THE HEART OF THE US PHARMA INDUSTRY
The 2023 CPHI North America conference is taking place in-person, at the Philadelphia Convention Centre. Take a look through our trend-led agenda to plan your schedule around hearing from leading speakers on the key topics shaping our industry. This year’s conference covers the full spectrum of the US pharma market, from supply chain dynamics to cell and gene therapy.
Add value to your time at the show by building out your industry knowledge – CPHI North America is your one-stop-shop for learning, partnering and doing business at the heart of pharma.
Can’t tear yourself away from the show floor? No problem! All our content will be captured on-site and made available in the event platform within 24 hours of taking place.
Track 1: US Market Policy and Regulation Insights
Location: Room 201A
Track Chair: Peter Stevenson, Non-Executive, Independent Director, Piramal
Track Sponsor: Lonza
Rapid and efficient development of drug candidates is increasingly important for pharmaceutical companies with accelerated timelines and funding constraints. However, many early drug candidates have poor oral absorption properties making it challenging to achieve target pharmacokinetic (PK) profiles. Without upfront knowledge of absorption risks and mitigation strategies, poor absorption can significantly impact preclinical and clinical study timelines and costs.
Physiologically-based pharmacokinetic (PBPK) modeling software, such as the GastroPlus® platform from Simulations Plus, simulates dynamic physiological factors impacting oral performance. When coupled with in vitro measurements, PBPK modeling is effective in early development for 1) identifying absorption risks, 2) assessing the potential for solubility enhancing formulations such as salts, cocrystals, or amorphous solid dispersions to mitigate these risks, and 3) designing and optimizing preclinical and clinical studies with respect to dose, prandial state, or gastric pH modification to maximize the likelihood of achieving desired PK profiles.
In this presentation, we will demonstrate how PBPK models combined with Lonza’s custom and off-the shelf in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development, reducing the need for drug product reformulation or repeated preclinical or clinical studies.
-Learn how PBPK modeling can identify potential oral absorption risks and mitigation strategies (e.g. bioavailability enhancement) for early drug candidates
- Learn how PBPK modeling coupled with in vitro testing can guide early selection of drug form and formulation to achieve clinical study goals
-Gain insights into how key drug and formulation factors including solubility, permeability, and dissolution rate can impact absorption risks such as poor oral bioavailability, food-drug interactions, and pH-dependent DDI effects
Speaker:
Deanna Mudie, PhD, Senior Principal Engineer, Lonza
Josh Marsh, Bioavailability Enhancement and PBPK Lead Scientist, Lonza
With US Pharma pledging to become net-zero by 2050, you musthave the right processes. Join our focused panel where our expertswill discuss the best ways to implement ESG in your organization:
- Defining ESG in Pharma to understand what makes it differentfrom 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 helpingthe industry move in the right direction
- What will ESG in pharma look like in five years? What shouldthe industry’s KPIs be?
Moderator:
Bob Girton, Partner, Edgewater Capital
Panelist:
Marisa Sharkey, Director, Corporate Communications, Harmony Biosciences
Michael G. Mahoney, Environmental Compliance Lead Teva Pharmaceuticals
Get the inside focus on the latest drug pricing developments in theUS market. Listen to the current legislator updates and how it willaffect patient costs while reviewing the rising manufacturing costsfrom inflation and supply constraints and the market’s reaction:
- Examining current manufacture drug costs vs patient costs andhow this reflects in current market pricing
- Reviewing legislator updates in the market and expectedchanges to the industry
- Calculating rising inflation and supply constraints, what will bethe impact on the cost of manufacturing?
Speaker:
James Manser, Executive Director, Government & External Affairs, Endo Pharmaceuticals
Join our thought leadership session to understand the current stateof Psychedelics in the pharmaceutical industry. Delve into the potentialpsychedelics can bring and why the industry needs to take notice ofits growing importance:
- How psychedelics can play a role in the treatment of mentalhealth conditions
- Emerging investigator initiated and sponsored clinical trials
- Drug development and regulatory challenges to counter beforemass adoption
Speaker:
Jessica R. Riggleman, Sr. Director, Clinical and Regulatory Affairs, Mydecine Innovations Group
As we bring in 2023, pharmaceutical companies will undoubtedly be looking ahead. But how will the events of the past two COVID years influence future aspirations? In the past, pharmaceutical companies used a mix of bottom-up and top-down processes to budget for the next fiscal year, and then made quarterly revisions during the year. Nowadays, both on the revenue side and on the expense side, volatility is more of a rule than the exception. Brands in different diseases are impacted differently in terms of demand by COVID-19: some experience an increased need; others are temporarily less needed, and demand will spike again once hospitals are able to take on less urgent cases. The timing of the impact of post COVID-19 era varies by country and is hard to predict, which makes strategy and financial forecasting more of a crystal ball exercise. Finally, various payers in health care systems will have budget issues themselves, having to redirect their budgets on the fly. How the market is bouncing back and forecasting is aligning itself to the new normal will be understood better by this presentation The presentation will cover:
- A typical forecasting process- cross functional process
- How do you value / forecast a drug / company’s pipeline? What techniques to use?
- What are the forecasting models and best practices for earlystage assets in drug/IP commercialization processes?
- Who are the stakeholders in the forecasting process and how to influence them?
Speaker:
Sanobar Syed, Associate Director, Beigene
Track 2: Drug Manufacturing Dynamics
Location: Room 201A
Track Chair: Rick Knight, Global Head of Strategic Account Management, Pfizer CentreOne
Track Sponsor: Pfizer CentreOne
Where QBD was the orchestral sheet music that determined howdrug product development has been harmonized over the last 15 orso years, contemporary patient-centric risk-based approaches todrug development are the pop evolution. The music is still beautifulwhen produced well - but the focus is no longer on the fullorchestra, it's on key players and moments. First - think McCartneyand Lennon - one without the other and we don’t have the Beatles.The same can be said for collaboration between drug processdevelopment and commercial production colleagues. They arecentral to ensuring that products are easier to transfer and can bescaled, and that manufacturing challenges are identified early onand addressed proactively.In his keynote, Bernd Schümmelfeder Director-Team Leader PPDBusiness Development, Pfizer explores how lyrics (communication),rhythm (standardization), bass (structured development processes),and lead guitar (the use of smart technologies) throughout the drugdevelopment process come together to create beautiful music - adrug that gets to patients safely and at pace.
Key areas for discussion include:
- Clear decision and inflection points to manage costs andprioritize projects with a higher probability of success
- Smart technologies like modeling to identify challenges early onand avoid late-stage pitfalls
- Use of platform technologies to simplify the tech transferprocess and improve process robustness
- Areas to optimize the product development and manufacturingprocess to make it more efficient, cost-effective, and patientfocused
Speaker:
Bernd Schuemmelfeder, Director-Team Leader PPD Business Development, Pfizer
Companies must have the right partner to avoid potential setbacksin clinical development. To avoid disappointment, join our panel andgain expert analysis and best practices in sourcing the right CDMOfor your study:
- 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 ensureyour targets are met
- Why mapping out deadlines is crucial to avoid untimely delays• Assessing why having multiple partnerships can help manage expectations
Moderator:
Peter Stevenson, Non-Executive, Independent Director, Piramal
Panelist:
Rick Peevey, Executive Director, Manufacturing's Operations & External Supply, Elucida Oncology, Inc
Rick Knight, Global Head of Strategic Account Management, Pfizer CentreOne
Jennifer Johns, Head of Product Development Strategy, Bristol Myers Squibb
With the industry shifting to become more sustainable, it is crucialfor both end-users and vendors to work together when sourcinggreener raw materials. Join and learn about the need for globalcollaboration and what you can do to adopt green chemistrypractices to your business:
- Assessing the current state of sourcing sustainable materials,what changes are needed?
- Identifying the common pitfalls within the industry and whatcan be done to avoid them
- Reviewing the latest technologies available and how they canbe best applied to traditional chemistry
- Improving communication with suppliers to ensure the rightmaterials 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
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Track 3: Navigating Supply Chain & Capacity Challenges
Location: Room 201A
Track Chair: TBC
Track Sponsor: Thermo Fisher Scientific
Managing the biopharma supply chain is a highly complex undertaking that is becoming ever more so as the number of new products rises and new process technologies are introduced. Moving with ease from one step to the next (R&D, production, distribution)while adhering to regulations and meeting customer demands involves managing many moving parts. It also requires managing a growing number of channels through which data needs to be sent, received, and tracked. Awareness and oversight over every activity and relationship along the continuum is critical for avoiding disruptions that can negatively influence distribution processes.
This presentation will provide insight into some of common blind spots that threaten supply chain quality, including:
- Supply chain vulnerabilities
- Insufficient demand signals
- Under-nurtured supplier relationships
- Supply chain network customization
Attendees will learn about the measures that should be embedded throughout the supply chain, from procurement through last-mile delivery, to avoid these blind spots and build customer trust and confidence.
Christy Eatmon, Global SME, Sterile Drug Product, 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:
David Malenfant, Executive Vice President, Biotech Supply Management Alliance
Sheila Iyer, Executive Director - Head of Global Supply Planning and Transformation, Amgen
David McCarthy, Senior Director/TL - Supply Assurance and Risk Management, Pfizer
Join our case study to learn more about the current supply chain set-up across the industry and gain takeaways on how to reduce your environmental footprint:
- How does the PSCI make a positive impact towards the creation of sustainable supply chains?
- Audit Program
- Capability Building
- Special Projects
Bridget Ferrari,Director, Supply Sustainability, Takeda
Join our focused session, where our market expert will provide aninsightful analysis of the supply chain set-up from the pandemic tonow. Understand the industry learnings from Covid and what hasevolved within the supply chain industry:
- 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
Ben Mills, Senior Director of Audit Operations , Rx-360
Track 4: Biologics: Cell & Gene Therapy Outlook
In Partnership with Jefferson University
Location: Room 201A
Track Chair: Parviz Shamlou, VP, Ex. Director, Jefferson Institute for Bioprocessing, Thomas Jefferson University
C> manufacturers face unique quality challenges that can hinder progress. In this session, hear about quality challenges in cell therapy studies and learn 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 the industry
Manufacturers face unique quality challenges that can hinder progress. In this session hear about quality challenges in Cell and Gene Therapy (CGT) and learn common practices for overcoming them:
- The amc was formed in 2010 to focus on manufacturing when everything at the time was focused on clinical
- How CGTs have different challenges from a quality perspective to other biologics and small molecules
- Challenges over the last 13 years of the amc being in existence and how they've been overcome
- Current challenges
- How to achieve the right quality at the right time with manufacturing readiness
- Cell line development for allogeneic cell therapies Variability of starting materials for autologous cell therapies
- Analytical challenges in viral vector manufacturing
Speaker:
Angela Osborne, Member, AMC
- GUCY2C is a mucosally-restricted, immunologically compartmentalized self-antigen overexpressed in GI adenocarcinomas
- GUCY2C Vaccination in MRD (minimal residual disease) setting for recurrence prevention
- GUCY2C adoptive cell therapy for treatment of metastatic GI cancers
Speaker:
Babar Bashir, Assistant Professor, Thomas Jefferson University
Join our fireside chat, where Stephen Chen of Tevogen Bio will go through the opportunities and challenges in Allogeneic Cells:
- Current quality and manufacturing procedures
- Reviewing short- and long-term challenges
- Forecasting the opportunities for Allogenic Cells
Speaker:
Stephen Chen, Chief Technical Officer, Tevogen Bio
Finish off your day by hearing the latest trends and excitement occurring in Philadelphia. Join our panel, where our speakers will dive into the current state of the industry and why Philadelphia is 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
Babar Bashir, Assistant Professor, Thomas Jefferson University
Stephen Chen, Chief Technical Officer, Tevogen Bio
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
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Track 5: Technological Innovation & Advancement in Pharma
Location: Room 201A
Track Chair: Modestus Obochi, Executive VP, Strategy & Business Development, Phlow
Track Sponsor: Phlow
In The CDMO X-Factor, Andrew Carpenter, Ph.D, a leader in cGMP manufacturing of small molecule APIs, with a passion for continuous manufacturing, will challenge the boundaries of what the industry once believed possible for advanced pharmaceutical ingredients manufacturing. This engaging session will include strategies that pharmaceutical companies can take to leverage effective partnerships with next-gen CDMOs, with in-house scientific expertise and state-of-the-art facilities, capable of deploying both continuous and batch manufacturing proven to drive down cost and reduce environmental impact.
- Learn how a creative relationship with a next-gen CDMO partner can help you develop and scale your pharmaceutical products in the United States more cost-effectively.
-Learn what factors today can reduce production costs, increase quality, and lower environmental impact tomorrow.
-Explore extensive manufacturing capabilities, that will take your project from route scouting, and process development to scale-up and commercial production, for your life-changing medicines.
Andrew Carpenter, Ph.D. Executive Vice President, Manufacturing, Science, and Technology, Phlow Corp
With the industry digitally evolving, you and your team need tokeep up and not be left behind. Join and take part in our panel andlearn how to equip and prepare yourself with the latest digitaltools in pharma:
- 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
Juan Piacquadio, Vice President, Information Services, Phlow
AI is ever-growing in pharma and plays a prominent role in drug development. Listen to the latest developments in AI and what you need to know to utilize its potential in drug development. Join our focused session to get key takeaways from our expert:
- Understanding what AI can bring to your organization and identifying the areas you want to implement the technology
- How to maximize the business value from your AI initiatives
- Reviewing regulatory considerations for successfully implementing AI into your business
Lucas Glass, Vice President of AI, IQVIA
Pharmaceutical and other healthcare innovations have extended and improved countless lives in recent decades. Today, advanced manufacturing technologies such as pharmaceutical continuous manufacturing are gaining increasing interest for their potential to serve as one more way to improve global health by bolstering medicines supply chain resilience and bringing products to market faster. However, obstacles to industry adoption remain. Recognizing the need, USP is working with partners like Phlow Corp., a U.S.-based public benefit corporation and contract development and manufacturing organization, to lower technical and knowledge barriers to advanced and enabling technologies adoption through quality-focused solutions. Working together, pharmaceutical and biotech companies are now positioned to reduce production costs, decrease development time, and lower their environmental impact through the use of advanced manufacturing technologies.
Gabriela Grasa Mannino, Acting PCM Programs Director, Advanced Manufacturing Technologies, US Pharmacopeia
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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.
