External Factors Impacting New Oncology Products

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Pharmaceutical Workshops

The two workshops with examples of pharmaceutical workshop designs are Hands On: Continuous OSD Pharma Processing Workshop and the Bay Area Biotech-pharma Statistics Workshop (BBSW).


Pharmaceutical Workshops

1. HANDS ON: CONTINUOUS OSD PHARMA PROCESSING WORKSHOP

  • This workshop was conducted by Technology Training Center (TTC) and is a brief theoretical introduction with the main focus on hands-on introduction, training, and life demonstration on Continuous Manufacturing of Oral Solid Dosage within the Pharmaceutical Industry.
  • The workshop provides practical knowledge of continuous manufacturing processes for the pharmaceutical industry.
TOOLS
  • The following participants in the workshop are actively participating the following process such as Continuous Wet Granulation, a twin screw granulator/extruder integrated with a continuous wet granulation and drying processor, dry milling (calibrating), and pneumatic conveying.
  • These are all integrated into a supervising control system and a continuous direct compression that includes dry mixing, feeding, and compression based on a Multiple Unit Pellet System (MUPS) formulation.
STRUCTURE
  • The workshop provided transportation from the hotel to TTC for the first day. Followed by reception and registration then an introduction and discussion of the topics with coffee break and lunch break.
  • It also offers transfer to hotel and workshop dinner.
SUCCESS METRIC
  • The workshop was a complete success which was mostly attended by different participants such as engineers, researchers, and operators from the international pharmaceutical industry.
  • The special combination of theory and practice generated positive feedback from all participants. The evening program provided an ideal platform for the exchange of experience and social networking.

2. Bay Area Biotech-Pharma Statistics Workshop (BBSW 2018)

  • The BBSW was mainly for the Bay Area statistics community but it was open for participation from broader audiences.
  • The workshop is to promote statistical impact and innovation and to create a long-lasting annual conference for the local statistics community in the San Francisco Bay area focusing three booming industries: pharmaceutical, biotech, and high tech.
  • The Bay Area Biotech-Pharma Statistics Workshop (BBSW 2018) discussed cutting-edge statistical methodologies and best practices in the analytical field that will change patient care with the theme “Innovation and Impact.”
TOOLS
Discussion questions from featured sessions include:
  • Innovative Trial Design;
  • Innovative Technology and Applications in Clinical Trials;
  • Reflection on Recent Regulatory Guidance;
  • Successful Examples in Statistical Innovation and Leadership;
  • Machine Learning, Al, Big Data, and Applications in Clinical Trials; and
  • Panel Discussion on Innovation, Impact, and Leadership
STRUCTURE
  • The workshop opened with a keynote by Lisa LaVange, 2018 ASA president, and her presentation focused on fostering statistical leaders and increasing their impact through day-to-day work.
  • Following LaVange was Steven Shak, co-founder and CMO/CSO of Genomic Health, who gave a talk titled “Technology Innovations in Health Care and Medicine.”
  • The afternoon program included a session on innovative trial design and a panel discussion on recently released ICH and regulatory guidance. The dinner session was presented by a banquet speech and shared thoughts on how statisticians can drive strategic decisions to improve drug development efficiency by Mingxiu Hu, Senior Vice President at Nektar Therapeutics.
  • The second day of the workshop began with a session on innovative technology and applications in a clinical trial and a roundtable discussion in which six experts in their respective fields led informative discussions with their groups during lunch of the second day.
  • The workshop ended with a panel discussion on innovation, impact, and leadership.
SUCCESS METRIC
  • The workshop was completely successful with more than 250 participants in related fields.
  • It was hosted by DahShu, a nonprofit organization founded in 2015 to promote research and education in data science.

Research Strategy:

We began searching through trusted sources focusing mainly into pharmaceutical industry workshops. We searched through The National Academics Press, DahShu, and Glatt Integrated Process Solutions for any information about pharmaceutical workshops. This yield helpful results that provided two examples of pharmaceutical workshop designs. We have identified the following pharmaceutical workshop presented above by making sure that these workshops present how it is structured, the tools used, the topics discussed, and the available success metrics.
Sources
Sources

Quotes
  • "This workshop is giving a brief theoretical introduction with main focus on hands-on introduction, training, and life demonstration on CONTINUOUS MANUFACTURING of ORAL SOLID DOSAGE within the Pharmaceutical Industry."
  • "This workshop is the perfect investment for those who wish to acquire practical knowledge of continuous manufacturing processes for the pharmaceutical industry."
Quotes
  • "The Bay area Biotech-pharma Statistics Workshop (BBSW)is a new conference designed mainly for the Bay Area statistics community while open for participations from broader audiences. "