THE HEART OF THE US PHARMA INDUSTRY
Track 1: US Market Policy and Regulation Insights
Location (Room 201A)
A common supply chain issue is that of products being held up in customs owing to incorrect paperwork. This session offers a guide to best practice and compliance, helping to avoid common mistakes and subsequent delays.
- A break-down of how to stay compliant with the latest customs regulations
- Reviewing current processes and tools to help stay on top when collaborating with local customs authorities
- Highlighting common mistakes made within the industry and what you can do to avoid them.
Reserved for Track Sponsorship
Many US pharma companies now have ambitious plans in place to achieve carbon neutrality in the coming decades, but strategies and timelines vary. In this panel discussion, experts discuss the best ways to implement ESG in your organization, and the long-term outlook for pharma:
- Defining ESG in Pharma to understand what makes it different from other industries
- Establishing what is needed for implementing ESG practices in your organization
- Reviewing common pitfalls and how to avoid them
- Evaluating the role of the Chief Substantiality Officer in helping the industry move in the right direction
- What will ESG in pharma look like in five years? What should the industry’s KPIs be?
Moderator:
Bob Girton, Partner, Edgewater Capital
Panelist:
John Warner, Senior Vice President, Chemistry and Distinguished Research Fellow, Zymergen
Marisa Sharkey, Director, Corporate Communications, Harmony Biosciences
Cavan Farley, Senior Vice President, Global Business Groups DoubleRainbow Biosciences
Reserved:
Michael G. Mahoney, Environmental Compliance Lead Teva Pharmaceuticals
In December 2022, Reuters reported that US drugmakers will raise prices on 350 products in January 2023, bringing drug pricing back into the spotlight. This session offers an inside focus on the latest drug pricing developments in the US market.
- Examining current manufacture drug costs vs patient costs and how this reflects in current market pricing
- Reviewing legislator updates in the market and expected changes to the industry
- Calculating rising inflation and supply constraints, what will be the impact on the cost of manufacturing?
Speaker:
James Manser, Executive Director, Government & External Affairs, Endo Pharmaceuticals
A potentially huge opportunity for Big Pharma, this session will map the current state of psychedelics in the pharma market, what are the key milestones and opportunities to pave the way for commercialization?
- How psychedelics can play a role in the treatment of mental health conditions
- Why psychedelic therapies present a huge commercial opportunity for pharma
- Drug Development and regulatory challenges to counter before mass adoption
Speaker:
Jessica R. Riggleman, Sr. Director, Clinical and Regulatory Affairs, Mydecine Innovations Group
Track 2: Drug Manufacturing Dynamics
Location (Room 201A)
Track sponsor: Pfizer CentreOne
In our opening keynote, hear from market leader Pfizer CentreOne on how to overcome challenges in dose formulation. Gain key insights on creating a robust system for successful development.
- A step-by-step process for devising development strategies for early-stage success
- Why envisioning a larger-scale process early on will help address challenges early in development
Reserved for Pfizer CentreOne
Choosing the right CDMO partner is essential for avoiding potential setbacks in clinical development. Help ensure speed to market, by joining our panel discussion for practical advice on partner selection.
- Strategies for getting the most out of our CDMO partnership – mapping objectives, defined ways of working and clear communication
- Understanding what services and resources you need to ensure your targets are met
- Why mapping out deadlines is crucial to avoid untimely delays
- Assessing why having multiple partnerships can help manage expectations
Moderator:
TBC
Panelist:
Rick Peevey, Executive Director, Manufacturing's Operations & External Supply, Elucida Oncology, Inc
Mikaella Gorelik, Executive Director, Global Procurement, Global Product Supply Operations, Bristol Myers Squibb
Rick Knight, Global Head of Strategic Account Management, Pfizer CentreOne
As the industry looks to reduce environmental impact and become more sustainable, it is crucial for both end-users and vendors to work together when sourcing raw materials. Discover the need for global collaboration and what you can do to adopt green chemistry practices within your business:
- Assessing the current state of sourcing sustainable materials, what changes are needed?
- Identifying the common pitfalls within the industry and what can be done to avoid them
- Reviewing the latest technologies available and how they can be best applied to traditional chemistry
- Improving communication with suppliers to ensure the right materials are sourced
Speaker:
Feng Peng, Principal Scientist, Merck
The European ban on the use of titanium dioxide for food products has subsequently called into question its use in pharmaceutical products. The European ban is not based on hard science or a real safety issue, but on the precautionary principle. This presentation will help participants:
- Understand the real facts about TiO2 safety and the possibilities of the precautionary EU food ban being extended to pharmaceuticals
- Realize what this could mean to patient access to critical drugs in the EU and what the potential for a similar ban occurring in other countries
- Identify what a ban of TiO2 in pharma would mean to the potential for serious drug shortages in the EU and global pharmaceutical development regarding the reformulation of thousands of existing products and the associated regulatory reviews which would be needed
Speaker:
Dave Schoneker, IPEC- Americas Chair of QbD/Composition Committee IPEC Americas & Consultant, BDRC
Explore more content
Track 3: Navigating Supply Chain & Capacity Challenges
Location (Room 201A)
Track sponsor: Thermo Fisher Scientific
In a keynote address, leading CDMO Thermo Fisher Scientific will highlight the best way to set up your supply chain to meet current climate demands, and offer actionable insights into maximizing supply chain efficiency:
- Understanding why the supply chain can become the center of attention in supplying material faster and more efficiently.
- Learn how connecting and optimizing supplies with upstream manufacturing planning to Last-Patient-In allows for faster and risk-free clinical programs.
- Providing case studies to illustrate why the supply chain is one of the key enablers of faster time to market
Reserved for Thermo Fisher Scientific
High demand for clinical supplies has led to constraints within the supply chain, and the industry is scrambling to find a solution. Join our focused panel, where our experts will offer strategies for designing a supply chain to help meet current needs:
- Investing in smarter processes and forecasting technology to avoid timely delays
- Establishing why having local and international suppliers will help reduce the burden of scarce materials
- Re-aligning your business practices to ensure you stay within budget and meet global sustainability initiatives
- Reviewing current technological solutions to help address supply chain constraints
Moderator:
Bikash Chatterjee, CEO, Pharmatech Associates- A USP Company
Panelist:
Jennifer Northcott, Director, West Point Clinical Supplies Operations, Merck
David Malenfant, Executive Vice President, Biotech Supply Management Alliance
Sheila Iyer, Senior Director Supply Chain Planning and Strategy, GSK
David McCarthy, Senior Director/TL - Supply Assurance and Risk Management, Pfizer
Join our case study for practical advice on how to make your supply chain more sustainable in the long-term:
- Assessing current technologies to help improve supply chain sustainability
- How can pharma drive supply chain circularity in a financially viable way, and how does sustainability factor into this?
- Establishing what steps the industry should take for carbon neutrality
- Considerations in redefining your sustainability strategy
Bridget Ferrari,Director, Supply Sustainability, Takeda
This session will provide an overview of how the supply chain set-up has evolved during the COVID-19 pandemic to the present day, what are the key learnings to take forward?
- Reviewing current developments in pharmaceutical supply chain security and data integrity
- Why remote pharmaceutical auditing will play a key role in supply chain set-up
- Comparing pharmaceutical supply chain Integrity and Material quality during and after the Pandemic (COVID-19)
- Joint Audit Programs® for the Pharmaceutical Industry
Speaker:
Jim Fries, CEO, Rx-360
Track 4: Biologics: Cell & Gene Therapy Outlook
Location (Room 201A)
Viral vector technologies are taking center stage in the development of therapies to combat some of the most complex disease profiles. This session will offer guidance for managing supply and scale up of your viral vector manufacturing:
- Establishing close collaboration with regulatory authorities to avoid delays in scaling up
- Understanding that no single system is right for all assets and why it is vital to understand what stage you are at
Reserved for Cytiva
C> manufacturers face unique quality challenges that can hinder drug development progress. In this session, hear about quality challenges in cell therapy studies and the common practices for overcoming them:
- Expanding your supplier base when sourcing raw materials
- Planning to help mitigate the rising costs of materials
- Assessing current manufacturing platforms available to theindustry
Speaker:
Angela Osborne, Member, AMC
Understand the regulatory updates you need to ensure the success of your cell therapy study in this session, which will help you to map your regulatory process step-by-step.
- Current guidelines for considerations
- Understanding what stage you need to recognize regulations inyour design and development process
- Regulatory considerations when incorporating newtechnologies
Speaker:
TBC
Patients are playing an increasingly vital role in clinical studies, from R&D to Clinical Trials. Learn how to truly embed patient centricity into every stage of your design process for optimal success.
- Why providing good quality and educational information can give the patient a better understanding of the overall study
- Getting the patient involved in the clinical design process to maximize engagement and retention
Speaker:
Howard Federoff, Co- Founder and Chief Medical Officer, Ryne Biotechnology
Finish off your day by hearing about the latest developments in the pharma hub that is Philadelphia. In our panel discussion, local speakers will dive into the current state of the industry and explore why Philadelphia is such a hotspot for C>:
- Overview of the C> market in Philadelphia, investments, launches and developments
- Why Philadelphia is such a hotbed for C>
- How to ensure success as an emerging biotech
Moderator:
Parviz Shamlou, VP, Ex. Director, Jefferson Institute for Bioprocessing, Thomas Jefferson University
Panelist:
Angela Osborne, Member, AMC
Howard Federoff, Managing Director, Ryne Biotechnology
Explore more content
Track 5: Technological Innovation & Advancementin Pharma
Location (Room 201A)
Join our opening session to learn the latest developments in data management and its growing importance in continuous manufacturing. Get the inside knowledge and key takeaways to help set up:
- Understanding what regulations and processes are needed to avoid any potential penalties
- Defining a framework that works for you
- Pin-pointing potential challenges and solutions in gatheringand collecting data
Reserved for Track Sponsorship
With pharma 4.0 being considerably more than an abstract concept, ensuring your team are equipped for the pharma workplace of the future is essential for success. This session offers tangible advice on how to build a digital skill-set within your team.
- Assessing what resources and training services are available
- Introducing practical assessments for understanding currentand new hire skill sets and experience
- Why building skills and not compliance training will providebetter insight into your team
- How universities can play their part by merging traditionalsubjects with technology
Moderator:
Cimi Sivaneri, Head of Business Technology & Innovation, LEO Pharma Inc
Panelist:
Alain Bindels,Technology and Innovation Leader, Roche
Michael Frank, Business Development and Digital Ventures Lead, Memorial Sloan Kettering Cancer Center
One of the most promising applications of artificial intelligence in pharma is in the drug development sector. This session offers a deep-dive into the latest advancements in AI, and its role in bringing the most promising drug candidates to market.
- Understanding what AI can bring to your organization and identifying the areas you want to implement the technology
- Reviewing regulatory considerations for successfully implementing AI into your business
- Forecasting cost-effective measures to stay within budget
Victoria Gamerman, Global Head of Data Governance and Insights, Boehringer Ingelheim
An increasingly digital world brings significant advantages, but also new threats. This session will outline the cybersecurity considerations which pharma companies should be aware of, and offers practical steps for keeping your business secure.
- Identifying common security pitfalls companies
- What requirements do you need to ensure your data is safe?
- Why you don’t need to spend big for better protection
- Tips that personnel can do to ensure their origination is moresecured
Speaker:
TBC
Explore more content
CPHI North America is the premier event connecting the entire US pharmaceutical drug development and manufacturing supply chain.
Part of the CPHI global network, the event brings together over 3,000 attendees from over 70 countries for 3 days of engaging and inspirational program content and unrivalled networking opportunities.
