintain supersaturation), stability and manufacturability for both conventional and solubilizing (i.e., amorphous solid dispersions, lipid-based, and nanoparticle) formulations, effect of excipients on organoleptic properties and bioavailability for pediatric dosage forms, qualification of novel excipients including compatibility and biocompatibility studies, selection of excipients to optimize viscosity for parenteral products, incorporation of excipient considerations in early QbD risk assessment, and use of excipients with active pharmacological effects such as permeation enhancers.
Biomolecules topics may include: effect of excipients on solubility, viscosity, and stability for therapeutics peptides/proteins/mAbs, pharmacologically active "excipients" to facilitate administration of larger volume biologics (e.g., hyaluronidase for SC administration), importance of adjuvants and their effect on vaccine stability/safety/efficacy; and challenges and opportunities in co-formulation of biologics.
Theme 2: Delivery Systems for Effective Shuttling Across Biological Barriers
Formulations and delivery systems that can aid the transport of therapeutic agents across biological barriers are increasingly important, especially for biologics that often face challenges in their transit across membranes. This theme covers the advancement of delivery systems for the oral, inhalation, nasal, ocular, and transdermal routes that promote delivery of therapeutic agents across biological barriers. Also included are long-acting injectable formulations, injector systems, microneedles, and particulate-based delivery systems for both chemical entities and biomolecules. This theme will also cover biologically based approaches for enhancing transport across biological barriers including the use of exosomes as a drug carrier, cell-penetrating peptides and transporters, and approaches used in delivery of gene therapy to specific organs.
Theme 3: Formulation Development for New Therapeutic Modalities
Advances in basic science and molecular engineering have led to the emergence of multiple modalities such as bi-/tri-specific antibodies, BiTE® antibody construct, peptibody, antisense oligonucleotides, short interfering RNA, viral and non-viral gene therapy, genome editing technologies, oncolytic viruses, and cell therapy as potential breakthrough treatments for life-threatening diseases. Development of these novel modalities into effective therapies requires establishing novel, robust, and scalable formulations and drug product development strategies. This theme will cover challenges and progress in formulation and drug product development for chemical (e.g., peptide, antisense oligos, short interfering RNA) and biological (e.g., bi-/tri-specific antibodies, BiTE technology, ADCs, genome editing, and gene and cell therapy) modalities.
2021 AAPS PharmSci 360 Exhibit and Sponsorship Opportunities
Exhibiting and sponsorship opportunities are now available! Booth and non-booth packages are available to meet the business goals of scientific leadership, lead generation, brand awareness, and product/service demonstration. To learn more, go to www.aapspharmsci360.org, or contact Rich Hodge at SalesAAPS@ntpevents.com.
Volunteer at PharmSci 360
Help others learn and grow by volunteering at PharmSci 360
We need volunteers to help AAPS create an amazing experience at this year’s PharmSci 360, which will be held October 17–20 in Philadelphia. There are a variety of volunteer opportunities that will expand your network and give you an opportunity to share your expertise and help others learn and grow.
Tuesday, Oct. 19, 7:00 am‒8:30 am E
AAPS needs experienced scientists from a variety of backgrounds – including academia, industry, and regulatory – to lead breakfast participants in discussions of their career plans and goals. The only qualification is your willingness to share your experience and insights!
By serving as a mentor, you give tomorrow’s scientists—and the future leaders of AAPS—the benefit of your insight and experience through informal, one-on-one conversations.
How It Works:
- Sign-up to participate in the Mentoring Breakfast, including uploading your 1-page biography, which will be shared with attendees to help them connect with the right mentor.
- Receive a confirmation from AAPS.
- Attend the Mentoring Breakfast and sit at your assigned table, so mentees can find you!
If you can commit to attending this breakfast as a mentor, please complete this brief online form by September 30, 5:00 pm ET.
Monday‒Tuesday, Oct. 18‒19, 9:00 am‒5:00 pm
Wednesday, Oct. 20, 9:00 am‒1:30 pm
Leave a lasting impact by sharing your expertise with emerging scientists. Volunteer to be a resume reviewer in the Career Development Center at PharmSci 360.
How It Works:
- Get matched with emerging scientists based on your field of expertise.
- Choose from various 90-minute time slots available to best fit your conference schedule.
- Meet with an emerging scientist in a private space provided in the Career Center.
Complete the volunteer form by September 30, 5:00 pm ET and receive your placement!
Sunday, Oct. 17‒Wednesday, Oct. 20
The PharmSci 360 Conference Buddy program connects first-time attendees with meeting veterans who know the people and the programming that AAPS events attract. It’s an easy way to enrich your conference experience and meet fellow professionals in the scientific field.
How It Works:
- Sign-up by September 30.
- AAPS will match meeting veterans with first-time attendees who have similar interests approximately a week before the meeting begins.
- Meeting veterans will contact their assigned conference buddies before the meeting and will schedule a time to connect during the event.
- At the event, paired buddies can discuss the sessions they have seen, have lunch or dinner, walk the solution center, and discuss projects. What you do together is up to you!
To participate in the Conference Buddy program, apply by September 30, 5:00 pm ET.
Monday‒Tuesday, Oct. 18‒19, 9:00 am‒5:00 pm
Wednesday, Oct. 20, 9:00 am‒1:30 pm
Help evaluate other professionals’ LinkedIn profiles and create a great first impression by improving their professional brand on the internet. Volunteer to be a LinkedIn profile reviewer in the Career Development Center at PharmSci 360.
How It Works:
- Choose from various 90-minute time slots available to best fit your conference schedule.
- Meet with emerging scientists at the LinkedIn Bar in the Career Center.
- Review emerging scientists’ LinkedIn profiles and provide tips to help build leads, grow a professional audience, or find a new job.
Complete the volunteer form by September 30, 5:00 pm, ET and receive your placement!