WEBINARS AND VIDEOS

• IND Submission Advice From The Front Lines

  NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim share parting shots and nuggets of IND submission wisdom, and respond to a few final audience questions, in this final segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray.

• Resources For Successful IND Submissions

  In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim offer several of their go-to resources for guidance when preparing an IND submission.

• So, You’ve Been Put On Clinical Hold…

  As the frequency of clinical holds increases, so do the chances it’ll happen to you. What’s a biopharma leader to do if it happens? Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. offer advice on direct engagement with the FDA to expedite the release of a clinical hold.

• How To Avoid A Clinical Hold

  Having covered what a clinical hold is and the disruption they cause, Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. dig into how biopharmas can avoid them from the outset in this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray.

• IND Submissions Are On The Rise

  During this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, we asked our live audience about their near-term IND submission plans. Our panelists, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim, reflected on the uptick in submissions to the FDA in recent years and prognosticated on the trend.

• The Impact Of The Clinical Hold

  In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. discuss the ramifications of a clinical hold on your study progress, investor perception, and timelines.

• Why Clinical Holds Happen

  The volume of clinical holds doled out by the FDA has skyrocketed in recent years. In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim explain clinical holds and discuss why they happen.

• Animal Testing & Tox: What’s Required Today?

  In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Heln Kim entertains audience questions on FDA toxicology and animal study requirements in light of the Reducing Animal Testing Act passed in December, 2022.

• Pre-IND Prep: A Primer

  Meet Daniela Drago, Ph.D. and Helen Kim, regulatory affairs experts at NDA Partners and Umoja Biopharma, respectively, in the opening segment of our recent Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray. Here, Drago and Kim address the value of a pre-IND meeting and the resources required of successful submissions.

• Accelerating mAb Development To Meet Increase In mAb Approvals

  To accelerate the delivery of life-saving therapeutics, it is essential to evaluate ways to maximize efficiencies, while minimizing risk, to stay up to speed with the growing demand.

• Enabling GMP Production with Enhanced Single-Use Fermentors

  As more products are moved into single use fermenters, there is greater need to improved oxygen delivery closer to or beyond the abilities of stainless-steel vessels.

• A Collaborative Path To Single-Use Supply Assurance

  Learn how leading biopharma companies such as Sanofi and single-use solutions provider Thermo Fisher Scientific are addressing supply challenges and developing collaborative processes. 

• Optimizing Cell & Gene Therapy Manufacturing Post-COVID

  Cell and gene therapy developers have felt the pressure to optimize processes and streamline activities in order to ensure clinical and commercial success of these critical therapies.

• Accelerating Progress: Key Considerations For CDMOs To Maximize Productivity And Scalability

  Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.

• Single-Use Technologies In The Battle Against SARS-CoV-2

  The Single-Use Technologies (SUT) business at Thermo Fisher Scientific is helping our customers in their fight against SARS-CoV-2 by providing assurance of supply. This video discusses our escalation routes through the Coronavirus Command Centre, our SUT capacity expansions and contains a customer testimonial from AGC Biologics.

• Accelerating Delivery In The Next Stage Of The SARS-CoV-2 Battle

  What does pressure to address critical challenges of speed, scale, and supply mean for technologies enabling production, and how does it impact the future of vaccine and biotherapeutic manufacturing?