uintiles Consulting today announced three key appointments in its US Regulatory and Quality consulting practice. These new appointments expand Quintiles` experience in regulatory compliance and quality system development. They also bring industry-leading expertise to the table to help clients navigate a rapidly changing regulatory environment and fully optimize the development of a new drug, biologic or medical device.
"Our customers are facing intense pressure in the marketplace due to ever-increasing scrutiny by regulators and public demand for quality products," said Geoff Garabedian, Vice President and Managing Director for the Regulatory and Quality practice. "With these new appointments, Quintiles` Consulting practice offers a uniquely experienced global Regulatory and Quality consulting group to drive our clients` success. Our exceptional understanding of regulatory and compliance environments, combined with our strategic advice and operational counsel, can build clients` competitive advantage in the regulatory and quality sectors."
* Bob Rhoades joins Quintiles Consulting as Head of the Quality Systems business units (bio/pharma and device) within the United States. Bob brings more than 30 years experience in regulatory compliance, Quality System Regulation (QSR) and the pharmaceutical Good Manufacturing Practices (GMPs), with expertise designing and implementing compliance improvement initiatives for major manufacturers in the US, Europe and China. Bob has authored numerous articles on quality-related topics as well as the book, "Risky Business: Managing the Quality of America`s Medicines," which was released in February 2004 by FDANews, and is now in its second edition. His second book, "Sustaining Compliance: Strategies for Maintaining Drug Quality," was released in July 2005. Bob holds an MBA, Operations and Strategic Planning, from Lake Forest Graduate School of Management and a B.S., Microbiology, from Purdue University.
* Michael Swiatocha joins Quintiles Consulting as Head of the R&D Compliance business unit, focusing on clinical and non-clinical research activities for device and pharmaceutical companies to ensure compliance with applicable regulations and guidelines. Michael joins Quintiles from Schering-Plough Corporation where he served as Vice President and Compliance Officer for the Schering-Plough Research Institute. Prior to that, Michael was a Director in the Global Pharmaceutical and Health Sciences practice at PricewaterhouseCoopers LLP where he concentrated on the development and implementation of strategic compliance, ethics and risk management programs at life sciences companies. Michael brings more than 25 years experience in the life sciences industry and has held management positions in compliance, regulatory affairs, clinical research, manufacturing, quality and sales. Michael holds an M.S. degree in Medical Biology from Long Island University and a B.S. degree in Psychology from Fordham University. He has been a frequent speaker on drug and device industry compliance issues for the Pharmaceutical Compliance Forum and the National Congress on Health Care Compliance.
* Barbara (Jan) Holladay Pierre has joined the Quintiles Consulting BIMO group as a Principal Consultant. Jan is based in the Rockville, Md., office and will be working with foreign and domestic clients in the pharmaceutical, medical device and biotechnology industries to develop quality assurance and regulatory strategies for compliance. Jan brings to Quintiles more than 10 years experience in clinical research, with a unique combination of expertise in inspections, regulatory compliance, auditing, quality assurance and training. She is a former member of FDA Foreign Inspection Cadre and former FDA investigator, with more than six years experience auditing/inspecting sponsors, IRBs, clinical investigators, manufacturers and non-clinical laboratories. Jan holds an M.P.H. in International Health Policy from George Washington University and a B.S., International Relations, from Florida State University.
About Quintiles Consulting
Quintiles Consulting works with pharmaceutical, biotech and medical device companies to maximize potential and minimize risk, from discovery through development and commercialization by providing expert strategic, operational, and technical advice. Building on the global reach and expertise of Quintiles Transnational, Quintiles Consulting practice areas include Product Development and Commercialization, Regulatory and Quality, Market Intelligence and Market Access. For more information, please visit www.quintiles.com/consulting.
About Quintiles
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.
Showing posts with label Pharmacology Consulting. Show all posts
Showing posts with label Pharmacology Consulting. Show all posts
Friday, October 30, 2009
Monday, September 21, 2009
Semafore Retains Management Consulting Firm; Names Principal to Key Management Position
Semafore Pharmaceuticals, Inc., a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics targeting the phosphoinositide-3-kinase (PI3K) pathway for the treatment of cancer and other serious diseases, announced today that its board of directors has named Michael D. Becker as the company’s acting chief executive officer.
Mr. Becker continues as CEO of MD Becker Partners LLC, a boutique management and strategy consulting firm focusing on both public and private companies in emerging growth industries, such as pharmaceuticals, biotechnology, and medical devices. MD Becker Partners has been retained by Semafore Pharmaceuticals to develop and implement a strategic plan for the company. Prior to founding MD Becker Partners, Mr. Becker was president and chief executive officer of several publicly-traded biotechnology companies focused in the field of oncology.
Joseph Garlich, Ph.D., Co-founder and Chief Scientific Officer of Semafore Pharmaceuticals said, “We are extremely pleased to have Michael Becker and his firm’s hands-on executive experience at this point of Semafore Pharmaceutical’s evolution. Recent deal terms highlight the drug industry’s enthusiasm for the PI3K target in oncology and we are in the final dose cohort of single agent Phase 1 trials in both solid tumors and hematological malignancies with our lead clinical candidate, SF1126, in this area. Michael brings us exactly the kind of industry expertise we need and we’re making him acting CEO during this key period so that he can have the maximum effect on our business.”
About SF1126
Semafore Pharmaceuticals’ lead product candidate, SF1126, inhibits both the phosphoinositide-3-kinase (PI3K) and mammalian target of rapamycin (mTOR), two key members of the PI3K signaling pathway that is vital to several essential biological processes, such as cell proliferation and survival. PI3K is commonly altered in human cancers, making inhibition of the target attractive for cancer therapy. In view of the fact that mTOR can be activated in a PI3K-independent manner, dual PI3K-mTOR inhibitors, such as SF1126, are expected to offer a therapeutic advantage.
As a prodrug that is administered in an inactive form, SF1126 is also unique among clinical stage, dual PI3K-mTOR inhibitors. Once administered, SF1126 targets specific transmembrane cell adhesion proteins known as integrins that are expressed in new tumor vasculature and within the tumor compartment. Because of the targeted design of SF1126 there is a markedly lower chance of inhibiting PI3K and mTOR in healthy, non-cancerous cells which reduces the potential for side-effects.
Data from an ongoing Phase 1 clinical trial of SF1126 in patients with solid tumors recently presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated selective inhibition of the PI3K pathway in tumor tissue but not in normal skin tissue. Notably, there were no clinically significant changes in glucose or insulin levels reported at biologically active doses. Upon completion of single agent Phase 1 trials, Semafore Pharmaceuticals expects to initiate combination trials in the near future.
About Semafore Pharmaceuticals, Inc.
Semafore Pharmaceuticals is a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics targeting the phosphoinositide-3-kinase (PI3K) pathway for the treatment of cancer and other serious diseases. Semafore Pharmaceuticals has successfully discovered and developed a portfolio of proprietary, unpartnered drug candidates. The company’s lead clinical product candidate, SF1126, is unique among clinical stage, dual PI3K-mTOR inhibitors as it is a prodrug designed to selectively inhibit PI3K by targeting integrins expressed on the surface of new tumor vasculature and within the tumor compartment. The company’s preclinical pipeline includes SF2626, which has demonstrated the ability to inhibit both PI3K and mitogen-activated protein kinase (MEK), the key component of the RAS/RAF/MEK/ERK pathway. For more information see the company’s web site at www.semaforepharma.com.
About MD Becker Partners LLC
MD Becker Partners is a boutique management and strategy consulting firm focusing on both public and private companies in emerging growth industries, such as pharmaceuticals, biotechnology, and medical devices. The firm integrates the three independent disciplines of investor relations, strategic advisory and operational improvement and applies them to carefully conceived and expertly enacted strategies that help companies increase visibility, unlock stakeholder value and access resources to grow their business. For more information, visit the website: http://www.mdbpartners.com.
Mr. Becker continues as CEO of MD Becker Partners LLC, a boutique management and strategy consulting firm focusing on both public and private companies in emerging growth industries, such as pharmaceuticals, biotechnology, and medical devices. MD Becker Partners has been retained by Semafore Pharmaceuticals to develop and implement a strategic plan for the company. Prior to founding MD Becker Partners, Mr. Becker was president and chief executive officer of several publicly-traded biotechnology companies focused in the field of oncology.
Joseph Garlich, Ph.D., Co-founder and Chief Scientific Officer of Semafore Pharmaceuticals said, “We are extremely pleased to have Michael Becker and his firm’s hands-on executive experience at this point of Semafore Pharmaceutical’s evolution. Recent deal terms highlight the drug industry’s enthusiasm for the PI3K target in oncology and we are in the final dose cohort of single agent Phase 1 trials in both solid tumors and hematological malignancies with our lead clinical candidate, SF1126, in this area. Michael brings us exactly the kind of industry expertise we need and we’re making him acting CEO during this key period so that he can have the maximum effect on our business.”
About SF1126
Semafore Pharmaceuticals’ lead product candidate, SF1126, inhibits both the phosphoinositide-3-kinase (PI3K) and mammalian target of rapamycin (mTOR), two key members of the PI3K signaling pathway that is vital to several essential biological processes, such as cell proliferation and survival. PI3K is commonly altered in human cancers, making inhibition of the target attractive for cancer therapy. In view of the fact that mTOR can be activated in a PI3K-independent manner, dual PI3K-mTOR inhibitors, such as SF1126, are expected to offer a therapeutic advantage.
As a prodrug that is administered in an inactive form, SF1126 is also unique among clinical stage, dual PI3K-mTOR inhibitors. Once administered, SF1126 targets specific transmembrane cell adhesion proteins known as integrins that are expressed in new tumor vasculature and within the tumor compartment. Because of the targeted design of SF1126 there is a markedly lower chance of inhibiting PI3K and mTOR in healthy, non-cancerous cells which reduces the potential for side-effects.
Data from an ongoing Phase 1 clinical trial of SF1126 in patients with solid tumors recently presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated selective inhibition of the PI3K pathway in tumor tissue but not in normal skin tissue. Notably, there were no clinically significant changes in glucose or insulin levels reported at biologically active doses. Upon completion of single agent Phase 1 trials, Semafore Pharmaceuticals expects to initiate combination trials in the near future.
About Semafore Pharmaceuticals, Inc.
Semafore Pharmaceuticals is a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics targeting the phosphoinositide-3-kinase (PI3K) pathway for the treatment of cancer and other serious diseases. Semafore Pharmaceuticals has successfully discovered and developed a portfolio of proprietary, unpartnered drug candidates. The company’s lead clinical product candidate, SF1126, is unique among clinical stage, dual PI3K-mTOR inhibitors as it is a prodrug designed to selectively inhibit PI3K by targeting integrins expressed on the surface of new tumor vasculature and within the tumor compartment. The company’s preclinical pipeline includes SF2626, which has demonstrated the ability to inhibit both PI3K and mitogen-activated protein kinase (MEK), the key component of the RAS/RAF/MEK/ERK pathway. For more information see the company’s web site at www.semaforepharma.com.
About MD Becker Partners LLC
MD Becker Partners is a boutique management and strategy consulting firm focusing on both public and private companies in emerging growth industries, such as pharmaceuticals, biotechnology, and medical devices. The firm integrates the three independent disciplines of investor relations, strategic advisory and operational improvement and applies them to carefully conceived and expertly enacted strategies that help companies increase visibility, unlock stakeholder value and access resources to grow their business. For more information, visit the website: http://www.mdbpartners.com.
Wednesday, August 26, 2009
ClinPharm Consulting Forms Strategic Partnership with Leading Pharmacokineticist
Early phase drug development consulting firm ClinPharm Consulting and 23-year pharmaceutical industry veteran Bill Wargin, Ph.D. have announced a strategic partnership to further enhance ClinPharm Consulting's clinical pharmacology expertise.
Formerly with Burroughs-Wellcome and then GlaxoWellcome, Dr. Wargin has spent the last eight years consulting with numerous clients in all aspects of pre-clinical and clinical pharmacokinetics including study design, data analysis, and strategic planning.
"We're thrilled to be working with a professional like Dr. Wargin and this strategic partnership enhances our efforts to be the premier consulting firm focused exclusively on clinical pharmacology" said Geoffrey Banks, Ph.D., ClinPharm Consulting president. "Bill is well-respected in pharmaceutical and biotechnology circles for his expertise in pharmacokinetics and biopharmaceutics, two key areas of focus for our firm," he added.
Under this partnership, Dr. Wargin will make his breadth of experience available to ClinPharm Consulting's expanding client base of small, emerging pharmaceutical and biotechnology companies that have minimal R&D infrastructure and need assistance with early phase human trials.
"I've known Geoff Banks for many years and have worked with him on numerous projects," Dr. Wargin said, adding, "I have a lot of respect for what he's doing with ClinPharm Consulting and look forward to helping our clients with their development programs."
ClinPharm Consulting is able to offer a full clinical pharmacology development package to clients and be a complete resource for virtual companies seeking to advance early phase drug development programs.
For more information on ClinPharm Consulting, contact Dr. Geoffrey Banks at geoff@clinpharmworld.com or visit www.clinpharmworld.com
About ClinPharm Consulting
ClinPharm Consulting, LLC is a specialized consulting firm focused on clinical pharmacology and is uniquely positioned to offer a full range of early phase drug development services and solutions to the industry. Our business model centers on providing cost-effective expertise to small, emerging pharmaceutical and biotechnology companies that have minimal R&D infrastructure. We work as a fully integrated resource for clients needing in-house assistance across their early phase development program, including PK/PD, strategic planning, clinical operations, regulatory, medical writing, project management, etc. This allows ClinPharm Consulting to be a complete resource for virtual companies, thereby reducing costs through increased efficiencies in the drug development process. ClinPharm Consulting can engage clients as early as the IND planning stages to develop robust clinical pharmacology strategies and then assist with the execution and analysis of those strategies, including efforts to transition from nonclinical research into early phase clinical trials as well as transitioning from healthy volunteers into patients with the target disease.
Formerly with Burroughs-Wellcome and then GlaxoWellcome, Dr. Wargin has spent the last eight years consulting with numerous clients in all aspects of pre-clinical and clinical pharmacokinetics including study design, data analysis, and strategic planning.
"We're thrilled to be working with a professional like Dr. Wargin and this strategic partnership enhances our efforts to be the premier consulting firm focused exclusively on clinical pharmacology" said Geoffrey Banks, Ph.D., ClinPharm Consulting president. "Bill is well-respected in pharmaceutical and biotechnology circles for his expertise in pharmacokinetics and biopharmaceutics, two key areas of focus for our firm," he added.
Under this partnership, Dr. Wargin will make his breadth of experience available to ClinPharm Consulting's expanding client base of small, emerging pharmaceutical and biotechnology companies that have minimal R&D infrastructure and need assistance with early phase human trials.
"I've known Geoff Banks for many years and have worked with him on numerous projects," Dr. Wargin said, adding, "I have a lot of respect for what he's doing with ClinPharm Consulting and look forward to helping our clients with their development programs."
ClinPharm Consulting is able to offer a full clinical pharmacology development package to clients and be a complete resource for virtual companies seeking to advance early phase drug development programs.
For more information on ClinPharm Consulting, contact Dr. Geoffrey Banks at geoff@clinpharmworld.com or visit www.clinpharmworld.com
About ClinPharm Consulting
ClinPharm Consulting, LLC is a specialized consulting firm focused on clinical pharmacology and is uniquely positioned to offer a full range of early phase drug development services and solutions to the industry. Our business model centers on providing cost-effective expertise to small, emerging pharmaceutical and biotechnology companies that have minimal R&D infrastructure. We work as a fully integrated resource for clients needing in-house assistance across their early phase development program, including PK/PD, strategic planning, clinical operations, regulatory, medical writing, project management, etc. This allows ClinPharm Consulting to be a complete resource for virtual companies, thereby reducing costs through increased efficiencies in the drug development process. ClinPharm Consulting can engage clients as early as the IND planning stages to develop robust clinical pharmacology strategies and then assist with the execution and analysis of those strategies, including efforts to transition from nonclinical research into early phase clinical trials as well as transitioning from healthy volunteers into patients with the target disease.
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