BioPharma Services, winner of four CRO Leadership Awards

BioPharma Services is excited to receive CRO Leadership awards in four areas this year – Expertise, Capability, Reliability, Compatibility.

Renzo Dicarlo, CEO shared “The passion and dedication of the BioPharma Services team to building and maintaining long lasting relationships through quality service and reliable research results is humbling. Their unwavering commitment to our clients is evident by receiving awards in these four categories.”

For the 2018 CRO Leadership Awards, Life Science Leader magazine once again teamed up with Industry Standard Research (ISR) to determine the award recipients. More than 70 contract research organizations were assessed on 25+ performance metrics in ISR’s annual CRO Quality Benchmarking survey.

“Industry Standard Research is honored to conduct the research for Life Science Leader’s CRO Awards. ISR’s stringent screening processes and the high caliber of qualification required to participate in our CRO benchmarking research means that real customers provide experiential feedback on their involvement with contract suppliers over the past 18 months. This enables users of ISR’s research to make confident business decisions based on the experiences of their industry peers” said Andrew Schafer, President of Industry Standard Research.

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

About BioPharma Services Inc.

BioPharma 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. 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.

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

MedReleaf and BioPharma Services Inc. announce Strategic Alliance

Exclusive agreement to conduct clinical research to advance the development of MedReleaf’s cannabinoid health and drug products

Toronto, ON May 29­­ – MedReleaf Corp. (TSX:LEAF) (“MedReleaf” or the “Company”) and BioPharma Services Inc. (BioPharma) today announced they have entered into an exclusive agreement to conduct clinical research for cannabis and cannabis derived products. Under the agreement BioPharma will become an extension of MedReleaf’s clinic development team.

BioPharma will provide medical, clinical, pharmacological and lab expertise to expedite MedReleaf’s product strategy to support in-market products as well as products under development for registration in Canadian and international markets.

Biopharma is well positioned to accelerate MedReleaf’s product development and clinical research programs through their international experience in running early phase clinical trials. MedReleaf and Biopharma will jointly provide scientific and regulatory guidance to clinical research studies supporting MedReleaf’s product launches in the months to come.

“This strategic alliance sets us apart in the clinical research and development space for cannabis and cannabis derived products and will facilitate much needed cannabinoid therapies to assist in the treatment of pain, inflammatory conditions, mental health, palliative care and underserved therapeutic areas.” said Angelo Fefekos, Senior Vice President Clinical Affairs and Quality Assurance at MedReleaf.

“We are very proud to work with MedReleaf in support of their cannabinoid natural health and drug strategy. This alliance is a great example of Biopharma’s capabilities as a Phase I industry leader with expertise in CNS, pain and abuse liability.” said Renzo DiCarlo, CEO at Biopharma Services, Inc.

About MedReleaf (TSX.LEAF)

Canada’s most awarded licensed producer, MedReleaf is an R&D-driven company dedicated to innovation, operational excellence and the production of industry leading, top-quality cannabis. Sourced from around the world and carefully cultivated in one of two state-of-the-art ICH-GMP and ISO 9001 certified facilities in Ontario, with a third facility currently in development, a full range of premium MedReleaf products are delivered to the global medical market. We serve the therapeutic needs of patients seeking safe, consistent and effective medical cannabis and provide a compelling product offering for the adult-use recreational market.

For more information on MedReleaf, its products, research and how the company is helping patients #livefree, please visit MedReleaf.com or follow @medreleaf

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.

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

Contact Information:
Denise Riposati, Corporate Communications, driposati@medreleaf.com, 289-317-1000 ext. 1118
Ms. Anna Taylor, Executive Vice President, Business Development, BioPharma Services, Inc.
ataylor@biopharmaservices.com

BioPharma Services Inc. Welcomes their New VP of Pharmacology and PI with AL Expertise

BioPharma Services, Inc. Welcomes Abuse Liability Experts, Dr. John Oldenhof, VP of Clinical Pharmacology and Dr. Isabella Szeto, Principal Investigator to the BioPharma Team

Toronto, ON­­ (BUSINESS WIRE) ­­ BioPharma Services, Inc. (BioPharma) is honored to announce the addition of Dr. John Oldenhof, PhD, and Dr. Isabella Szeto, MD, CCFP, FCFP, CPI, to the Senior Management team here at BioPharma.  Dr. Oldenhof, joins the BioPharma organization as the VP of Clinical Pharmacology and Dr. Szeto joins the Medical Affairs team at BioPharma as Principal Investigator.  The addition of these two key research professionals, experienced in Phase I and Abuse Liability trials, fortifies BioPharma’s early stage clinical expertise and strength, and positions itself to become an industry leader in the conduct of Human Abuse Liability and Abuse Potential clinical studies.

BioPharma welcomes Dr. Oldenhof who has 18+ years of Sr. Management experience in Phase I clinical pharmacology, product development, biostatistics, data management and regulatory and scientific affairs.  His published work and experience includes the development of novel methodologies, innovative study designs and direct collaboration with the US Food and Drug Administration (FDA) to advance human abuse potential studies and pharmacometrics analyses.  Over his tenure in Clinical Pharmacology, Dr. Oldenhof has provided scientific and regulatory guidance to biotech and pharmaceutical sponsors on over 200 clinical pharmacology studies including FIM, SAD/MAD, DDI and TQT studies to support pre-IND, NDA, ANDA and product launches.

Dr. Oldenhof who will lead the units of Scientific Affairs/PK, BioStatistics, CDM and Medical Writing under the new umbrella of Clinical Pharmacology at BioPharma Services, Inc. stated, “I am excited to be joining an agile, Early Phase focused company. I look forward to contributing my skills to the BioPharma team and in turn help our clients to maximize their Early Phase efforts.”

Dr. Szeto comes to BioPharma with 13+ years of Phase I clinical research experience as Principal and Sub-Investigator.  Having started her clinical research career under the mentorship of Dr. Ed Sellers, Dr. Szeto has continued on to conduct over 150 clinical studies on various CNS products to evaluate their abuse liability or abuse potential.  In addition to her AL/AP expertise, she also has managed a variety of early stage clinical research trials which include FIM, QT, DDI, BA/BE, Food-Effect, Skin Irritation/Sensitization and vaccine trials.

“The addition of these two medical and pharmaceutical experts has further propelled us into the CNS, pain and HAL/HAP sector. Our current research and development initiatives in cannabinoids, opioids and numerous other controlled substances has set up apart as a research leader in this domain” said Renzo Dicarlo, CEO at BioPharma Services, Inc.

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:
Ms. Anna Taylor
Executive Vice President, Business Development, BioPharma Services, Inc.
ataylor@biopharmaservices.com

BioPharma Services Inc. has completed its 1st First-to-File Bioanalytical project in less than 48 hours!

After an intense three month development process, BioPharma Services is excited to report the completion of our 1st bioanalytical, First-to-File bioequivalence project. With increased process efficiencies and reduced lab timelines, we were able to analyze several thousand samples and produce two final reports in less than 48 hours.

Our Bioanalytical Lab, which is GLP certified and has been inspected by FDA, MHRA, Health Canada, EMA (ANSM & DKMA) and ANVISA, is led by Dr. Nicola Hughes, VP of Lab Operations. Dr. Hughes’ 20+ years’ experience in the CRO industry was a major contributor to the success of this project. She praised her team’s dedication saying “This team always produces outstanding work but their commitment and dedication to this project, our sponsor and the company was truly astounding to witness.  Our Lab and QA teams worked around the clock to ensure that a successful, quality outcome was achieved. They really went above and beyond”.

“We are exceptionally proud that our amazing Lab Team was able to meet this very challenging target. It proves once again that our planning, organisation and execution strategies are well managed. These process improvements will certainly be beneficial for all future projects” said Anna Taylor, Executive Vice-President of Business Development.

The Lab, and also our 120-bed clinic facility in Columbia, MO are both First-to-File ready.  Contact us now to find how we can work together on competitive winning timelines for your project.

We look forward to collaborating with you!

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