2019 AAPS PharmSci 360
Clinical Pharmacology Track Themes Announced for 2019 AAPS PharmSci 360!
AAPS PharmSci 360 combines all the energy and resources of a large scientific conference with the content depth of a small, focused gathering.
All of the PharmSci 360 scientific programming is themed, so jump into the track of your expertise and dive deep into your field’s hottest topics with your peers. Here are the themes for the clinical pharmacology track:
Theme 1
Role of Modeling and Simulation in Dose and Dosing Regimen Selection
The value of model-informed drug discovery and development (MID3) in enabling decision-making and increasing efficiency is well established across drug discovery, development, commercialization, and life-cycle management stages. Clinical pharmacology is the key player in selecting the right (or best) dose and dosing regimen. Quantitative modeling approaches represent an integral component in dose selection at different stages of development including selection of first-in-human dose, dose escalation decisions, recommended phase 2 dose (or doses), fixed-dose combination products, supporting the label dosing recommendations, the design of postmarketing dose refinement/finding studies, and personalized dosing.
Approaches of modeling and simulations pertinent to dose selection include pharmacokinetics (PK)/pharmacodynamics for target coverage, population PK, exposure-response analyses, and physiologically based PK modeling. This theme will discuss novel modeling and simulation approaches in guiding dose selection throughout the continuum of drug development. Case studies (both successful and not) where modeling and simulation informed decisions around dose selection as well recent advances, challenges, and future applications of MID3 in dose selection will be discussed.
Theme 2
Clinical Pharmacology Paths for Small Populations
Several patient subpopulations are typically excluded from pivotal clinical trials. These subpopulations include, but are not limited to, patients with advanced degrees of renal or hepatic impairment, children, ethnic subpopulations in support of global registrational plans, women of child-bearing age, and pregnant women, to name a few. Furthermore, patients with rare genetic makeup could also be either excluded from pivotal trials or enrolled in numbers insufficient for adequate characterization of the benefit-risk profile in these subpopulations. Underrepresentation of these subpopulations presents a challenge to extrapolating findings from the general population to these vulnerable patients. Clinical pharmacology plays an important role in bridging this gap through the design of efficient dedicated clinical trials in these subpopulations, use of quantitative modeling approaches, and modernizing eligibility criteria for pivotal clinical trials. Sessions in this theme will explore clinical pharmacology associated challenges and novel approaches to guide efficient drug development in underrepresented subpopulations from the perspective of the pharmaceutical industry, regulatory authorities, academic institutions, and health care providers.
Theme 3
Lessons Learned from Regulatory Interactions in Clinical Pharmacology for Innovative New Chemical Entities, Complex Generics, and Biosimilars
Expediting novel drug development and approval is vital for making useful therapies available to patients with unmet medical need. Streamlining the development and path to approval of new chemical entities (NCEs), complex generics, and biosimilars promise cost savings and increased patient access to innovative and affordable therapies. Interactions between academia, the pharmaceutical industry, and health authorities around the globe can be complex, often resulting in enlightening perspectives related to state-of-the-art study design, data analyses, interpretation, and compromise. Although some of these interactions may be partially available to the public through review documents or assessment reports, an integrated story of events and lessons learned are usually not available. Sessions in this theme will focus on learnings from these interactions, offering a novel perspective on the current status, challenges, opportunities, and future directions of drug development, with a focus on topics related to clinical pharmacology from development to approval of NCEs, complex generics, and biosimilars.
Register today!
The advance registration rate expires October 9.
Need help getting approval?
Visit the
PharmSci 360 website to download our justification letter template to share with your boss.
Katherine A. High, M.D., Confirmed to Close PharmSci 360 on November 6!
An accomplished hematologist with a long-standing interest in gene therapy for genetic disease, High began her career studying the molecular basis of blood coagulation and the development of novel therapeutics for the treatment of bleeding disorders.
Her pioneering bench-to-bedside studies of gene therapy for hemophilia led to a series of studies that characterized the human immune response to adeno-associated virus vectors in a variety of target tissues. High’s work has evolved to encompass clinical translation of potential gene therapies for multiple inherited disorders. As the director of the Center for Cellular and Molecular Therapeutics at the Children’s Hospital of Philadelphia, High assembled a multidisciplinary team of scientists and researchers working to discover new gene and cell therapies for genetic diseases and to facilitate rapid translation of preclinical discoveries into clinical application.
As president at Spark Therapeutics, she has led the development and regulatory approval of the first gene therapy for a genetic disease in the United States. Spark has shown human proof-of-concept of its leading gene therapy platform in both the retina and the liver and has received breakthrough therapy designations for three different therapeutics across two different tissue targets, the eye and the liver.
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Volunteer at PharmSci 360!
Be a Conference Buddy
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 is an easy way to enrich your conference experience and meet fellow professionals in the scientific field.
How It Works
- AAPS will match meeting veterans with first-time attendees who have similar interests about 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!
Participate
Apply to be a Conference Buddy by September 30, 5 pm ET.
Questions?
Email Me’Gesha Portlock.
Mentor a Student
AAPS is hosting its Annual Mentoring Breakfast on Tuesday, November 5, from 7:00 am to 8:30 am, during this year’s AAPS PharmSci 360.
AAPS needs experienced scientists from a variety of backgrounds—including academia, industry, and government—to lead breakfast participants in discussions of their career plans and goals. The only qualification is your willingness to share your experience and insights!
The Mentoring Breakfast typically attracts dozens of students, as well as a few early- and mid-career attendees. This year’s breakfast will be held at the Grand Hyatt San Antonio.
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.
If you can commit to attending this breakfast as a mentor, please visit www.aaps.org/volunteer to complete a brief online form and upload your current biography. Your biography should be no more than one page. (Please note: Biographies longer than one page are subject to editing by AAPS staff to ensure consistency.)
Please note, there are no funds available to support travel expenses to this event.
Apply today!
Application deadline is Friday, October 4, 5 pm ET.
Review Résumés in the Career Development Center
AAPS is seeking seasoned professionals to meet with attendees to discuss their résumé through our résumé review program. Email and let us know if you are interested in helping!
AAPS FALL 2019 WORKSHOPS
Opportunities and Challenges in Translating Cell and Gene Therapy Products
Hilton London Tower Bridge, London • September 4 – 5, 2019
In collaboration with 
Sponsored by
This workshop focuses on the rapidly evolving and complex advanced therapeutics and medicinal products (ATMP) field. ATMPs encompass a wide range of therapies, from gene and cell therapies to gene editing technology. While there has been exciting progress in the preclinical and clinical stages in recent years, this success does not necessarily equal commercial success.
We will bring together different perspectives from academia, industry, and regulatory fields to discuss and clarify the main issues confronting ATMP development, and offer a broad overview of the challenges of developing ATMPs. Topics will include adoption challenges, clinical provisions, supply chains, manufacturing, and health economics.
Participants in this event will:
- understand the current cell and gene therapy pipelines across disease areas;
- discuss recent breakthroughs in gene editing approaches, especially on advancing nonviral vectors for ex vivo/in vivo gene editing; and
- discover key preclinical development and testing work packages to enable rapid clinical translation of cell and gene therapy products.
Register today!
AAPS Guidance Forum
DoubleTree Bethesda, Bethesda, Md. • September 5 – 6, 2019
This workshop will discuss challenges, issues, and concerns for two Food and Drug Administration guidance documents that are of high importance to AAPS members.
Day 1: Quality Considerations for Continuous Manufacturing
Draft guidance for industry, February 2019
Speakers will address:
- technical and regulatory challenges for continuous manufacturing
of solid oral dosage forms,
- regulatory expectations compared to traditional batch manufacturing,
- opportunities to remove constraints in the current regulatory framework,
- how to structure continuous manufacturing in a dossier, and
- how the FDA guidance can influence and support global implementation.
Day 2: In Vitro Metabolism and Transporter-Mediated Drug-Drug Interaction Studies
Draft guidance for industry, October 2017
Speakers will address:
- metabolism and transporter mediated drug-drug interactions (DDI),
- validation requirements for analytical methods of in vitro experiments,
- requirements for phenotyping and challenges in data interpretation,
- the rationale underlying methods for in vitro to in vivo extrapolation (IVIVE) in the guidance,
- challenges of current IVIVE methods for metabolism and transporter-mediated DDIs and how to address them; and
- emerging quantitative and translational approaches to predict DDIs.
Both days will feature plenary speakers and have breakout-style sessions on several topics. This format will provide ample opportunity for participants to engage in open dialogue with regulators, academics, and industry scientists, with the goal of providing insight into the guidance for submission of regulatory applications.
Register today!
Workshop Thought Leadership and Sponsorship Opportunities
For workshop thought leadership and sponsorship opportunities, please view the workshop website. Or to discuss your organization’s unique needs, contact the Business Development Team directly:
Contact
Erik Burns, Ed.D., M.B.A., M.A. | +1.703.248.4738
Kate Hawley, CEM | +1.703.248.4785