Transcelerate Biopharma Inc

“The members of the corporation consist of such firms and corporations that are approved for membership from time to time by the board of directors or its designees in accordance with the policies and procedures of the corporation. The corporation has the following categories of members: a. Tier i members - to be eligible for tier i membership, a firm or corporation must be a pharmaceutical or biotechnology company with an annual budget for research and development in excess of $2.5 billion. Eligibility for tier i membership is established based upon a company's publically available research and development expenditures over the three (3) year period preceding the date the company applies to join the corporation. The initial tier i members are further defined as the "charter members." b. Tier ii members - to be eligible for tier ii membership, a firm or corporation must be a pharmaceutical or biotechnology company with an annual budget for research and development that is less than $2.5 billion but more than $100 million. Eligibility for tier ii membership will be established based upon a company's publically available research and development expenditures over the three (3) year period preceding the date the company applies to join the corporation. C. Associate members - to be eligible for associate membership, a firm or corporation must be a pharmaceutical or biotechnology company with an annual budget for research and development that is less than $100 million.”

“The board of directors shall be comprised of up to twenty-two (22) directors; provided that: (i) ten (10) seats are filled by directors who are representatives of the charter members; (ii) up to four (4) additional seats shall be filled by directors who are representatives of the tier i members who are not charter members; (iii) up to six (6) seats shall be filled by directors who are representatives of the tier ii members; (iv) one (1) seat shall be filled by a director who is a representative of the associate members; and (v) one (1) seat shall be filled by the chief executive officer of the corporation. The corporation's bylaws state that directors shall be elected or appointed, as applicable, annually at the annual meeting of members and shall serve until the following annual meeting of members and until their successors are elected or appointed, as applicable, and qualified. Each charter member shall have the right to appoint a representative of the charter member to serve as a charter member director. Tier i at-large directors shall be elected by a plurality vote of the tier i members, which include the charter members. Tier ii directors shall be elected by a plurality vote of the tier ii members. Any associate member director shall be elected by a plurality vote of the associate members. The ceo director shall serve ex-officio, for so long as he or she shall hold the office of chief executive officer. Transcelerate does not presently have any assoicate members therefore, the assoicate member board seat is currently vacant. Each tier i member shall be entitled to three (3) votes at every meeting of members on matters which tier 1 members are entitled to vote. Each tier ii member shall be entitled to one (1) vote at every meeting of members on matters which tier ii members are entitled to vote. Associate members shall be entitled to notice of and to attend meetings of the members but shall not be entitled to vote at such meetings, provided however, associate members shall have the right to cast one (1) vote each with respect to the election of the nominee to fill the associate member board position. Notwithstanding the above, in order to be eligible to vote, a member must be in good standing and its dues and assessments paid in full.”

“The finance committee and management review and approve the form 990. The form is then distributed to all members of the board for their review before filing with the internal revenue service.”

“Each director and officer of the corporation is required to annually acknowledge the conflict of interest policy, affirming that such person has received, read and understands, and agreed to comply with the conflict of interest policy.”

“The board chair, with input from other directors or a subcommittee of the board, annually reviews and approves the ceo's compensation package. The ceo approves the compensation for the chief operating officer, and all other employees.”

“The organization's governing documents, financial statements, and conflict of interest policy and other corporate policies are available upon request.”

“The interpretations of pharmacovigilance guidances & regulations (igr-pv) and the interpretations of clinical guidances & regulations (igr-clinical) initiatives launched their new solutions pages. The igr clinical's quality tolerance limits team released several solutions: in dia tirs, a peer-reviewed publication entitled "quality tolerance limits: framework for successful implementation in clinical development." a qtl infographic, a set of frequently asked questions that address some of the common misconceptions about qtls. A qtl plan template that will allow a company to document a qtl monitoring approach at the study level. Igr clinical's general data privacy regulation (gdpr) data reuse topic also released its suite of solutions. The cornerstone of this set is "a privacy framework for clinical data reuse: secondary data use in the pharmaceutical industry." an overview video and additional tools from the framework, including a glossary, step-by-step best practice model, definition of primary and secondary use of clinical data, and a reuse assessment form. The intelligent automation opportunities in pharmacovigilance (iao) initiative has launched its solutions page. The impetus of this launch is the interactive icsr and automation technologies tool (iatt), which is an interactive process flow depicting each step within the individual case safety report (icsr) process. A refresh later in 2020 serves as a platform to report technology implementation data within the same icsr process map structure as the original tool. Accompanying this refresh is a video demonstrating how this tool can be properly used and adopted. Additionally, iao released one of its foundational manuscripts in pharmaceutical medicine. The paper, "automation opportunities in pharmacovigilance: an industry survey," offers a systematic review framework for automation of the icsr process. Iao authored an additional paper, "utilizing advanced technologies to augment pharmacovigilance systems: challenges and opportunities." the iao initiative added the 2020 technology matrix to its solutions page. Additionally, the team has added a case for adoption resource that will help companies better understand and utilize transcelerate's iao solutions. The interpretations of guidance & regulations in pharmacovigilance (igr-pv) initiative has collaborated on two new papers: in the first paper, "industry experience and perspective on clinical trial safety reporting to the fda." the second paper, "the evolving remit of the reference safety information: observations on implementation of the 2017 clinical trials facilitation group (ctfg) question & answer document" focuses on the 2017 ctfg q&a on reference safety information. Igr pv's presentation of safety risks throughout the product lifecycle (portl) topic team completed its 2020 solutions. "a framework on the safety risks throughout the product lifecycle" provides an outline of regulatory requirements and considerations for presenting risks within key safety-related regulatory documents required at the various product lifecycle stages. A video gives an overview of the framework. Transcelerate established a new initiative entitled pharmacovigilance agreements optimization (pvao). The advancing safety analytics (asa) initiative launched its assets page, featuring the team's first published paper, "investigating overlap in signals from evdas, faers, and vigibase." it also published an infographic that illustrates the results of its drug safety manuscript that indicates, for the majority of drugs, that there is no significant difference between the number and types of safety signals that arise from the three main data sources. The asa initiative published a paper, "signal management: current landscape and considerations for best practices." this paper reviews the current landscape of signal management and proposes a simplified, end-to-end framework while highlighting some best practices. Bayer became a member company in early 2”

“Project management fees: program service expenses 8,892,797. Management and general expenses 0. Fundraising expenses 0. Total expenses 8,892,797. External contractor support: program service expenses 2,406,397. Management and general expenses 1,862. Fundraising expenses 0. Total expenses 2,408,259. Communications fees: program service expenses 342,336. Management and general expenses 615,319. Fundraising expenses 0. Total expenses 957,655.”