Khelan Patel Msc, PgCertIP / LLM, MTOPRA
Managing Director
Khelan has over 19 years of experience in the life science industry, supporting transactions and executing strategy and technical consulting engagements across numerous therapeutic areas. Khelan has supported sell and buy side opportunities totaling over 200 million in deal value and has executed over >100 consulting engagements.
Areas of particularly deep expertise include neuroscience, biologics, call and gene therapy (rare disease), specialty pharmaceuticals, evergreening strategies to improve enterprise value, and launch readiness in emerging markets.
Khelan commands strong diplomatic skills and a natural affinity for cultivating relationships and persuading, convening, facilitating, and building consensus among diverse individuals.
Prior to the private equity merger between Tower Brook Capital Partners L.P. and ICS (Independent Clinical Services), which created the Acacium Group, Khelan was a founding team member of Proclinical’s Consulting division and has worked for both NASDAQ and NYSE listed leading Clinical Research Organisations (CRO’s); Covance Laboratories and PAREXEL Consulting.
In his free time Khelan is an accomplished diver, and has successfully dived at several key oceanic sites, most recently with Giant Manta Rays of the coast of Komodo Island, in Indonesia. Khelan has a B.Sc. in Genetics, a M.Sc. in Biotechnology from University of Wisconsin -Madison and a Postgraduate Certificate in Intellectual Property Law from Bournemouth University.
Publications on: https://www.linkedin.com/in/khelanpatel-tbs/
Patent Pending: Named Inventor for Monoclonal antibody in current development: UK patent application: No.:2204813.6. submitted April 2022
OVERVIEW
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Over 19 years of experience in the Biopharmaceutical Arena​ Broad General Commercial and Strategic Regulatory experience across the GxP’s in the preparation of high-quality submissions to regulatory agencies for clinical trial and marketing approval across multiple markets​
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Proven record of team leadership, project oversight and problem solving​
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Regulatory compliance and Quality Assurance - Product Recalls and CAPA
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Provide non-clinical expertise for IND/CTA enabling toxicology studies; specifically on ICH S7A and S7B (Safety pharmacology)​
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Managing global complex Pivotal Phase III Studies​
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Supporting supply chain rationalization and scale up activities​
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Hands on experience with Life Cycle Management and Evergreening activities for diverse portfolio including line extensions, CMC maintenance activities, technology transfers (site transfers) and labelling changes​
EXPERIENCE PROFILE
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Founder Proclinical Consulting and CEO of Trident BioPharm Solutions
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Regulatory Manager – Covance Laboratories Inc​
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Programme Leadership & Portfolio Management – Parexel Consulting​
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Regulatory SME – Amdipharm (AmCo), Teva, Actavis, Watson/Allergan​
EDUCATION AND TRAINING
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PgCert/LLM in Intellectual Property Law – Bournemouth University, UK​
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MSc in Biotechnology – University of Wisconsin-Madison, USA​
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BSc in Genetics – University of Wisconsin-Madison, USA​
Let's Work Together