Events from the AJ Clark School of Engineering http://eng.umd.edu/events/ Mon, 01 Jun 2026 17:20:00 EDT http://eng.umd.edu/images/clark_logo_4email.gif http://eng.umd.edu/events/ Wednesday, June 24, 2026 1:00 PM, University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201, Date: June 24-25, 2026 Time: 8 a.m.-5 p.m. Location: University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201 About the Event Recent progress and advancements in drug delivery technologies and formulation sciences have created new opportunities for developing better pediatric medicines. However, multiple challenges and hurdles need to be overcome before these technologies can become fully available to children. By bringing together the pediatric community including pharmaceutical scientists, regulators and clinical counterparts from diverse functions, this workshop is intended to shed light on the barriers to and opportunities for patient-focused pediatric formulations. Advancing pediatric formulations will require sharing and building on experiences from patients/caregivers, industry, academia, and regulators. It is hoped that the participants will better understand the principles, gaps, technical, and process challenges encountered during formulation and dosage product development as well as considerations for regulatory assessments and ultimately policy development. Sessions Patient-Centricity  Scope:  Patient-centric product development in the context of pediatric formulation means using a user-focused approach that understands the physiological, developmental and psychological needs of the pediatric population that spans from neonates to adolescence. This translates into tailoring dosage forms to address factors such as dosing flexibility, taste-masking and swallowing abilities across this age group and ascertain that caregivers can deliver these medications where needed to ensure adherence to dosing regimen to impact health outcomes. This concept also applies to easing the burden of clinical studies and arriving at appropriate dosing regimens with minimal hardships on this vulnerable population. This session will present perspectives on some of these aspects to promote understanding and generate discussion on some of these key topics. Formulation and Analytical Aspects of a Pediatric Dosage Form:  Mini tablets Scope:  This session will focus on key aspects of developing mini tablets as a dosage form for pediatrics. This session will provide a forum to discuss acceptability of mini tablets across pediatric age groups, inconsistencies in nomenclature, manufacturing and packaging challenges and limitations, and strategies for identifying appropriate food vehicles. Formulation and Analytical Aspects of a Pediatric Dosage Form: Excipients for Pediatric Formulations Scope:  This session features presentations on the assessment of excipients for pediatric formulations, including tools such as the IID and ELSA, delivered by FDA experts.  Industry perspectives are provided through talks on challenges and considerations in selecting excipients for pediatric products, including the use of the PERA tool. Additional insights focus on excipient needs for special populations—such as neonates.  The program concludes with a breakout session on the PARA tool and a forward-looking panel discussion on future needs, research priorities, and regulatory challenges in pediatric excipient development. Imagining the Future of Pediatric Formulation Development  Scope:  Since our last pediatric workshop in 2019, we have seen transformational innovations in drug delivery systems, the evolution of complex biologics, as well as new techniques for gene editing and gene therapy. Furthermore, recent advances in AI/ML methodologies, including agentic AI, are having a broad impact on drug discovery and development. In this session, we will discuss these recent trends and how they will shape the future of developing better drugs and delivery systems for children. Collaboration for Kids (across Academia, Health Authorities, Industry, and Non-profit Organizations) Scope:  This session will look towards establishing potential collaboration opportunities through shared understanding of the work done by various organizations such as industry, academia, philanthropic organizations or governments. The distinguished panel members from each of these organizations will share their perspectives through panel discussion. Workshop participants are encouraged to share their questions even ahead of time to enable productive, focused discussion on key topics as they relate to pediatric formulation development.   Discussion Points:  innovation, acceleration, coordination, international harmonization, incentives To register please visit: https://www.eventbrite.com/e/shaping-the-future-of-pediatric-formulation-development-tickets-1073482367659?aff=oddtdtcreator The Agenda can be found via this link    Funding Statement   This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science and Innovation, U01FD005946 totaling $10,000 funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. government. http://www.cersi.umd.edu/events/index.php?mode=4&id=20434 http://www.cersi.umd.edu/events/index.php?mode=4&id=20434 Thursday, June 25, 2026 1:00 PM, University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201, Date: June 24-25, 2026 Time: 8 a.m.-5 p.m. Location: University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201 About the Event Recent progress and advancements in drug delivery technologies and formulation sciences have created new opportunities for developing better pediatric medicines. However, multiple challenges and hurdles need to be overcome before these technologies can become fully available to children.  By bringing together the pediatric community including pharmaceutical scientists, regulators and clinical counterparts from diverse functions, this workshop is intended to shed light on the barriers to and opportunities for patient-focused pediatric formulations. Advancing pediatric formulations will require sharing and building on experiences from patients/caregivers, industry, academia, and regulators. It is hoped that the participants will better understand the principles, gaps, technical, and process challenges encountered during formulation and dosage product development as well as considerations for regulatory assessments and ultimately policy development. Sessions Patient-Centricity  Scope:  Patient-centric product development in the context of pediatric formulation means using a user-focused approach that understands the physiological, developmental and psychological needs of the pediatric population that spans from neonates to adolescence. This translates into tailoring dosage forms to address factors such as dosing flexibility, taste-masking and swallowing abilities across this age group and ascertain that caregivers can deliver these medications where needed to ensure adherence to dosing regimen to impact health outcomes. This concept also applies to easing the burden of clinical studies and arriving at appropriate dosing regimens with minimal hardships on this vulnerable population. This session will present perspectives on some of these aspects to promote understanding and generate discussion on some of these key topics. Formulation and Analytical Aspects of a Pediatric Dosage Form: Mini tablets Scope:  This session will focus on key aspects of developing mini tablets as a dosage form for pediatrics. This session will provide a forum to discuss acceptability of mini tablets across pediatric age groups, inconsistencies in nomenclature, manufacturing and packaging challenges and limitations, and strategies for identifying appropriate food vehicles. Formulation and Analytical Aspects of a Pediatric Dosage Form: Excipients for Pediatric Formulations Scope:  This session features presentations on the assessment of excipients for pediatric formulations, including tools such as the IID and ELSA, delivered by FDA experts.  Industry perspectives are provided through talks on challenges and considerations in selecting excipients for pediatric products, including the use of the PERA tool. Additional insights focus on excipient needs for special populations—such as neonates.  The program concludes with a breakout session on the PARA tool and a forward-looking panel discussion on future needs, research priorities, and regulatory challenges in pediatric excipient development. Imagining the Future of Pediatric Formulation Development  Scope:  Since our last pediatric workshop in 2019, we have seen transformational innovations in drug delivery systems, the evolution of complex biologics, as well as new techniques for gene editing and gene therapy. Furthermore, recent advances in AI/ML methodologies, including agentic AI, are having a broad impact on drug discovery and development. In this session, we will discuss these recent trends and how they will shape the future of developing better drugs and delivery systems for children. Collaboration for Kids (across Academia, Health Authorities, Industry, and Non-profit Organizations) Scope:  This session will look towards establishing potential collaboration opportunities through shared understanding of the work done by various organizations such as industry, academia, philanthropic organizations or governments. The distinguished panel members from each of these organizations will share their perspectives through panel discussion. Workshop participants are encouraged to share their questions even ahead of time to enable productive, focused discussion on key topics as they relate to pediatric formulation development.   Discussion Points:  innovation, acceleration, coordination, international harmonization, incentives To register, please visit: https://www.eventbrite.com/e/shaping-the-future-of-pediatric-formulation-development-tickets-1073482367659?aff=oddtdtcreator The Agenda can be found via this link   Funding Statement   This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science and Innovation, U01FD005946 totaling $10,000 funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. government. http://www.cersi.umd.edu/events/index.php?mode=4&id=20433 http://www.cersi.umd.edu/events/index.php?mode=4&id=20433 Thursday, July 16, 2026 2:00 PM, FDA White Oak Campus, Silver Spring Maryland , ​Thursday, July 16, 20269-11:30 a.m. ​Workshop LocationFDA White Oak CampusBuilding 31, Conference Center, The Great Room (Room 1503)10903 New Hampshire Ave.Silver Spring, MD 20993 ​Organized ByCDER Office of New Drugs, Division of Pediatrics and Maternal HealthM-CERSI ​Background and SynopsisTreatment of chronic hypertension in pediatric patients, particularly children from birth to under 6 years of age, remains an area of unmet medical need, with limited FDA-approved therapies for use in this age group. Products are also being developed for the treatment of uncontrolled and/or resistant hypertension in adults. This public workshop will bring together key stakeholders, including clinicians, academicians, regulators, industry, and patients/caregivers, to discuss the similarities and differences in disease pathophysiology and drug response across age groups, determine the extent to which efficacy can be extrapolated, identify development priorities for both initial therapy and uncontrolled hypertension, and explore feasible strategies to generate evidence for the safe and effective use of antihypertensive treatment(s) in pediatric patients with hypertension. ​AgendaThe full agenda is available here. RegistrationTo register, please click this link ​Visiting the FDA CampusEntrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. ​Virtual Attendance InformationThis workshop will be hybrid. The Zoom link will be provided to all registered attendees via email before the workshop. ​Food & DrinkAttendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening. ​AccessibilityThe FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email OPRWorkshop@fda.hhs.gov at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities. http://www.cersi.umd.edu/events/index.php?mode=4&id=20713 http://www.cersi.umd.edu/events/index.php?mode=4&id=20713 Wednesday, July 15, 2026 2:00 PM, FDA White Oak Campus, Silver Spring Maryland , Workshop DatesWednesday, July 15, 20269 a.m.-5 p.m. ​Thursday, July 16, 20269-11:30 a.m. ​Workshop LocationFDA White Oak CampusBuilding 31, Conference Center, The Great Room (Room 1503)10903 New Hampshire Ave.Silver Spring, MD 20993 ​Organized ByCDER Office of New Drugs, Division of Pediatrics and Maternal HealthM-CERSI ​Background and SynopsisTreatment of chronic hypertension in pediatric patients, particularly children from birth to under 6 years of age, remains an area of unmet medical need, with limited FDA-approved therapies for use in this age group. Products are also being developed for the treatment of uncontrolled and/or resistant hypertension in adults. This public workshop will bring together key stakeholders, including clinicians, academicians, regulators, industry, and patients/caregivers, to discuss the similarities and differences in disease pathophysiology and drug response across age groups, determine the extent to which efficacy can be extrapolated, identify development priorities for both initial therapy and uncontrolled hypertension, and explore feasible strategies to generate evidence for the safe and effective use of antihypertensive treatment(s) in pediatric patients with hypertension. ​AgendaThe full agenda is available here. RegistrationTo register, please click this link ​Visiting the FDA CampusEntrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. ​Virtual Attendance InformationThis workshop will be hybrid. The Zoom link will be provided to all registered attendees via email before the workshop. ​Food & DrinkAttendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening. ​AccessibilityThe FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email OPRWorkshop@fda.hhs.gov at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities. http://www.cersi.umd.edu/events/index.php?mode=4&id=20712 http://www.cersi.umd.edu/events/index.php?mode=4&id=20712 Thursday, July 30, 2026 2:00 PM, FDA White Oak Campus, Silver Spring Maryland , Workshop LocationFDA White Oak CampusBuilding 31, Conference Center, The Great Room (Room 1503)10903 New Hampshire Ave.Silver Spring, MD 20993 ​Organized ByCDER Office of New Drugs, Division of Pediatrics and Maternal HealthM-CERSI ​BackgroundSystemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by inflammation, autoantibody production, and alternating periods of disease flares and remission. Approximately 10–20% of cases have onset during childhood. Currently, only one biologic therapy is approved for pediatric SLE, leaving a substantial unmet need for additional safe and effective treatment options. ​Conducting clinical trials in pediatric SLE presents several challenges, including a small patient population, limited specialized centers, and difficulties with recruitment and retention. In addition, there is a need to evaluate how existing data, often from adult SLE studies, may be appropriately extrapolated to pediatric populations to streamline drug development and reduce the burden of clinical research in pediatric patients with SLE to ensure timely availability of safe and effective therapies in this population. ​AgendaThe full agenda is available here. ​Visiting the FDA CampusEntrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. ​Virtual Attendance InformationThis workshop will be hybrid. The Zoom link will be provided to all registered attendees via email before the workshop. ​Food & DrinkAttendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening. ​AccessibilityThe FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email Meshaun Payne or Kerri-Ann Jennings at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities. ​ContactFor additional details, contact Meshaun Payne or Kerri-Ann Jennings. http://www.cersi.umd.edu/events/index.php?mode=4&id=20714 http://www.cersi.umd.edu/events/index.php?mode=4&id=20714 Friday, July 31, 2026 2:00 PM, FDA White Oak Campus, Silver Spring Maryland , Workshop LocationFDA White Oak CampusBuilding 31, Conference Center, The Great Room (Room 1503)10903 New Hampshire Ave.Silver Spring, MD 20993 ​Organized ByCDER Office of New Drugs, Division of Pediatrics and Maternal HealthM-CERSI ​BackgroundSystemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by inflammation, autoantibody production, and alternating periods of disease flares and remission. Approximately 10–20% of cases have onset during childhood. Currently, only one biologic therapy is approved for pediatric SLE, leaving a substantial unmet need for additional safe and effective treatment options. ​Conducting clinical trials in pediatric SLE presents several challenges, including a small patient population, limited specialized centers, and difficulties with recruitment and retention. In addition, there is a need to evaluate how existing data, often from adult SLE studies, may be appropriately extrapolated to pediatric populations to streamline drug development and reduce the burden of clinical research in pediatric patients with SLE to ensure timely availability of safe and effective therapies in this population. ​AgendaThe full agenda is available here. Registration To register, please click this link  ​Visiting the FDA CampusEntrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. ​Virtual Attendance InformationThis workshop will be hybrid. The Zoom link will be provided to all registered attendees via email before the workshop. ​Food & DrinkAttendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening. ​AccessibilityThe FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email Meshaun Payne or Kerri-Ann Jennings at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities. ​ContactFor additional details, contact Meshaun Payne or Kerri-Ann Jennings. http://www.cersi.umd.edu/events/index.php?mode=4&id=20715 http://www.cersi.umd.edu/events/index.php?mode=4&id=20715