Over the past five years, 3D Communications has gotten a rare behind-the-scenes look at CHMP meetings as they prepare companies for these private, high-stakes interactions with EMA regulators. Their scientists and communications experts understand what it takes to overcome the unique challenges when communicating in these fast-paced, high-pressured, timebound meetings – whether face-to-face or virtual.
In this webinar, they will leverage their first-hand experience and share insights from former CHMP members and pharma executives who have been successful at these critical meetings.
3D’s Kate Dion will lead an expert panel discussion focused on how to leave a lasting impression when it’s needed most – during private CHMP deliberations that determine the fate of your application.
During this interactive session, the panelists will discuss how to:
- Navigate the regulatory and scientific challenges specific to EMA marketing authorization
- Overcome the challenges of an all-virtual CHMP meeting
- Develop an effective communications strategy
- Leverage technology to clearly present data
- Credibly answer tough questions
- Maximize a virtual environment
They will also share learnings from successful and unsuccessful CHMP regulatory meetings – both face-to-face and remote – sharing valuable insights on CHMP’s position and current thinking that can increase your chance of success.
Speakers
Diane Fiorenza, Vice President Global Regulatory Affairs, Insmed
Diane Fiorenza is the Vice President Global Regulatory Affairs at Insmed Incorporated, overseeing the Regulatory Affairs department that is responsible for the development and execution of all global regulatory strategies.
Diane is a knowledgeable regulatory professional with more than 30 years of regulatory affairs experience in leading and executing the regulatory affairs strategies, registrations, and post-approval activities for numerous approved products across several therapeutic areas with a specific focus on rare diseases. She has extensive experience in facilitating constructive interactions with various global regulatory agencies to ensure clearly defined regulatory paths leading to successful filings and approvals.
Achievements specific to innovative Regulatory programs that facilitate and expedite drug development include Breakthrough Therapy, Accelerated Approval, Orphan and Qualified Infectious Disease Product designations. Diane also led the regulatory strategy that resulted in the approval of the first drug under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs. Additional significant accomplishments include the successful approval and commercialization of combination drug-device products including GATTEX® and ARIKAYCE®.
Prior to joining Insmed, Diane held senior regulatory roles at NPS Pharmaceuticals Inc., IKARIA Inc., Johnson and Johnson and was instrumental in leading interactions with global regulators for the development of the regulatory strategies leading to the successful filing of marketing applications. Diane holds a Bachelor of Science degree in Chemistry, Foods and Nutrition from Douglass College, Rutgers University.
Message Presenter
Tanya Lewis, Executive Vice President, Chief of Regulatory Affairs and Strategic Operations, Karyopharm Therapeutics
Tanya Lewis is a pharmaceutical industry executive with greater than 20 years of experience in global drug development across a variety of therapeutic areas.
Ms. Lewis currently serves as the Executive Vice President, Chief Regulatory and Quality Officer at Karyopharm Therapeutics, a publicly traded biopharmaceutical company (Nasdaq: KPTI) where she navigated the approval of XPOVIO®. Prior to joining Karyopharm, Ms. Lewis held leadership positions at several companies, including Tesoro and Millennium, where she developed approval strategies and led interactions with U.S. and European regulators for clinical trial applications, marketing applications (including ODAC presentations) and drug labeling. Tanya’s past accomplishments include the successful negotiations for registration trial designs, approval, and/or commercialization of VELCADE®, VARUBI®, INTEGRILIN®, and ZEJULA®.
Tanya holds a Bachelor of Science degree in Biology from Northeastern University and a Master of Science degree in Regulatory Affairs and Public Health from Massachusetts College of Pharmacy and Allied Health Science.
Message Presenter
Kell Cannon, Scientific Lead, 3D Communications
Kell Cannon leverages 20 years of leadership at some of the world’s largest pharmaceutical companies along with over a decade of healthcare consulting experience to help clients achieve regulatory success and communicate product value. He has been instrumental in developing 3D Communications’ processes, tools and training which help clients prepare for regulatory submissions, key regulatory meetings at FDA and EMA and important meetings with payers.
Kell collaborates with clients to systematically identify the strengths and weaknesses in their data, consider the realities of their environment, and develop compelling messages that help companies differentiate their products. His knowledge and broad experience in regulatory affairs, science, marketing, and value communications provide the unique holistic approach that is essential in today’s competitive market.
Kell has held U.S. and international leadership positions at Roche, Novartis, Ciba and Merck in clinical development and trial strategy, branding and positioning, advocacy development, commercialization, and payer strategy. Kell has an MBA and a BS in Microbiology from Penn State University.
Message Presenter
Michelle Zucatti, Communications Lead, 3D Communications
Michelle Zucatti is a strategic communications lead who specializes in making scientific data relevant to both clinical and lay audiences. With her background in public health and passion for clear communications, she helps clients translate complex data into clear, memorable messages. Over the past 10 years, she has prepared 3D Communications’ clients for more than 50 FDA and EMA high-stakes regulatory meetings across therapeutic areas.
Michelle takes an evidence-based approach to communications and tailors proven methods to each presenter’s personal style. Her first conversation with pharma and healthcare professionals is always about the communications goal of the organization and how to bring it back to the patients. When developing
Message Presenter
Kate Dion, Executive Communications Coach, 3D Communications
Kate Dion is an executive communications coach with a specialty in value communications, Kate works closely with executives to cut through the noise and focus on smart communications strategies that maximize the impact of their narratives.
Before joining 3D, Kate had careers in both the pharmaceutical industry and as a Life Sciences reporter. Kate worked as a Reuters correspondent based in Zurich, where she covered the Swiss healthcare industry. She then moved to industry, working at F. Hoffmann-La Roche’s pharmaceutical division in Switzerland, where she held numerous positions in the Global and Regional Europe organizations, including the role of International Communications Lead for Pricing.
Message PresenterWho Should Attend?
- Senior level professionals working within Regulatory Affairs and Clinical Operations for pharma, medical device, and biologics companies
- Anyone preparing for interactions and regulatory meetings with CHMP/EMA
This includes team members from research, development, regulatory affairs, statistics, and communications including but not limited to:
- Chief Medical Officer
- VP, Clinical Development
- Director, Clinical Development Lead
- VP, Regulatory Affairs
- Director, Regulatory Affairs
What You Will Learn
In this webinar, you will learn about how to:
- Initiate proactive activities to prepare for a critical regulatory meeting;
- Prepare clear messages and credible data presentation to overcome major objections;
- Anticipate and understand the challenges with these private meetings – whether face-to-face or virtual;
- Learn what CHMP members need to hear and see to support a positive vote – after you leave the room; and
- Develop effective strategies that increase the likelihood of success at these meetings.
Xtalks Partner
3D Communications
3D Communications is the global leader in preparing Pharmaceutical, Biotech, and Medical Device companies for FDA and EMA regulatory meetings, including FDA Advisory Committee meetings and CHMP/SAG/Oral Explanations. We also specialize in preparing teams for launch and value communications, including market access negotiations. 3D’s team of 65 full-time colleagues specializes in all aspects of both virtual and live meeting preparation. Our team’s experience from hundreds of regulatory and commercial projects, our proven 3D ACT® process, and our state-of-the-art technology ensure our clients are prepared for the best possible outcome in the most challenging situations.
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