Prescheduled, Signature Classes
Biotech Primer’s face-to-face signature classes are delivered on specific dates, in convenient locations throughout the US. With industry experts behind the podium and continuously updated materials, Biotech Primer provides the most relevant, engaging instruction anywhere.
Our Signature Face-to-Face Courses
The following Biotech Primer Signature Courses can be delivered in-house at your company, anywhere in the world exactly as shown. Or let us modify the agenda to include different topics that meet your company’s training needs.
Interested? Contact Stacey Hawkins at 410.377.4429 or firstname.lastname@example.org
Biotech for Non-Scientists Courses
A two-day course for those who want to better understand the science driving the industry.
BioBasics™: Biotech for the Non-Scientist is an intensive two-day course that starts with a review of the scientific concepts required for understanding the biopharma industry. Building on this knowledge, the course quickly ramps up to include a survey of the hottest applications in biotech today, including precision medicine, genomics and genome-based therapies, immunotherapies, and biomanufacturing. If you are a non-scientist who wants to better understand the science driving the industry, this course is for you.
- Scientific background needed to better understand your company or client’s
- Fluency in the essential terminology of the industry
- An understanding of where your company “fits” in the biopharma landscape
- An improved ability to communicate with colleagues and stakeholders
- An overview of the most innovative new developments within the biopharma
A one-day, fast-paced course focused on the science driving today’s hottest biopharma innovations.
BioBriefing™: Biotech for the Non-Scientist is a one-day, fast-paced course focused on the science driving today’s hottest biopharma innovations. Learn how basic biology is translated into novel vaccines and therapeutics that save lives. Taught by an industry expert who knows the technology, products, and companies.
- Scientific basics needed to better understand the biopharma industry
- Command of the essential terminology of the industry
- Improved ability to communicate with scientists, colleagues and clients
- Fluency in the fundamental pharmacology of novel therapies
- Roadmap of the life science industry sectors
A three-day, in-depth course that delves into the scientific details on a broad number of biotechnology topics.
BioImmersion™: Biotech for the Non-Scientist is a three-day, in-depth course that delves into the scientific details on a broad number of biotechnology topics. BioImmersion is divided into three distinct sections : the fundamental biology upon which the healthcare industry is built; the science driving the innovative therapeutics that are saving lives; and the business of biopharma including drug discovery, development and manufacturing. Become fluent in the science and business of biopharma by taking this comprehensive course.
- Fluency in the terminology and acronyms of the biopharma industry
- Comprehensive scientific background needed to understand your company’s, competitor’s or client’s products
- Improved ability to communicate with scientists, regulators, colleagues and clients
- Understanding of how a molecule moves from the lab to the marketplace
- Innovative new developments within the biopharma industry
Advanced Therapies: Immunotherapies, Cell Therapies and Gene Therapies
A one-day course focused on the most innovative drugs currently in development or newly on the market including immunotherapies, gene therapies, RNA therapies, CRISPR and more.
Advanced Therapies: Immunotherapies, Cell Therapies and Gene Therapies course focuses on the most innovative drugs currently in development or newly on the market. The inspiration for these emerging medicines is our own immune system, so we begin with a look at immunology. The rest of the day is spent learning about the science, development challenges and healthcare potential of immunotherapies, gene therapies and cell therapies.
- The rationale behind cancer immunotherapies
- The challenges and second-generation opportunities for immunotherapies
- Differentiation between the types of DNA- and RNA- based therapies
- Improved understanding of gene therapy and genome editing
- Ability to discuss multiple applications of genome editing
Drug development Courses
Drug Development Immersion
A two-day, intensive course focused on the regulatory, commercial and scientific considerations required to bring a drug successfully to market.
Drug Development Immersion is a two-day, intensive course focused on the regulatory, commercial and scientific considerations required to bring a drug successfully to market. Discussion points feature both small molecule drugs and biologics. Numerous personal accounts and war stories are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development. Learn what it takes to get a molecule from the bench into the marketplace by an industry expert.
- Fluency in the terminology and acronyms of drug development
- In-depth look at the FDA and EMA regulatory process
- Understanding of the key issues related to manufacturing a product
- Familiarity with preclinical testing requirements
- Appreciation of different aspects of clinical studies and their design.
Drug Development Primer
A one-day course concentrating on the FDA regulatory considerations required to successfully bring a drug to market in the US.
Drug Development Primer is a one-day course concentrating on the FDA regulatory considerations required to successfully bring a drug to market in the US. Discussion points focus on biologic products. Numerous personal accounts illustrate the decision-making process biopharma’s use, giving you an overview of strategic development.
- Overview of the FDA regulatory process
- Introduction to drug development terminology and most used acronyms
- Familiarity with preclinical testing requirements
- Understanding of the clinical studies process
Understanding Commercialization Within Biopharma
A two-day course that uses real world examples to explain both the big picture of strategic commercialization as well as the tactics necessary for a successful pharmaceutical launch.
Understanding Commercialization Within Biopharma is a two-day course that uses real world examples to explain both the big picture of strategic commercialization as well as the tactics necessary for a successful pharmaceutical launch. Discussion points focus on creation of the Therapeutic Target Profile (TPP), the power of market segmentation, crafting the value story, and building/sustaining competitive advantage. This course is for both scientists and non-scientists who need to better understand how therapeutics are successfully launched and commercialized.
- Key commercialization success factors and their value as a core, differentiating competency
- Commercialization “toolbox” that can be immediately and practically applied
- Deep understanding of the product launch process
- Key issues, opportunities, and challenges of effective commercialization strategy and tactics
- Tools needed to build compelling and effective value-demonstration stories that help optimize reimbursement and market access
Strategic Commercialization Primer
A one-day overview course focused on the major strategic considerations and tactics integral to successful commercialization within biopharma.
This one-day overview course is focused on the major strategic considerations and tactics integral to successful commercialization within biopharma. Discussion points focus on practical concepts, applications, and tools that help participants effectively build and implement strategic plans to address the needs of multiple stakeholders in creation of reimbursable innovation.
Understanding Drug Pricing & Reimbursement
A one-day course that examines the complexity of the US healthcare market.
Understanding Drug Pricing and Reimbursement is a one-day course that examines the complexity of the US healthcare market. The relationships between drug manufacturers, government policy, insurers and patients are explained in detail giving participants a better understanding of drug use in America. Numerous topics are covered including pharmacoeconomics, the various methodologies of drug pricing and reimbursement strategies.
- Understanding drug formularies, how they differ from one another, and what considerations are accounted for when deciding which drugs to accept onto a formulary
- Familiarity with the types of information used to inform drug policy
- Ability to apply different types of analysis used in determining drug prices
- Appreciation of the role of the drug product lifestyle in drug pricing, marketing and reimbursement
- Overview of the relationship between drug manufacturers, policy-makers, pharmacies, employers and patients.
Medical Device & Diagnostic Courses
The Science of Molecular Diagnostics
A one-day course exploring the growing role of molecular diagnostics within healthcare.
The Science of Molecular Diagnostics is a one-day course exploring the growing role of molecular diagnostics within healthcare. Participants learn how mutations happen and cause disease, and which diagnostics are used to identify where and how disease occurs. If you have a limited science background and are new to the diagnostics sector this course is a great introduction.
- Scientific background to understand how mutations occur and cause diseas
- An overview of the most innovative diagnostics within the biopharma industry
- Importance of biomarkers in disease and diagnostics
- An understanding of how DNA-and protein-based diagnostics work
- How to interpret diagnostic results
Molecular Diagnostics Development
A one-day course that explores how diagnostics are developed, approved and reimbursed.
Molecular Diagnostics Development is a one-day course that explores how diagnostics are developed, approved and reimbursed. The course introduces concepts such as sensitivity, specificity, false positives, false negatives, and ROC curves, which are used to determine how well the diagnostic performs. Once the strength of a diagnostic is determined participants learn how the diagnostic is evaluated by the FDA and the various pathways to approval a company can pursue. The course ends with a look at how diagnostics are reimbursed once in the marketplace.
- An improved ability to communicate with scientists, regulators and clients
- Fluency in the essential terminology used in the diagnostics sector
- Statistics background needed to understand basic diagnostic measurements
- An understanding of how to interpret diagnostic measurements
- The ability to predict if a diagnostic would be approved by the FDA based on statistical analysis of sensitivity and specificity results
Medical Device Development Immersion
A two-day course examining all aspects of medical device development in detail.
Medical Device Development Immersion is a two-day course examining all aspects of medical device development in detail. Starting with the changing regulatory environment, different regulatory pathways are reviewed, and a comparison of FDA vs. EU approval process is made. The five phases of medical device development, market opportunity, evaluation, design, verification, and manufacturing, are described in detail. Take this course to develop an understanding of the entire process required to bring a new medical device to market.
- An improved ability to communicate with engineers, colleagues and manufacturers
- Medical device terminology and processes
- A toolbox to help design a medical device prototype
- Knowledge of the various approval pathways for each medical device class
- Risk mitigation in medical device development and approval
Medical Device Development Primer
A one-day preparatory course designed for those seeking introductory industry understanding.
Medical Device Development Primer is a one-day preparatory course designed for those seeking introductory industry understanding. This course examines all aspects of medical device development, including a detailed description of the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course delves into the changing regulatory environment and focuses on the different regulatory pathways that devices can undertake for FDA or EMA marketing approval.
- Fluency in essential terminology and acronyms of the medical device industry
- Knowledge of the various approval pathways for a medical device to be marketed to patients
- An understanding of how to mitigate risk in a medical device
- An improved ability to communicate with engineers, colleagues and clients
- The ability to construct a medical device by following the traditional 5 phases of development
A two-day course that examines all aspects of biomanufacturing
Biomanufacturing Immersion is a two-day course that examines all aspects of biomanufacturing. Learn about the equipment and facilities necessary to produce biologics; the regulatory oversite that assures the biologic’s safety; and the science behind small- and large-scale production. Biomanufacturing Immersion is taught by an expert who offers practical insights into biologic-derived product production.
- Equipment, controls, utilities and facilities needed to produce biologics
- Typical procedures to prevent and address contamination
- Master cell bank and working cell bank testing and handling requirements
- Important consideration when scaling upstream, midstream and downstream
- FDA guidance on process validation through the creation of a validation master plan
Frequently Asked Questions
Where are the face-to-face classes held?
How many people attend a face-to-face class?
What is the dress code for the class?
What time does the class start? End?
Do you send out training materials prior to the class or do we get them when we arrive at the class?
Do we have to do pre-work prior to the class?
What sorts of training materials do you provide?
With the purchase of any face-to-face course, we will register you to receive our WEEKLY e-newsletter so that you can use of all your new-found knowledge. The WEEKLY is sent to your in-box every Thursday and explains the science behind the headlines. (You may unsubscribe with one click at any time.)
Do you provide refreshments and snacks? Breakfast and lunch?
Who are your instructors? What is their background?
Do I get a certificate for attending?
Do you provide credit hours?
Do you provide face-to-face courses internationally?
Do you provide discounts?
We provide discounts for companies who send five or more registrants to one class if they are not members of the partner organization.