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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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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Date

Date: Thursday 18th January, 2024
Time: 2pm GMT / 3pm CET / 9am EST / 6:30pm IST
Duration: 45 minutes
Format: Webinar

Abstract 

G protein-coupled receptors (GPCRs) are a very large and important class of drug targets. They are also a very difficult class in terms of modeling with adequate accuracy the necessarily many atoms that constitute the protein, ligands, membrane lipids and solvent. Faster and more accurate computational solutions are required for these challenging systems. In this session we discuss a workflow using computational chemistry methods that are available within Cresset’s CADD software platform, Flare™ to arrive at accurate binding free energies for a set of P2Y1 ligands bound to a lipid-exposed binding site.  

The methods are: 

• Molecular Dynamics (MD)  
• Water analysis solving the Ornstein-Zernike equation (3D-RISM) 
• Alignment of ligands for FEP (Conf Hunt & Align) 
• Relative binding free-energy (RBFE) perturbation theory (Flare FEP). 

We show that using MD, water analysis and careful ligand alignment prior to RBFE calculations can result in reliable predictions for protein-ligand binding affinities even in the case where the ligand is at the lipid-protein interface. Until recently the computational cost of such a large system (93,255 atoms) would be prohibitively large. Implementing methods that ensure a stable and appropriately hydrated binding site (a suitable snapshot of in vivo binding action) as input to the RBFE calculation results in an efficient process for setting up the RBFE job to yield accurate results. The RBFE calculation itself is improved, in terms of efficiency, by the implementation of adaptive Lambda (λ) schedules and automated intermediate generation. The results that will be presented show that the predicted binding free energy of 30 ligands matches the measured experimental affinity closely (mean unsigned error is 1.17 kcal/mol). This difficult computational problem can now be solved relatively quickly with good accuracy by using these methods, and, in principle this workflow could be extended to further membrane protein targets in drug discovery.  

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As academic health centers experience unprecedented disruption and change as a result of the COVID-19 pandemic, chairs are being asked to become more extensively involved in institutional decision making with regard to programs, staffing, operating and capital budgets, and other issues. These responsibilities are in addition to their traditional concerns within their own departments. At the same time, chairs have to consider to a greater degree the relationship between institutional priorities, departmental decisions, and collaboration with other services. These new tasks call for new leadership and managerial skills.

The Program for Chairs of Clinical Services (PCCS) brings together chairs of major clinical departments in teaching hospitals and health systems and an experienced interdisciplinary faculty for two weeks of intensive and systematic study of some of the critical leadership and management issues facing chairs, their departments, and teaching hospitals.

Curriculum

The curriculum of the program is organized around the following interrelated courses taught by a faculty experienced in executive education for physicians and other key decision-makers in the health system:

• Competitive Strategy
• Health Policy
• Financial Analysis and Control
• Innovative Problem Solving
• Operations Management
• Organizational Issues
• Leadership Challenges

A carefully integrated curriculum permits participants to examine fundamental managerial issues from the perspective of several disciplines. A new program initiative or downsizing proposal, for example, may raise managerial problems concerning departmental and institutional strategy; the application and utility of systems analysis and quantitative analytical methods; basic economic trends and legal constraints; financial analysis and control; and organizational behavior, design, and development.

The overriding purpose for learning concepts, techniques, and skills in any of the management disciplines in this program is to understand their managerial use and limitations. For example, the course in financial analysis and control does not aim to develop expert accountants or to provide accounting skills, per se. The purpose in learning to analyze the cost and financial implications of program decisions, for instance, is: (a) to better understand the fundamental methodological issues involved, the driving factors behind any particular analysis, the limits of such analysis, and the need to blend this with clinical, strategic, and other non-financial judgements; and (b) to improve the ability of a participant both to manage staff and to interact more effectively with the fiscal affairs personnel in their hospital, health system, or medical school.

Teaching Method

The principal method of instruction in the program is the case method, a technique pioneered and refined at Harvard Business School. Most of the cases present actual problem situations familiar to chairs of clinical departments. Special case materials based on field studies of specific issues faced by service chairs have been and continue to be prepared by the faculty.

The case method confronts the participant with an actual management problem, halted at a point where decisions must be made, and forces the participant to choose a course of action. Participants go through a three-step study process. First, participants study each case independently. Participants then meet in small discussion groups to test their individual analyses against those of their peers. Finally, the entire class discusses the case, with the professor as catalyst and guide. The professor points out considerations the class has overlooked; elicits from participants the lessons of experience; pursues each line of investigation to its conclusion; and finally, summarizes the discussion and draws out the major lessons it has taught.

Assigned readings and guest lecturers supplement and augment the use of cases. In addition, an important part of the learning process occurs during the informal exchange of insights and experience among participants and faculty.

Program organization

Classes and discussion groups are scheduled six days a week. Preparation for classes averages six hours a day. Registration is scheduled for 3:00 – 4:00 pm on the first day of the program. The following Sunday is free except for cases to be prepared for Monday’s classes. Participants are required to free themselves of professional and family responsibilities for the period of the program so that full attention can be devoted to the educational experience.

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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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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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