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, 2020What 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.

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.





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.





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.





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
Former Vice President, Quality TCR2 Therapeutics Inc.

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
Vice President, Regulatory CMC TG Therapeutics, Inc.

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 PharmaceuticalsOnline 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.
We encourage all participants to login to our networking app. Details will be sent via email prior to the event starting and the networking features will be held open for a week following the online event.
Emerging Biopharma: Difficulties in Development – From MedChem to first GMP supplies
Integrated Drug Development: CMC Complexities & Challenges in Drug Development
Process Research & Scale-Up: It is not enough to have the best chemistry – working well with upstream and downstream partners makes for seamless collaboration
Intermediates & API: Appropriate Development: why, what and when…
RIM and Data Management: IDMP and the impact in regulatory affairs
Regulatory Operations/Regulatory Strategy: Ensuring Business Continuity during Mergers & Acquisitions, Divestments and Portfolio Swaps
Medical Devices: When regulatory strategy planning becomes a benefit in global submissions
We encourage all participants to login to our networking app. Details will be sent via email prior to the event starting and the networking features will be held open for a week following the online event.
Kick the afternoon off with a keynote presentation given by a renowned industry leader.
Strategies to Ensure Strong and Efficient CMC Function at Startup Biotechs
Key considerations for sterile drug product development for the marketplace
Development and Transfer of Analytical Assays for Polysorbate Excipients in your Drug Product
Early stage CMC development strategy to speed IND
Selecting the right route to ensure fast development and scale-up across all the project phases and supporting the API projects requirements
Rationale, Strategies and Execution for Developing API & Intermediate Supply
Impact of E2E solutions on the drug development workflows and roles
Early communication with regulatory agencies for gene therapy products: INTERACT and ITF meetings
Implementing change control in a newly commercialised company
How to comply with industry standards such as 21 CFR Part 11, 21 CFR Part 820, cGMP, ICH, ISO 13485, ISO 14971, and ISO 9000
Strategies to mitigate the risk of noncompliance
Strategies to reduce resource requirements and increase efficiency through the Parent-Child framework
How a shared-risk partnership model can reduce the cost of outsourcing manufacturing – advantages and disadvantages
We encourage all participants to login to our networking app. Details will be sent via email prior to the event starting and the networking features will be held open for a week following the online event.
Using “one-stop-shop” CDMOs compared to using providers best suited for each step of the process – advantages and disadvantages
Preparation and Process Validation Practices for Drug Product Development & Manufacturing and Concerns Surrounding Outsourcing Partners
Maximising the value and impact of a technology transfer package by facilitating the interplay between data, its integration into the knowledge base, decision making based on said knowledge based and ensuring data integrity
Methods to drive new regulatory and drug pricing policies.
Scale-Out Biomanufacturing – A Paradigm Change to Scale-Up
Mitigating risks associated with API suppliers
How gaining intelligence from RIM via utilizing medicinal product analytics can accelerate business
Effectively preparing for late phase development and mitigation of risk associated
How to ensure proper quality oversight of change management at CROs/CMOs
Drug-Device Combination Treatments & Diagnostics
Switching to electronic labelling to improve patient engagement and experience
Strategies to successfully transmit information in the required format while maintaining an audit trail throughout the process
Key considerations when approaching investors – investor insights
Co-Hosts














Pro-Partners
















Talent Acquisition Sponsor


Want to find out more?
Check out the full agenda for 2020 or read the reports from the 2019 strategy meetings.