5th Human Abuse Liability Testing & Market Access conference provides an unequaled forum for networking with the leaders in pain management, toxicology, drug safety, abuse deterrence, commercialization, and pharmacovigilance. If you are interested in highlighting your skill at assisting drug companies with regulatory approval, securing reimbursement, or other related areas, please contact Christopher Summa at 917.932.0432 or [email protected].
Alcami is a world-class fully-integrated end-to-end contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With over 1,000 employees operating at 10 global locations, Alcami provides customizable and innovative services to small and mid-size pharmaceutical and biotechnology companies by offering individualized and integrated services across multiple areas. We connect our clients with innovative solutions for API development and manufacturing, solid-state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. For more information, please visit alcaminow.com.
Altasciences is a contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, Altasciences provides preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Altasciences’ full-service solutions offering in this critical stage of drug development includes preclinical safety testing, clinical pharmacology services, medical writing, biostatistics, data management, bioanalysis and overall program management.
Analgesic Solutions, LLC., founded in 2006, is a privately held company that reduces the risks in clinical trials through consulting, innovative tools and technology. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for mitigating risk associated with measurement error in clinical trials.
Since 2006, BioPharma Services has conducted early phase clinical research on conventional pain therapies including opioid, narcotic and cannabinoid products and have successfully executed clinical studies for submission to the US FDA. BioPharma operates globally with major clinical centers in Toronto, Canada and Columbia, USA and a Bioanalytical Laboratory serving both sites. With a database of over 3500 recreational drug users and approved storage for controlled drug products, BioPharma is well positioned to support Abuse Liability programs. Additional services include: Regulatory and Scientific Affairs, Project Management, Bioanalysis (LC/MS/MS platform), Biostatistical Analysis, Data Management (CDISC data standards including SDTM and ADaM datasets) and Medical Writing (eCTD ready reports).
DRUGSCAN©’s CAT.one® laboratory-based manipulation and extraction studies are designed and conducted to produce data that can predict a product’s strengths and weaknesses to physical and chemical manipulations as well as support abuse-deterrent label claims. Employing state of the art technology and abuse-deterrent testing expertise, DRUGSCAN© has been at the forefront of designing and conducting manipulation and extraction studies for many of the leading innovator and generic abuse-deterrent product developers in the US and around the world.
We are an entrepreneurial, science-based pharmaceutical company – specialized in pain, gout and inflammation – with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients.
We are an independent, family-owned company headquartered in Aachen, Germany; present in approx. 30 countries with affiliates in Europe, Latin America and the US. Our products are sold in more than 100 countries and approx. 5,200 employees are working for Grünenthal worldwide. In 2017, Grünenthal achieved revenues of approx. € 1.3 bn.
Hassman Research Institute
Hassman Research Institute (HRI) is a leading clinical research organization conducting studies in a wide variety of therapeutic areas. HRI’s 40-bed inpatient facility offers safety resources required for the unique needs of abuse liability studies.
HRI’s staff is highly trained and experienced, including board-certified investigators with DEA schedule I and II licenses, X Waivers, a pharmacist with compounding and over-encapsulation experience, and Doctorate and Masters-level dedicated raters with decades of experience in addiction research and the administration of over 50 common HAL/addictions assessments. HRI is associated with five multi-specialty medical practices with addiction treatment clinics located in the Philadelphia area. The area is home to over thirty colleges, allowing HRI’s full-time dedicated enrollment staff access to a vast population of drug abusers, recreational drug users, and healthy subjects.
The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System collects timely product- and geographically-specific prescription drug abuse, misuse and diversion data and provides these data to the pharmaceutical industry, regulatory agencies, policymakers and medical/public health officials. The RADARS® System is a governmental nonprofit operation of Denver Health and Hospital Authority.
RADARS System data have been utilized by manufacturers, regulatory agencies, and medical and public health officials to characterize and monitor prescription drug abuse, misuse, and diversion. The data have been presented at several United States (US) Food and Drug Administration (FDA) advisory committee meetings and scientific meetings as well as in reports to the FDA, new drug applications, labeling claims, postmarketing requirements, and Risk Evaluation and Mitigation Strategies (REMS) evaluation. Data may also be used for the development of interventions, to assess the impact of interventions (i.e. abuse deterrent formulations), and to monitor ever-changing market trends.
Syneos Health Consulting is a management consulting firm specializing in the biopharmaceutical industry and part of Syneos Health, the only fully integrated biopharmaceutical solutions organization. We provide services across a comprehensive range of key areas, including portfolio strategy, brand commercialization, and commercial model strategy/planning; medical and regulatory affairs; risk and program management; and pricing, market access, and HEOR. Recognized by Forbes magazine as one of America’s Best Management Consulting Firms, we combine industry focus and depth of functional expertise with strong scientific and market knowledge to tackle highly complex business and market challenges and develop actionable strategies for our clients. For more information, visit https://www.syneoshealth.com/solutions/consulting