This document provides information about an upcoming event hosted by Women In BIO Chicago on March 19th, 2015 titled "Confessions of the Clinical Minds". It includes brief biographies of several speakers who will share their experiences in clinical development and operations. The event will be held at 5:30pm at the Astellas office in Northbrook, Illinois. Contact information is provided for any questions. Additional past and upcoming events organized by Women In BIO Chicago are also listed.
Avoca Quality Consortium Summit 2013 Bio BookletThe Avoca Group
The document summarizes an upcoming summit hosted by the Avoca Quality Consortium. The summit will explore how sponsors and CROs can balance timelines, costs, and quality in clinical trials. It will include panels on effective oversight, risk assessment, risk management, and culture. Industry leaders will also discuss key priorities for quality moving forward. The summit aims to advance best practices for proactive quality management among members, which include pharmaceutical, biotech, and CRO companies.
The survey examined how clinical research outsourcing relationships between sponsors and service providers are expected to change between 2010-2014. 285 respondents participated, including 109 sponsors and 174 service providers. For sponsors, the top changes made/planned to improve efficiency included better measurement of provider performance, increased use of preferred providerships, and better methods for provider selection. Respondents were asked about drivers of change and how planned changes may impact outsourcing strategies and relationships over this time period.
The document describes an upcoming summit hosted by the Avoca Quality Consortium in 2013. The Consortium brings together quality, outsourcing, and operational professionals from pharmaceutical, biotech, and clinical research organizations to develop best practices for proactive quality management in outsourced clinical trials. The summit will feature sessions on finding the right balance between timelines, costs, and quality in clinical trials, and will include discussions on effective oversight, risk assessment, risk management, and culture in ensuring quality. Industry leaders will also discuss key imperatives for quality moving forward.
The Avoca Quality Consortium Summit, held May 8-9, 2013, in
Princeton, NJ, was the Second Annual meeting for The Avoca
Group’s Quality Consortium, a cooperative effort that brings
together quality, outsourcing, and operational professionals
from Member pharma, biotech, and CRO organizations to
accelerate the development of a best-practices approach to
quality management and CRO oversight.
Currently, the Avoca Group’s Quality Consortium includes
26 Members: 16 pharma/biotech companies and 10 Contract
Research Organizations (CROs). The corporate sponsors of the Quality Consortium are Eli Lilly and Company and Pfizer, Inc. ICON Clinical Research was the corporate sponsor of the May Summit.
Special thanks to our Executive Summary Sponsor,
inVentiv Health Clinical.
Avoca Quality Consortium 2014 Summit Bio BookletThe Avoca Group
The document summarizes the 2014 Avoca Quality Consortium Summit, which brought together quality and operations professionals from pharmaceutical, biotechnology, and clinical research organizations. The goal was to accelerate the development of best practices for proactive quality management in clinical trials. Key topics included breaking down silos, advancing technology, and building bridges to patients. Guest speakers addressed transforming clinical trial execution to improve quality. The summit provided a forum for open discussion and new ideas to emerge.
Vedic Lifesciences is a contract research organization founded in 2000 that provides drug development services to pharmaceutical companies. It has managed over 34 clinical trials and 248 preclinical studies across multiple therapeutic areas. Services include regulatory submissions, clinical project management, data management, biostatistics, and medical writing. Vedic has experience in areas such as oncology, diabetes, orthopedics, andrology, and inflammation. It employs a team of experts including clinical researchers, medical writers, and regulatory specialists to support its clients.
Vedic Lifesciences is a contract research organization founded in 2000 that provides drug development services to pharmaceutical companies. It has managed over 34 clinical trials and 248 preclinical studies across multiple therapeutic areas. Services include regulatory submissions, clinical project management, data management, biostatistics, and medical writing. Vedic has experience in areas such as oncology, diabetes, orthopedics, andrology, and inflammation. It employs a team of experts including clinical researchers, medical writers, and regulatory specialists to support its clients.
Clinical Research|Clinical Research Organisation|Clinical Development of drugskeerthipriya197
Abiogenesis Clinpharm Private Limited is a Clinical Research Organization(CRO) having experience and expertise in Clinical development of drugs, Bio-similar, Vaccine and Devices from preclinical to Phase IV clinical trials involving different study populations and many therapeutic areas for Nutraceutical and Pharmaceutical Companies & Pharmacovigiance Companies in Hyderabad and Clinical Research Companies in Hyderabad. Our expertise team will ensure efficient project management in managing Clinical trial services in different areas like Cancer Clinical Research Services, Oncology Clinical trial, Pharmaceutical data management, Clinical Study data management, Vaccienceutical clinical Trials, Pre-clinical drug development, Bio-similar Clinical Trials, Cancer Clinical Research Services. We offered end-to-end service for organisation whether it may be single project or designing a full-service. We are ready to assist you in clinical trial management for Clinical trials in oncology new drug development.
Avoca Quality Consortium Summit 2013 Bio BookletThe Avoca Group
The document summarizes an upcoming summit hosted by the Avoca Quality Consortium. The summit will explore how sponsors and CROs can balance timelines, costs, and quality in clinical trials. It will include panels on effective oversight, risk assessment, risk management, and culture. Industry leaders will also discuss key priorities for quality moving forward. The summit aims to advance best practices for proactive quality management among members, which include pharmaceutical, biotech, and CRO companies.
The survey examined how clinical research outsourcing relationships between sponsors and service providers are expected to change between 2010-2014. 285 respondents participated, including 109 sponsors and 174 service providers. For sponsors, the top changes made/planned to improve efficiency included better measurement of provider performance, increased use of preferred providerships, and better methods for provider selection. Respondents were asked about drivers of change and how planned changes may impact outsourcing strategies and relationships over this time period.
The document describes an upcoming summit hosted by the Avoca Quality Consortium in 2013. The Consortium brings together quality, outsourcing, and operational professionals from pharmaceutical, biotech, and clinical research organizations to develop best practices for proactive quality management in outsourced clinical trials. The summit will feature sessions on finding the right balance between timelines, costs, and quality in clinical trials, and will include discussions on effective oversight, risk assessment, risk management, and culture in ensuring quality. Industry leaders will also discuss key imperatives for quality moving forward.
The Avoca Quality Consortium Summit, held May 8-9, 2013, in
Princeton, NJ, was the Second Annual meeting for The Avoca
Group’s Quality Consortium, a cooperative effort that brings
together quality, outsourcing, and operational professionals
from Member pharma, biotech, and CRO organizations to
accelerate the development of a best-practices approach to
quality management and CRO oversight.
Currently, the Avoca Group’s Quality Consortium includes
26 Members: 16 pharma/biotech companies and 10 Contract
Research Organizations (CROs). The corporate sponsors of the Quality Consortium are Eli Lilly and Company and Pfizer, Inc. ICON Clinical Research was the corporate sponsor of the May Summit.
Special thanks to our Executive Summary Sponsor,
inVentiv Health Clinical.
Avoca Quality Consortium 2014 Summit Bio BookletThe Avoca Group
The document summarizes the 2014 Avoca Quality Consortium Summit, which brought together quality and operations professionals from pharmaceutical, biotechnology, and clinical research organizations. The goal was to accelerate the development of best practices for proactive quality management in clinical trials. Key topics included breaking down silos, advancing technology, and building bridges to patients. Guest speakers addressed transforming clinical trial execution to improve quality. The summit provided a forum for open discussion and new ideas to emerge.
Vedic Lifesciences is a contract research organization founded in 2000 that provides drug development services to pharmaceutical companies. It has managed over 34 clinical trials and 248 preclinical studies across multiple therapeutic areas. Services include regulatory submissions, clinical project management, data management, biostatistics, and medical writing. Vedic has experience in areas such as oncology, diabetes, orthopedics, andrology, and inflammation. It employs a team of experts including clinical researchers, medical writers, and regulatory specialists to support its clients.
Vedic Lifesciences is a contract research organization founded in 2000 that provides drug development services to pharmaceutical companies. It has managed over 34 clinical trials and 248 preclinical studies across multiple therapeutic areas. Services include regulatory submissions, clinical project management, data management, biostatistics, and medical writing. Vedic has experience in areas such as oncology, diabetes, orthopedics, andrology, and inflammation. It employs a team of experts including clinical researchers, medical writers, and regulatory specialists to support its clients.
Clinical Research|Clinical Research Organisation|Clinical Development of drugskeerthipriya197
Abiogenesis Clinpharm Private Limited is a Clinical Research Organization(CRO) having experience and expertise in Clinical development of drugs, Bio-similar, Vaccine and Devices from preclinical to Phase IV clinical trials involving different study populations and many therapeutic areas for Nutraceutical and Pharmaceutical Companies & Pharmacovigiance Companies in Hyderabad and Clinical Research Companies in Hyderabad. Our expertise team will ensure efficient project management in managing Clinical trial services in different areas like Cancer Clinical Research Services, Oncology Clinical trial, Pharmaceutical data management, Clinical Study data management, Vaccienceutical clinical Trials, Pre-clinical drug development, Bio-similar Clinical Trials, Cancer Clinical Research Services. We offered end-to-end service for organisation whether it may be single project or designing a full-service. We are ready to assist you in clinical trial management for Clinical trials in oncology new drug development.
The document summarizes a proposal for a new bus terminal in downtown Toronto. It would replace the existing Union Station and Toronto Coach terminals by consolidating all commuter bus services into a single large terminal. The proposed design is helix-shaped, with separate circulation routes for eastbound and westbound buses to improve efficiency. It provides more bus platforms and capacity than the existing terminals to accommodate future growth in ridership. The helical design reduces road congestion by allowing buses to park internally without blocking traffic.
Now What? Federal Market Outlook After the March Budget MadnessPrivia LLC
Brian Friel and Kevin Brancato, senior analysts with Bloomberg Government, break down the impact that sequestration and looming budget cuts will have on federal agencies and the contracting industry.
This presentation was originally given at Achieve 2013, Privia's annual user's conference, on February 20, 2013. It has been reproduced with permission from Bloomberg Government. Get more on the federal market at http://www.bgov.com.
The 2014 ACE Business Meeting covered the organization's year in review, finances, leadership transition, and goals for the future. Key topics discussed included completing the membership database, establishing SIG leadership, hosting professional development webinars, improving communications, and strategic planning. The treasurer presented the financial report. New directors and officers were welcomed while others continued in their roles. The meeting thanked volunteers and looked ahead to ACE's centennial celebrations.
This document provides a summary of key differences and new features between Windows 7 and Windows 8. It notes that Windows 8 has a slightly smaller image size and faster installation time than Windows 7. It also discusses enhancements to BitLocker, UEFI, Secure Boot, and new application packaging in Windows 8. The document outlines changes to tools like DISM, USMT, ADK, and the addition of tools like Storage Spaces and Windows Performance Toolkit in Windows 8. It encourages readers to learn more about deployment and management of Windows 8 using the Microsoft Deployment Toolkit.
Oficina de Distribuição e Marketing para Cinema com José Agripino_Aula 1 Hellen Cortezolli
O documento discute estratégias de distribuição e marketing para curtas-metragens, incluindo envio de filmes para festivais, produção de sinopses, fotos e press kits. Também fornece dicas sobre prazos de festivais, circuito de festivais e apoio da ANCINE.
HBA Metro, Women in Science: Personalized Medicine Seminar at BMSAlane Taratuska
The document summarizes a panel discussion event on personalized medicine hosted by the HBA Metro Affinity Group and Women In Science. It provides details on the event agenda, location, speakers, and topics. The event will bring together experts from Bristol-Myers Squibb, Coriell Institute, and Genomic Expression to discuss obstacles and opportunities in personalized medicine from research to clinical use. The panel will provide insights on how personalized medicine can transform the pharmaceutical industry.
HealthXL is the global clearing house for innovation in healthcare. We catalyse collaboration between leading brands in healthcare and the most exciting tech companies to improve the lives of millions of people.
Together with our partners we establish audacious goals (Moonshots) to work towards within healthcare. Then we search for innovators in digital health that can work with us and our partners to achieve those Moonshots. We help them find each other, create business partnerships and facilitate their relationship through collaboration.
Our partners are Bupa, Cleveland Clinic, Becton Dickinson, IBM, ICON, ResMed, Janssen Healthcare Innovation, Linde Healthcare, Novartis, Partners HealthCare, Silicon Valley Bank, EY, SoftServe, and Hermitage Medical Clinic.
PJ Anand is the founder and CEO of Alcyone Lifesciences, with over 20 years of experience in the life science industry. Prior to founding Alcyone, he held executive roles at Arsenal Medical and Spire Biomedical, where he was responsible for business development, strategic partnerships, and establishing business units. PJ has a background in biochemistry and several patent pending inventions.
This document lists the speakers for the BUAMCP Round Table Event Fall 2016. It provides brief biographies for each speaker, including their name, education background, current role, and some details about their career experience. The speakers represented various organizations in the pharmaceutical industry and payer sectors, including Allergan, Eli Lilly & Company, Myers and Stauffer LC, Indiana University Health, and a consulting firm.
This document summarizes the experience and qualifications of an individual with over 20 years of experience in the pharmaceutical industry and life sciences. They have held senior leadership roles managing teams of up to 100 people. They have broad scientific expertise including two doctoral degrees and over 100 publications. Operationally, they have experience managing clinical trials from Phase I through IV and regulatory submissions in the US, Europe and internationally. Regarding business skills, they have entrepreneurial experience owning their own consulting company and have helped develop value propositions and increase clinical productivity. Their therapeutic experience spans many areas including rare diseases, oncology, and cardiology.
Bay View Advisory Services is a subsidiary of Bay View Clinic that provides hospital management consulting, research and development consultancy, and hospital project consulting. It has a team of experienced professionals with expertise in various areas of healthcare, including clinical research, hospital administration, and biomedical engineering. The company aims to help hospitals and healthcare organizations with services spanning concept development, operations management, research, and regulatory compliance. It also runs online platforms for medical equipment sales and education institution listings.
World’s Influential Leaders Making A Footprint in Pharma and Biotech, 2023.pdfWorlds Leaders Magazine
Mario DiPaola, Co-Founder and CEO at Therebene, Inc grace the cover of the renowned World’s Leaders Magazine as one of World's Influential Leaders Making A Footprint in Pharma and Biotech, 2023
Most Influential Canadian Women Leaders in Healthcare, 2024 January 2024.pdfinsightscare
As we step into a new era of healthcare leadership, it is both a privilege and a responsibility to present to you our special edition: “Most Influential Canadian Women Leaders in Healthcare, 2024.” While the Canadian healthcare system has made commendable strides in embracing diversity, it is crucial to acknowledge that there is still a considerable distance to cover.
PAREXEL is a global biopharmaceutical services organization that helps clients expedite time-to-market for new drugs and devices. It provides clinical development and launch services, integrated technologies, regulatory consulting, and commercialization services. PAREXEL values its employees and offers career growth opportunities across its global locations. It has a passion for making a difference by advancing worldwide healthcare.
Final file - Top 5 Visionary Leaders to Watch in Healthcare Industry 2023.pdfinsightscare
This document profiles Chris Perkin, the CEO of Altasciences, and discusses his visionary leadership in the healthcare industry. Some key points:
- Chris founded Altasciences with a vision to create an integrated contract research organization (CRO) that can seamlessly guide a drug through all early stages of development, from preclinical to clinical trials.
- Under his leadership, Altasciences has grown to nine facilities across North America and the UK, providing preclinical, clinical, manufacturing, and other services to pharmaceutical companies.
- Chris' integrated approach aims to eliminate communication gaps and resolve issues more efficiently to accelerate drug development. He focuses on collaboration and bringing the right people together to realize
This document provides an overview of Boston Therapeutics and its diabetes drug portfolio. It discusses BTI-320, a non-systemic diabetes drug that completed a Phase IIa clinical trial showing a 45% reduction in blood sugar levels in 40% of patients. The company is conducting two Phase IIb trials of BTI-320 in the US and France. It also mentions IPOXYN, an anti-necrosis and anti-hypoxia drug, and OXYFEX, a veterinary oxygen therapy product. Boston Therapeutics focuses on using complex carbohydrate chemistry to develop novel drug candidates and has a team with expertise in clinical development, regulatory affairs, and carbohydrate drug design.
Real World Evidence HEOR and Post Approval Studies SummitWorldCongress
This executive level summit explores strategies for innovation in the evolving world of data. Hear from a variety of stakeholder perspectives including industry, regulatory, CRO, and related organizations who will address the key strategies for success in the ever-changing post-marketing environment. The agenda features cutting-edge methods and in-depth case studies that provide pragmatic, real world takeaways. Attend this summit to gain critical insights and collaborate with your peers on the best methods and strategies for post-approval success.
http://www.worldcongress.com/events/PB14019/
Most Visionary Women Transforming Pharma and Life Sciences in 2023.pdfCIO Look Magazine
This edition features a handful of The Most Visionary Women Transforming Pharma and Life Sciences that are leading us to a better future
Read More: https://ciolook.com/most-visionary-women-transforming-pharma-and-life-sciences-in-2023-december2023/
The document summarizes a proposal for a new bus terminal in downtown Toronto. It would replace the existing Union Station and Toronto Coach terminals by consolidating all commuter bus services into a single large terminal. The proposed design is helix-shaped, with separate circulation routes for eastbound and westbound buses to improve efficiency. It provides more bus platforms and capacity than the existing terminals to accommodate future growth in ridership. The helical design reduces road congestion by allowing buses to park internally without blocking traffic.
Now What? Federal Market Outlook After the March Budget MadnessPrivia LLC
Brian Friel and Kevin Brancato, senior analysts with Bloomberg Government, break down the impact that sequestration and looming budget cuts will have on federal agencies and the contracting industry.
This presentation was originally given at Achieve 2013, Privia's annual user's conference, on February 20, 2013. It has been reproduced with permission from Bloomberg Government. Get more on the federal market at http://www.bgov.com.
The 2014 ACE Business Meeting covered the organization's year in review, finances, leadership transition, and goals for the future. Key topics discussed included completing the membership database, establishing SIG leadership, hosting professional development webinars, improving communications, and strategic planning. The treasurer presented the financial report. New directors and officers were welcomed while others continued in their roles. The meeting thanked volunteers and looked ahead to ACE's centennial celebrations.
This document provides a summary of key differences and new features between Windows 7 and Windows 8. It notes that Windows 8 has a slightly smaller image size and faster installation time than Windows 7. It also discusses enhancements to BitLocker, UEFI, Secure Boot, and new application packaging in Windows 8. The document outlines changes to tools like DISM, USMT, ADK, and the addition of tools like Storage Spaces and Windows Performance Toolkit in Windows 8. It encourages readers to learn more about deployment and management of Windows 8 using the Microsoft Deployment Toolkit.
Oficina de Distribuição e Marketing para Cinema com José Agripino_Aula 1 Hellen Cortezolli
O documento discute estratégias de distribuição e marketing para curtas-metragens, incluindo envio de filmes para festivais, produção de sinopses, fotos e press kits. Também fornece dicas sobre prazos de festivais, circuito de festivais e apoio da ANCINE.
HBA Metro, Women in Science: Personalized Medicine Seminar at BMSAlane Taratuska
The document summarizes a panel discussion event on personalized medicine hosted by the HBA Metro Affinity Group and Women In Science. It provides details on the event agenda, location, speakers, and topics. The event will bring together experts from Bristol-Myers Squibb, Coriell Institute, and Genomic Expression to discuss obstacles and opportunities in personalized medicine from research to clinical use. The panel will provide insights on how personalized medicine can transform the pharmaceutical industry.
HealthXL is the global clearing house for innovation in healthcare. We catalyse collaboration between leading brands in healthcare and the most exciting tech companies to improve the lives of millions of people.
Together with our partners we establish audacious goals (Moonshots) to work towards within healthcare. Then we search for innovators in digital health that can work with us and our partners to achieve those Moonshots. We help them find each other, create business partnerships and facilitate their relationship through collaboration.
Our partners are Bupa, Cleveland Clinic, Becton Dickinson, IBM, ICON, ResMed, Janssen Healthcare Innovation, Linde Healthcare, Novartis, Partners HealthCare, Silicon Valley Bank, EY, SoftServe, and Hermitage Medical Clinic.
PJ Anand is the founder and CEO of Alcyone Lifesciences, with over 20 years of experience in the life science industry. Prior to founding Alcyone, he held executive roles at Arsenal Medical and Spire Biomedical, where he was responsible for business development, strategic partnerships, and establishing business units. PJ has a background in biochemistry and several patent pending inventions.
This document lists the speakers for the BUAMCP Round Table Event Fall 2016. It provides brief biographies for each speaker, including their name, education background, current role, and some details about their career experience. The speakers represented various organizations in the pharmaceutical industry and payer sectors, including Allergan, Eli Lilly & Company, Myers and Stauffer LC, Indiana University Health, and a consulting firm.
This document summarizes the experience and qualifications of an individual with over 20 years of experience in the pharmaceutical industry and life sciences. They have held senior leadership roles managing teams of up to 100 people. They have broad scientific expertise including two doctoral degrees and over 100 publications. Operationally, they have experience managing clinical trials from Phase I through IV and regulatory submissions in the US, Europe and internationally. Regarding business skills, they have entrepreneurial experience owning their own consulting company and have helped develop value propositions and increase clinical productivity. Their therapeutic experience spans many areas including rare diseases, oncology, and cardiology.
Bay View Advisory Services is a subsidiary of Bay View Clinic that provides hospital management consulting, research and development consultancy, and hospital project consulting. It has a team of experienced professionals with expertise in various areas of healthcare, including clinical research, hospital administration, and biomedical engineering. The company aims to help hospitals and healthcare organizations with services spanning concept development, operations management, research, and regulatory compliance. It also runs online platforms for medical equipment sales and education institution listings.
World’s Influential Leaders Making A Footprint in Pharma and Biotech, 2023.pdfWorlds Leaders Magazine
Mario DiPaola, Co-Founder and CEO at Therebene, Inc grace the cover of the renowned World’s Leaders Magazine as one of World's Influential Leaders Making A Footprint in Pharma and Biotech, 2023
Most Influential Canadian Women Leaders in Healthcare, 2024 January 2024.pdfinsightscare
As we step into a new era of healthcare leadership, it is both a privilege and a responsibility to present to you our special edition: “Most Influential Canadian Women Leaders in Healthcare, 2024.” While the Canadian healthcare system has made commendable strides in embracing diversity, it is crucial to acknowledge that there is still a considerable distance to cover.
PAREXEL is a global biopharmaceutical services organization that helps clients expedite time-to-market for new drugs and devices. It provides clinical development and launch services, integrated technologies, regulatory consulting, and commercialization services. PAREXEL values its employees and offers career growth opportunities across its global locations. It has a passion for making a difference by advancing worldwide healthcare.
Final file - Top 5 Visionary Leaders to Watch in Healthcare Industry 2023.pdfinsightscare
This document profiles Chris Perkin, the CEO of Altasciences, and discusses his visionary leadership in the healthcare industry. Some key points:
- Chris founded Altasciences with a vision to create an integrated contract research organization (CRO) that can seamlessly guide a drug through all early stages of development, from preclinical to clinical trials.
- Under his leadership, Altasciences has grown to nine facilities across North America and the UK, providing preclinical, clinical, manufacturing, and other services to pharmaceutical companies.
- Chris' integrated approach aims to eliminate communication gaps and resolve issues more efficiently to accelerate drug development. He focuses on collaboration and bringing the right people together to realize
This document provides an overview of Boston Therapeutics and its diabetes drug portfolio. It discusses BTI-320, a non-systemic diabetes drug that completed a Phase IIa clinical trial showing a 45% reduction in blood sugar levels in 40% of patients. The company is conducting two Phase IIb trials of BTI-320 in the US and France. It also mentions IPOXYN, an anti-necrosis and anti-hypoxia drug, and OXYFEX, a veterinary oxygen therapy product. Boston Therapeutics focuses on using complex carbohydrate chemistry to develop novel drug candidates and has a team with expertise in clinical development, regulatory affairs, and carbohydrate drug design.
Real World Evidence HEOR and Post Approval Studies SummitWorldCongress
This executive level summit explores strategies for innovation in the evolving world of data. Hear from a variety of stakeholder perspectives including industry, regulatory, CRO, and related organizations who will address the key strategies for success in the ever-changing post-marketing environment. The agenda features cutting-edge methods and in-depth case studies that provide pragmatic, real world takeaways. Attend this summit to gain critical insights and collaborate with your peers on the best methods and strategies for post-approval success.
http://www.worldcongress.com/events/PB14019/
Most Visionary Women Transforming Pharma and Life Sciences in 2023.pdfCIO Look Magazine
This edition features a handful of The Most Visionary Women Transforming Pharma and Life Sciences that are leading us to a better future
Read More: https://ciolook.com/most-visionary-women-transforming-pharma-and-life-sciences-in-2023-december2023/
This document provides an agenda and materials for a symposium titled "Improving Medication Safety in the Radiology Setting". The agenda includes presentations on medication administration systems and medications used in radiology, medication safety issues and strategies in radiology, and regulatory and accreditation requirements related to medication use in radiology. The objectives are to describe how medications are handled in radiology, explain new FDA classifications for contrast, identify medication errors in radiology, discuss safety strategies, and describe regulatory standards. Faculty include experts from the Institute for Safe Medication Practices who will discuss actual error cases and risk reduction.
PRA Health Sciences provides innovative drug development solutions across all phases of clinical trials and therapeutic areas. It has over 10,000 employees operating in more than 80 countries and has worked on over 3,500 clinical studies and consulting projects in the past 5 years. PRA's culture encourages employees to find creative solutions to challenges in order to help clients develop life-saving drugs. PRA has experience conducting the pivotal trials that led to approval of over 50 drugs across several therapeutic areas.
PRA Health Sciences provides innovative drug development solutions across all phases of clinical trials and therapeutic areas. It has over 10,000 employees operating in more than 80 countries and has worked on over 3,500 clinical studies and consulting projects in the past 5 years. PRA's culture encourages employees to find creative solutions to challenges in order to help clients develop life-saving drugs. PRA has experience conducting the pivotal trials that led to approval of over 50 drugs across several therapeutic areas.
The document discusses future prospects and challenges for biotherapeutics. It begins by defining biotherapeutics as products produced using living cells or organisms, such as recombinant hormones, vaccines, monoclonal antibodies, growth factors, and gene and cell therapies. It then contrasts biotherapeutics, biosimilars, and generics. The document outlines the complex manufacturing process for biotherapeutics and challenges in characterizing their large, complex structures. It concludes by discussing switching and interchangeability studies required to demonstrate a biosimilar is as safe and effective as the reference biologic.
India's first Int'l Conference on Best Practices in Pharma Microbiology Biocon
This is the first time that Pharmig, an international Pharmaceutical Microbiology think tank based out of the UK is organizing a conference on the "Best Practices in Pharma Microbiology" for the first time in India. You can register
by sending an email to maxine@pharmig.org.uk. For booking a seat for the conference, please visit: http://bit.ly/1J4gtLh
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India's first Int'l Conference on Best Practices in Pharma Microbiology
Booklet_03.19.15_Confessions of the Clinical Minds_Booklet_Final_18MAR15_4
1. Women In BIO
Chicago Chapter
Women’s History Month
Questions? Contact us at Chicago@womeninbio.org
Event Sponsors
Confessions of the Clinical Minds
Thursday, March 19, 2015
5:30 p.m. @ Astellas
1 Astellas Way, Northbrook, IL 60654
2. she was vice president of clinical operations at MedGenesis Therapeutix Inc. in British Columbia, Canada, and
prior to that vice president of clinical operations at NeoPharm developing unique therapies targeting primary
brain cancer, other cancers, and Parkinson’s disease. During her career, Ms. Grahn has also held various senior
level positions at Takeda Pharmaceuticals North America, Inc., Searle and Abbott developing drugs for HIV,
asthma, diabetes and chemotherapy-induced neutropenia. During her career, Ms. Grahn has authored and
co-authored over 15 peer reviewed publications of clinical trial results.
Amy Grahn, MS
Senior Vice President, Clinical Development and Operations
Horizon Pharma, Inc.
Amy Grahn has more than 20 years of pharmaceutical industry experience spanning
pre-clinical research to commercial roles, with a primary focus on clinical
development and operations. She has been responsible for the clinical portion of the
New Drug Applications (NDAs) for two recently approved drugs, DUEXIS®
(ibuprofen/famotidine) for OA and RA, and RAYOS® (delayed-release prednisone)
for a variety of indications primarily focused in rheumatologic diseases. She has lead
clinical trials teams for many registration trials both Ex-US and US based. Previously
Gillian Hodkinson
Vice President, Clinical Operations, AbbVie Inc.
Gill is a 35 year veteran of Abbott/AbbVie and an immigrant in the USA from the UK,
which makes her, by her own admission, an “Ancient Alien” in the USA!
A Pharmacist by training, she gained her Pharmacy degree from Nottingham
University in the UK where she specialized in Drug Development, Medicinal
Chemistry and Pharmaceutical Sciences. She completed her pre-Registration
training Residency in Abbott and retail Pharmacy and was hired into a Formulation
development role in Abbott Queenborough England after completion of her
Residency. Although she has worked in the R&D environment for her whole career, she has held multiple different
roles but always kept a focus on improving the way we do business and she has a passion for continuous
improvement and operational excellence. About a third of her career was spent in the clinical supply arena, a
third in drug development and clinical development operations project management and the remaining third in a
variety of roles focused on either building or “fixing” organizations: R&D Operations, Outsourcing, Process
Improvement, Project Office, Centralization of Development Operations, Quality Assurance and now Clinical
Operations. Gill is a big believer in Teamwork and loves to collaborate across the organization to take full
advantage of diverse skill sets and opinions – a particular mission in AbbVie for Gill is to “Bureaucracy-bust” and
simplify given the complex world we live in today.
Beverly Paperiello
Executive Director, Clinical Programming/Clinical Science, Astellas Pharma
Global Development
Beverly has over 15 years of experience in the pharmaceutical industry. Throughout
her professional career, she has held many key roles in the top pharmaceutical
companies. Some these roles include: Clinical Program Scientist at Pfizer and
Director of the Clinical Program Management for Abbott where she served for over
seven years. Currently, Beverly is the Global Head of the Clinical Program
Management department at Astellas Pharma. Beverly graduated with a Bachelor of
Science degree in health administration from Northern Illinois University.
3. Melynda Geurts
Vice President of Operations, DAC Patient Recruitment Services
Imperial Company
Melynda Geurts' career has focused on advancing education within the healthcare
industry for the past 23 years. Since 1998, Melynda has shifted her focus on
educating the public about participating in clinical trials through global programs.
She currently serves as the Vice President of Operations for DAC Patient
Recruitment Services, an Imperial Company. Melynda is responsible for the
strategic growth of the organization and integral in ensuring DAC as a leader within
the patient recruitment and retention niche. Melynda is invited often to present and
train worldwide at industry conferences and has contributed to the industry's overall body of literature through
her writing contributions. In 2008, she was recognized by PharmaVoice as 100 Most Inspiring People in Life
Sciences.
Teresa Raich, PhD
Senior Director, Regulatory Affairs, Abbott Diagnostics
Dr. Terry Raich joined Abbott Diagnostics in May, 2014, and brings over 20 years
of experience leading strategic initiatives and driving global projects as well as
developing, managing, launching and supporting multiple in vitro diagnostic
products in the medical device industry. At Abbott, she is responsible for
managing and executing the global regulatory strategy for the Immunoassay and
Clinical Chemistry product life cycle franchise including the ARCHITECT and the
next-generation ICQ systems. Prior to Abbott, she was Vice-President of Global
Clinical, Regulatory and Scientific Affairs for Nanosphere, Inc.; Director of Assay
Product Development at HandyLab/BD Diagnostics and Director of Medical &
Scientific Affairs at Roche Diagnostics. Dr. Raich received her Ph.D. in
Microbiology from Colorado State University and her B.S. in Veterinary Sciences from West Virginia
University. She completed an AAM/CPEP-approved Postdoctoral Training Fellowship in Medical and Public
Health Laboratory Microbiology at Baylor College of Medicine in Houston, Texas. She received a MBA from
Indiana Wesleyan University focusing on organizational leadership and management.
Nancy Sacco, PhD
Executive Director, Astellas Global Development Strategic Operations
In her current role at Astellas, Nancy has executive leadership and management
responsibilities in the Astellas global and medical organization functions
including Process Improvement/Standards Management, Training Design and
Deployment, LMS Technology and Management and Divisional Integration. In
addition, Nancy is the Astellas representative on the AVOCA Executive
Directors Board and on the Transcelerate Biopharmaceutics Operating
Committee. She is also the Chair of the Global Medical and Development
Information Strategy Steering Committee and a member of the Development
Leadership Team and Synopsis/Protocol review and approval committees.
Nancy has been a leader in the pharmaceutical industry for over 20 years. Prior to joining Astellas 6 years
ago, she was the Global Head of Clinical Operations at Takeda and Head of Clinical Research Operations
Pfizer-Michigan overseeing clinical trials spanning more than 5 therapeutic areas. Nancy completed her
doctorate at the West Virginia School of Medicine in Anatomy/Cell Biology and a post-doctoral fellowship at
Loyola Stritch School of Medicine in Physiology.
4. SNAPSHOT – PAST & UPCOMING EVENTS
Upcoming Events – details forthcoming
April 30, 2015 – Biosimilars Panel
May 2015 – Mentoring Panel Part 1: Mentoring Entrepreneurs and Start Ups
June 2015 – Mentoring Panel Part 2: Mentoring and Sponsorship in Big Pharma
June 15-18, 2015 – BIO convention, Philadelphia- WIB National and 12 WIB chapters
July 2015 – TBD
August 2015 – Symphony in the Park Metro Mix and Mingle Networking Event
September 2015 – “Dolphin Tank” – Entrepreneurial Pitch Session
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