American Association of Pharmaceutical Scientists

American Association of Pharmaceutical Scientists

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Formation 1986
Headquarters Arlington, VA
Location
  • United States
Membership
10,000
Official language
English
President
Greg Amidon
Key people
Binodh DeSilva (President Elect), Alice Till (Past President), Bill Weiser (Treasurer), Joe Polli (Member-at-Large), Bob Chapman (Member-at-Large), Chris McCurdy (Member-at-Large), Stacey Tannenbaum (Member-at-Large), Andy Vick (Member-at-Large), Walt Marlowe (Executive Director)
Website www.aaps.org

The American Association of Pharmaceutical Scientists (AAPS) is a nonprofit organization supporting interaction, knowledge exchange and career growth opportunities for approximately 10,000 scientific professionals within industry, government and academia.[1] The association is divided into various functional sections, focus groups and regional discussion groups[2] and is governed by an executive council elected by the membership.[3]

AAPS supports several public outreach efforts through social media: YouTube,[4] Facebook,[5] Linked In[6] and Twitter.[7] The organization also publishes peer-reviewed scientific journals such as Pharmaceutical Research, The AAPS Journal[8] and AAPS PharmSciTech[9] as well as a monthly newsmagazine.[10] Career development and learning opportunities are available to the membership through electronic courses, webinars and posters[11] as well as an annual meeting and exposition.[12]

Mission: The mission of AAPS is to continue providing an interactive international forum for knowledge exchange between academic and industrial scientist and thereby allowing them to promote pharmaceutical sciences in the best interest of public health.[1] Vision: In its endeavor to serve its membership, AAPS is dedicated to providing a forum for facilitation of discovery, development and knowledge dissemination for the pharmaceutical sciences, biomedical and biotechnological sciences community.[1] Values: AAPS serves as the primary forum that fosters the integration of those sciences related to discovery, design, analysis, development, production, quality control, safety, clinical evaluation, regulation, distribution, and utilization of drugs and drug delivery systems. The organization aims to achieve these objectives through strong values including effective communications, diversified membership portfolios and continued commitment to innovation in science and technology. AAPS members are encouraged to actively participate in shaping the organization and in turn having an opportunity for professional development through networking, mentoring, education, and scientific exchange.

AAPS Publications

The American Association of Pharmaceutical Scientists (AAPS) currently produces three official journals, the AAPS Journal, AAPS Pharm SciTech, and Pharmaceutical Research.[13] The AAPS Journal is an online, peer-reviewed journal that focuses on issues within the scope of pharmaceutical sciences as well as seeking to foster the dissemination of scientific information that can be presented in a number of forums such as through AAPS-sponsored meetings, workshops, or symposia.[14] The AAPS Pharm SciTech is also an online peer-reviewed journal that utilizes electronic technology to deliver information to readers coupled with a focus on serving pharmaceutical scientists that have interest in research, development and evaluation of pharmaceutical dosage forms and delivery systems.[15] Also, Pharmaceutical Science seeks to present papers that describe innovative research that span the entire spectrum of drug discovery, development, evaluation, and regulatory approval. The areas of interest for Pharmaceutical Science encompass preformulation, drug delivery and targeting, formulation design, and engineering to name a few.[16] Along with the three official journals, AAPS also publishes an online monthly access news magazine titled AAPS Newsmagazine which is a source of industry insight and association news for leading pharmaceutical scientists with topics that cover drug delivery system, use of technology, and industry modernization.[17] The development of the AAPS blog serves as a forum for pharmaceutical scientists, AAPS members, key leaders in pharmaceutical and biotechnology industries, regulatory and governmental bodies, pharmaceutical bloggers, and the media, and other related professionals to provide timely perspectives/insight on relevant issues that impact their profession and ongoing practices.[18]

AAPS Meetings

Annual Meeting

AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health. Timely scientific programs, ongoing education, opportunities for networking, and professional development are provided through the annual and biotech meetings.[12]

The annual meeting generally occurs in November and is scheduled for five days. The 2013 AAPS Annual Meeting and Exposition is a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health, which was attended by more than 8,000 professionals from government, academia, and industry. In one place, scientists can meet their peers in all disciplines; discuss the latest research presented at contributed paper poster sessions; discuss projects with current and new suppliers; and enjoy a scientific program focused on the discovery, development, and manufacture of pharmaceutical products and therapies that advance science and technology. The meeting is a rich resource of knowledge about how to advance scientific projects. Attendees include scientists working in drug design, discovery, development, delivery, packaging, scale-up, clinical trials, and regulatory sciences.

In addition, there are many opportunities for continued education credits, typically through the many pre conference short courses, meeting symposia, workshops, open forums, and hot topics.

National BioTech Conference

The annual National Biotechnology Conference (NBC) generally occurs in the third week of May and the main meeting goes over 3 days with training courses (continued education credits offered) and workshops that occur the weekend just before the meeting and on the days just after. Typically there is a plenary session to start the meeting and symposia, sunrise session, roundtables, posters and hot topics. Additionally there is an exposition hall that typically hosts over 100 major companies.[19]

Online Courses

AAPS's online training course, Biotechnology 101, is a comprehensive online training course developed for those interested in learning more about the field of biologic development and to fill training gaps. The training gaps addressed by the AAPS Biotechnology 101 elearning series include the fact that drug development of biotech products is quite different from that of small molecules and current biotechnology curricula may lack the practical drug development aspects to prepare students for the biopharmaceutical industry.[20]

AAPS Sections

The American Association of Pharmaceutical Sciences (AAPS) currently supports nine (9) sections with forums to facilitate exchange of ideas, scientific findings, research data and examine regulatory and ethics concerns in the area of pharmaceutical sciences. All sections promote the continued growth and collaborate with other AAPS sections for the advancement in the area of their common interests. They offer an opportunity for networking, presentation of new data, and exchange of ideas from academia, industry, and regulatory agencies. The sections are summarized in the following:

APQ (Analytical and Pharmaceutical Quality)

Overview

APQ Section is composed of members who have strong interest in analytical method development and validation and the use of these methods in quality control of drug substances and drug products for small molecules and biologics. Information pertaining to emerging scientific development, technologies, regulatory and compendial issues, and assurance of quality are their focus.[21][22]

Activities

The Analysis and Pharmaceutical Quality[23] (APQ) section of AAPS encompasses those scientists interested in assessing the identity, purity and potency of biologically active compounds, within both drug substances and drug products. This section provides an environment for members to discuss practical and regulatory issues of emerging technologies and scientific developments for analytical chemistry and bioanalysis. The APQ section also encourages members to contribute to the scientific literature by submitting research articles to international peer reviewed publications such as the Journal of Pharmaceutical and Biomedical Analysis.[24]

Focus Groups

The APQ section sponsors several focus groups to encourage discussion and interaction on specific topics. The primary groups include: bioanalytical,[25] CRO,[26] in-vitro release and dissolution testing,[27] non-clinical dose formulation and analysis,[28] pharmaceutical impurities[29] and stability.[30] Additional secondary focus groups include: API Manufacturing Technology,[31] Biosimilars,[32] CMC,[33] CMC statistics,[34] Generic Pharmaceuticals,[35] Ligand Binding Assay Bioanalysis,[36] Microdialysis[37] and PAT.[38]

RS (Regulatory Sciences)

RS Overview

RS section is composed primarily of professionals who practice regulatory affairs in the pharmaceutical and biopharmaceutical industries, academia, and health authorities, and are involved with all aspects of drug development—from discovery through life cycle management. It provides the tools and networking opportunities for members who are interested in the areas of regulatory compliance, GMP, clinical, pre-clinical practices, legal and protection of intellectual property.[39][40]

RS Activities

The RS section includes four primary focus groups that are aligned with the overall focus of the section on manufacturing and quality assurance: Bioequivalence Focus Group, Chemistry, Manufacturing, and Controls (CMC) Focus Group, CMC Statistics Focus Group and Process Modeling and Generic Pharmaceuticals Focus Group. In addition RS is also affiliated with numerous other AAPS focus groups (secondary focus groups) which activities touch upon regulatory aspects of drug/biologics development and include Biosimilars, Excipients, In Vitro Release and Dissolution Testing, Patient-Centric Drug Development, Product Design, and Manufacturing, Pharmaceutical Impurities, Protein Aggregation and Biological Consequences, Process Analytical Technology, QbD and Product Performance, and Stability Focus Groups.[41]

RS section sponsors awards and travelships, including the AAPS Regulatory Sciences Achievement Award that is awarded to regulatory scientists who have made outstanding contributions to the field of regulatory sciences.

PPDM (Pharmacokinetics, Pharmacodynamics, and Drug Metabolism)

PPDM section is composed primarily of individuals whose research interests include characterization of drug/drug products, drug disposition, and biotransformation at the organism, tissue, cellular, and subcellular levels. It provides a forum to examine issues related to the biopharmaceutics, pharmacokinetics, pharmacodynamics, drug metabolism, and transport of pharmaceuticals and biologicals.[42]

PPB (Physical Pharmacy and Biopharmaceutics)

PPB Scientific Areas of Interest

Biopharmaceutics refers to the "study of the relationships between the physical and chemical properties, form and route of administration of a drug and its activity in the body".[43] Studying the properties of drug compounds and excipients used in pharmaceutical formulations, establishing the link between physicochemical properties and the drug dosage form in vitro and in vivo performance and subsequently utilizing this knowledge to improve drug delivery is the common theme of the AAPS PPB section’s scientific areas of interest. The PPB Section is composed of members who are active in diverse areas of research on both small molecules and biologics including preformulation, drug absorption, biopharmaceutics, nanotechnology, and drug delivery systems development and evaluation including targeted drug delivery and prodrugs.[44] The PPB section strives to advance the science in the fields of physical pharmacy and biopharmaceutics by:

PPB Activities

AAPS PPB Section promotes the active knowledge exchange between its members by helping with the organization of relevant sessions in the AAPS Annual Meeting,[45] AAPS Annual Biotechnology Meeting and relevant AAPS workshops. In addition the PPB section via its affiliated focus groups helps organize AAPS webinars in relevant areas of research, e.g. on “Biopharmaceutics of Non-orally Administrated Drugs”.[46] The AAPS focus groups serve as an additional mechanism to bring together members with a common interest/focus in specific scientific disciplines. The PPB section includes four primary focus groups that are aligned with the overall focus of the section on physical pharmacy and biopharmaceutics: Nanotechnology Focus Group, Oral Absorption Focus Group, Preformulation Focus Group and Targeted Drug Delivery and Prodrug Focus Group. In addition PPB is also affiliated with numerous other AAPS focus groups (secondary focus groups) which activities touch upon aspects of biopharmaceutical evaluation and include Dermatopharmaceutics, Discovery Modeling and Simulation, Drug Candidate Selection, Excipients, Inhalation and Nasal Technology, Lipid-Based Drug Delivery Systems and Modified Release Focus Groups.

In addition to the programming activities that are coordinated with the help of the focus groups, the PPB section members serve in various committees throughout the AAPS organization to help with overall AAPS operations. In addition, PPB section helps drive the growth of new research talent by actively maintaining a Mentoring Program for graduate students or postdoctoral fellows as well as sponsoring Awards and Travelships that facilitate both the execution of academic research in the field of pharmaceutics, drug delivery or pharmaceutical technology and help support students attendance to the AAPS Annual Meeting.

MSE (Manufacturing Science and Engineering)

MSE Overview

Delivery of drug products at commercial scale requires significant investment in the development of appropriate pharmaceutical manufacturing capabilities, operations and controls that would ensure the consistency of drug supply to the marketplace. The goal of the MSE section of AAPS is to bring together scientists with a common interest in the fields of process development and manufacturing of pharmaceutical products, medical devices or API.[51] MSE members are active across a wide range of manufacturing activities such as process optimization, scale-up, and technology transfer. MSE members are also active in quality assurance activities such as Pharmaceutical Quality by Design, which has been more recently emphasized by the Food and Drug Administration.[52]

MSE Activities

Similar to the other AAPS sections, one of the major activities of the MSE section is to promote knowledge exchange and continuous education of its member though relevant programming both during the AAPS Annual Meeting or the AAPS Annual Biotechnology meeting but also via specialized workshops, courses, webinars and its members’ publications. The MSE section includes four primary focus groups that are aligned with the overall focus of the section on manufacturing and quality assurance: Chemical and Biological Active Pharmaceutical Ingredient Manufacturing Technology Focus Group, Process Analytical Technology Focus Group, Process Development Focus Group and Process Modeling and Simulation Focus Group. In addition MSE is also affiliated with numerous other AAPS focus groups (secondary focus groups) which activities touch upon aspects of manufacturing, especially groups active in the area of formulation development under the AAPS FDD section and include Chemistry, Manufacturing and Controls (CMC), CMC Statistics, Modified Release, Patient-Centric Drug Development, Product Design, and Manufacturing, Pharmaceutical Impurities, QbD and Product Performance and Sterile Products.[53]

MSE section sponsors awards and travelships that facilitate the execution of research in the field of pharmaceutical manufacturing and engineering, and similar to other sections supports the AAPS organization through member volunteers to various AAPS committees.

FDD (Formulation Design and Development)

FDD Scientific Areas of Interest

For drug compounds to be delivered safely and effectively for therapeutic use it is important that they are processed into an appropriate pharmaceutical formulation.The goals of the formulation maybe multifaceted and can include improving drug bioavailability, stability, or palatability. The AAPS FDD section, founded in 2009, aims to bring together scientists across industries, academia or regulatory agencies whose research focuses on the design and development of pharmaceutical formulations. It is one of the largest AAPS sections, its members comprising 36% of total AAPS membership. FDD members are active in areas of delivery across routes of administration (such as parenteral, inhalation, ocular or transdermal) and across multiple disciplines ranging from the characterization of the inactive components of formulations (commonly referred to as excipients) to the design of dosage forms and delivery technologies and the evaluation of the performance of such systems (e.g. via dissolution tools).[56]

FDD Activities

FDD section strives to be the forum of choice for worldwide scientists dedicated to the design and development of dosage forms. A major goal of FDD section is to help with the personal and professional development of its members by providing multiple learning opportunities via the organization of relevant programming in the AAPS Annual Meeting, AAPS Annual Biotechnology Meeting and relevant AAPS workshops, the communication of scientific updates via AAPS publication and on AAPS websites and the support of AAPS focus groups that further bring together FDD members that work in specific scientific disciplines. The FDD section includes eight primary focus groups that are aligned with the overall focus of the section on formulation design and development.[57] These focus groups represent either specific routes of administration such as the Dermatopharmaceutics, Inhalation and Nasal Technology, Ocular Drug Delivery & Disposition and Sterile Products Focus Groups, specific formulation technologies such as the Lipid-Based Drug Delivery Systems Focus Group and the Modified Release Focus group or specific activities related to design and understanding of formulations such as the Excipients Focus Group and the QbD and Product Performance Focus Group. In addition FDD is also affiliated with numerous other AAPS focus groups (secondary focus groups) which activities touch upon aspects of formulation development. FDD collaborates with other AAPS sections to provide AAPS members with programming and information of broad interest.

DDDI (Drug Discovery and Development Interface)

Overview

DDDI section is composed of members whose efforts are directed toward discovering, optimizing, and effectively transitioning preclinical candidates into the clinical development phase including colleagues from other professional organizations. Its focus is on issues at the critical interface between drug discovery and drug development.[59][60]

Activities

Drug Discovery and Development Interface (DDDI) is a scientific section[61] of the American Association of Pharmaceutical Scientists (AAPS). This section provides a forum for members to discuss the challenges and opportunities involved with discovering, optimizing and selecting suitable drug candidates for advancement into clinical research and development.[62] DDDI encompasses drug discovery and preclinical research by fostering collaborations both across and within numerous individual scientific disciplines. The DDDI section also encourages members of other professional organizations such as the American Chemical Society (ACS) to collaborate on programming.[63]

DDDI fulfills its mission through a number of focus groups[64] in which members discuss specialized scientific topics such as Discovery Modeling and Simulation,[65] Drug Candidate Selection,[66] Nutraceutics and Natural Products,[67] Drug Metabolism,[68] Drug Transport,[69] Nanotechnology,[70] Oral Absorption,[71] Pharmaco-Imaging,[72] Pharmacogenomics[73] and Targeted Delivery and Prodrugs.[74] The section also publishes semi-annual newsletters.[75] The DDDI section sponsors short courses, symposia, and roundtable discussions at the AAPS National Biotechnology Conference[76] as well as the AAPS Annual Meeting and Exposition.[77]

BIOTEC (Biotechnology)

BIOTEC section is composed of members from many diverse backgrounds in industry and academia who share a common interest in the research, development, and commercialization of new biotechnology based pharmaceuticals during all phases of development for both therapeutic and diagnostic agents. Its focus is on issues related to molecular biology, cell culture, recovery process, pharmacokinetics, metabolism, analytical biochemistry, regulatory affairs, and formulation sciences.[78]

CPTR (Clinical Pharmacology and Translational Research)

CPTR section is composed of members who are concerned with developing knowledge and understanding related to the clinical use of pharmaceuticals (chemical agents and biological agents), in clinical research dimension within the comprehensive range of pharmaceutical sciences. Its focus is on the therapeutics and clinical assessment of drugs and biologicals, including experimental design, conduct, and analysis of clinical trials; regulatory aspects of clinical trials and drug registration; risk assessment, therapeutic extrapolation from animals to humans; pharmacoepidemiology; drug interactions; and, in appropriate populations, therapeutic efficacy/safety and the response to alternative dosage forms.[79]

CPTR section organizes several focus groups to make a common platform for the members with a common interest in a specific discipline. The goals of the focus groups are to promote science through education and scientific programming and to provide opportunity to exchange ideas and communication network to scientists. Focus groups encourage the members to participate in open forums to discuss research advances and challenging tasks with colleagues and develop joint programs.

CPTR’S Focus Groups:

Animal Pharmaceutics & Technology: Animal Pharmaceutics & Technology focus group provides opportunities to exchange ideas and discuss new initiatives related to animal health and develop the relationship between veterinary and human health professionals.

Biomarkers in Translational Medicine: The aim of the Biomarkers in Translational Medicine focus group is to provide educational programs to its members in biomarkers for clinical applications and promote science in translating genomic, proteomic, and metabolomic biomarkers.

Drug Transport: Objectives of the Drug transport focus group is to exchange ideas on state-of-the-art techniques in drug transport, molecular and cellular characterization of transporters to enhance knowledge about the mechanisms of action of drug transporters.

Microdialysis: Microdialysis focus group provides opportunities to exchange of information relating to current and potential applications of microdialysis and related techniques in qualitative and quantitative drug research and development.

Pharmaceuticals in Global Health: Pharmaceuticals in Global Health focus group emphasis on vaccines and diagnostics for diseases that affect the poor people in disregarded communities and drug products that are produced and sold throughout the world.

Pharmaco-imaging: The vision of the pharmaco-imaging group is to provide educational programs to its members in imaging and its application in preclinical and clinical areas.

Pharmacogenomics (PGx): Pharmacogenomics is a focus group engaged in information exchange on topical developments in pharmacogenetics and pharmacogenomics and organizes symposia, workshops, and roundtables to discuss the advances and challenges.

Pharmacometrics: The objectives of the pharmacometrics focus group is to provide an inter-disciplinary forum for students, scientists and trainees with an interest in pharmacometrics to collaborate, educate, learn and innovate to increase the application and impact of pharmacometrics in the drug development process.

Protein Aggregation and Biological Consequences: The goals of the Protein Aggregation and Biological Consequences are to promote research and cross-functional collaborations and provide solutions to understand protein aggregation.

Systems Pharmacology: The purpose of the system pharmacology focus group is to advance the applications of systems pharmacology in drug discovery, development and pharmacotherapy and facilitate networking between its members and members of AAPS to exchange the knowledge.

Therapeutic Protein Immunogenicity: Therapeutic Protein Immunogenicity focusses on clinical application of immunogenicity and validation of the risk factors and underlying cause-effect relationships affecting the immunogenicity of therapeutic proteins.

References

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