BioPharma Services Inc. (BPSI) announces the 2017 recipient of the Lorelei Lutter Fine Arts Scholarship

BioPharma Services Inc. (BPSI) announces the 2017 recipient of the Lorelei Lutter Fine Arts Scholarship

‎December 4th, 2017

BioPharma Services Inc. (BPSI) announces the 2017 recipient of the Lorelei Lutter Fine Arts Scholarship (LLFAS) in memory of Lorelei Lutter, VP Business Development. The scholarship is meant to be a reflection of Lorelei’s love of fine arts.

“I am very pleased to award Sophia Kington with the Lorelei Lutter Fine Arts Scholarship.  Sophia has shown remarkable talent in Musical Theatre and art, winning a number of awards as well as a grant for her artistic painting. — commented Renzo DiCarlo, CEO of BioPharma Services Inc.

The scholarship will be awarded this year, 2017 to Sophia Kington, daughter of Jolene Kington, a Biopharma employee.

Sophia is entering her third year at Hickman High school.  Sophia has been the recipient of many awards during 2016 and one being the recipient of the 2016 Presidents Education Award honoring students who meet challenging standards of academic excellence, as well as overcome obstacles to their learning, recognizing achievement and hard work. Sophia has performed in several musicals/variety shows at Hickman High School, as well as a member of Missouri Symphony Society Children’s Choir and also plays the violin. With interest in fine arts, Sophia painted a ceiling tile in competition for a $3000 grant at Hickman High School and received a perfect score on the project.  Sophia future aspirations is to specialize in science/medical field or fine arts (such as painting and performing arts).

About BioPharma Services Inc. BioPharma Services Inc. is a physician-owned, physician-run, FDA-inspected, UK MHRA-inspected, and Health Canada-inspected International Contract Research Organization (CRO) which specializes in the conduct of Phase I/IIa clinical trials and bioanalysis for innovative pharmaceutical, biotech and medical device companies from US, Canada, Australia and Europe. The company currently has a modern 174-bed clinical facility and a co-located bioanalytical laboratory in Toronto, Canada. The company is privately held and is headquartered in Toronto, Canada.

Contacts
BioPharma Services Inc.
Patricia Polisena, 1-416-747-8484
scholarship@biopharmaservices.com

BioPharma Services, Inc. Completes its 1st year of a 5 year Phase 1 Program with the US FDA

Toronto, ON­­ (BUSINESS WIRE) ­­ BioPharma Services, Inc. (BioPharma) is proud to announce that it has successfully completed its first year of collaboration with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA).  The first year program involved the use of a smart pill technology to investigate in vivo PK on a generic drug product in a drug-drug interaction bioequivalence study.   The final cohort of this Phase 1 study is set to be completed in October of 2017.   Planning and discussions are underway with the FDA for follow up studies as part of BioPharma’s 5 year contract term.

“We are very proud to work with the FDA in support of their early stage research needs.  We are truly excited and honored to be continuing our collaboration with new programs for 2018.” said Renzo DiCarlo, CEO at BioPharma Services, Inc.

The FDA studies conducted by BioPharma will allow CDER to proactively address scientific questions in developing approval standards and ensure post­market safety and efficacy of approved drug products. Ultimately, the outcome of these studies will help improve the generic drug review practice within CDER.  As part of this contract, BioPharma will provide the FDA with a full service offering from protocol development, clinical conduct, and bioanalysis to final report.

Dr. Janice Faulknor, Chief Medical Director at BioPharma Services, Inc. added: “We are thrilled that our capabilities of conducting complex Phase I programs including abuse deterrent studies will assist the FDA in approving safe and effective pharmaceuticals.”

The statements in this press release are solely made by BioPharma and does not represent the official views of the FDA.

About BioPharma Services Inc.

BioPharma Services Inc. is a full­service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Medical Writing and Data Management.

Contacts

Main Telephone:  +1 844 747 8484
Email: info@biopharmaservices.com
Website:  www.biopharmaservices.com

For more information regarding this press release, please contact:
BioPharma Services, Inc.
Ms. Anna Taylor
Executive,Vice-President,Business Development
ataylor@biopharmaservices.com

BioPharma Services, Inc. Successfully Completes 3 FDA Inspections with ZERO Form 483’s

Toronto, Canada – BioPharma Services, Inc. (BioPharma) is proud to announce that it has successfully completed 3 inspections this month by the US FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, Missouri.   Over the course of 2 weeks, the back-to-back inspections focused on a total of 9 studies including 4 bioanalytical validations that were conducted in support of ANDA and NDA filings to the US FDA.  All 3 inspections concluded without a 483 Form being issued as BioPharma continues to build on its impressive regulatory track history with zero observations.

BioPharma’s US-based clinical facility in Columbia, MO, underwent 2 sequential FDA inspections with impressive results.  Since our opening in 2014, the US-based clinical site has completed a number of pivotal programs to support drug submissions to the US FDA and is poised to undergo a clinical expansion to 120-beds this summer.  Following these 3 inspections across both sites, no Form 483s were issued, once again demonstrating BioPharma’s excellence and dedication to quality research.

All 3 inspections were hosted and led by BioPharma’s Sr. Management Team, Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs, Louis Co, VP of Global Clinical Operations and Dr. Nicki Hughes, VP of Bioanalytical Operations.  Under their leadership and direction, BioPharma continues to lead the industry in quality, innovation, and cost effectiveness.

“I am proud of both our teams in Canada and the US for maintaining the highest quality standards in delivering outstanding service to our clients. The dedication of our teams to provide excellent quality and timely service to our clients sets us apart,” stated BioPharma’s VP of Global Clinical Operations, Louis Co.

“The Bioanalytical audit was a success thanks to our attention to detail and highly skilled and competent laboratory team,” added Nicki Hughes, VP of Bioanalytical Lab Services.

Andjica Tasic, VP of Global Quality Assurance and Regulatory Affairs at BioPharma added, “The successful outcome of all three inspections is the direct result of hard work and dedication of our teams!   I’m extremely proud of all that we have and continue to accomplish!”

 

About BioPharma Services Inc.

BioPharma Services Inc. is a Full-Service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide.  The company has clinical facilities both in the USA and in Canada with a total bed capacity of 250 with access to healthy volunteers, special populations and patients.  Headquartered in Toronto, Canada, BioPharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.

For more information regarding this press release, please contact Ms. Anna Taylor, Executive VP of Business Development at ataylor@biopharmaservices.com

BioPharma Services, Inc. Completes Another Successful Inspection by the European Medicines Agency (EMA)

Toronto, ON – Bio Pharma Services, Inc. (Bio Pharma) ended their 10th year anniversary celebrations by announcing the successful EMA inspection of their Toronto based clinical and bioanalytical site.  The 5-day inspection which included a complete audit of their clinical, bioanalytical and pharmacokinetic units, was the first inspection conducted by the French National Agency for Medicines and Health Products Safety (ANSM) and the Danish Medicines Agency (DKMA) at Bio Pharma.  With the strong and positive outcome of this last inspection, Bio Pharma continues to build on its impressive regulatory achievements, having now completed inspections for all major jurisdictions in the global marketplace.  Bio Pharma’s outstanding regulatory history includes successful inspections by the US FDA, UK MHRA, Health Canada, Standards Council of Canada and ANVISA.

“This EU GCP audit comes on the heels of Bio Pharma successfully renewing its GLP certification with the Standards Council of Canada (SCC) just last week.  Our attention to detail and high quality is what sets us apart in the marketplace.  I am very proud of our contributions to safe and effective medicines,” stated Bio Pharma’s CEO, Renzo DiCarlo.

Andjica Tasic, Vice-President, Quality Assurance and Regulatory Affairs at Bio Pharma added: “The successful outcome of this EMA inspection was years in the making.  All of us here at Bio Pharma are committed to continuous improvement in our pursuit of excellence and executing R&D to the highest of standards.”

About Bio Pharma Services, Inc.

Bio Pharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide.  With clinical facilities in Columbia, Missouri and Toronto, Canada, Bio Pharma’s total bed capacity sits at 250 with an impressive subject database of healthy volunteers, special populations (which includes post-menopausal females, hypogonadal males, and recreational drug users) and patients.  Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.

 

For more information regarding this press release, please contact Ms. Anna Taylor, Vice President of Business Development at ataylor@biopharmaservices.com