Welcome and Opening Remarks

Jun 28, 2022 7:45am ‐ Jun 28, 2022 8:00am

Opening Keynote

Jun 28, 2022 8:00am ‐ Jun 28, 2022 9:30am
As the global biopharmaceutical industry continues to grow and evolve, companies, regulators and scientist are constantly facing pressures to focus on the patient as they improve the quality, efficacy, safety, cost, and compliance of their life-saving products. The Biotechnology Conference brings together the “who’s who” of biopharmaceutical executives, regulatory directors that operate in the space, cutting-edge technology providers and scientist. The audience will hear from premier speakers to indulge their thirsty minds.

Operations Readiness, Tech Transfer & Risk-based Case Studies

Jun 28, 2022 10:15am ‐ Jun 28, 2022 12:00pm

The Biomanufacturing Industry has risen to a number of challenges in supply chain, drug shortages, and global deployment of manufacturing capabilities in connection with the new geopolitical map and current market needs. We have successfully introduced new ways of working and collaborating between industry and regulatory agencies starting with development and clinical trials and ending at the patient’s side. This session will provide examples of ways of working that have proven beneficial for these processes and highlight how we can continue to develop our ways of working and communication channels to further improve the global reach of our products to meet the patient’s needs. Operational readiness and a focus on reducing environmental impact as well as other areas of sustainability are important factors to further this area of production in a responsible way. The work we do now gives us an excellent opportunity to keep those aspects in everything from design for new as well as retrofitted facilities, drug formulation, and logistics solutions.

Applications of mRNA Technologies

Jun 28, 2022 10:15am ‐ Jun 28, 2022 12:00pm
The outbreak of COVID-19 brought the mRNA technology to light. From a silent long-term technology that needed to prove its potential, well behind other technologies like C&G therapies, to the focus of everyone's attention. Lead by Moderna, BioNTech and CureVac the number of players in this field is growing rapidly. New starts-up as well as establish pharmaceutical companies are now turning to mRNA. What are the exciting applications for mRNA technology beyond the COVID-19 vaccine? The goal of this session is to explore the potential of mRNA applications from vaccines to personalized medicines and beyond as a catalysator for such transformation.

Expanding Your Footprint: Opportunities in Biotech presented by Women in Pharma®

Jun 28, 2022 1:15pm ‐ Jun 28, 2022 3:00pm

The biotechnology industry has changed as a result of the pandemic and has accelerated innovation at an unprecedented pace. As we evolve into a new era of biotechnology, the science and future scientific research will pioneer the pathway to cutting-edge technologies, modalities, and patient-centric therapies.   

This collaborative Think Tank panel discussion, sponsored by Women in Pharma ®, will engage all conference attendees in a thought-provoking conversation about the future opportunities for the industry. Designed for everyone, regardless of their level of experience, this session will guide all participants to think of the future from a personal, professional, and industry level: From regulators and industry leaders to young professionals and students, collaboration and engagement between academia, research and development, and industry will be encouraged. All participants will have the opportunity to share new innovative ideas and gain insights to broaden their footprint as they either embark on or continue their pathway in this impactful and exciting industry.

Enabling Digital Transformation(s) in Biotech

Jun 29, 2022 7:45am ‐ Jun 29, 2022 9:15am

With rapid advancements in data infrastructure and tools, the Biomanufacturing Industry is implementing new technologies and ways of working to accelerate the delivery of complex biotherapeutics to patients. These digital data transformations require connectivity between highly skilled SMEs in facilities design, equipment selection and validation, technology transfer, manufacturing operations, Quality Assurance, and Regulatory Authorities. This session invites case studies demonstrating the details and value of such digital transformations, including program acceleration, advanced data modeling, rapid technology transfer, enhanced operational readiness, and data-enhanced regulatory submissions.

ATMPs/C&GT - Projects & Commercial Manufacturing

Jun 29, 2022 7:45am ‐ Jun 29, 2022 9:15am

The quality attributes of advanced therapy medicinal products (ATMPs) that correlate with safety and efficacy in patients are determined not only by manufacturing process inputs such as starting and raw materials, but also by how the manufacturing process itself is designed and controlled. To ensure regulatory compliance, the manufacturing process should therefore be developed based on thorough characterization of the ATMP during all stages of process and analytical development; this ensures that the critical quality attributes that correlate with safety and efficacy are identified and that their specifications can be met during routine manufacturing.  This session will include presentations exemplifying design, manufacturing and operation of the commercial manufacturing of medicinal products.

Process Intensification

Jun 29, 2022 10:00am ‐ Jun 29, 2022 11:30am
There has been a desire for increased efficiency in the manufacturing process to produce therapies with smaller markets. Adoption of new technologies and methodologies can allow for such an evolution of manufacturing under the rubric of process intensification. There are various instances of implementation of process intensification in the biopharmaceutical industry. This session will offer successful stories of several companies using this approach.

ATMPs/C&GT - Data Science and R&D

Jun 29, 2022 10:00am ‐ Jun 29, 2022 11:30am

ATMPs and/or C&GT when applied to the world of Research and Development and Data Science require specific approaches compared to its manufacturing counterpart. Due to the small processing volumes, a Scale Out approach is implemented over a Scale Up approach. Unlike Mab therapy that begins from a Working Cell Bank, ATMPs begin with the patient itself and the variability of the starting material is what characterizes the uniqueness behind personalized medicine. The R&D efforts for ATMPs are focused on a five-dimensional framework where the “five R’s” incorporates notions regarding the right target, the right tissue, the right safety, the right patients, and the right commercial potential. This session invites attendees to explore novel and collaborative methods to achieve a consistent robust process in developing a sustainable, scalable manufacturing platform. Improvements in smart manufacturing of ATMPs/C> supported by AI tools, digitalization and data science are key drivers to scientific, technical and operational progress. Coupled with non-invasive sensors for process monitoring along with dynamic contamination control strategies, the pathway from bench scale to market through smart manufacturing of ATMPs becomes a more tangible reality.

Convergence of Digital Transformation and Process Intensification: Panel Discussion and Q&A

Jun 29, 2022 12:45pm ‐ Jun 29, 2022 1:45pm