10:00AM ET | Making a Splash in the US Market: How PBPK Modeling is Playing a Central Role in Risk Reduction in early drug development Rapid and efficient development of drug candidates is increasingly important for pharmaceutical companies with accelerated timelines and funding constraints. However, many early drug candidates have poor oral absorption properties making it challenging to achieve target pharmacokinetic (PK) profiles. Without upfront knowledge of absorption risks and mitigation strategies, poor absorption can significantly impact preclinical and clinical study timelines and costs. Physiologically-based pharmacokinetic (PBPK) modeling software, such as the GastroPlus® platform from Simulations Plus, simulates dynamic physiological factors impacting oral performance. When coupled with in vitro measurements, PBPK modeling is effective in early development for 1) identifying absorption risks, 2) assessing the potential for solubility enhancing formulations such as salts, cocrystals, or amorphous solid dispersions to mitigate these risks, and 3) designing and optimizing preclinical and clinical studies with respect to dose, prandial state, or gastric pH modification to maximize the likelihood of achieving desired PK profiles. In this presentation, we will demonstrate how PBPK models combined with Lonza’s custom and off-the shelf in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development, reducing the need for drug product reformulation or repeated preclinical or clinical studies. Key Learning Objectives - Learn how PBPK modeling can identify potential oral absorption risks and mitigation strategies (e.g. bioavailability enhancement) for early drug candidates
- Learn how PBPK modeling coupled with in vitro testing can guide early selection of drug form and formulation to achieve clinical study goals
- Gain insights into how key drug and formulation factors including solubility, permeability, and dissolution rate can impact absorption risks such as poor oral bioavailability, food-drug interactions, and pH-dependent DDI effects
| Deanna Mudie, PhD Senior Principal Engineer, Lonza Josh Marsh, Bioavailability Enhancement and PBPK Lead Scientist, Lonza |
10:30AM ET | Panel: Best Practices in Implementing a Successful ESG Framework Many US pharma companies now have ambitious plans in place to achieve carbon neutrality in the coming decades, but strategies and timelines vary. In this panel discussion, experts discuss the best ways to implement ESG in your organization, and the long-term outlook for pharma: - Defining ESG in Pharma to understand what makes it different from other industries
- Establishing what is needed for implementing ESG practices in your organization
- Reviewing common pitfalls and how to avoid them
- Evaluating the role of the Chief Substantiality Officer in helping the industry move in the right direction
- What will ESG in pharma look like in five years? What should the industry’s KPIs be?
| Moderator: Bob Girton, Partner, Edgewater Capital Panelist: Marisa Sharkey, Director, Corporate Communications, Harmony Biosciences Michael G. Mahoney, Environmental Compliance Lead, Teva Pharmaceuticals Feng Peng, Principal Scientist, Merck |
11:45 AM ET | Understanding Current Drivers in Drug Pricing and what this means for the industry Get the inside focus on the latest drug pricing developments in the US market. Listen to the current legislator updates and how it will affect patient costs while reviewing the rising manufacturing costs from inflation and supply constraints and the market’s reaction: - Examining current manufacture drug costs vs patient costs and how this reflects in current market pricing
- Reviewing Legislative updates in the market and expected changes to the industry
- Calculating rising inflation and supply constraints, what will be the impact on the cost of manufacturing?
| James Manser Executive Director, Government & External Affairs, Endo Pharmaceuticals |
12:15PM ET | Psychedelic Research: Where Do We Stand in the Global Market? Join our thought leadership session to understand the current state of Psychedelics in the pharmaceutical industry. Delve into the potential psychedelics can bring and why the industry needs to take notice of its growing importance: • How psychedelics can play a role in the treatment of mental health conditions • Emerging investigator initiated and sponsored clinical trials • Drug development and regulatory challenges to counter before mass adoption
| Jessica R. Riggleman, Sr. Director, Clinical and Regulatory Affairs, Mydecine Innovations Group |
12:45pm | Forecasting and Strategy – Maximizing product accessibility and uptake, improving commercial forecasting skills and analytics As we bring in 2023, pharmaceutical companies will undoubtedly be looking ahead. But how will the events of the past two COVID years influence future aspirations? In the past, pharmaceutical companies used a mix of bottom-up and top-down processes to budget for the next fiscal year, and then made quarterly revisions during the year. Nowadays, both on the revenue side and on the expense side, volatility is more of a rule than the exception. Brands in different diseases are impacted differently in terms of demand by COVID-19: some experience an increased need; others are temporarily less needed, and demand will spike again once hospitals are able to take on less urgent cases. The timing of the impact of post COVID-19 era varies by country and is hard to predict, which makes strategy and financial forecasting more of a crystal ball exercise. Finally, various payers in health care systems will have budget issues themselves, having to redirect their budgets on the fly. How the market is bouncing back and forecasting is aligning itself to the new normal will be understood better by this presentation The presentation will cover. - A typical forecasting process- cross functional process.
- How do you value / forecast a drug / company’s pipeline? What techniques to use?
- What are the forecasting models and best practices for early-stage assets in drug/IP commercialization processes?
- Who are the stakeholders in the forecasting process and how to influence them?
| Sanobar Syed, Associate Director – Market Insights, Beigene |