Seminars Archives - MassBio https://www.massbio.org/massbio-member-event-category/913720004/ Massachusetts Biotechnology Council Tue, 02 Jan 2024 18:01:34 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.2 Section 1202: Qualified Small Business Stock https://www.massbio.org/member-events/section-1202-qualified-small-business-stock/ Tue, 02 Jan 2024 12:01:10 +0000 https://www.massbio.org/member-events/section-1202-qualified-small-business-stock/ Join BDO USA and Nutter for an overview on Section 1202, Qualified Small Business Stock, which offers tax gain exclusions on stock sales. The event will provide strategies for startups and small businesses (whether corporations or LLCs), founders, investors, and corporate officers to take advantage of this provision and maximize the amount of gain exclusion. […]

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]]> Join BDO USA and Nutter for an overview on Section 1202, Qualified Small Business Stock, which offers tax gain exclusions on stock sales. The event will provide strategies for startups and small businesses (whether corporations or LLCs), founders, investors, and corporate officers to take advantage of this provision and maximize the amount of gain exclusion. It will also discuss common traps for the unwary and health check measures.

AGENDA
8:30 AM to 9:00 AM – Registration & Breakfast
9:00 AM to 10:00 AM – Presentation
10:00 AM to 10:30 AM – Networking

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]]> Certara Webinars Presents: First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic Modeling https://www.massbio.org/member-events/certara-webinars-presents-first-in-human-fih-faster-the-power-of-physiologically-based-pharmacokinetic-modeling/ Thu, 14 Dec 2023 08:32:08 +0000 https://www.massbio.org/member-events/certara-webinars-presents-first-in-human-fih-faster-the-power-of-physiologically-based-pharmacokinetic-modeling/ Advanced Strategies and Best Practices for Predictive Pharmacokinetics using Simcyp™ Discovery   Refine your approach to early drug development with insights from industry experts in our upcoming webinar, “First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic Modeling (PBPK).” If you’re seeking strategies to identify and advance your small molecule drug candidates, expedite product profiling, formulation, and […]

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]]> Advanced Strategies and Best Practices for Predictive Pharmacokinetics using Simcyp™ Discovery

 

Refine your approach to early drug development with insights from industry experts in our upcoming webinar, “First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic Modeling (PBPK).” If you’re seeking strategies to identify and advance your small molecule drug candidates, expedite product profiling, formulation, and dose recommendations, and seamlessly integrate in vitro, physchem, and preclinical data into insilico tools, this is a must-attend event.

Join our expert panel as we explore the potential of advanced PBPK modeling, showcasing how Simcyp Discovery leverages existing data to guide decisions supporting Investigational New Drug Application (IND) submissions. Our best practices empower pre-clinical teams to seamlessly translate in vitro data into reliable predictions of pharmacokinetics (PK) and pharmacodynamics (PD) in animal models and human dosing, increasing confidence in decision making. This not only reduces time and costs but also mitigates ethical complications associated with imperfectly planned in vivo studies.

Webinar Highlights:

  1. PBPK Best Practices: Explore how PBPK modeling allows understanding ADME processes, translating in vitro data into precise predictions for animal models and human dosing.
  2. Insights from Experts: Gain firsthand experiences leveraging Simcyp Discovery for better informed human trials.

Key Takeaways:

  1. User Experience and Consultancy Insights
  2. FIH Dose Prediction Process
  3. Process Enhancements and Streamlining
  4. Best Practices in Early Discovery
  5. Choosing Between In Vitro/Animal Studies and Modeling
  6. IND Applications and Impact of PBPK Modeling

Panelists:

Masoud Jamei, SVP, Research and Development

Hannah Jones, SVP, PBPK Consultancy

Kevin Romer, VP (Simcyp)

Himanshu Mishra, Director (Simcyp)

Freddy Chen, Principal PBPK Consultant

Don’t miss the opportunity to learn tips to boost confidence in early-stage drug development decisions!

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]]> Certara Webinars Presents: Off-Target Drug Safety: Replacing Educated Guesswork with Evidence-Based Risk Assessment https://www.massbio.org/member-events/certara-webinars-presents-off-target-drug-safety-replacing-educated-guesswork-with-evidence-based-risk-assessment/ Tue, 02 Jan 2024 13:01:31 +0000 https://www.massbio.org/member-events/certara-webinars-presents-off-target-drug-safety-replacing-educated-guesswork-with-evidence-based-risk-assessment/ Secondary pharmacology profiling involves the screening of small molecule compounds against a broad range of targets in order to try to predict off-target interactions leading to safety issues in humans.  To date, this has generally required an opinion-based approach, but opinions vary and are inherently unreliable.  To evaluate this quantitatively requires the use of surrogate […]

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]]> Secondary pharmacology profiling involves the screening of small molecule compounds against a broad range of targets in order to try to predict off-target interactions leading to safety issues in humans.  To date, this has generally required an opinion-based approach, but opinions vary and are inherently unreliable.  To evaluate this quantitatively requires the use of surrogate measures of the level of receptor occupancy required to elicit pharmacodynamic effects at the receptor in humans in vivo.  The only universally available data to do this are the minimally effective plasma concentration (unbound) and its relationship to the Ki at the receptor, for clinically used drugs targeting a particular receptor for their clinical efficacy.  This webinar will describe how this has been achieved for >100 receptors (G protein-coupled receptors, ion channels, nuclear hormone receptors, enzymes, kinases and transporters) to build a software tool called Secondary Intelligence™.

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]]> Life sciences industry forecast for 2024 and beyond https://www.massbio.org/member-events/life-sciences-industry-forecast-for-2024-and-beyond/ Mon, 06 Nov 2023 13:03:09 +0000 https://www.massbio.org/member-events/life-sciences-industry-forecast-for-2024-and-beyond/ Baker Tilly’s outlook on what lies ahead for industry leaders

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]]> Date and time

Jan 24, 2024

11:00 AM — 12:30 PM CST

Join Baker Tilly for our third annual Life Sciences Industry Forecast event where we will explore developments from this past year, discuss the current state of the environment and look at trends and challenges shaping the industry in 2024 and beyond. Topics of discussion will include capital markets, market access, medical affairs and patient access, compliance and regulatory landscape, and more. New to this year’s event will be discussions about developments within the European, Middle East, and Africa (EMEA) as well as Asian-Pacific (APAC) markets for established multinational companies or U.S. based companies that are looking to expand into the global market from a perspective of our colleagues at Baker Tilly International affiliate firms.  

We look forward to seeing you on Jan. 24!  

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]]> Knowledge Culture: CHO Solutions Day https://www.massbio.org/member-events/knowledge-culture-cho-solutions-day/ Wed, 29 Nov 2023 10:00:49 +0000 https://www.massbio.org/member-events/knowledge-culture-cho-solutions-day/ Sharing our CHO product innovations and insights to help enhance your productivity

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]]> From scalable cell culture bioprocessing solutions to accelerating the path from development to commercialization, Thermo Fisher Scientific stands by your side every step of the way. Our trusted products and expertise have consistently supported the development and manufacture of over 230 commercial biologics, spanning cell and gene therapies, monoclonal antibodies(mAbs), and vaccines.

Join us at Knowledge Culture: CHO Solutions Day 2023, where bioprocessing scientists from Thermo Fisher will guide you in unlocking the future of cell culture bioprocessing. During this face-to-face and virtual event, our knowledgeable speakers will share ways to enhance your current cell culture process, focusing on innovations to enhance output and streamline large-scale cell culture workflows.

Key topics covered will include:

  • Next-generation media and feed systems
    – Gain insight into supporting the nutritional requirements of high-cell-density cultures and higher protein titers
  • A multi-omics strategy for optimizing cell culture media to produce biotherapeutics
    – Learn how to improve cell culture media and processes—and further increase the titers of therapeutic proteins—utilizing proteomics and metabolomics
  • Rapid media and feed screening options for targeted CHO clones
    – Discover important ways upstream developers can rapidly screen and identify an optimal medium and feed for targeted CHO clones
  • Scalability with the Thermo Scientific™ DynaDrive™ Single‑Use Bioreactor
    – Explore how this innovative technology efficiently supports scale‑up volumes in manufacturing, from pilot to production

Registration deadline is January 22nd 

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]]> FUJIFILM Diosynth Biotechnologies https://www.massbio.org/member-events/fujifilm-diosynth-biotechnologies-in-person-lunch-and-learn/ Tue, 02 Jan 2024 13:01:34 +0000 https://www.massbio.org/member-events/fujifilm-diosynth-biotechnologies-in-person-lunch-and-learn/ In Person Lunch and Learn

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]]> Event Title: The Vector for Plasmids: An Overview of FDB Plasmid Manufacturing Strategy to Support Viral Gene Therapies

Date and Time: January 25, 2024 11:30 am EST

Speaker: Jason Fairlee, Director of Upstream Process Development, FUJIFILM Diosynth Biotechnologies

Join us as we discuss FDB’s approach to delivering plasmid raw materials to our viral gene therapy business. Topics include:

• Current network GMP plasmid production capabilities

• Overview of next generation platform process and efficiencies gains                                                                                                                                       

• Leveraging network capabilities to de-risk plasmid raw material supply

Lunch will be provided

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]]> Streamlining the HCP engagement process through complianceNOW https://www.massbio.org/member-events/streamlining-the-hcp-engagement-process-through-compliancenow/ Tue, 19 Dec 2023 11:02:11 +0000 https://www.massbio.org/member-events/streamlining-the-hcp-engagement-process-through-compliancenow/ A technology-driven, end-to-end HCP engagement solution

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]]> Join Baker Tilly for a live walkthrough of our complianceNOW technology-driven solutions that couples with Baker Tilly’s depth and breadth of healthcare industry experience to create one end-to-end HCP engagement and reporting solution. Throughout the demonstration, we will highlight the functionalities of our complianceNOW suite, encompassing fmvNOWTM, kolNOWTM, engagementNOW and transparencyNOW; and illustrate how companies can effectively utilize these tools both independently and synergistically. We will specifically focus on how companies can use these tools to: 

  • Evaluate business needs  
  • Enhance their relationships with HCPs through an improved customer experience 
  • Improve internal operational efficiency through streamlining reviews and approvals and achieving a seamless cross-functional alignment  
  • Execute easily pre-engagement compliance controls from HCP selection to FMV determination, tiering and due diligence  
  • Manage all critical engagement execution components  
  • Easily reconcile documentation for payment and performance verification 
  • Adhere to global spend transparency reporting requirements 

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]]> Certainty by Certara User Group Meeting https://www.massbio.org/member-events/certara-certainty-user-group-meeting/ Thu, 14 Dec 2023 08:32:14 +0000 https://www.massbio.org/member-events/certara-certainty-user-group-meeting/ Certainty by Certara offers exclusive access to Certara experts, industry leaders and your peers with an opportunity hear the latest innovations and opportunities to achieve better certainty to your drug development lifecycle.

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]]> Certainty by Certara offers exclusive access to Certara experts, industry leaders and your peers with an opportunity hear the latest innovations and opportunities to achieve better certainty to your drug development lifecycle.

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