3D COMMUNICATIONS - Key Persons
Agnes is an avid supporter of science education for children, volunteering and holding scientific demonstrations for students in kindergarten through junior high school. She is an active volunteer leader of the UC Davis alumni group supporting environmental restoration efforts and women in STEM fields. In her spare time, she enjoys reading, traveling, and spending time with family and friends.
Agnes is an experienced medical writer with a strong background in biomedical research and clinical trial publications. She is recognized for her ability to understand and effectively communicate complex scientific results and their clinical application, in a clear and precise manner. Her research has spanned multiple clinical areas - with a focus on oncology and autoimmunity.
Job Titles:
- Key Member
- Key Member of 3D
Alicia is a key member of 3D Communications' operations team, bringing 25 years of accounting experience to her role. She is recognized for her expertise in planning and operations, as well as her attention to detail and commitment to quality.
Allison is an award-winning communicator, specializing in providing strategic communications, content development, and coaching services to clients engaged across the healthcare spectrum - whether working on regulatory, commercial, patient engagement, or public affairs programs.
Amanda is an experienced graphic designer and project manager celebrated for her dual expertise in visual communication and strategic thinking.
A skilled physician who brings her experience in clinical medicine to 3D Communications' clients, Amy is known for her ability to help clients interpret and communicate the true meaning behind the science.
Amy brings more than 25 years of experience building and leading corporate communications teams, creating communications strategies, and advising C-suite and other executives to develop and deliver impactful messages.
Amy focuses on helping clients truly understand what their regulatory audiences need and want to hear so they can anticipate questions and concerns to pre-empt review issues and achieve their objectives. She has demonstrated success with submission strategy and writing, FDA meeting preparation, Advisory Committee and Panel meetings, and developing and executing global regulatory strategies. Amy utilizes her abilities to translate complex scientific and clinical data into clear messages, taking into consideration the broader regulatory landscape.
Background
Amy has more than 15 years of experience in global regulatory affairs and has held regulatory leadership positions at Allergan, Alcon, and BVI Medical, spanning a wide range of therapeutic areas. She specializes in clinical and regulatory strategy - helping companies work with regulators to get products approved for patients in need. Amy received a Bachelors of Science degree in Chemical Engineering from the University of Washington and a PhD in Chemical Engineering from the University of California at Santa Barbara.
Amy Tezel, PhD leverages a powerful combination of scientific, regulatory, and communications expertise to help clients achieve success in their highest stakes regulatory interactions.
Bernd brings his expertise as a business coach for multinational organizations, and experience in human resources management and personnel development to his communications consulting work.
As a medical doctor with three decades of experience in the pharmaceutical industry, Bert is an invaluable resource for the 3D Communications team and provides in-depth scientific knowledge. He is known for his sharp strategic mind and thorough understanding of data.
Bruce Burlington, MD, is an infectious disease internist and currently serves as the industry representative on the FDA's Drug Safety and Risk Management Advisory Committee. Dr. Burlington held senior management positions at the FDA and in the pharmaceutical industry. He now advises companies on drug development, risk management strategies, and preparation for key FDA meetings.
Cara's 20 years of healthcare and pharmaceutical industry experience brings 3D Communications' clients valuable insights into a broad range of communications. Her ability to quickly size up a situation, analyze the complex stakeholder environment, understand the science, and decipher what messages will make a difference, helps transform executives into master communicators - and companies into trusted partners.
Job Titles:
- Founder and President of Poland
Caroline Poland is the Founder and President of Poland and Associates Consulting. She is a Licensed Mental Health Counselor, a Licensed Clinical Addictions Counselor, a Certified Clinical Trauma Professional, a Certified Compassion Fatigue Professional, and a Nationally Certified Counselor. She is also certified in EMDR therapy, a form of therapy designed for those who experience distress around traumatic memories and Post Traumatic Stress Disorder. Ms. Poland is the creator of the Preferred Cognitive Styles and Decision-Making Model, which was first discussed in a 2011 article published in Vaccine. This model outlines a series of cognitive styles that individuals employ in decision making, and outlines communication strategies that the health care provider can use to communicate effectively with that patient to create behavior change - in particular in regard to vaccine acceptance.
Caroline is the Founder and President of Poland and Associates Consulting. She is a Licensed Mental Health Counselor, a Licensed Clinical Addictions Counselor, a Certified Clinical Trauma Professional, a Certified Compassion Fatigue Professional, and a Nationally Certified Counselor.
Cat is an experienced communications professional who has prepared companies across a wide range of therapeutic areas for more than 40 FDA Advisory Committee meetings and other regulatory interactions. She combines her background as an academic writer, researcher, and lecturer with her understanding of science to develop clear, concise, and relevant messages that align across deliverables - ensuring an effective communication strategy for every interaction.
Catherine goes beyond just understanding a client's data - to focus on why the data are meaningful. She then transforms it into a clear and logical narrative. Catherine's understanding of the principles of good aural and visual communication helps her create credible and memorable messages, support them with data, and develop a compelling presentation.
Background
Catherine began her career as a neuroscientist, performing experiments to better understand how connections are made between parts of the developing brain. Realizing she preferred explaining science to doing it, she transitioned to teaching graduate students and postdocs at Johns Hopkins Medicine to communicate their research clearly and effectively. After further honing her communication skills as Associate Director of the Wharton Communications Program at the University of Pennsylvania. Returning to her science background, she spent a brief stint supporting the Specialty R&D Clinical Pharmacology team at Teva Pharmaceuticals. She holds a bachelor's degree in Neuroscience from the University of Virginia and a PhD in Neurobiology from Duke University.
Catherine combines her research background in neuroscience and understanding of how the brain processes information, with her teaching experience to post-doc science students, to help clients prepare clear and meaningful presentations to FDA and EMA - and answer their most challenging questions.
Chris is an avid supporter of Doctors Without Borders and 3D's nonprofit, Get Stuff Done 4 Kids. In his spare time, he enjoys walking his dog around one of Minnesota's 10,000 lakes, reading, attending concerts, trying new restaurants, and traveling.
Chris is a skilled biostatistician who brings his experience in the design, analysis, and interpretation of clinical trials to 3D Communications' clients. He leverages his statistical expertise with excellent communications and medical writing skills to integrate complex data with key messages in sponsors' regulatory submission documents and during regulatory meetings.
Cindy has built a reputation as a leading healthcare communications consultant by working with top executives at some of the world's largest companies. Her strength is helping companies translate complex scientific and health economics information into interesting and relevant messages - and then coaching executives to deliver that information clearly and confidently in the face of objections.
Cory is an avid supporter of 3D's nonprofit, Get Stuff Done 4 Kids. When he isn't working, he enjoys spending time with his family and friends and training in martial arts as a brown belt in Brazilian jiujitsu.
Cory is an experienced project manager known for his work ethic and ability to deliver for clients under pressure. He has supported more than 30 FDA Advisory Committee meetings and interactions with regulators.
Job Titles:
- Professor of Cardiology at the University of Texas Southwestern
Darren McGuire, MD is a Professor of Cardiology at the University of Texas Southwestern. Since the COVID outbreak, Dr. McGuire has been involved in conducting randomized controlled trials for COVID anti-viral therapies and has been on the front-line of treating COVID patients at Parkland Hospital in Dallas. Dr. McGuire is also the Deputy Editor of the Journal Circulation, which has reviewed more than 2,000 submissions related to COVID-19.
Job Titles:
- Member of the American Gastroenterological Association
Debra has been an active member of the American Gastroenterological Association, participating on many of their committees. In her free time, she enjoys traveling and reading as well as multiple outdoor activities including biking, sailing, and kayaking while spending time with her husband and two adult children.
Debra is an experienced Gastro-Intestinal (GI) physician and a clinical development and regulatory expert who has held global positions at several major pharmaceutical companies. As the former Global Vice President and Head of Clinical Science/Development for GI at Takeda/Shire, Debra provided leadership, oversight, and expertise to program teams in Clinical Development and lead discussions with FDA and EMA regulatory authorities to advance programs in a wide range of GI therapeutic areas.
Drew is a productions specialist who supports clients by helping them maximize technology to present and communicate with confidence in high-stakes engagements. Drew is recognized for his client-focused and strategic approach to productions.
Drew is an avid supporter of Karen Beasley Sea Turtle Rescue and Rehabilitation Center and Share the Table Food Pantry. When he isn't working, he enjoys traveling the world and exercising.
"I'm passionate about giving patients, healthcare professionals, and communities a seat at the table and a feeling of empowerment in decisions affecting healthcare and access to life-changing products. For more than a decade, I have seen the positive impact these voices have on the FDA's understanding and decision-making."
Eileen brings more than 20 years of experience as a communications and advocacy specialist to clients in the pharmaceutical, medical device, and public health arenas. She works with 3D Communications' clients to engage with professional and patient groups and leverage that support throughout the product life cycle, including FDA Advisory Committee meetings and grassroots disease-education programs.
Job Titles:
- Director of the Center for Clinical Pharmacology
Eric Brass is director of the Center for Clinical Pharmacology at Harbor-UCLA Medical Center and professor of medicine at the David Geffen School of Medicine at UCLA. Dr. Brass has been a chair and voting member on numerous FDA Advisory Committees since 1995 and continues to serve as a periodic consultant to the FDA.
Eric brings a unique perspective to 3D clients from his more than 15 years in virtually every function of the pharmaceutical industry - from R&D and regulatory affairs to medical affairs, market access, and product launch and commercialization. He leverages this rich experience to help clients develop clear, credible, scientific communications designed to achieve regulatory, market access, and commercial success.
Eva serves as a project manager on communications excellence programs and leads program logistics and client relations for 3D Executive Communications. Eva draws on her experience of preparing companies for high-stakes communications, including FDA and EMA regulatory meetings. She is recognized for her attention to detail, performance under pressure, and ability to help clients communicate in their unique voice through the spoken word and compelling visuals.
George is an experienced production specialist on 3D Communications' technology team. He is known for being solutions oriented and delivering under pressure for clients.
Gregory Poland, MD is a Professor of Medicine and Director of the Vaccine Research Group at the Mayo Clinic. He focuses on "vaccinomics", a coin he coined to refer to the development of personalized vaccines based on the increased understanding of immune response phenotype-genotype information. He aims to explain how vaccine-induced immune responses and vaccine-related adverse events may be genetically determined.
Gregory Burkhart, MD, is a regulatory consultant who was a former team leader and epidemiologist at the FDA. Dr. Burkhart has significant FDA and industry experience in both pre-marketing and post-marketing drug development.
Job Titles:
- Director of Outreach and Advocacy for 3D
Heidi is director of outreach and advocacy for 3D's nonprofit, Get Stuff Done 4 Kids. She also supports World Vision and ChildFund International through sponsorships for children and families in extreme poverty around the globe. She serves as a GriefShare leader for women who have lost loved ones, and actively supports Hope for Heroes Foundation and Franklin County Veterans Services. When she is not busy working or volunteering, she enjoys hiking, kayaking, reading, painting, and being part of the movement to make all homes safe and chemical-free.
Heidi has built a reputation for honesty and commitment to the goals of 3D Communications, clients and patients alike. She brings her heart of care and compassion for people in need to the research, sales, and advocacy fields of 3D. Her organized integrity assists her in creating the best possible outcomes for all around her.
Hilary's design work starts by looking beyond the obvious to ensure that her visuals are delivering against a client's communications goal.
Job Titles:
- Senior FDA Productions Engineer
Ian is an avid outdoorsman and off-road enthusiast. When not assisting clients, he enjoys heading out into the woods and onto the trails for never-ending adventure. He supports many organizations, including Ducks Unlimited, Delta Waterfowl, Quality Deer Management Association, Coastal Conservation Association, Rocky Mountain Elk Foundation, National Wild Turkey Foundation, Road to Recovery, and The Kurt Caselli Foundation.
As an experienced senior FDA productions engineer, Ian has assisted more than 100 companies as they prepare for FDA Advisory Committee meetings. He is recognized for his fast and furious yet calculated approach to supporting the front stage, his dependability, and his focus on proper practice.
With over 25 years of experience, Jack's extensive knowledge in the latest video, post-production, and online tools allows 3D Communications to offer clients a variety of video and online training tools for both internal teams and external outreach.
As a highly skilled speaker, coach, and communications strategist, Jerry has over 35 years of experience in the art and science of effective communication. He has worked with CEOs, new management, and sales in a wide variety of industries to ensure people communicate with authenticity, conviction, and the motivating persuasiveness needed to accomplish their goals.
Jim uses his vast experience designing and developing robust IT platforms for entrepreneurial companies to create systems that assist clients across all phases of Advisory Committee preparation.
Jodi is a supporter of BackPack Buddies and 3D's nonprofit, Get Stuff Done 4 Kids. She is also a member of Meeting Professionals International. In her spare time, she enjoys family time, remodeling, decorating, and playing and watching sports.
Jodi brings more than a decade of meeting planning and conference experience to 3D Communications' clients - having planned investigator meetings and scientific conferences around the world for thousands of doctors and scientists.
John Pottage Jr, MD is a Non-Executive Director and Chair of the Development Committee for Spero Therapeutics, a biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections. His interests and expertise include infectious diseases, HIV medicine, research and development, good clinical practice, safety and pharmacovigilance, and regulatory affairs.
Justin uses his background in electrical infrastructure and live music production to provide clients with seamlessly supported prep and Advisory Committee meetings as a production specialist.
Jürgen has spent more than 20 years in the life sciences industry providing clients with implementable commercial, pricing, reimbursement, and market access strategies and tactics. He helps clients develop their market access strategies and then translate them into commercial strategies. Jürgen's broad experience and deep understanding of the payer, thought leader, policy, and regulatory environment in markets throughout the EU, allow him to work at a strategic and tactical level, helping clients from dossier preparation through submission. Jürgen has advised large and small biotech, pharma and generic companies seeking to expand or defend existing markets and geographies. His indication experience includes oncology, hematology, vaccines, respiratory, rheumatology, neurology, endocrinology, and women's health, as well as significant orphan drug experience. Prior to working in industry, he spent five years conducting bench research in neuroendocrinology.
Jürgen Reiher has spent more than 20 years in the life sciences industry providing clients with implementable commercial, pricing, reimbursement and market access strategies and tactics.
Based in Europe, Kate has built a strong foundation working with pharma executives and industry thought leaders to engage more effectively with key audiences both internal and external, from employees and upper management to policymakers, payers, and the media. A former reporter and Fortune 500 communications executive, she has valuable insights into how the pharma industry and media work.
As an experienced researcher, Katie is responsible for profiling former and current Advisory Committee members, as well as tracking all Advisory Committee meetings.
As a senior project manager, Katina has extensive experience organizing and managing teams as they prepare for FDA Advisory Committee and EMA meetings. She is recognized for her technical expertise, open communication, and ability to distill complicated science into clear, simple concepts.
Kell leverages 20 years of leadership at some of the world's largest pharmaceutical companies along with a decade of healthcare consulting experience to help clients achieve regulatory success and communicate product value.
Kimberly founded Kid Risk, Inc. as a non-profit to develop the field of pediatric risk analysis. She is considered a world leader in risk analysis and decision science, health policy, global health, and system dynamics.
Kristina takes a client-centered approach. She leverages her attention to detail and communication skills to optimize clients' experience when preparing for Advisory Committee meetings.
Lara is an experienced medical writer who uses her academic research background and strong technical writing skills to prepare regulatory documents - primarily FDA Advisory Committee briefing documents - for 3D Communications' clients.
As an Operations Associate at 3D Communications, Lauren reports to the Chief Operating Officer and General Counsel to support daily operations as well as manage project staffing, budgets, and company contracts.
An experienced regulatory affairs professional and medical writer with a strong background rooted in science and research, Lee is recognized for her ability to process and summarize complex information, which allows her to effectively communicate key elements of each product in concise, easily understood briefing documents.
Lee is a respected strategic and crisis communications expert with a specialty in coaching C-suite executives.
Lesley is an experienced project coordinator with a strong clinical laboratory background. She is proficient in both technical and communication skills - with a sharp eye towards continually improving the process in every project.
As a project manager at 3D Communications, Lindsay helps pharmaceutical and medical device sponsors prepare for FDA Advisory Committee meetings.
Job Titles:
- Communications Consultant
Loren is a communications consultant who specializes in regulatory affairs and helping pharmaceutical, biologic, and device sponsors with FDA Advisory Committee meeting preparation.
Job Titles:
- Professor of Neurosciences at the Mayo Clinic
Thomas is the Eugene and Marcia Applebaum Professor of Neurosciences at the Mayo Clinic.
As a marketing and business development specialist, Maria leverages her rich background in media, healthcare, and marketing to ensure that 3D positions itself in the marketplace in a way that is consistent with its mission and vision - a global leader who clients trust with their most important, highest-stakes communications.
Job Titles:
- Certified Executive Coach
Marie-Claude is a certified executive coach and facilitator with decades of communications experience in healthcare, academia, consumer products, and luxury goods.
Mark uses his expertise in communications and graphic design - and his vast experience in preparing clients for high-stakes meetings - to help 3D clients develop compelling presentations.
Mark brings nearly two decades of healthcare IT, management, and logistics experience to 3D Communications' team and clients.
Job Titles:
- Director of the Center for Intervention Vascular Therapy
Martin is the director of the Center for Intervention Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital.
Job Titles:
- Strategic Communications Lead
Michelle is a strategic communications lead who specializes in making scientific data relevant to both clinical and lay audiences.
As an experienced project manager, Mike has channeled his expertise in communications, business administration, and education to prepare more than 75 clients for high-stakes global and regional meetings and milestone communications and executive communications programs for leaders and customer-facing teams.
Mimi brings nearly 20 years of experience in communications to her work with clients, with particular expertise in working with third-party groups and advocates.
Job Titles:
- Medical Director and Principal Investigator of Clinical Research for the Minnesota Lung Center
Mitchell is medical director and principal investigator of clinical research for the Minnesota Lung Center. He has been an investigator for more than 50 clinical trials in the areas of COPD, asthma, idiopathic pulmonary fibrosis, sarcoidosis, hypertension, rhinovirus, and narcolepsy.
Job Titles:
- 3D Communications' Chief Operating Officer and General Counsel
As 3D Communications' chief operating officer and general counsel, Nate develops and oversees all service proposals, manages project staffing and budgets, and negotiates and maintains company contracts.
Paul is a regulatory consultant, and previously worked as an FDA medical reviewer and special consulting reviewer, responsible for assessing new drug applications and investigational drug applications.
For nearly two decades, Penny has coached executives in complex industries like healthcare, technology, and defense to communicate as leaders in urgent, high-pressure environments.
Rachael is an accomplished scientific lead with many years of experience at 3D Communications, helping clients successfully prepare for FDA regulatory submissions, interactions, and Advisory Committee meetings.
Job Titles:
- Partner at Consilium Salmonson & Hemmings
Robert is a Partner at Consilium Salmonson & Hemmings. He was the Head of Statistics and Pharmacokinetics, Licensing Division at the Medicines and Healthcare Products Regulatory Agency in the United Kingdom.
Roger is a pharmaceutical strategy consultant at 1.618 Consulting LLC, and was also involved in numerous FDA Advisory Committee meetings as a presenter and team lead.
Ryan brings over seven years of experience producing and providing technology support for more than 75 regulatory meetings at the CDER and CDRH divisions.
Sam leverages his experience as a medical writer, corporate communications strategist, and newspaper journalist to distill complex data into focused narratives that support specific business and regulatory objectives.
Sanjay Kaul is a Cardiologist at Cedars-Sinai Medical Center in Los Angeles, California, and Professor of Medicine at the David Geffen School of Medicine at UCLA.
Scott is a seasoned professional who uses his 20 years of experience in FDA and EMA regulatory preparation, marketing, and business development to cultivate strategic partnerships for 3D Communications.
Semele is a seasoned finance professional who brings more than 25 years of experience in accounting to 3D Communications' clients.
Job Titles:
- Healthcare and Communication Strategist
Shannan is an experienced healthcare and communication strategist, recognized for her detail-oriented nature and understanding of how to tailor specific messages.
Shaunna plays a critical role in planning and preparing for Advisory Committee and CHMP meetings.
Shoshana supports the team that develops and maintains 3D databases, such as KOLLEAD and International KOLLEAD, and helps to produce ADCOM RADAR and other reports for clients. Her responsibilities include research, data entry, transcript review, formatting, copy editing, and writing.
Shruthi combines her knowledge of FDA Advisory Committee meetings with first-rate research skills to provide sponsors with the most relevant information for their regulatory meeting preparation.
Stephanie is an experienced senior manager, assisting clients across all phases of Advisory Committee preparation.
Susan brings over 25 years of experience in clinical research, medical device technology, and regulatory strategy to 3D Communications' clients.
Job Titles:
- Senior Production Specialist
Tedd is a senior production specialist and leads technology coordination for 3D Communications' team supporting EMA activities.
Todd is a production specialist who leverages applied technology to help clients communicate with confidence during high-stakes meetings, presentations, and negotiations. He is recognized for his client-focused approach and get-it-done attitude.
Job Titles:
- Partner at Consilium Salmonson & Hemmings
Tomas is a Partner at Consilium Salmonson & Hemmings in Uppsala, Sweden. He was the Senior Scientific Advisor of Medical Products Agency in Sweden until 2019 as well as the Chair of the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMA) until 2018.
Virginia has spent more than 25 years in healthcare communications, including at the highest levels of government.