Page * *

Curriculum Vitae

Lynda Cedar, Pharm.D., Ph.D

*** ******* **., ************ (Qc) H9W 3L5

Tel.: 514-***-****

Email address: adl6i1@r.postjobfree.com

PROFESSIONAL PROFILE

Dr. Lynda Cedar has extensive clinical research experience, spent mainly in the early stage of Clinical R&D. She planned, managed and monitored 100s of clinical trials from initiation through close-out, both in Europe, Canada and abroad. She works closely with study stakeholders to design clinical studies right from the first time and to develop strong protocols to achieve study objectives and meet sponsors' goals.

Dr. Cedar manifests a-deep interest in:

* Clinical R&D of early-stage, scientific affairs and clinical operations (e-clinical suites),

* Innovative centered practices,

* Artificial intelligence - clinical development and Health applications,

* Real World Solutions, Real World Evidence,

* Continuing education is a Passion (Regulatory, Ethics, New Normal of clinical research). Forward-thinking clinical research executive, passionate about the start-up of phase 1 pharmacology units (3 times) and their rapid implementation in GCP-ICH form and regulatory compliance while operating in an environment of paperless solutions. Over 20 years of experience in managing and supervising clinical studies, training personnel, budgets, strategic planning and daily operations and management in large and small CROs (Europe and Canada) offering their services to Pharma /Biotech (international) who develop products to cure and improve lives and Healthcare system.

Focused on the details and analytical skills necessary to assess the performance of a CRO in the event of subcontracting, gauge its ability to conduct clinical studies in terms of safety and efficacy in order to maximize the success of the inspections and profit margins. Committed to innovation in the field of clinical research, whether during the updating of ICH and regulatory directives, and determined to harmonize the operations under ISO 9001-2008 certified procedures for the best quality, and 21 CRF Part 11 requirements for electronic recordings and signatures in harmony with CTMS automatic project management through e-clinical solutions. Over 20 years of project management, seeing clinical studies move from source documents in paper format to the innovative solutions described above, offering more flexibility and speed in implementing changes when necessary during the project. These tools, while respecting ICH and regulatory directives, positively transform and facilitate project management while considerably reducing the costs of clinical studies and enhancing the study quality. Page 2 6

PROFESSIONAL EXPERIENCE SUMMARY

Entrepreneurship:

- Experienced in budget development and implementation of business plans (CROs phase 1) and daily management of the operating budget (scientific affairs, clinical operations, Bioanalytical, business development and sales).

- Passionate about implementing rapidly the revised guidelines of ICH and guidance to a framework focused on quality, efficiency, security and data integrity. That is positively revolutionizing the landscape of clinical studies. Communication and Negotiation:

- Strong interpersonal skills and experienced in managing multicultural teams to function effectively on an international scale with a minimum of supervision and direction. If and when necessary, make the best compromises to achieve the objectives of the parties.

- Effective in approaching clients, regulatory agencies, Ethics Committees, Creditors, Senior Management.

- Contribution to the scientific community by organizing pharmaceutical discussion forums and relevant workshops when revisions of practices are introduced by the ICH, regulatory agencies and laws. Efficient Project Management: on-site / remote / traveling

- Qualified problem solver in troubleshooting all aspects of clinical studies, always looking for new ways, strategies and methodologies to improve management tasks: early clinical research (FIM / Phase 1), bioequivalence and proof-of-concept studies.

- Strong skills in patient recruitment and retention strategies as well as the development of pilot project plan to assess as much as possible the behavior of the clinical study protocol in the real world. WORK EXPERIENCE

Research Institute-McGill University Health Centre. Phase 1 Unit (8 neg.pressure rooms)

Role: Combined of Head, Phase I Unit and Manager of Phase 1 Clinical Research: Typically, it’s about bringing previous experience of starting Phase 1 CROs in the private sector (Labopharm inc. and Atlantic Life Sciences inc.) to the Academia sector. (Letter of accomplishment is attached).

Role: Manager, Phase I Clinical studies: Jul. 2017 – Dec. 2017 Insynergy BioPharmaceutics inc.

Role: Clinical research consultancy services: 2010 – 2017 Atlantic Life Sciences inc. Phase I Clinic, 100 beds (mid-virtual CRO). Role: Co-Founder acting as Executive General Manager & Chief Scientific Officer: 2002 – 2010 Achievements:

- Effectively implemented a-successful and profitable Phase 1 Unit.

- Responsible for overseeing the day-to-day management: Scientific and clinical affairs, Corporate finance, Studies budget, claim of the SR&ED tax incentive.

- Ensured the transfer of source documents, SOPs from CéMAX (France) to ALS inc. (Montreal). The SOPs are certified ISO 9001-2008. Implemented them to harmonize the clinical operations between CéMAX (France) and ALS inc (Montreal) in respect of the applicable laws and regulatory aspects. Studies run in France and Montreal with ClinPlus CTMS software;

- Oversee clinical conduct of Phase I clinical research studies by performing procedures and providing medical assessments, judgments and leadership in support of recruitment, screening and study conduct, while adhering to professional, regulatory and company standards. Responsible for the welfare, health and safety of study subjects.

Page 3 6

LAB Pharmacological inc. Phase I Clinic, 126 beds. Role: Assistant Director. Became quickly Director, Scientific Affairs. Responsibilities:

Running day-to-day projects, setting up the operational and logistical fundamentals for the scientific affairs department and activities pertaining to company's business goals.

• Worked closely with dedicated clients and Physicians (PI) to design and plan medical translational research into clinical practice in order to find better treatment for patients.

• Conducted early clinical research trials, including first-in-human studies, with a special focus on special population and therapies proposed by clients.

• Reviewed and developed most of routes of drug administration protocols for FIM, BioE and DDI (drug-drug interactions) clinical studies.

• Responsible for scientific affairs in assisting to include the review of RFPs, study budget, study contract agreement (CTRA), CTA package (reg. approval),

• Interacting with 36 clinical research scientists, Biostatistician, DM team and Medical Doctors. Working closely with the marketing department to produce and review RFPs, study design to optimize the sales.

• Interacting and managing client relationships, along with support, input and expertise;

• Overseeing implementation of plans to achieve clinical research scientists, study directors, goals and objectives, ensuring convergence with corporate strategy and clients’ objectives;

• Reviewing and then submit study protocol, informed consent form and documentation to IRB committee;

• Managing projects, coordinating and supervising clinical research scientists and study directors. Liaising with other early phase groups to ensure projects are completed accurately and within timelines (Interacting with various departments including the bioanalytical director, Marketing, Clinical operations, Human resources and Regulatory agents);

• Review and approval of new SOPs, developing PK guidelines and report formats;

• Contribute to final report writing and participate in the authorship of research reports, leading study team in the review and discussion of PK and statistical reports;

• Lead seminars of projects management and deliverable: carry out tasks in compliance with marketing objectives, evaluate and manage the implementation of processes to improve efficiency. Technically, as a representative resource to the clinical/bioanalytical/regulatory/marketing departments:

• Contribute/Review/Provide the study design, selection of sampling time points, estimation of study sample size, medical writing of SOPs, worksheets, master documents, CRFs, protocols, Integrated study reports

(Clinical, Bioanalytical, Biostatistics in compliance with ICH E3 guidance, etc.);

• Overseeing all aspects of the study progress. Ensuring trials are conducted, recorded and reported according to the study protocol, SOPs/Regulatory and Ethics requirements;

• Assessment of pilot study results for pivotal study;

• Monitor clinical data, quality and progress of trials in complete compliance according to the regulatory requirement US-FDA, EMA, Health Canada;

• Work closely with the Regulatory department to resolve queries for BA/BE studies;

• Organize and conduct pre-study site selection in term of outsourcing and feasibility of study within hospitals, training, monitoring and audit according to LAB SOPs and applicable regulatory guidelines;

• Planning the project to achieve the required results within required constraints such as time limit, effective cost and desired quality standards;

• Study background for the study design and budget;

• Analysis of results using Phoenix WinNonlin 5.0.1.

• Assist the Responsible of Human resources in selecting qualified staff in respect of ICH guidelines; Labopharm inc. Start Phase 1 Unit, 12 beds (pilot clinical studies) Role: Clinic Director.

Page 4 6

Realization and achievement :

The company started its scientific operations by 3 key-leaders supervised by the vice-president who provided the attached letter of reference.

I implemented a pharmacology unit of 12 beds designed for pilot bioequivalence studies. I was in charge of the whole project from the lease negotiation, site design, equipment purchase, medical writing of clinical master documents, SOPs development and implementation and run the clinical studies.

• Quality Assurance System Implementation;

• Develop and review the study protocols, informed consent form, amendments, investigator brochures, CRFs;

• Clinical conduct, according to the ICH administrative structure checklists;

• Coordination of activities in the lab. to review Bioanalytical methods validation report;

• Assessment of the analysis and results in comprehensive standard reports (Bioanalytical, Clinical, Pharmacokinetic and Statistics) :

• Assist regulatory in the preparation of pre-IND or pre-NDA meeting package;

• Assessment of data analysis, distill information and make presentations for communications and recommendations to Marketing, R&D, Bioanalytical, Regulatory Affairs;

• Assist the management with drug development strategies in assessing chemical entities which would clinically benefit from being combined with Labopharm proprietary drug delivery system and make recommendations.

• Participate as internal consultant and ad-hoc member of project/product development teams in providing scientific/technical input to ensure that the clinical utility of company's products meets the clinical need.

• Present data at key scientific meetings/conferences regarding clinical study results. Contribute to patent applications, scientific literature, presentations to Board of Directors and other Stakeholders. European Organization for Research and Treatment of Cancer (EORTC). Belgium. Role: CRA/Manager of projects, Breast Cancer group. Projects management, Phase 2-3 oncology and HIV studies, remote-monitoring, ensure adherence to GCPs, SOPs, WHO guidelines, investigator integrity, compliance with all study procedures. Pre-Study - Preparation and Implementation:

• Develop the Study Protocol, Informed Consent Form and IRB process;

• Assist the Biostatistician with encoding studies in the database. Participate in code review and software validation(CDM);

• Implementation: select the hospital sites, investigators and study coordinators. Ensure Principal Investigator

(PI) integrity, ensure compliance with protocol requirements, effective patient identification and put in place the recruitment plan;

• Assist medical staff of hospitals with the preparation of study start up materials and tools. On-Study: Follow-up:

• Study follow-up and progress. Data management, ensure timely reporting of AEs/ SAEs and Protocol Deviations/Violations; regularly check (IP) accountability;

• Maintain timely and effective communication with staff of sites;

• Ensure compliance with regulations, ICH – GCP and WHO guidelines, Sponsor SOPs;

• Perform clinical data listings, reviews as needed;

• Review the status of study binders before each bi-annual Investigators ’meeting;

• Ensure timely completion and submission of CRFs according to Clinical Monitoring Plan and Data Management Plan;

• Ensure timely and accurate completion of Data Clarification Forms;

• Prepare and present an update report at the bi-annually Investigators’ meeting and visit the sites as needed to clear queries before the PIs bi-annual meeting. The monitoring is remote “mostly”.

• Contribute to Statistics as required.

Page 5 6

Close-out and Post-Study:

• Ensure completion of the Toxicology Case Report Forms and the Study out-come Case Report Forms.

• Ensure completion of the questionnaire of Quality of life.

• Participate to publications.

Central Lab. Jules Bordet Institute affiliated to ULB/Oncology centres. Belgium. Role: Student Job liaising Medical team and laboratories performing medical analysis.

• Technical Clinical Operations - medical diagnosis/follow-up analysis (biochemistry, hematology/ coag., immunology and bacteriology).

• Contribute actively to the Lab. QC/QA process.

• Management and monitoring of patients’ chart.

QUALIFICATIONS – Clinical research

• Ph.D Pharmaceutical sciences, Pharmacology, highest grade avec «La plus haute Distinction ». ULB,Belgium.

• Post-Ph.D, Pharmacology, Pharmacodynamics/Pharmacokinetics, University of Montreal, Quebec, Canada.

• M.Sc. Toxicology/Mutagenesis. Université Catholique de Louvain, Belgium.

• DESS, Drug development, Clinical research specialty, University of Montreal, Quebec, Canada.

• Certificates of pharmacy practice in Canada. Pharmacy Examining Board of Canada:

- Evaluation examination (PEBC1),

- Qualifications examination (PEBC2).

Continuing education and knowledge update: Courses/certificates available upon request. COMPUTING SKILLS

Standard Apps of editing, Microsoft office and PDF. CTMS software and e-clinical suite cloud. Special software programs used for PK/PD analysis and Biostatistics. SAS, WinNonLin, Thermo Scientific Kinetica PK/PD data analysis, simulation and reporting system and GastroPlus PBBM / PBPK modeling and simulation package. OTHERS

• Language: French (Native or Bilingual Proficiency). English (Full Professional Proficiency)

• Interest: Diversity practice and Innovations.

Page 6 6

Peers’ Recommendations, field of clinical research.

Lynda is the head of ALS in Montreal and runs an excellent phase I organization. She also organized a major presentation in Montreal on drug safety drawing speakers and attendees from all over North America. She is a tireless worker, knows her field thoroughly and has enormous personal charm as well. A pleasure to work with.

I have known Lynda for several years and have recommended her services to third parties several times. Have received positive feedback in all cases. Lynda runs a first rate Phase I, IIa CPU in Montreal. Happy to supply additional information upon request.

I write to recommend the Lynda Cedar to you and to explain the nature of my experience working with her on a study. As the Clinical Director, Lynda has demonstrated that her qualifications and work ethic are attributes that are well desired in this industry. Lynda is a serious minded, focused and works as a part of your organization in order to accomplish your goals. She displayed sound analytical skills both in the clinical and pharmacokinetics areas of the clinical trial. She sees the heart of an issue and seeks guidance from the regulatory agencies when necessary. As is evident from her personality, she has excellent interpersonal skills. I have no doubt that she has both the ability and motivation to succeed in conducting a clinical trial of any size. Lynda’s industry knowledge and determination have undoubtedly equipped her in her role as clinical director.

Lynda is a success-driven and passionate entrepreneur with a remarkable personality, and impeccable work ethic. Her solid experience in the pharmaceutical and CRO industry is a unique blend of knowledge on clinical research, drug development, scientific and regulatory affairs, marketing, and business development . I'm very pleased to be a part of Lynda's professional network, and I highly recommend her for business collaborations.

Lynda is an articulate, intelligent pharmaceutical development scientist who openly shares her solid knowledge and experience with colleagues and, through her diligent efforts leading the “Challenges in FIM…” LinkedIn Group, helps to stimulate productive conversation and move this important topic forward.

Lynda is an extremely knowledgeable expert in the area of pharmaceutical sciences with special interests in early stage development. We've interacted in relation to my participation in a conference she organized that was intended to link academic researchers with industrial partners. I was very impressed with Lynda's organization and interpersonal skills. I'm happy to recommend her for future employment and business partnerships.

Lynda is a level-headed, fair, and diplomatic professional who exhibits a comprehensive understanding of the drug development life cycle. As a GCP QA professional, I can tell you that Lynda knows how to practically apply compliance principals. This is especially true for Phase I systems.

Lynda is a forward-looking scientist and excellent manager. She is full of practical ideas and knows how to implement them. I worked with her for one of the DIA Canada meetings and was impressed by her. I was also impressed by a workshop she organized subsequently at which I and some of my staff made presentations. Very well organized, well received. I can recommend her highly.

Great to be part of Lynda's trusted professional network. It's a pleasure and an honor to recommend you to all others as a consummate and dedicated professional. Thank you for your contributions and loyalty.

Lynda has pioneered the use of LinkedIn, Twitter and other social media to discuss issues in clinical research. Engaging with Lynda in these forums, and listening to debates she drives, has given me a clearer understanding of issues affecting the clinical trial community. Combining a willingness to engage through social media and ability to clearly communicate complex ideas makes Lynda a rarity and a valuable asset to those trying to understand clinical research.

Contact this candidate