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Complex Medicines: Science, Regulation, and Accelerating Development

Complex Medicines: Science, Regulation, and Accelerating Development

Monday, May 13, 2019, 8:00 AM - 6:00 PM

The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York

Presented By

The Non Biological Complex Drugs Working Group

The New York Academy of Sciences

 

The rise of bio- and nano-technologies has accelerated the development of complex medicines, and at the same time it has revealed new hurdles in regulatory science and accelerating patient access to new therapies. Complex medicines include biologics (e.g. vaccines, gene therapies, recombinant proteins) and non-biological complex drug products (e.g. glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions, and liposomes). Their diverse nature poses challenges for the development of regulatory guidelines. While complexity is not new in medicines, our technical capacity to measure and analyze data has increased. This requires a determination of which measurements are relevant to demonstrate therapeutic efficacy and safety. Further, many obstacles remain in regulatory harmonization across global authorities, given their different approaches and legal frameworks.

To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry, and drug manufacturing. The Non Biological Complex Drugs Working Group and the New York Academy of Sciences will present the conference Complex Medicines: Science, Regulation, and Accelerating Development to stimulate this discussion. This convening is a follow up to the 2016 event, Equivalence of Complex Drug Products: Scientific and Regulatory Challenges. The conference will identify the best scientific approaches for complex medicines development and regulation, will outline outstanding challenges in the assessment of equivalence, and will discuss how to improve timely patient access for new medicines and building a sustainable healthcare system. The end goal is to facilitate the translation of scientific findings into advancements in medicine for the benefit of patients.

Abstracts and Travel Fellowships

Abstract submissions are invited for a poster session and applications are invited for early career travel fellowships, underrepresented minority fellowships, and child care fellowships. Complete submission instructions will be posted shortly. The deadline for submission is March 18, 2019.

Registration

Member
By 04/01/2019
$90
After 04/01/2019
$130
Nonmember Academia, Faculty, etc.
By 04/01/2019
$180
After 04/01/2019
$260
Nonmember Corporate, Other
By 04/01/2019
$250
After 04/01/2019
$350
Nonmember Not for Profit
By 04/01/2019
$180
After 04/01/2019
$260
Nonmember Student, Undergrad, Grad, Fellow
By 04/01/2019
$100
After 04/01/2019
$145
Member Student, Post-Doc, Fellow
By 04/01/2019
$50
After 04/01/2019
$70
Earlybird Registration:
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Scientific Organizing Committee

Jon de Vlieger, PhD

Lygature

Beat Fluhmann, PhD

Vifor Pharma

Scott McNeil, PhD

Nanotechnology Characterization Lab

Sesha Neervannan, PhD

Allergan

Vinod Shah, PhD

Non Biological Complex Drugs Working Group

Gillian Woollett, DPhil, MA

Avalere Health

Melanie Brickman Borchard, PhD

The New York Academy of Sciences

Alison Carley, PhD

The New York Academy of Sciences

Speakers

Henning Blume, PhD

SocraTec R&D

Scott McNeil, PhD

Nanotechnology Characterization Lab

Sesha Neervannan, PhD

Allergan

Gillian Woollett, DPhil, MA

Avalere Health