BioPharma Services Inc. (BPSI) announces the 2016 recipient of the Lorelei Lutter Fine Arts Scholarship

BioPharma Services Inc. (BPSI) announces the 2016 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 May He Tesoro with the Lorelei Lutter Fine Arts Scholarship.  May has shown remarkable talent in fine arts genre of vocalist and dancer, winning a number of Kiwanis and provincial musical awards — commented Renzo DiCarlo, CEO of BioPharma Services Inc.

final-medium

The scholarship will be awarded on September 28th, 2016 to May He Tesoro, daughter of Juan He, a Biopharma employee.

May is entering her first year at St. Brother Andres Catholic High school.  May started singing at the age of two (2) and on stage solo at age four (4).  She also plays piano and also does ballet and traditional dance. May’s future educational goals are to specialize in Human Sciences and continue her studies as a vocalist.

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

Bio Pharma Services, Inc. Acquires Key Intellectual Property and Human Resource Assets of Bioanalytical Laboratory Services (BLS)

Bio Pharma Services, Inc. Acquires Key Intellectual Property and Human Resource Assets of Bioanalytical Laboratory Services (BLS).

 Toronto, Canada – Bio Pharma Services, Inc. (Bio Pharma) is proud to announce that it has acquired key human resource assets along with a list of validated assays from Bioanalytical Laboratory Services (BLS). Over the past 3 years, BLS, led by Lab Director, Nicola Hughes, Ph.D., has built a leading bioanalytical research centre specializing in complex method development, method validation and the analysis of biological samples for pre-clinical and clinical drug trials (BA/BE studies). BLS assets will be combined with Bio Pharma’s existing Bioanalytical Lab to further expand and fortify its analytical services and become a global leader in clinical research.

“We are very proud to combine the best of Bio Pharma’s existing bioanalytical lab with the best of BLS. Under the scientific leadership of Dr. Hughes, the expanded lab at Bio Pharma will be able to immediately offer challenging and complex new assays while strengthening our Scientific R&D team. This is just one  of a list of benefits associated with merging the assets of two great labs at Bio Pharma.” said Renzo DiCarlo, CEO at Bio Pharma Services, Inc.

Effective immediately, Dr. Hughes will be appointed to the Bio Pharma Executive Team as the Vice- President of Lab Operations. “I am extremely excited about my team joining the Bio Pharma team and believe together, by offering scientific excellence, high quality assays and our commitment to providing exceptional service to our clients, we are ideally suited for the early stage research market.”

With this news, existing BLS client projects will be honoured and completed as planned at the current BLS facility. Anna Taylor, Vice-President of Business Development reiterated, “We truly are a client centered organization driven by science and quality research. I am excited that we have this opportunity to share our expanded BA lab expertise and service for both past and future clients under this new team at Bio Pharma.”

The statements in this press release are solely expressed and made by Bio Pharma Services, Inc.

 
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 and Bioequivalence clinical trials for international pharmaceutical companies worldwide. Bio Pharma has clinical facilities both in the USA and Canada with a total capacity of 250 beds with access to healthy volunteers, special populations and patients. Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis, Medical Writing and Data Management.

 
About Bioanalytical Laboratory Services (“BLS”)

Bioanalytical Laboratory Services is a Contract Research Organization (“CRO”) that specializes in the development, validation and application of LC-MS/MS bioanalytical methods for pre-clinical, non-clinical, Phase 1, and BA/BE clinical trials. The business employs a team who service clinical CROs and generic drug manufactures from BLS’ Toronto based laboratory.

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

BioPharma Services USA Inc. Awarded a 5 Year – $20 Million USD Contract with the US FDA

COLUMBIA, MO.­­ (BUSINESS WIRE)­­ BioPharma Services USA, Inc. (BioPharma) is proud to announce that it has been awarded a 5­-year, $20 million contract with the Center for Drug Evaluation and Research

(CDER), a division of the US Food and Drug Administration (FDA). The contract is to conduct in vivo studies of generic drug products in human subjects over a period of five years, from 2016 through to 2021.

“We are very proud to work with the FDA in support of their Generic Drug programs. This award is a great example of BioPharma’s capabilities as a leading industry expert in Bioequivalence and Early Stage clinical research,” said Renzo DiCarlo, CEO at BioPharma Services, Inc.

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

Brent Matthews, COO at BioPharma Services Inc. added: “I am certain that our outstanding regulatory history with the FDA and our team’s extensive expertise in the conduct of Bioequivalence trials played a major role in landing this important contract with the FDA.”

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 250 beds with access to healthy volunteers, special populations and patients. 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, 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
Vice President, Business Development
ataylor@biopharmaservices.com

Source: BioPharma Services, Inc.
View this news release online at: http://www.businesswire.com/news/home/20160520005856/en

BioPharma Services Inc. – Three inspections, Two sites, One company, Zero 483’s!

Toronto, ON – BioPharma Services Inc. (BioPharma) is proud to announce that it has once again successfully completed inspections by the US FDA, with concurrent audits at both of the Phase I/IIa clinical sites in Toronto, and Columbia, MO.

With back to back audits of the clinical facilities and bioanalytical laboratory in Toronto, BioPharma continues to build an impressive regulatory track record, having now completed 6 successful FDA inspections at their parent location.

BioPharma’s US-based clinical site in Columbia, MO underwent a simultaneous FDA inspection, with equally impressive results.  Since it’s opening in 2014, the US-based clinic has completed a number of pivotal studies for submission to the US FDA.  This inspection marks a critical milestone for the organization as the first-ever regulatory inspection for the US site.

Following all three inspections across both sites, no Form 483s were issued, once again demonstrating BioPharma’s excellence and dedication to quality research. These inspections add to the long list of BioPharma’s outstanding audit history with USA FDA, UK MHRA, Standards Council of Canada, Health Canada and ANVISA.

“This is a significant milestone for our USA site in Missouri as this was their first FDA audit and I am proud of both our teams in Canada and USA for maintaining the highest quality standards in delivering outstanding service to our international clients. The dedication of our teams to provide excellent quality and timeline oriented service to our clients is what makes us so successful!” stated BioPharma’s CEO, Renzo DiCarlo.

Andjica Tasic, Sr. Director of 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 everyone at BioPharma as well as our commitment to upholding the highest quality standards in conducting clinical trials at our facilities in Canada and USA!”

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 U.S.A. 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, Senior Director, Business Development at ataylor@biopharmaservices.com