Contributors

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Host

Keith Parent

Keith Parent founded Court Square Group in January 1995 and has been the company’s CEO since inception. Under Keith’s leadership Court Square Group has built a reputation as an industry leader in the Life Sciences industry. With over 35 years of technology and leadership experience in the Life Science industry, Keith has a clear understanding of regulatory challenges and the Good System Practices (GSPs) required to maintain a Qualified state for the company’s clients.

Keith holds a Master of Science in Computer Science (MSCS) from Rensselaer Polytechnic Institute and a Bachelor of Science in Computer Science from Siena College. Keith has been involved in the implementation and maintenance of enterprise-level systems across the pre-clinical and clinical organizations of numerous Life Science clients. 

https://courtsquaregroup.com/leadership_team/keith-parent/
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Producer

Roy Strunin

Roy, the founder of BrandUp Strategy, is an innovative, strategic, results-driven marketing leader of Life Science solutions. Expertise in demand generation, account-based marketing, branding and positioning, social media, PR, and digital marketing. Effective leader of cross-functional teams. Passionate and energetic marketer with excellent analytical thinking, keen business acumen and attention to measurable results.

Skills
> Strategic Planning and Management
> Demand Generation and Nurturing
> Digital Marketing
> Team Development
> Branding and Positioning
> Marketing Analytics
> Customer Acquisition and Retention
> Social Media Engagement

https://www.linkedin.com/in/roystrunin/

Guests

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Arielle Smith

Arielle Smith serves as the President of Life Science at Event Cadence. Under her leadership, Event Cadence has attracted heavy-hitters such as Merck, AstraZeneca, Jazz Pharma, Sanofi, and more. Her primary role focuses on the expansion of both current and new clientele.

  

With 10+ years of expertise in the event tech space, Arielle was one of the founding members of Event Cadence and helped build the company’s industry-leading Professional Services team. Pulling from her experiences with Lampire Biological Laboratories and Jefferson Health, she is dedicated to providing the Healthcare industry with the best all-in-one industry solution for medical conferences, and a platform for optimizing the complete HCP journey.

https://www.linkedin.com/in/Ariellele-smith-965771a1/

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Betty Cory

Betty has over 30 years of proven success in the pharmaceutical industry.  This includes leading operational and strategic support of regulatory, quality and pharmacovigilance activities for big Pharma, generic firms, contract research organizations and consultants.  Betty is an excellent negotiator with a trusted reputation with key agency personnel. Her experience ranges from pre-clinical research and development through all clinical phases of study with direct experience with drug, biological and medical device development for international registration and pharmacovigilance. In 2007, Betty co-founded Regxia as a consulting firm focused on fostering long-term client relationships based on trust, reliability and common values.  

https://www.regxia.com/about#about-betty

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Bryan Reynolds

Mr. Reynolds has over 25 years of experience as a successful entrepreneur, senior executive and managing consultant with core competencies focused on enterprise content management, mobility, business process engineering, imaging, and records management. Currently, Mr. Reynolds is the Founder and CEO of Docxonomy. The breadth of his knowledge includes the architectural design and development as well as project management of numerous global, large-scale document/records management initiatives across multiple industries including pharmaceutical, biotechnology, medical devices, financial services, insurance, healthcare and public sector.

https://docxonomy.com/

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Catherine Lunardi

Catherine Lunardi, a seasoned expert with over 20 years in healthcare and life sciences consulting, founded GENAIZ in 2016. GENAIZ is headquartered in Montreal, Canada. Catherine's vision was to address the industry's challenges in data utilization and decision-making by creating an open, flexible platform that leverages artificial intelligence and concepts inspired by neuroscience

https://www.linkedin.com/in/catherine-lunardi-436276a/

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James Blackwell, Ph.D., MBA

Dr. Blackwell has been a prominent industry consultant for over seventeen years, working on a wide variety of CMC and quality issues for a broad range of companies, investors, and product types at all stages of the product life cycle.​

Prior to consulting, he held several senior positions in technical operations, manufacturing, and process development at prominent operating companies and has been on the founding team of several start-ups.​

Dr. Blackwell is trained as a scientist, engineer, and businessman. He received his Ph.D. in Chemical Engineering from Northeastern University. He received his dual M.B.A./M.S. in Technology Management from the University of Maryland, and graduated with B.S. Chemical Engineering and M.S. Microbiology degrees from The Ohio State University.​

https://windshire.com/leadership/

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Jim Kernan

Jim Kernan is a seasoned life-science professional with broad experience in quality and manufacturing operations. He has held senior executive and board level roles in a number of multi-national and SME companies. He combines a collaborative style with an in-depth knowledge of the manufacturing and quality functions. Results driven, with an entrepreneurial spirit and an ability to quickly focus on key issues Jim is comfortable operating at both operational and strategic levels. He is the owner and Chief Executive Officer of PRONAV Clinical Limited, which provides Early Phase Clinical Trial Supply Solutions including EU Site of Importation, QP Release, Labelling, Packing, Kitting, Comparator Sourcing, Depot and Distribution services. 

https://www.linkedin.com/in/jim-kernan-7734816/

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Kalyan Obalampalli

Kalyan Obalampalli is a disruptor and technology innovator with over 20 years of experience in Clinical Operations and Outsourcing. With a unique perspective from advisory roles in Silicon Valley, he bridges clinical development and technology to address industry challenges. As the Founder and President of Clin.AI, Kalyan is revolutionizing vendor selection and management by developing user-friendly solutions to create, send, and receive proposals for clinical trial vendors, using AI-based analytics to compare vendors and manage clinical trial finances.

https://www.linkedin.com/in/kalyano/

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Kevin J. Bittorf, PhD, MBA, PEng

Kevin J. Bittorf is a seasoned executive and consultant specializing in pharmaceutical development, technical innovation, and regulatory strategy. With extensive experience in GMP compliance, business development, contract manufacturing, and long-term strategy, Kevin collaborates with CEOs and executives to drive pharmaceutical advancements by evaluating strategic approaches, securing regulatory approvals, and implementing emerging technologies that improve the drug development lifecycle.
As the Founder of SCxCMC, Kevin provides expert consulting to small and medium-sized pharmaceutical and biotechnology companies, focusing on pharmaceutical development, process chemistry, formulation, regulatory affairs, quality assurance, supply chain, and packaging. His work ensures that companies efficiently navigate CMC challenges, optimize manufacturing strategies, and successfully transition from early development to commercialization.

https://www.linkedin.com/in/bittorf/

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Kimberly Guedes, RN, BSN, MBA

Kimberly (Kim) Guedes is an executive clinical development and operations leader with 30 years of experience, spanning pre-clinical, Phase I-IV trials, translational research, and multiple drug development disciplines.

Kim has a wide range of experience in new product development, process improvement initiatives, portfolio and corporate integrations. 

In her various roles, Kim has demonstrated global regulatory and quality product development leadership. She has been responsible for product portfolios timelines, and budgets, as well as implementing policies, processes, and tools needed to optimize project execution. 

Kim is an active member of the Alzheimer's Executive Leadership Committee for the Ride to End Alz. She holds an MBA from The University of Dayton, and an RN, BSN in Nursing from Salve Regina University. Kim was awarded the Carolyn E. Green Scholarship for leadership opportunities for women in the life sciences industry.

https://www.linkedin.com/in/kimberlyguedes

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Sam Ali

Sam Ali is the Co-Founder of Precision Evolution Global, a leading life sciences events company headquartered in Toronto and Fort Lauderdale. Precision Evolution Global produces a dynamic portfolio of summits across Clinical Research, Drug Discovery, Medical Devices, and Pharma Supply Chain. Under Sam's leadership, the company specializes in high-value networking through curated one-to-one meetings, qualified exhibitor engagements, and targeted lead generation for the life sciences industry. In the past, Sam has been a consultant for other event planners and biopharma solution providers - giving him knowledge from an attendee and organizer viewpoints.

https://www.linkedin.com/in/sam-ali-5341b8168/

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Samantha Trotman Burman

Samantha’s background combines experience in investment banking and private equity with a dedication to advocating for and advancing the quality of care, particularly in mental health. She has been offering a blend of empathy, support, and resources to parents and caregivers for more than a decade, establishing the Isleworth Group to provide professional peer-to-peer support to families with social and emotional challenges.

 

In 2024, Samantha founded StoryCatch Partners, a Public Benefit Corporation committed to improving global health & wellbeing through experience-informed, tech-enabled support, resources and connection.

 

Samantha holds a BA and MEng from Cambridge University, UK and an MBA from Harvard University. Born in the UK, Samantha resides in Massachusetts with her four children.

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Sara Tylosky

Sara Tylosky, MBA, CEO at Farmacon Global, brings over 20 years of experience leading teams in both large and small pharmaceutical and biotech environments. She has led Farmacon Global, a strategic CRO of medical consultants, in accelerating clinical trials, increasing diversity, supporting enrollment, and paving the way to market access in emerging markets.

Known for her high cultural intelligence and problem-solving skills, Sara and her team specialize in Rare Diseases, Immunology, Infectious Diseases, Cancer, and Vaccines. Fluent in Spanish and having lived on four continents, she has a special focus on Latin America while actively expanding into other key markets globally. Sara’s direction plays a pivotal role in steering Farmacon Global toward healthcare innovation and global market leadership.

https://www.linkedin.com/in/stylosky/

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Shelley Amster

Shelley Amster, Founder and Principal, ShelleyCO, LLC, is a connector and relationship catalyst. Shelley nurtures healthy business and scientific relationships, uncovers new opportunities, and provides business development resources for her clients. With a large Rolodex of strong relationships from the healthcare and life science industries, Shelley has an extensive track record bringing leaders in industry, academia, government, the investment community, and (non) profit organizations together – locally, nationally, and globally. Shelley’s clients range from women’s health companies to academic and trade organizations.  

Prior to founding ShelleyCO, Shelley was a pioneer in the infertility/IVF industry. Besides being one of the first IVF lab directors in the US, Shelley helped commercialize products and services in that industry. 

https://www.linkedin.com/in/shelleyamster/

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