BioPharma: Human Abuse Potential experts ready to support your clinical studies

OUR SERVICES

PHASE I/IIA

With our breadth and diverse medical and scientific expertise, BioPharma has created Phase I Centers of Excellence able to execute a wide variety of Phase I clinical trials for our global pharmaceutical community. With two Phase I centers located in each Toronto, Canada and Columbia, Missouri, BioPharma has been integral in the success of completing the following Phase I trials for our valued clients:

Proof-of-Concept
First-in-Human
SAD/MAD
Abuse Liability/Deterrent
Drug-Drug and Alcohol Interaction
Food-Effect
PK/PD
Safety and Tolerability
Medical Cannabis

BioPharma’s Physician Team has dedicated their professional careers to improving healthcare and providing innovative medical solutions to our communities. We’ve crafted a medical team that can be your trusted partner in the creation of leading-edge healthcare solutions and essential medical therapies.

For over 10+ years, the BioPharma team has worked tirelessly to build and develop a reliable and compliant database of healthy subject volunteers and special populations. With a current database of 18,000 active subject participants, our healthy volunteer segments are:

Healthy males and females
Caucasian males
Post-menopausal females and/or surgically sterile females
Hypogonadal males
Recreational drug users (opioid, cannabinoids and stimulants)

HUMAN ABUSE POTENTIAL

From our inception in 2006, BioPharma has amassed extensive experience in the conduct of clinical studies in opioids, narcotics and cannabinoid products. Under the Leadership of Dr. Janice Faulknor MD, CCFP, a 15 year veteran in clinical research on CNS products, Human Abuse Potential (HAP) and Abuse Deterrent Assessment programs, BioPharma’s capabilities to operationalize clinical trials to support abuse potential programs was developed.

BioPharma’s HAP team consists of a core team of abuse potential specialists that have been involved in the very first human abuse potential studies conducted under GCP in the early 2000s, and prior to the introduction of the FDA Guidances on Abuse Potential and Abuse Deterrent Assessment.
The team includes:

Dr. Janice Faulknor MD, CCFP, Medical Director and Principal Investigator – 15 years of research experience in HAP and Abuse Deterrent Assessment
Dr. Isabella Szeto MD, CCFP, FCFP, CPI, Principal Investigator – 13 years of clinical research experience with 200+ studies
Dr. John Oldenhof, MSc, PhD, VP of Clinical Pharmacology – 18 years of experience having overseen 300+ early phase and HAP and Abuse Deterrent Assessment studies
Shein Nanji, Manager of Subject Recruitment with over 10 years of experience building a robust database of recreational drug users

Dr. Oldenhof’s 18 year tenure in clinical pharmacology has largely been dominated by his work on the design and execution of HAP programs to support the FDA’s mandate for assessing the abuse potential of novel chemical entities and abuse deterrence for tamper-resistant technologies. 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.
Our competencies to support abuse potential clinical programs include:

 Protocol design and development
 Regulatory consultation
 Clinical study execution
 Recreational drug user recruitment
 Data Management
 Biostatistical analysis, including Statistical Analysis Plan (Development)
 Interpretation and report writing
 Ancillary services are also provided through our preferred partners

BIOEQUIVALENCE (BE) &
BIOAVAILABILITY (BA)

With over 2000+ studies conducted between two clinical sites in Toronto, Canada and Columbia, USA, BioPharma has built a brand of excellence in the conduct of Bioequivalence (BE)/Bioavailability (BA) studies to support both generic and hybrid drug filings and 505(b)(2) New Drug Applications.

With impeccable quality and reputable data in mind, the BioPharma team is trained and empowered to deliver its very best each and every day. This attention to detail is supported by numerous successful Regulatory Inspections from the US FDA, EMA, UK MHRA, ANVISA and Health Canada. With our in-house scientific and regulatory expertise, proficient in all major drug markets, BioPharma can support the full study conduct from study design and protocol inception to the issuance of the final Clinical Study Report.

With a strong profile of studies conducted on solid oral formulations, BioPharma has also amassed scientific intelligence in the conduct of studies for:

ODT and SL formulations
Inhalation products
Transdermal patches
Long-acting depot injections
Creams, suppositories and ointments

Our team of PK Scientists, Clinical Operation specialists and Clinical Investigators work together to ensure the competent execution of BE studies that adhere to the GCP principles that govern our industry. Supported by our Quality Control processes and governed by our Quality Assurance experts, we remain committed to delivering excellence in clinical research with an unwavering commitment to service and client satisfaction.

BioPharma has created two Phase I Centers of Excellence able to execute a wide variety of Phase I clinical trials for our global pharmaceutical community. With our Phase I centers located in Toronto, Canada and Columbia, Missouri, BioPharma has been integral in the success of completing the following Phase I trials for our valued clients:

First in Human (FIH)
Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD)
Absolute bioavailability
Safety and Tolerability
Food Effect study
Age and gender
Dose proportionality
Drug-Drug and Alcohol interaction studies
Human Abuse Potential/Abuse Deterrent Assessment
Medical Cannabis
Pharmacokinetics/Pharmacodynamics (PK/PD)
Exploratory clinical models for Proof-of-Concept decision making
BA/BE for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and deport injections)

Healthy males and females
Caucasian males
Post-menopausal and/or surgically sterile females
Hypogonadal males
Recreational drug users (opioid, cannabinoids and stimulants)

Dr. Janice Faulknor MD, CCFP, Medical Director and Principal Investigator – 15 years of research experience in HAP and Abuse Deterrent Assessment
Dr. Isabella Szeto MD, CCFP, FCFP, CPI, Principal Investigator – 13 years of clinical research experience with 200+ studies
Dr. John Oldenhof, MSc, PhD, VP of Clinical Pharmacology – 18 years of experience having overseen 250+ early phase and HAP and Abuse Deterrent Assessment studies
Shein Nanji, Manager of Subject Recruitment with over 10 years of experience building a robust database of recreational drug users

Protocol design and development
Regulatory consultation
Clinical study execution
Recreational drug user recruitment
Data Management
Biostatistical analysis, including Statistical Analysis Plan (Development)
Interpretation and report writing
Ancillary services are also provided through our preferred partners

With a strong profile of studies conducted on solid oral formulations, BioPharma has also amassed scientific intelligence in the conduct of studies for:

Solid oral dosage forms for IR, ER, MR formulations
ODT and SL formulations
Inhalation products
Transdermal patches
Long-acting depot injections
Creams, suppositories and ointments

BIOANALYSIS

With the constant change in technology driving science forward, bioanalysis continues to leap ahead improving the quality, accuracy and speed with which drug analysis in biological fluids is handled. Led by Dr. Nicki Hughes, a 20-year veteran in Bioanalytical Research, the lab team at BioPharma appreciates the importance of delivering quality and innovative solutions to support the drug development programs of our clients. Whether it’s combining the analysis of multiple compounds into a single assay (ie. Dolutegravir/Tenofovir/Lamuvidine) or utilizing a double extraction method to analyze drug products, we find solutions to expedite the turn-around times for analysis with quality and robust assays. This all starts with R&D and developing sound, rugged analytical methods that can be reproduced and repeated with consistent and accurate results time and time again.

With successful inspections by the US FDA, EMA, UK MHRA, ANVISA and Health Canada and GLP-certified by the Standards Council of Canada, BioPharma can provide reliable, reputable data to support drug submissions to multiple agencies for market authorization.

With almost impossible timelines in mind, the bioanalytical team at BioPharma has also successfully executed the analysis of clinical trial samples to support First-to-File ANDA submissions to the US FDA. With a turn-around target of a mere 48-hours, the team will work tirelessly around the clock to support our client’s endeavours in an increasingly competitive market place. Given our proven track record of success, let us assess the feasibility of your FTF program so we can be a valuable partner in your future achievements.

As drug potency also increases, driving the need for sensitive methodologies to detect even lower concentrations of drug in biological samples, BioPharma utilizes state-of-the-art LC/MS/MS platforms to meet this need. The scope of bioanalytical services offered at BioPharma include:

Method feasibility
Method development (GLP and non-GLP) and validation
Method transfers
Bioanalysis of biological samples from BE/BA studies and clinical PK studies
Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices

DATA MANAGEMENT

Along with the successful execution of a clinical study, of equal importance is the management of the data the study produces. That is, to assure the precise, reliable and accurate collection of data organized and packaged to meet the current regulatory and industry standards.

BioPharma ‘s onsite Phase I Data Management team is constantly looking for innovative and creative solutions to expand and improve on our processes and procedures that will allow us to give back to our clients by offering efficient, cost-effective services in a timely, expeditious manner.

BioPharma’s full offering of Data Management services includes:

Data Management Plan (DMP) development
eCRF design and development
Database Build & Design
Data validation specifications
Edit checks Programming & Testing
Collection of pharmacodynamics data and review
Single or double data entry
EDC Training
eCRF Completion Guidelines
Query Management
Third-party data integration
Customized clinical data management programming
Safety Data Management & Reconciliation
Interim Analysis readiness
Medical coding (CM, AE, MH)
Serious Adverse Event (SAE) reconciliation
Customized status reporting and data listings
Data Export/Transfer
Database closeout and delivery

Our comprehensive CDISC data conversion services include:

SDTM annotated CRFs
SDTM datasets
ADaM analysis datasets
Pooled analysis datasets (ISS/ISE)
Define.xml metadata and Define.pdf
CDISC controlled terminology
Data Handling report
FDA reviewers’ Guide
eCTD structure

SCIENTIFIC AFFAIRS

The regulatory landscape for drug approvals can often be a labyrinth, complex web to navigate through when trying to bring novel, life-saving medicines to the marketplace and to patients in need. With this in mind, the BioPharma team recognizes the value of our in-house expertise having spread our wings over a diverse number of clinical drug development programs for multiple therapeutic areas. Led by Dr. John Oldenhof and his 18+ years of being involved in innovative clinical development program design, BioPharma believes the blending of our expertise together with our clients proves to be a potent and effective strategy in the advancement of medical research.

The Scientific team at BioPharma includes a subset of seasoned Pharmacokinetic Scientists responsible for drug product design across multiple regulatory markets and Clinical Research Scientists focused on protocol/ICF development and CSR writing in eCTD format. Together, this team can advise on creative methodologies and innovative clinical development plans for all drug programs from generic equivalents to novel chemical entities. Designs include:

SAD/MAD
Absolute bioavailability
Food Effect study
Age and gender
BA/BE
Dose proportionality
Drug-Drug and Alcohol interaction studies
Human Abuse Liability and Potential
PK/PD
Cardiac safety including definitive QTc/Thorough QT (TQT)
Exploratory clinical models for Proof-of-Concept Proof-of-Concept

All study designs and clinical development plans at BioPharma are supported by our panel of expert Medical Physicians that ensure foremost that the safety and well-being of our study volunteers is priority. Whether the strategy is to dose a generic drug equivalent in healthy volunteers versus a patient panel or proceed with a new drug candidate, our Physician team’s primary objective is to maintain the health and welfare of our subjects with ethical considerations driving their decisions. By understanding the drug product’s pharmacokinetics, pharmacodynamics, mechanism of action and potential serious or adverse events, our Physicians are pioneers providing advanced, revolutionary solutions to clinical development programs.

Method feasibility
Method development (GLP and non-GLP) and validation
Method transfers
Bioanalysis of biological samples from BE/BA studies and clinical PK studies
Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices

BioPharma’s full offering of Data Management services includes:

Data Management Plan (DMP) development
eCRF design and development
Database Build & Design
Data validation specifications
Edit checks Programming & Testing
Collection of pharmacodynamics data and review
Single or double data entry
EDC Training
eCRF Completion Guidelines
Query Management
Third-party data integration
Customized clinical data management programming
Safety Data Management & Reconciliation
Interim Analysis readiness
Medical coding (CM, AE, MH)
Serious Adverse Event (SAE) reconciliation
Customized status reporting and data listings
Data Export/Transfer
Database closeout and delivery

Our comprehensive CDISC data conversion services include:

SDTM annotated CRFs
SDTM datasets
ADaM analysis datasets
Pooled analysis datasets (ISS/ISE)
Define.xml metadata and Define.pdf
CDISC controlled terminology
Data Handling report
FDA reviewers’ Guide
eCTD structure

The regulatory landscape for drug approvals can often be a labyrinth to navigate through when trying to bring novel, life-saving medicines to the marketplace and to patients in need. With this in mind, the BioPharma team recognizes the value of our in-house expertise having spread our wings over a diverse number of clinical drug development programs for multiple therapeutic areas. Led by Dr. John Oldenhof and his 18+ years of being involved in innovative clinical development program design, BioPharma believes the blending of our expertise together with our clients proves to be a potent and effective strategy in the advancement of medical research.

The Scientific team at BioPharma includes a subset of seasoned Pharmacokinetic Scientists and Clinical Research Scientists responsible for drug development and protocol design across multiple regulatory markets. Together, this team can advise on creative methodologies and innovative early stage clinical development plans for all drug programs from generic equivalents to novel chemical entities. Designs include:

First in Human (FIH)
Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD)
Absolute bioavailability
Safety and Tolerability
Food Effect study
Age and gender
Dose proportionality
Drug-Drug and Alcohol interaction studies
Human Abuse Potential/Abuse Deterrent Assessment
Medical Cannabis
Pharmacokinetics/Pharmacodynamics (PK/PD)
Exploratory clinical models for Proof-of-Concept decision making
BA/BE for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and deport injections)

All study designs and clinical development plans at BioPharma are supported by our panel of expert Medical Physicians, that ensure foremost, that the safety and well-being of our study volunteers is priority. Whether the strategy is to dose a generic drug equivalent in healthy volunteers versus a patient panel or proceed with a new drug candidate, our Physician team’s primary objective is to maintain the health and welfare of our subjects with ethical considerations driving their decisions. By understanding the drug product’s pharmacokinetics, pharmacodynamics, mechanism of action and potential serious or adverse events, our Physicians provide safe, reliable, data driven solutions to clinical development programs.

RECRUITMENT

Method feasibility
Method development (GLP and non-GLP) and validation
Method transfers
Bioanalysis of biological samples from BE/BA studies and clinical PK studies
Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices

BIOMETRICS/CDISC

Upon the successful execution of a clinical study, of equal importance is the management of the data the study produces. That is, to assure the precise, reliable and accurate collection of data organized and packaged to meet the current regulatory standards our industry is governed by.

The Data Management and Biometric teams at BioPharma is constantly looking for innovative and creative solutions to expand and improve on our processes and procedures that will allow us to give back to our clients by offering efficient, cost-effective services in a timely, expeditious manner.

BioPharma’s full offering of Data Management services includes:

eCRF design
Database build, set-up and validation
Double data entry
Data cleaning and query resolution
Medical coding
Reconcilliation of Serious Adverse Events
Third party data handling and database transfers
Quality review (QC/QA assessments) for final DB lock

DM activities are executed in a parallel fashion with Biostatistic activities. Like a symbiotic relationship, data that is captured, cleaned, and verfied is then passed on to our Biostatisticians to derive the data sets and analyses that are submitted to the agencies for review.

BioPharma’s suite of biostatistical services include:

Sample size calculations
Randomization schemes
Statisitcal Analysis Plan (SAP including mock shells)
SAS programming and validation
STDM and ADaM datasets
Tables, listings and figures

With the release of the US FDA’s guidance on Standardized Study Data (Dec 2014), CDISC data standards are becoming routine and common place for all phases of clinical drug development and submissions to the FDA.

Study data standards defines a way to present data in a consistent format. Examples of these standards include Study Data Tabulation Model (SDTM) for the tabulation of data and CDISC Analysis Data Model (ADaM) for statistical analysis.

Compliance with CDISC standards at Bio Pharma will start at data collection. By designing the CRF using CDASH standards this will allow for the smooth and easy flow of data into SDTM and ADaM datasets.

Standard CDISC services offered by BioPharma include:

CDASH compliant CRF’s
SDTM and ADaM datasets
XML formats

PHARMACOKINETICS

Pharmacokinetics (PK) is a fundamental component of the clinical drug development process. Understanding the basic PK and metabolism characteristics of the drug compound will eventually reveal the appropriate drug regimen for a patient. Before this milestone materializes, years of clinical design and research is needed with copious amounts of PK data generated to establish the appropriate route of administration, safe and effective therapeutic doses, and the frequency and duration of dosing to sustain the intended therapeutic effects.

BioPharma’s team of Pharmacokinetic Scientists are experts in their field, having generated thousands of study designs to support drug submissions to multiple regulatory markets across the globe. The team is also responsible for developing innovative design solutions for all drug programs from generic equivalents to new drug candidates.

All study designs and clinical development plans at BioPharma are supported by our panel of expert Medical Physicians that ensure foremost that the safety and well-being of our study volunteers is priority. Whether the strategy is to dose a generic drug equivalent in healthy volunteers versus a patient panel or proceed with a new drug candidate, our Physician team’s primary objective is to maintain the health and welfare of our subjects with ethical and safety considerations driving their decisions. By understanding the drug product’s pharmacokinetics, pharmacodynamics, mechanism of action and potential serious or adverse events, our Physicians provide safe, reliable, data driven solutions to clinical development programs.

Subject recruitment has long been recognized as a fundamental element of success for any clinical trial. Failure to meet recruitment goals can have devastating and costly impacts to any drug program so the need for a reliable database of study volunteers and proven and effective recruitment campaigns are paramount. Over the years at BioPharma, the Recruitment Team have implemented a comprehensive approach to trial recruitment that has built our database to over tens of thousands of compliant, well-informed and willing study participants including special populations. Developing strong relationships with our subject volunteers, building rapport and simply treating them with civility and honesty builds mutual trust and respect to ensure the integrity and reliability of the data they produce.

With a current database of 18,000 active subject participants between our two clinical sites, our healthy volunteer segments are:

Healthy males and females
Caucasian males
Post-menopausal females
Low testosterone males
Recreational drug users (opioid, cannabinoids and stimulants)

To further ensure the integrity of the data produced and the safety and well-being of our subjects, at our Toronto Headquarters, BioPharma utilizes a biometric fingerprint technology that avoids dual enrolment by study participants with other clinical sites. By using a secure and blinded database validated according to 21 CFR Part 11, BioPharma improves the clinical trial landscape for all stakeholders.

Data management processes are executed in a parallel fashion with the Biostatistic activities. Like a symbiotic relationship, data that is captured, cleaned, and verified is then passed on to our Biostatisticians to derive the data sets and produce the analyses that are submitted to the agencies for review.

BioPharma’s suite of biostatistical services include:

Sample size calculations
Randomization schemes
Statistical Analysis Plan (SAP including mock shells)
SAS programming and validation
Tables, listings and figures

Compliance with CDISC standards at BioPharma will start at data collection. By designing the CRF using CDASH standards, this will allow for the smooth and easy flow of data into SDTM and ADaM datasets.

Standard CDISC services offered by BioPharma include:

CDASH compliant CRF’s
SDTM and ADaM datasets
Define .XML formats

All study designs and clinical development plans at BioPharma are supported by our panel of expert Medical Physicians that ensure foremost that the safety and well-being of our study volunteers is priority. Whether the strategy is to dose a generic drug equivalent in healthy volunteers versus a patient panel or proceed with a new drug candidate, our Physician team’s primary objective is to maintain the health and welfare of our subjects with ethical and safety considerations driving their decisions. By understanding the drug product’s pharmacokinetics, pharmacodynamics, mechanism of action and potential serious or adverse events, our Physicians provide safe, reliable, data driven solutions to clinical development programs.