Thomas Wrona Email & Phone Number

South San Francisco , Ca, Us

ArsenalBio is a clinical stage, programmable cell therapy company focused on solid tumors. Utilizing in-licensed and internally developed CRISPR- and synthetic biology-based platform technologies, ArsenalBio creates autologous CAR T-cell therapies designed to minimize on-target, off-tumor activity and to overcome the hurdles of the tumor micro environment and T-cell exhaustion. To do this, a patient’s immune cells are removed, engineered by inserting a logic-gate based expression system at a precise location in the genome, then administered back into the patient. The expression system contains an AND logic gate such that the presence of one tumor antigen drives the expression of a CAR directed to a second tumor antigen, along with other components such as payloads, synthetic signaling molecules, and shRNA cassettes.I am responsible for all intellectual property matters at ArsenalBio. These responsibilities include:- building and maintaining a global patent portfolio directed to platform- and product-specific innovations- meeting regularly with R&D leadership to discuss invention disclosures along with patent filing and maintenance strategy- communicating intellectual property analysis and strategy to functional leadership, executives, and the Board of Directors - identifying potential freedom-to-operate risks, evaluating invalidity and noninfringement positions, and creating mitigation strategies- negotiating and providing counsel on contract intellectual property provisions

Vancouver, Washington, Us

Responsibilities include:- all Intellectual Property matters, including client counseling, patent drafting, prosecution, and global strategy, trade secrets, trademarks, publication review, opinion matters, patent landscape and freedom-to-operate analysis, transaction support, and due diligence - managing and developing a team of IP professionals- communicating IP strategy, risks, and mitigation options to company executives and the Board of Directors - leading the Patent Review Committee, which is responsible for determining and managing invention disclosures, along with patent filing strategy and maintenance Technical areas of IP support include AI-assisted molecule design and production optimization, cell line and expression technology, antibody discovery, and affinity-based screening assays

Vancouver, Washington, Us

Thousand Oaks, Ca, Us

From 2019-2021, I was intellectual property lead for several clinical and pre-clinical molecules and cell therapies. As intellectual property lead, I was responsible for all IP matters related to that program, including patent landscape analysis, development of and management of the global IP strategy, patent drafting and prosecution, trademarks, transactional support, and management and support of IP disputes, such as IPRs, Oppositions, and litigation. My work also included involvement in Amgen Ventures, in particular, as the point of contact for Texas-based opportunities for its Research & Development Seed Fund.From 2018-2019, I was intellectual property lead for the Herceptin biosimilar product KANJINTI (trastuzumab), supporting the product through global marketing approval applications and launches including the U.S. launch in July of 2019. From 2016-2019, I was intellectual property lead for the Soliris (eculizumab) biosimilar candidate ABP 959. In this role, I evaluated the IP landscape related to the reference product and communicated my analysis to the biosimilar leadership, worked with European counsel in Opposition proceedings and the drafting and submitting of third-party observations, and with U.S. counsel in the drafting and filing of three inter partes review (IPR) petitions.*The postings on this site are my own and do not represent Amgen's positions, strategies, or opinions

Chicago, Illinois, Us

As Special Counsel, I conducted intellectual property due diligence and counseled large biopharma and startup clients on the intellectual property opportunities and risks associated with licensing, partnership, and M&A opportunities, including those in the CAR T-cell area. I also managed and maintained an extensive foreign and domestic prosecution docket, analyzed potential freedom-to-operate issues, and developed and implemented legal strategies to support pre-clinical and clinical therapeutic molecules. I also filed several U.S. patent term extension applications.

As Associate General Counsel - Intellectual Property, I was responsible for all intellectual property matters at Epirus Biopharmaceuticals, a pure-play biosimilar company based in Boston. My duties included:• Conducting landscape and freedom-to-operate analysis and create legal strategy for biosimilar candidates of Remicade®(infliximab), Humira®(adalimumab), Actemra®(tocilizumab), Soliris®(eculizumab), Stelara®(ustekinumab), and Simponi®(golimumab)• Counseling executives and upper management on intellectual property issues and strategy• Working closely with scientists to identify inventions, to assess the value of protecting the inventions, and to receive input on the technical aspects of third-party patents and pending applications• Negotiating, drafting, and counseling on contract IP provisions• Conducting and participating in due diligence supporting M&A, partnering, and licensing opportunities• Managing outside counsel handling trademark and freedom-to-operate matters• Creating and managing intellectual property budget

Thousand Oaks, Ca, Us

• Developed and implemented global legal strategies for pre-clinical and clinical molecules through commercial launch, including antibodies, antibody-drug conjugates (ADCs), and engineered cytokines• Provided Intellectual Property support for Vectibix (panitumumab), an anti-epidermal growth factor receptor (EGFR) human monoclonal antibody for treatment of metastatic colorectal cancer (mCRC)• As Large Molecule Intellectual Property Due Diligence Lead, managed intellectual property due diligence for all Large Molecule in-licensing, collaboration, and M&A activity• Managed and maintained an extensive foreign and domestic prosecution docket, analyzed potential freedom-to-operate issues, and developed legal strategy, produced evidentiary support, and drafted briefs for inter partes proceedings• As legal liaison for Biologics (protein engineering) group, provided IP support for antibody engineering efforts including effectorless Fc and charge-based heterodimer engineeringREPRESENTATIVE LICENSING AND ACQUISITION PROJECTSKite Pharma Collaboration (January 2015)Performed intellectual property landscape analysis of chimeric antigen receptor (CAR) T cell technology. Presented summary of the intricate IP landscape to Research & Development, Business Development, and Legal leaders. Assisted with the Intellectual Property-related aspects of the Agreement.Micromet Acquisition (January 2012)Led intellectual property due diligence for Amgen’s $1.16 billion acquisition of Micromet Inc. Acted as intellectual property integration lead following the acquisition.Micromet Collaboration (July 2011)Served as intellectual property due diligence lead for a collaboration agreement between Amgen and Micromet to research and develop BiTE® molecules.XmAb5871 Option Agreement (January 2011)Provided intellectual property due diligence and assisted in finalization of an agreement between Amgen and Xencor wherein Amgen was granted an option to a pre-clinical molecule.

Chicago, Il, Us

Chicago, Illinois, Us

• Responsible for managing and maintaining an extensive prosecution docket for domestic and foreign biotechnology-related patent applications• Worked cohesively with in-house counsel developing the prosecution strategy for several biotechnology clinical and commercial products• Counseled clients in the form of due diligence analyses, patentability opinions, freedom-to-operate and non-infringement opinions

Chicago, Il, Us

• Responsible for prosecuting a majority of the firm’s biotechnology-related domestic and foreign patent applications• Integrally involved in several interference proceedings• Prepared freedom-to-operate and validity opinions

Assisted attorneys and patent agents in prosecution of biotechnology-related patent applications.

J.D., Intellectual Property

Ph.D., Microbiology

B.S., Microbiology