Manufacturing CMC and Regulatory Affairs (NEW) Online3813
Online

ONLINE:

Chemistry Manufacturing Control and Regulatory Affairs

Thank you to those that joined us for the first Online CMC & Regulatory Affairs Strategy Meeting on the 2nd & 3rd June. The post-event report coming soon available for download. We’ll be hosting more upcoming Strategy Meetings later on in the year, keep an eye out for the latest announcements.

Dates

02 Jun, 2020
Online Strategy Meetings

What makes our online strategy meetings unique?

No other event creates such a unique and personalised online experience. From the tailored agenda, to the senior delegation to our networking apps, our online strategy meetings provide the perfect learning and networking environment.

Discussions

Roundtable Discussions

Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.

Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.

Discussions

Unrivalled Networking

With senior delegation from big pharma and innovative biotech. Join in roundtables, set-up private 1-to-1 meetings via our networking app.

With senior delegation from big pharma and innovative biotech. Join in roundtables, set-up private 1-to-1 meetings via our networking app.

Discussions

Personalised Agenda

Choose the topics that matter to you. Reserve your place at roundtable discussions and ensure your whole day delivers the insights you need to hear.

Choose the topics that matter to you. Reserve your place at roundtable discussions and ensure your whole day delivers the insights you need to hear.

Discussions

Totally Online Format

It’s more important than ever to encourage collaboration while promoting safety and accessibility. That’s exactly what you can expect from our online meeting format.

It’s more important than ever to encourage collaboration while promoting safety and accessibility. That’s exactly what you can expect from our online meeting format.

Meet the Facilitators

Our panel of facilitators play a key role in shaping the agenda

Sheng Cui

Executive Director CMC Boston Pharmaceuticals

Stan Russell

Vice President Sebela Pharmaceuticals

Gregg Keaney

Vice President of Product Development Atlas Venture NewCo

Qinghai Zhao

VP Technical Development and Manufacturing (Chemistry Manufacturing Controls) Forty Seven Inc.

Nick Dunwoody

Vice President, CMC Tetraphase Pharmaceuticals, Inc.

James Stahl

Senior Director (Chemistry Manufacturing Controls) Promedior

Art Faulkner

VP Regulatory CMC TG Therapeutics

Fernando Aleman

Chief Scientific Officer Navega Therapeutics

Daniela Drago

Senior Director Regulatory Sciences Biogen

Daniel Hogan

Associate Director Tech Transfer and Manufacturing Portola Pharmaceuticals

Alex Goraltchouk

Vice President, Operations Anika Therapeutics

Cecile Riboud

Senior Director Europe IQVIA Integrated Global Compliance (Regulatory, Safety and Quality)

Lisa Kelsey

Head of Commercial Labelling Genentech

Karin McIntosh

Executive Director Stemline Therapeutics

Marcel J. Velterop

President – Drug Discovery Services & CDMO Jubilant Biosys Limited

Roger McDonald

Business Development – CMC services MercachemSyncom

Jim Stout

VP CMC Shattuck Labs

Dean Edney

Head of Process Research & Development (API) Sai Life Sciences Ltd

Praveen Prasanna

Senior Director Technical Operations AVEO Oncology

Branden Lee

Director Business Development Birdotech

Theodore Martinot

Head of Chemical Development Infinity Pharmaceuticals

Yuyi Shen

Associate Director Bolt Biotherapeutics

Angela Johnson

Senior Director Regulatory Affairs Sigilon Therapeutics, Inc.

Ramzan Tabasum

Head of manufacturing quality CSL Behring

Subhadip Jana

Emerging Market Regulatory Lead, Global Regulatory Affairs Takeda Pharmaceutical Company

Weijun Li

Director, Analytical Development and Quality Control Allakos Inc.

Trey Putnam

Vice President, Regulatory Affairs and CMC FAST BioMedical, Inc.

Van Leang

Sr. Director Global CMC Operations HJB Bio

Arul Joseph

Senior Director, Pharmaceutical Development and Clinical Supply Chain Avanir Pharmaceuticals
CMC and Regulatory Affairs

Online Strategy Meeting Agenda

Comparative analysis of available CDMOs – does more expensive always mean better?
Advances and Challenges in Nanomedicine and Nanotechnology
How to ensure clarity and communication of goals and expectations for successful technology transfer during drug development with your CDMO
Clinically Relevant Specifications
How to generate value for clinical stage companies with CMC strategy for commercial readiness
Addressing a wide range of API crystallization and early formulation challenges for drug development programs
Shifting to a unified RIM model with one unifying global process and system
Regulatory Challenges and Opportunities for the Global Development of Gene Therapies
Green/Brown fields – managing quality, regulatory and supply chain aspects for chemical raw materials and consumables during tech transfer
How to effectively manage shorter product life cycles, when taking into account increased legal and regulatory scrutiny across the global supply chain.
Multinational Trials – effectively translating, formatting and inspecting different languages and fonts for open and blinded labels
Strategies to manage differing country-specific requirements for submissions
Allocating an adequate yet conservative CMC budget from investment fund, investor recommendations.
Supported by our

Co-Hosts

Pro-Partners

Talent Acquisition Sponsor

Quick Links

Want to find out more?

Check out the full agenda for 2020 or read the reports from the 2019 strategy meetings.