Roger Lias, PhD, Joins Wheeler Bio as President and Chief Operating Officer

Life Science Partner announces the recruitment of Roger Lias, PhD, to Wheeler Bio to advance their expansion as cutting-edge biologics CDMO.

Wheeler Bio, a CDMO, retained Life Science Partner to recruit their President and Chief Operating Officer to accelerate their growth as an industry leader in biologics development services. With a new state-of-the-art Oklahoma City facility, Wheeler Bio has revolutionized the speed of drug discovery with their novel hub-and-spoke concept and Portable CMC® platform that fast-tracks the pathway to IND.

After a nationwide search campaign, Roger Lias, PhD, former Chief Commercial Officer of Vibalogics, was recruited by Life Science Partner to serve as Wheeler Bio’s President and Chief Operating Officer beginning in September 2022.

Lias’ well-established credibility in the biopharma CDMO industry combined with his entrepreneurial leadership experience made him an absolute fit for growing Wheeler Bio into the global partner of choice for biological companies.”

Tom Callaway, MD, Founder of Life Science Partner

Lias will hit the ground running joining the Wheeler Bio team at the BioProcess International Conference in Boston this month, September 2022. In his new role Lias will be responsible for spearheading strategic business opportunities, alliances and joint ventures and will lead a scalable business operations team keeping Wheeler’s technology development and functions aligned with the corporate strategy as industry demand increases.

Prior to joining Wheeler Bio, Lias served as the Chief Commercial Officer for Vibalogics, a Private Equity-backed CDMO that was acquired by Recipharm AB in February, 2022.  He has an extensive track record of entrepreneurial successes including Stelis Biopharma, Avid Biosciences, Allergan, Eden Pharma, Cytovance and KBI Biopharma.

Lias holds a Bachelor of Science degree in Physiology and Biochemistry from the University of Southampton in the United Kingdom. He earned his PhD from Clare College, University Cambridge.

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.

Katie Bishop Joins Life Science Partner as Senior Vice President, Chief of Staff

Life Science Partner is pleased to announce the return of our latest team member, Katie Bishop as Senior Vice President, Chief of Staff. Katie rejoins Life Science Partner after serving as a client liaison and regional account leader for INNOCEAN Worldwide. Katie previously worked at Life Science Partner from 2012 – 2017 where she started as an Assistant Researcher and worked her way up to Vice President, Client Relations and Business Development before joining INNOCEAN.

In her new role at Life Science Partner, Katie will be responsible for overseeing research, providing superior client relations, using her brand management experience to position the firm as a leader in recruiting transformative leaders, and creating new business development initiatives to attract new customers.

“It’s wonderful to have Katie back at LSP after a five-year hiatus. In this more senior role, she will elevate our service to clients and candidates beyond the high-standard that we have already set in the marketplace.”

Tom Callaway, MD, Founder of Life Science Partner.  

Katie started her career at Young & Rubicam and then moved on to Team One and TBWA\Chiat\Day working on brands such as Lexus and Infiniti. Katie holds a bachelor’s degree in marketing and international business from Miami University.

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.

Mark Bogart joins B-Secur as Senior Vice President, US Healthcare

Life Science Partner announces the recruitment of Mark Bogart to serve as Senior Vice President, US Healthcare for B-Secur, a global leader in accelerating the quality of EKG signals to create highly accurate analytics for digital heart health.

Life Science Partner served as a strategic consulting and executive search partner of B-Secur to support their U.S. launch of their signature SaaS technology, HeartKey 2.0®.  This cloud-based solution will accelerate the convergence of medical and consumer health devices by offering a proprietary conditioning, FDA-cleared software to improve health algorithms and wellness insights. B-Secur’s innovative biosensing algorithms refine and enhance signal clarity on micro processing chips (implantable or wearable), for consumer technology partner servers providing novel insights. Their technology also serves as an adjunctive tool for accelerating the adoption of medical device company’s proprietary and patient-centric solutions.

With B-Secur’s technology in high demand to improve signal quality, Bogart will secure and expand relationships with US-based medical device and digital health providers. Additionally, Bogart will build and lead the team to grow the US commercialization opportunities with leading cardiac device companies seeking to bring their EKG monitoring solutions to ambulatory and at-home patients.

“With his subject-matter expertise in digital healthcare and remote patient monitoring combined with his exceptional career as a sales leader, Bogart is well-suited to accelerate B-Secur’s growth and establishment within the US market.”

Tom Callaway, MD, Founder of Life Science Partner

Bogart joins B-Secur after serving as Senior Vice President, US Healthcare for AliveCor, a medical device company that produces ECG hardware and software for mobile devices. Bogart led the healthcare division’s go-to-market strategy spear heading critical partnerships and novel acquisitions during his tenure. Earlier in his career, Bogart served in revenue-generating business development leadership roles at companies such as G Medical Innovations, Viterion Corporation, LifeWatch, ZOLL Medical and Boston Scientific.

Bogart holds a Bachelor of Arts degree in Economics and Political Science from Lake Forest College.

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.

FDA Regulatory Leadership For Medtech/IT Convergence

Life Science Partner recruits 2 transformational leaders to the FDA

Doug Kelly, MD, Deputy Director for Science, FDA, CDRH

Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process. In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug Kelly, MD, MBA as Deputy Director for Science to the FDA’s CDRH Office. Since the creation of his role in August 2020, Dr. Kelly has already made a significant impact on improving FDA/innovator communication and accelerating patient access to high-quality, safe, and effective medical devices. Dr. Kelly has been instrumental in partnering with top leaders from industry and academia to expedite the regulatory clearance process to assure consumer confidence and advance innovative technologies.

“Through his serial entrepreneurship experience, Dr. Kelly understands the regulatory pathway obstacles that innovators face.”

Tom Callaway, MD, Founder of Life Science Partner.

In May 2022, Dr. Kelly spoke as the key note speaker at the AdvanSE Conference in Atlanta, GA where he presented CDRH’s role in the COVID-19 response, the future of the Medical Device User Fee Act and its introduction to TPLC TAP (Total Product Life Cycle Advisory Program); a new team of experts focused on providing strategic advice actively coordinated with FDA review teams and across the MedTech ecosystem.

Doug Kelly, MD, and Tom Callaway, MD, at AdvanSE 2022

Most recently, Life Science Partner recruited David McMullen, MD, to serve as Director, Office of Neurological and Physical Medicine Devices (OHT5) for the CDRH where Dr. McMullen is the technical authority and principal advisor for ninety individuals responsible for the total product life cycle (TPLC) review of neurological, neurointerventional and neurodiagnostics devices, as well as responsible for a separate group focused on neuromodulation and physical medicine devices.

“Co-leading The BRAIN Initiative at NIH, McMullen has demonstrated the leadership to oversee various multi-faceted programs simultaneously and evaluating cutting-edge technologies such as computer-brain interfaces.”

Tom Callaway, MD, Founder of Life Science Partner.
David McMullen, MD, Director FDA, CDRH, OHT5

McMullen’s team will oversee premarket evaluations, compliance and quality parameters, and surveillance programs for all neurological products and devices and be engaged in the decision-making process on device submissions, classifications, petitions, 501(k)s, PMAs, IDEs and all supplements and amendments to submissions.

Life Science Partner is pleased to have recruited Dr. Kelly and Dr. McMullen as transformative leaders contributing to the FDA CDRH ’s mission to accelerate the adoption of innovative technologies to improve the healthcare of patients.

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.

Stan Harris joins BioTissue as Vice President, Clinical Operations

Life Science Partner is pleased to announce the recruitment of Stan Harris as Vice President, Clinical Operations for BioTissue – the newly unified brand for TissueTech, Amniox, and Bio-Tissue. BioTissue is an emerging biotechnology leader in utilizing the power of human birth tissue for regenerative healing to treat ocular surface disease and in surgical, chronic wound, and musculoskeletal applications. and Board Member of Novum Medical.

“For years, health care professionals have known our products—regardless of their specific applications—for providing mother nature’s most natural gift of healing so their patients can get back to the lives they love,” said Ted Davis, president, and CEO, BioTissue. “Our new, unified brand supports our entire pipeline of human birth tissue products to aid the treatment of wounds, musculoskeletal conditions, trauma-induced injuries, ocular surface disease, and burns.”

With nearly 40 years dedicated to the medical device industry and a focus on regulatory, quality, and clinical affairs, Harris brings a wealth of knowledge and experience to the clinical operations team at BioTissue. The FDA and other global regulatory agencies are increasing the regulatory oversight of cell-derived therapies.  Harris will be responsible for developing and leading BioTissue’s clinical development with an emphasis in the ophthalmology, orthopedic and pain management indications.

Most recently Harris served as the Vice President, Regulatory, Clinical and Quality Affairs at Lifeline Scientific with previous clinical and regulatory roles at MiMedx, Integra Life Sciences, Ascension Orthopedics, and Wright Medical. “From his previous experience, Harris has direct relationships with key thought leaders in wound healing including excellent relations with the FDA, US, and European regulatory agencies for biological products,” states Tom Callaway, MD, MBA, Founder of Life Science Partner. “His experiences and enthusiasm will be ideal for BioTissue’s continued growth and product development.”

Harris earned a bachelor’s degree in biology from Mercer University. He completed Graduate Studies in Biotechnologies from the Georgia Institute of Technology. 

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

David McMullen, MD, Recruited as Director, Office of Neurological and Physical Medicine Devices (OHT5), FDA Center for Devices and Radiological Health (CDRH)

Life Science Partner has recruited David McMullen, MD, to serve as Director for The Office of Neurological and Physical Medicine Devices (OHT5), Center for Devices and Radiological Health (CDRH) at the Federal Drug Administration. The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. The Office of Health Technology 5 (OHT5) is within CDRH’s Office of Product Evaluation and Quality (OPEQ) and is responsible for the total product life cycle review of neurological and physical medicine devices.

As Director for OHT5, McMullen will serve as the technical authority and principal advisor to the OPEQ Director on the total product lifecycle of devices including premarket evaluation, compliance and quality, and surveillance programs for neurological products. 

Since 2016, McMullen has served as the Program Chief for the National Institute of Mental Health (NIMH) within the Neuromodulation and Neurostimulation Program, Division of Translational Research (DTR). His oversight included device development and biomarker discovery grants as well as clinical trials ranging from first-in-human to critical studies designed to gain FDA regulatory approval. McMullen’s experience includes acting as co-leader for the NIH BRAIN Initiative team and as the NIMH point of contact to the FDA on devices.

“McMullen’s neurovascular and neurostimulation expertise combined with his working relationships within the FDA make him a natural fit for his new leadership role at the Office of Neurological and Physical Medicine Devices,” states Tom Callaway, MD, MBA, Founder of Life Science Partner. In his new role at OHT5, McMullen will be tasked with navigating the complexities and multiple constituencies of the FDA’s neuroscience device regulatory division and industry agencies while managing a 90 plus person office.

McMullen earned his Bachelor of Science degree in Psychology and Neuroscience from Duke University and his Doctor of Medicine from Rutgers Robert Wood Johnson Medical School.

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Tom Afzal Joins Novum Medical as Chief Executive Officer

Life Science Partner has recruited Tom Afzal to become Chief Executive Officer and Board Member of Novum Medical.

Novum Medical is a private, medical device and orthopedics company developing advanced orthobiomaterials that are structurally sound and compatible to the body. Having shown success with their current applications in extremities, the company is entering the spine industry with their first cervical implant device (currently in FDA IDE clinical trials). The technology has already shown promising and superior results when compared to other implants such as titanium or PEEK plastic.

Afzal is a leader in the spine, orthopedic and cardiovascular industries. He will lead Novum in transforming the spine surgery and orthopedic markets, while continuing the growth of the company. As a co-Founder and former Chief Executive Officer of Spinal Kinetics, Afzal brought his company to profitability and led the commercial strategy for their artificial discs. He also gained extensive experience building international businesses across Europe, raising sales to over 60,000 implants in over 20 countries.

Prior to Spinal Kinetics, Afzal was the Chief Executive Officer of Cardiovention. He raised $45 M from venture capital firms, established U.S., German, and Swiss sales organizations, filed his own patents, and helped create a team to develop minimally invasive products for cardiovascular surgery.

Afzal spent the early 90s working overseas in Germany for Life System Medizintechnik and Krauth Medical, achieving annual revenue growth and leading Life System through its acquisition by Krauth Medical. He graduated from San Diego State University majoring in Business Administration and minoring in Finance.

Afzal will play a critical role in raising funds for Novum Medical with his financing background and connections in the spine, cardiovascular and sports medicine industries. As the company completes its FDA IDE clinical trials for their Vitrium cervical interbody spinal fusion device, Afzal will leverage his strengths in commercial and operational leadership to advance the company to its next level of growth.

Novum Medical is a private, medical device and orthopedics company developing advanced orthobiomaterials that are structurally sound and compatible to the body. Having shown success with their current applications in extremities, the company is entering the spine industry with their first cervical implant device (currently in FDA IDE clinical trials). The technology has already shown promising and superior results when compared to other implants such as titanium or PEEK plastic.

Afzal is a leader in the spine, orthopedic and cardiovascular industries. He will lead Novum in transforming the spine surgery and orthopedic markets, while continuing the growth of the company. As a co-Founder and former Chief Executive Officer of Spinal Kinetics, Afzal brought his company to profitability and led the commercial strategy for their artificial discs. He also gained extensive experience building international businesses across Europe, raising sales to over 60,000 implants in over 20 countries.

Prior to Spinal Kinetics, Afzal was the Chief Executive Officer of Cardiovention. He raised $45 M from venture capital firms, established U.S., German, and Swiss sales organizations, filed his own patents, and helped create a team to develop minimally invasive products for cardiovascular surgery.

Afzal spent the early 90s working overseas in Germany for Life System Medizintechnik and Krauth Medical, achieving annual revenue growth and leading Life System through its acquisition by Krauth Medical. He graduated from San Diego State University majoring in Business Administration and minoring in Finance.

Afzal will play a critical role in raising funds for Novum Medical with his financing background and connections in the spine, cardiovascular and sports medicine industries. As the company completes its FDA IDE clinical trials for their Vitrium cervical interbody spinal fusion device, Afzal will leverage his strengths in commercial and operational leadership to advance the company to its next level of growth.

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Jo Carol Hiatt, MD, MBA joins the Medical Device Innovation Consortium as Vice President, Health Economics & Patient Value

Life Science Partner is pleased to announce the recruitment of Jo Carol Hiatt, MD, MBA to become the Vice President, Health Economics and Patient Value for the Medical Device Innovation Consortium (MDIC).

The MDIC brings together representatives of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare and Medicaid Services (CMS), industry, non-profits, and patient organizations to improve the processes for development, assessment and review of new medical technologies. It is the only public-private partnership developed to work with government and industry stakeholders to advance solutions that promote patient access to innovative medical technologies.

Well-known across multiple industries, Dr. Hiatt will lead the MDIC’s efforts to increase predictability regarding the scientific and clinical evidence to support health economics assessment and the “reasonable and necessary” standard. She will act as the critical leader to interface between the MDIC, its members of the board, FDA, CMS, and other payors. In addition, she will manage the Health Economic and Patient Value committee to focus on projects that have a high priority for its members.

Previously, Jo Carol Hiatt was a Chair for the Inter-Regional New Technology Committee for Kaiser Permanente, where she led physicians and executives in reviewing evidence for new technologies. As an Assistant Medical Director, she acted as a liaison and strategist to produce recommendations for quality care based on available evidence and patient supply/demand forecasts. Her deep understanding of coverage processes as well as her connections with various organizations across the industry will make Hiatt a valuable addition to the MDIC leadership team.

Hiatt graduated from Stanford University with a Bachelor of Arts, received her Medical Degree from Duke University, and completed her internship and surgical residency at University of California, Los Angeles. She also earned her MBA from UCLA in 2001.

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

David Ramsingh, MD Joins Edwards Lifesciences as Vice President, Clinical & Medical Affairs – Critical Care

David Ramsingh, MD, incoming Vice President, Clinical & Medical Affairs for Edwards Critical Care

Life Science Partner is pleased to announce the recruitment of David Ramsingh as Vice President, Clinical & Medical Affairs – Critical Care at Edwards Lifesciences.

Edwards is a global leader in patient-focused medical innovations. Recently, their Critical Care division has expanded its role in AI-supported predictive software solutions that allow ICU physicians to make better patient care decisions. In doing so, the team sought an integrative leader to oversee clinical research activities, including clinical trials, data management, and systems development to help with future product approval. An anesthesiologist and researcher in hemodynamic monitoring and echocardiology, Ramsingh has a combination of skills which positioned him for this opportunity.

Ramsingh will direct multiple functions within clinical and medical affairs, oversee research activities around clinical trials, data management, and system development for future product approvals. In addition, he will oversee Edwards’ high standard of professional education through its Global Professional Development program.

Ramsingh possess valuable skills and experience, having come from Loma Linda University and University of California at Irvine, where he developed an innovative teaching program for anesthesiologists to apply whole-body, point-of-care ultrasound exams. At Loma Linda, his research focused on the use of ultrasound technology to improve perioperative care.

As the Director of Clinical Research and Perioperative Ultrasound at Loma Linda University Medical Center, Ramsingh spent most of his time leading a research team that he developed to focus on hemodynamic monitoring devices, partnering with corporate sponsors such as Edwards, Masimo, and General Electric. Ramsingh earned his medical degree from the Medical College of Georgia. He completed his residency in anesthesiology at Loma Linda University, and he was a cardiothoracic fellow at the University of California in Los Angeles.

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.

Doug Kelly, MD, MBA Joins FDA’s Center for Devices & Radiological Health as Deputy Director for Science

Life Science Partner is pleased to announce the recruitment of Doug Kelly, MD, MBA as Deputy Director for Science to the Food and Drug Administration’s Center for Devices and Radiological Health (FDA, CDRH).

FDA, CDRH is responsible for protecting and promoting public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. They provide the community with accessible science-based information about the products they oversee and facilitate medical device innovation by advancing regulatory science. The CDRH also provides industry with predictable, consistent, and transparent regulatory pathways to assure consumer confidence in the devices marketed in the United States.

With the tremendous advancements in technology and a new age for telemedicine and remote patient monitoring, the CDRH is also focusing on advancing their field of digital health. Housed within the CDRH is the Office of Strategic Partnerships and Technological Innovation. This unit provides leadership for all scientific collaborative and emerging technology, including the new division of Digital Health, which focuses on providing leadership and oversight in the development, review, and implementation of new software services that are aimed at healthcare.

Doug Kelly is a leader in the field of innovative medical technologies. After earning his medical degree from Albert Einstein College of Medicine and his MBA from Stanford University, Kelly was one of the founding members of Ligand Pharmaceuticals, where he served as the Manager of Business Development and helped recruit their Scientific Advisory Board and manage relationships with corporate partners. In 1996, he helped create a new venture fund, Alloy Ventures, and identified new opportunities for investments in seed- and later-stage medical device, drug discovery, biotechnology and healthcare IT companies.

Dr. Kelly will play a critical, external-facing role for the CDRH and the Office of Strategic Partnerships and Technological Innovation by collaborating with leaders in industry, academia, and healthcare innovation, leveraging his wealth of experience in the medical device investment community.

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.