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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

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, the Nanotechnology Characterization Laboratory, 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.

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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Deadline:
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Deadline:
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Keynote Speaker

Gregory W. Daniel, PhD, MPH, RPh

Duke-Margolis Center for Health Policy at Duke University

Speakers

Henning Blume, PhD

SocraTec R&D

Michael J.W. Johnston, PhD

Health Canada

Akm Khairuzzaman, PhD

US Food and Drug Administration (FDA)

Scott McNeil, PhD

Nanotechnology Characterization Lab

Sesha Neervannan, PhD

Allergan

Saraswathy V. Nochur, PhD

Alnylam Pharmaceuticals

Vinod Shah, PhD

Non Biological Complex Drugs Working Group

Beatriz Silva Lima, PhD

University of Lisbon

Florian Turk, PhD

Sandoz Biopharmaceuticals

Gillian Woollett, DPhil, MA

Avalere Health

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

Monday

May 13, 2019

8:00 AM

Registration and Breakfast

8:45 AM

Opening Remarks

Speakers

Alison Carley, PhD
The New York Academy of Sciences
Jon de Vlieger, PhD
Lygature and the Non Biological Complex Drugs Working Group

Session I: Outline of the Future of Complex Drugs

9:00 AM

Innovation in Complex Therapies to Treat Complex Diseases

Speaker

Sesha Neervannan, PhD
Allergan
9:25 AM

Regulatory Experience with ONPATTRO® (patisiran), a First-in-Class RNAi Therapeutic

Speaker

Saraswathy V. Nochur, PhD
Alnylam Pharmaceuticals
9:50 AM

Complex Drugs — The Future of Medicine

Speaker

Scott McNeil, PhD
Nanotechnology Characterization Laboratory

Complex drugs enable promising therapeutic breakthroughs, but also pose challenges for characterization and regulatory evaluation. The formulations being developed to treat cancer and other diseases have been specifically designed such that their physicochemical characteristics can curtail off-target toxicities and optimize pharmacokinetics. As these products increase in complexity, so too must the technologies and methods for characterization and evaluation. The Nanotechnology Characterization Laboratory has been helping developers for more than a decade by providing state of the art characterization services to help advance these products into clinical trials. This talk aims to highlight the emerging trends in complex drug characterization as well as the scientific challenges they face. Challenges in identifying critical quality attributes, defining bioequivalence for generic products, as well as strategies aimed at addressing regulatory questions and commercialization will be discussed.

10:15 AM

Coffee Break

Session II: The Importance of Regulatory Science

10:45 AM

Introduction to the Importance of Regulatory Science

Speaker

Vinod Shah, PhD
Non Biological Complex Drugs Working Group
10:55 AM

EU Regulatory Perspective on Complex Medicines

Speaker

Beatriz Silva Lima, PhD
University of Lisbon
11:20 AM

Title to be announced

Speaker

Akm Khairuzzaman, PhD
US Food and Drug Administration
11:45 AM

Complex Drugs — the Health Canada Perspective

Speaker

Michael J.W. Johnston, PhD
Health Canada

Health Canada is a department within the Canadian Federal Heath Portfolio (which comprises Health Canada, the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Patented Medicine Prices Review Board and the Canadian Food Inspection Agency) and is responsible for the regulation of consumer products, environmental and workplace health, food and nutrition, cannabis as well as drugs and medical devices. This presentation will outline Health Canada’s current perspective on complex drugs (specifically non-biological complex drugs) as well as follow-on complex drug products. Additionally, an overview of the activities of the International Pharmaceutical Regulators Programme Nanomedicines Working Group, currently co-chaired by Health Canada, will be provided.

12:10 PM

Science-driven Regulations for Complex Drugs and Necessity for Harmonization

Speaker

Henning Blume, PhD
SocraTec R&D and the University of Frankfurt
12:35 PM

Networking Lunch

Session III: Toward a Sustainable Healthcare System

1:50 PM

Keynote Lecture

Speaker

Gregory W. Daniel, PhD, MPH, RPh
Duke-Margolis Center for Health Policy at Duke University
2:30 PM

Title to be announced

Speaker

Florian Turk
Sandoz Biopharmaceuticals
2:55 PM

Short talk to be selected from submitted abstracts

3:10 PM

Coffee Break

Session IV: Regulatory World Future Directions

3:40 PM

Connecting the Dots: Global Development of Complex Drugs and Biosimilars using Consistent Science to Enable Efficient Regulation

Speaker

Gillian Woollett, DPhil, MA
Avalere Health
4:05 PM

To be announced

4:45 PM

Panel Discussion

5:15 PM

Closing Remarks

5:20 PM

Networking Reception and Poster Session

6:20 PM

Adjourn