Tag Archive for: BioTech and Pharma

Dave Booth Joins Be The Match as Vice President of Quality Assurance and Regulatory Affairs

Life Science Partner is pleased to announce the recruitment of Dave Booth as Vice President of Quality Assurance and Regulatory Affairs with Be The Match.

Booth is a seasoned quality executive with a broad background in building and leading global quality teams within the medical device industry. At Smiths Medical, Booth was Head of Quality for the Infusion Systems Business Unit, responsible for both Pre-market and Post-market Quality, overseeing customer-facing quality concerns, and establishing a new product quality leadership function.

Dave Booth

At Greatbatch Medical, he created new processes and an organization for Design Assurance and Product Monitoring for their Orthopedic business. Previously, Booth led the Quality Systems and Compliance organization within Medtronic’s Cardiac Disease Rhythm Management business.

Booth understands how to build and lead a quality organization and to prepare a company to enter a new regulatory environment. Throughout his career, Booth has overseen teams ranging from small post-market groups to large, multi-site Operations Quality teams. Trained as a statistician, Booth often approaches problem solving by applying his analytical skills in conjunction with insights stemming from his extensive experience in the industry.

Booth will play a pivotal role in helping Be The Match during its next stage of growth and development. The organization is best known as the world’s largest provider of unrelated matched bone marrow donors for life-saving therapies. As allogenic-derived cell therapies are revolutionizing the treatment of cancer and genetic illnesses,

Be The Match is preparing to become the preferred supplier of hematopoietic cells to enable these therapies. Booth’s leadership skills and his years of experience managing interactions with the FDA render him well-suited to prepare Be The Match for the regulatory rigors of FDA oversight they will face as they move into the cell therapy space.

About Life Science Partner

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Chris Fang joins Humacyte as Chief Medical Officer (CMO)

Life Science Partner is pleased to announce the recruitment of Chris Fang, MD, MBA, MHSc as Chief Medical Officer of Humacyte.

Fang’s expertise in biologics and medical devices will be an invaluable asset for Humacyte, a pioneering regenerative medicine company. Humacyte’s lab-grown, acellular blood vessels have been awarded FDA fast-track status for their use in dialysis grafts. The company is launching a series of trials to demonstrate their efficacy in general vascular repair/replacement, including in coronary, peripheral, and saphenous veins.

With a strong background in clinical trials, health economics and product development, Fang will spearhead Humacyte’s pursuit of additional indications for their flagship product, HUMACYL®.

Chris Fang

Fang has over twenty years of experience as a physician leader in the medical device and pharmaceutical industries. Prior to joining Humacyte, Fang founded Amaris Partners, an international consultancy which facilitated investment from principally Asia-based partners into U.S.-based companies that develop and implement novel medical technologies.

Before founding Amaris, Fang served as a Board Member and Worldwide Vice President, Strategic Medical Affairs and Medical Sciences for Johnson & Johnson DePuy for the Asia Pacific Region. In this role, Fang managed the clinical evidence strategy and product safety worldwide with responsibilities for new product development, reimbursement and business development.

Fang also served as the Medical Adviser to the Regenerative Medicine Business Unit and chaired the Worldwide Pipeline Committee responsible for the approval of investigator-initiated studies.

“Fang has a broad understanding of clinical trial management and development in pharmaceuticals, medical devices and regenerative medicine, combined with deep expertise in the regulatory approval process” notes Tom Callaway, MD, MBA, Founder of Life Science Partner. “His experience working in the Asian Pacific region will also be an asset to Humacyte as the company expands into these markets.”

About Life Science Partner Executive Search

Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Bert Slade, MD, Joins Tissue Tech as Vice President, Clinical Development

Former Chief Scientific and Medical Officer Advanced Wound Care, Smith & Nephew

Life Science Partner recruited Bert Slade, MD, to serve as the Vice President, Clinical Development for TissueTech.  Slade has built his career in leading clinical trials, medical affairs, and regulatory approvals for medical device and pharmaceutical companies worldwide.  He joins TissueTech while also providing clinical support for Chisholm Clinical Research Services where he has set up his own vehicle to conduct clinical trials using the European platform as an inroad to EU product approvals.

During his tenure at Smith and Nephew, Slade was challenged as the first CMO for the Advanced Wound Management Division to restructure the three-strategic business unit R&D Departments and two clinical groups into a single international R&D organization with the addition of post-marketing surveillance.

“With his extensive experience in FDA submissions of BLAs and NDAs including a clinical background in wound healing and regenerative medicine, Slade will serve as a critical asset for TissueTech’s clinical trial designs and submissions,” states Tom Callaway, President and Founding Partner of Life Science Partner.

Slade earned his Bachelor of Arts Degree in Biology from Hamilton College.  He earned his MD from the Upstate Medical Center at the University of New York.

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Chris Stein, MD, PhD, Joins Allergan As Director, Medical Safety Physician

Former Global Pharmacovigilance and Clinical Safety Physician Otsuka Pharmaceuticals

Chris Stein, MD, PhD, was recruited by Life Science Partner to serve as Director, Medical Safety Physician for Allergan where he will oversee Pharmacovigilance for Allergan’s CNS drug portfolio.

In his previous role at Otsuka, Stein partnered with safety physicians at Bristol Myers Squibb to co-market the block buster drug, Abilify, and formulate a regulatory compliance strategy and risk management plan while providing signal evaluation and drug safety reporting.

“Intelligent, articulate and passionate about pharmacovigilance, Stein will be able to hit the ground running in his CNS role for Allergan’s pharmacovigilance team,” states Tom Callaway, MD, Founder and President of Life Science Partner. “He brings exceptional analytical and writing skills to be a great addition to the team.”

Chris Stein earned his Bachelor of Science Degree in Biology and Computer Science in 1984 from the Southwest Missouri State University. He completed his MD and PhD from the St. Louis University School of Medicine and his MPH from the University of Kentucky College of Public Health.

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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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Michel Hermans, MD Joins TissueTech as Chief Medical Officer (CMO)

Former Medical Director, Global Medical Marketing, ConvaTec

Life Science Partner recruited Michel Hermans, MD, a surgically trained medical affairs executive to become Chief Medical Officer for TissueTech.

Hermans joins TissueTech after serving as a biopharma consultant for his own firm and Medical Director, Global Medical Marketing for ConvaTech.   Previously, Hermans served served as Medical Director for Ortec where he successfully led the new clinical trials for the commercialization of OrCel globally.

TissueTech, Inc. is a leader in regenerative amniotic tissue-based products for use in the ophthalmology, optometry, orthopedic reconstructive surgeries and wound care markets.

TissueTech offers its portfolio products through its commercial entities: BioTissue, Inc., the industry leader in regenerative tissue therapies for ocular surface diseases and disorders, and Amniox Medical, a leading technology provider to the orthopedic and wound care markets.

“Hermans has the direct clinical trials management experience that leads to the approval of biologics in the BLA regulatory pathway – and brings that background to TissueTech’s clinical and regulatory strategy,” states Tom Callaway, MD, Founder and President of Life Science Partner.  “In addition, as a specialist in treating burn patients, he brings real-life clinical experience to the company.”

Hermans earned his Medical Degree from the University of Groningen in the Netherlands and completed his training in general surgery, burn and trauma care from the Rode Kruis Ziekenhuis and Burn Center in Beverwijk, Netherlands.

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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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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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Jon Hopper, MBChB Recruited to Osiris Therapeutics

Former Vice President, Global Medical Director, Stryker

Life Science Partner recruited Jon Hopper, MBChB, an accomplished physician executive to become Chief Medical Officer for Osiris Therapeutics. Osiris is the leading stem cell company focused on developing products to treat conditions in wound care, orthopedic and sports medicine markets.

Hopper joins Osiris after serving as the Vice President, Global Medical Director at Stryker. In his new role, Hopper will report directly to CEO Lode Debrabandere and oversee medical affairs, clinical development and regulatory affairs globally. He will be responsible for providing high-level market strategy for Osiris’ leadership within regenerative medicine.

“Hopper has a worldview of developing and marketing both orthopedic and wound healing products in the US, Asia and Europe,” notes Tom Callaway, MD, President of Life Science Partner. “He has helped developing clinical and post-marketing plans for complex biologic products including living cells.”

Hopper earned both his Bachelor of Science Degree in Anatomical Studies and his MB ChB from the University of Birmingham, UK.

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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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