Face-to-Face Courses

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.

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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 stacey@biotechprimer.com

Biotech for Non-Scientists Courses

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BioBriefing: Biotech for the Non-Scientist

A lively one-day course on the science behind the latest, hottest biopharma innovations.

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BioBriefing: Biotech for the Non-Scientist is a lively one-day course on the science behind the latest, hottest biopharma innovations. Discover how human biology translates into novel vaccines and life-saving therapeutics. Learn from an industry insider who knows the technology, products, and companies.

Five takeaways

  1. Scientific basics needed to better understand the biopharma industry
  2. Command of essential industry terminology
  3. Improved ability to communicate with scientists, colleagues, and clients
  4. Roadmap of the life science industry sectors
  5. Fluency in drug manufacturing
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BioBasics 101: The Biology of Biotech For the Non-scientist

An intensive two-day course on the foundational science that forms the backbone of biopharma.

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BioBasics 101: The Biology of Biotech for the Non-Scientist is an intensive two-day course on the foundational science that forms the backbone of biopharma. We explore the connection between the basic biology and industry applications including personalized medicine, comparative genomics, and companion diagnostics. This course was designed for the non-scientist who wants to better understand how basic biology informs the development of biopharma products.

Five takeaways

  1. Fluency in the essential terminology of the biopharma industry
  2. Understanding of the science driving your company or client’s products
  3. Improved ability to communicate with colleagues and stakeholders
  4. Determination of where your organization “fits” in the healthcare landscape
  5. Explanation of innovative therapies within the biopharma industry
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BioBasics 201: Targeted Biologics for the Non-Scientist

An intensive, two-day course specifically designed for non-scientists who need to understand the science driving immunotherapies, cell therapies and gene therapies.

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BioBasics 201: Targeted Biologics for the Non-Scientist is an intensive, two-day course specifically designed for graduates of BioBasics 101 or learners who understand fundamental biopharma industry science. The inspiration for targeted biologics is our own immune system, so Day 1 begins with an in-depth explanation of immunology. Day 2 continues the conversation with immunotherapies, vaccines, cell therapies, regenerative medicines, gene therapies, and RNA-based drugs. Join us and enhance your fluency in the science, development challenges, and medical potential of targeted biologics.

Five Takeaways

  1. Rationale behind cancer immunotherapies
  2. Challenges and second-generation opportunities for immunotherapies
  3. Differentiation between the types of DNA- and RNA-based therapies
  4. Improved understanding of gene therapy and genome editing
  5. Ability to discuss multiple applications of genome editing
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BioImmersion: A Non-Scientist’s Deep Dive Into Biotech

Combines BioBasics 101 and BioBasics 201 into a comprehensive four-day course focused on three areas: the foundational biology that underlies the healthcare industry, immunology—which inspires targeted biologics, and cutting-edge therapies.

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BioImmersion: A Non-Scientist’s Deep Dive Into Biotech combines BioBasics 101 and BioBasics 201 into a comprehensive four-day course. We focus on three areas: the foundational biology that underlies the healthcare industry, immunology—which inspires targeted biologics, and cutting-edge therapies. Highlights include immunotherapies, vaccines, gene therapies, cell therapies, therapeutic antibodies and much more. Embrace the opportunity to become fluent in the science of biopharma.

Five takeaways

  1. Fluency in the essential terminology of the biopharma industry
  2. Understanding of the science driving your company or client’s products
  3. Improved ability to communicate with colleagues and stakeholders
  4. Determination of where your organization “fits” in the healthcare landscape
  5. Explanation of innovative therapies within the biopharma industry
  6. Rationale behind cancer immunotherapies
  7. Challenges and second-generation opportunities for immunotherapies
  8. Differentiation between the types of DNA- and RNA-based therapies
  9. Improved understanding of gene therapy and genome editing
  10. Ability to discuss multiple applications of genome editing

Drug development Courses

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Drug Discovery for the Scientist

A one-day intensive course specifically designed for scientists who need to better understand the drug discovery process using an application of risk assessment and multi-disciplinary approaches with considerations for how best to get medicine to patients.

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Drug Discovery for the Scientist is a one-day, intensive course specifically designed for scientists who need to better understand the drug discovery process using an application of risk assessment and multi-disciplinary approaches with considerations for how best to get medicine to patients. Learn from an industry expert what it takes to qualify/validate targets, screen, and optimize molecules to select a lead for safety and efficacy informing an investigational new drug application (IND) or clinical trial application (CTA) with regulatory agencies.

Five takeaways

  1. Fluency in drug discovery process including major milestones
  2. Selection of pharmacologically relevant targets
  3. Criteria to eliminate candidates
  4. Key development considerations for antibodies, cell and gene therapies
  5. Required regulatory studies and data to enable an IND or CTA
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Preclinical Development for the Scientist

A one-day, fast-paced course specifically designed for scientists who need to better understand the regulatory requirements of preclinical development.

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Preclinical Development for the Scientist is a one-day, fast-paced course specifically designed for scientists who need to better understand the regulatory requirements of preclinical development. Learn from an industry expert the approaches and criteria used to support a development candidate’s nomination for an IND or CTA to enable first-in-human studies.

Five Takeaways

  1. Fluency in preclinical/nonclinical development including required milestones
  2. Typical approaches and criteria used to support development candidate nominations for first-in-human trials
  3. Species selection and use of animal pharmacokinetics in describing the expose-response relationships
  4. Importance of toxicology in selecting compounds and establishing safety
  5. Estimating safe starting dose levels for clinical trials
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Drug Development Primer

A one-day course concentrating on the FDA regulatory considerations required to successfully bring a drug to market in the US.

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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.

Four takeaways

  1. Overview of the FDA regulatory process
  2. Introduction to drug development terminology and most used acronyms
  3. Familiarity with preclinical testing requirements
  4. Understanding of the clinical studies process
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Drug Development Immersion

A two-day, intensive course that explores the regulatory, commercial, and scientific factors behind bringing a drug successfully to market.

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Drug Development Immersion is a two-day, intensive course that explores the regulatory, commercial, and scientific factors behind bringing a drug successfully to market. Discussion features both small molecule drugs and biologics. Our instructor illustrates the corporate decision-making process with personal accounts, giving participants unique insight into strategic development. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace.

Five takeaways

  1. Discuss the typical criteria for supporting first in human clinical trials
  2. Fluency in clinical development terminology and acronyms 
  3. In-depth look at the FDA and EMA regulatory process 
  4. Understanding the different aspects of clinical studies and their design
  5. Appreciation of post-approval drug safety monitoring
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Strategic Commercialization Primer

A one-day overview course focused on the major strategic considerations and tactics integral to successful commercialization within biopharma.

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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.

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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.

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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.

 5 Takeaways

  1. Key commercialization success factors and their value as a core, differentiating competency
  2. Commercialization “toolbox” that can be immediately and practically applied
  3. Deep understanding of the product launch process
  4. Key issues, opportunities, and challenges of effective commercialization strategy and tactics
  5. Tools needed to build compelling and effective value-demonstration stories that help optimize reimbursement and market access
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Understanding Drug Pricing, Policy, & Utilization

A one-day course that examines the complexities of the US healthcare market.

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Understanding Drug Pricing, Policy and Utilization is a one-day course that examines the complexities of the US healthcare market. Find out more about relationships among drug manufacturers, government policy, insurers, and consumers. Learn about the world of pharmacoeconomics, the intricacies of drug pricing, and reimbursement strategies. Gain a comprehensive understanding of how drug prices and federal policy influence how consumers access and use medications.

Five takeaways

  1. Familiarity with the types of information used to inform drug policy
  2. Ability to apply different types of analysis to determine drug prices
  3. Rationale in drug placement on formularies
  4. Appreciation of the product lifestyle role in pricing, marketing, and reimbursement
  5. Relationship between manufacturers, policymakers, pharmacies, and patients

Medical Device & Diagnostic Courses

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The Science of Molecular Diagnostics

A one-day course on how diagnostics identify how and where disease occurs.

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The Science of Molecular Diagnostics is a one-day course on the growing role of molecular diagnostics in healthcare. Learn how disease-causing mutations occur and about the diagnostics that identify how and where disease occurs. If your science background needs strengthening or you’re new to the business, this course will have you up and running in no time.

Five takeaways

  1. Scientific background to understand how mutations occur and cause disease
  2. An overview of the most innovative diagnostics within the biopharma industry
  3. Importance of biomarkers in disease and diagnostics
  4. An understanding of how DNA-and protein-based diagnostics work
  5. How to interpret diagnostic results
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Molecular Diagnostics Development

A one-day exploration of diagnostics’ journey from development to reimbursement geared for newcomers to the medical device industry.

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Molecular Diagnostics Developmentis a one-day exploration of diagnostics’ journey from development to reimbursement geared for newcomers to the medical device industry. Understand concepts such as sensitivity, specificity, false positives, false negatives, and ROC curves. Learn how the FDA evaluates diagnostics and the various pathways to approval. The course ends with a look at how diagnostics are reimbursed on the market.

Five takeaways

  1. An improved ability to communicate with scientists, regulators and clients
  2. Fluency in the essential terminology used in the diagnostics sector
  3. Statistics background needed to understand basic diagnostic measurements
  4. An understanding of how to interpret diagnostic measurements
  5. The ability to predict if a diagnostic would be approved by the FDA based on statistical analysis of sensitivity and specificity results
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Medical Device Development Immersion

A two-day course that surveys all aspects of medical device development.

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Medical Device Development Immersion is a two-day course that surveys all aspects of medical device development. Learn about the changing regulatory environment and compare the FDA’s and European Union’s approval processes. Discover in detail the five phases of medical device development: market opportunity, evaluation, design, verification, and manufacturing. Take this course to develop an understanding of the entire process required to bring a new medical device to market.

Five takeaways

  1. An improved ability to communicate with engineers, colleagues and manufacturers
  2. Medical device terminology and processes
  3. A toolbox to help design a medical device prototype
  4. Knowledge of the various approval pathways for each medical device class
  5. Risk mitigation in medical device development and approval
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Medical Device Development Primer

A fast-paced, one-day preparatory course designed for professionals seeking a basic understanding of the industry.

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Medical Device Development Primeris a fast-paced, one-day preparatory course designed for professionals seeking a basic understanding of the industry. This course examines all aspects of medical device development, including the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course delves into the changing regulatory environment and focuses on the different pathways that devices travel for agency approval. Take this course to develop an understanding of the entire process required to bring a new medical device to market.

Five takeaways

  1. Fluency in essential terminology and acronyms of the medical device industry
  2. Knowledge of the various approval pathways for a medical device to be marketed to patients
  3. An understanding of how to mitigate risk in a medical device
  4. An improved ability to communicate with engineers, colleagues and clients
  5. The ability to construct a medical device by following the traditional 5 phases of development

Manufacturing Courses

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Biomanufacturing for the 21st Century: An Overview of Manufacturing Biologic, Cellular and Gene Therapies

A one-day journey into all aspects of production developed specifically for the non-scientist.

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Biomanufacturing for the 21st Century: An Overview of Manufacturing Biologic, Cellular and Gene Therapies is a one-day journey into all aspects of production developed specifically for the non-scientist. Learn about equipment and facilities, drug safety regulations, and the science behind the production of biologic, cellular and gene therapy therapeutics. Learn from a biomanufacturing professional who offers real-life insights into drug-derived product manufacturing.

Five takeaways

  1. Types of equipment, controls, utilities and facilities needed
  2. How to prevent and address contamination
  3. Testing and handling requirements for master and working cell banks
  4. Important considerations when scaling upstream, midstream and downstream
  5. Process validation guidance through the creation of a validation master plan

Frequently Asked Questions

Where are the face-to-face classes held?
Throughout the US in major cities. Less frequently we hold classes in Canada and Australia.
How many people attend a face-to-face class?
Depending on space between 20-35 people attend.
Who Attends?
We have a diverse audience in experience, education, and job description. Attendees range from C-level executives to manufacturing shift-workers; those new to the industry to season veterans who may find themselves in a different position or with a new company. This mix of backgrounds extends the learning for all, since everyone has something to contribute to and learn from the group.
What is the dress code for the class?
The dress code for the courses is business casual. We do recommend that you dress in layers as the rooms can tend to be a little chilly and we often can’t control the temperature.
What time does the class start? End?
The doors open at 8:30 am and the class begins promptly at 9:00 am. There are breaks throughout the day and an hour lunch. Classes end at 4:30 pm.
Do you send out training materials prior to the class or do we get them when we arrive at the class?
Class materials are distributed at the beginning of the class. Just bring a pen (and your ID which you will need to enter most venues)!
Do we have to do pre-work prior to the class?
No pre-work is assigned.
What sorts of training materials do you provide?
We provide a customized spiral workbook specific to each class. The workbook includes all presented slides and each slide’s “Take Home Points” so you can focus on and retain the most important information. All labs, activities, and case studies are included in the workbook. Depending on the class, some workbooks include a glossary of biotech terms and others may include a list of commonly used acronyms.

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?
We provide coffee and water throughout the day and a box lunch for the afternoon meal. We do not provide breakfast. We regret that we cannot accommodate those with food allergies as our meals are catered and we cannot guarantee the catering facility is free from allergy causing agents. In most cases we provide vegetarian alternatives. Please contact us with any dietary questions.
Who are your instructors? What is their background?
Our instructors are dynamic, industry-experienced subject matter experts. In fact, this is what sets us apart from other training organizations – our instructors! Anyone can “learn the presentation” but our instructors can handle your most difficult questions.
Do I get a certificate for attending?
Each participant gets a certificate of attendance. To receive your certificate, you must first complete the electronic survey that is emailed to you at the end of the class. Once submitted you will receive your certificate by email.
Do you provide credit hours?
We do not provide credit hours, however if an organization has access to accreditation, we are certainly willing to sign needed documents to get someone their credit hours.
Do you provide face-to-face courses internationally?
We can provide face-to-face training internationally, but we do require a local lead organization to market the course. If you are unable to find an international class, consider taking our online courses. Our online learning is on demand, so it is available wherever you are located.
Do you provide discounts?
Some face-to-face classes are done in conjunction with a partner; most partners are membership organizations. Discounts are extended to members of that specific partner for that specific training.

We provide discounts for companies who send five or more registrants to one class if they are not members of the partner organization.

Do classes sell out? Are classes ever canceled?
Classes often sell out, so if you want to attend sign-up early. When that happens, we usually offer a waiting list for the class. From time to time, we do cancel classes because of low attendance. Prior to making flight arrangements, please contact us and inquire if the class is in danger of being cancelled. We do not refund any travel costs due to course cancellation.
What is your refund policy?
We do not refund purchases. However, if you cannot attend, you may send someone from your organization in your place. Please contact us with the name of your replacement so we can update our records.

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