AN EXPERIENCED TEAM OF SCIENTIFIC & REGULATORY EXPERTS

Karin Astrid Kook is the Founder and Managing Director at Salamandra and serves as the company’s leading expert in clinical pharmacology and regulatory affairs.  As its strategic and technical leader, Karin is very proud of the reputation for quality that Salamandra has earned throughout the years, supported by Salamandra’s strong team of regulatory and scientific consultants, project managers, research/technical staff, and administrative support personnel.

Karin’s primary areas of technical expertise are in the clinical and regulatory aspects of pharmaceutical development, gained over the past 35+ years.  Prior to founding Salamandra in 1996, Karin served seven years at the FDA, where she was a clinical reviewer in the Division of Neuropharmacological Drug Products (6 years) and a clinical pharmacology reviewer (1 year).  Following her time with the FDA, she worked in the industry as a Clinical Scientist at an international pharmaceutical company and later, as a Managing Associate for another midsize regulatory consulting firm.

Karin holds a Ph.D. in Clinical Pharmacology (Pharmacokinetics) and serves as a member or advisor to several corporate and scientific advisory boards.  She is fluent in several languages, including French and Estonian, and is currently working on advancing her Spanish language skills.

What is the story behind the image in your letter?

“I greatly enjoy being surrounded by nature. I love to wind down with a long hike during the weekends and travel to places with natural beauty, like Estonia, which is covered in ancient bogs and mires.”

Richard’s involvement with Salamandra dates back before its inception, when it was only a faint concept. As a Salamandra co-founder and company jack-of-all-trades, Richard primarily handles administrative and managerial matters to enable Karin and her excellent team to devote their efforts to client work. Richard’s daily work includes financial matters, contracts, client and vendor invoices, IT issues, and dealing with landlords, plumbers, electricians, and various levels of officialdom.

Richard has always found himself in the research arena. Never having had any past roles in business, Salamandra has been a great learning environment for him. Before Salamandra, Richard was a theoretical physicist, having obtained his Ph.D. in Theoretical Physics from MIT; a research biophysicist and biologist trained at Harvard; and an American Association for the Advancement of Science (AAAS) Congressional Science Fellow.  He also holds a master’s degree in Economics from the London School of Economics.

Richard is motivated by getting things done in a wide range of areas, as evidenced by his multi-faceted role at Salamandra. While he’s now in the pharma field, it is physics that Richard thinks about when he cannot sleep.

“Life is what happens when you’re busy making other plans.”     –John Lennon

What is the story behind the image in your letter?

“My letter’s image is a high-resolution photograph of Jupiter. It is a stunning and elegant example of science and the beauty to be found in it.”

Jennifer joined Salamandra in January 2019 in the newly formed role of Executive Director and provides “hands-on” day-to-day support and leadership to Salamandra’s talented staff and diverse client portfolio.  In this capacity, she works strategically across a wide range of company needs including corporate and facility operations, team and staff development, business development and contracting, and overall client/project oversight and management.  Jennifer holds a Ph.D. in Human Genetics from the Medical College of Virginia and an MBA from the Robert H. Smith School of Business, University of Maryland.

As a wearer of many hats, Jennifer has brought to Salamandra her deep experience as an innovative and dedicated leader with almost 30 years of proven success in life sciences, operations, business development, strategic and financial planning, technical project management, and resource management. She is passionate about applying her science and business expertise to challenging scientific concerns and toward developing, commercializing and supporting technologies and services across diverse high-technology sectors.  Jennifer is equally passionate about developing talent in others and strives to create and sustain a superior work ethos at Salamandra.

Prior to joining Salamandra, Jennifer was Director of Venture Creation at a large university research park where she developed and ran specialized accelerator, incubation, and entrepreneurial programs for early-stage and start-up life sciences and technology companies.  Jennifer was also a founding executive and operational leader at a molecular diagnostics company with applications in infectious disease, pharmacogenetics and chronic human disease, among many others. Previous to these roles, Jennifer was a Forensic Laboratory Director and Senior Manager at a premier U.S. DNA forensic testing laboratory, where she also served as an expert DNA witness in well over 100 criminal trials throughout the country.

At Salamandra, Jennifer enjoys being surrounded by an amazing, collaborative group of people who take such pride in their work and work so well together. “Such a group is hard to find, and I feel lucky to be part of this team.”

Jennifer enjoys interior design and has designed and built her own furniture (which she hopes to do again soon).

What is the story behind the image in your letter?

“I love the mountains and greatly enjoy the peace and beauty you can experience while hiking or just sitting outside enjoying the beautiful vistas with family and friends (especially with a good glass of wine in hand).”

Kaylee provides regulatory and strategic advice to Salamandra’s clients to help optimize their overall development programs and ensure key regulatory requirements are addressed. In addition, she prepares meeting request letters, briefing packages, IND and NDA summaries, and other regulatory documents, as well as interacts with regulatory authorities on behalf of clients. Concerning project management, Kaylee is the primary point of contact for clients, facilitates interactions and meetings, and supports the internal team. 

Kaylee started with Salamandra over 16 years ago in a research role and now serves as Salamandra’s Director of Regulatory Affairs and Strategic Development.  In this role, Kaylee provides strategic input regarding development plans supporting gap analyses and regulatory submissions for complex small molecules, combination products, and biologics/peptides across various therapeutic areas. She has also successfully managed project teams preparing IND, CTA, and NDA submissions for more than ten products in the past five years. In addition, Kaylee provides strategic input for regulatory meetings, including drafting meeting request letters and briefing documents, advising on the timing of meetings, developing questions, and responding to questions from Health Authorities.

Her favorite part about working at Salamandra is being continually challenged and having the opportunity to learn about new products and therapeutic areas. And due to the dynamic and fast-paced consulting environment, she loves the diversity of working with new teams. 

What is the story behind the image in your letter?

“I selected this picture because I love to spend time outdoors and enjoy the beauty of nature. This scene brings together some of my favorite things: water, mountains, flowers, and the peace of a quiet hike.”

Tenecia provides regulatory guidance to clients throughout all stages of their development programs, from pre-investigational to the preparation and submission of marketing applications, across various therapeutic areas. She has been with Salamandra for almost 20 years, and her experience includes liaising with clients and regulatory authorities as a project manager, preparing or reviewing regulatory documents for submission globally, as well as providing clients with support for their clinical programs, which may include developing or reviewing clinical study-related documents such as protocols, informed consent forms, various study plans, pharmacovigilance documents, and study reports. She has supported a variety of clinical studies, ranging from Phase 1 studies at a single site to Phase 3 global studies conducted across 20 countries and four continents in parallel. In addition, Tenecia attends meetings with regulatory authorities, including all key milestone meetings with FDA, pre-CTA meetings with Health Canada, and Scientific Advice/Protocol Assistance meetings with EMA.

Tenecia’s favorite part of working at Salamandra is that every day is unique and challenging. She enjoys problem-solving, and every product, formulation, disease, and population brings its own regulatory and scientific challenges that require resolution. It’s about being part of something bigger – work that supports the development of a product that could ultimately help a patient in need, which Tenecia finds thrilling and fulfilling. 

In her spare time, Tenecia loves to experience the gastronomy and culture of new places and cannot wait to keep exploring the world.  Tenecia also enjoys working out, especially going to spin classes – ironically, while she loves to travel, she also loves to ride a bike that goes nowhere. 

What is the story behind the image in your letter?

“I love vibrant colors, particularly orange, which is cheerful, energetic, and optimistic. I also enjoy abstract art with swashes of color, and this reminded me of such a piece.”

Allison is a Clinical Development Consultant at Salamandra. In this role, Allison is responsible for authoring of clinical safety and efficacy portions of regulatory submissions and other clinical documents as well as proposed product labeling.

Allison completed her Doctor of Pharmacy from the University of Maryland while working at Salamandra. She authored a substantial amount of the clinical portions of a recent NDA that received first-round approval.

In addition to her work at Salamandra, Allison has regulatory experience through externships at the FDA (Division of Anti-infectives) and AstraZeneca (early oncology clinical development), as well as working on a team under an FDA grant to conduct literature reviews evaluating the efficacy of frequently compounded drugs. She has gained clinical knowledge from pharmacy school and experience treating patients across a variety of healthcare settings.

After almost ten years with Salamandra, Allison likes the team dynamic and how well everyone works together. She also appreciates the flexibility and encouragement for self-improvement and travel.

What is the story behind the image in your letter?

“I grew up in the Pacific Northwest so I gravitate toward images that remind me of that location. I like the vastness of the overall forest image and the individual trees’ detail and beauty.”

Ana joined Salamandra almost 5 years ago following a 15-year career at BD (Becton, Dickinson and Company) where most recently she served as Senior Vice President, World-Wide Regional Medical Affairs and Global Health.  Board-certified in Clinical Pathology with a subspecialty training in Blood Bank/Transfusion Medicine and Hematopathology, she also holds MS and PhD degrees in immunology, as well as a MSPH.

Crystal has developed regulatory, strategic, and technical expertise in clinical development as well as extensive knowledge of the international regulatory landscape of FDA, HC, and EMA throughout her involvement in global development programs over the past 10+ years with Salamandra. She manages projects across several therapeutic areas, with an emphasis on development of clinical study protocols, reports, and other related documents for Phase 1 through Phase 3 studies as well as preparation of the clinical sections of INDs, CTAs, and marketing applications. In addition, she liaises with regulatory authorities on behalf of clients and supports regulatory meetings, including preparation of meeting request letters and briefing packages. She has also completed courses held by the Regulatory Affairs Professional Society (RAPS) and Center for Professional Innovation and Education (CfPIE) on European Regulatory Procedures and Good Clinical Practice, and she is a key resource for Salamandra’s internal team and clients for knowledge in these areas.

Over the course of her time with Salamandra, Crystal has had the benefit of growing with the company while utilizing the skills and knowledge gained in biology, chemistry, and technical writing during her studies. During her first few years at Salamandra in a research role and subsequent years involved with project management, she gained significant experience in many areas that she is currently involved with or manages (e.g., data gathering and analysis, clinical development and management, and global regulatory submissions). This has equipped her with a strong foundation that allows her to effectively work with Salamandra’s talented group of scientists, research associates/assistants, and submissions team.

Working at Salamandra, Crystal loves the endless opportunity for intellectual stimulation and growth with creative, flexible, independent thinkers open to exploring new ideas and taking on challenges. It is motivating because it has not only given her the knowledge base that allows her to draw on prior experience, which is invaluable in the world of consulting, but it also applies to many areas outside of work. It has been, and continues to be, a truly unique experience that she appreciates.

Crystal is passionate about food and wine – she loves exploring cultures through their traditional cuisines and winemaking, eating out at creative restaurants, or simply connecting with friends and family over a great meal.

What is the story behind the image in your letter?

“One of my favorite things about traveling is seeing beautiful, unique architecture – and I especially love interesting doors. The photograph behind my letter is the door of a small building on a cobblestone street in Hondarribia, a charming, colorful fishing village close to where I live in Spain’s Basque Country. The various shades and textures caught my eye, inspiring me to see more of the world!”

Dr. Ken Hastings, formerly the Associate Director for Pharmacology/ Toxicology for CDER (FDA), is a Senior Nonclinical Advisor for Salamandra. He provides advice on toxicology studies, primarily for the pharmaceutical industry, and specializes in anti-microbial drugs, immunotoxicology, and biologic drug products. Ken’s extensive experience crosses many other drug classes, such as transplant, endocrine and metabolic, and neuropharmacological drugs. Past roles include Sanofi US, where he served as Associate Vice President for Regulatory Policy.

What is the story behind the image in your letter?

“This is my favorite way to stay somewhat healthy.”

Kristin has been with Salamandra for over a decade, focusing on the authoring and preparation of biopharmaceutics and clinical pharmacology content for all types of regulatory documents, including INDs, NDAs, Meeting Briefing Packages, and others. She is proud to have contributed as a primary author to the preparation of NDA sections for drugs that are now approved and available to the U.S. market. Kristin also provides support and advice to clients on the design, interpretation, and implications of results of in vitro and in vivo clinical pharmacology studies. In addition, Kristin has particular interest in pharmacokinetic and pharmacodynamic modeling and has completed graduate-level coursework in pharmacometrics. 

At Salamandra, Kristin enjoys the variety of projects she works on as a consultant and being part of a multidisciplinary team. She is motivated by the desire to be a continual learner and is always looking for ways to become a better technical writer. Kristin hopes to become a great mentor for junior staff in coming years.

In her spare time, Kristin enjoys obedience and scent training with her fur baby, Ollie. 

What is the story behind the image in your letter?

“My photograph reminds me of a summer day in Philadelphia, my hometown. I gravitated toward the historical stone bridge and buildings shown, the river, and the greenery. There is even a little graffiti in the background, something you would see in Philly.”

As the CMC Practice Lead at Salamandra, Mona provides scientific and regulatory guidance to clients regarding CMC/quality aspects in support of development work, investigational efforts, and drug approval dossiers.  Prior to joining the Salamandra team approximately 20 years ago, Mona served in the capacity of Senior Chemistry Reviewer and Team Leader in the Division of Neuropharmacological Drug Products at FDA.  She was also involved in various initiatives in support of FDA’s efforts to establish and disseminate guidance to the pharmaceutical industry, including being the CMC representative for 7 years on the Complex Structures Committee undertaking the preparation of the first FDA Guidance for Industry on Botanical Drug Development.  As such, she was heavily involved in authoring of the CMC sections of the original guidance. 

During her time at Salamandra, Mona has been key in preparing the CMC summary sections of over 80 IND, CTA, NDA, BLA, and MAA and related submissions, in addition to CMC sections of numerous Meeting Briefing Packages, Investigator’s Brochures, and Annual Reports across multiple therapeutic areas. Notably, she supported the Type 2 Drug Master File (DMF) holder in authoring their DMF, as well as complying with cGMP requirements in preparation of the NDA for the first approved botanical drug in the United States.  In addition to authoring assistance, Mona provides support and advice to clients on quality expectations for drug substances and drug products based on the stage of development and eventual commercial presentation.  She reviews and assesses source documentation, methods, facilities, raw materials from laboratories, pharmaceutical/contract research organization (CRO) partners, and any other companies to ensure they align with regulatory requirements and/or client needs.  Mona has also mentored and trained over 30 Research Assistants, Project Managers, and senior professionals of disciplines other than CMC in CMC aspects of their job needs and is impressed with her team’s growth. 

Before her time at FDA and then Salamandra, Mona worked as a consultant for environmental companies doing contract work for various EPA programs including Solid Waste, Chemical Manufacturing Applications, and Pesticide Registration.

At Salamandra, Mona loves mentoring, writing, solving technical impasses and supporting clients while working closely with her colleagues and contributing to the company’s success.

In her spare time, Mona practices yoga and loves to read.

What is the story behind the image in your letter?

“I chose my image for my love of the sea.”

Rebecca joined the Salamandra team over ten years ago and currently serves as a Project Manager (PM).  In this role, she has been key in managing over 15 IND, CTA, and NDA submissions across multiple therapeutic areas. Rebecca has a particular expertise in Chemistry, Manufacturing, and Controls (CMC) regulatory requirements across all stages of product development and has managed the preparation or review of CMC summary sections for over 30 applications in addition to providing strategic advice to clients.

As a PM at Salamandra, Rebecca coordinates with clients regarding the status of ongoing projects and ensures the delivery of high-quality work products and advice. She creates and maintains project timelines and tracks deliverables against them to ensure that regulatory submissions and project deadlines are met, and any risks are identified at early stages. Rebecca provides regulatory and project management expertise, leveraging Salamandra’s multidisciplinary expert team, to assist clients with their regulatory and technical challenges.  

Before joining Salamandra, Rebecca worked in the Neurobiology and Anatomy Department at the Wake Forest University Baptist Medical Center, where she co-authored a paper on radiation-induced cognitive impairment in a juvenile rat model of cranial radiotherapy. Rebecca also spent time as a Visiting Scholar at the University of Technology, Sydney, in the Plant Functional Biology and Climate Change Departments. 

Rebecca plays other roles at Salamandra, including overseeing employee growth and training, participating in hiring initiatives, contributing to business development activities, and coordinating social events. She particularly enjoys developing creative solutions to challenges arising during drug development with the support of her talented team. 

In her spare time, Rebecca enjoys studying frameworks for understanding our personalities, such as the Enneagram and astrology. You may also find her chasing after her two mischievous dachshunds, Russell and Theo.

“We have an abiding sense, however obscure and obscured, that the lives we do lead are informed by the lives that escape us.”     –Adam Phillips

What is the story behind the image in your letter?

“I’ve always loved cityscapes and skylines. The beauty of this image – of an on-ramp high above the city to an unknown destination – resonated with me.” 

Bonnie has been working with Salamandra for close to 20 years and holds a BS in Pharmacy from the University of Kansas and a Pharm D from Creighton University. She has a decade of experience working in managed care and the pharmaceutical industry in pharmacovigilance and medical research departments, where she also served on the pharmacy school faculty at the University of Missouri Kansas City.

As a Senior Medical Writer, Bonnie authors documents such as clinical trial protocols, study reports, and safety narratives. She has assisted in preparing sections of Investigator’s Brochures, annual reports, and clinical sections for INDs/NDAs.

She began her career in freelance medical writing 25 years ago and has experience in a variety of therapeutic areas, including, but not limited to, oncology, neurology, cardiology, diabetes, urinary incontinence, erectile dysfunction, and rheumatoid arthritis.

My favorite part of working with Salamandra is their dedication to quality while being able to think outside the box. They have assembled a nimble team that can adjust to meet the client’s needs. Salamandra is not a one-size-fits-all group; rather, they work to meet the unique requirements of an individual client while maintaining top-notch quality and adherence to applicable guidelines.

What is the story behind the image in your letter?

“Having been born and raised in Colorado, the image reminds me of home and the beauty in nature.”

Jessica supports staff in the authoring of INDs, NDAs, Investigator Brochures, Annual Reports, and CMC regulatory documents, as well as supports submissions to regulatory authorities.  She also researches current and relevant regulatory news and supports staff in maintaining Salamandra’s internal Quality Assurance System.

Before joining Salamandra, she studied at Virginia Polytechnic Institute and State University.  

In her spare time, Jessica loves watching movies and virtually attended the Sundance Film Festival and AFI Docs Film Festival in 2021.

What is the story behind the image in your letter?

“Growing up near the ocean, I have always loved the water and what’s found underneath the surface.”

Kailee joined Salamandra in April 2023 and supports senior staff in developing deliverables for clients by assisting with literature reviews and the production of documents. She also looks for precedence to support advice for Salamandra’s clients and their products; and stays updated on changes to guidance from regulatory bodies.

Before joining Salamandra, Kailee interned at Merck within their publications department, which was her first exposure to the technical aspects of drug development. She also worked at the University of Pennsylvania School of Veterinary Medicine’s Working Dog Center, where she participated in research studies on using canines to detect ovarian cancer and COVID-19. After finishing her Bachelor’s degree, Kailee graduated with three molecular biology publications. At Salamandra, she is motivated by the prospect of making a difference in the lives of others.

Kailee loves the outdoors. She has hiked the Franconia Ridge portion of the Appalachian Trail and has sat in the woods for hours helping train and certify Search and Rescue dogs.

What is the story behind the image in your letter?

“I’ve always loved trying new restaurants while traveling. The photo of a warmly lit corner makes me think of opportunities to connect with loved ones and explore new places.”

Sonomi is a recent addition to the Salamandra team. She conducts research for the preparation of Salamandra deliverables and helps review documents to ensure they meet the company’s standards of quality. She is excited to learn more about the pharmaceutical regulatory landscape and contribute to work that allows groundbreaking medications to surpass regulatory hurdles and become accessible to patients in need of care.

Before working at Salamandra, Sonomi engaged in scientific research in the fields of ecology and neuroscience. Her ecological work provided an opportunity to develop her technical skills and improve her fieldwork abilities, while her research and studies in neuroscience gave her insight into how entangled the scientific and regulatory aspects of understanding and treating disease are. This enabled Sonomi to join Salamandra with knowledge about and empathy for the challenges and complexities of drug development from the perspective of both developers and patient populations. 

In her spare time, Sonomi loves traveling and knitting. She is also an avid music and podcast listener who is always looking for new recommendations.

What is the story behind the image in your letter?

“My image is the Cosmic Cliffs in the Carina Nebula, captured by NASA’s James Webb Space Telescope. I consider it a beautiful image, but I’m also inspired by the work that went into its collection. For me, it serves as a reminder of the great achievements that curiosity, collaboration, and perseverance can bring into the world.” 

Sara has worked in research-related positions for 24 years, including 20 years in the regulatory field and four years in clinical research. At Salamandra, Sara assists in writing and editing clinical research protocols, clinical study reports, and regulatory narratives and performs quality control of regulatory documents for FDA submission to ensure clarity and accuracy. She has assisted in preparing clinical sections for NDA submissions that ultimately received FDA approval. 

Sara brings a wealth of nursing and research experience to the 20 years she has been with Salamandra. Before joining the team, she was a Research Nurse with the AIDS Clinical Trials Unit at Georgetown University Medical Center in Washington, DC, for four years and a Staff Nurse at Georgetown University Hospital in Washington, DC, for 15 years.

In her spare time, Sara enjoys traveling, volunteering, visiting family, reading and participating in three book groups.  

What is the story behind the image in your letter?

“I chose this image because I love the ocean and going to the beach.”

As a Submissions Specialist at Salamandra, Chandra works closely with the Project Managers to organize and manage the workflow of all eCTD submissions. She takes the lead on building sequences using LORENZ docuBridge. Chandra also submits all sequences via the FDA’s ESG platform. As the resident Document Quality Specialist, Chandra ensures the SOP Team is organized and tracks all SOPs.

Chandra is peer/self-taught in how to write XML for FDA eCTD submissions. She has been with Salamandra for 26 years. Her longevity at Salamandra has allowed her to witness the evolution of FDA submissions from the paper world to CTD format and finally to eCTD. She has stayed on top of this evolution and managed Salamandra’s submission process throughout all these changes.

Working at Salamandra, Chandra likes that there is always something new to learn as the industry evolves.

“We are stardust brought to life, then empowered by the universe to figure itself out – and we have only just begun.”     –Neil deGrasse Tyson

What is the story behind the image in your letter?

“Since childhood, I have been somewhat obsessed with images from space. When I was young, the unknown appealed to me. Today it reminds me not only of how small our world is but that even in the chaos of the cosmos, there is beauty to be found.”

Malia provides administrative support for accounting, human resources and facilities at Salamandra – from answering phones to managing payroll and benefits. She has been with the Company for over 20 years, starting before she finished college. Malia loves the diverse and brilliant group of people she works with at Salamandra, particularly when she can help solve problems or when unexpected issues arise.  She also greatly enjoys cultivating relationships with colleagues, vendors and clients.

When not working, she enjoys spending time with her husband and two daughters.

“You have to find what sparks a light in you so that you in your own way can illuminate the world.”     –Oprah

What is the story behind the image in your letter?

“The fibers on the heart depict that love is electric, magnetic and light-giving even in the darkest places.”

Stephan has been with Salamandra for almost a decade. He brings over 16 years of experience in the IT field – from basic IT support to managing an organization’s entire IT systems and infrastructure.

At Salamandra, he is responsible for designing, developing, implementing, and maintaining computerized systems and the IT infrastructure. Stephan is also a key member of the submissions team, completing thousands of submissions to FDA, HC, and EMA.

Stephan’s favorite part about working at Salamandra is the accepting work culture and the personalities of the people working here. “In particular, I enjoy taking part in some truly geeky conversations.”

In his spare time, Stephan likes playing video games and building Lego sets. He once won a contest at Kmart where he guessed the correct number of Lego pieces used to build a particular set.

What is the story behind the image in your letter?

“The art behind my letter represents my enjoyment of all things superhero, sci-fi, and fantasy related, including comic books, video games, and movies/TV shows.”