General Manager and Executive Director of clinical studies conducted at ALS Inc. PK expertise and extensive experience in clinical development of Phase 1 to 3 and bioequivalence studies.

1. Lynda Cedar, Ph.D.,
Expert, Clinical Development.
Achievements ProvenTrack Records:
2009: * Alberta Voucher Grant filed and obtained for a client (start-up Pharma
company)
* Health Canada approval given to this client (start-up Pharma company) at an early
stage of clinical development.
1995 – 2003: Start-up of a successful Phase I CPU clinics:
ALS Inc.: 24 beds (2003), 36 beds (2006) and 96 beds (2008):
Maxxam Analytics Inc., Clinical research: 60 beds (1999)
Labopharm Inc.: 12 beds ( 1995).
1997 – 2005: Successful forums of pharmaceutical discussions.
2000 – 2006: Contribution to creating the Canadian DIA. Chair of the clinical track of its 2 first
Canadian annual meetings.
1983 – 1997: 18 Publications and articles.
Career Summary:
 Expert, Phase 1 CPU clinic start-up and the day-to-day management.
 Relevant experience in the pharmaceutical and biotechnology industries that apply to clinical
development. I collaborated with regulatory agencies, IRB committee, and pharmaceutical and
medical device companies in all phases of clinical development, including support for CTA, IND and
NDA including meetings.
 Experience in the methodology and implementation of clinical trials Phase I to III gained over 10
years experience. I was involved but not limited to the following therapeutic areas (Cardiovascular,
Diabetes, Endocrinology, Gastroenterology, Immunology, Neuroscience, Oncology, Osteoporosis,
Pain, Parkinson and Vaccine.). I designed the studies, proposals, budget evaluation, produced the
protocols, CRFs, SOPs, supervised the clinical operations, project management, data management,
biostatistics with emphasis on pharmacokinetic/pharmacodynamic.
 I helped some clients to obtain grants and funds from sources of investment/financing: review of
business plans to evaluate the potential of technologies and products. I produce reports by
simulation to show the potential of these technologies and products.
I contributed to publish study results for press-release and reports presented to the Board and
Investors. I developed successful strategies for pharma start-ups to obtain regulatory approvals
while products are still in the early stage of pharmaceutical development.
 I contributed to the scientific community by providing forum of pharmaceutical discussions and
workshops pertinent to pharmaceutical development aspects. I contributed in a leadership position
for the Canadian DIA in recruiting members for the Steering Committee from Montreal, discussing
topics of interest; hired and selected speakers. I chaired the clinical tracks of the 1st and the 2nd
Canadian DIA Annual meetings.
References and recommendations:
Eight recommendations from collaborators : Linked In platform.
Labopharm employer provided a letter of recommendation (available in French only).
A Pharma Company recommended Lynda Cedar and ALS team.
(http:www.alsclinic/english/testimonials.html)
Linked In/group.: Challenges of FIM, Phase I and Bioequivalence clinical studies.
Contact: alscontact@alsclinic.com Tel.: 1 514 750 6017

2. Lynda Cedar, Ph.D., Founder.
Atlantic Life Sciences, Inc., Provider of Clinical services since 2003.
Summary of Qualifications and skills:
 Ph.D Pharmaceutical sciences, 1983 - 1988
 Post-Doc in Pharmacokinetic, 1993 - 1995
 M.Sc. Toxicology, 1981 - 1982
 DESS, Drug product development1 , 1993 - 1996
 BEPC 1&2 Qualifications2 , 1995, 1996
 B.Sc. Pharmacy, 1976 - 1980
1.: DESS = Diplôme d’Etudes Supérieures Spécialisées, développement du médicament.
2.: BEPC = Board Evaluation for Pharmacy in Canada.
 Deep knowledge, all aspects of Clin.Research Phase I to III
 International Regulations and Ethics requirements
 Use of MS office, Statistics and PK/PD programs
 Budget development and deliverables by milestones
 Contract review and negotiation,
 Coordination, Communication, White papers.
 Management and Supervision
 Technical skills - Phase I clinic start-up.
 Planning, Leadership and Implementation of events.
Employment History:
First-in-man, Phase I and bioequivalence clinical studies: 1994 to present
 Atlantic Life Sciences, Inc. Montreal, Qc., Canada. CPU Phase I Clinic, 96 beds.
Founder, General Manager and Executive Director, Clinical Trials: Responsible for overseeing the
day-to-day clinic management, quality operations and administration
 Maxxam Analytics, Inc. Montreal, Qc., Canada. CPU Phase I Clinic, 60 beds.
Independent, Clinic Founder.
 LAB Pharmacological, Inc. Vaudreuil, Qc., Canada. CPU Phase I Clinic, 126 beds.
Director, Scientific Affairs.
 Labopharm, Inc. Laval, Qc., Canada. Clinical center, 12 beds.
Clinical Centre Director and Founder. Responsible for the day-to-day projects delivery setting up
the operational and logistical fundamentals for the scientific affairs department and activities
pertaining
to company's business goals.
Phase I-III clinical studies: 1986 to present
 Atlantic Life Sciences, Inc. Montreal, Qc., Canada. CPU Phase I Clinic, 96 beds.
CRA and Monitor roles
 European Organization for Research and Treatment of Cancer (EORTC). Brussels, Belgium.
Projects manager, Breast Cancer group.
 Central Lab. Jules Bordet Institute, ULB hospital, Tumors center Brussels, Belgium.
Medical analysis testing and Coordinator (laboratory ~ Medical Clinical staff).
Excellent use of PC and programs:
 Word Format and Presentation: Applications of MS Office, Open Office and Corel Wordperfect 7
 Project Management: MS Project and Smart Draw
 PK/PD and Statistics: WinNonLin, SAS program, Kinetica, SigmaStat and Sigmaplot, nQuery,
SMART
 Communication and Internet: Internet Explorer/Firefox/Beta, Outlook Express
 Multimedia and web design: AceFTP3 software, FTP Manager, Macromedia applications