Tag Archive for: Regulatory

Joe Jimenez Joins TissueTech as Vice President, Quality Assurance and Regulatory Affairs

Former Vice President, PGT Quality Teva Pharmaceuticals

Joe Jimenez, Vice President, formerly PGT Quality for Teva Pharmaceuticals has recently become Vice President, Quality Assurance and Regulatory Affairs for TissueTech, a Miami-based company producing regenerative amniotic tissue-based products for use in the ophthalmology, optometry, musculoskeletal and wound care markets.

Life Science Partner partnered with CEO Amy Tseng and founder Shefferd Tseng, MD, PhD, to recruit Jimenez to prepare the company for the changing regulatory landscape of regenerative medicine products.

At Teva, Jimenez was responsible for leading the global quality team for the PGT joint venture between Proctor & Gamble and Teva where he oversaw an international team based in Switzerland.  “Jimenez has global view of quality,” states Tom Callaway, MD, Founder and President of Life Science Partner.  “He has a broad hands-on approach to developing analytical methods and quality systems combined with a can-do energy that will mesh well with the culture at TissueTech.”

Jimenez earned a Bachelor of Arts degree in Chemistry from Queens College in New York.

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Susan Blank Joins BioConfirm Laboratories as Chief Medical Officer

Founder and Chief Medical Officer of Atlanta Healing Center and President of the Georgia Society of Addiction Medicine

Life Science Partner is pleased to announce the recruitment of Susan Blank, MD, Founder and Chief Medical Officer for the Atlanta Healing Center to become the Chief Medical Officer for BioConfirm Laboratories-a new company based in Atlanta committed to providing personalized physician-led solutions and services for patients and clinicians surrounding addiction and substance abuse.

With her entire career focused on the treatment of addiction and behavioral health with a true passion for healing through comprehensive programs, Life Science Partner identified Blank as a key expert for establishing the therapy platform at BioConfirm.

As an active expert and advocate for addiction recovery, Blank can be heard nationwide every Tuesday on her weekly radio show “Detailing Addiction” on America’s Web Radio. “Her passion, enthusiasm, and in depth knowledge of comprehensive addiction therapy will be a major asset to BioConfirm’s growth,” states Tom Callaway, President and Founder of Life Science Partner.

Blank earned her Bachelor of Arts degree in Psychology from Augusta College and she completed her MD from the Medical College of Georgia.

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Robert Rajalingam Joins Smiths Medical as VP, Global Product Management, Vascular Access

Former Site Leader and Vice President for Global Marketing at Medtronic/Covidien Vascular Therapies

As a medical device leader and strategic marketing executive, Robert Rajalingam has been selected to lead Smith Medical’s $300 M Vascular Access business.

Life Science Partner collaborated closely with Vice President, Carl Stamp to recruit Rajalingam from Medtronic.

Vascular medicine has been his passion and interest, having worked both in the venous therapy area (spearheading the re-branding with Rethink Varicose Veins campaign including an Olympic spokesperson at Covidien) and in arterial disease at Medtronic Vascular in business development, including a partnership with Abbott Vascular.

“Robert is passionate and articulate about medical devices and their ability to improve patient lives. Experienced in managing a maturing product portfolio while simultaneously spearheading product innovation, he has the know-how, tenacity, and marketing instincts to build highly effective teams at Smiths Medical,” states Tom Callaway, MD, Founder and President of Life Science Partner.

Rajalingam earned his Bachelor of Science in Engineering degree from Duke University and his MBA from Stanford Graduate School of Business.

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Yanshan Ma, MD, PhD, Joins Allergan As Senior Director, Medical Safety Physician

Former Senior Director, Global Safety Officer at The Medicines Company

Life Science Partner recruited Yanshan Ma, MD, PhD, to become Senior Director, Medical Safety Physician, Internal Medicine and Infectious Diseases for Allergan. 

In her new role Dr. Ma will be responsible for the group’s safety strategy, pharmacovigilance and medical risk management.

Dr. Ma joins Allergan after leading a cross-functional safety management team at The Medicines Company where she was responsible for ensuring accurate safety evaluation and signal detection.  She’s been a key member in the growth of The Medicines Company.

“Dr. Ma has hands-on leadership experience of both small groups and matrix organizations of physicians and safety scientists,” commented Tom Callaway, MD, Founder and President of Life Science Partner.  “She has the work ethic and pharmacovigilence knowledge that will fit nicely with the entrepreneurial environment of Allergan.”

Dr. Ma earned her PhD in Biochemistry from East Tennessee State University’s James E. Quillen College of Medicine and her MD from Sun Yat-sen University of Medical Sciences in China.

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Bob Wassman, MD, Recruited to become Chief Medical Officer for Lineagen

Former Chief Medical Officer Rosetta Genomics

Life Science Partner recruited Bob Wassman, MD, to become Chief Medical Officer of Lineagen to lead The Company’s clinical direction, product strategy, medical affairs, and global trials and registration process for Lineagen’s products and services.

Previously, as Chief Medical Officer for Rosetta Genomics, Wassman played a critical role in building the commercial, clinical and reimbursement strategy for the Rosetta’s microRNA-based platform technologies. He partnered closely with CEO Ken Berlin to evaluate new technologies to build out a fully personalized medicine resulting in the acquisition of PersonalizedDx.

Wassman joined Rosetta after leading the pharmagenomics services program at CVS Caremark, after, It’s acquisition of Generation Health, to improve precision therapy management and guide program development. Throughout his career Wassman has served in several key genomic leadership roles for cutting edge companies such as Good Start Genetics, Celula, Genzyme, and Prometheus.

“With a successful track record in building CLIA-based laboratory businesses combining scientific and clinical knowledge, Wassman will be a critical asset for Lineagen’s future growth and development,” stated Tom Callaway, MD, President and Founder of Life Science Partner.

Wassman earned a Bachelor of Science Degree in Biology from Yale University and his MD from Albany Medical College.

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Gloria Matthews, DVM, Joins Histogenics as Chief Medical Officer

Former Senior Director, Research and Development At Genzyme/Sanofi

Life Science Partner has recruited Gloria Matthews, DVM, PhD to become Chief Medical Officer at Histogenics.

In her new role Matthews will report directly to the Chief Executive Officer, Adam Gridley, and will serve as the senior physician within Histogenics responsible for clinical direction, product strategy, medical affairs, and strategic oversight of the global clinical trials for the Company’s products.

Mathews joins Histogenics from Genzyme/Sanofi where she led the global development team focused on two autologous cell therapies for cartridge repair including Carticel. She is a well published and leader in the field of regenerative medicine, with a corporate background that integrates fundamental science, clinical development, and global regulatory expertise.

“As a globally recognized thought leader for orthopedic R&D, Matthews has led global teams focused on regenerative medicine including US, Europe and Asia,” noted Tom Callaway, MD, President of Life Science Partner. “With her deep knowledge of cartilage regeneration and its challenges, Matthews will bring her considerable experience to help commercialize Histogenics’ portfolio.”

Matthews received her Bachelor of Science degree in biochemistry and Animal Science, as well as her PhD in Cell/Matrix Biology and DVM from Cornell University.

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Barb DeBaun, RN, MSN Recruited to Vestagen as Consulting Vice President, Clinical Affairs

Improvement Advisor for Cynosure Health Joins Vestagen

Life Science Partner recruited Barb DeBaun, RN, MSN, CIC, to become Vice President, Clinical and Regulatory Affairs for Vestagen Technical Textiles, Inc.

DeBaun joins Vestagen after serving as an Improvement Advisor for Cynosure Health where she provided vision and leadership in the development, implementation and facilitation of performance improvement initiatives for healthcare organizations.

In her new role at Vestagen, DeBaun will serve as the senior clinical leader for The Company overseeing clinical direction, product strategy, medical affairs and key thought leader development. “DeBaun’s passion for protecting the healthcare worker from infection while providing quality care makes her a natural fit for Vestagen’s VP of Clinical and Regulatory Affairs,” states Tom Callaway, MD, Founder and President of Life Science Partner.

DeBaun earned her Bachelor of Science in Nursing from Pace University and her Master of Science in Nursing from San Francisco State University. DeBaun is an active member of APIC having served as the chair of the 2012 APIC Annual Conference Committee and as a member of the APIC Education Committee and the APIC Practice Guidance Council. In 2008, she was selected as Infection Control Today‘s Educator of the Year.

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Jim Schneider, JD, Joins American Medical Systems as Manager of Compliance

Former Senior Business Process Analyst, Global Compliance at Boston Scientific

Life Science Partner recruited Jim Schneider, JD to become Manager of Compliance for American Medical Systems, a subsidiary of Endo Health Solutions.

In his new role at AMS, Schneider will have strong business and sales facing responsibilities including training, investigations and the development of new policies across various sales organizations.

Schneider joins AMS after serving as the Senior Business Analyst for the Global Compliance department at Boston Scientific where he was a key member of the team that implemented the first annual CIA Arrangements Audit.

“Smart, engaging, and incredibly resourceful, Schneider has the capability to get the job done under complex circumstances,” states Thomas Callaway, MD, President of Life Science Partner. “He is an excellent communicator and a ‘lead-by-example’ type of manager.”

Schneider earned his Bachelor of Arts in Political Science from Bemidji State University and his Master of Art in Administration and Business Management from Hamline University. He received his Juris Doctor from the William Mitchell College of Law.

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Andre Daniels, MBChB, Joins Allergan as Vice President, Head of Medical Safety Physicians

Former Global Head of Safety Surveillance for Amgen

Life Science Partner recruited Andre Daniels, MBChB, Executive Director, Pharmacovigilance at Amgen to become Vice President, Head of Medical Safety Physicians at Allergan.

In his new role, Daniels will lead a team of physician executives to support the four key commercial franchises and their pipeline of innovative products.

“Daniels has built safety organizations with global portfolios as diverse as oncology, metabolic diseases, and virology,” stated Tom Callaway, MD, MBA, President of Life Science Partner.

During his first eight years at Amgen, Daniels led the Global Head of Safety Surveillance team with accountability for monitoring clinical safety and all post-marketing safety for all Amgen products.

Prior to his roles at Amgen, Daniels was the Director of Medical Review, Global Drug Safety for Gilead Science.  He began his pharmaceutical career at Pfizer and he became the Global Therapeutic Safety Head, supervising a global team for endocrine, metabolic, and cardiovascular product development.

Originally from South Africa, Daniels earned his MBChB from the University of Cape Town. He earned his diploma in Clinical Epidemiology and Biostatistics as well as his Master in Medical Science (Clinical Epidemiology) from the University of Newcastle, Australia.

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Frank Rivas, JD, Joins American Medical Systems as Compliance Officer

Former Vice President, Compliance and Integrity Programs for NSF Health Sciences

Life Science Partner recruited Frank Rivas, JD to become Compliance Officer for American Medical Systems, a subsidiary of Endo Health Solutions. 

Rivas was previously the Vice President, Chief Compliance Officer of Spectranetics Corporation, an interventional cardiology medical device company under a Corporate Integrity Agreement with the Office of Inspector General of the Health and Human Services.

Most recently Rivas was the Vice President, Compliance and Integrity Programs for NSF Health Sciences, a consulting firm in the field of compliance and corporate integrity.

“Rivas has the leadership background of building a team under the pressure of a DOJ investigation and a CIA,” states Tom Callaway, MD, President of Life Science Partner.  “Rivas has the concise communication skills and gravitas that can only come with experience.”

Rivas earned his Bachelor of Science degree in Marine Science from the United States Merchant Marine Academy and he received his JD from Washburn University in Topeka.

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