Certara, Inc. · NASDAQ:CERT
Certara — Certara Biotech Forum: Developing Investor-Ready Strategies (Boston, 2026)
119 slides from Certara's conference presentation, September 2026
Slide 1: Certara Biotech Forum: Developing Investor-Ready Strategies
Certara Biotech Forum: Developing Investor-Ready Strategies In partnership with
Slide 2: Welcome
Welcome Fran Brown, PhD Senior Vice President and Global Head of Drug Development Science Certara Drug Development Solutions Fran.brown@certara.com 10:00 – 10:15 AM
Slide 3: Presenters
Presenters Tong Zhu, PhD, FCP Tony Arulanandam, DVM, PhD Geoff Fatzinger VP, Global Head, Clinical Pharmacology & CEO & Founder VP, Global Regulatory Strategy Translational Medicine Synaptlmmune Therapeutics Certara Certara Wojciech Dworakowski Max Vargas, PhD, MBA Fran Brown, PhD Vice President, He
Slide 4: The investor-ready biotech
The investor-ready biotech Fran Brown, PhD SVP, Global Head of Drug Development Science Certara
Slide 5: Find the hidden gems: How to be the 1 in 10!
Find the hidden gems: How to be the 1 in 10! • Constant pressure to show progress, often with limited capital and data • Limited margin of error to allow pivots, delay, or failure • Every dollar spent before a clear, evidence- based plan multiplies future risk • Opportunity and commercial value need
Slide 6: Problems and Solutions
Problems and Solutions of drugs fail in 90% clinical development of R&D costs 60% due to attrition Failure o Phase 3 most expensive at compound level o Phase 2 most expensive at portfolio level How to increase the probability of Success o Example from Pfizer o Example from Astra Zeneca • Narrow TA F
Slide 7: Comprehensive translational PK/PD understanding correlates with higher rate of successful Proof of Mechanism
Comprehensive translational PK/PD understanding correlates with higher rate of successful Proof of Mechanism • Projects with datasets consistent with the requirements of the 5Rs framework (in particular the Right Tissue and Right Target dimensions) and with non-clinical PK/PD insights incorporated i
Slide 8: Core elements of asset value
Core elements of asset value Team Expertise, Freedom to Operate Competence & (Intellectual Property) Infrastructure Product Development DATA Pathway & Planning Opportunity Assessment (landscape analyses, TPP development & testing) Probability of Success Risk Identification & Commercial Mitigation St
Slide 9: Elements for a Compelling Investor Proposition
Elements for a Compelling Investor Proposition 1 2 3 4 5 6 Clear Value Regulatory and Evidence Experienced Financials and Exit Value of strong Proposition Commercial Generation Leadership Team Strategy networks Investors seek Strategy Evidence Strong leadership Investors expect Building pitches addr
Slide 10: Threading the Impossible Needle
Threading the Impossible Needle What do we mean by “Integrated” Development Plan that…. Meets Regulatory Requirements Generates data to support Decision Making Generates Data to Increase Investor Value Derisks the Program Makes best use of Resources & Funds Delivers data to support TPP & Commercial
Slide 11: Workshop Agenda
Workshop Agenda 10 AM – The investor-ready biotech 10:15 AM – Building a Clear Value Proposition 11:00 AM – Regulatory & Commercial Strategy 11:45 AM – Evidence Generation 12:30 PM – Meeting the Experts & Networking Lunch 1:30 PM – Panel: Corporate Factors featuring LSN 2:00 PM – Panel: Future trend
Slide 12: Session 1: Building a Clear Value Proposition
Session 1: Building a Clear Value Proposition Kevin Hershberger, BPharm, Tony Arulanandam, DVM, PhD MBA CEO & Founder Vice President Nonclinical Synaptlmmune Therapeutics Development Sciences Certara Max Vargas, PhD, MBA VP, Value & Access Strategy Certara 11:15 AM – 12 PM
Slide 13: Value Proposition – Therapeutic Newco
Value Proposition – Therapeutic Newco Tony Arulanandam, DVM, PhD CEO & Founder Synaptlmmune Therapeutics 13
Slide 14: Considerations Strategy / Solutions
Considerations Strategy / Solutions Unmet Medical Need • Clinical / Biological hypothesis • Commercial opportunity • Target Selection Therapeutic Approach • Differentiated MOA, functionality and technology Lead Candidate • Differentiated vs Standard of Care /Competition • Enhanced Efficacy, Safety a
Slide 15: Know the product you are building before you build it
Know the product you are building before you build it: Why a target product profile is one of the most valuable assets you own before your first dollar of clinical spend Kevin Hershberger, BPharm, MBA Vice President Nonclinical Development Sciences Certara 15
Slide 16: Do not fail on definition.
Do not fail on definition. THE PROBLEM — A molecule is not a product. A product has a patient, a claim, a comparator and a price. — If the team cannot state the product in one sentence, it cannot design a study that proves it. — Definition is nearly free to fix early in development and painfully exp
Slide 17: A target product profile is your blueprint.
A target product profile is your blueprint. TPP = DECISION GUIDE → IDP = DECISION MAP DEFINITION A strategic document stating the desired characteristics of the product — intended use, population, performance, regulatory path and commercial targets — that aligns every function behind them. Clarifies
Slide 18: The same program sounds very different with and without one.
The same program sounds very different with and without one. DILIGENCE LENS WITHOUT A PROFILE WITH A PROFILE “We are developing a promising compound.” For whom, exactly? An indication you can state in one defensible sentence. Endpoints chosen after the data arrive. Endpoints tied to the claim you in
Slide 19: Three questions decide whether your raise lands.
THE CORE OF THE PROFILE Three questions decide whether your raise lands. 01 02 03 Medical need Differentiation Indication What health problem, and precisely why What measurable advantage against the Who exactly, and in what words on the current care is not enough. standard of care at launch. label.
Slide 20: Define the problem, not the molecule.
Define the problem, not the molecule. 01 MEDICAL NEED — State the health problem and the specific reason the current standard of care falls short. — Name the target population, the primary beneficiary, and who administers the product. — Describe the use scenario: setting, frequency, prior testing, c
Slide 21: “Better” is not a differentiation strategy.
“Better” is not a differentiation strategy. 02 DIFFERENTIATION — Replace subjective claims with measurable thresholds: at least X% response, no more than Y% discontinuation. — Benchmark against the standard of care at launch; not the one in clinic today. — Decide the single attribute you intend to w
Slide 22: The narrowest credible label beats the broadest hopeful one.
The narrowest credible label beats the broadest hopeful one. 03 INDICATION — Write it as label language “X is indicated for…” borrowing structure from approved comparators. — One indication, one population, one lead geography. Expansion is a later slide, not this one. — Confirm a clinical endpoint f
Slide 23: Set minimum and optimistic targets (your go/no-go) in advance.
Set minimum and optimistic targets (your go/no-go) in advance. DECISION DISCIPLINE Minimum Optimistic The threshold below which the product is not viable. This is your What would make the product substantially more attractive — go/no-go, and it must be quantitative. broader, deeper, faster impact. —
Slide 24: What a complete TPP covers.
What a complete TPP covers. SCOPE Patient population Clinical performance User requirements Primary users, beneficiaries, special Efficacy and safety endpoints and target Dosage form, route, dose frequency and populations levels duration Market and price Regulatory plans CMC considerations COGS targ
Slide 25: Every target needs a source. That is what survives diligence.
Every target needs a source. That is what survives diligence. EVIDENCE AND RATIONALE — Cite the basis for each number: published data, expert consensus, regulatory precedent, or your own assumption. — “Our assumption” is a legitimate answer; an unlabeled number is not. — Annotate the rationale, not
Slide 26: Update it on triggers, not on calendars.
Update it on triggers, not on calendars. MAINTENANCE Development milestones Regulatory or policy change A new competitor entering Investment decisions Technical advances Stakeholder feedback Plus, a scheduled review every one to two years, whether or not anything has changed. Version it. Major chang
Slide 27: Before your next investor meeting.
Before your next investor meeting. 01 Write the indication in one sentence, in label language. 02 Set minimum and optimistic targets for efficacy, safety, dosing, COGS and price. 03 Name your comparator at launch, and the one attribute you intend to win on. 04 Reference every number and label your a
Slide 28: The profile is only as good as the evidence behind the numbers.
The profile is only as good as the evidence behind the numbers. Quantitative targets Regulatory strategy Value and access Model-informed dose and endpoint Pathway definition and agency Price, COGS and payer narrative built selection; thresholds you can defend. interaction planning across markets. in
Slide 29: Begin With the End in Mind: Building a Value Proposition Patients Can Actually Use
Begin With the End in Mind: Building a Value Proposition Patients Can Actually Use Max Vargas, PhD, MBA VP, Value & Access Strategy Certara 29
Slide 30: Beginning with the end in mind: a product patients can use
Beginning with the end in mind: a product patients can use • Tracing the steps backwards from your product helping a patient 1. Site of care determines reimbursement in US 2. Regulatory approval packages rarely satisfy global payer requirements or meet Regulatory commercial aspirations Unmet need ap
Slide 31: Great product, wrong launch sequence
Great product, wrong launch sequence Inpatient hospital setting clarifies unmet need, but is very cost constrained • Product X, mental health crisis What could have been done differently: o Scientifically sound drug: minimal safety issues, reasonable efficacy in an 1. Understand site of care, which
Slide 32: Certara executed a two-phase methodology to narrow five potential indications to one
Certara executed a two-phase methodology to narrow five potential indications to one to pursue for development Case study • Situation: Client requested an opportunity assessment of an internal asset that showed clinical promise in multiple indications • Key objective: Inform client’s commercial plan
Slide 33: Analysis on each area of interest for Product X
Analysis on each area of interest for Product X was investigated and compared and an indication was identified as favorable in each scenario © Copyright 2025 Certara, Inc. All rights reserved. 33
Slide 34: Session 2: Regulatory & Commercial Strategy
Session 2: Regulatory & Commercial Strategy Kevin Hershberger, BPharm, MBA Wojciech Dworakowski Vice President Nonclinical Vice President, Head of DMPK, Development Sciences Toxicology and Preclinical M&S Certara Pioneering Medicines
Slide 35: Designing a development plan that supports financing and regulatory success
Designing a development plan that supports financing and regulatory success 35
Slide 36: Factors Driving Investment Attractiveness
Factors Driving Investment Attractiveness Investors weigh two questions before they commit capital Value Proposition Confidence in Delivery ● What you have, including technology ● Team ● What you intend to do with it ● Access to resources ● What the advantages are ● Innovation ● What the strategy is
Slide 37: A Well-Conceived Integrated Development Plan Is An Essential Tool
A Well-Conceived Integrated Development Plan Is An Essential Tool TPP = DECISION GUIDE → IDP = DECISION MAP Regulatory Special programs, region(s), PRS Communication & News Flow Nonclinical & Clinical Development Long range view; target best events CMC, ADME, Tox, Indication, biomarker, special popu
Slide 38: Leverage the IDP: Align Goals, Manage Risks, Stronger Decisions
Leverage the IDP: Align Goals, Manage Risks, Stronger Decisions, etc… Anticipate Align • Build IDP beyond next milestone • Company strategic objectives with • Brainstorm risks and matching mitigation options operating capital needs • Feedback loop: How do emerging data change • Program needs with ca
Slide 39: Designing a Faster Path to IND That Maximizes Investment and Clinical Success
Designing a Faster Path to IND That Maximizes Investment and Clinical Success Wojciech Dworakowski Vice President, Head of DMPK, Toxicology and Preclinical M&S Pioneering Medicines Data Package Requirements Where Things Go Wrong Where the Real Leverage Is
Slide 40: What Each Package Realistically Requires
What Each Package Realistically Requires CMC DMPK Toxicology Translational Sciences Process Full ADME package Formal safety studies A translational model - characterization, early enough to shape that clearly establish a PK/PD, biomarkers, formulation, and a candidate selection, safe dose - plus and
Slide 41: Where Lead-Opt-to-IND Programs Actually Stall
Where Lead-Opt-to-IND Programs Actually Stall These rarely stay contained to one discipline: a DMPK liability reshapes tox and clinical plans; an integrated DMPK-Pharmacology-Tox view is what PK/PD and regulatory strategy rest on. Workflow Example failure / delay A liability surfaces in GLP tox inst
Slide 42: Where Early Teams Underestimate the Work
Where Early Teams Underestimate the Work Silo-based thinking, often paired with limited technical depth, turns program planning into a Gantt chart or checkbox exercise - especially at small companies, where IND-enabling work gets treated as one activity to tick off. Liabilities are underestimated an
Slide 43: Discovery Learnings Have to Carry Forward
Discovery Learnings Have to Carry Forward • Lead-opt and IND-enabling work move faster - and with a higher probability of success - when they build on early discovery data: non-GLP tox informs GLP study design, early PK/efficacy work informs definitive efficacy studies, and DMPK metabolism screening
Slide 44: Science Cannot Fail Either
Science Cannot Fail Either Speed and cost discipline only pay off if the underlying science is right - a gap in one package doesn't stay contained to that package. Gap Downstream consequence Unanticipated toxicity or drug-drug interactions (DDIs) Lack of DMPK profiling surface later, not earlier For
Slide 45: Cost Is the Most Underestimated Variable
Cost Is the Most Underestimated Variable • Teams budget the "textbook" version - one tox study, 15-20%+ one CMC campaign, one DMPK dataset. • No reserve for the redo: a failed stability batch, an added tox arm, a CRO delay forcing a bridging study. • Complexity is underappreciated too: more work mea
Slide 46: Timing and Location Drive Vendor and Site Selection
Timing and Location Drive Vendor and Site Selection • CRO selection - especially for tox - should align with your clinical plan: that alignment is what delivers interoperability and regulatory consistency, often the fastest and sometimes the cheapest path to the clinic. • Timing and location aren't
Slide 47: Modality Matters
Modality Matters Biologics & Novel Small Molecule Constructs • Standardized path, well- • Species selection driven by precedented playbook. pharmacologic relevance - often requires NHPs. • Two-species GLP tox and genotoxicity battery are well • TMDD, immunogenicity (ADA), and defined. FcRn-driven ha
Slide 48: Novel Constructs: No Default "Minimum"
Novel Constructs: No Default "Minimum" • For a well-precedented molecule, a standard playbook works and questions get addressed at IND submission. Early agency • For a novel construct, running the "standard alignment is a minimum" package risks discovering post-hoc capital allocation that FDA wants
Slide 49: Quantitative Pharmacology: The Value Lever
Quantitative Pharmacology: The Value Lever • PK/PD work, translational biomarkers, and QSP models at the preclinical stage turn FIH into an interpretable test of mechanism - work that de-risks program investment, informs next steps, and helps validate the program for both regulators and investors. •
Slide 50: Where Innovation (AI / QSP) Adds Value
Where Innovation (AI / QSP) Adds Value The AI revolution in drug discovery isn't only about QSP - it spans the whole toolkit. Pillar Where AI/QSP helps The limit Predicts stability/degradation profiles to cut Still need real GMP batches and CMC screening experiments stability data In silico PBPK pre
Slide 51: Executing Lead-Opt-to-IND Faster
Executing Lead-Opt-to-IND Faster Levers that compress execution AI/PBPK-assisted DMPK, high- time throughput experimentation, and Lead optimization integrated cross-functional teams • Integrated, cross-functional teams spanning shorten the design-test-analyze loop. target ID through tox can cut ~1 y
Slide 52: Session 3: Evidence Generation
Session 3: Evidence Generation Diana Marcantonio, PhD Max Vargas, PhD, MBA Senior Director, ABS VP, US Access Strategy Certara Certara Kevin Hershberger, BPharm, Tong Zhu, PhD, FCP MBA VP, Global Head, Clinical Pharmacology Vice President Nonclinical & Translational Medicine Development Sciences Cer
Slide 53: Leveraging modeling & simulation to select the best candidate and de-risk early decisions
Leveraging modeling & simulation to select the best candidate and de-risk early decisions Diana Marcantonio, PhD Senior Director, ABS Certara
Slide 54: Modeling & Simulation integrates data to de-risk decisions
Modeling & Simulation integrates data to de-risk decisions Biotech aims to develop innovative therapies nimbly but faces key challenges • Limited data, complex mechanisms of action Biology Pharmacology • Resources are tight • Must tell a compelling story to investors Model Modeling & Simulation fill
Slide 55: M&S maximizes company runway by decreasing spend, accelerating timelines
M&S maximizes company runway by decreasing spend, accelerating timelines across R&D Discovery: fewer, Ph1: fewer dose better leads levels, better patients Preclinical Ph2+: fewer studies, Development: fewer, better indications more informative experiments
Slide 56: Case Study 1: Concept feasibility assessment for differentiation
Case Study 1: Concept feasibility assessment for differentiation Proposed TPP: • mAb targeting immuno-modulation receptor in chronic inflammation • Drug concept: inhibit ligand-receptor binding to down-regulate immune cell type • Dose regimen is critical part of go/no-go Challenge: Competitor at l
Slide 57: Case Study 1: QSP-enabled acceleration of a superior concept
Case Study 1: QSP-enabled acceleration of a superior concept Assessment Results: • Competitor TPP could be improved upon with weaker KD due to TMDD • By tuning TPP, could achieve weekly dosing Further Client Results & Value: • 6+ months saved, 25% reduction in FTE, over $1m in direct cost savings (e
Slide 58: Case Study 2: Clinical dose predictions early to prioritize resources
Case Study 2: Clinical dose predictions early to prioritize resources Background: • Client developing a bispecific TCE with pMHC targeting • Excellent properties (stable & soluble, favorable PK) • Limited preclinical data because not cross-reactive • Observed variability between experiments & donor
Slide 59: Case Study 2: Model-predicted trimer formation justified 10x higher Ph1 dose
Case Study 2: Model-predicted trimer formation justified 10x higher Ph1 dose NCI-H1703 (MAGE-A4hi) Cell Killing IFN𝛾 Release Model Impact: • This work supported the rational selection of a 10x higher starting dose than the traditional exposure-based MABEL approach, and this starting dose was…
Slide 60: Example of streamlining preclinical if the program qualifies
Example of streamlining preclinical if the program qualifies New approach methodologies (NAMs), in plain terms: what they are, where regulators already accept them, and how to tell whether you qualify Kevin Hershberger, BPharm, MBA Vice President Nonclinical Development Sciences Certara 60
Slide 61: New approach methodologies, in plain terms.
New approach methodologies, in plain terms. THE IDEA Human-relevant ways to predict how a drug will behave in people, without running the animal study. Organ-on-chip Computational models Artificial intelligence Advanced in vitro assays Living human cells in Simulation of exposure, dose Pattern-findi
Slide 62: Why this is a CEO question and not only a tox question.
Why this is a CEO question and not necessarily only a tox question. WHAT IS AT STAKE — FDA puts discovery-to-patient at an estimated 10 to 12 years. Nonclinical safety work sits squarely on that critical path, just before your first human data. — For a company measuring runway in months, the questio
Slide 63: This is now the regulator's own position.
This is now the regulator's own position. WHAT CHANGED Dec 2022 FDA Modernization Act 2.0 Removed the statutory requirement for animal testing. Apr 2025 Roadmap to reducing animal testing FDA sets out how it intends to reduce and replace animal testing in preclinical safety studies. Dec 2025 Draft g
Slide 64: Three levers
HOW A PROGRAM ACTUALLY GETS STREAMLINED Three levers 01 02 03 Eliminate Reduce Replace A study may be unnecessary where there One relevant species instead of two, An evidence-based risk assessment in is no binding or pharmacologic activity to where the science supports it. place of the study, which
Slide 65: Does your program fit? Five questions.
Does your program fit? Five questions. THE CRITERIA 01 Is your modality precedented? Monospecific antibodies and oncology biologics have named guidances. Novel formats do not, yet. 02 Do you know your species relevance? Comparative binding and activity data across species is the evidence the argumen
Slide 66: A hypothetical program, walked through.
A hypothetical program, walked through. ILLUSTRATIVE EXAMPLE An invented candidate, for illustration: a monospecific antibody for a solid tumour indication, against a target with no binding in rodent or primate. WHAT THE PLAN LEFT OUT WHAT IT PUT IN INSTEAD — The long-duration primate study. — Speci
Slide 67: What it saves and what it does not.
What it saves and what it does not. THE TRADE Saves Months on the critical path before first-in-human, and the cost of the studies you do not run. Shifts Spend moves to human-cell work, modelling and evidence assembly. Cheaper, usually. Free, no. Does not remove The obligation to characterize risk.
Slide 68: What still must be true.
What still must be true. BEFORE YOU PLAN AROUND IT — A method must be good enough for the job: as predictive as what it replaces, for the specific question you are asking. — Regulators expect an integrated argument (eg assays, modelling and existing human data read together) not one test swapped for
Slide 69: Three things worth doing before you budget the program.
IF YOU WANT TO TEST THE IDEA Three things worth doing before you budget the program. Write down the species question Pull the class safety record Ask the agency early Do you have comparative binding and activity What is already known in humans about Put the approach on the agenda for your pre- data
Slide 70: Multi-stakeholder evidence generation
Multi-stakeholder evidence generation Max Vargas, PhD, MBA VP, US Access Strategy Certara 70
Slide 71: One evidence package meets differing needs for multiple stakeholders
One evidence package meets differing needs for multiple stakeholders across the development timeline Regulators, HTA bodies and payers, clinicians, and patients each ask different questions of the same data Regulatory Agencies Safety and efficacy evidence, from the first IND-enabling study onward Pr
Slide 72: Evidence needs shift as the asset matures
Evidence needs shift as the asset matures Plan for the next stakeholder before the current one is fully satisfied. Preclinical Phase 1 Phase 2 Phase 3 Filing Launch+ Regulatory P E AK P E AK P E AK P E AK Agencies HTA Bodies P E AK P E AK P E AK (ex-US) Payers P E AK P E AK P E AK (US) Physicians &
Slide 73: It Isn't Just a Data Problem — It's an Org Chart Problem
It Isn’t Just a Data Problem — It’s an Org Chart Problem A handful of moments across development disproportionately determine whether an asset reaches patients — the evidence plan is how you prepare for each one, together. One evidence package utilized by two distinct functions Your Peers Are Alread
Slide 74: Payer-Ready Clinical Trials
Payer-Ready Clinical Trials EARLY STAGE · PRE PHASE II LATE STAGE · COMMITMENT TO PHASE III Strategic Foundation Readiness and Execution Extend the target product profile to create a target value profile Solicit stakeholder input (formal and informal) to support market including payer success measur
Slide 75: Where Programs Fail: The Typical Evidence Gaps
Where Programs Fail The Typical Evidence Gaps Comparator not aligned with local standard of care STRATEGIC MISALIGNMENT Trial size insufficient to support subgroup cost-effectiveness Endpoints accepted by regulators but not meaningful to HTAs, regulator-payor evidence gap Inadequate thought given to
Slide 76: Approval package was insufficient for commercial goals
Approval package was insufficient for commercial goals Common theme among accelerated approval products • Initially approved via accelerated pathway on increase of micro- dystrophin blood levels, for patients aged 4-5 • Payer access restricted to only the studied population (only 4-5 years), while c
Slide 77: Designing a High-Value Drug Development Program: From Concept to First-in-Human
Designing a High-Value Drug Development Program: From Concept to First-in-Human Tong Zhu, PhD, FCP VP, Global Head, Clinical Pharmacology & Translational Medicine Certara 77
Slide 78: Understanding therapeutic potential: biomarkers for decision making in early clinical trials
Understanding therapeutic potential: biomarkers for decision making in early clinical trials ‘Three Pillars of Survival’ Principle Proof of Pharmacology Prediction of Efficacy 78
Slide 79: Comprehensive Translational PK/PD Package Correlates with Greater Clinical PoM
Comprehensive Translational PK/PD Package Correlates with Greater Successful Clinical Proof-of-Mechanism (PoM) After implementing the 5R framework in 2012, the success rate of projects transitioning from candidate drug nomination to Phase III completion improved from 4% in 2005–2010 to greater than
Slide 80: Biomarkers in Oncology Trials is a Growing Regulatory Expectation
Biomarkers in Oncology Trials is a Growing Regulatory Expectation https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus 80
Slide 81: Growing MIDD Toolbox for Dose Optimization
Growing MIDD Toolbox for Dose Optimization ‘Well-socialized’ subset Emerging approaches • Clinical Utility Index analysis • PK/PD models • Longitudinal modeling • PopPK • Quantitative Systems Pharmacology • E-R analyses • Model-based meta-analysis • PBPK models • Artificial intelligence/ machine lea
Slide 82: Why is Early Development Important?
Why is Early Development Important? • Putting the time and effort into early development strategy improves the probability of both regulatory and development success • Risk identification and mitigation and greater probability of success → cost efficiency • Understanding flags that are coming up are
Slide 83: Certara's Approach to Translational PK/PD
Certara’s Approach to Translational PK/PD Translational Challenges We Help Our Clients Avoid or Solve Poor translation of drug Knowledge gaps and not Selecting biomarkers too effects from nonclinical to leveraging latest late in development; failing clinical results remains a technological to recogn
Slide 84: Considerations for PD Biomarkers in Early Development
Considerations for PD Biomarkers in Early Development Work Begins in Development Candidate Selection Phase
Slide 85: Certara's Pillars of FIH/Translation
Certara’s 4 Pillars of FIH/Translation Certara’s offerings for preclinical to clinical translation I. Translational Planning II. Execution Data III. Integrated Translational IV: Adaptation Model Generation Modeling Refinement with Develop a Translational Support nonclinical study Emerging Data Scien
Slide 86: Real Time Application of MIDD in a FIH Study
Real Time Application of MIDD in a FIH Study Physiological-based PK model Case Study: • The drug in question is a cyclic peptide conjugated to a PEG-40 (total MW is a ~44 kDa) While the drug is approved and marketed, we’ll refer to the molecule as a pegylated cyclic peptide or Peg40- peptide to main
Slide 87: FIH Schema and Project Workflow: Hybrid Allometry Workflow
FIH Schema and Project Workflow: Hybrid Allometry Workflow Real Time PK Prediction in First-in-Human Studies Courtesy of Elliot Offman BSc Pharm, MSc, PhD. © Copyright 2025 Certara, Inc. All rights reserved. 87
Slide 88: Initial Dose Prediction vs Observed SAD Cohort 1
Initial Dose Prediction vs Observed SAD Cohort 1 Preliminary BLINDED & LOCKED PK Data • PopPK and PPBK models reasonably predicted • First human cohort but with some over- prediction Courtesy of Elliot Offman BSc Pharm, MSc, PhD. 88
Slide 89: Hybrid Allometry
Hybrid Allometry Real Time PK Prediction in First-in-Human Studies Referred to as hybrid allometry for two reasons • Uses the model developed from animals • For Population PK models, assumes that the same Clhuman= Clmonkey* (~3 kg/70kg)c structural PK model describes both the animal (in this case Vh
Slide 90: Initial Dose Prediction vs Observed SAD Cohort 1
Initial Dose Prediction vs Observed SAD Cohort 1 Preliminary BLINDED & LOCKED PK Data • After hybrid allometric optimization of Cohort 1, the model predicted subsequent SAD cohorts with good agreement with the observed data • The model was then considered suitable for further prediction for MAD and
Slide 91: Corporate Factors Panel - Investor Panel: Building a biotech company investors can believe in
PANEL DISCUSSION CORPORATE FACTORS PANEL - INVESTOR PANEL Building a biotech company investors can believe in Leadership, milestone financing and the networks that shape outcomes Guide for early-stage biotech executives moderated by John H Abeles, MD John Pennett Koji Yasuda Sougato Das Northlea Par
Slide 92: Three signals behind investor confidence
DISCUSSION FRAME Three signals behind investor confidence Leadership 01 Can this team make good decisions when the path changes? Capital plan 02 Does each financing round create a meaningful step-up in value? Network 03 Can the company reach the right expertise, capital and partners? 02
Slide 93: Experienced leadership team
Experienced leadership team What strong leadership signals Where advisors add value • Judgment under uncertainty • Fill a specific capability gap • Credible development planning • Challenge assumptions before capital is spent • Ability to recruit and retain talent • Open doors without replacing mana
Slide 94: Leadership questions for the panel
Leadership questions for the panel Which leadership gap creates the greatest risk at the earliest stage? How do investors distinguish an engaged advisor from a name on a slide? When should a scientific founder add experienced development leadership? What signals that a team can hear difficult advice
Slide 95: Financial plan tied to value-creating milestones
Financial plan tied to value-creating milestones 01 02 03 04 Now Next round Value step-up Strategic path Define the next proof point Fund the milestone Show reduced risk Create options Runway and core Evidence that changes the Partner, license or Capital required and timing assumptions story acquisi
Slide 96: Exit strategy without false precision
FINANCIAL AND EXIT STRATEGY Exit strategy without false precision A credible exit thesis Questions for the panel ? How early should management discuss exit 1 Names likely buyer types and their strategic logic pathways? 2 Connects transaction timing to development ? Which milestones attract pharma at
Slide 97: Strong networks improve the quality and speed of decisions
Strong networks improve the quality and speed of decisions Investors Market feedback, syndication and access to follow-on capital Operators and consultants Specialized expertise without building every function internally Strategic partners Development insight, validation and potential transaction pa
Slide 98: Closing discussion
TAKEAWAYS Closing discussion The strongest companies connect all three Leadership makes sound decisions and earns trust Capital strategy funds the next value-changing milestone Network brings expertise and opportunity within reach Final question What should every early-stage biotech CEO strengthen i
Slide 99: Panel: Future Trends in Regulatory Science
Panel: Future Trends in Regulatory Science Tong Zhu, PhD, FCP Katya Tsaioun, PhD VP, Global Head, Clinical Geoff Fatzinger Pharmacology & Translational Vice President CEO Akttyva Therapeutics Medicine Regulatory Strategy Certara Certara Fran Brown, PhD Senior Vice President and Global Head of Drug M
Slide 100: Investors Fund Decisions, Not Datasets: What's Actually Changing in Regulatory Science
Investors Fund Decisions, Not Datasets: What's Actually Changing in Regulatory Science Katya Tsaioun, PhD CEO Akttyva Therapeutics 100
Slide 101: Regulatory science is shifting toward human-relevant, model-informed evidence
Regulatory science is shifting toward human-relevant, model-informed evidence What it means for early- Timeline: what changed What to do now stage companies 2006 First FDA draft guidance on drug • Evidence is judged against a defined Define the context of use for each interaction studies, in vitro a
Slide 102: Public examples: NAMs and in silico models already appear in FDA reviews
Public examples: NAMs and in silico models already appear in FDA reviews FDA NAMs use-case database, Sep 2026 PBPK in regulatory review Eye irritation BCOP (10) PBPK-containing submissions to FDA Clinical Pharmacology rose from 1 Skin irritation EpiSkin SIT (4), EpiDerm SIT (1) (2008) to 27 (2017, 2
Slide 103: PBPK submissions to FDA Clinical Pharmacology grew from rare to routine
PBPK submissions to FDA Clinical Pharmacology grew from rare to routine 2020–2024 26.5% This is 65 of 245 FDA novel approvals with PBPK models submitted as pivotal evidence (Li et al., Pharmaceutics 2025). Li Y, Sun H, Zhang Z, Pharmaceutics 2025;17(11):14 PBPK has moved from rare to routine in regu
Slide 104: Preppin' for RESI & JPM
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Slide 105: John Abeles MD
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Slide 106: WEB200 for $200 off RESI JPM!
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Slide 107: LSN Investor Database, RESI and Education & Support
DATABASE CONFERENCE EDUCATION & LSN Investor HANDS-ON Redefining Every Database Stage of Investments SUPPORT 3,500+ investors across (RESI) is an early-stage 10 categories of BD Assist investment focused investors Empowering Life conference, bringing together startups and Science Companies for LSN B
Slide 108: Know Your Audience with the Investor Database
Know Your Audience with the Investor Database Different investors might require different messaging: +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142, USA
Slide 109: Apply to Pitch at RESI
Apply to Pitch at RESI +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142, USA
Slide 110: Compliments of Life Science Nation
Compliments of Life Science Nation Life Science Nation is happy to offer these valuable insights: • Investability Report. Based on 12 years of teaching fundraising companies how to pitch, our genAI model asks you some questions, looks at your deck, and gives you an extensive SWOT analysis. Access it
Slide 111: What is JPM?
What is JPM? JPM = JP Morgan Healthcare Conference, but not really • Every year in San Fran (Union Square) in early Jan • It’s an ecosystem gathering, not a conference, no central organizer • Famous for: – Sky-high hotel prices – Walking all over Union Square – Receptions – Hotel room partnering – S
Slide 112: What JPM beginners need to know
What JPM beginners need to know • How to get meetings • How to network (other than partnering meetings) • How to find a place to stay • How to eat (and drink) • What to wear and your most important accessories +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142,
Slide 113: How to get meetings
How to get meetings • Sign up for partnering conferences • Reach out to your contacts • Reach out to good targets (need help with contact info?) • How to find good contacts • Start in November +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142, USA
Slide 114: How to network (other than partnering meetings)
How to network (other than partnering meetings) • Sign up for daytime events • Sign up for nighttime events • Hang out in the popular spots (Marriott Marquis, Hilton Union Square, etc.) • Have no fear +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142, USA
Slide 115: How to find a place to stay
How to find a place to stay • Book now • Consider AirBnBs • Consider staying a little further out (BART stops like Mission & 24th) +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142, USA
Slide 116: How to eat (and drink) on the cheap
How to eat (and drink) on the cheap • Sign up for daytime events • Sign up for nighttime events • Trader Joe’s across from Marriott Marquis +1 (617) 600-0668 | LifeScienceNation.com | One Broadway, 14th Floor, Cambridge, MA 02142, USA
Slide 117: What to wear and your most important accessories
What to wear and your most important accessories • Men: – slacks, collared shirt, sports coat/blazer/suit top – Comfortable shoes or ‘dress’ sneakers • Women – ? • Both – Umbrella – Backup shoes incase your first pair gets soaked • Don’t forget business cards +1 (617) 600-0668 | LifeScienceNation.co
Slide 118: Panel Discussion: Cross Functional Perspectives on Investor Readiness
Panel Discussion: Cross Functional Perspectives on Investor Readiness MODERATOR: Fran Brown, PhD Sougato Das Senior Vice President and Global Head of President & Chief Operating Drug Officer Life Science Nation Katya Tsaioun, PhD Tony Arulanandam, DVM, PhD CEO CEO & Founder Akttyva Therapeutics Syna
Slide 119: Thank you!
Thank you! Certara’s Certainty US 2027 – you are invited! Scan to pre-register for Certainty US 2027
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