Advancing Women's Leadership Skills & OpportunitiesIn Pharma & Healthcare
Attendees will hear first-hand from accomplished female Pharma and Healthcare executives who have leapt over barriers and created their success. These leading women will share stories and lessons learned from their climb to the top. Through keynotes, panels, and unique mentoring breaks, this event shines a spotlight on influential women in Pharma and Healthcare, bringing industry role models and their journeys to the forefront.
Our event will engage attendees to develop methods for escalating women into leadership roles to continue to close the gender parity industry gap. Attendees will have a chance to facilitate career & business connections with other women in leadership roles. Featured speakers will share effective practices they've deployed to develop female talent and ideas for continued leadership development at all levels. During the conference, attendees will be exposed to and have plenty of networking opportunities with key thought leaders, mentors and industry influencers.
Top 5 Reasons to Attend
- Rare opportunity to learn and prosper from women who’ve achieved C-Level positions
- Hear ideas and best practices for overcoming barriers to success
- Network with peers, mentors and those on their “way up” in leadership roles
- Create a road map for achieving your next leadership role in Pharma or Healthcare
- Learn strategies for fostering diversity and inclusion
Mid-Level Leaders who are emerging and seeking knowledge to facilitate upward mobility. This conference is for Managers, Directors and VPs looking to continue their career path to Senior Level, Executive Level and C-Suite Roles with:
- Pharmaceutical companies
- Hospitals, healthcare system & healthcare providers
- Health insurance companies
- Biotech companies
- Medical device manufacturers
- Healthcare related associations, foundations, solutions providers, educational organizations, government entities and venture capitalists
Monday, December 2nd, 2019 | Day 1
8:00 AM - 8:30 AM
Registration & Continental Breakfast
8:30 AM - 8:45 AM
8:45 AM - 10:45 AM
FDA Scope & Organization
With US spending on Healthcare among the highest in the world with some of the lowest rates of life expectancy, it’s time to change our patterns of care. This overview will set the stage for contracting in 2020 and beyond and will examine how to contract and build your network. Learn how to seamlessly move away from the fee-based system and gain the trust of all stakeholders.
- What is the impact of new technologies and adding approved services to your overall plan?
- How to design value-based contracts and get buy-in from all parties
- Understand what new ancillary services will be best for your organization’s contracting goals
- Explore strategies in network development designed to cover newly approved areas of service and technology
10:45 AM - 11:15 AM
Networking & Refreshment Break
11:15 AM - 12:15 PM
History of US Regulation
You may feel like there are massive requirements to get a product developed & approved. A system so complex and intricate that you may never learn to successfully navigate it. However, while there are complexities, it is navigable and understandable. This session will explore the interesting historical events leading to our current regulatory framework and the currently available pathways to drug approval.
- Learn the submissions required for study and approval for your drug, device, biologic, medical food, or dietary supplement
- Learn the format required for your submissions in an effort to give patients
- Overview of devices regulation for IDE/510(k)/PMA
- Address biologics and biosimilars including IND/BLA
- Touch on dietary supplements and medical foods
12:15 PM - 1:15 PM
1:15 PM - 2:15 PM
History of US Regulation (Continued)
2:15 PM - 3:15 PM
Special Programs to Consider
To add the complexity of possibilities for development of drugs, there are several special programs available that you may want to consider for your product. These special programs can provide any various advantages for your product, such as faster time to market, fewer studies, more FDA interaction and guidance, and cast-savings.
This session will go in depth on the advantages & qualifying requirements for the following:
- Orphan drugs
- Breakthrough therapy designation
- Parallel review
- Fast Track
- RX to OTC switch
- Pediatric development
- Patient’s Right to Try
- Appreciate the history of how we got to where we are today
1. Practical Application Exercise: Map out considerations for your product and its requirements
2. Practical App Ex.: Test your knowledge on the requirements of special programs to see if your products fits
3. Discussion: What creative strategies can you employ to advance your products
3:15 PM - 3:30 PM
Networking & Refreshment Break
3:30 PM - 4:30 PM
Special Programs to Consider (Continued)
Tuesday, December 3rd, 2019 | Day 2
8:00 AM - 9:00 AM
9:00 AM - 9:15 AM
Recap of Day One Sessions
9:15 AM - 10:45 AM
Meetings with the FDA
To assist in navigating the intricate web of regulations and requirements, the FDA offer several key points of interaction during the development process.
- Learn what meetings are possible for your products during your development life cycle and what you should aim to get out of them.
- Learn how to take advantage of these meetings from scheduling to planning and conducting the meeting to gain full understanding and actionable output.
- Review case studies of successful negotiation and communication during meetings.
- See lessons learned from less successful meetings and how to manage that during the meeting and recover after the meeting.
10:45 AM - 11:15 AM
11:15 AM - 1:15 PM
Beginning with the End Target in Mind
The largest goal of every development program is to help patients and enhance their lives. However, that cannot be accomplished philanthropically, so you have to consider what you need to have at the end of the day in order to make money. So how do you ensure that you will hit the target!
- What is a Target Product Profile (TPP) and how do you create it.
- One step beyond the TPP – the claims needed to resonate with customers.
- Materializing the development plan from your targets.
- Practical Application Exercise: Turn a TPP into a Development Program.
2019 Speaker Faculty
Managing Director, Life Sciences Strategy and Operations, R&D Practice
Head of Clinical Innovation
Foley & Lardner, LLP
General Counsel & Chief Privacy Officer
Doctor on Demand
Foley & Lardner, LLP
Digital Medicine and Clinical Innovation Lead
Senior Manager, Drug Delivery and Device Development
Director, R&D Information Head for Clinical Biologics
Director, Head of Clinical Trial Business Capabilities
PhD Candidate, Health Care Ethics
Saint Louis University
Director of Professional Relations, Patient Advocacy
Accreditation Council for Medical Affairs (ACMA)
Patient Advocacy & Education
Chief Medical Officer
Chief Product Officer & Partner
Product Delivery, Advisor, Technical Center of Excellence
Eli Lilly and Company
SVP Global Clinical Operations, Site Management & Trial Optimization
Worldwide Clinical Trials
Senior Director, MAF Clinical Operations
Johnson & Johnson
* SUPER EARLY BIRD *Before 5/1/20
EARLY BIRDBefore 7/1/20
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ON-SITERegister at Event
Register 2 Attendees, Get 1 Complimentary Registration*!
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Contact Michael Goldberg at (561) 221-6202