Meet us at #ATW26 in San Diego, February 9-12.
Supply risk management, formal risk assessments, and risk mitigation plans are critical throughout the biopharmaceutical development lifecycle, however the scale and nature of these risks evolve over time.
Since the COVID-19 pandemic, companies have taken a more proactive approach to supply risk management, responding to a broader set of risks, new regulations and policies, and the opportunities presented by enhanced data analytics tools.
Join experts from Converge Consulting and Apellis Pharmaceuticals as we explore these emerging drivers of supply risk, assess the growing range of internal, industry-driven, and supplier-related risks, and share real-world insights to help you in anticipating and mitigating supply disruptions in your organization.
Presented by: Jeremy Friedler (Moderator), Alex Spivak, and Chris Wixson.
Supply risk management, formal risk assessments, and risk mitigation plans are critical throughout the biopharmaceutical development lifecycle, however the scale and nature of these risks evolve over time.
Since the COVID-19 pandemic, companies have taken a more proactive approach to supply risk management, responding to a broader set of risks, new regulations and policies, and the opportunities presented by enhanced data analytics tools.Join experts from Converge Consulting and Apellis Pharmaceuticals as we explore these emerging drivers of supply risk, assess the growing range of internal, industry-driven, and supplier-related risks, and share real-world insights to help you in anticipating and mitigating supply disruptions in your organization.
Presented by: Jeremy Friedler, Ashutosh Pandit, Gordon Pugh, David Peters, Chad Presher.
Developers of cell and gene-modified cell therapies face a unique set of challenges when it comes to defining production schedules and optimizing operational planning. The complexity of manufacturing these advanced therapies—combined with stringent regulatory requirements and evolving industry demands—makes it essential to establish efficient, scalable, and cost-effective manufacturing strategies.
DHC Principal Liz Cauldwell and Senior Consultant Catherine Colandro explored key considerations for driving production efficiency and operational excellence in cell and gene therapy manufacturing in this webinar.
This session was designed for professionals in biomanufacturing, operations, supply chain management, and process development who are looking to improve manufacturing efficiencies and mitigate the cost of facility operation and production.
This webinar (hosted by Elizabeth Figueroa, Ph.D. and Christina Fuentes, Ph.D.) addressed unique product development considerations for the evolving gene editing and delivery landscape, including viral and non-viral delivery vectors such as lipid nanoparticles (LNPs) and adeno-associated virus (AAV). Topics included:
A webinar on the most urgent international logistics challenges and issues facing life science companies today, especially regarding US-China interactions, future trends, and recommendations for life science leaders. Converge Consulting experts were joined by the VP of Supply Chain & Logistics from CG Oncology who shared her personal experience navigating the dynamics of US-China trade and logistics in previous roles.
US life science companies face ongoing trade and logistical challenges to develop and produce their drug products in the global market. Issues include:
Adding to the complexity, governments are increasingly using global trade as a component of their foreign policy. Those policy decisions may be out of industry control, but they have significant ramifications on life science supply chains. Right now, this is most notable in the volatile dynamic between the US and China.
Presented by: Sandra Gutierrez, Todd Applebaum, Mile Iliev.
While providing phase-appropriate considerations and recommendations for IND authorship, DHC experts Wendy Liang and Sara Mills included a survey of the recommended general structure of a CGT IND, discussed defining and codifying drug substance and drug product, reviewed best practices for streamlining authorship, and provided insight into what to expect after IND submission.
This webinar, hosted by Principal Jacob Staudhammer, focused on best practices and trends for implementing advanced methods for empty/full analysis, next-generation sequencing, and post translational modification analysis into AAV release panels throughout clinical development. Jacob also discussed some of the technical hurdles, regulatory considerations, industry trends, and advantages for implementing novel methods.
Join us for a webinar with experts on navigating serialization compliance and beyond. Discussion will range from the most critical aspects of the new requirements to best practices for dealing with requests and exceptions. You will also gain insight on efficiently and effectively managing serialization programs that you can apply in your own organization.BackgroundSince the DSCSA entered its enforcement phase last year, license holders of drugs marketed in the U.S. are now working to:
Because wholesalers and dispensers (including specialty pharmacies) are now facing serialization requirements for the very first time, they are also responding by pushing demands back onto the manufacturers.
On top of that, there are manufacturers still struggling with ongoing situational assessment and solution selection.Whether you have an active serialization program for your commercial product portfolio already or are in the process of standing up your program for the first time, this event will help ensure you have the adequate set-up, as well as best practices and procedures to avoid the ramifications of missing the FDA’s November enforcement deadline.
Presented by: Brian Recchione, Ulpiano Flores.
When it comes to nonclinical development strategy for CGT products, a ‘one size fits all’ approach generally does not apply. As an increasing number of CGT products reach the clinic, we can look back on their preclinical paths to identify common pitfalls and how to overcome them. This webinar, co-hosted by Senior Principal and Head of Nonclincal Nathan Manley and Senior Consultant Sean O'Farrell, explored the current state of nonclinical development for CGT products, focusing on big picture questions such as selection of suitable model systems, dose determination, and design of GLP tox studies.
Developing a novel enabling technology for the cell and gene therapy industry? This webinar provided a practical discussion on how to understand and navigate key issues. Our team has deep experience supporting CGT enabling technology companies to successfully commercialize their products, from which Master Practice Expert Richard Grant, Principal Michael Kinzie, and Senior Consultant Madeline St. Onge shared lessons learned and best practices developed.
The final Unbridled Excellence webinar for 2023 featured DHC Managing Partners—CEO Anthony Davies, COO Katy Spink, and GM of DHC Europe Rob Allen—on the topic of 2023 takeaways, 2024 predictions! Our MPs discussed their top big-picture takeaways from 2023 and their list of predictions of what-to-watch for in 2024.
Our first Regulatory Roundup LIVE saw participants joining with our unparalleled team of former FDA regulators in discussing the latest and greatest regulatory news of the day. Thank you to DHC Master Principal Kimberly Benton and Master Practice Expert Don Fink, as well as Senior Principal Heath Coats, former Dark Horse Kevin Whittlesey, and Practice Expert Tal Salz.
In this third episode of the DHC webinar series, we heard from DHC Principal Brent Morse in conjunction with Senior Consultant Joshua Beckett (featuring content from Senior Consultant Alicja Fiedorowicz MSc) on the topic of Phase Appropriate Analytics to Support Cell and Gene Therapy Development. Presenters discussed considerations for implementation of a phase-appropriate analytical strategy to support the development of cell and gene therapies. The concept of phase-appropriateness was be introduced, along with a discussion of how this concept may influence the strategy for release and characterization testing as a product proceeds through development. Presenters also discussed phase-appropriateness in the context of assay qualification, validation, and potency assay strategy.
How ready are you for inspection?
Join former Dark Horse David Jasek in addressing these questions.
Digital transformation allows companies to reinvent themselves. Organizations can reimagine how work is done and how to create and deliver value to customers. Your company will need to decide when it’s appropriate to embark on your digital transformation.Digitally enabled data-driven insights are influencing key decisions, actions, and processes more than ever before. Digitization of supply chain planning in particular almost always results in better insights and improved business outcomes.
Join Converge Consulting and Eiger Biopharmaceuticals as we zero in on digital enablement of Supply Planning, with discussion focused on:
Presented by: Marc A. Osterhaus, Robert Cantow.
One of the most important early decisions you will make is the selection of your CDMO partner. Not all CDMOs are created equal, and there is no easy answer to which is the best suited for your program. Performing a detailed, rigorous, and comparative quantitative analysis of proposals must be paired with real-world knowledge and insight into the operating history and track record of the candidate CDMOs. DHC has a long track record of working with CDMOs and helping clients to choose the right CDMO partner, granting us an extensive knowledge of the growing CDMO landscape. With DHC Senior Consultant Uzma Shoukat-Mumtaz.
Preparing for commercial launch is a big deal for most companies. It requires strong leadership and coordination across many functional areas. There are also technical and regulatory hurdles. The company is investing significant efforts and capital before market approval is assured. These all dramatically raise the level of business risk.
Join us for an evening discussion of how to avoid the traps companies face most frequently when preparing for commercial launch:
By preventing these pitfalls, you will reduce the risk of a launch delay and build closer coordination between the Technical Operations and Commercial/Market Access teams and other critical functional groups like Quality, Regulatory, Finance, and IT.
Presented by: Jeff Goldberg, Todd Applebaum.
Supply chain leaders in life sciences companies operate in a highly uncertain environment. Commercial and regulatory uncertainty is now compounded by the risk of supply disruptions and geopolitical barriers. For companies managing the complexity of multiple products, regions and supply chains, the ability to analyze and evaluate scenarios before they turn into emergencies is critical. It allows for understanding options and developing contingency plans. Taking uncertainty into account in the supply chain planning process and S&OP improves manufacturing and supply decision-making in a way that is easily adaptable as the portfolio grows.
Join us for a webinar on dealing effectively with risk and uncertainty in your planning process and S&OP.
Attendees will gain:
You will also hear directly from an industry leading company who has successfully managed these risks in their planning process.
Presented by: Thierry Bilbault, Jeremy Friedler, Sean Carroll.
CMC and Finance leaders often find themselves at odds with one another at many emerging companies. The CMC landscape is dynamic, often changing substantially. It can be difficult to capture the strategic and budgetary implications of those changes in a manner that Finance can absorb and use for their purposes. Building alignment between these functions eliminates those roadblocks and can unlock significant additional benefits.
This webinar is for CMC and Finance leaders interested in:
Presented by: Hugh Wight, Todd Applebaum, Ashutosh Pandit.
The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS).
There have been recent developments to business requirements to fulfill DSCSA obligations. Manufacturers need to start now to meet requirements for November 2022 and beyond.
This event will provide insights on:
Presented by: Dean Caravoulias, Stephanie Byrne, Todd Applebaum.
This event will provide insights on emerging methods and practices for designing supply chains focused on building and maintaining close relationships with physicians and patients. Supply Chain Working Group members will discuss the important components and challenges in building a patient focused supply chain, including best practices in:
Presented by: Natalie C. Costa, Todd Applebaum.
The Coronavirus Aid, Relief, and Economic Security ("CARES") Act, signed in March 2020, provides emergency assistance and health care response for individuals, families, and businesses affected by the 2020 coronavirus pandemic. Our focus will be on understanding the impact of the CARES Act on the life sciences and the pharmaceutical industry with respect to:
Presented by: Chris Silva, Todd Applebaum, Jeremy Friedler.
Clinical supply professionals are charged with getting the right drug to the right patient at the right time – at the lowest possible cost and resource allocation. While the supply chain itself has held up well during the pandemic, the couriers and sponsors have had to get creative to get the drug to the patient on time which may include longer lead times and increased costs. Now more than ever, the industry needs to consider moving towards a digital supply chain.
Join us for an interactive panel discussion to:
Presented by: Neeraj Shah, Barry Moore, Michael Nest.
We are seeing new global logistics and trade challenges emerging in our “new normal” business environment, which includes fast-changing trade wars, restrictions on cross-border transport, and huge demands for cold-chain and vaccine logistics capacity. Our focus will be on understanding the implications of these changes on:
Presented by: Carsten Nielsen, Todd Applebaum.
Sign up as a member of the Life Sciences Supply Chain Working Group by registering for this inaugural event. The group currently has over 30 members who are supply chain executives at the Director level or above.
The meeting program includes:
We hope you will join the Supply Chain Working Group and choose to attend December’s meeting.
There are constantly unforeseen risks inherent when planning for clinical supply. For instance, when the COVID-19 pandemic began, there was concern that supply chains would be disrupted. Overall supply chains remained operational but questions remained on how to manage demand and forecast through the pandemic. As the world slowly begins to open back up, the focus now needs to shift to understand what we’ve learned from the pandemic and past experience and how that knowledge can be applied as a default in mitigating risks moving forward.
This webinar brings together a panel of supply chain experts to bring insight into managing the uncertainty and risk that comes along with clinical supply decisions. Questions to be addressed include:
Presented by: Chad Presher, Michael Nest, Neta Bendelac, Jan Pieter Kappelle (Moderator).
Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place. By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The challenge is in establishing an appropriate level of rigor and controls for the particular stage of the development lifecycle.
From the identification of critical characteristics to the development of methods and procedures, flexibility and discretion early in development give way to more rigorous controls for commercial GMP operations.
The QS journey begins with steps leading to IND submission. As companies progress through Phase 2 clinical trials and are preparing for a Phase 3 trial, BLA/NDA submission, PAI readiness and ultimately commercialization, they need to progressively enhance their quality system. After product approval, companies continue improving their QS for operational efficiency, as well as to avoid costly product failures and regulatory sanctions.
They must design and transition to a commercial quality system to support the new operations involved in scaling production, often via outsourcing, while continuing to manufacture clinical material.
Participants will hear expert discussion focused on three main phases of QS development:
This webinar is appropriate for CXOs, Quality, Development, Regulatory, Clinical Operations, Manufacturing, Supply Chain, Technical Operations, and other functional leads engaged with or interested in the stage-appropriate quality system for companies in preclinical development to commercial operations.
Presented by: Melanie Cerullo, Todd Applebaum, Dr. James Blackwell.
Now that federal DSCSA serialization regulations are being enforced for U.S. manufacturers, focus is shifting from first-time implementation to the challenges in serialization execution, management and delivery of business value. Forward-thinking companies are developing strategies for analyzing serialized data to identify efficiencies and improve outcomes.
Even companies that are implementing serialization for the first time are finding the experience very different than it would have been just a few years ago. New entrants and offerings make the solution landscape more confusing. In addition, ongoing support and administration reaches broadly across the organization and can be more than expected.
Join Supply Chain, Manufacturing, QA, IT, Finance, and CMC peers to discuss these new challenges along with ways to increase the value of your serialization efforts and data. This will include tips addressing compliance, management and maintenance, along with using data to gain competitive advantage.
Presented by: Gary Abernathy, Todd Applebaum, Stephanie Byrne.