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/

Guests

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Guest

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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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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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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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/