Maximiliano Kunze Küllmer
Associate Director, Business Development & Corporate Strategy at Cells for Cells S.A.- Claim this Profile
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Bio
Experience
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Cells for Cells
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Chile
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Biotechnology Research
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1 - 100 Employee
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Associate Director, Business Development & Corporate Strategy
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Oct 2021 - Present
Santiago Metropolitan Area • Directed C4C’s internationalization and legal restructuring strategies, creating US-based start-up company (C4C subsidiary) developing targeted treatments based on a proprietary vehicle-therapy exosome technology platform. • Accelerated IND submission process and clinical trial initiation of exosome technology platform by managing CRO and CDMO selection and negotiation process based on a self-developed Technical-Financial evaluation method. • Secured 5.2 million USD from investors after… Show more • Directed C4C’s internationalization and legal restructuring strategies, creating US-based start-up company (C4C subsidiary) developing targeted treatments based on a proprietary vehicle-therapy exosome technology platform. • Accelerated IND submission process and clinical trial initiation of exosome technology platform by managing CRO and CDMO selection and negotiation process based on a self-developed Technical-Financial evaluation method. • Secured 5.2 million USD from investors after presenting portfolio valuation report, extending runway by four years. Executed market research and collaborated with consultants to formulate tailored financial valuation models for each technology. • Collaborated with company leadership (founders and C-level executive colleagues) in writing grant application, securing 15.7- million-USD to create IMPACT, LatAm’s first center of excellence for translating advanced therapies (https://centerimpact.cl) • Leveraged my entrepreneurial skills, taking the initiative to ideate project harnessing milk-derived exosomes’ potential as nutraceuticals which enabled IMPACT’s first co-development agreement.
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Lead Biomedical Project Engineer
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Sep 2019 - Oct 2021
Santiago Metropolitan Area • Managed a cross-functional team through the COVID-19 pandemic in the product development of three tissue engineering technologies, monitoring and advancing them from discovery phase to proof-of-concept studies in large animals and materializing those results into two patent filings. • Spearheaded the identification and pursuit of national and international grant opportunities, obtaining four grants in two challenging years, which enabled the validation of technologies and the successful… Show more • Managed a cross-functional team through the COVID-19 pandemic in the product development of three tissue engineering technologies, monitoring and advancing them from discovery phase to proof-of-concept studies in large animals and materializing those results into two patent filings. • Spearheaded the identification and pursuit of national and international grant opportunities, obtaining four grants in two challenging years, which enabled the validation of technologies and the successful expansion of their applications. • Directed R&D strategy, regulatory strategy, manufacturing strategy, and market access strategy for an early-stage cardiovascular Type III medical device, obtaining the 2020 Chilean National Innovation Award (Avonni), securing IP rights in the US and the EU and demonstrating superior in vivo performance of the product over FDA-approved competitors.
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ISCT, International Society for Cell & Gene Therapy
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Canada
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Biotechnology Research
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1 - 100 Employee
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Business Development & Finance (BDF) Committee Member
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Feb 2021 - Present
Global • Led research and authored paper on Cell & Gene Therapy (CGT) investment by surveying 110 Life Sciences Private Equity and Venture Capital investors, exposing top drivers for CGT ventures investment and essential factors to consider when fundraising. • Participate in monthly executive meetings and provide insight to develop tailored content for biotech investors and investigators, presented as workshops and roundtables at ISCT Annual Meetings… Show more • Led research and authored paper on Cell & Gene Therapy (CGT) investment by surveying 110 Life Sciences Private Equity and Venture Capital investors, exposing top drivers for CGT ventures investment and essential factors to consider when fundraising. • Participate in monthly executive meetings and provide insight to develop tailored content for biotech investors and investigators, presented as workshops and roundtables at ISCT Annual Meetings and webinars. Some topics included Allogeneic manufacturing due diligence, Viral and non-viral vectors for drug and gene delivery, Decentralized manufacturing of autologous therapies, etc. Show less
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Alliance for Regenerative Medicine
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United States
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Biotechnology Research
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1 - 100 Employee
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Intern, Science & Technology
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May 2019 - Aug 2019
Washington D.C. Metro Area • Evaluated Cell & Gene Therapy FDA and EMA guidelines for timely patient access to Advanced Therapy Medicinal Products, disclosing impacts of expedited approval pathways on developers’ manufacturing strategies. • Oversaw the initial progress of A-Gene, contributing to first comprehensive industry book of knowledge for new developers on application of Quality by Design principles during manufacture of gene therapies and gene vectors. • Working hand-in-hand with leadership,… Show more • Evaluated Cell & Gene Therapy FDA and EMA guidelines for timely patient access to Advanced Therapy Medicinal Products, disclosing impacts of expedited approval pathways on developers’ manufacturing strategies. • Oversaw the initial progress of A-Gene, contributing to first comprehensive industry book of knowledge for new developers on application of Quality by Design principles during manufacture of gene therapies and gene vectors. • Working hand-in-hand with leadership, drafted industry’s Statement of Principles on the use of gene editing in the wake of CRISPR- baby scandal in China, publishing first international bioethical framework for the safe and effective application of these therapeutics. Key events: – ARM-USP CMC Workshop on Comparability – 2019 BIO International Convention in Philadelphia, PA Show less
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Duke University
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United States
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Higher Education
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700 & Above Employee
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Graduate Teaching Assistant for Biomedical Product Development
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Dec 2018 - May 2019
Durham, North Carolina, United States TA of MD and Professor Peter C. Johnson in the course of Biomedical Product Development. • Guided functional groups co-developing a theoretical Class II medical device in adherence to Stage-Gate Product Development Process (overseeing Design and Gate Reviews for clearance through 510(k) Pathway) • Developed and maintained Document Management System (complying with QSR (FDA 21 CFR Part 820) and cGMP)
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Pontificia Universidad Católica de Chile
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Higher Education
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700 & Above Employee
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Graduate Research Assistant
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May 2018 - Jul 2018
Santiago Metropolitan Area Ph.D. and Professor Loreto Valenzuela's Biomaterials Lab • Constructed and characterized co-polymeric scaffolds that induced skeletal muscle regeneration and growth when combined with precursors of muscle cells and electrical stimuli
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Pontificia Universidad Católica de Chile
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Higher Education
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700 & Above Employee
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Delegate and Captain of the Track & Field Team
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Mar 2015 - Jul 2017
Santiago Metropolitan Area • Participated in meetings with authorities to propose the construction of a 1000-seats stadium for Track & Field • Created a motivated team by organizing invitationals, generating belonging with our institution, building the fan base, and increasing the number of athletes. Became their voice and directed their concerns • Led the male T&F team to finish second in the nation for two consecutive years
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Teaching Assistant for Biomaterials
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Mar 2016 - Jul 2016
Santiago Metropolitan Area TA of Ph.D. and Professor José Tomás Egaña in the course of Biomaterials.
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Promedon
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Argentina
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Medical Device
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200 - 300 Employee
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Intern
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Jan 2016 - Jan 2016
Santiago Metropolitan Area
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Federación de Estudiantes de la Universidad Católica
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Chile
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Political Organizations
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1 - 100 Employee
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Director of the Student Union’s Sports Committee
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Mar 2015 - Dec 2015
Santiago Metropolitan Area • Advocated for improvement of conditions to practice sports in the San Joaquín Campus • Managed sponsor relationships and reach out, leading financial commitment to our events and initiatives for university students • Organized events such as the Race UC and the Inter-schools Olympics that promoted a healthy lifestyle among students and faculty
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Pontificia Universidad Católica de Chile
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Higher Education
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700 & Above Employee
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Delegate of the Biomedical Engineering Major
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Mar 2014 - Jul 2015
Santiago Metropolitan Area
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Education
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University of California, Berkeley - School of Law
VC University (Cohort 14), Venture Finance -
Duke University
Master of Engineering - MEng, Biomedical/Medical Engineering -
Technical University Munich
International Exchange Program, Bioengineering and Biomedical Engineering -
Pontificia Universidad Católica de Chile
Bachelor of Science - BS, Bioengineering and Biomedical Engineering