10th Annual

Global Regulatory Affairs CMC Conference

October 8-9, 2024 | Philadelphia, PA
The Warwick Rittenhouse Square

Securing Timely and Positive CMC Regulatory Approvals through a Comprehensive Understanding of ICH Standard Expectations and Decoding the Global Regulatory Landscape

Speakers

Program Presenters:

Chong-Hui Gu
Head of CMC and QA
FOGHORN THERAPEUTICS

Shilpa Thosar
Principal Reg CMC Consultant
CARA THERAPEUTICS

Sai Bhamidipati
Regulatory Affairs Associate Director
VERTEX PHARMACEUTICALS

Christina Markus
Partner
KING AND SPALDING

Yolanda Caringal
Director
BRISTOL MYERS SQUIBB

Angela Turner
Senior Director, Regulatory Affairs
ALMATICA PHARMA

Gopi Vudathala
Head, Global Regulatory Affairs CMC
INCYTE CORPORATION

Amy Moran
CMC Associate Director
VERTEX PHARMACEUTICALS

Vijaya Lakshmi
VP, Operations
GENPACT

Yanhuai Ding
Senior Director, CMC
EVOVLEIMMUNE THERAPEUTICS

John Serio
Partner
WITHERS BERGMAN LLP

Paddy Navuluri
VP Growth & Commercial Solutions
GENPACT

A Special Thanks to Our Sponsor:

Day One Agenda
Tuesday, October 8

8:30 REGISTRATION & WELCOME COFFEE

9:20 CHAIRPERSON’S OPENING REMARKS

9:30 OPENING ICE BREAKER: SUCCESSES AND CHALLENGES OF CMC OPERATIONS
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives on the daily challenges of CMC operations, discussing challenges associated with the evolution of CMC role and regulations. Furthermore, participants in this warm-up session are also given the opportunity to directly build contacts.

10:00 KEYNOTE PANEL: INDUSTRY INFLUENCE IMPACTING THE EVER-CHANGING CMC ROLE
• Review upcoming regulatory changes and pending guidances
• Role of AI and ML in CMC operations
• Global supply chain and ingredient challenges impacting teams
• Impact of accelerated approvals on future EUAs of new products
Gopi Vudathala, INCYTE CORPORATION
Yanhuai Ding, EVOVLEIMMUNE THERAPEUTICS
Yolanda Caringal, BRISTOL MYERS SQUIBB

10:45 COFFEE AND NETWORKING BREAK

11:30 INTERACTIVE DISCUSSION SESSION: EXPLORE ROLE OF ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING IN CMC OPERATIONS
• Impact of AI and ML on product submission approval package development
• Machine learning vs. deep learning automation methodologies in CMC
• Realistic integration of AI automation through the CMC lifecycle
• Benchmarking the pros vs. cons of AI/ML utilization in current processes
Shilpa Thosar, Principal Reg CMC Consultant
VSanTech Pharmaceutical LLC

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:30 GENPACT REGULATORY CO-PILOT
This presentation will focus on how Gen AI can be leveraged to streamline and enhance regulatory processes. By integrating Gen AI, the way CMC processes are managed , has been revolutionized, particularly in gathering regulatory intelligence, getting the right insights and the creation of CMC narrative summaries for regulatory submissions. This innovative approach aims to provide superior services to clients in the pharmaceutical and biotechnology industries, ultimately contributing to the development of safe and effective products.
Hasan SM, Transformation Leader Pharma
GENPACT
Vijaya Lakshmi, VP, Operations
GENPACT

2:15 DEVELOPMENT OF A SEAMLESS CMC STRATEGY FOR COMBINATION PRODUCTS
• Outlining the Essential Performance Requirements
• Decoding submission expectations for combination products
• Employing a risk-based approach into overall life cycle processes
• Approval process hurdles and mitigation strategies to overcome
• Combination product change management considerations
Sai Bhamidipati, Regulatory Affairs Associate Director
VERTEX PHARMACEUTICALS

3:00 COFFEE AND NETWORKING BREAK

3:30 FRAMEWORK FOR GLOBAL POST APPROVAL CHANGE MANAGEMENT OPERATIONS
• Benchmarking differing regional post approval requirements
• Proactive creation of regional specific processes & strategies
• Integration of thorough IT systems for tracking oversight
• Maintaining manufacturing & supply chain during approval review

4:15 CMC FACTORS & OPERATIONAL PROCEDURES FOR 505(B)(2) APPLICATIONS
• Specifications leading to approval or denial of 505(B)(2) approval pathways
• Phase specific CMC informational needs in 505(B)(2) products
• Highlighting the importance of not de-prioritizing CMC for 505(B)(2) therapies
• Acceptable pre-existing data sources for drug submissions
Christina Markus, Partner
KING AND SPALDING

5:00 Closing Remarks & End of Day 1

Day Two Agenda
Wednesday, October 9

8:30 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 SUCCESSFULLY NAVIGATING ACCELERATE REVIEW SUBMISSIONS
• Assessing eligibility requirements for accelerate review
• Impact of reduced clinical review timelines on CMC teams
» Limited time to upscale manufacturing & supply chains
» Garnering essential data for proper final formulations
» Creation of required regulatory submission documentation
• Prioritization of resources to ensure CMC obligations are met
Chong-Hui Gu, FOGHORN THERAPEUTICS

9:45 ROUNDTABLE GROUP DISCUSSION: NAVIGATING THE COMPLEXITIES OF THE ICH Q12 GUIDANCE
These interactive executive discussion groups will allow all participants to engage in dynamic discussions and exchange perspectives on the challenges and experiences related to the implementation and compliance with the ICH Q12 guidelines.

10:30 COFFEE AND NETWORKING BREAK

11:00 EARLY PIPELINE ACTIVITIES RELATED TO SMALL MOLECULE, BIOLOGICS
Amy Moran, CMC Associate Director
Vertex Pharmaceuticals

11:45 DECODING THE COMPLEXITIES OF NITROSAMINES REGULATORY COMPLIANCE
• Review of applicable global guidances related to impurities & nitrosamines
» FDA
» EMA
» Health Canada
• Risk evaluation and mitigation strategies to control nitrosamine non-compliance
• Development of scientifically based rationale to justify nitrosamine limits
Angela Turner, Senior Director, Regulatory Affairs
ALMATICA PHARMA

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

1:30 ROUNDTABLE GROUP DISCUSSIONS: ASSESSING THE CHALLENGES OF ICH PRODUCT GUIDANCES
As the complexities of pharmaceutical therapies continue to grow the hurdles and complexities of global regulatory expectations concurrently become increasingly intricate. The need for continued holistic and harmonized guidelines and regulatory standards is essential and this session series will highlight key ICH guidelines from vital areas within CMC operations including post approval changes, continuous manufacturing, and analytical development.
GROUP ONE: ICH Q13
GROUP TWO: ICH Q14

2:15 COFFEE & NETWORKING BREAK

2:30 UPCOMING & PROPOSED REGULATIONS OF SPECIFIED PRODUCT MATERIALS
• EMA proposed ban utilization of titanium dioxide (TiO2)
• FDA guidance expediting reformulation of products with benzene
• Policies related to the inclusion of ethyl alcohol materials
Angela Turner, Senior Director, Regulatory Affairs
ALMATICA PHARMA

3:15 Closing Remarks & Conference Conclusion

Pricing & Registration

Previous Attendees Include:

Sr. Director, Regulatory Affairs CMC, ABBVIE
Senior Director, Regulatory Affairs CMC, AGIOS PHARMA
CMC Director, Regulatory Affairs, ALEXION PHARMACEUTICALS
Writing Manager, ASTRAZENECA
Senior Director, Pharmaceutical Development, AVANIR PHARMA
Senior Director, Global Reg CMC Head, Small Molecule, BEIGENE
Associate Director, Regulatory Affairs, BIOGEN
CMC Lead, BIOGEN
Director, CMC, BMS
Sr. Manager, BMS
Head, Regulatory-CMC, CONSTELLATION PHARMA
Manager, Global Regulatory Affairs, CMC, CSL BEHRING
Sr. Manager, Regulatory CMC, DECIPHERA PHARMACEUTICALS
Principal Consultant Regulatory, ELI LILLY
Senior Director, Regulatory Affairs, EMERGENT BIOSOLUTIONS
Senior Director, CMC, FORMA THERAPEUTICS
Manager, CMC, GSK
Lead Consultant, Regulatory CMC, HALLORAN CONSULTING
Scientific Director, JANSSEN PHARMACEUTICALS
Associate Director, Regulatory Affairs, CMC, KARUNA
Manager, NA/EMEA Regulatory Affairs – CMC, KYOWA KIRIN
Senior Director, Regulatory Affairs CMC, MACROGENICS
Associate Director of Vaccines CMC, MERCK
Head of Global Chemistry, Manufacturing, and Controls, MERCK
Regulatory CMC Manager, NEUROCRINE BIOSCIENCES
Sr. Manager RA CMC, PACIRA PHARMACEUTICALS
Director Reg. Global CMC, LATAM Regional Advisor, PFIZER
Director, CMC Regulatory Affairs, RHYTHM PHARMA
VP, Head of CMC Biologics and Gene Therapy, SUMITOVANT
Associate Director, TAKEDA
Sr. Submissions Manager, TEVA PHARMACEUTICALS
Team Lead Non-Active Medical Devices, TUV SUD
Executive Director, Global Regulatory Affairs CMC, VERTEX
and many more

Who should attend:

Executives responsible for regulatory affairs CMC activities throughout the product lifecycle will find this meeting of immediate application to current responsibilities. Sessions will cover the full spectrum of CMC activities from pre-approval considerations to the increasing challenges of handling post-approval activities for the duration of the product lifecycle. Job titles of most relevance for this meeting will include VPs and Sr. Directors and Directors of:

Job titles for this meeting include:
• Regulatory Affairs CMC
• Global Regulatory Affairs CMC
• CMC Regulatory Affairs
• Regulatory CMC

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