In-Person Conference

17-19 May, Philadelphia Convention Centre

10:00

Coffee & Networking

Start your day with breakfast and networking

10:30-12:00

Pharma Marketing Strategy Workshop

Join us for our 1 hour workshop, where industry experts will discuss the latest B2B marketing strategies in Pharma and what can be done to help evolve and create an omnichannel between CDMO’s and Biotech

Moderator: Susan Stipa, EVP of Public Relations, CG Life

Raman Sehgal, Founder and Host, Molecule to Market Podcast

Debra Harrsch, President and CEO, Brandwidth Solutions.

Laurie Actman, CMO, Penn Center for Innovation

Pharma Marketing Forum - May 19

Marketing Forum: Engaging a Pharma Audience All Year Round

May 19 | 10:30 AM -12:30 PM ET

Over the course of the pandemic, pharma marketing strategies have shifted. While in-person events were typically relied upon as a primary source of lead generation and visibility, astute pharma marketers turned to digital opportunities to bridge the gap and explore new avenues for partnerships and new business generation.

This forum will feature marketing experts and industry case studies, providing tangible strategies for reaching your target audience in new ways.

US Market Insights - May 17

Presentation \| 10:00 AM ET	Market Trends Impacting Practice Economics As the healthcare landscape continues to change, the results can deeply impact the economics of a practice. This session will discuss medical vs pharmacy benefit trends, PBMs, national and government payer changes, and how to stay five steps ahead for community based physicians and infusion centers	Elizabeth Johnson, CEO, MedicoCX
Panel \| 10:30 AM ET	ESG Framework: What Investors are Looking For As global governments and businesses increasingly make bold claims and commitments to tackle the climate emergency, investors are starting to take note by using the ESG framework to move beyond environmental concerns and focus on a company's impact on all the different ecosystems it operates in. The rise of ESG mutual funds Increase market value with SDG targeting. How are your activities impacting growth & profitability? Do you have a clear roadmap to achieve your sustainability goals in each step of the value chain?	Moderator: Bob Girton, Partner, Edgewater Capital Panellists: Robert Popovian, Chief Science Policy Officer, Global Healthy living Foundation Nate Kimball, Sustainability Practice lead \| USA, Antea Group Jordan Johnson, Chief Innovation Officer, Oncospark
11:30 AM ET	Coffee & networking break
Presentation \| 11:45 AM ET	Are Pricing Reforms on the Horizon? Recent Congressional proposals have been targeted at drug pricing reform, including opportunities to allow Medicare to negotiate prices for certain drug products, penalizing prices that rise faster than the rate of inflation, and capping out-of-pocket costs for beneficiaries in the Medicare Part D program. This session will explore where the proposals currently stand, what types of drugs are likely to be impacted, and the likelihood of passage of these proposals. Additionally, the session will explore actions that could be taken on drug pricing through the Administration's authority under the Center for Medicare and Medicaid Innovation (CMMI)	Mallory O'Connor, Executive Director, Public Policy, Mallinckrodt Pharmaceutical
Presentation \| 12:15 PM ET	In Pharma Services, Where Have All the Entrepreneurs Gone? Merger, acquisition, and consolidation activity in CRO/CDMO world has intensified to the point where many of my colleagues are beginning to wonder how big the global players can actually become. While many of the mid-sized players have disappeared, a huge number of small pharma service organizations are thriving; creating a giant divide between the small and large players. This also creates a tremendous opportunity for the small pharma service provider to fill the void that’s been created. Today, these entrepreneurial companies are doing incredible science and providing a highly-tailored, fast, and flexible business model to the pharma and biopharma industry. This presentation will take a close look at key market statistics within the smaller pharma services demographic here in the US, as well as a distillation of our findings from discussions with over 200 business owners over the past 18 months. Key questions to be addressed: What are the keys to your current success? What are the barriers to future growth? How has the pandemic impacted your businesses? What are the key risks and opportunities facing the market?	Brian Scanlan, Operating Partner - Life Sciences, Edgewater Capital
Break \| 1:00 PM ET	Light refreshments and networking

Drug Manufacturing Dynamics - May 17

Sponsored by Thermo Fisher Scientific

Presentation \| 2:00 PM ET	Form and fit: Mobilizing integrated resources to transform complex small molecules into high-performing drugs As clients seek to gain maximum benefit from each clinical stage, the advantages offered by contract partners with integrated services are making these higher returns tangible. This presentation will highlight key activities under Thermo Fisher’s integrated drug substance and product development services for the clinical development of small molecule APIs that decrease development risk, decrease timelines, and enable success in Phase 1 and beyond.	Kevin Kane, Ph.D., Sr. Staff Scientist, R&D, Thermo Fisher
Panel \| \|2:30 PM ET	Continuous Manufacturing - What’s Driving Adoption? CDMO’s accelerating adoption Reshoring: CM can help when competing with Asian producers on price. Government investment during Covid to protect against supply chain issues & increased focus on critical drugs supply New guidance based on GMP - ICH Q13 will likely see smaller companies deciding to use CM Opportunities for generic manufacturers – cost savings, beyond production efficiencies	Moderator: Wayne Weiner, Principal, Pharmatech Solutions LLC Panellists: Bikash Chatterjee, CEO, Pharmatech Associates- A USP Company Graziano Castaldi, President/CEO, Chemelectiva Kai Donsbach, Professor, Virginia Commonwealth University William A. Hein II, Senior Director Technical Operations Small Molecule Platform, Janssen
Presentation \| 3:45 PM ET	Covid Therapeutics Outlook Focus on Medicines for All's work in process improvements for COVID therapeutics, including work done thus far on remdesivir and molnupiravir. The session will also describe how Medicines for All shares its results with the global market and how this has led to uptake of its processes on critical COVID drugs. The Medicines for All Institute (M4ALL) is part of Virginia Commonwealth University; M4ALL is committed to improving access to high-quality medications across the globe by driving down production costs. M4ALL does this by optimizing active pharmaceutical ingredient (API) production and providing access to manufacturers around the world to enhance the security of medicine supply chains	Frank Gupton, Department Chair, Virginia Commonwealth University
Presentation \| 4:15 PM ET	Novel Excipient Pilot Program Review Launched at the end of 2021, the voluntary Novel Excipient Review Pilot Program (Pilot Program) allows excipient manufacturers to obtain an FDA review of certain novel excipients before their use in drug formulations. Fundamental to the creation of the program, IPEC Americas talks us through the historical challenges that led to this first-in-kind program and an update from the FDA on the first four excipients approved in the pilot and what this means for the future of excipient manufacturing. In partnership with IPEC Americas What was the need for the program? Results from the December 2021 pilot.	Nigel Langley, Director Technical Service & Scientific Affairs, BASF Pharma Solutions

Presentation | 10:00 AM ET

Where’s the Sugar?

In this session Pfizer CentreOne’s presenters, Tom Wilson and Nicole Strauss will take a deep dive into what makes the recipe for supply chain management success in the face of capacity challenges and the steps CDMOs should take to deal with them.

Solving those challenges revolves around trust; building it, nurturing it and using it. In a way, it’s like having all the ingredients to bake the perfect cake. If you are missing a key ingredient, the whole recipe is in jeopardy.
Supply chain issues and logistics can feel startlingly similar.
Raw materials, schedules, processes and communication are all key elements, any of which can be thrown off track by missing components or information.
Learn how to make sure you have all the ingredients to make a delicious cake.

Tom Wilson, Global Business Development Lead, Pfizer CentreOne

Panel | 10:30 AM ET

Rethinking the supply chain - What are the realities? Who is this really working for?

Talk of bringing back domestic manufacturing to North America has dominated conversations around pharma manufacturing for years, and have been a key talking point in government post-pandemic recovery plans, but how far have we come and who is this really working for?

Asian CDMO’s recognizing the trend for western domestic production are globalizing their operations.
Will there be an increase in the Civica Rx business model?
The Department of Health and Human Services (HHS) led a public-private consortium to increase the U.S production of critical drugs list with a $60 million investment to create “novel platform technologies” for domestic API production.

Moderator:

Wayne Weiner, Principal, Pharmatech Solutions LLC

Panellists:

David R. Gaugh, R.Ph, Senior VP Sciences & Regulatory Affairs, Association for Accessible Medicines

Sam Woods Thomas, Senior Director, Office of Business Attraction and Retention, Department of Commerce | City of Philadelphia

Leah Stilwell Director of Business Development, Asymchem

Presentation | 11:45 AM ET

Proven Framework for Managing Your Outsourcing Partner

Outsourcing drug manufacturing is a common solution to building manufacturing capacity among drug sponsors. Developing appropriate oversight for CDMO’s is key to a successful product launch.

This session will discuss key responsibilities for drug sponsors in overseeing their providers, including which responsibilities can be delegated and when. We will also explore best practices in obtaining optimum performance and adjusting oversight as necessary to reduce overall program risk.

Stephanie Gaulding, CQA, CPGP, Executive Director, Regulatory Compliance, Pharmatech Associates, Inc.

Presentation | 12:15 PM ET

Impact of Supply Chain Challenges on CDMOs and Key Future Trends

Q&A featuring Raman Sehgal, host of Molecule to Market and Stephanie Watson,
Global Strategy and Commercial Planning
Lead at Pfizer CentreOne
Diving into the biggest challenges the supply chain are currently facing, as well as potential solutions
Dissect successful responses and shed light on the future trends we should all be preparing for

Raman Sehgal, Founder of ramarketing & host of Molecule to Market

Karen Lauxmann, Global Marketing and Communications Lead, Pfizer CentreOne

Break | 1:00 PM ET

Light refreshments and networking

Navigating Supply Chain & Capacity Challenges - May 18

Sponsored by Pfizer CentreOne

Biologics & Bioprocessing - May 18

We are delighted to be partnering with Jefferson Institute of Bioprocessing for this year's Biologics and Bioprocessing conference track at CPhI North America.

The Jefferson Institute for Bioprocessing (JIB), is the first - and only - education and training institute for biopharmaceutical processing in North America that combines commercial single-use processing equipment with the internationally recognized NIBRT curriculum.

JIB is a full-service development and training organization specializing in biopharmaceuticals and biologics. They offer early phase pre-clinical process development, product development, analytical, quality control, stability and release testing, world-class industry training, and strong credential programs through Thomas Jefferson University.

View the full program over the page

Biologics & Bioprocessing - May 18

Presentation \| 2:00pm ET	Manufacturing of Cell and Gene Therapies – Challenges and Opportunities This presentation will focus on: The complexities of bioprocessing and manufacturing of biologics to provide a roadmap for development of effective Efficient and scalable processes and platforms that can be adopted successfully to provide patients wide access to cell and gene therapies	Parviz Shamlou, VP, Ex. Director, Jefferson Institute for Bioprocessing, Thomas Jefferson University
Presentation \| 2:15pm ET	Bioprocessing of Hypo-immune iPSC: Toward Cost-effective, High-quality Allogeneic Cell Therapies Discuss strategies and methodologies to develop scalable, robust, and cost-effective manufacturing processes for allogeneic cell therapies Showcase how induced pluripotent stem cells (iPSC) are being used as renewable sources of allogeneic cancer therapies Demonstrate the criticality of GMP manufacturing capabilities to the success of cell therapies, i.e. leverage biologics manufacturing framework to increase patient access to “off-the-shelf” cellular therapies	Bruno Marques, Executive Director, Head of Product & Process Development, Century TherapeuticS
Presentation \| 2:30pm ET	Strategic Manufacturing Development for Cell Therapy Products This discussion will focus on four critical areas for process development and overall product life cycle management: Quality, Scalability, COGS and Sustainability Strategies for accelerating process development in efforts to initiate clinical trials quicker will also be discussed Examples, from both Imvax and other industry products, will be provided	Joe Vitale, PhD, Head of Manufacturing Science and Technology (MSAT) and Process Development (PD), Imvax, Inc.
Presentation \| 2:45pm ET	Biomanufacturing and Moore's Law Need for new modalities Evolution of bio manufacturing of new modalities Comparison with semiconductor manufacturing	Hari Pujar, Chief Operating Officer Chief Operating Officer, Tessera Therapeutics
Presentation \| 3:15pm ET	Panel: Major bottlenecks – Skilled Workforce, Product Quality, Manufacturing Capacity, Cost and Speed to Market Join our panel discussion, where out experts will conduct a deep dive through the challenges in drug manufacturing. Key discussion points include: Bottlenecks in skilled workforce and what can be done to overcome this Assessing the challenges in both product and manufacturing quality and identifying solutions to this Reviewing the costs and why it’s a driver to the speed to market	Moderator: Parviz Shamlou, VP, Ex. Director, Jefferson Institute for Bioprocessing, Thomas Jefferson University Bruno Marques, Executive Director, Head of Product & Process Development, Century Therapeutics Hari Pujar, Chief Operating Officer Chief Operating Officer, Tessera Therapeutics Joe Vitale, PhD, Head of Manufacturing Science and Technology (MSAT) and Process Development (PD), Imvax, Inc. Nripen Singh, Executive Director, Passage Bio