Here are some of the testimonials I have received:

Barbara Tobichuck, Consulting Head of Clinical Operations for Impel Pharmaceuticals (Consultant & direct report): “I had the pleasure of working with Steve at Impel Pharmaceuticals. Steve hired me as a consultant to be responsible for the management and oversight of clinical development operations. While working with Steve he was a consummate leader who provided direction and guidance when needed. Steve has extensive clinical development experience in the pharmaceutical industry over many years working across numerous indications. More importantly, he is a seasoned leader who consistently praises your work and remains positive even when unplanned events occur during a project. There were many twists and turns in the proof-of-concept study we were working on. Steve was always open-minded and collaborative when solutions were proposed while implementing our program. While at Impel, I had the pleasure of being part of an Advisory Board, which Steve led, during which I observed how well respected Steve is by his peers, colleagues, superiors and team members, with whom he willingly shares his clinical expertise – attributes that will serve him well as a consultant. Steve created a forum during the Advisory Board where great insights were gained for developing future studies from both a regulatory and clinical development perspective. Steve has been a forward-thinking leader as Chief Medical Officer at Impel. There were several initiatives and clinical development plans Steve was working on. There were many iterations and challenges in developing a protocol for approval by the FDA for a novel indication treating a sensitive, protected patient population. Steve brings the compassion needed as a clinician when working with delicate patient populations and their families and the business acumen to develop a program to meet an unmet medical need for many patients and caregivers. It was indeed a pleasure to work with Steve. I would welcome the opportunity to work under his direction again. He is experienced in leading a clinical development team and creating a collaborative, empowering environment for all his direct reports”. Posted April 10, 2023

Len Paolillo, Chief Commerical Officer for Impel Pharmaceuticals (Fellow C suite executive & peer): “I had the pleasure of working with Steve during his tenure at Impel Pharmaceuticals where we collaborated on both early-stage development and commercial planning and execution. He is a strategic, patient-focused and hands-on development and medical affairs leader who delivered a first-cycle approval of a drug device combination product with a novel route of administration. Steve’s strategic eye on commercial-enabling data generation throughout the development journey supported our ability to differentiate and succeed in a competitive therapeutic area”. Posted April 7, 2023

Tom Bevington, Director of Clinical Supply for Impel Pharmaceuticals (development colleague and direct report):
“I had the pleasure of working for Steve at Impel Pharmaceuticals on the development of several investigational drug-device combination products.  Steve is very highly respected not only for his intelligence and scientific knowledge, but also for his tireless leadership and drive for success.  Throughout my time at Impel we faced many unique and unexpected challenges across all facets of drug development, including site management, vendor management, recruitment, and drug supply.  Steve’s leadership through these many challenges was invaluable.  He has a thorough understanding across all disciplines in clinical operations and could always be relied upon to provide valuable insights to the most intractable problems when needed.  Steve was also an absolute joy to work with.  I always came away energized and motivated after meeting with him”. Posted March 26, 2023

Dr. Noam Butterfield, Senior Director, Product Planning, Aquinox Pharmaceuticals (development colleague):
“I worked closely with Steve in developing our lead molecule at Aquinox Pharma, and it was a true pleasure to collaborate with him. Steve is thoughtful, passionate, intellectual, creative, and insightful, bringing high energy, a positive attitude and tremendous work ethic to every project he is involved with. His depth of medical and scientific knowledge and experience in drug development makes Steve highly effective in developing the thread that connects mechanistic, non-clinical and clinical data into a clear story. Steve’s ability and willingness to transition from high-level strategic guidance and oversight to hands-on work in writing manuscripts, regulatory dossiers, etc, further strengthen his value to any organization. Engaging with external consultants, investigators, and thought leaders is effortless for Steve, and he immediately earns respect amongst all members of an organization. Steve’s drive for success is invaluable. I highly recommend Steve as a key member of any drug development team”.  Posted November 16, 2016

Dr. Gordon Lutz, Chief Executive Officer, LifeSplice Pharma (client) hired me:
“I recommend, in the strongest way, without any reservations, Steve Shrewsbury (Shrewd Consulting) as a Consultant for Preclinical and Clinical Development and Regulatory Affairs. LifeSplice Pharma, established in October of 2010 is developing two pre-clinical drug candidates, supported by SBIR grants, which are on an accelerated path to open INDs and clinical trials. To achieve this goal, we engaged Steve to work with our founders (both former academics) to guide us though the process of every aspect of our IND-enabling pharm-toxicology program and to lead the design and implementation of expected follow-on clinical trials. Steve identified that additional value to our lead program would be gained by Orphan Drug designation, encouraged us to apply, and wrote the application which was quickly granted by the FDA.
On a personal level, working with Steve is truly enjoyable. I can personally attest that Steve seems to have mastered the art of communicating with and providing guidance to his clients that are new to this area. He takes painstaking efforts to both provide his expertise and at the same time offer you a range of options. Thus, Steve never pushes an agenda, but rather is always friendly, engaged, and enthusiastic, to help you learn and succeed.
Finally, if one sentence sums up my experience with Steve over the past year it is that you can expect to get more than you paid for, and will be delighted with the results.”Posted January 27, 2013

Dr. Robert Cook, Senior Director, Product Commercialization, MicroDose Therapeutx (client) hired me:
Top qualities: Great Results, Personable, Expert
“Steve is a distinct pleasure to work with and is an accomplished clinical developer in the pharmaceutical/biopharmaceutical industry. His expertise is of the highest class and his passion and commitment to getting the job done is truly outstanding. Steve can always be counted on to go the extra mile and beyond. As a consultant, his availability and involvement feels like he is part of your organization, and his insight and knowledge of clinical operations, development and medical oversight is remarkable. I highly recommend Steve.” Posted April 29, 2012

Dr. Lorianne Masuoka, SVP, Chief Medical Officer, Nektar Therapeutics (colleague) worked directly with me:
“I had the pleasure to meet Stephen at Chiron where he took over the medical leadership of the newly acquired pulmonary unit. He was a strategically intelligent and capable leader who also demonstrated a calm and professional demeanor at all times. Because of this positive experience, we engaged Stephen’s services as a consultant for a pulmonary program at Nektar. His advice and services proved invaluable for a complex program during a time of great change. I would welcome the opportunity to work with Stephen again.” Posted June 14, 2011

Rupa Desai, Klinera Clinical Research  (client) hired me as a Medical Monitor in 2010:
“Dr. Shrewsbury has worked with Klinera in previous CMO roles but is now, through Shrewd Consulting LLC, providing medical and clinical operational advice on a complex inhaled anti-infective program. He has been an excellent resource for our India and US based teams to provide strategic advice, rapid assessment of operational and medical issues and therapeutic area training for our CRO staff, the sponsor and the site. He has worked in the role of a medical monitor for Klinera for several Phase I studies, as well as later Phase studies which have been executed and completed ahead of schedule on several continents simultaneously. He has extensive clinical research and industry experience in multiple therapeutic areas, with different routes of administration, for large pharma companies and small biotechs and is very flexible and approachable. Working on some of our global projects, he never hesitates to respond to questions even in the middle of the night!” Posted February 4, 2012

Anuradha Dutta, Associate Director Clinical Operations, MicroDose Therapeutx (business partner) was with another company when working with you: “I have had the pleasant opportunity to work with Dr. Shrewsbury and am pleased to say that he is a dedicated team player and a delight to work with. Steve’s greatest strengths are his open communication style, program and workplace optimism, timely delivery of documents and advice and deep hands-on knowledge of pharmaceutical and clinical development and regulatory processes.” Posted February 24, 2012

Nancy R. Katz, Ph.D., President and Principal Medical Writing Consultant, Illyria Consulting Group, Inc. (colleague) worked for me:
“I am impressed with Steve’s ability to work with a team, and in particular the medical writer, to enable the creation and sign-off of articles for peer-reviewed publication and eCTD-compliant regulatory documents. These include Module 2 summaries, notably sections 2.4, 2.5, 2.6 and 2.7, as well as documents in other sections of the CTD – the IB (Section 1), nonclinical reports (Section 4), and protocols, CSR’s, ISEs, and ISSs (Section 5). Steve provides expert, clear, and concise interpretations of clinical and nonclinical data (“messages”) and always reviews documents in a timely manner. He has a thorough understanding of the regulations governing documents for submissions and of course of those that allow him to be the seasoned medical monitor he is. Above all, he understands that documents, especially regulatory documents, evolve over time; he expends every effort to gather input and respond to comments from all team members – the biostatistician, regulatory affairs, clinical operations, and nonclinical specialists, and the medical writer—to ensure the creation of scientifically accurate, regulatory-compliant, readable biomedical documents.” Posted March 2, 2012

Paul Medeiros, SVP and Chief Business Officer, AVI BioPharma (colleague) worked with me:
“Steve is a consummate biopharma professional who has been a proactive business partner to corporate and business development teams throughout his career. Beyond his considerable skills as a C-level clinician, he also demonstrates a keen understanding of the commercial imperatives of the business and he works closely with corporate executive teams to advance key operational and strategic objectives. I can highly recommend Steve as a high-energy manager and leadership team member.” Posted September 6, 2011

Melinda Kile Miles, Chief Accounting Officer, AVI BioPharma (colleague) worked with me:
“Stephen is a highly professional and knowledgeable Chief Medical Officer” Posted July 9, 2011

Dr. Alison Heald, Senior Director, Clinical Development, AVI BioPharma (colleague) reported to me:
“Steve was a pleasure to work with at AVI. Intelligent, considerate, and thoughtful – a winning combination.” Posted July 26, 2011

Dale Usner, Director, Biostatistics, AVI BioPharma (colleague) reported to me
“Stephen is a very thought provoking and detail oriented manager who encourages and enables statistical input into study design and analyses. Stephen actively identifies areas to engage statisticians and promotes development of statistical manuscripts and presentations.” Posted September 7, 2011

Dr. Graham Johnson, SVP Preclinical Development and Research, AVI BioPharma (colleague) worked with me:
“Steve Shrewsbury is an innovative and broadly experienced clinician who brings high energy and drive to every challenge that he takes on. Working with him was also made more productive and pleasurable by his great sense of humor and outgoing demeanor.” Posted September 9, 2011

David Walsey, Senior Director of Investor Relations and Corporate Communications, AVI BioPharma (colleague) worked with me:
“Steve was a pleasure to work with at AVI. As head of Corporate Communications and Investor Relations, I found Steve not only very supportive and understanding of the company’s communications needs, but also critical in making sure press releases and other announcements clearly communicated important and relevant clinical and medical information.” Posted September 24, 2011

Tim Axtelle, Senior Director, Clinical Development at AVI BioPharma (colleague) worked for me:
“I highly recommend Steve Shrewsbury. Steve has extensive Clinical and Regulatory Affairs experience in all phases of drug development from early phase studies through post-marketing development. He has achieved success at big pharma and small biotech. What’s more, Steve is extremely personable. He commands respect through his intellect, insight and interpersonal charm without being overbearing. In my 25 years in the industry, I have worked with many Chief Medical Officers. If I had to pick among them, Steve would be my first choice.”  Posted January 5, 2012

Dr. Paul Spence, SVP Research and Project Management, Adamas (colleague) worked directly with me:
“I worked with Steve at Adamas. As Chief Medical Officer he was responsible for all Adamas’ clinical programs. He especially focused on the complex international clinical planning that was required to establish research programs in Asia. He also contributed significantly to Adamas’ grant writing efforts to gain funding for a BARDA program. As the Adamas dementia project leader, I used his invaluable clinical development skills to help take the program forward to Phase 2 status. I would strongly recommend Steve based on his history as a clinical development Physician and a scientist ready to contribute to work across quite disparate clinical areas. If the opportunity arose to work with Steve again I would happily do so.” Posted September 14, 2011

Mahtab Fatemi, Director Regulatory Affairs, MAP Pharmaceuticals (colleague) reported to me:
“I reported directly to Steve, as Regulatory Affairs Manager and then Director, for over two years. I had no pharmaceutical experience when I started working for Steve. He mentored me and I greatly benefited from his professional experience. We opened two INDs, held two EOP2 meetings and initiated Phase 3 studies together. He was closely involved in all aspects of these submissions. He was always open to hearing different perspectives and new ideas. It would be a pleasure to work with Steve again.” Posted October 5, 2011

Kenneth Wu, Consultant in Clinical Operations, Adamas Pharmaceuticals (business partner) was a consultant contractor to me
“I enjoyed consulting for Dr. Shrewsbury at Adamas, where he was chief medical officer (CMO). In a short few months, Dr. Shrewsbury made great strides in framing global clinical and regulatory strategies in three programs. Key to Dr. Shrewsbury’s success was the ability to assemble an experienced team in weeks of his arrival at the company. It was a pleasure to work for this clinical professional- who has high standards for data quality and management integrity. I now understand why my former colleagues were eager to work with Dr. Shrewsbury again. It would be my pleasure to work with Dr. Shewsbury again.” Posted August 27, 2011

Maurice Gaubatz, CEO, Pyxant Labs Inc. (business partner) contracted with me:
“Steve is a forthright and quite accomplished leader for clinical pharmaceutical development programs. He is among the most effective medical directors, of the many with whom I have had the good fortune to collaborate. I am happy to provide an unqualified recommendation of Dr. Shrewsbury’s qualifications and work performance.” Posted August 26, 2011

Les Pennelly, Vice President, Biostatistics, Omnicare / Clinimetrics (business partner) contracted with me:
“Dr. Shrewsbury is one of the most complete and well rounded pharmaceutical research MDs that I have had the pleasure to work with in 35 years. I observed his preparation for FDA strategy meetings and resulting agency interactions/negotiations/agreements and they were outstanding. I also observed protocol development sessions he led with industry MD experts and was again very impressed with his ability to get the best possible protocol written. Stephen successfully participates at the most detailed level (e.g: data issues) through visionary level (e.g: regulatory approval strategy). He treats the lowest ranking project team members through the most senior company employees with respect. Expect Dr. Shrewsbury to provide a quality product for whatever he commits to.” Posted August 27, 2011

John Burnett, PMP, Clinical Program Manager, MAP Pharmaceuticals (colleague) worked indirectly for me:
“Dr. Shrewsbury is one of the most intelligent men I’ve had the pleasure of working with. His ability to understand the clinical operations execution aspect in addition to the clinical trial / development program design is what sets him apart from others in his position. He is a tireless worker willing to do whatever it takes to move a product through the development process toward filing. He is a leader not just by word, but by example. He has great people skills which allows him to effectively communicate not only what he wants done, but also garner the support of those who he will work with to execute the work that needs to be done.” Posted June 14, 2011

Bonnie Perkins, Senior Project Manager, MAP Pharmaceuticals (colleague) worked indirectly for me:
“Steve raised the bar for all of us, both through his professional guidance and also through his skills at generating positive collaborative energy. He set a compelling example of personal dedication and passion for his work and engaged us all in the excitement of meeting company objectives. It was a pleasure to work under his leadership – one always looked forward to coming to work where things were so capably managed.” Posted July 19, 2011

Dr. Min (Min-Hui) Wang, Director, Biostatistics, MAP Pharmaceuticals (colleague) reported to me:
“I had the pleasure to work with Steve at MAP Pharmaceuticals as his statistician and headed up the Biostatistics and Data Management group for him. Steve is a stand-out among all the executives I have met. As a Chief Medical Officer at a small start-up like MAP, he efficiently operated his teams in an extremely resource and budget constrained environment to meet very aggressive corporate timelines and delivered high quality of products per corporate objectives. Steve was also a mentor and a very supportive boss. He was up-to-date with cutting edge technology and encouraged his teams setting up the trials using EDC systems as much as possible which streamlined the data management process and increased the data integrity. He had comprehensive statistics knowledge and recognized its importance in the development of pharmaceutical products which provided me lots of support when I was operating my department. He is definitely the boss I would love to work for again!” Posted August 2, 2011

Deborah Benkelman, Executive Administrative Assistant, MAP Pharmaceuticals Inc. (colleague) reported to me:
“Steve is a terrific boss. Always appreciative, I always felt we were a team and appreciated his respect for me and the job I was doing. Steve is a dedicated, hardworking individual who always takes his co-workers into consideration no matter the project or situation. I truly appreciated my time as his assistant and anyone who would be so lucky to be his current or future assistant is truly fortunate. Steve is truly a wonderful human being and the best boss that I every had the pleasure to work with.” Posted May 13, 2011

Dr. John Tran, Associate Director Clinical Operations, MAP Pharmaceuticals (colleague) reported to me:
“I worked with Steve at MAP Pharmaceuticals where he set up Clinical Development and Regulatory Affairs Departments. He was an inspiration to work with – always supportive, well mannered and good humored, yet he took his job and his role as Chief Medical Officer very seriously striving to continually set himself high standards which were inspirational to myself and my staff. Steve was also a strategic thinking, knowlegable physician and approachable leader, consistently beating timeline and budget goals. I enjoyed working with him and would greatly enjoy a chance to do so again. ” Posted September 7, 2011

Dan Combs, Owner, Combs Consulting Service (business partner) contracted with me:
“I worked as a pharmacokinetics consultant for Stephen when he was a Vice President or Senior Vice President of Clinical Development at different companies. Stephen was always very helpful in giving information and feedback on my work. Stephen is passionate about his work and cheerfully responded to my questions. I recommend Stephen as someone dedicated and experienced in clinical development.” Posted September 7, 2011

Please check out my updated testimonials and recommendations on:

www.linkedin.com/Stephen Shrewsbury

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